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As
filed with the Securities and Exchange Commission on April 14, 2023
Registration
No. 333-256448
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
Oncotelic
Therapeutics, Inc.
(Formerly
Mateon Therapeutics, Inc.)
(Exact
name of Registrant as specified in its charter)
Delaware |
|
5417 |
|
13-3679168 |
(Incorporation |
|
(Primary
Standard Industrial |
|
(I.R.S.
Employer |
or organization) |
|
Classification
Code Number) |
|
Identification
Number) |
29397
Agoura Road, Suite 107 |
Agoura
Hills, CA 91301 |
|
(650)
635-7000 |
(Name,
address, telephone number of agent for service) |
|
Vuong
Trieu
Chief
Executive Officer
Oncotelic
Therapeutics, Inc.
29397
Agoura Road, Suite 107
Agoura
Hills, CA 91301
(650)
635-7000 |
(Address
and Telephone Number of Registrant’s Principal Executive Offices and Principal Place of Business) |
|
Communication
Copies to |
Jeff
Turner
JDT
Legal, PLLC
897
W Baxter Dr.
South
Jordan, UTAH 84095
Telephone:
(801) 810-4465
Facsimile:
(888) 920-1297
Email:
jeff@jdt-legal.com |
Approximate
date of proposed sale to the public: As soon as practicable and from time to time after the effective date of this Registration Statement.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, check the following box. ☒
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering.
If
this Form is a post-effective amendment filed pursuant to rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company”
in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☐ |
Smaller
reporting company |
☒ |
(Do
not check if a smaller reporting company) |
|
Emerging
Growth Company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
The
Registrant hereby may amend this registration statement on such date or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective
on such date as the Commission, acting pursuant to such Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed without notice. The Selling Security Holders may not sell these securities
until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell
these securities, and neither the Registrant nor the Selling Security Holders are soliciting offers to buy these securities, in any state
where the offer or sale of these securities is not permitted.
PRELIMINARY
PROSPECTUS |
SUBJECT
TO COMPLETION |
DATED
APRIL 14, 2023 |
ONCOTELIC
THERAPEUTICS, INC.
33,863,445
SHARES OF COMMON STOCK
This
prospectus relates to the resale of shares of our Common stock, par value $0.01 per share (the “Common Stock”), of an aggregate
of 33,863,445 Common Stock Shares pursuant to our May 3, 2021 Equity Purchase Agreement which may be offered by Peak One Opportunity
Fund, LP (“Peak One”) and Peak One Investments (“Peak One Investments) (the “EPA”), as follows: (a) up
to 29,878,445 Common Stock Shares to be issued to Peak One pursuant to put notices under the May 3, 2021 Equity Purchase Agreement with
Peak One; (b) 3,735,000 shares sold as of the date of this filing under the Equity Purchase Agreement with Peak One (c) 125,000 Commitment
Fee Shares issued to Peak One and Peak One Investments for an aggregate of 250,000 Commitment Fee Shares (Peak One Investments is the
General Partner of Peak One, both of which are Delaware corporations) and which Peak One and Peak One Investment have sold as of the
date of this filing; and (c) pursuant to Rule 416 under the Securities Act, an indeterminate number of shares of common stock that are
issuable upon stock splits, stock dividends, recapitalizations or other similar transactions affecting the shares of the selling stockholder.
The remaining amount of shares of Common Stock which
may be sold pursuant to this Prospectus would constitute 7.1% of the Company’s issued and outstanding Common Stock as of
April 12, 2023 (29,878,445 divided by current outstanding of 392,871,880 plus 29,878,445 for a total of 422,750,325,
which includes the 250,000 Commitment Fee Shares, and assuming that we sell all the remaining 29,878,445 shares to the selling security
holders (the “Selling Stockholders”).
Peak One and Peak One Investments are the Selling
Stockholders and are deemed to be each an “underwriter” within the meaning of the Securities Act of 1933, as amended (the
“Act”) and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters”
within the meaning of the Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents
and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or equivalent expenses and expenses
of legal counsel applicable to the sale of the shares.
Our Common Stock is subject to quotation the OTCQB
Market under the symbol “OTLC”. On April 13, 2023, the last reported sales price for our Common Stock was $0.041
per share. We urge prospective purchasers of our Common Stock to obtain current information about the market prices of our Common
Stock. We will not receive proceeds from the sale of shares of our Common Stock in the open market or negotiated prices by the Selling
Stockholders. However, we will receive cash proceeds from Peak One pursuant to Purchase Notices they issue to us. The Selling Stockholders
may offer all or part of the shares for resale from time to time through public or private transactions, at either prevailing market
prices or at privately negotiated prices. We provide more information about how the Selling Stockholders may sell its shares of common
stock in the section titled “Plan of Distribution” on page 34. We will pay for all expenses of this Offering, except that
the Selling Stockholders will pay fifty percent (50%) of any broker discounts or commissions or equivalent expenses and all expenses
of legal counsel applicable to the sale of the shares.
The prices at which the Selling Stockholders may sell
the shares of Common Stock in this Offering will be determined by the prevailing market prices for the shares of Common Stock or in negotiated
transactions.
Our independent registered public accounting firm
has expressed substantial doubt as to our ability to continue as going concern.
An investment in our common stock involves a high
degree of risk. You should purchase our common stock only if you can afford a complete loss of your purchase.
We urge you to read carefully the “Risk Factors”
section beginning on page 10 where we describe specific risks associated with an investment in these securities before you make your investment
decision.
Prior to this Offering, there has been a limited market
for our securities. While our common stock is quoted on OTC Markets, there has been limited trading volume of our stock. There is no guarantee
that an active trading market will develop in our securities.
This Offering is highly speculative, and these
securities involve a high degree of risk and should be considered only by persons who can afford the loss of their entire investment.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved these securities or determined
if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this Prospectus is April 14, 2023.
Explanatory
note
Oncotelic
Therapeutics, Inc. (the “Company”) is refiling this post-effective amendment for the registration statement under Form S-1
(the “Revised POS AM”) solely to correct a clerical error in the post-effective amendment for the registration statement
under Form S-1, previously filed on April 14, 2023 (the “Original POS AM”). The clerical error was the Report of Independent
Registered Public Accounting Firm filed with the Original POS AM only referred to the consolidated financial statements as of and for
the year ended December 31, 2022. A revised Report of Independent Registered Public Accounting Firm is included herein and covers the
consolidated financial statements as of and for the years ended December 31, 2022 and 2021.
No
attempt has been made in this Revised POS AM to otherwise modify or update the other disclosures presented in the Original POS AM.
This Revised POS AM does not reflect events occurring after the filing of the Original POS AM (i.e., those events occurring after
April 14, 2023) or modify or update those disclosures as may be affected by subsequent events. Such subsequent event matters shall
be appropriately addressed in subsequent reports filed with the Securities and Exchange Commission. Accordingly, this Revised POS AM
should be read in conjunction with the Original POS AM and the Company’s other filings with the Securities and Exchange
Commission. To further clarify, the Revised Form 10-K has only been modified for the following (1) the approval by the Directors
and Officers permitting the filing as of the date of the filing and (2) the revised Report of Independent Registered Public Accounting
Firm.
Table
of Contents
The
following table of contents has been designed to help you find information contained in this prospectus. We encourage you to read the
entire prospectus.
Please
read this Prospectus carefully and in its entirety. This Prospectus contains disclosure regarding our business, our financial condition
and results of operations and risk factors related to our business and our Common Stock, among other material disclosure items. We have
prepared this Prospectus so that you will have the information necessary to make an informed investment decision.
You
should rely only on information contained in this Prospectus. We have not authorized any other person to provide you with different information.
This Prospectus is not an offer to sell, nor is it seeking an offer to buy, these securities in any state where the offer or sale is
not permitted. The Selling Stockholder may not sell the securities listed in this Prospectus until the Registration Statement filed with
the Securities and Exchange Commission is effective. The information in this Prospectus is complete and accurate as of the date on the
front cover, but the information may have changed since that date.
The
Registration Statement containing this Prospectus, including the exhibits to the Registration Statement, provides additional information
about us and our Common Stock offered under this Prospectus. The Registration Statement, including the exhibits and the documents incorporated
herein by reference, can be read on the Securities and Exchange Commission website or at the Securities and Exchange Commission offices
mentioned under the heading “Where You Can Find More Information.”
PROSPECTUS
SUMMARY
You
should carefully read all information in the prospectus, including the financial statements and their explanatory notes under the Financial
Statements prior to making an investment decision.
This
summary highlights selected information appearing elsewhere in this prospectus. While this summary highlights what we consider to be
important information about us, you should carefully read this entire prospectus before investing in our Common Stock, especially the
risks and other information we discuss under the headings “Risk Factors”, our “Management’s Discussion and Analysis
of Financial Condition and Results of Operation” and our consolidated financial statements and related notes beginning on page
F-1. Our fiscal year end is December 31 and our audited financial statements for fiscal years ended December 31, 2022 and 2021
are included in this prospectus. Some of the statements made in this prospectus discuss future events and developments, including our
future strategy and our ability to generate revenue. These forward-looking statements involve risks and uncertainties which could cause
actual results to differ materially from those contemplated in these forward-looking statements. See “Special Note Regarding Forward-Looking
Statements” at page 10 of this Prospectus.
Except
as otherwise required by the context, references in this prospectus to “we,” “our,” “us” refer to
Oncotelic Therapeutics, Inc. Peak One Opportunity Fund, LP is referred to herein as “Peak One” or “Investor”
and Peak One Investments is referred to herein a “Peak One Investments”.
This
summary contains basic information about us and the offering. Because it is a summary, it does not contain all the information that you
should consider before investing. You should read the entire prospectus carefully, including the risk factors and our financial statements
and the related notes to those statements included in this prospectus.
We
have not authorized anyone to provide you with different information and you must not rely on any unauthorized information or representation.
We are not making an offer to sell these securities in any jurisdiction where an offer or sale is not permitted. This document may only
be used where it is legal to sell these securities. You should assume that the information appearing in this prospectus is accurate only
as of the date on the front of this prospectus, regardless of the time of delivery of this prospectus, or any sale of our common stock.
Our business, financial condition and results of operations may have changed since the date on the front of this prospectus. We urge
you to carefully read this prospectus before deciding whether to invest in any of the common stock being offered.
Overview
We
are a clinical-stage biopharmaceutical company developing drugs for the treatment of orphan oncology indications, developing antisense
and small molecule injectable drugs for the treatment of cancer. After the acquisition of Mateon Therapeutics, Inc through a reverse
merger in 2019, we realigned the company pipeline to focus on rare pediatric cancers. The United States Food and Drug Administration
(“FDA”) has granted us Rare Pediatric Designations (“RPD”) for pediatric Diffuse Intrinsic Pontine
Glioma (“DIPG”) for OT-101, pediatric melanoma for CAP4 and acute myeloid leukemia (“AML”) for
Oxi4503. This strategy aims to capitalize on a voucher program in the United States (“US”). By focusing on RPD we
anticipate: 1) reducing the cost of clinical development by way of a smaller and faster clinical trial, 2) acceleration of the approval
process and final approval, 3) obtaining regulatory/ marketing exclusivity for up to 12 years as a biologic, and 4) obtaining vouchers
worth a significantly large value on regulatory approval, which can be upwards of several million dollars. Approval in US would allow
for approval in the rest of the world (“ROW”) using the US dossier. Phase 3 clinical trials for approval in adult
indications will be conducted following the positive interim read of the pediatric trials. This approach maximize return on investment
for the shareholders.
Concurrently
we also explore opportunity to create values for shareholders by forming strategic alliances and/or licensing our product portfolio.
The Company entered into a joint venture (“JV”) with Dragon and GMP Bio, affiliates of GMP in
March 2022. GMP Bio and the Company are also looking to take the JV into an initial public offering (“IPO”) of the
JV and which is anticipated to be a liquidity event for Company, especially if the IPO is successful. While we believe that the IPO can
be completed and would be successful, we cannot provide assurance for either of the events to occur; or if they occur, then they
would be successful.
As
a result of the reverse merger of Oncotelic and Oncotelic Inc. in April 2019 and the acquisition of PointR in November 2019, respectively,
we believe we are well positioned as a biotech company with: (1) Oncotelic Inc.’s antisense platform with our drug candidate OT-101
through our JV- targeting high value TGF-β2 target for various cancers and COVID-19, (2) PointR artificial intelligence (“AI”)
for clinical trials, research and development, (3) Edgepoint for developing technologies for manufacturing and for developing technologies
for supporting our COVID-19 programs, (4) Artemisinin for COVID-19, (5) the Company’s vascular disruptor proven safe in more than
500 patients capable of causing massive antigen release which would stimulate immune response against the cancerous tumor and (6) apomorphine,
which we in-licensed in 2021, for developing against Parkinson’s Disease (“PD”), erectile disfunction (“ED”)
and female sexual disfunction (“FSD”). Since the JV is formed with GMP Bio, we will now plan to accelerate the development
of apomorphine as our flagship drug candidate.
We
will also be developing OT-101, also through our JV, an antisense against TGF-β2 – for the treatment
of various viruses, including the severe acute respiratory syndrome (“SARS”) and the current coronavirus (“COVID-19”),
on its own and in conjunction with other compounds. Viral replication cannot occur without TGF-β; and TGF-β surge and a cytokine
storm cannot occur without TGF-β. A Phase 2 trial was completed for OT-101 in South America. This was a randomized, double-blind,
placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with positive
COVID-19 and pneumonia.
Based
on the final results of the trial, the trial can expand into a Phase 3 trial if there is a need, as an example in the event of a resurgence
in COVID-19 cases. In the meantime, we are conducting an observational study, looking at OT-101 and long COVID-19, in conjunction with
BARDA.
In
addition, during 2020 and 2021, the Company was developing Artemisinin as a potential therapy for the virus causing COVID-19 (“SARS-CoV-2”).
Artemisinin, purified from the plant Artemisia annua. It can inhibit TGF-β activity and is able to neutralize COVID-19.
The Company initially conducted a study and the test results during an in vitro study at Utah State University showed Artemisinin having
an EC50 of 0.45 ug/ml, and a Safety Index of 140. Artemisinin can target multiple viral threats, including COVID-19, by suppressing both
viral replication and clinical symptoms that arise from viral infection. Viral replication cannot occur without TGF-β. In a clinical
study undertaken in India called ARTI-19, clinical consequences related to the TGF-β surge, including ARDS and cytokine storm, were
suppressed by targeting TGF-β with Artemisinin. The ARTI-19 trials were conducted in India by Windlas Biotech Limited (“Windlas”),
the Company’s business partner in India. Windlas had applied for regulatory approval for it’s Artemisinin based product,
ArtiShieldTM, but has not been able to obtain regulatory approval for use of ArtiShieldTM as a COVID-19 therapy
and as such, no significant revenues have been reported by Windlas nor have we accrued any royalties on Artemisinin due from Windlas.
We intend to focus future development on Artemisinin against other respiratory viruses with unmet needs but do not know how successful
we will be with those efforts as the incidence of COVID-19 has reduced substantially over the past couple years.
In
September 2021, Oncotelic entered into an exclusive License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”),
pursuant to which Autotelic granted Oncotelic, among other things: (i) the exclusive right and license to certain Autotelic Patents (as
defined in the Agreement) and Autotelic Know-How (as defined in the Agreement); and (ii) a right of first refusal to acquire at least
a majority of the outstanding capital stock of Autotelic prior to Autotelic entering into any transaction that is a financing collaboration,
distribution revenues, earn-outs, sales, out-licensing, purchases, debt, royalties, merger acquisition, change of control, transfer of
cash or non-cash assets, disposition of capital stock by way of tender or exchange offer, partnership or any other joint or collaborative
venture, research collaboration, material transfer, sponsored research or similar transaction or agreements. In exchange for the rights
granted to Oncotelic, Autotelic will be entitled to earn the milestone payments. This transaction brings in AL-101 - an intranasal apomorphine
asset with clear 505(b)2 pathway to approval for PD as well unique mechanism of action for treatment of ED and FSD.
We
currently have eight primary drug and AI technology programs we are seeking to advance:
|
● |
Intranasal
drug and delivery system for intra-nasal Apomorphine for the treatment of PD, ED and FSD. |
|
|
|
|
● |
OT-101
- an antisense against TGF-β2 – for the treatment of solid tumors with focus on brain cancer in adult and DIPG in children.
A RPD for pediatric DIPG has been granted by US FDA. This is being advanced through our JV. |
|
|
|
|
● |
OT-101
- an antisense against TGF-β2 –for the treatment of various viruses, including the SARS and the current COVID-19, on its
own and in conjunction with other compounds. |
|
|
|
|
● |
Artemisinin
– a natural derivative from an Asian herb Artemisia Annua - Artemisinin has shown to be highly potent at inhibiting the ability
of the COVID-19 causing virus to multiply while also having an excellent safety index as well as against hepatitis B and C viruses,
human herpes viruses, HIV-1, influenza virus A, and bovine viral diarrhea virus in the low micromolar range. |
|
|
|
|
● |
CA4P-
a vascular disrupting agent (“VDA”) - in combination with Ipilimumab for the treatment of solid tumors with focus on
melanoma in adult and pediatric melanoma. A RPD has been granted to the Company by the FDA for pediatric melanoma. |
|
|
|
|
● |
Oxi4503-
a second generation VDA - for the treatment of liquid tumors with focus on childhood leukemia. A RPD has been granted to the Company
by the FDA for AML. |
|
|
|
|
● |
Backoffice
support using PointR fabric cluster computing grids for blockchain/AI for pharmaceutical manufacturing and clinical trials and monitoring;
and PointR AI for drug development through various stages of development. |
|
|
|
|
● |
Developing
AI based technologies to enhance the development and commercialization of our Artemisinin
based products and support technologies. Further, as part of the JV Agreement, the JV
has acquired a non-exclusive license for the AI platform developed by PointR/EdgePoint for
implementation in a planned CDMO.
In
addition, the Company formed a Decentralized autonomous organization (“DAO”)
entity, Pet2DAO, Inc. (“Pet2DAO”), as a wholly owned subsidiary. A DAO
is an emerging form of legal structure, that has no central governing body, and whose members
share a common goal to act in the best interest of the entity. Pet2DAO is a DAO technology
company, integrating the strong governance of traditional corporations with the innovative
DAO architecture. The Company will look to engage stakeholders, to build value through the
DAO, while maintaining the rigor of traditional corporations, including governance, compliance,
and accountability through a team of veterans in public companies with innovators in AI,
blockchain and Web3. Pet2DAO will initially be looking to develop products for the animal
health space. The Company will initially issue regular tokens and non-fungible tokens (“NFT”
and cumulatively “Tokens”) of Pet2DAO called PDAO to its employees, shareholders
and key opinion leaders (“KOLs’) and use the Tokens to propose and vote
on various animal health related programs. In the future, the Company will evaluate and plan
to register these tokens with the SEC to make such Tokens freely tradable at a future point
in time. |
Corporate
History
Oncotelic
Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) (“Oncotelic”), was formed in the State of New York in 1988 as
OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic
Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly-owned subsidiaries, Oncotelic,
Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO, Inc., a Delaware corporation
and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic,
Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”).
The Company is currently developing OT-101 for various cancers and COVID-19 through its joint venture, GMP Biotechnology Limited (“GMP
Bio”), with Dragon Overseas, Limited (“Dragon”), Artemisinin for COVID-19 and AI technologies for clinical
development and manufacturing. The Company has acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual
dysfunction. In addition, the Company is evaluating the further development of its product candidates OXi4503 as a treatment for acute
myeloid leukemia and myelodysplastic syndromes and CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic
melanoma. The Company is also planning to address the animal health industry through Pet2DAO. Our principal corporate office is
in the United States at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 (telephone: 650-635-7000). Our internet address is www.oncotelic.com.
Amendments
to Certificate of Incorporation
In
March 2021, the Company received approval from the Financial Industry regulatory Authority (“FINRA”) on its
notice of corporate action to change the name of the Company from Mateon Therapeutics, Inc. to Oncotelic Therapeutics, Inc, and
the Company’s ticker symbol has changed from “MATN” to “OTLC”.
In
January 2021, the Company filed an additional amendment to its Certificate of Incorporation, as amended (the “Charter Amendment”),
with the Secretary of State for the State of Delaware, which Charter Amendment went effective immediately upon acceptance by the Secretary
of State for the State of Delaware. The Charter Amendment increased the number of authorized shares of Common Stock from 150,000,000
shares to 750,000,000 shares.
In
addition, the Company registered an additional total of 20,000,000 shares of its Common Stock, which may be issued pursuant to the Company’s
Amended and Restated 2015 Equity Incentive Plan (the “Plan”). As such, the total number of shares of the Company’s
Common Stock available for issuance under the 2015 plan is 27,250,000.
Summary
of Risk Factors
This
Offering, which provides for the registration of Shares by Peak One and Peak One Investments as the Selling Stockholders and the subsequent
public resale of such shares, involves substantial risk. Our ability to execute our business strategy is also subject to certain risks.
The risks described under the heading “Risk Factors” included elsewhere in this Prospectus may cause us not to realize the
full benefits of our business plan and strategy or may cause us to be unable to successfully execute all or part of our strategy. Some
of the most significant challenges and risks are:
|
● |
We
may encounter difficulties in expanding our operations successfully, if and when we evolve from a company that is primarily involved
in clinical development to a company that is also involved in commercialization. |
|
● |
We
will need substantial additional funding to continue our operations, which could result in dilution to our stockholders. |
|
● |
If
physicians and patients do not accept our future products or if the market for indications for which any product candidate is approved
is smaller than expected, we may be unable to generate significant revenue, if any. |
|
● |
The
Equity Purchase Agreement with Peak One may cause material dilution to our existing stockholders |
|
● |
Our
stock price may decline because Peak One will pay less than the then-prevailing market price of our common stock. |
|
● |
An
investment in our shares is highly speculative. |
|
● |
We
may not have access to the full $10,000,000 amount of the Equity Purchase Agreement. |
Before
you invest in our Common Stock, you should carefully consider all the information in this Prospectus, including matters set forth under
the heading “Risk Factors.”
Where
You Can Find Us
Our
principal executive office and mailing address and phone number are 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301, (650) 635-7000.
Our
Filing Status as a “Smaller Reporting Company”
We
are a “smaller reporting company,” meaning that we are not an investment company, an asset-backed issuer, or a majority-owned
subsidiary of a parent company that is not a smaller reporting company and have a public float of less than $75 million and annual revenues
of less than $50 million during the most recently completed fiscal year. As a “smaller reporting company,” the disclosure
we will be required to provide in our Securities and Exchange Commission (“SEC”) filings are less than it would be if we
were not considered a “smaller reporting company.” Specifically, “smaller reporting companies” are able to provide
simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley
Act of 2002 requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal
control over financial reporting; are not required to conduct say-on-pay and frequency votes until annual meetings occurring on or after
January 21, 2013; and have certain other decreased disclosure obligations in their SEC filings, including, among other things, being
permitted to provide two years of audited financial statements in annual reports rather than three years. Decreased disclosures in our
SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our results of
operations and financial prospects.
For
more details regarding this exemption, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations
- Critical Accounting Policies and Significant Judgments and Estimates.”
SUMMARY
OF FINANCIAL INFORMATION
The
following summary consolidated statements of operations data for the fiscal year ended December 31, 2022 and December 31, 2021
have been derived from our audited consolidated financial statements and notes included elsewhere in this prospectus. The historical
financial data presented below is not necessarily indicative of our financial results in future periods, and the results for the full
fiscal year ended December 31, 2022 is not necessarily indicative of our operating results to be expected for the full fiscal
year ending December 31, 2023 or any other period. You should read the summary consolidated financial data in conjunction with
those financial statements and the accompanying notes and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations.” Our consolidated financial statements are prepared and presented in accordance with United States generally
accepted accounting principles, or U.S. GAAP. Our consolidated financial statements have been prepared on a basis consistent with our
audited financial statements for the year ended December 31, 2022 and December 31, 2021 and include all adjustments, consisting
of normal and recurring adjustments that we consider necessary for a fair presentation of the financial position and results of operations
as of and for such periods.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
| |
December 31, | | |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 241,452 | | |
$ | 568,769 | |
Restricted cash | |
| 20,000 | | |
| 20,000 | |
Accounts receivable | |
| 19,748 | | |
| 19,748 | |
Prepaid & other current assets | |
| 21,964 | | |
| 18,778 | |
| |
| | | |
| | |
Total current assets | |
| 303,164 | | |
| 627,295 | |
| |
| | | |
| | |
Intangibles, net of accumulated amortization of $201,180 and $188,339 as of Dec 31, 2022 and 2021 | |
| - | | |
| 821,841 | |
In process R&D | |
| 1,101,760 | | |
| 1,101,760 | |
Goodwill, net of impairment | |
| 12,071,376 | | |
| 21,062,455 | |
Investment in GMP Bio at fair value | |
| 22,640,519 | | |
| - | |
Total assets | |
$ | 36,116,819 | | |
$ | 23,613,351 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 2,510,864 | | |
$ | 3,092,723 | |
Accounts payable - related party | |
| 332,432 | | |
| 403,423 | |
Contingent consideration | |
| 2,625,000 | | |
| 2,625,000 | |
Derivative liability on notes | |
| 198,140 | | |
| 340,290 | |
Convertible and short-term debt, net of costs | |
| 10,091,923 | | |
| 8,166,622 | |
Convertible debt and short-term debt - related party, net of costs | |
| 1,165,048 | | |
| 826,862 | |
| |
| | | |
| | |
Total current liabilities | |
| 16,923,407 | | |
| 15,454,920 | |
| |
| | | |
| | |
Commitments and contingencies (Note 13) | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Convertible Preferred stock, $0.01 par value, 15,000,000 shares authorized; 0 and 278,188 shares issued and outstanding | |
| - | | |
| - | |
Common stock, $.01
par value; 750,000,000 shares authorized;
391,846,880 and 375,288,146
issued and outstanding, respectively | |
| 3,918,469 | | |
| 3,752,881 | |
Additional paid-in capital | |
| 41,416,632 | | |
| 35,223,842 | |
Accumulated deficit | |
| (25,926,069 | ) | |
| (31,021,050 | ) |
| |
| | | |
| | |
Total Oncotelic Therapeutics, Inc. stockholders’ equity | |
| 19,409,032 | | |
| 7,955,673 | |
Non-controlling interests | |
| (215,620 | ) | |
| 202,758 | |
| |
| | | |
| | |
Total stockholders’ equity | |
| 19,193,412 | | |
| 8,158,431 | |
Total liabilities and stockholders’ equity | |
$ | 36,116,819 | | |
$ | 23,613,351 | |
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
| |
2022 | | |
2021 | |
| |
For the Year Ended
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Operating expenses: | |
| | | |
| | |
Research and development | |
$ | 756,910 | | |
$ | 3,658,617 | |
General and administrative | |
| 4,853,664 | | |
| 5,467,266 | |
Goodwill impairment (See note 2 and 3) | |
| 4,111,079 | | |
| - | |
Total operating expenses | |
| 9,721,653 | | |
| 9,125,883 | |
| |
| | | |
| | |
Loss from operations | |
| (9,721,653 | ) | |
| (9,125,883 | ) |
Other income (expense): | |
| | | |
| | |
Interest expense, net | |
| (2,971,046 | ) | |
| (2,002,813 | ) |
PPP loan forgiveness | |
| - | | |
| 346,761 | |
Gain on derecognition of non-financial asset | |
| 16,951,477 | | |
| - | |
Reimbursement for expenses - related party | |
| 533,485 | | |
| - | |
Change in fair value of derivative on debt | |
| 142,150 | | |
| 292,149 | |
Loss on debt conversion | |
| (257,810 | ) | |
| (27,504 | ) |
Total other income (expense) | |
| 14,398,256 | | |
| (1,391,407 | ) |
Net income (loss) before non-controlling interests | |
| 4,676,603 | | |
| (10,517,290 | ) |
Net loss attributable to non-controlling interests | |
| (418,378 | ) | |
| (1,126,248 | ) |
Net income (loss) attributable to Oncotelic Therapeutics, Inc. | |
$ | 5,094,981 | | |
$ | (9,391,042 | ) |
| |
| | | |
| | |
Basic net income (loss) per share attributable to common stock | |
$ | 0.01 | | |
$ | (0.03 | ) |
Basic weighted average common stock outstanding | |
| 384,075,369 | | |
| 303,078,548 | |
| |
| | | |
| | |
Diluted net income (loss) per share attributable to common stock | |
$ | 0.01 | | |
$ | (0.03 | ) |
Diluted weighted average common stock outstanding | |
| 457,299,890 | | |
| 303,078,548 | |
Special
Note Regarding Forward-Looking Statements
The
information contained in this Prospectus, including in the documents incorporated by reference into this Prospectus contains forward-looking
statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange
Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such
as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,”
“would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,”
“predict,” “potential,” “seek,” “indicate,” or “continue” or the negative
of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include,
but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding
the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected
expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for
and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially
desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise
the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors
and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become
obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products
and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for
supporting the development of OT-101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P
and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research
and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other
limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization
of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures
or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners
for the joint venture: building and the success of our nanoparticle platform and the related success of launching the platform, the success
of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal
health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of
the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement,
the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain
orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our
ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize
our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance
and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials;
our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon
the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such
exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint
ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential
markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the
volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects
of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future;
our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental
third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic
and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct
or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery
plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated
by reference herein or therein.
The
forward-looking statements contained in this document are based on our current expectations and beliefs concerning future developments
and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated.
These forward-looking statements involve several risks, uncertainties (many of which are beyond our control) or other assumptions that
may cause actual results or performance to be materially different from those expressed or implied by these “forward-looking statements.”
Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may
vary from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward- looking statements,
whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. The sections
captioned “Risk Factors” as well as other sections in this document or incorporated by reference into this document discuss
some of the factors that could contribute to these differences.
The
forward-looking statements made in this document relate only to events as of the date on which the statements are made. We undertake
no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made
or to reflect the occurrence of unanticipated events.
RISK
FACTORS
The
shares of our Common Stock being offered for resale by the Selling Shareholders are highly speculative in nature, involve a high degree
of risk and should be purchased only by persons who can afford to lose their entire amount invested in the Common Stock. Accordingly,
prospective investors should carefully consider, along with other matters referred to herein, the following risk factors in evaluating
our business before purchasing any shares of Common Stocks. If any of the following risks actually occurs, our business, financial condition
or operating results could be materially adversely affected. In such case, you may lose all or part of your investment. In addition to
the risk factors described below, and some of which are part of our 2022 Annual Report on Form 10-K filed with the SEC on April
14, 2023, you should carefully consider the risks and the other information in this Prospectus before investing in our
Common Stock.
Risks
Related to Our Business
If
we are unable to obtain additional funding, we may be forced to cease operations.
We
have experienced net losses every year since inception. In April 2019, the Company entered into an Agreement and Plan of Merger with
Oncotelic Inc. for developing investigational drugs for the treatment of orphan oncology indications. The Company completed the Merger
and Oncotelic Inc. became a wholly-owned subsidiary of the Company. The Merger was treated as a recapitalization and reverse acquisition
for financial accounting purposes. Oncotelic was considered the acquirer for accounting purposes, and the Company’s historical
financial statements before the Merger were been replaced with the historical financial statements of Oncotelic Inc. prior to the Merger
in the financial statements and filings with the Securities and Exchange Commission.
The
Company, as of December 31, 2022, had an
accumulated deficit of approximately $25.9 million, including a net income of approximately $5.1 million in 2022 related to
approximately $16.9 million non-cash gain on derecognition of non-financial asset related to the JV and offset by a non-cash impairment
of goodwill of approximately $4.1 million. We have no source of product revenue and do not expect to receive any product revenue
in the near future, except if we generate product revenues from Artemisinin in countries around the globe other than India and which
at the current time is not anticipated. We may generate revenues from services rendered in the future, but we cannot expect that to be
of a regular and of recurring nature. If we remain in business, we expect to incur additional operating losses over the next several
years, principally as a result of our plans to continue clinical trials for our investigational drugs. As of December 31, 2022,
we had approximately $0.3 million in cash and current liabilities of approximately $16.9 million, of which $1.3 million
pertains to Mateon’s liabilities prior to the Merger and $2.6 million of contingent liabilities, incurred upon our merger
with PointR Data, Inc. in November 2019, that would be issuable in shares of common stock of the Company to the PointR shareholders upon
satisfaction of certain conditions. Based on our planned operations, we expect our cash to only support our operations for a short period
of time. Therefore, we will need to secure near-term funding, or we will be forced to curtail or terminate operations. Because
we do not currently have a guaranteed source of capital that will sustain operations for at least the next twelve months, Management
has determined that there is substantial doubt about our ability to continue as a going concern.
The
principal source of our working capital to date has been the proceeds from the sale of equity and debt, a substantial portion of which
has been provided by officers and certain insiders. If we are unable to access additional funds in the near term, whether through the
sale of additional equity, debt or another means, we may not be able to continue in business. We also may not be able to continue the
development of our investigational drugs. Any additional equity or debt financing, if available to us, may not be available on favorable
terms and would most likely be dilutive to stockholders. Any debt financing, if available, may involve restrictive covenants and also
be dilutive to current stockholders. If we obtain funds through collaborative or licensing arrangements, we may be required to relinquish
rights to some of our technologies or product candidates on terms that are not favorable to us. Our ability to access capital when needed
is not assured.
In
their audit report with regard to our financial statements as of December 31, 2022, we as well as our independent registered public
accountants have expressed an opinion that substantial doubt exists as to whether we can continue as a going concern. Because we have
limited cash resources, we believe that it will be necessary for us to either raise additional capital in the near term or to enter into
a license or other agreement with a larger pharmaceutical company. If we do not succeed in doing so, we may be required to suspend or
cease our business, which would likely materially harm the value of our common stock.
Due
in part to our limited financial resources, we may fail to select or capitalize on the most scientifically, clinically or commercially
promising or profitable indications or therapeutic areas for our product candidates, and we may be unable to pursue and complete the
clinical trials that we would like to pursue and complete.
We
have limited financial and technical resources to determine the indications on which we should focus the development efforts for our
product candidates. Due to our limited available financial resources, we have curtailed clinical development programs and activities
that might otherwise have led to more rapid progress of our product candidates through the regulatory and development processes. We currently
have insufficient financial resources to complete any additional drug development work.
If
we are able to raise funds and continue developing investigational drugs for cancer, we may make incorrect determinations with regard
to the indications and clinical trials on which to focus the available resources that we do have. Furthermore, we cannot assure you that
we will be able to retain adequate staffing levels to run our operations and/or to accomplish all the objectives that we otherwise
would seek to accomplish. The decisions to allocate our research, management and financial resources toward particular indications or
therapeutic areas for our product candidates may not lead to the development of viable commercial products and may divert resources from
better opportunities. Similarly, our decisions to delay or terminate drug development programs may also cause us to miss valuable opportunities.
In addition, from time to time, we may in-license or otherwise acquire product candidates to supplement our internal development activities.
Those activities may use resources that otherwise would have been devoted to our internal programs, and with research and development
programs there is no way to assure that the outcome of any trials or other activities will be positive, whether the program was internally
generated or in-licensed.
We
may encounter difficulties in expanding our operations successfully if and when we evolve from a company that is primarily involved in
clinical development to a company that is also involved in commercialization.
As
we advance our product candidates through later stages of clinical trials, we will need to expand our development, regulatory, manufacturing,
marketing and sales capabilities or contract with third parties to provide these capabilities for us. As our operations expand, we expect
that we will need to manage additional relationships with such third parties, as well as additional collaborators, distributors, marketers
and suppliers.
Maintaining
third party relationships for these purposes will impose significant added responsibilities on members of our management and other personnel.
We must be able to manage our development efforts effectively, manage our participation in the clinical trials in which our product candidates
are involved effectively, and improve our managerial, development, operational and finance systems, all of which may impose a strain
on our administrative and operational infrastructure.
If,
following any approval of our product candidates, we enter into arrangements with third parties to perform sales, marketing or distribution
services, any product revenues that we receive, or the profitability of these product revenues to us, are likely to be lower than if
we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements
with third parties to sell and market our products or in doing so on terms that are favorable to us. We likely will have little control
over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively.
If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will
not be successful in commercializing our products.
If
we were to submit an NDA for our drug candidates in the United States or a marketing application in the EU, we would need to undertake
commercial scale manufacturing activities at significant expense to us in order to proceed with the application for approval for commercialization.
We or our external vendors may encounter technical difficulties that preclude us from successfully manufacturing the required registration
and validation batches of active pharmaceutical ingredient, or API, and/or drug product and we may be unable to recover any financial
losses associated with the manufacturing activities. Further, our research or product development efforts may not be successfully completed,
any compounds currently under development by us may not be successfully developed into drugs, any potential products may not receive
regulatory approval on a timely basis, if at all, and competitors may develop and bring to market products or technologies that render
our potential products obsolete. If any of these problems occur, our business would be materially and adversely affected.
We
may not be able to partner with other pharmaceutical companies or even form any types of alliances with third parties.
As
we plan to advance our product candidates through later stages of clinical trials but with lack of adequate capital resources, we will
need to form alliances or enter into partnerships with other pharmaceutical companies or even other third parties. We cannot assure you
that we would be able to do so at terms beneficial to the Company or at all.
We
may not be able to successfully set up an IPO with third parties.
As
we plan to advance our product candidates through later stages of clinical trials but with lack of adequate capital resources, we will
need to form alliances or enter into partnerships with other pharmaceutical companies or even other third parties and create shareholder
value, including through IPOs. We cannot assure you that we would be able to do so at terms beneficial to the Company or at all. While
the Company has formed a joint venture with Dragon Overseas and GMP Bio, and taking that through an IPO, there can be no assurances that
such IPO will be made or will be successful.
We
have no manufacturing capacity and have relied on, and expect to continue to rely on, third-party manufacturers to produce our product
candidates.
We
do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates or any
of the compounds that we are testing in our preclinical programs, and we lack the resources and the capabilities to do so. As a result,
we currently rely, and we expect to rely for the foreseeable future, on third-party manufacturers to supply our product candidates. Reliance
on third-party manufacturers entails risks to which we would not be subject if we manufactured our product candidates or products ourselves,
including:
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reliance
on third-parties for manufacturing process development, regulatory compliance and quality assurance; |
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limitations
on supply availability resulting from capacity and scheduling constraints of third-parties; |
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the
possible breach of manufacturing agreements by third-parties because of factors beyond our control; and |
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the
possible termination or non-renewal of the manufacturing agreements by the third-party, at a time that is costly or inconvenient
to us. |
If
we do not maintain our developed important manufacturing relationships, we may fail to find replacement manufacturers or develop our
own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our products and substantially
increase our costs or deplete profit margins, if any. If we do find replacement manufacturers, we may not be able to enter into agreements
with them on terms and conditions favorable to us, and there could be a substantial delay before new facilities could be qualified and
registered with the FDA, EMA and other foreign regulatory authorities.
The
FDA, EMA and other foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding
foreign regulators also inspect these facilities to confirm compliance with current good manufacturing practices, or cGMPs. Contract
manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation
where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements
or other FDA, EMA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability
to develop our product candidates and market our products after approval.
Our
current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our ability
to develop our product candidates, our ability to commercialize any products that receive regulatory approval and our potential future
profit margins on these products.
Our
product candidates have not completed clinical trials, and may never demonstrate sufficient safety and efficacy in order to do so.
Our
product candidates are in the clinical stage of development. In order to achieve profitable operations, we alone or in collaboration
with others, must successfully develop, manufacture, introduce and market our products. The time frame necessary to achieve market success
for any individual product is long and uncertain. The products currently under development by us may require significant additional research
and development and additional preclinical and clinical testing prior to application for commercial use. A number of companies in the
biotechnology and pharmaceutical industries have suffered significant setbacks in clinical trials, even after showing promising results
in early or later-stage studies or clinical trials. Although we have obtained some favorable results to date in preclinical studies and
clinical trials of certain of our potential products, such results may not be indicative of results that will ultimately be obtained
in or throughout such clinical trials, and clinical trials may not show any of our products to be safe or capable of producing a desired
result. Additionally, we may encounter problems in our clinical trials that may cause us to delay, suspend or terminate those clinical
trials.
Adverse
events observed to date and associated with CA4P and OXi4503 have generally been found to be manageable for drugs treating the indications
for which we are developing our product candidates. However, we will be required to continue to test and evaluate the safety of our product
candidates in additional clinical trials, and to demonstrate their safety to the satisfaction of appropriate regulatory agencies, as
a condition to receipt of any regulatory approvals. In clinical trials to date, transient hypertension believed to be associated with
CA4P and OXi4503 has been effectively managed through pre-treatment with anti-hypertensive medication. We cannot assure you, however,
that we will be able to make the necessary demonstrations of safety to allow us to receive regulatory approval for our product candidates
in any indication.
We
only have a limited number of employees to manage and operate our business.
We had twenty-two full-time employees and
consultants as of April 12, 2023 however, all the employees and consultants, other than Dr. Maida who was partially compensated
through the Company up to March 2022, were compensated from our JV from February 2022 onwards. We rely on consultants and
professionals to augment our staffing needs. Our limited financial resources require us to manage and operate our business in a
highly efficient manner. We cannot assure you that we will be able to retain adequate staffing levels to run our operations and/or
to accomplish all of the objectives that we otherwise would seek to accomplish.
We depend on our executive officers and principal
consultants and the loss of their services could materially harm our business.
We believe that our success depends, and will likely
continue to depend, upon our ability to retain the services of our current executive officers, particularly our Chief Executive Officer,
Chief Technology Officer, Chief Business Officer, Chief Medical Officer, Chief Regulatory Officer and Chief Financial Officer,
our principal consultants and others. This increases the risk that we may not be able to retain their services. The loss of the services
of any of these individuals could have a material adverse effect on our business. In addition to these key service providers, we have
established relationships with universities, hospitals and research institutions, which have historically provided, and continue to provide,
us with access to research laboratories, clinical trials, facilities and patients. Additionally, we believe that we may, at any time
and from time to time, materially depend on the services of consultants and other unaffiliated third parties. We cannot assure you that
consultants and other unaffiliated third parties will provide the level of service to us that we require in order to achieve our business
objectives.
Our
industry is highly competitive, and our product candidates may become obsolete.
We
are engaged in a rapidly evolving field. Competition from other pharmaceutical companies, biotechnology companies and research and academic
institutions is intense and likely to increase. Many of those companies and institutions have substantially greater financial, technical
and human resources than we do. Many of those companies and institutions also have substantially greater experience in developing products,
conducting clinical trials, obtaining regulatory approval and in manufacturing and marketing pharmaceutical products. Our competitors
may succeed in obtaining regulatory approval for their products more rapidly than we do. Competitors have developed or are in the process
of developing technologies that are, or in the future may be, the basis for competitive products. Some of these competitive products
may have an entirely different approach or means of accomplishing the desired therapeutic effect than products being developed by us.
Our competitors may succeed in developing products that are more effective and/or cost competitive than those we are developing, or that
would render our product candidates less competitive or even obsolete. In addition, one or more of our competitors may achieve product
commercialization or patent protection earlier than we do, which could materially adversely affect us.
If
clinical trials or regulatory approval processes for our product candidates are prolonged, delayed or suspended, we may be unable to
out-license or commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay or
prevent our receipt of any proceeds from potential license agreements or product sales.
We
cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or
any regulatory authority to delay or suspend those clinical trials or delay or invalidate the analysis of data derived from them. A number
of events, including any of the following, could delay the completion of our other ongoing and planned clinical trials and negatively
impact our ability to obtain regulatory approval for, and to market and sell, a particular product candidate:
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conditions
imposed on us by the FDA, EMA or another foreign regulatory authority regarding the scope or design of our clinical trials; |
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delays
in obtaining, or our inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical
sites selected for participation in our clinical trials; |
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insufficient
supply of our product candidates or other materials necessary to conduct and complete our clinical trials; |
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slow
enrollment and retention rate of subjects in clinical trials; |
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any
compliance audits and pre-approval inspections by the FDA, EMA or other regulatory authorities; |
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negative
or inconclusive results from clinical trials, or results that are inconsistent with earlier results; |
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serious
and unexpected drug-related side effects; and |
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failure
of our third-party contractors to comply with regulatory requirements or otherwise meet their contractual obligations to us. |
Commercialization
or licensure of our product candidates may be delayed or prevented by the imposition of additional conditions on our clinical trials
by the FDA, EMA or another foreign regulatory authority or the requirement of additional supportive clinical trials by the FDA, EMA or
another foreign regulatory authority. In addition, clinical trials require sufficient patient enrollment, which is a function of many
factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites,
the availability of effective treatments for the relevant disease, the conduct of other clinical trials that compete for the same patients
as our clinical trials, and the eligibility criteria for our clinical trials. Our failure to enroll patients in our clinical trials could
delay the completion of the clinical trial beyond our expectations, or it could prevent us from being able to complete the clinical trial.
In addition, the FDA and EMA could require us to conduct clinical trials with a larger number of subjects than we have projected for
any of our product candidates. We may not be able to enroll a sufficient number of patients in a timely or cost-effective manner. Furthermore,
enrolled patients may drop out of our clinical trials, which could impair the validity or statistical significance of the clinical trials.
We
do not know whether our clinical trials will begin as planned, will need to be restructured, or will be completed on schedule, if at
all. Delays in our clinical trials will result in increased development costs for our product candidates, and our financial resources
may be insufficient to fund any incremental costs. In addition, if our clinical trials are delayed, our competitors may be able to bring
products to market before we do and the commercial viability of our product candidates could be limited.
If
physicians and patients do not accept our future products or if the market for indications for which any product candidate is approved
is smaller than expected, we may be unable to generate significant revenue, if any.
Even
if any of our product candidates obtain regulatory approval, they may not gain market acceptance among physicians, patients, and third-party
payers. Physicians may decide not to prescribe our drugs for a variety of reasons including:
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timing
of market introduction of competitive products; |
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demonstration
of clinical safety and efficacy compared to other products; |
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cost-effectiveness; |
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limited
or no coverage by third-party payers; |
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convenience
and ease of administration; |
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prevalence
and severity of adverse side effects; |
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restrictions
in the label of the drug; |
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other
potential advantages of alternative treatment methods; and |
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ineffective
marketing and distribution support of our products. |
If
any of our product candidates is approved, but fails to achieve market acceptance, we may not be able to generate significant revenue
and our business would suffer.
The
uncertainty associated with pharmaceutical reimbursement and related matters may adversely affect our business.
Market
acceptance and sales of any one or more of our product candidates that we develop will depend on reimbursement policies and may be affected
by future healthcare reform measures in the United States and in foreign jurisdictions. Government authorities and third-party payers,
such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels.
We cannot be certain that reimbursement will be available for any product candidates that we develop. Also, we cannot be certain that
reimbursement policies will not reduce the demand for, or the price paid for, our products. If reimbursement is not available or is available
on a limited basis, we may not be able to successfully commercialize any product candidates that we develop.
In
the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the Medicare Modernization
Act, or MMA, changed the way Medicare covers and pays for pharmaceutical products. The legislation established Medicare Part D, which
expanded Medicare coverage for outpatient prescription drug purchases by the elderly but provided authority for limiting the number of
drugs that will be covered in any therapeutic class. The MMA also introduced a new reimbursement methodology based on average sales prices
for physician-administered drugs.
The
United States and several foreign jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals
to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payers
in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of
containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry
has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. We expect to experience
pricing pressures in connection with the sale of any products that we develop due to the trend toward managed healthcare, the increasing
influence of health maintenance organizations and additional legislative proposals.
In
March 2010, the Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, ACA,
became law in the U.S. The goal of ACA is to reduce the cost of health care and substantially change the way health care is financed
by both government and private insurers. While we cannot predict what impact on federal reimbursement policies this legislation will
have in general or on our business specifically, the ACA may result in downward pressure on pharmaceutical reimbursement, which could
negatively affect market acceptance of, and the price we may charge for, any products we develop that receive regulatory approval.
More
recently, the current U.S. presidential administration has made statements suggesting plans to seek repeal of all or portions of the
ACA. There is uncertainty regarding the impact that the President’s administration may have on matters currently governed by the
ACA, if any, and any regulatory or legislative changes will likely take time to unfold. These changes could have an impact on coverage
and reimbursement for healthcare items and services covered by plans that were authorized by the ACA. However, we cannot predict the
ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us. Any reduction in
reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation
of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or
commercialize our products.
Our
business and operations could suffer in the event of system failures.
Despite
the implementation of security measures, our internal computer systems and those of our third-party CROs and other contractors and consultants
are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical
failures. Furthermore, we have little or no control over the security measures and computer systems of our third-party CROs and other
contractors and consultants. While we have not experienced any material system failure, accident, or security breach to date, if such
an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs. For example,
the loss of clinical trial data for our product candidates could result in delays in our marketing approval efforts and significantly
increase our costs to recover or reproduce the data. To the extent that any disruption or security breach results in a loss of or damage
to our data or applications or other data or applications relating to our technology or product candidates, or inappropriate disclosure
of confidential or proprietary information, we could incur liabilities and the further development of our product candidates could be
delayed.
REGULATORY AND LEGAL RISK FACTORS
If we are unable to obtain required regulatory
approvals, we will be unable to market and sell our product candidates.
Our product candidates are
subject to extensive governmental regulations relating to development, clinical trials, manufacturing, oversight of clinical investigators,
recordkeeping and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory review and approval
process are required to be successfully completed in the United States, in the European Union and in many other foreign jurisdictions
before a new drug can be sold. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain, and subject
to unanticipated delays. The time required to obtain approval by the FDA or the European Medicines Agency, or EMA, is unpredictable and
often takes many years following the commencement of clinical trials.
In connection with the clinical
development of our product candidates, we face risks that:
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our
product candidates may not prove to be safe and efficacious; |
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patients
may die or suffer serious adverse effects for reasons that may or may not be related to the product candidate being tested; |
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we
fail to maintain adequate records of observations and data from our clinical trials, to establish and maintain sufficient procedures
to oversee, collect data from, and manage clinical trials, or to monitor clinical trial sites and investigators to the satisfaction
of the FDA, EMA or other regulatory agencies; |
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we
may not have sufficient financial resources to complete the clinical trials that would be necessary to obtain regulatory approvals; |
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the
results of later-phase clinical trials may not confirm the results of earlier clinical trials; and |
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the
results from clinical trials may not meet the level of statistical significance or clinical benefit-to-risk ratio required by the
FDA, EMA or other regulatory agencies for marketing approval. |
Only a small percentage of
product candidates for which clinical trials are initiated are the subject of NDAs and even fewer receive approval for commercialization.
Furthermore, even if we do receive regulatory approval to market a product candidate, any such approval may be subject to limitations
such as those on the indicated uses for which we may market the product.
If we or the third parties on which we rely
for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices
and related regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We currently use independent
clinical investigators in all of our clinical trials and, in many cases, also utilize contract research organizations, or CROs, and other
third-party service providers to conduct and/or oversee the clinical trials of our product candidates and expect to continue to do so
for the foreseeable future. We rely heavily on these parties for successful execution of our clinical trials. Nonetheless, we are responsible
for confirming that each of our clinical trials is conducted in accordance with the FDA’s requirements and our general investigational
plan and protocol. Currently, we have clinical trial activities involving CA4P and OXi4503 being conducted by clinical investigators
who are independent of us, but with whom we have agreements for them to provide the results of their clinical trials to us. In order
for us to rely on data from these ongoing clinical trials in support of a New Drug Application, or NDA, for approval of any of our product
candidates by the FDA or similar types of marketing applications that are required by other regulatory authorities, the independent investigators
are required to comply with applicable good clinical practice requirements.
The FDA and corresponding
foreign regulatory authorities require us and our clinical investigators to comply with regulations and standards, commonly referred
to as good clinical practices, or GCPs, for conducting and recording and reporting the results of clinical trials to assure that data
and reported results are credible and accurate and that the trial participants are adequately protected. Our reliance on third parties
that we do not control does not relieve us of these responsibilities and requirements. Third parties may not complete activities on schedule
or may not conduct our clinical trials in accordance with regulatory requirements or the respective trial plans and protocols. The failure
of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product
candidates or result in enforcement action against us.
We have taken and continue
to take steps to strengthen our procedures and practices, but we cannot assure you that the FDA will be satisfied with our procedures
or that the FDA will not issue warning letters or take other enforcement action against us in the future. The steps we take to strengthen
our procedures and conduct future clinical trials necessary for approval will be time-consuming and expensive.
The use of our products may result in product
liability exposure, and it is uncertain whether our insurance coverage will be sufficient to cover all claims.
The use of our product candidates
in clinical trials may expose us to liability claims in the event such product candidates cause death, injury or disease, or result in
adverse effects. We may be exposed to liability claims even if our product did not cause death, injury or diseases, but is merely presumed
or alleged to have caused any of these. If our product candidates are ever commercially approved, the commercial use of these products
may also expose us to similar liability claims. Any of these claims could be made by health care institutions, contract laboratories,
patients or others using such products. Although we have obtained liability insurance coverage for our ongoing clinical trials, this
coverage may not be in amounts sufficient to protect us from any product liability claims or product recalls which could have a material
adverse effect on our financial condition and prospects. Further, adverse product and similar liability claims could negatively impact
our ability to obtain or maintain regulatory approvals for our technology and product candidates under development.
We have been granted orphan drug status
for certain of our product candidates and may seek orphan drug status for additional indications for those product candidates or for
additional product candidates. We may be unsuccessful in maintaining orphan drug exclusivity for our product candidates and may be unsuccessful
in our efforts to seek orphan drug status and orphan drug exclusivity.
Regulatory authorities in
some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations
as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare
disease or condition, which is generally defined as a disease with a patient population of fewer than 200,000 individuals in the United
States. Our lead product candidate, OXi4503, has been awarded orphan drug status by the FDA and the European Commission for the treatment
of acute myelogenous leukemia. Our other product candidate, CA4P, has been awarded orphan drug status by the FDA for the treatment of
anaplastic, medullary, Stage IV papillary and Stage IV follicular thyroid cancers, ovarian cancer, neuroendocrine tumors and glioma.
CA4P has also been awarded orphan drug status by the European Commission in the European Union for the treatment of anaplastic thyroid
cancer, ovarian cancer and neuroendocrine tumors.
Generally, if a product with
an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the
product is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application
for the same drug for the same indication during the period of exclusivity. The applicable period is seven years in the United States
and ten years in the European Union. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria
for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug
exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective, if the manufacturer
is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
Even if we obtain orphan drug
exclusivity for a product candidate or additional product candidates, that exclusivity may not effectively protect the product candidate
from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently
approve a different drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to
be safer, more effective or makes a major contribution to patient care.
Our product candidates will remain subject
to ongoing regulatory review even if they receive marketing approval, and if we fail to comply with continuing regulations, we could
lose these approvals and the sale of any approved commercial products could be suspended.
Even if we receive regulatory
approval to market a particular product candidate, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising,
promotion, and record keeping related to the product will remain subject to extensive regulatory requirements. If we fail to comply with
the regulatory requirements of the FDA, EMA and other applicable domestic and foreign regulatory authorities or previously unknown problems
with any approved product, manufacturer, or manufacturing process are discovered, we could be subject to administrative or judicially
imposed sanctions, including:
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Our employees, principal investigators,
CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
and insider trading.
We are exposed to the risk
that our employees, principal investigators, CROs and consultants may engage in fraudulent conduct or other illegal activity. Misconduct
by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violate
the regulations of the FDA and other regulatory authorities, including those laws requiring the reporting of true, complete and accurate
information to such authorities; healthcare fraud and abuse laws and regulations in the United States and abroad; or laws that require
the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare
industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive
practices. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or
creating fraudulent data in our preclinical studies or clinical trials, which could result in regulatory sanctions and cause serious
harm to our reputation.
We have a code of conduct
applicable to all of our employees, but it is not always possible to identify and deter misconduct by employees and other third parties,
and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses
or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or
regulations. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions
could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary
fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational
harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate
our business and our results of operations.
RISKS RELATED TO INTELLECTUAL PROPERTY
We depend extensively on the patents and
proprietary technology we license from others, and we must maintain these licenses in order to preserve our business.
We have licensed in rights
to CA4P, OXi4503 and other programs from third parties. If our license agreements terminate or expire, we may lose the licensed rights
to our product candidates, including CA4P and OXi4503, and we may not be able to continue to develop them or, if they are approved, we
may not be able to market or commercialize them.
We depend on license agreements
with third-parties for certain intellectual property rights relating to our product candidates, including patent rights. Currently, we
have licensed in certain patent rights from Arizona State University, or ASU, and the Bristol-Myers Squibb Company for CA4P and OXi4503
and from Baylor University for other programs. In general, our license agreements require us to make payments and satisfy performance
obligations in order to keep these agreements in effect and retain our rights under them. These payment obligations can include upfront
fees, maintenance fees, milestones, royalties, patent prosecution expense, and other fees. These performance obligations typically include
diligence obligations. If we fail to pay, be diligent or otherwise perform as required under our license agreements, we could lose the
rights under the patents and other intellectual property rights covered by the agreements. While we are not currently aware of any dispute
with any licensors under our material agreements with them, if disputes arise under any of our in-licenses, including our in-licenses
from ASU, the Bristol-Myers Squibb Company and Baylor University, we could lose our rights under these agreements. Any such dispute may
not be resolvable on favorable terms, or at all. Whether or not any disputes of this kind are favorably resolved, our management’s
time and attention and our other resources could be consumed by the need to attend to and seek to resolve these disputes and our business
could be harmed by the emergence of such a dispute.
If we lose our rights under
these agreements, we may not be able to conduct any further activities with the product candidate or program that the license covered.
If this were to happen, we might not be able to develop our product candidates further, or following regulatory approval, if any, we
might be prohibited from marketing or commercializing them. In particular, patents previously licensed to us, such as the patents we
previously licensed from Angiogene, might after termination be used to stop us from conducting activities in the patents’ respective
fields.
We depend on patents and proprietary technology
in the course of our business, and we must protect those assets in order to preserve our business.
Although we expect to seek
patent protection for any compounds we discover and/or for any specific use we discover for new or previously known compounds, any or
all of them may not be subject to effective patent protection. Further, the development of regimens for the administration of pharmaceuticals,
which generally involve specifications for the frequency, timing and amount of dosages, has been, and we believe, may continue to be,
important to our effort, although those processes, as such, may not be patentable. In addition, the issued patents may be declared invalid
or our competitors may find ways to avoid the claims in the patents. Further, our lack of access to adequate capital may cause us to
curtail payment of fees necessary to maintain patents that we otherwise would seek to maintain, and we may make incorrect decisions regarding
which patents to keep and which to abandon.
Our success will depend, in
part, on our ability to obtain and maintain patents, protect our trade secrets and operate without infringing on the proprietary rights
of others. We are the exclusive licensee, sole assignee or co-assignee on a number of granted United States patents, pending United States
patent applications, and granted patents and/or pending applications in several other major markets, including the European Union, Canada
and Japan. The patent position of pharmaceutical and biotechnology firms like us is generally highly uncertain and involves complex legal
and factual questions, resulting in both an apparent inconsistency regarding the breadth of claims allowed in United States patents and
general uncertainty as to their legal interpretation and enforceability. Accordingly, patent applications assigned or exclusively licensed
to us may not result in patents being issued, any issued patents assigned or exclusively licensed to us may not provide us with competitive
protection or may be challenged by others, and the current or future granted patents of others may have an adverse effect on our ability
to do business and achieve profitability. Moreover, because some of the basic research relating to one or more of our patent applications
and/or patents were performed at various universities and/or funded by grants, one or more of these universities, employees of such universities
and/or grantors could assert that they have certain rights in such research and any resulting products. Further, others may independently
develop similar products, may duplicate our products, or may design around our patent rights. In addition, as a result of the assertion
of rights by a third-party or otherwise, we may be required to obtain licenses to patents or other proprietary rights of others in or
outside of the United States. Any licenses required under any such patents or proprietary rights may not be made available on terms acceptable
to us, if at all. If we do not obtain such licenses, we could encounter delays in product market introductions while our attempts to
design around such patents or could find that the development, manufacture or sale of products requiring such licenses is foreclosed.
In addition, we could incur substantial costs in defending ourselves in suits brought against us or in connection with patents to which
we hold licenses or in bringing suit to protect our own patents against infringement.
We require employees and the
institutions that perform our preclinical and clinical trials to enter into confidentiality agreements with us. Those agreements provide
that all confidential information developed or made known to a party to any such agreement during the course of the relationship with
us be kept confidential and not be disclosed to third-parties, except in specific circumstances. Any such agreement may not provide meaningful
protection for our trade secrets or other confidential information in the event of unauthorized use or disclosure of such information.
Risks
Related to Our Securities
Dilution
of our shares will likely be adversely affected by sales of our common stock pursuant to our agreement with the Selling Stockholders.
Sales
of an aggregate of 33,863,445 shares of our Common Stock being registered herein on behalf of Peak One and Peak One Investments and the
subsequent resale of those shares will have a material dilutive effect upon our shares and will likely have a depressive effect on the
market price of our Common Stock.
The
price of our common stock is volatile, and is likely to continue to fluctuate due to reasons beyond our control; a limited public trading
market may cause volatility in the price of our common stock.
The
market price of our common stock has been, and likely will continue to be, highly volatile. Factors, including our financial results
or our competitors’ financial results, clinical trial and research development announcements and government regulatory action affecting
our potential products in both the United States and foreign countries, have had, and may continue to have, a significant effect on our
results of operations and on the market price of our common stock. We cannot assure you that an investment in our common stock will not
fluctuate significantly. One or more of these factors could significantly harm our business and cause a decline in the price of our common
stock in the public market. Substantially all of the shares of our common stock issuable upon exercise of outstanding options and warrants
have been registered or are likely to be registered for resale or are available for sale pursuant to Rule 144 under the Securities Act
and may be sold from time to time. As of December 31, 2022, we had approximately 139 million shares of common stock underlying
currently outstanding convertible debt, warrants and options. Sales of any of these shares on the market, as well as future sales of
our common stock by existing stockholders, or the perception that sales may occur at any time, could adversely affect the market price
of our common stock.
Our
common stock is currently quoted on the OTCQB Market. The quotation of our common stock on the OTCQB Market does not assure that a meaningful,
consistent and liquid trading market currently exists, and in recent years such market has experienced extreme price and volume fluctuations
that have particularly affected the market prices of many smaller companies like us. Our common stock is subject to this volatility.
Sales of substantial amounts of common stock, or the perception that such sales might occur, could adversely affect prevailing market
prices of our common stock and our stock price may decline substantially in a short time and our stockholders could suffer losses or
be unable to liquidate their holdings.
The
price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our
common stock.
Our
stock price may be volatile. The stock market in general and the market for smaller specialty pharmaceutical companies and biotechnology,
in particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies
or the quality of the underlying assets. As a result of this volatility, you may not be able to sell your common stock at or above the
price you paid for such shares. The market price for our common stock may be influenced by many factors, including but not limited to:
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We
will require additional capital funding, the receipt of which may impair the value of our common stock.
Our
future capital requirements depend on many factors, including our research, development, sales and marketing activities. We will need
to raise additional capital through public or private equity or debt offerings or through arrangements with strategic partners or other
sources in order to continue to develop our product candidates. There can be no assurance that additional capital will be available when
needed or on terms satisfactory to us, if at all. To the extent we raise additional capital by issuing equity securities, our shareholders
may experience substantial dilution and the new equity securities may have greater rights, preferences or privileges than our existing
common stock.
Our
common stock is currently subject to the “Penny Stock” Rules of the SEC and the trading market in our securities is limited,
which makes transactions in our stock cumbersome and may reduce the value of an investment in our stock.
As
of December 31, 2022, we had net tangible assets of $22.9 million and our common stock had a market price per share of
less than $5.00. As a result, transactions in our common stock are subject to the SEC’s “penny stock” rules. The designation
of our common stock as a “penny stock” likely limits the liquidity of our common stock. Prices for penny stocks are often
not available to buyers and sellers and the market may be very limited. Penny stocks are among the riskiest equity investments. Broker-dealers
who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. The document
provides information about penny stocks and the nature and level of risks involved in investing in the penny stock market. A broker must
also provide purchasers with bid and offer quotations and information regarding broker and salesperson compensation and make a written
determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written agreement to the
purchase. Many brokers choose not to participate in penny stock transactions. Because of the penny stock rules, there may be less trading
activity in penny stocks. Because shares of our common stock are currently subject to these penny stock rules, your ability to trade
or dispose of shares of our common stock may be adversely affected.
We
may not be able to achieve secondary trading of our stock in certain states because our common stock is no longer nationally traded,
which could subject our stockholders to significant restrictions and costs.
Our
common stock is not currently eligible for trading on the Nasdaq Capital Market or on a national securities exchange. Therefore, our
common stock is subject to the securities laws of the various states and jurisdictions of the United States in addition to federal securities
law. While we may register our common stock or qualify for exemptions for our common stock in one of more states, if we fail to do so
the investors in those states where we have not taken such steps may not be allowed to purchase our stock or those who presently hold
our stock may not be able to resell their shares without substantial effort and expense. These restrictions and potential costs could
be significant burdens on our stockholders.
If
we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial
results. As a result, current and potential stockholders could lose confidence in our financial reporting, which could harm our business
and the trading price of our stock.
Effective
internal control over financial reporting are necessary for us to provide reliable financial reports. If we cannot maintain effective
controls and reliable financial reports, our business and operating results could be harmed. For example, our small size and limited
staffing levels do not allow for segregation of duties that exist at larger companies. We have conducted an evaluation of the effectiveness
of our internal control over financial reporting as of December 31, 2022 based on the criteria established in Internal Control
- Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework). Based on that
evaluation, our management concluded that our internal control over financial reporting were not effective as of December 31, 2022.
We continue to work on remedying our weaknesses and maintaining effective internal controls over financial reporting; however, there
can be no assurance that a material weakness will not occur in the future. Any failure to implement and maintain controls over our financial
reporting or difficulties encountered in the implementation of improvements in our controls, could cause us to fail to meet our reporting
obligations. Any failure to maintain our internal controls over financial reporting or to address identified weaknesses in the future,
if they were to occur, could also cause investors to lose confidence in our reported financial information, which could have a negative
impact on the trading price of our stock.
Issuance
of additional equity securities may adversely affect the market price of our common stock.
We
were authorized to issue up to 750,000,000 shares of our common stock. As of December 31, 2022, we had 391,846,880 shares
of common stock issued and outstanding, including 1,019,303 shares of common stock to be issued. As of December 31, 2022, we also
had approximately 81 million warrants outstanding, approximately 26 million options and approximately 139 million
shares of common stock issuable upon conversion of convertible notes.
To
the extent that additional shares of common stock are issued or options and warrants are exercised, holders of our common stock will
experience dilution. In addition, in the event of any future issuances of equity securities or securities convertible into or exchangeable
for common stock, holders of our common stock may experience dilution.
Our
Board of Directors is authorized to issue preferred stock without any action on the part of our stockholders. Our Board of Directors
also has the power, without stockholder approval, to set the terms of any such preferred stock that may be issued, including voting rights,
conversion rights, dividend rights, preferences over our common stock with respect to dividends or if we liquidate, dissolve or wind
up our business and other terms. If we issue preferred stock in the future that has preference over our common stock with respect to
the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute
the voting power of our common stock, the market price of our common stock could decrease. Any provision permitting the conversion of
any such preferred stock into our common stock could result in significant dilution to the holders of our common stock.
We
also consider from time-to-time various strategic alternatives that could involve issuances of additional common or preferred stock,
including but not limited to acquisitions and business combinations.
We
have no plans to pay dividends on our common stock, and you may not receive funds without selling your common stock.
We
have not declared or paid any cash dividends on our common stock, nor do we expect to pay any cash dividends on our common stock for
the foreseeable future. We currently intend to retain any future earnings, if any, to finance our operations and growth and, potentially,
for future stock repurchases and, therefore, we have no plans to pay cash dividends on our common stock. Any future determination to
pay cash dividends on our common stock will be at the discretion of our Board of Directors and will be dependent on our earnings, financial
condition, operating results, capital requirements, any contractual restrictions, and other factors that our board of directors deems
relevant.
Accordingly,
you may have to sell some or all of your common stock in order to generate cash from your investment in the Company. You may not receive
a gain on your investment when you sell our common stock and may lose the entire amount of your investment.
The
Company will require additional capital funding, the receipt of which may impair the value of our Common Stock and EdgePoint’s
Common Stock.
Our
future capital requirements and EdgePoint’s future capital requirements depend on many factors, including our research, development,
sales and marketing activities as well as the development of EdgePoint’s business. We and EdgePoint will need to raise additional
capital through public or private equity or debt offerings or through arrangements with strategic partners or other sources in order
to continue to develop our product candidates. There can be no assurance that additional capital will be available when needed or on
terms satisfactory to us or EdgePoint, if at all. To the extent we and/or EdgePoint raise additional capital by issuing equity securities,
our shareholders and EdgePoint’s shareholders may experience substantial dilution and the new equity securities may have greater
rights, preferences or privileges than our existing Common Stock and EdgePoint’s Common Stock and the Securities contemplated to
be issued as described in this Confidential Offering Memorandum.
General
Risk Factors
Unfavorable
global epidemic or pandemic conditions could adversely affect our business, financial condition or results of operations.
Our
operations and the financial results of our operations could be adversely affected by general conditions in the global economy and in
the global financial markets. Global financial concerns have caused, and may continue to cause, extreme volatility and disruptions in
the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including
our ability to raise additional capital when needed on acceptable terms, if at all. We cannot currently anticipate all of the ways in
which the current economic climate and financial market conditions could adversely impact our business.
Our
business may suffer from the severity or longevity of the COVID-19 Global Outbreak.
The
COVID-19 is currently impacting countries, communities, supply chains and markets, as well as the global financial markets. To date,
COVID-19 has not had a material impact on the Company, other than as set forth above. However, the Company cannot predict whether COVID-19
will have a material impact on our financial condition and results of operations due to understaffing, disruptions in government spending,
among other factors. In addition, at this time we cannot predict the impact of COVID-19 on our ability to obtain financing necessary
for the Company to fund its working capital requirements. In most respects, it is too early in the COVID-19 pandemic to be able to quantify
or qualify the longer-term ramifications on our business, our customers and/or our potential investors.
A material amount
of our assets represents intangible assets, and our net income would be reduced if our intangible assets became impaired.
As of December 31, 2022, our gross intangible
assets from our 2019 PointR acquisition represented approximately $17 million, or approximately 43% of our total assets. Goodwill is
generated in our acquisitions when the cost of an acquisition exceeds the fair value of the net tangible and identifiable intangible
assets we acquire. Goodwill and indefinite-lived intangible assets are subject to an impairment analysis at least annually based on fair
value. Intangible assets relate primarily to in-process research and development (IPR&D) and patents acquired by us as part of our
acquisitions of other companies and are subject to an impairment analysis whenever events or changes in circumstances exist that indicate
that the carrying value of the intangible asset might not be recoverable. If market and economic conditions or business performance deteriorate,
the likelihood that we would record an impairment charge would increase, which impairment charge could materially and adversely affect
our financial condition and operating results. As the market capitalization of our Company was adversely impacted due to a reduction
in the stock price of our Common Stock, we recorded an impairment of approximately $4.1 million on the Goodwill representing the difference
in net assets over the fair value of the Company, based on our market capitalization.
We,
or the third parties upon whom we depend, may be adversely affected by earthquakes or other natural disasters and our business continuity
and disaster recovery plans may not adequately protect us from a serious disaster.
Earthquakes
or other natural disasters could severely disrupt our operations and have a material adverse effect on our business, results of operations,
financial condition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a
significant portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party
contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue
our business for a substantial period of time. The disaster recovery and business continuity plan we have in place may prove inadequate
in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster
recovery and business continuity plans, which could have a material adverse effect on our business.
We have formed a DAO company to operate
as a DAO with the rigor of a corporation
In November 2022, the Company formed a DAO entity,
Pet2DAO Inc., as a wholly owned subsidiary. Pet2DAO is a DAO technology company, integrating
the strong governance of traditional corporations with the innovative DAO architecture. The Company will look to engage stakeholders,
to build value through the DAO, while maintaining the rigor of traditional corporations, including governance, compliance, and accountability
through a team of veterans in public companies with innovators in AI, blockchain and Web3. Pet2DAO will initially be looking to
develop products for the animal health space. The Company will initially issue regular tokens and NFTs of Pet2DAO called PDAO to its
employees, shareholders and KOLs and use the Tokens to propose and vote on various animal health related programs. In the future, the
Company will evaluate and plan to register these tokens with the SEC to make such Tokens freely tradable at a future point in time. The
Company cannot predict the outcome of Pet2DAO as an entity, how investors will look at this new development, especially with what is
happening in the crypto currency environment, the success of the tokens, whether we will be able to register the tokens as securities
or the success to make these tokens freely tradable. Any failure for any of the needs for a successful DAO, could also cause investors
to in the Company, which could have a negative impact on the trading price of our stock.
Risks
Related to Peak One Equity Line
Peak
One’s sales of our Shares into the open market may cause material decreases in our stock price.
The
33,863,445 shares of our common stock that were originally registered and may be sold into the market by Peak One and Peak
One Investments, could cause our stock price to decline. In turn, if our stock price declines and we issue more Purchase Notices, this
would cause more shares to come into the market, which could cause a further drop in our stock price.
Funding
from our Purchase Agreement with Peak One may be limited or insufficient to fund our operations or to implement our strategy.
Under our Equity Agreement with Peak One, and upon
effectiveness of the registration statement of which this prospectus is a part, and subject to other conditions, we may direct Peak One
to purchase up to 29,878,445 shares of our common stock over a 24-month period. at 91% of the closing price of our common stock on
the date prior to our request to purchase. Furthermore, we may receive substantially less than $10,000,000 in gross proceeds from
the financing (or $10,000,000 if we receive the maximum financing of $10,000,000) due to our share price, discount to market and other
factors relating to our common stock.
There
can be no assurance that we will be able to receive all or any of the total commitment from Peak One because the Equity Purchase Agreement
contains certain limitations, restrictions, requirements, conditions and other provisions that could limit our ability to cause Peak
One to buy common stock from us. For instance, we are prohibited from issuing a Put Notice if the amount requested in such Put Notice
exceeds the Maximum Put Amount, or the sale of Shares pursuant to the Put Notice would cause us to sell or Peak One to purchase an aggregate
number of shares of the Company’s common stock which would result in beneficial ownership by Peak One of more than 4.99% of our
common stock (as calculated pursuant to Section 13(d) of the Exchange Act and the rules and regulations thereunder). Moreover, there
are limitations with respect to the frequency with which we may provide Put Notices to Peak One under the Equity Purchase Agreement.
Also, as discussed above, there must be an effective registration statement covering the resale of any Shares to be issued pursuant to
any draw down under the Equity Purchase Agreement, and the registration statement of which this prospectus is a part covers the resale
of only 29,878,445 Shares that may be issuable pursuant to put notices under the Equity Purchase Agreement. The registration statements
may be subject to review and comment by the staff of the Commission and will require the consent of our independent registered public
accounting firm. Therefore, the timing of effectiveness of the registration statements cannot be assured.
The
extent to which we rely on Peak One as a source of funding will depend on a number of factors, including the amount of working capital
needed, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources.
If obtaining sufficient funding from Peak One were to prove unavailable or prohibitively dilutive, we would need to secure another source
of funding. Even if we sell all 29,878,445 shares of common stock under the Purchase Agreement with Peak One, we will still need additional
capital to fully implement our current business, operating plans and development plans.
The
sale or issuance of our common stock to Peak One at a discount may cause substantial dilution and the resale of the shares of common
stock by Peak One into the public market, or the perception that such sales may occur, could cause the price of our common stock to fall.
Under the Equity Purchase Agreement with
Peak One, upon effectiveness of the registration statement of which this prospectus is a part, and subject to other conditions, we had
registered an aggregate of 33,863,445 (including 3,735,000 shares already sold and 250,000 Commitment shares already issued) shares
of common stock in the registration statement of which this prospectus is a part pursuant to the Registration Rights Agreement, representing
shares which have been and may be issuable to Peak One under the Equity Purchase Agreement. Notwithstanding Peak One’s beneficial
ownership limitation set forth in the Equity Purchase Agreement, if all of the 33,863,445 shares offered under this prospectus were issued
and outstanding as of April 12, 2023, such shares would represent approximately 7.1% of the total number of shares of our
common stock outstanding of 422,750,325 including the issuance of such shares and 19% of the total number of outstanding
shares of our common stock held by non-affiliates, and including the issuance of such shares to be purchased and Commitment Fee Shares
to be issued, in each case as of April 12, 2023. The number of shares ultimately offered for sale by Peak One under this prospectus
is dependent upon a number of factors, including the number of Shares we ultimately issue and sell to Peak One under the Equity Purchase
Agreement. Because the actual Purchase Price for the Shares that we may sell to Peak One will fluctuate based on the market price of
our common stock during the term of the Equity Purchase Agreement, we are not able to determine at this time the exact number of shares
of our common stock that we will issue under the Equity Purchase Agreement and, therefore, the exact number of shares we will ultimately
register for resale under the Securities Act.
Specifically,
because the per share Purchase Price for the Shares subject to a Put Notice will be equal to a 9% discount to certain trading prices
of our common stock as set forth in the Equity Purchase Agreement, Peak One will pay less than the then-prevailing market price for our
common stock, and the actual Equity Purchase price for the Shares that we may sell to Peak One will fluctuate based on the VWAPs and
closing prices of our common stock during the term of the Equity Purchase Agreement. As a result of this discount, Peak One may have
a financial incentive to sell our common stock immediately to realize the profit equal to the difference between the Equity Purchase
price and the market price. If Peak One sells the common stock, the market price of our common stock could decrease. If the market price
of our common stock decreases, Peak One may have a further incentive to sell the common stock that it holds. These sales may have a further
impact on the market price of our common stock.
Moreover,
there is an inverse relationship between the market price of our common stock and the number of shares of our common stock that may be
sold pursuant to the Equity Purchase Agreement. That is, the lower the market price, the more shares of our common stock that may be
sold under the Equity Purchase Agreement. Accordingly, if the market price of our common stock decreases (whether such decrease is due
to sales by Peak One in the market or otherwise) and, in turn, the Equity Purchase price of our common stock sold to Peak One under the
Equity Purchase Agreement decreases, this could allow Peak One to receive greater numbers of shares of our common stock pursuant to put
notices under the Equity Purchase Agreement. Although the number of shares of our common stock that our existing stockholders own will
not decrease, the common stock owned by our existing stockholders will represent a smaller percentage of our total outstanding shares
after any such sales to Peak One. Depending on market liquidity at the time, the sale of a substantial number of shares of our common
stock to Peak One at a discount to the then-prevailing market price for our common stock under the Equity Purchase Agreement, and the
resale of such shares by Peak One into the public market, or the perception that such sales may occur, could cause the trading price
of our common stock to decline, result in substantial dilution to existing stockholders and make it more difficult for us to sell equity
or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
For
a tabular disclosure of the number of securities and percentage ownership to be issued assuming we sell all the securities on the registration
statement and assuming sales to Peak One at various discounts to our current market price, please see “Equity Purchase Agreement
with Peak One Opportunity Fund” on page 27 of this prospectus.
We
may use the net proceeds from sales of our common stock to Peak One pursuant to the Equity Purchase Agreement in ways with which you
may disagree.
We
intend to use the net proceeds from sales of our common stock to Peak One pursuant to the Equity Purchase Agreement for working capital
and general corporate purposes. As of the date of this prospectus, we cannot specify with certainty all of the particular uses of the
proceeds from sales of common stock to Peak One pursuant to the Equity Purchase Agreement. Accordingly, we will have significant discretion
in the use of the net proceeds of sales of common stock to Peak One pursuant to the Equity Purchase Agreement. It is possible that we
may allocate the proceeds differently than investors in this offering desire or that we will fail to maximize our return on these proceeds.
We may, subsequent to this offering, modify our intended use of the proceeds from sales of common stock to Peak One pursuant to the Equity
Purchase Agreement to pursue strategic opportunities that may arise, such as potential acquisition opportunities. You will be relying
on the judgment of our management with regard to the use of the net proceeds from the sales of common stock to Peak One pursuant to the
Equity Purchase Agreement, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds
are being used appropriately. Any failure to apply the proceeds from sales of common stock to Peak One pursuant to the Equity Purchase
Agreement effectively could have a material adverse effect on our business and cause a decline in the market price of our common stock.
Cautionary
Note
We
have sought to identify what we believe to be the most significant risks to our business, but we cannot predict whether, or to what extent,
any of such risks may be realized nor can we guarantee that we have identified all possible risks that might arise. Investors should
carefully consider all of such risk factors before making an investment decision with respect to our common stock.
USE
OF PROCEEDS
We
will not receive any proceeds from the disposition and/or resale of the shares of common stock by the Selling Stockholders or their transferees.
We will, however, receive cash proceeds from the Put Notices we issue to Peak One Opportunity Fund, LP (“Peak One”), which
we, while we retain broad discretion on the use of proceeds, intend to use for funding our product development programs, acquisition
of new products, working capital and to fund general operational needs.
DETERMINATION
OF OFFERING PRICE
In
determining the offering price of the shares pursuant to the Equity Purchase Agreement, we considered several factors including the following:
|
● |
prevailing
market conditions, including the history and prospects for the industry in which we compete; |
|
● |
our
future prospects; and |
|
● |
our
capital structures. |
Therefore,
the offering price of the shares does not necessarily bear any relationship to established valuation criteria and may not be indicative
of prices that may prevail at any time or from time to time in the public market for the common stock.
DILUTION
The
Shares registered under this registration statement are not being offered for purchase. The shares are being registered on behalf of
Peak One pursuant to Put Notices we issue to Peak One.
SELLING
SECURITY HOLDERS
The
selling security holders identified in this prospectus may offer and sell:
|
1. |
Peak One – up to 29,878,445, of our originally registered 33,863,445, Shares of our Common Stock to be
purchased by Peak One pursuant to the Equity Purchase Agreement (“EPA”), registered for resale herein, and would
represent 7.1% of our issued and outstanding shares of common stock as of April 12, 2023 and including the issuance of such shares
to be purchased and Commitment Fee Shares to be issued; |
|
|
|
|
2. |
Peak
One –3,735,000 Shares of our Common Stock issued to Peak One pursuant to sale under
the EPA, registered for resale herein, and would represent 0.9% of our issued and outstanding
shares of common stock as of April 12,
2023 and including the issuance of such shares to be purchased and Commitment Fee Shares
to be issued.
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|
|
|
|
3. |
125,000
Commitment Fee Shares issued to Peak One on May 3, 2021, which represents less than 1% (0.03%) of our issued and outstanding shares
of common stock as of April 12, 2023 and including the issuance of such shares to be purchased and Commitment Fee Shares to
be issued. |
|
|
|
|
4. |
125,000
Commitment Fee Shares issued to Peak One Investments, LLC on May 3, 2021, which represents less than 1% (0. 03%) of our issued and
outstanding shares of common stock as of April 12, 2023 and including the issuance of such shares to be purchased and Commitment
Fee Shares to be issued. |
Peak
One Investments is the general partner of Peak One Opportunity Fund, LP.
We
may require the selling security holders to suspend the sales of the shares of our common stock being offered pursuant to this prospectus
upon the occurrence of any event that makes any statement in this prospectus or the related registration statement untrue in any material
respect or that requires the changing of statements in those documents in order to make statements in those documents not misleading.
The
selling security holders identified in the table below may from time to time offer and sell under this prospectus any or all of the shares
of common stock described under the column “Shares of Common Stock Being Offered” in the table below.
Peak
One and Peak One Investments will be deemed to be underwriters within the meaning of the Securities Act. Any profits realized by the
selling stockholders may be deemed to be underwriting commissions.
We
cannot give an estimate as to the number of shares of common stock that will actually be held by the selling stockholders upon termination
of this offering, because each selling security holder may offer some or all of the common stock being registered on their individual
behalf under the offering contemplated by this prospectus or acquire additional shares of common stock. The total number of shares that
may be sold hereunder will not exceed the number of shares offered hereby. Please read the section entitled “Plan of Distribution”
in this prospectus.
The
manner in which the selling stockholders acquired or will acquire shares of our common stock is discussed below under “The Offering.”
The
following table sets forth the name of the selling stockholder, the number of shares of our common stock beneficially owned by such stockholder
before this offering, the number of shares to be offered for such stockholders’ account and the number and (if one percent or more)
the percentage of the class to be beneficially owned by such stockholders after completion of the offering. The number of shares owned
are those beneficially owned, as determined under the rules of the SEC, and such information is not necessarily indicative of beneficial
ownership for any other purpose. Under such rules, beneficial ownership includes any shares of our common stock as to which a person
has sole or shared voting power or investment power and any shares of common stock which the person has the right to acquire within 60
days of the date as of which the information is provided, through the exercise of any option, warrant or right, through conversion of
any security or pursuant to the automatic termination of a power of attorney or revocation of a trust, discretionary account or similar
arrangement, and such shares are deemed to be beneficially owned and outstanding for computing the share ownership and percentage of
the person holding such options, warrants or other rights, but are not deemed outstanding for computing the percentage of any other person.
Beneficial ownership percentages are calculated based on 392,871,880 shares of our common stock outstanding as of April 12,
2023 and including the issuance of such shares to be purchased and Commitment Fee Shares to be issued.
Unless
otherwise set forth below, (a) the persons and entities named in the table have sole voting and sole investment power with respect to
the shares set forth opposite the selling stockholder’s name, subject to community property laws, where applicable, and (b) no
selling stockholders had any position, office or other material relationship within the past three years, with us or with any of our
predecessors or affiliates. The number of shares of common stock shown as beneficially owned before the offering is based on information
furnished to us or otherwise based on information available to us at the timing of the filing of the registration statement of which
this prospectus forms a part.
Name of Selling Shareholder | |
Shares Beneficially Owned Prior to Offering* | | |
Shares to be Offered | | |
Amount Beneficially Owned After Offering %(3) | |
Peak One Opportunity Fund | |
| - | | |
| 29,878,445 | (1)(2)(3)(4) | |
| 0 | (2) |
Peak One Opportunity Fund | |
| 125,000 | | |
| 125,000 | (5) | |
| 0 | (2) |
Peak One Investments, LLC | |
| 125,000 | | |
| 125,000 | (6) | |
| 0 | (2) |
Notes:
|
1) |
Beneficial
ownership is determined in accordance with Securities and Exchange Commission rules and generally includes voting or investment power
with respect to shares of common stock. Shares of common stock subject to options, warrants and convertible debentures currently
exercisable or convertible, or exercisable or convertible within 60 days, are counted as outstanding. The actual number of shares
of common stock issuable upon the conversion of the convertible debentures is subject to adjustment depending on, among other factors,
the future market price of our common stock, and could be materially less or more than the number estimated in the table. |
|
2) |
Because
the selling security holders may offer and sell all or only some portion of the 29,878,445 shares of our common stock being offered
pursuant to this prospectus and may acquire additional shares of our common stock in the future, we can only estimate the number
and percentage of shares of our common stock that the selling stockholder will hold upon termination of the offering. The column
titled “Number of Shares Owned After Offering” assumes that the Selling Stockholders will sell all of their Shares. |
|
3) |
Jason
Goldstein exercises voting and dispositive power with respect to the shares of our common stock that are beneficially owned by Peak
One and Peak One Investments. |
|
4) |
Consists
of 29,878,445 shares of Common Stock to be sold by Peak One pursuant to Put Notices we shall issue to Peak One pursuant to the Equity
Purchase Agreement but does not include 3,735,000 shares already sold to Peak One pursuant to Put Notices we issued to Peak One pursuant
to the EPA. |
|
5) |
Consists
of 125,000 Commitment Shares issued to Peak One on May 3, 2021. |
|
6) |
Consists
of up to 125,000 shares of Commitment Shares issued to Peak One Investments on May 3, 2021
|
THE
OFFERING
|
|
Summary
of the Offering |
|
|
|
Shares
currently outstanding: |
|
392,871,880 (not including the
issuance of such shares to be purchased by Peak One and Peak One Investments, LLC) |
|
|
|
Shares
being offered: |
|
29,878,445
shares of common stock that we may issue to Peak One pursuant to put notices under the Equity Purchase Agreement, not including 250,000
shares equally issued as Commitment Shares to Peak One and Peak One Investments, LLC and 3,735,000 shares already sold under multiple
tranches. |
|
|
|
Offering
Price per share: |
|
The
selling stockholders may sell all or a portion of the shares being offered pursuant to this prospectus at fixed prices, at prevailing
market prices at the time of sale, at varying prices, or at negotiated prices. |
|
|
|
Use
of Proceeds: |
|
We
will not receive any proceeds from the sale of the shares of our common stock by the Selling Stockholders. However, we will receive
proceeds from receive cash proceeds from Put Notices we issue to Peak One Opportunity Fund pertaining to the 29,878,445 shares being
registered on behalf of Selling Shareholder Peak One. |
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|
|
OTC
Markets Symbol: |
|
OTLC |
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|
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Risk
Factors: |
|
See
“Risk Factors” beginning on page 10 and the other information in this prospectus for a discussion of the factors you
should consider before deciding to invest in shares of our common stock. |
Equity
Purchase Agreement (“EPA”) with Peak One Opportunity Fund
On
May 3, 2021, we entered into the EPA with Peak One and Peak One Investments (also referred to herein as the “Investor). Although
we are not required to sell shares under the EPA, the EPA gives us the option to sell up to an aggregate of $10,000,000 worth of our
common stock to Peak One (the “Maximum Commitment Amount”), in increments, over the period ending on the Commitment Period
(the Commitment Period is mean the period commencing on the Execution Date, and ending on the earlier of (i) the date on which the Investor
shall have purchased Put Shares equal to the Maximum Commitment Amount, (ii) 24 months after the initial effectiveness of the Registration
Statement, (iii) our written notice of termination to the Investor, (iv) the Registration Statement is no longer effective, or (v) the
date that, pursuant to or within the meaning of any Bankruptcy Law, the Company commences a voluntary case or any Person commences a
proceeding against the Company, a Custodian is appointed for the Company or for all or substantially all of its property or the Company
makes a general assignment for the benefit of its creditors. Additionally, we are required to issue Commitment Fees of 125,000 Shares
each to Peak One and Peak One Investments.
There
is no assurance the market price of our common stock will increase in the future. Dependent upon the share price, the number of
common shares that remain issuable may be insufficient to allow us to access the full amount contemplated under the EPA. If the
bid/ask spread remains the same, we will be unable to place puts for the full commitment under the EPA. Based on the closing trading
price of our common stock on April 13, 2023 of $0.041, the registration statement covers the offer and possible sale of up to
33,863,445 shares to Peak One, which includes the 125,000 Common Stock Commitment Fee Shares we issued to each Peak One and Peak One
Investments on May 3, 2021 for an aggregate of 250,000 Commitment Fee Shares and 3,735,000 Shares sold to Peak One pursuant to
EPA.
During
the Commitment Period, we may, in our sole discretion, deliver a Put Notice to Peak One stating the dollar amount we intend to sell to
Peak One on a designated closing date. The purchase price of our Common Stock will be set at ninety-one percent (91%) of the Market Price
on such date on which the Purchase Price is calculated. The Market Price is defined in the EPA as the lesser of the (i) closing bid price
of the Common Stock on the Principal Market on the Trading Day immediately preceding the respective Put Date, or (ii) the lowest closing
bid price of the Common Stock on the Principal Market for any Trading Day during the Valuation Period. The Valuation Period is defined
as the period of seven (7) Trading Days immediately following the Clearing Date associated with the applicable Put Notice. The Valuation
Period begins on the first Trading Day following the Clearing Date.
Section
2.2 of the EPA sets forth the “mechanics” of the Put Notices and the Put Shares, as follows:
|
1. |
at
any time during the Commitment Period, we may deliver a Put Notice to Peak One The initial price per share provided for in the Put
Notice will be equal to the Initial Purchase Price (the Initial Purchase Price is defined as 91% of the lowest closing bid price
of our common stock on the trading day immediately preceding the respective Put Date), subject to adjustment during the Valuation
Period. |
|
2. |
we
shall deliver the Put Shares to Peak One within 2 trading days following the Put Date. |
|
3. |
a
Put Notice shall be delivered on the trading day that Peak One receives the notice or the immediately succeeding trading day or on
a non-trading day. |
|
4. |
at
the end of the Valuation Period, the Purchase Price of the then applicable Put Shares shall be determined, as follows: (i) if the
value of the Put Shares delivered to Peak One causes the Maximum Commitment Amount (Maximum Commitment Amount is defined as Ten Million
Dollars) to be exceeded, then immediately after the Valuation Period, Peak One shall return to us the surplus amount of Put Shares
associated with such Put and the Purchase Price with respect to such Put, which shall be reduced by any Clearing Costs related to
the return of such Put Shares; (ii) the Closing of a Put shall occur within three (3) Trading Days following the end of the Valuation
Period, whereby the Investor shall deliver the Investment Amount by wire transfer of immediately available funds to an account that
we designate. |
We
are not entitled to deliver a Put Notice and Peak One is not obligated to purchase any Put Shares at a Closing unless all of the following
conditions are met:
|
1. |
A
registration statement has been declared effective and remains effective (or a post-effective registration statement, if needed,
has been filed and declared effective). |
|
2. |
We
maintain and continue our stock quotation on the Principal Market and the trading of our common stock shall not have been suspended
by the SEC, the Principal Market, or FINRA. |
|
3. |
We
have performed, satisfied and completed in all material respects with all covenants, agreements and conditions of the EPA to be performed,
satisfied or complied with by us. |
|
4. |
The
issuance of the shares has not violated any shareholder approval requirements of Principal Markets. |
|
5. |
The
lowest trading price of our common stock in the 10 trading days preceding the respective Put Date must exceed $0.01 per share. |
|
6. |
The
issuance of the Put Shares shall not exceed the Exchange Cap; Exchange Cap is defined as if when the issuance of the Put Shares exceeds
the aggregate number of common stock shares which we may issue without breaching our obligations under the rules and regulations
of the Principal Market. |
|
7. |
Since
the date of filing of our most recent SEC Document, no event that had or is reasonably likely to have a Material Adverse Effect has
occurred. |
|
8. |
The
number of Put Shares then to be purchased by the Investor shall not exceed the number of such shares that, when aggregated with all
other shares of Common Stock then owned by the Investor beneficially or deemed beneficially owned by the Investor, would result in
the Investor owning more than the Beneficial Ownership Limitation, as determined in accordance with Section 16 of the Securities
Exchange Act of 1934 and the regulations promulgated thereunder. |
|
9. |
We
shall have no knowledge of any event more likely than not to have the effect of causing the Registration Statement to be suspended
or otherwise ineffective (which event is more likely than not to occur within the fifteen (15) Trading Days following the Trading
Day on which such Put Notice is deemed delivered). |
|
10. |
Our
Common Stock must be DWAC Eligible. |
|
11. |
All
reports, schedules, registrations, forms, statements, information and other documents required to have been filed by the Company
with the SEC pursuant to the reporting requirements of the Securities Exchange Act of 1934 shall have been filed with the SEC within
the applicable time periods prescribed for such filings under the Securities Exchange Act of 1934. |
|
12. |
We
shall have reserved 100% of the Required Minimum for the Investor’s benefit under this Agreement and satisfied the reserve
requirements with respect to all other contracts between us and the Investor. |
If
any of the events described above occurs during a pricing period, then Peak One shall have no obligation to purchase the shares delivered
in the Put Notice.
Further,
the EPA required that we use our reasonable best efforts to have the registration statement be effective no more than 90 days following
the date the EPA was executed, May 3, 2021 and was made effective by the SEC on June 2, 2021
Neither
Peak One nor any of its affiliates are permitted to execute any short sales involving our common stock, during the period commencing
on the Execution Date of the EPA, May 3, 2021, and continuing through the end of the Commitment Period, however, sales of our common
stock by Peak One after delivery of a put notice of such number of shares reasonably expected to be purchased by Peak One under a put
will not be deemed short sales.
As
we Put on the Equity Line pursuant to the EPA, shares of our common stock will be sold into the market by Peak One. The sale of these
shares could cause our stock price to decline. If our stock price declines and we issue more puts, more shares will come into the market,
which could cause a further decline in our stock price. We determine when and whether to issue a put to Peak One, so we will know precisely
both the stock price used as the reference point, and the number of shares issuable to Peak One upon such exercise. You should be aware
that there is an inverse relationship between the market price of our common stock and the number of shares to be issued under the EPA.
We have no obligation to utilize the full amount available under the EPA and all determinations regarding the execution of a put provision
remains solely in the discretion of our company.
Neither
the EPA nor any of our rights or Peak One’s rights thereunder may be assigned to any other person.
Peak
One has agreed that during the term of the EPA, neither Peak One nor any of its affiliates will execute any short sales during the period
from the date of the EPA to the end of the Commitment Period.
Pursuant
to the EPA, the number of Put Shares to be purchased by Peak One shall not exceed the Beneficial Ownership Limitation of 4.99% of the
number of common stock shares outstanding immediately after giving effect to the issuance of common stock shares issuable pursuant to
the Put Notice.
Further,
in addition to the above, the EPA contains representations, warranties and covenants by, among and for the benefit of the parties and
before Peak One is obligated to purchase any Put Shares pursuant to a Put Notice, certain conditions specified in the EPA, none of which
are in Peak One’s control (although may be duplicative of the requirements for Peak One to purchase any Put Shares at a Closing),
must be satisfied, including the following:
|
(1) |
Neither
Peak One nor any of its affiliates are permitted to execute any short sales involving our common stock, during the period commencing
on the Execution Date of the EPA, May 3, 2021, and continuing through the end of the Commitment Period, however, sales of our common
stock by Peak One after delivery of a put notice of such number of shares reasonably expected to be purchased by Peak One under a
put will not be deemed short sales. |
|
(2) |
Each
of our representations and warranties in the EPA must be true and correct in all material respects. |
|
(3) |
We
must have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required to be
performed, satisfied or complied with by us. |
|
(4) |
The
registration statement of which this prospectus forms a part must be effective under the Securities Act of 1933 and neither we nor
the Investor shall have received a stop order from the SEC regarding the registration statement. |
|
(5) |
We
shall have no knowledge of any event more likely than not to have the effect of causing the Registration Statement to be suspended
or otherwise ineffective. |
|
(6) |
So
long as the EPA remains in effect, we agree that without the prior consent of Peak One, we will not enter into any other equity line
of credit agreement with any other party. |
|
(7) |
We
agreed to file a Form 8-K, including the transaction documents describing their material terms of the EPA and the Registration Rights
Agreement, which was satisfied on May 7, 2021. |
|
(8) |
We
must have complied with all applicable federal, state and local governmental laws, rules, regulations and ordinances in connection
with the execution, delivery and performance of the EPA and the Registration Rights Agreement. |
|
(9) |
No
statute, regulation, order, decree, writ, ruling or injunction by any court or governmental authority of competent jurisdiction shall
have been enacted, entered, promulgated, threatened or endorsed which prohibits the consummation of or which would materially modify
or delay any of the transactions contemplated by the EPA and the Registration Rights Agreement. |
|
(10) |
No
actions, suits, investigations, inquiries or proceedings pending or threatened against us or any of our subsidiaries nor having received
notice of same. No judgment, order, write, injunction or decree or award has been issued, requested of any court, arbitrator or government
agency that would have a material adverse effect and no pending or contemplated investigation by the SEC involving us or any of our
subsidiaries or any officer or director. |
|
(11) |
No
event has occurred that would have a Material Adverse Effect on us that has not been disclosed in subsequent filings. |
There
is no guarantee that we will be able to meet the foregoing conditions or any of the other conditions in the EPA or that we will be able
to Put any portion of the Total Commitment available under the EPA with Peak One.
The
obligations of Peak One under the EPA to purchase shares of our common stock may not be transferred to any other party, and none of the
terms or conditions contained in the EPA may now be amended or waived by the parties. The registration statement of which this prospectus
is a part will not cover sales by Peak One’s transferees, notwithstanding Peak One’s right to assign its rights under the
Registration Rights Agreement to its affiliates.
The
EPA provides that no termination of the EPA will limit, alter, modify, change or otherwise affect any of the parties’ rights or
obligations with respect to any pending Put Notice, and that the parties must fully perform their respective obligations with respect
to any such pending Put Notice under the EPA, provided all of the conditions to the settlement thereof are timely satisfied.
We
paid to Peak One and Peak One Investments a commitment fee of 125,000 shares each for entering into the EPA, for aggregate Commitment
Fee Shares of 250,000 equal to a Black-Scholes fair value of $28,208 calculated using a per share closing price of $0.30 as of April
30, 2021, the last trading day prior to May 3, 2021 the day such Commitment Fee Shares were issued, using an expected term of 1 year,
expected volatility of 98.02%, risk free interest rate of 0.05% and dividend yield of 0%.
The
EPA also provides for indemnification of Peak One and its affiliates in the event that Peak One incurs losses, liabilities, obligations,
claims, contingencies, damages, costs and expenses related to a breach by us of any of our representations and warranties under the EPA
or the other related transaction documents or any action instituted against Peak One or its affiliates due to the transactions contemplated
by the EPA or other transaction documents, subject to certain limitations. The Registration Rights Agreement indemnifies Peak One for
the aggregate in losses, claims, damages liabilities, judgements, fines, penalties, charges, costs, reasonable attorneys’ fees,
amounts paid in settlement, incurred in investigating, preparing or defending any action, claim, suit inquiry, proceeding, investigation
or appeal taken from the foregoing by or before any court or governmental, administrative, or other regulatory agency, body or the SEC,
to which the Company may become based upon any material violation by Peak One of the Securities Act of 1933, the Securities Exchange
Act of 1934, state securities laws relating to the offer or sale of the Registrable Securities pursuant to the Registration Statement.
The
issuances of the Commitment Shares and the sale of the Shares to Peak One under the EPA are exempt from registration under the Securities
Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of and Regulation
D under the Securities Act.
Registration
Rights Agreement with Peak One
We
have a May 3, 2021 Registration Rights Agreement with Peak One requiring us to file a Registration Statement on Form S-1 providing for
the registration of an indeterminate number of shares of our common stock that result from our selling to Peak One an indeterminate number
of shares up to an aggregate purchase price of $10,000,000 and the subsequent resale by Peak One of such shares, the initial share amount
of which to be registered is 33,863,445 shares. We are responsible for all legal expenses pertaining to the registration statement. We
are required to use our reasonable best efforts to have the Registration Statement on Form S-1 declared effective by the SEC within 90
calendar days from the Execution Date of EPA, May 3, 2021. Our filed Form S1 related to registration of aforementioned securities was
deemed effective as of June 2, 2021.
The
effectiveness of the registration statement of which this prospectus is a part is a condition precedent to our ability to sell common
stock to Peak One under the EPA. We have agreed to file with the Commission one or more additional registration statements to cover all
of the securities required to be registered under the Registration Rights Agreement that are not covered by this prospectus, in each
case, as soon as practicable, but in no event later than the applicable filing deadline for such additional registration statements as
provided in the Registration Rights Agreement. We also agreed, among other things, to indemnify Peak One from certain liabilities and
fees and expenses of Peak One incident to our obligations under the Registration Rights Agreement, including certain liabilities under
the Securities Act of 1933 (the “Securities Act”). Peak One has agreed to indemnify and hold harmless us and each of our
directors, officers and persons who control us against certain liabilities that may be based upon written information furnished by Peak
One to us for inclusion in the registration statement of which this prospectus is a part, including certain liabilities under the Securities
Act. As discussed above, the obligations of Peak One under the EPA to purchase shares of our common stock may not be transferred to any
other party. Peak One may not assign its rights under the Registration Rights Agreement other than to an affiliate of Peak One. The registration
statement of which this prospectus is a part will not cover sales by Peak One’s transferees, notwithstanding Peak One’s right
to assign its rights with respect to Commitment Fee under the Registration Rights Agreement. None of the terms or conditions contained
in the Registration Rights Agreement may now be amended or waived by the parties.
We
are subject to the following obligations under the Registration Rights Agreement:
1.We
shall file with the SEC an initial Registration Statement covering 33,863,445 of the Registrable Securities (beginning with the Commitment
Shares with respect to Investor and Investments).
2.We
shall use our reasonable best efforts to have the Registration Statement declared effective by the SEC within ninety (90) calendar days
from the Execution Date of the Registration Rights Agreement, May 3, 2021, for which we have received from Peak One the above-described
extension, and any amendment declared effective by the SEC at the earliest possible date.
3.We
shall use reasonable best efforts to keep the Registration Statement effective during the term of the EPA.
4.The
Registration Statement (including any amendments, post-effective amendments, or supplements thereto and prospectuses contained therein)
shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary
to make the statements therein, in light of the circumstances in which they were made, not misleading.
5.In
the event the number of shares available under the Registration Statement is insufficient to cover all of the Registrable Securities,
we shall amend the Registration Statement or file a new Registration Statement, so as to cover all of such Registrable Securities.
6.If
the SEC seeks to characterize any offering pursuant to a Registration Statement filed pursuant to this Agreement as constituting an offering
of securities that does not permit such Registration Statement to become effective and be used for resales by the Investor under Rule
415 at then-prevailing market prices (and not fixed prices), or if after the filing of the initial Registration Statement with the SEC
pursuant to Section 2(a), we are otherwise required by the Staff or the SEC to reduce the number of Registrable Securities included in
such initial Registration Statement, then we shall reduce the number of Registrable Securities to be included in such initial Registration
Statement until such time as the Staff and the SEC shall so permit such Registration Statement to become effective and be used as aforesaid.
7.We
shall prepare and file with the SEC such amendments (including post-effective amendments) and supplements to any registration statement
and the prospectus used in connection with such registration statement, which prospectus is to be filed pursuant to Rule 424 promulgated
under the Securities Act, as may be necessary to keep the Registration Statement or any New Registration Statement effective at all times
during the Registration Period.
8.We
shall permit the Investor to review and comment upon the Registration Statement or any New Registration Statement and all amendments
and supplements thereto at least two (2) Business Days prior to their filing with the SEC, and not file any document in a form to which
Investor reasonably objects.
9.As
promptly as practicable after becoming aware of such event or facts, we shall notify the Investor in writing of the happening of any
event or existence of such facts as a result of which the prospectus included in any registration statement, as then in effect, includes
an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements
therein, in light of the circumstances under which they were made, not misleading, and promptly prepare a supplement or amendment to
such registration statement to correct such untrue statement or omission, and deliver a copy of such supplement or amendment to the Investor
(or such other number of copies as the Investor may reasonably request).
10.We
shall use reasonable best efforts to prevent the issuance of any stop order or other suspension of effectiveness of any registration
statement, or the suspension of the qualification of any Registrable Securities for sale in any jurisdiction and, if such an order or
suspension is issued, to obtain the withdrawal of such order or suspension at the earliest possible moment and to notify the Investor
of the issuance of such order and the resolution thereof or its receipt of actual notice of the initiation or threat of any proceeding
for such purpose.
11.We
shall maintain the quotation of our common stock with the Principal Market of which our common stock is quoted, which currently quoted
on OTCQB market operated by OTC Markets Group, Inc. under the symbol “OTLC”.
12.We
shall use reasonable best efforts to cause the Registrable Securities covered by any registration statement to be registered with or
approved by such other governmental agencies or authorities as may be necessary to consummate the disposition of such Registrable Securities.
13.We
shall make and keep public information available, as those terms are understood and defined in Rule 144;
14.We
shall file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Securities
Exchange Act of 1934.
At an assumed purchase price
of $0.0373 (equal to 91% of the closing price of our common stock of $0.041 on April 13, 2023, and assuming the
sale by us to Peak One of all of the 29,878,445 Shares, or approximately 7.1% of our issued and outstanding common stock, and
including the issuance of such shares to be purchased and Commitment Fee Shares to be issued, being registered hereunder pursuant to
put notices under the EPA, we would receive only approximately $1.2 million in gross proceeds. Furthermore, we may receive substantially
less than this $10,000,000 in gross proceeds from the financing due to our share price, discount to market and other factors relating
to our common stock. If we elect to issue and sell more than the 29,878,445 Shares offered under this prospectus to Peak One, which we
have the right, but not the obligation to do, we must first register for resale under the Securities Act any such additional shares,
which could cause additional substantial dilution to our stockholders. Based on the above assumptions, we would be required to register
an additional approximately 238 million shares of our common stock to obtain the balance of approximately $8.9 million
of the Total Commitment that would be available to us under the EPA. We currently have authorized and available for issuance of 750,000,000
shares of our common stock pursuant to our charter.
The number of shares of our
common stock ultimately offered for resale by Peak One is dependent upon a number of factors, including the extent to which we ultimately
issue and sell to Peak One under the EPA. The following table sets forth the total number of Shares that would be issued at varying purchase
prices for us to receive the entire $10,000,000 in gross proceeds under the EPA (without accounting for certain fees and expenses):
Assumed
Average Purchase
Price(1) | | |
Total
Number of Shares
to be Issued if Full
Purchase | | |
Percentage
of Currently Outstanding Shares
(1) | | |
Gross
proceeds from the
Sale of Shares to Peak
One Under
the EPA | |
$ | 0.0093 | (2) | |
| 1,072,098,633 | | |
| 272.89 | % | |
| 10,000,000 | |
$ | 0.0187 | (3) | |
| 536,049,317 | | |
| 136.44 | % | |
| 10,000,000 | |
$ | 0.0280 | (4) | |
| 357,366,211 | | |
| 90.96 | % | |
| 10,000,000 | |
$ | 0.0466 | (5) | |
| 214,419,727 | | |
| 54.58 | % | |
| 10,000,000 | |
$ | 0.0560 | (6) | |
| 178,683,106 | | |
| 45.48 | % | |
| 10,000,000 | |
(1)The
denominator is based on 392,871,880 shares outstanding as of April 12, 2023, which includes 250,000 Initial Commitment Shares comprised
of 125,000 issued each to Peak One and Peak One Investments as consideration for its commitment to purchase our common stock pursuant
to the EPA and 3,735,000 shares already sold under the EPA. The numerator is based on the number of Shares issuable to Peak One under
the EPA at the corresponding assumed average purchase price set forth in the adjacent column.
(2)Assumed
average purchase price of $0.0093 is equal to 91% of 25% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(3)Assumed
average purchase price $0.0187 is equal to 91% of 50% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(4)Assumed
average purchase price of $0.0280 is equal to 91% of 75% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(5)Assumed
average purchase price of $0.0466 is equal to 91% of 125% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(6)Assumed
average purchase price $0.0560 is equal to 91% of 150% of the closing sale price of our common stock of $0.041 on April 13, 2023.
The
following table sets forth the amount of proceeds we would receive from Peak One from the sale of Shares under the EPA that are registered
in this offering at varying purchase prices (without accounting for certain fees and expenses) in the event Peak One is restricted to
hold no more than 4.99% of the issued and outstanding shares of common stock, including 250,000 Initial Commitment Shares comprised of
125,000 issued each to Peak One and Peak One Investments as consideration for its commitment to purchase our common stock pursuant to
the EPA:
Assumed Average Purchase Price | | |
Number
of Registered Shares to be Issued | | |
Percentage
of Currently Outstanding Shares (1) | | |
Proceeds from the Sale of Shares to Peak One Under the EPA | |
$ | 0.0093 | (2) | |
| 19,604,307 | | |
| 4.99 | % | |
$ | 182,859 | |
$ | 0.0187 | (3) | |
| 19,604,307 | | |
| 4.99 | % | |
$ | 365,718 | |
$ | 0.0280 | (4) | |
| 19,604,307 | | |
| 4.99 | % | |
$ | 548,578 | |
$ | 0.0466 | (5) | |
| 19,604,307 | | |
| 4.99 | % | |
$ | 914,296 | |
$ | 0.0560 | (6) | |
| 19,604,307 | | |
| 4.99 | % | |
$ | 1,097,155 | |
(1) The denominator is based on 392,871,880
shares outstanding as of April 12, 2022, which includes 250,000 Initial Commitment Shares comprised of 125,000 issued each
to Peak One and Peak One Investments as consideration for its commitment to purchase our common stock pursuant to the EPA and 3,735,000
shares already sold under the EPA. The numerator is based on the number of Shares issuable to Peak One under the EPA at the corresponding
assumed average purchase price set forth in the adjacent column.
(2)Assumed average purchase price of $0.00093
is equal to 91% of 25% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(3)Assumed average purchase price $0.0187
is equal to 91% of 50% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(4)Assumed average purchase price of $0.0280
is equal to 91% of 75% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(5)Assumed average purchase price of $0.0466
is equal to 91% of 125% of the closing sale price of our common stock of $0.041 on April 13, 2023.
(6)Assumed average purchase price $0.0560
is equal to 91% of 150% of the closing sale price of our common stock of $0.041 on April 13, 2023.
PLAN
OF DISTRIBUTION
The
Selling Security Holders, Peak One and Peak One Investments, may, from time to time, sell any or all of its shares of our common stock
on otcmarkets.com or any other stock exchange, market or trading facility on which the shares of our common stock are traded, or in private
transactions. These sales may be at fixed prices, prevailing market prices at the time of sale, at varying prices, or at negotiated prices.
The selling stockholder may use any one or more of the following methods when selling shares:
|
● |
Ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchases; |
|
● |
Block
trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction; |
|
● |
Purchases
by a broker-dealer as principal and resale by the broker-dealer for its account; |
|
● |
Privately
negotiated transactions; |
|
● |
Broker-dealers
may agree with the selling stockholders to see a specified number of such shares at a stipulated price per share; or |
|
● |
A
combination of any such methods of sale. |
Additionally,
broker-dealers engaged by the Selling Security Holders may arrange for other brokers-dealers to participate in sales. Broker-dealers
may receive commissions or discounts from the selling stockholder (or, if any broker-dealer acts as agent for the purchaser of shares,
from the purchaser) in amounts to be negotiated, but except as set forth in a supplement to this prospectus, in the case of an agency
transaction not in excess of a customary brokerage commissions in compliance with FINRA Rule 2440; and in the case of a principal transaction,
a markup or markdown in compliance with FINRA IM-2440. Broker-dealers may agree with the selling stockholder to sell a specified number
of shares at a stipulated price per share, and, to the extent such a broker-dealer is unable to do so acting as agent for the selling
stockholder, to purchase as principal any unsold shares at the price required to fulfill the broker-dealer commitment to the selling
stockholder. Broker-dealers who acquire shares as principal may thereafter resell such shares from time to time in one or more transactions
(which may involve crosses and block transactions and which may involve sales to and through other broker-dealers, including transactions
of the nature described above and pursuant to the one or more of the methods described above) at fixed prices, at prevailing market prices
at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices, and in connection with such resales
may pay to or receive from the purchasers of such shares commissions computed as described above. To the extent required under the Securities
Act, an amendment to this prospectus or a supplemental prospectus will be filed, disclosing:
|
● |
the
name of any such broker-dealers; |
|
● |
the
number of shares involved; |
|
● |
the
price at which such shares are to be sold; |
|
● |
the
commission paid or discounts or concessions allowed to such broker-dealers, where applicable; |
|
● |
that
such broker-dealers did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus,
as supplemented; and |
|
● |
other
facts material to the transaction. |
Peak
One has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to
distribute the common stock.
There
can be no assurance that the selling stockholder will sell any or all of the shares of common stock registered pursuant to the registration
statement, of which this prospectus forms a part.
The
Selling Security Holders are underwriters within the meaning of the Securities Act of 1933, as amended (“Securities Act”)
and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters” within the meaning
of the Securities Act of 1933 in connection with such sales. Any commissions received by such broker-dealers or agents, and any profit
on the resale of the shares purchased by them, may be deemed to be underwriting commissions or discounts under the Securities Act of
1933. Peak One has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any
person to distribute our common stock. Pursuant to a requirement by FINRA, the maximum commission or discount to be received by any FINRA
member or independent broker-dealer may not be greater than 8% of the gross proceeds received by us for the sale of any securities being
registered pursuant to Rule 415 promulgated under the Securities Act.
Discounts,
concessions, commissions and similar selling expenses, if any, attributable to the sale of shares will be borne by the selling stockholders.
The selling stockholders may agree to indemnify any agent, dealer, or broker-dealer that participates in transactions involving sales
of the shares if liabilities are imposed on that person under the Securities Act.
We
are required to pay certain fees and expenses incurred by us incident to the registration of the shares covered by this prospectus. We
have agreed to indemnify the selling stockholders against certain losses, claims, damages and liabilities, including liabilities under
the Securities Act. We will not receive any proceeds from the resale of any of the shares of our common stock by the Selling Security
Holders. We will, however, receive cash proceeds from Peak One pursuant to Put Notices issued to us by Peak One upon our demand to Peak
One.
We
have entered into agreements with Peak One to keep this prospectus effective until each: (i) has sold all of the common shares purchased
by it and (ii) has no further right to acquire any additional shares of common stock under the agreements.
The
resale shares will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws.
In addition, in certain states, the resale shares may not be sold unless they have been registered or qualified for sale in the applicable
state or an exemption from the registration or qualification requirement is available and is complied with.
Under
applicable rules and regulations under the Securities Exchange Act of 1934, as amended (“Exchange Act”) any person engaged
in the distribution of the resale shares may not simultaneously engage in market making activities with respect to the common stock for
the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling
stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation
M, which may limit the timing of purchases and sales of shares of the common stock by the selling stockholder or any other person. We
will make copies of this prospectus available to the selling stockholders.
We
have agreed to pay all expenses of the registration of the shares of common stock pursuant to the registration rights agreement, estimated
to be approximately $40,000 in total, including, without limitation, Securities and Exchange Commission filing fees and expenses of compliance
with state securities or “Blue Sky” laws; but not including fifty percent (50%) of Peak One’s selling commissions,
concessions and discounts, and other amounts payable to underwriters, dealers or agents, if any, that we agreed to pay or all of Peak
One’s transfer taxes and certain other expenses associated with the sale of the shares of common stock, if any. We have agreed
to indemnify Peak One and certain other persons against certain liabilities in connection with the offering of shares of common stock
offered hereby, including liabilities arising under the Securities Act or, if such indemnity is unavailable, to contribute amounts required
to be paid in respect of such liabilities. Peak One has agreed to indemnify us against liabilities under the Securities Act that may
arise from any written information furnished to us by Peak One specifically for use in this prospectus or, if such indemnity is unavailable,
to contribute amounts required to be paid in respect of such liabilities.
At
any time, a particular offer of the shares of common stock is made by the selling stockholder, a revised prospectus or prospectus supplement,
if required, will be distributed. Such prospectus supplement or post-effective amendment will be filed with the Commission to reflect
the disclosure of any required additional information with respect to the distribution of the shares of common stock. We may suspend
the sale of shares by the selling stockholder pursuant to this prospectus for certain periods of time for certain reasons, including
if the prospectus is required to be supplemented or amended to include additional material information
DESCRIPTION
OF SECURITIES TO BE REGISTERED
Common
Stock Rights
Each
share of Common Stock shall have one (1) vote per share for all purposes. Our Common Stock does not provide preemptive, subscription
or conversion rights and there is no redemption or sinking fund provisions or rights. Our Common Stockholders are not entitled to cumulative
voting for election of Board members. Each share of our Common Stock entitles its holder to one vote in the election of each director
and on all other matters voted on generally by our stockholders. Holders of our Common Stock will be entitled to dividends in such amounts
and at such times as our Board of Directors in its discretion may declare out of funds legally available for the payment of dividends.
We currently intend to retain our entire available discretionary cash flow to finance the growth, development and expansion of our business
and do not anticipate paying any cash dividends on the Common Stock in the foreseeable future. Any future dividends will be paid at the
discretion of our Board of Directors.
Holders
of our Common Stock Shares
As of April 12, 2023, there were approximately
79 stockholders of record of our common stock.
Authorized
Capital Stock
We
are authorized to issue 765,000,000 shares of capital stock in the denominations set forth below, $0.01 par value.
Common
Stock
We are authorized to issue 750,000,000 shares of
common stock, of which 392,871,880 shares are issued and outstanding as of April 12, 2023.
Preferred Stock
We are authorized to issue
15,000,000 preferred shares, of which we had 0 issued and outstanding as of April 12, 2023 and December 31, 2022.
Options and Warrants
As of April 12, 2023 and December 31, 2022,
we had approximately 107 million shares of common stock underlying currently outstanding warrants and options.
Convertible Debt
As of April 12, 2023 and December 31, 2022,
we had approximately 139 million shares of common stock underlying convertible debt.
Dividend
Rights
There
are no restrictions in our Articles of Incorporation or Bylaws that prevent us from declaring dividends. The Delaware General Corporation
Law, however, does prohibit us from declaring dividends where after giving effect to the distribution of the dividend:
1.We
would not be able to pay our debts as they become due in the usual course of business; or
2.Our
total assets would be less than the sum of our total liabilities plus the amount that would be needed to satisfy the rights of shareholders
who have preferential rights superior to those receiving the distribution
We
have never declared or paid any cash dividends on our common stock. We currently intend to retain future earnings, if any, to finance
the expansion of our business. As a result, we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Sales
Pursuant to Rule 144
Any
shares of common stock covered by this prospectus which qualify for sale pursuant to Rule 144 under the Securities Act may be sold under
Rule 144 rather than pursuant to this prospectus.
Rule
144
In
general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for 90 days, a person
(or persons whose shares are aggregated) who is not deemed to have been an affiliate of ours at any time during the three months preceding
a sale, and who has beneficially owned restricted securities within the meaning of Rule 144 for a least six months (including any period
of consecutive ownership of preceding non-affiliated holders) would be entitled to sell those shares, subject only to the availability
of current public information about us. A non-affiliated person who has beneficially owned restricted securities within the meaning of
Rule 144 for at least one year would be entitled to sell those shares without regard to the provisions of Rule 144.
In
general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for 90 days, our affiliates
or persons selling shares on behalf of our affiliates who own shares that were acquired from us or an affiliate of ours at least six
months prior to the proposed sale are entitled to sell upon expiration of the lock-up agreements described above, within any three-month
period beginning 90 days after the date of this prospectus, a number of shares that does not exceed the greater of:
●
1% of the number of shares of common stock then outstanding, which will equal 3,786,301 shares as of the date of this Prospectus; or
●
the average weekly trading volume of the common stock during the four calendar weeks preceding the filing of a notice on Form 144 with
respect to such sale.
Sales
under Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to certain manner of sale provisions
and notice requirements and to the availability of current public information about us.
Transfer
Agent and Registrar
Our
transfer agent is American Stock Transfer & Trust Company, a SEC Registered transfer agent. American Stock Transfer & Trust Company
is located at 6201 15th Avenue, Brooklyn, NY 11219 and its telephone number is (800) 937-5449.
INTEREST
OF NAMED EXPERTS AND COUNSEL
No
expert or counsel named in this Prospectus as having prepared or certified any part of this Prospectus or having given an opinion upon
the validity of the securities being registered or upon other legal matters in connection with the registration or Offering of the Common
Stock was employed on a contingency basis, or had, or is to receive, in connection with the Offering, a substantial interest, direct
or indirect, in the registrant. Nor was any such person connected with the registrant as a promoter, managing or principal underwriter,
voting trustee, director, officer, or employee.
JDT
Legal PLLC will pass on the validity of the Common Stock being offered pursuant to this Registration Statement. JDT Legal PLLC has never
owned any of our securities.
The
consolidated financial statements of Oncotelic Therapeutics, Inc. (Formerly Mateon Therapeutics, Inc.) as of December 31, 2022 and
2021 incorporated in this Prospectus by reference from the Oncotelic Therapeutics, Inc. (Formerly Mateon Therapeutics, Inc.) Annual
Report on Form 10-K for the year ended December 31, 2022 have been audited by Rose, Snyder and Jacobs LLP. This is an independent
registered public accounting firms, as stated in their reports thereon which report expresses an unqualified opinion and includes an
explanatory paragraph relating to the Company’s ability to continue as a going concern, incorporated herein by reference, and have
been incorporated in this Prospectus and Registration Statement in reliance upon such reports and upon the authority of such firm as
experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
filed this Registration Statement on Form S-1 with the SEC under the Act with respect to the Common Stock offered by Selling Shareholders
in this Prospectus. This Prospectus, which constitutes a part of the Registration Statement, does not contain all of the information
set forth in the Registration Statement or the exhibits and schedules filed therewith. For further information with respect to us and
our Common Stock, please see the Registration Statement and the exhibits and schedules filed with the Registration Statement. Statements
contained in this Prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the Registration
Statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract
or other document filed as an exhibit to the Registration Statement. The Registration Statement, including its exhibits and schedules,
may be inspected without charge at the public reference room maintained by the SEC, located at 100 F Street, N.E., Room 1580, Washington,
D.C. 20549, and copies of all or any part of the Registration Statement may be obtained from such offices upon the payment of the fees
prescribed by the SEC. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. The SEC also maintains
an Internet website that contains reports, proxy and information statements and other information regarding registrants that file electronically
with the SEC. The address of the site is www.sec.gov.
DESCRIPTION
OF BUSINESS
Company
Background
Oncotelic
Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) (“Oncotelic”), was formed in the State of New York in 1988 as
OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic
Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly-owned subsidiaries, Oncotelic,
Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO, Inc., a Delaware corporation
and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic,
Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”).
The Company is currently developing OT-101 for various cancers and COVID-19 through its joint venture, GMP Biotechnology Limited (“GMP
Bio”), with Dragon Overseas, Limited (“Dragon”), Artemisinin for COVID-19 and AI technologies for clinical
development and manufacturing. The Company has acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual
dysfunction. In addition, the Company is evaluating the further development of its product candidates OXi4503 as a treatment for acute
myeloid leukemia and myelodysplastic syndromes and CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic
melanoma. The Company is also planning to address the animal health industry through Pet2DAO. Our principal corporate office is
in the United States at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 (telephone: 650-635-7000). Our internet address is
www.oncotelic.com.
Amendments
to Certificate of Incorporation
In
March 2021, the Company received approval from the Financial Industry regulatory Authority (“FINRA”) on its
notice of corporate action to change the name of the Company from Mateon Therapeutics, Inc. to Oncotelic Therapeutics, Inc, and
the Company’s ticker symbol has changed from “MATN” to “OTLC”.
In
January 2021, the Company filed an additional amendment to its Certificate of Incorporation, as amended (the “Charter Amendment”),
with the Secretary of State for the State of Delaware, which Charter Amendment went effective immediately upon acceptance by the Secretary
of State for the State of Delaware. The Charter Amendment increased the number of authorized shares of Common Stock from 150,000,000
shares to 750,000,000 shares.
In
addition, the Company registered an additional total of 20,000,000 shares of its Common Stock, which may be issued pursuant to the Company’s
Amended and Restated 2015 Equity Incentive Plan (the “Plan”). As such, the total number of shares of the Company’s
Common Stock available for issuance under the 2015 plan is 27,250,000.
Overview
We
are a clinical-stage biopharmaceutical company developing drugs for the treatment of orphan oncology indications, developing antisense
and small molecule injectable drugs for the treatment of cancer. After the acquisition of Mateon Therapeutics, Inc through a reverse
merger in 2019, we realigned the company pipeline to focus on rare pediatric cancers. The United States Food and Drug Administration
(“FDA”) has granted us Rare Pediatric Designations (“RPD”) for pediatric Diffuse Intrinsic Pontine
Glioma (“DIPG”) for OT-101, pediatric melanoma for CAP4 and acute myeloid leukemia (“AML”) for
Oxi4503. This strategy aims to capitalize on a voucher program in the United States (“US”). By focusing on RPD we
anticipate: 1) reducing the cost of clinical development by way of a smaller and faster clinical trial, 2) acceleration of the approval
process and final approval, 3) obtaining regulatory/ marketing exclusivity for up to 12 years as a biologic, and 4) obtaining vouchers
worth a significantly large value on regulatory approval, which can be upwards of several million dollars. Approval in the US
would allow for approval in the rest of the world (“ROW”) using the US dossier. Phase 3 clinical trials for approval
in adult indications will be conducted following the positive interim read of the pediatric trials. This approach maximizes return
on investment for the shareholders.
Concurrently
we also explore opportunities to create value for shareholders by forming strategic alliances and/or licensing our product portfolio.
The Company entered into a joint venture (“JV”) with Dragon and GMP Bio, affiliates of GMP in March
2022. GMP Bio and the Company are also looking to take the JV into an initial public offering (“IPO”) of the JV and
which is anticipated to be a liquidity event for Company, especially if the IPO is successful. While we believe that the IPO can be completed
and would be successful, we cannot provide assurance for either of the events to occur; or if they occur, then they would
be successful.
As
a result of the reverse merger of Oncotelic and Oncotelic Inc. in April 2019 and the acquisition of PointR in November 2019, respectively,
we believe we are well positioned as a biotech company with: (1) Oncotelic Inc.’s antisense platform with our drug candidate OT-101
through our JV- targeting high value TGF-β2 target for various cancers and COVID-19, (2) PointR artificial intelligence (“AI”)
for clinical trials, research and development, (3) Edgepoint for developing technologies for manufacturing and for developing technologies
for supporting our COVID-19 programs, (4) Artemisinin for COVID-19, (5) the Company’s vascular disruptor proven safe in more than
500 patients capable of causing massive antigen release which would stimulate immune response against the cancerous tumor and (6) apomorphine,
which we in-licensed in 2021, for developing against Parkinson’s Disease (“PD”), erectile disfunction (“ED”)
and female sexual disfunction (“FSD”). Since the JV is formed with GMP Bio, we will now plan to accelerate
the development of apomorphine as our flagship drug candidate.
We
will also be developing OT-101, also through our JV, an antisense against TGF-β2 – for the treatment of various
viruses, including the severe acute respiratory syndrome (“SARS”) and the current coronavirus (“COVID-19”),
on its own and in conjunction with other compounds. Viral replication cannot occur without TGF-β; and TGF-β surge and a cytokine
storm cannot occur without TGF-β. A Phase 2 trial was completed for OT-101 in South America. This was a randomized, double-blind,
placebo-controlled Phase 2 study intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with positive
COVID-19 and pneumonia.
Based
on the final results of the trial, the trial can expand into a Phase 3 trial if there is a need, as an example in the event of a resurgence
in COVID-19 cases. In the meantime, we are conducting an observational study, looking at OT-101 and long COVID-19, in conjunction with
BARDA.
In
addition, during 2020 and 2021, the Company was developing Artemisinin as a potential therapy for the virus causing COVID-19 (“SARS-CoV-2”).
Artemisinin, purified from the plant Artemisia annua. It can inhibit TGF-β activity and is able to neutralize COVID-19.
The Company initially conducted a study and the test results during an in vitro study at Utah State University showed Artemisinin having
an EC50 of 0.45 ug/ml, and a Safety Index of 140. Artemisinin can target multiple viral threats, including COVID-19, by suppressing both
viral replication and clinical symptoms that arise from viral infection. Viral replication cannot occur without TGF-β. In a clinical
study undertaken in India called ARTI-19, clinical consequences related to the TGF-β surge, including ARDS and cytokine storm, were
suppressed by targeting TGF-β with Artemisinin. The ARTI-19 trials were conducted in India by Windlas Biotech Limited (“Windlas”),
the Company’s business partner in India. Windlas had applied for regulatory approval for it’s Artemisinin based product,
ArtiShieldTM, but has not been able to obtain regulatory approval for use of ArtiShieldTM as a COVID-19 therapy
and as such, no significant revenues have been reported by Windlas nor have we accrued any royalties on Artemisinin due from Windlas.
We intend to focus future development on Artemisinin against other respiratory viruses with unmet needs but do not know how successful
we will be with those efforts as the incidence of COVID-19 has reduced substantially over the past couple years.
In September 2021, Oncotelic entered into an exclusive
License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”), pursuant to which Autotelic granted
Oncotelic, among other things: (i) the exclusive right and license to certain Autotelic Patents (as defined in the Agreement) and Autotelic
Know-How (as defined in the Agreement); and (ii) a right of first refusal to acquire at least a majority of the outstanding capital stock
of Autotelic prior to Autotelic entering into any transaction that is a financing collaboration, distribution revenues, earn-outs, sales,
out-licensing, purchases, debt, royalties, merger acquisition, change of control, transfer of cash or non-cash assets, disposition of
capital stock by way of tender or exchange offer, partnership or any other joint or collaborative venture, research collaboration, material
transfer, sponsored research or similar transaction or agreements. In exchange for the rights granted to Oncotelic, Autotelic will be
entitled to earn the milestone payments. This transaction brings in AL-101 - an intranasal apomorphine asset with clear 505(b)2 pathway
to approval for PD as well unique mechanism of action for treatment of ED and FSD.
We
currently have eight primary drug and AI technology programs we are seeking to advance:
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Intranasal
drug and delivery system for intra-nasal Apomorphine for the treatment of PD, ED and FSD. |
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OT-101
- an antisense against TGF-β2 – for the treatment of solid tumors with focus on brain cancer in adult and DIPG in children.
A RPD for pediatric DIPG has been granted by US FDA. |
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OT-101
- an antisense against TGF-β2 –for the treatment of various viruses, including the SARS and the current COVID-19, on its
own and in conjunction with other compounds. |
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Artemisinin
– a natural derivative from an Asian herb Artemisia Annua - Artemisinin has shown to be highly potent at inhibiting the ability
of the COVID-19 causing virus to multiply while also having an excellent safety index as well as against hepatitis B and C viruses,
human herpes viruses, HIV-1, influenza virus A, and bovine viral diarrhea virus in the low micromolar range. |
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CA4P-
a vascular disrupting agent (“VDA”) - in combination with Ipilimumab for the treatment of solid tumors with focus on
melanoma in adult and pediatric melanoma. A RPD has been granted to the Company by the FDA for pediatric melanoma. |
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Oxi4503-
a second generation VDA - for the treatment of liquid tumors with focus on childhood leukemia. A RPD has been granted to the Company
by the FDA for AML. |
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Backoffice
support using PointR fabric cluster computing grids for blockchain/AI for pharmaceutical manufacturing and clinical trials and monitoring;
and PointR AI for drug development through various stages of development. |
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Developing
AI based technologies to enhance the development and commercialization of our Artemisinin
based products and support technologies. Further, as part of the JV Agreement, the JV
has acquired a non-exclusive license for the AI platform developed by PointR/EdgePoint for
implementation in a planned CDMO.
In
addition, the Company formed a Decentralized autonomous organization (“DAO”)
entity, Pet2DAO, Inc. (“Pet2DAO”), as a wholly owned subsidiary. A DAO
is an emerging form of legal structure, that has no central governing body, and whose members
share a common goal to act in the best interest of the entity. Pet2DAO is a DAO technology
company, integrating the strong governance of traditional corporations with the innovative
DAO architecture. The Company will look to engage stakeholders, to build value through the
DAO, while maintaining the rigor of traditional corporations, including governance, compliance,
and accountability through a team of veterans in public companies with innovators in AI,
blockchain and Web3. Pet2DAO will initially be looking to develop products for the animal
health space. The Company will initially issue regular tokens and non-fungible tokens (“NFT”
and cumulatively “Tokens”) of Pet2DAO called PDAO to its employees, shareholders
and key opinion leaders (“KOLs’) and use the Tokens to propose and vote
on various animal health related programs. In the future, the Company will evaluate and plan
to register these tokens with the SEC to make such Tokens freely tradable at a future point
in time. |
AL-101:
PD/ ED/FSD
Oncotelic
acquired AL-101 for the intranasal delivery of apomorphine for the treatment of PD. Over 60,000 new patients being diagnosed with PD
in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030.
In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics.
AL-101 is also being developed for ED. ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED
are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019).
Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it
was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed
to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed
for FSD. FSD is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as
women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal
chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the FDA approved Vyleesi (bremelanotide)
to treat acquired, generalized hypoactive sexual desire disorder (“HSDD”) in premenopausal women. This is the only
available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD, however, it has a long list of drug-drug interactions,
including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use
with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective
therapy against FSD and HSDD.
OT-101:
An Antisense Against TGF-β2
Trabedersen
(AP12009, OT-101) is a novel antisense oligodeoxynucleotide (“ODN”) developed by Oncotelic Inc. for the treatment
of patients with pancreatic carcinoma, malignant melanoma, colorectal carcinoma, high-grade glioma (“HGG”), and other
transforming growth factor beta 2 (“TGF-β2”) overexpressing malignancies (e.g. prostate carcinoma, renal cell
carcinoma, etc.). Trabedersen is a synthetic 18-mer phosphorothioate oligodeoxynucleotide (“S-ODN”) complementary
to the messenger ribonucleic acid (“mRNA”) of the human TGF-β2 gene.
TGF-β
is a multifunctional cytokine with a key role in promoting tumor growth and progression including cell proliferation, cell migration,
and angiogenesis. Above all, TGF-β is a highly potent immunosuppressive molecule. Inhibition of TGF-β overexpression in tumor
tissue represents a novel multimodal treatment principle leading to the reduction of tumor growth, inhibition of metastasis, and restoration
of host antitumor immune responses. Despite its recognized pivotal role in cancer, therapeutics targeting TGF-β have not been successful
and many have failed due to toxicity issues possibly due to inhibition of TGF-β1 essential functions. The high level of homology
between the various TGF-β isoforms is making it impossible to create mAb or small molecule inhibitor without TGF-β1 cross-inhibition.
Therefore, Oncotelic Inc. chose to target TGF-β2 only using OT-101 antisense approach. The sequence of OT-101 can only target TGF-β2
and does not have any impact on other TGF-β isotypes. However, suppression of TGF-β2 directly by OT-101 would also result in
suppression of TGF-β2 indirectly, but not TGF-β3.
Trabedersen
is believed to reverse TGF-β’s immunosuppressive effects, rendering the tumor visible to a patient’s immune system and
resulting in priming and specific activation of the patient’s anti-tumor immune response. OT-101 has completed multiple clinical
trials with promising outcomes. OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination
with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers. Oncotelic
plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. During phase 2 clinical trials
in pancreatic cancer, melanoma, and colorectal cancers (Study P001) and in high-grade gliomas (Study G004), meaningful single agent activity
with meaningful tumor reduction was observed, and OT-101 exhibited a favorable safety profile. Both partial and complete responses have
been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors.
Oncotelic
Inc.’s self-immunization protocol (SIP©) is based on the novel and proprietary sequential treatment of cancers with OT-101
(antisense against TGF-β2) and chemotherapies. Proper Sequencing of treatments is key to optimal immunotherapy. Leveraging from
its in-depth knowledge of TGF-β immunotherapy, Oncotelic Inc. ordered the various treatments in the following sequence: (1) expand
immune reserve through IL-2 treatment or infusion of immune cells; (2) prime immune response with TGF-β inhibitor OT-101; (3) boost
immune response with chemotherapy; and (4) revitalize the exhausted of immune response with checkpoint inhibitors. This sequential treatment
strategy is aimed at achieving effective self-immunization against a patients’ own cancer, resulting in robust therapeutic immune
response and consequently better control of the cancer and improved survival. Prolonged states of being cancer-free have been observed
in some patients with the most aggressive forms of cancer, raising a renewed hope for a potential cure. The use of OT-101 lifts the suppression
of the patient’s immune cells around the cancer tissue, providing the foundation for an effective initial priming, which is critical
for a successful immune response. The subsequent chemotherapy results in the release of neoantigens that result in a robust boost of
the immune response. This process is termed Xenogenization process and can be: (1) hypermutation by temozolomide in the treatment of
brain cancer, (2) immunogenic cell death by taxanes and 5FU in pancreatic cancer, or (3) necrotic cell death by VDA (vascular disrupting
agent) in melanoma and MDS. Additionally, the Company believes that a rational combination of the Oncotelic Inc. SIP platform with immune-modulatory
drugs like interleukin 2 (IL-2) and/or immune checkpoint inhibitors has the potential to help achieve sustained and robust immune responses
in patients with the most difficult-to-treat forms of cancer. The combinations with IL-2 and NK are already partnered with external corporate
partners. The Company entered into a JV with Dragon Overseas Capital Limited (“Dragon Overseas”) and GMP Biotechnology
Limited (“GMP Bio”), affiliates of GMP on March 31, 2022. GMP Bio and the Company will focus to further expand the development
of OT-101 for various oncology indications like pancreatic cancer, melanomas, gliomas etc. as also for viral infections like COVID-19.
This path is being evaluated as a monotherapy, as well as combination therapies in conjunction with other drugs like checkpoint inhibitors.
Pancreatic
Cancer
Pancreatic
cancer is associated with the poorest prognosis of gastrointestinal cancers and is expected to become the second leading cause of cancer-related
mortality in the USA by 2030. Pancreatic cancer is traditionally considered to be an immune-resistant disease. There is a lack of effector
T cells, an abundance of myeloid-derived suppressor T cells, and a dearth of key immune effector and regulatory cells. This may be part
of the reason why single-agent checkpoint inhibitors are not as effective in comparison to other diseases. Here is where breaking immune
tolerance by inhibiting TGF-β with OT-101 will have a significant impact.
The
P001 trial was an open-label, multicenter dose-escalation study to evaluate the safety and tolerability of OT-101 (TGF-β2-specific
Phosphorothioate Antisense Oligodeoxynucleotide) in adult patients with advanced tumors known to overproduce TGF- β2, which are
not or no longer amenable to established therapies. The primary objective of the study was to determine the maximum tolerated dose (MTD)
and the dose-limiting toxicities (DLTs) of two cycles of trabedersen administered intravenously (i.v.) on a 7-days-on/7-days-off or 4-days-on/10-days-off
schedule. Secondary objectives included were: (1) determining the safety and tolerability of OT-101 administered intravenously at weekly
intervals for four days every other week; (2) assessing the plasma pharmacokinetic profile of OT-101 administered intravenously at weekly
intervals and for four days every other week; (3) establishing a suitable determination method and to assess the urine pharmacokinetic
profile of OT-101 administered intravenously for four days every other week; (4) determining the effect of OT-101 administered intravenously
at weekly intervals and for four days every other week on TGF-β2 plasma concentration levels; and (5) Assessing the potential antitumor
activity of OT-101 administered intravenously at weekly intervals and for four days every other week, as assessed by the effect on tumor
size and tumor markers.
Of
the 61 patients treated, 37 had advanced treatment failure pancreas cancer, a very difficult-to-treat cancer with an overall survival
rate that is measured in months even with the best available chemotherapy regimens. Globally, over 400,000 people die of pancreatic cancer
each year. MTD was not reached for the 4-days-on/10-days-off schedule, which became the schedule adopted for the phase 2 expansion phase
of the trial. Disease control (complete response (CR)), partial response (PR) or stable disease (SD)) was achieved in 19 of 35 evaluable
pancreas cancer patients (54%). Among liver mets only patients, there are exceptional single-agent activity and survival. Patient 1006
was pushed to complete response (CR) and survived as far out as 77 mos. This patient failed multiple lines of therapies: (1) surgery:
Whipple’s procedure, (2) 1st line: 5-FU/LV, Dose 425 mg/m2, (3) 2nd line: 5-FU/LV, Dose 2600 mg/m2/24hr, (4) 3rd line: Gemcitabine,
Dose 1000 mg/m2/week, and (5) went on to OT-101with liver mets and complete response. Patient 1022 was pushed to stable disease (“SD”)
with overall survival of 40 months. This patient had also failed multiple lines of therapies: (1) surgery: Whipple’s procedure,
(2) 1st line: radiation therapy (50 Gy), (3) 2nd line: 5FU, and (4) went on to OT-101 with liver mets and SD.
OT-101
treatment more than doubled the ratio of patients being able to go onto subsequent chemotherapy versus not being able, and consistent
with the expected immunization boost coming from Xenogenization with subsequent chemotherapies (taxanes and 5FU/Cisplatin) as discussed
for SIP, those with subsequent chemotherapy exhibited increased mOS and more than doubled their 1-year survival. Patients treated
with the non-SIP agent did not exhibit these properties.
Gliomas
Brain
tumors in the United States are rare and only accounted for 2% of all adult cancers. However, the rate of brain tumors on the rise for
the last 30 years. The more common and most malignant form of brain tumors – glioblastoma (“GBM”) has more than
doubled from 2.4 to 5.0 per 100,000. In the face of this increase, treatment remained essentially unchanged during the last decade. And
despite aggressive surgery followed by radiation and/or chemotherapy, GBM has the worst five–year survival rates among all human
cancers, with an average survival from diagnosis of only about 1 year and less than 5% of the patient survived after 5 years. On top
of it all, GBM will recur or regrow in most patients. Treatment of recurring a high-grade GBM that has recurred does not always improve
survival compared with hospice care alone and deciding when to stop treating the cancer and entering into hospice care is frequently
recommended when the patient is unlikely to live longer than six months.
GBM
resilience and persistence is in stark contrast with the recent excitement in oncology where Immuno Oncology (IO) agents have shown promise
to be curative by driving the immune cells to attack the tumors. Though extraordinarily effective against the growing number of tumors,
IOs have been ineffective against GBM. GBM is generally considered immunologically “cold” with few immune effector cells
needed for successful immunotherapy. The overexpression of transforming growth factor-beta 2 (“TGF-β2”) is associated
with poor prognosis of tumors and plays a key role in malignant progression of various tumors including GBM by inducing proliferation,
metastasis, angiogenesis, and immunosuppression. Oncotelic Inc. is developing a novel TGF- β2 antisense agent OT-101 as immunotherapy
against GBM.
G004
is a multinational, multicenter, open-label, randomized, active-controlled, parallel-group study in adult patients with either recurrent
or refractory AA (WHO grade III) or recurrent or refractory GBM (WHO grade IV). There were 3 treatment groups: (1) 10 µM Trabedersen,
(2) 80 µM Trabedersen, and (3) standard chemotherapy (mostly TMZ). Tumor control rate at 6 months was the primary endpoint. Response
assessment included the tumor control rate and the overall response rate, which were assessed at 6, 12, and 14 months by central MRI
reading. The tumor control rate was defined as the percentage of patients with either CR, PR, or SD and the overall response rate was
defined as percentage of patients with either CR or PR. An independent blinded central MRI reading was performed to obtain a standardized
response assessment for the efficacy analysis. Central reading was performed by 2 independent neuroradiologists with an additional adjudicator
deciding in case of conflicting opinions.
All
patients had previous tumor surgery, almost all patients had previous radiation therapy, and more than half of the patients had received
previous chemotherapy. A total of 134 patients, 89 patients in the OT-101 test group and 45 patients in the standard chemotherapy control
group were assessed. The findings of a randomized Phase II study further confirmed the feasibility of intratumoral application of OT101
via convection enhanced delivery (CED) for up to 6 months and showed that it results in early disease control at 6 months at a rate comparable
to that achieved with temozolomide. OT101 was administered to 89 R/R high-grade glioma (HGG) (Anaplastic Astrocytoma/AA:27; Glioblastoma
multiforme/GBM: 62) patients with an intratumoral catheter using a convection enhanced delivery (CED) system. 77 patients (Efficacy population;
GBM: 51; AA: 26) received at least the intended minimum number of 4 OT101 treatment cycles. Response determinations were based on central
review of MRI scans according to McDonald criteria. Standard statistical methods were applied for the analysis of data. Nineteen patients
had a complete response (CR) or partial response (PR) following a slow but robust size reduction of their target lesions. In addition,
7 patients had stable disease (SD) lasting ≥6 months. For the combined group of 26 AA/GBM patients with favorable responses, the median
PFS was >3 years and OS was >3.5 years (16, 17). Hence, OT101 administered intratumorally exhibits clinically meaningful single-agent
activity and induces durable CR/PR/SD in R/R HGG patients. These results provided the proof of concept that targeting TGFβ2 with
intratumoral OT101 therapy can result in a favorable survival outcome for R/R HGG patients (AA, WHO grade 3 and GBM, WHO Grade 4).
OT-101:
Pediatric DIPG
DIPG,
the second most common malignant pediatric brain tumor, has a dismal outcome with available standard treatment modalities. No significant
therapeutic advances have been accomplished in the treatment of this poor prognosis brain tumor and the average overall survival has
remained <1 year with a 2-year survival rate of <10%. In solid tumors, the expression level of the TGFβ has been identified
as a significant contributor to disease progression and poor prognosis as well as resistance to standard therapy and metastasis. In particular,
TGFβ has been implicated in treatment resistance to targeted therapeutics, chemotherapy as well as immune-oncology drugs. Importantly,
TGFβ restrains anti-tumor immunity by restricting cytotoxic T-cell infiltration, recruiting regulatory T cells and inhibiting the
maturation as well as function of natural killer (“NK”) cells. Amplified activity of the TGFβ-Smad signaling
pathway enhances tumor growth, invasion, as well as angiogenesis and has been implicated in the malignant phenotype and poor prognosis
of high-grade gliomas in adults. Therefore, TGF-β has emerged as an attractive target for the therapeutic intervention of high-grade
gliomas.
We
recently performed a meta-analysis of TGFβ2 gene expression in primary tumor specimens from 29 pediatric DIPG patients in the publicly
available archived datasets. Our data provided unprecedented evidence that TGFβ2 is expressed at high levels in pediatric DIPG.
Three TGFβ2 probesets exhibited 1.8-2.5-fold increased levels of expression in DIPG patients. Our meta-analysis provided new evidence
that TGFβ2 gene and its interactome are expressed in pediatric DIPG at significantly higher levels than in normal tissues or low-grade
gliomas. Hence, TGFβ2 is an attractive molecular target for immunotherapy of pediatric DIPG.
The
US FDA has granted the Company a RPD for pediatric DIPG.
OT-101
for Treatments of Corona Viruses
When
COVID-19 emerged in China, the Company and GMP contemplated a collaboration to develop drug candidates for COVID-19. Oncotelic Inc. and
GMP entered into a research and services agreement (the “GMP Agreement”) in February 2020 memorializing their collaborative
efforts to develop and test COVID-19 antisense therapeutics. In March 2020, Oncotelic reported the anti-viral activity of OT-101 –
its lead drug candidate currently in phase 3 testing in pancreatic cancer and glioblastoma. In an in vitro antiviral testing performed
by an independent laboratory, OT-101 showed that it was highly active against COVID-19. Further, in March 2020, the Company, Oncotelic
Inc. and GMP entered into a supplement to the Agreement (the “Supplement”) to confirm the inclusion of OT-101 within
the scope of the GMP Agreement, pending positive confirmatory testing against COVID-19. In consideration for the financial support provided
by GMP for the research, pursuant to the terms of the GMP Agreement (as amended by the Supplement), GMP is entitled to obtain certain
exclusive rights to the use of the Product in the field of the treatment of COVID-19 on a global basis, and an economic interest in the
use of the Product in the field of the treatment of COVID-19 including 50/50 profit sharing. In March 2020, the Company reported the
anti-viral activity of OT-101, in an in vitro antiviral testing performed by an independent laboratory, OT-101 has an 50% effective concentration
(EC50) of 7.6 µg/mL and is not toxic at the highest dose of 1000 µg/mL giving a safety index (SI) value of >130, which
is considered highly active and on par or superior to Remdesivir- a Gilead’s drug. Unlike Remdesivir- OT-101 targets not only the
virus replication but also the virus induced pneumonia and fibrosis.
A
Phase 2 C001 Covid Study: “A Double-Blind, Randomized, Placebo Controlled, Multi-Center Study of OT-101 in Hospitalized COVID-19
Subjects” was completed for OT-101 in South America, that can expand into a Phase 3 trial if the data supports the safety of the
drug. This was a randomized, double-blind, placebo-controlled Phase 2 study intended to evaluate the safety and efficacy of OT-101 in
adult patients hospitalized with positive COVID-19 and pneumonia. By suppressing TGF-β, OT-101 suppresses COVID-19 replication directly
and has the potential to also suppressed viral induced pneumonia and fibrosis. In October 2021, Data lock and Study Data and Analysis
Data Models (SDTMs & ADaMS Databases) were generated for the trial. The trial compares OT-101 in combination with Standard of Care
(“SOC”) versus Placebo plus SOC (N= 32 pts at 2:1 randomization ratio). SOC includes dexamethasone, the only drug
known to improve outcomes in severe cases of COVID-19. The top line data was:
|
1) |
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Safety
endpoints met. OT-101 as a TGF-β inhibitor was safe to administer to COVID-19 patients including severe/critical COVID-19 patients. |
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2) |
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Efficacy
signals were obtained. End of treatment (Day 7) mortality for the entire study population was 4.5% OT-101 versus 20% for placebo. |
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3) |
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Incidence
of >96% viral load knockdown on End of Treatment (Day 7) was 89% for OT-101 versus 67% for placebo. |
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4) |
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Overall
survival improved 3X for critical COVID-19 pts (4 days for placebo versus 14 days for OT-101, p < 0.0166). |
Artemisinin
for Treatment of COVID-19
Artemisinin
derived from Chinese herb Artemisia annua L. (Sweet wormwood) has been used medicinally to treat fevers for centuries in China. Like
other potential COVID-19 therapeutic agents such as Hydrochloroquine and Remesidivir, the efficacy of Artemisinin remains to be tested
in well controlled and sufficiently powered clinical trials.
We
discovered that Artemisinin was highly potent at inhibiting the ability of SARS-CoV-2 to multiply while also having an excellent safety
index. The Company’s’ test results during an in vitro study at Utah State University showed Artemisinin having an EC50 of
0.45 ug/ml, and a Safety Index of 140. Artemisinin has the potential to target multiple viral threats, including COVID-19, by suppressing
both viral replication and clinical symptoms that arise from viral infection. Viral replication cannot occur without TGF-β. Artemisinin
also has been reported to have antiviral activities against hepatitis B and C viruses, human herpes viruses, HIV-1, influenza virus A,
and bovine viral diarrhea virus in the low micromolar range. TGF-β surge and cytokine storm cannot occur without TGF-β. Clinical
consequences related to the TGF-β surge, including ARDS and cytokine storm, are suppressed by targeting TGF-β with Artemisinin.
The
availability of Artemisinin as a pre-existing dietary supplement may allow it to be deployed in many countries, including developing
countries where the healthcare system can easily be overwhelmed. Its safety was clearly superior to chloroquine and remesidivir. The
Company’s ARTI-19 trial in India was conducted by Windlas, the Company’s business partner in India, as part of the Company’s
effort at deploying ArtiShieldTM across India, and a variation of that in Asia, Africa, and Latin America. No adverse events
were reported that required discontinuation of treatment. When ARTIVeda™ / PulmoHeal™ was added to
the SOC, more patients recovered faster than SOC alone.31 of 39 (79.5%) of patients taking became asymptomatic after 5-day of therapy.
In comparison, only 12 of 21 control patients (57.1%) treated with SOC alone became asymptomatic on day 5. For the sicklier patients
(WHO scale 4), the median time to becoming asymptomatic was only 5 days for the ARTIVeda™ / PulmoHeal™ +
SOC group, as compared to 14 days for the SOC alone group. These data sets provided clinical support that targeting the TGF-β pathway
with ARTIVeda™ / PulmoHeal™ may contribute to a faster recovery of patients with mild to moderate COVID-19
patients. The Company has published the results of the trial in certain renowned publications. The Company is intending to continue developing
Artemisinin as pharmaceutic for tropical viral diseases. Windlas had applied for regulatory approval for it’s Artemisinin based
product, ArtiShieldTM, but has not been able to obtain regulatory approval for use of ArtiShieldTM as a COVID-19
therapy and as such, no significant revenues have been reported by Windlas nor have we accrued any royalties on Artemisinin due from
Windlas.
CA4P
as an Immuno-Oncology Agent
Radiation
therapy, recognized for its potent cytotoxic effect on cancer cells by inducing direct DNA damage, can sometimes elicit a systemic antitumoral
response. Irradiation releases a plethora of neoantigens and pro-inflammatory cytokines, acting like an in-situ vaccine, resulting in
tumor regression within the primary site, but may also occasionally result in regression of distant secondary lesions. This regression
of distant cancer metastases when the primary tumor is irradiated is defined as the abscopal effect. Yet, an abscopal effect with radiotherapy
alone occurs infrequently, signifying that the antitumor immunity caused by radiation is not sufficient enough to abolish the tumor and
its metastases nor able to prevent the metastatic process or the immunosuppressing effect the cancer exhibits on the host’s systemic
macroenvironment. Recently, several studies have confirmed the synergistic antitumoral immunity caused by the combination of radiation
with immunotherapy, which has demonstrated a durable abscopal effect in patients with advanced malignancies. Postow, et al, Golden, et
al, Hinicker, et al and others have all described early findings of a reproducible abscopal effect when combining irradiation with Ipilimumab
and/or Nivolumab.
Similarly,
CA4P causes rapid and widespread tumor cell necrosis. A number of laboratories have shown that the type of tumor cell death induced by
ischemic necrosis not only controls the presence or absence of specific tumor antigens, but also can result in immunological responses
ranging from immunosuppression to anti-tumor immunity. The terms “immunogenicity of cell death” or “immunogenic cell
death” (ICD) is often used by scientists to describe the ability of dead/dying cells (especially of tumor cells) to mount antigen-specific
and particularly CD8 + T-cell-mediated adaptive immune responses and not simply lead to innate inflammation. CD8 + T-cells play significant
role in tumor protection and development of this type of immunity. A modernized concept has emerged which defines immunogenic cell death
in general because of mutual or consequent processes including endoplasmic reticulum stress release of “find-me” signals
(e.g., ATP), exposure of “eat-me” signals (e.g., calreticulin, phosphatidylserine) and damage-associated molecular patterns
(DAMPs [HMGB1, F-actin]). These molecular changes might occur in the cells undergoing necrotic death. These and other signals appear
to be relevant to the potential for CA4P to increase immunogenicity following induction of ischemic necrosis.
Preclinical
studies in which CA4P was combined with an anti-CTLA4 antibody using an EMT-6 mammary tumor model showed that 7 out of 8 mice receiving
a combination of CA4P and an anti-CTLA4 antibody experienced complete remission of their tumors, compared to only 1 of 8 in the CA4P
monotherapy arm and 2 of 8 in the anti-CTLA4 antibody monotherapy.
Three
of four follow-up preclinical studies confirmed that CA4P combined with immuno-oncology agents could delay tumor growth. Follow-up studies
were conducted in a CT26-32 colon cancer model, a larger tumor EMT-6 mammary cancer model, and a C3H mammary cancer model. Studies in
a CT-26-32 colon cancer animal model using CA4P combined with anti-CTLA4 antibodies demonstrated a 77% reduction in tumor size compared
to immuno-oncology agents alone, and an 89% reduction in tumor size compared to control. This large tumor model also showed a survival
benefit for the animals receiving combination therapy, with all animals in the combination therapy group surviving to the end of the
study, compared to no animals surviving on the control and only half of the animals surviving that received immuno-oncology agents alone.
Additional
analyses of changes induced within tumors following combination therapy have shown that CA4P increases the immunogenic effect of checkpoint
inhibitors when used alone as monotherapy. Tumor-fighting white blood cell counts, T-cells and cytotoxic T-cells compared to immuno-oncology
agents alone. Tumor necrosis with the combination of CA4P and immuno-oncology agents is nearly double the necrosis with only immuno-oncology
agents (63.9% compared to 32.8%, control = 25.8%).
The
overall data from all these studies provides evidence that CA4P may enhance the activity of immuno-oncology agents for the treatment
of cancer, including anti-CTLA4 antibodies. Furthermore, CA4P has clinical activity in melanoma in early clinical testing and repeated
demonstration of CA4P mediated necrotic tumor cell death across 17 completed clinical trials and >500 patients. During various phase
1 studies, we found that CA4P treatment resulted significant disease control among patients with solid tumors who progressed on standard
therapies. CA4P treatment resulted in 2 Stable Disease (SD) of 5 melanoma patients treated. The combination of CA4P with carboplatin
and paclitaxel was well tolerated in the majority of patients with adequate premedication and had antitumor activity in patients who
were heavily pretreated. Patients with advanced cancer refractory to standard therapy were treated with CA4P as a 10-min infusion, 20
h before carboplatin, paclitaxel, or paclitaxel, followed by carboplatin. Responses were seen in 10 of 46 (22%) patients with ovarian,
esophageal, small-cell lung cancer, and melanoma. One Partial Response (PR) was observed of 6 melanoma patients treated follow progressing
during first-line trial therapy with dacarbazine and sorafenib. In melanoma animal model- B16-F10 murine melanoma experimental tumors-
seventy-four hours after drug administration, a decrease in the number of tumor blood vessels was apparent and necrotic areas within
tumors were visible. Building on the single agent activity of CA4P, we are expecting that combination of CA4P with Ipilimumab or other
immune-oncology drug would result in improved tumor control for these patients above the 2 PR out of 17 patients treated with Ipilimumab
alone which supported the approval of Ipilimumab in pediatric melanoma.
CA4P:
Pediatric Melanoma
Until
the recent approval of ipilimumab as the first immunotherapy agent approved for children, metastatic or nonresectable pediatric melanoma
did not have any FDA-approved therapies available. As for adult melanoma patients, the mainstay of care is surgical excision. Studies
also show that children treated for melanoma should be closely monitored as they are at increased risk of recurrence later in life. However,
there are only very limited data on the efficacy of systemic therapy in children and adolescents with advanced melanoma and new effective
therapies are urgently needed. There are only very limited data on the efficacy of systemic therapy in children and adolescents with
advanced melanoma. Several phase I/II trials have been designed to evaluate therapies for pediatric cancer patients that included subsets
of patients with advanced melanoma.
Ipilimumab
was evaluated in a phase I clinical study in children with unresectable stage IIIC or IV melanoma and in a pediatric phase II trial (NCT01696045)
that included children aged 12 years or older with previously treated or untreated, unresectable stage III or IV malignant melanoma.
Of the 17 melanoma patients older than 12 years treated with ipilimumab across both studies, two experienced objective responses. Immune-related
adverse events included pancreatitis, pneumonitis, endocrinopathies, colitis, and transaminitis, with dose-limiting toxicities observed
at 5 mg/kg. No grade 2 or higher immune-related toxicities were identified at doses of 3 mg/kg or less. Based upon the results of these
studies and evidence from studies in adult patients, in July 2017, the FDA approved ipilimumab for the treatment of unresectable or metastatic
melanoma in children aged 12 years and older.
It
is expected that combination of CA4P with Ipilimumab or other immune-oncology drugs would result in improved tumor control for these
patients above the 2 PR out of 17 patients treated with ipilimumab.
The
FDA granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin tromethamine for the treatment of stage IIB–IV melanoma
due to genetic mutations that disproportionately affect pediatric patients as a drug. Preclinical studies in which CA4P was combined
with an anti-CTLA4 antibody using an EMT-6 mammary tumor model showed that 7 out of 8 mice receiving a combination of CA4P and an anti-CTLA4
antibody experienced complete remission of their tumors, compared to only 1 of 8 in the CA4P monotherapy arm and 2 of 8 in the anti-CTLA4
antibody monotherapy. This application is based on observed CA4P activity in melanoma in early clinical testing. During various phase
1 studies, we found that CA4P treatment resulted significant disease control among patients with solid tumors who progressed on standard
therapies. CA4P treatment resulted in 2 Stable Disease (SD) of 5 melanoma patients treated. One Partial Response (PR) was observed of
6 melanoma patients treated follow progressing during first-line trial therapy with dacarbazine and sorafenib. Building on the single
agent activity of CA4P, we are expecting that combination of CA4P with Ipilimumab or other immune-oncology drug would result in improved
tumor control for the target pediatric population above the 2 PR out of 17 patients treated with Ipilimumab alone which supported the
approval of Ipilimumab in pediatric melanoma.
OXi4503
for Acute Myeloid Leukemia
OXi4503
(combretastatin A1-diphsphate; CA1P) is a novel investigational vascular disrupting agent (“VDA”) that has been shown
to have a significant in vitro cytotoxic as well as chemo-sensitizing activity against human Acute Myeloid Leukemia (“AML”)
cells. OXi4503 also exhibited in vivo anti-leukemic activity in xenografted mice with human AML.
OXi4503
employs a new, broader strategy against AML than currently exists for standard chemotherapy, as it provides a dual mechanism of action
involving both anti-vascular effects and direct cytotoxicity to AML cells. Vascular and/or Bone marrow endothelial cells (“ECs”)
appear to provide a protective effect for AML cells, keeping them dormant within the bone marrow. VDAs may target these ECs and reverse
their chemo protective effect, providing a novel approach to the treatment of AML which may otherwise be resistant to other chemotherapeutic
therapies. Preclinical data indicate that OXi4503 alone and in combination with traditional AML treatments such as cytarabine may provide
significant benefit in eliminating AML cells. Results from two completed Phase I clinical trials demonstrated the clinical impact potential
of OXi4503 against relapsed AML when it is alone or in combination with the standard chemotherapy drug cytarabine (“ARA-C”)
can induce complete remissions in relapsed AML patients. Notably, OXi4503 showed single agent activity in a clinical Phase I trial and
resulted in complete remission of a relapsed AML patient. Sustained complete remissions were also achieved in relapsed AML patients who
were treated with OXi4503 in combination with ARA-C.
OXi4503
has received orphan designation for AML in both the United States (Designation No. 12-3824) and the European Union (Designation No. EU/3/15/1587
- EMA/OD/144/15). In 2017, the FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML. Oxi4503
met the qualifying criteria for the Fast Track designation since AML is a serious and life-threatening condition, and a large unmet medical
need exists for additional treatment strategies for this disease.
The
Investigator-Sponsored trial (IST) UF OXi4503 AML MDS Ph 1 (UF4503), “A Phase 1 Clinical Trial of OXi4503 for Relapsed and Refractory
AML and Myelodysplastic Syndromes (“MDS”) was designed to evaluate the safety profile and the maximum tolerated dose
(“I”) as well as a recommended Phase 2 dose (RP2D) of OXi4503 in patients with recurrent/refractory (R/R) AML and MDS (ClinicalTrials.gov
NCT01085656) (14, 50). The clinical single agent activity of OXi4503 was also assessed within the confines of a Phase 1 clinical trial
setting. A total of 18 patients enrolled in the study from February 2011 to January 2016. The patients were predominantly male (78%)
and the median age was 62.5 years. Of the 15 patients with AML, 4 (27%) had primary refractory AML, 2 (13%) were in first relapse, and
9 (60%) had refractory AML beyond CR1.
Eight
patients (44%) completed at least one cycle of CA1P and were evaluable for efficacy assessments. Of the eight patients evaluable, one
achieved morphologic remission with incomplete blood count recovery (“CRi”) after 1 cycle but came off study in cycle
2 due to fungal pneumonia. Three patients had stable disease after at least one cycle of CA1P. Three patients experienced progressive
disease after 1 cycle of CA1P and were withdrawn from the study.
The
Phase 1 dose-escalation combination of the Company sponsored study OX1222 (NCT02576301) was a Phase 1b dose escalation study of OXi4503
as a single agent and in combination with Cytarabine with subsequent combination Phase 2 cohorts for subjects with relapsed/refractory
(R/R) AML and MDS. 29 subjects were treated with OXi4503 in combination with Cytarabine.
Of
these 29 patients, one was evaluable for safety analysis, but no EFS/OS data or response data were available for activity evaluations.
Of the 28 patients evaluable for EFS/OS outcome analyses, 26 had AML and 2 had MDS. For the 26 AML patients, there were 4 CRs. The CR
responses were associated with prolonged overall survival substantially better the median OS time: One patient who became eligible for
allogeneic PBSCT remains alive, free-of-leukemia at 720+ days. The overall survival times were 434 days, 521 days, 535 days and 720 days,
respectively. The median OS time for the 4 patients who achieved a CR/CRi was 528 (95% CI: 434 - NA) days which was significantly better
than the median OS time of 113 (95% CI: 77 - 172) days for the remaining 22 AML patients who did not achieve a CR (Log Rank = 11.8, P-value
= 0.0006).
Three
of the 4 CR/CRis were achieved in 1st relapse patients while one patient with CRi had failed 5 previous regimens, including 7:3, HiDAC,
and PBSCT. Patients who achieved a CR/CRi went on to receive other treatments after receiving 4-6 cycles of OXi4503. The median OS for
all 26 AML patients who received therapy was 119 (95% CI: 87 - 232) days. Patients who had rapidly progressive disease or developed toxicity
could not get as many OXi4503 doses as patients who responded to their treatment favorably. The median OS time for 18 patients receiving
1-3 doses Of OXi4503 was 82 (95% CI: 66 - 135) days and these patients exhibited a worse survival outcome compared to 9 patients receiving
4-6 doses which was recorded at 434 (95% CI: 191 - NA) days (Log Rank = 12.3, P-value = 0.0004).
OXi4503:
Pediatric AML
Pediatric
AML is most common during the first 2 years of life and during the teenage years. In the United States, about 730 people under age 20
are diagnosed with AML each year. The number of deaths was 0.6 per 100,000 children per year. These rates are age-adjusted and based
on 2012-2016 cases.
Compared
with pediatric ALL, the outlook for pediatric AML patients is far worse. Even though pediatric AML cases are far fewer than pediatric
ALL, the mortality rate is about the same, illustrating that AML is a devastating disease and the need for continuing research to identify
effective treatments for these children. The prognosis for AML in children remains relatively poor, with a 5-year survival rate of 64%
compared with 90% in ALL.
Patients
with poor-risk cytogenetics include those that lack any favorable changes and harbor any of the following cytogenetic abnormalities:
monosomy 7, monosomy 5, deletion of 5q, abnormalities of 3q, t(6;9)(p23;q34), and complex karyotype which is defined as three or more
cytogenetic abnormalities. Children and adolescents harboring these unfavorable features have survival of less than 50 percent, and in
many cases less than 20 percent.
The
standard of care for management of pediatric AML involves predominantly induction therapy intended to put the patient into remission
and consolidation chemotherapy designed to eradicate leukemia cells that may have escaped front line induction therapy. Whereas, >80%
of pediatric AML patients will achieve remission, only about half will remain disease-free for an appreciable period of time. Approximately
30 percent of children with AML will experience relapse and only one third of them become long-term survivors after salvage therapy.
Although cure rates for children and adolescents with AML have improved, outcomes for pediatric AML patients with adverse prognostic
biologic features (e.g. high risk genetic mutations or chromosomal abnormalities) and refractory or relapsed disease who failed or did
not respond to their initial standard induction chemotherapy remains poor and limited treatment options are available for these patients.
Novel therapies for these high-risk patients are urgently needed. OXi4503 shows clinical potential and promise for this indication based
on the proof-of-concept data obtained from nonclinical and clinical studies.
The
FDA has granted a RPD for OXi4503 for the treatment of pediatric AML.
AI/Blockchain:
EdgePoint
PointR,
an acquisition made in November of 2019, develops, and deploys high performance cluster computers and artificial intelligence (“AI”)
technologies for inference processing of a camera-grid that are interconnected to create 360-degree vision-grid to track men and materials
indoors. The scope has expanded to include the entire life cycle of a drug: discovery, clinical trials, and manufacturing. These grids
provide real-time, localized decision-making harvesting complex data from structured and unstructured sources. Originally intended to
be used exclusively for operator tracking in manufacturing, the AI is broadened to automate surveillance and inspections in processing
lines. In addition, AI is being targeted to provide support for clinical trials and pre-clinical research.
The
deployment of this supercomputing grid enables data capture and insight extraction in real time in blocks which are chained into blockchain
ledger records serving as immutable transactions for stakeholders such as regulatory agencies, caretakers, insurers, payers, and manufacturers.
The vision grid can integrate and fuse data from any type of sensors or collection devices. For example, the platform is a network of
activity detection cameras and proximity beacons functionalized with AI algorithms to monitor, evaluate, and archive real time visual
data as a series of metadata entries in a Blockchain ledger.
The
use of AI and machine learning will streamline operations, enhance efficiency, and create immutable audit records for regulators while
reducing labor overhead and source of human errors. The deployment of this supercomputing grid enables data capture and insight extraction
in real time in blocks which are chained into blockchain ledger records serving as immutable transactions for stakeholders such as regulatory
agencies, caretakers, insurers, payers, and manufacturers. The PointR grid can integrate and fuse data from any type of sensors or collection
devices. For example, the platform is a network of activity detection cameras and proximity beacons functionalized with AI algorithms
to monitor, evaluate, and archive real time visual data as a series of metadata entries in a Blockchain ledger.
In
the pharmaceutical industry PointR’s AI combined with Blockchain will be used in the entire life cycle of a drug: discovery, clinical
trials and manufacturing. Leveraging its deep partnership with IBM, the PointR team will combine its own AI Vision technology with industry
standard Blockchain to transform drug manufacturing and real-world evidence monitoring for clinical trials. The combined system has the
potential to automatically record individual key steps in cGMP manufacturing operations including the flow of people, raw materials and
operations in trusted perpetual blockchain ledgers that are indisputable. This has the potential to create much more efficient GMP manufacturing
operations while simultaneously improving reliability and data security.
Data
integrity is a large and unsolved problem within drug development and manufacturing. Data from prior FDA inspection records, for
four major markets: China, India, Europe, and the United States, revealed endemic data integrity issues including data manipulation.
These stipulate that all manufacturing data must be preserved — unaltered — and made available to regulators. The consequences
of data manipulation would be the invalidation of clinical data based on the adulterated drug product, safety concerns and liabilities
to the patients, and FDA sanction and legal action. Some statistics of the FDA inspections and violations can be found at https://www.thefdagroup.com/blog/2019-fda-warning-letter-inspection-observation-trends.
The
local real time AI processing of the data through grid computing allows for flexibility in data processing and AI training. Federated
learning through grid supercomputing is inherently faster and more effective than mainframe supercomputing. In general, AI methods excel
at automatically recognizing complex patterns in imaging data and providing quantitative assessments of the underlying characteristics.
PointR AI deep learning algorithms have the capability of detecting meaningful relationships in image-recognition tasks in radiology
and pathology. The coupling of image algorithm with Vision allows us to integrate imaging data frequently encountered during patient
care into coherent metadata for blockchain ledgers. This can transform the design and implementation of clinical trials and accelerate
outcomes. Combined with Blockchain the technologies will create trusted irrefutable ledgers which track real world monitoring and evidence
gathering.
The
Company’s non-controlling interest subsidiary, EdgePoint, is working to bring a solution that addresses both issues using proven
technology. We intend to solve this problem with AI “machine vision” based on our proprietary technology, which is integrated
with IBM and re-sold by IBM and its partners. We address the data integrity problem in a step-wise fashion. We start with streamlining
the warehouse supply chain component. Later we add modules that spread across the plant in a comprehensive manner. We may spin-off Edgepoint
as a separate publicly traded entity.
We
expect our warehouse modules will streamline many labor issues in a manner very similar to Amazon-Go stores that run without cashiers.
Monitored by a camera grid, shoppers simply enter, grab items and leave. A shopper can grab a sandwich and soda and leave within few
minutes without checkout lines and delays. Amazon’s AI machine vision automation identifies the shoppers, the items they picked-up,
consummates the transaction and sends receipt. Sounds like science fiction but there are 11 such stores nationwide and disrupting the
retail industry.
Manufacturing AI Deployment:
Leveraging
its partnerships with industry leaders, the AI team will combine its own AI technology with industry standard Blockchain to transform
drug manufacturing. The combined system has the potential to automatically record individual key steps in cGMP manufacturing operations
including the flow of people, raw materials, and operations in trusted perpetual blockchain ledgers that are indisputable. This has the
potential to create much more efficient GMP manufacturing operations while simultaneously improving reliability and data security.
The Company is in discussions with
our JV partners for designing a nanoparticle manufacturing plant to produce its own as well as 3rd party products. The
plant is planned to be paperless incorporating integrated computer automation with a real-time dashboard that includes AI for
predictive maintenance and control of its fill-finish lines. Also, AI-based machine vision will inspect final vials for quality control
before labeling, packing and distribution. The cost-benefit for AI is clear when it replaces labor-intensive and error-prone manual process
of vial-inspections to detect inconsistencies such as accidental particulates in the mix, level-of the fill, and damaged
stoppers. The AI promises to replace labor-intensive and error-prone manual processes.
The
deployment of this supercomputing grid enables data capture and insight extraction in real time in blocks which are chained into blockchain
ledger records serving as immutable transactions for stakeholders such as regulatory agencies, caretakers, insurers, payers, and manufacturers.
The vision grid can integrate and fuse data from any type of sensors or collection devices. For example, the platform is a network of
activity detection cameras and proximity beacons functionalized with AI algorithms to monitor, evaluate, and archive real time visual
data as a series of metadata entries in a Blockchain ledger.
The
use of AI and machine learning will streamline operations, enhance efficiency, and create immutable audit records for regulators while
reducing labor overhead and source of human errors.
Taking
Retail AI to Drug Manufacturing
Using
its Amazon-Go-like cashier-less AI proprietary technology, EdgePoint intends to address the human element in the drug manufacturing industry.
Its TrustPoint product is designed to track men and materials with a camera grid and commit each transaction to a series of immutable
blockchain records that are irrefutable permanent record of men and materials. The addition of blockchain technology enables manufacturers
to conduct audits in a reliable and streamlined manner in a trustworthy system.
This
automation of manual verification eliminates wasted and indeterministic human cycles. The product is a novel and potentially disruptive
application of AI neural networks and blockchain to ensure compliance with drug sponsors and the FDA while ensuring a return on investment
(“ROI”) for manufacturers by slashing labor costs.
The
EdgePoint technology is already proven in the retail sector and generating revenues at a US east-coast, convenience store chain When
the shopper leaves the store, the AI automatically recognizes the shopper and items retrieved to issue a receipt. No human cashier is
involved. TrustPoint is planned to be a re-deployment of this type of tested technology for GMP drug manufacturing, relieving
human errors in supply chain and increasing compliance with warehouse operating procedures. For example, the warehouse module of TrustPoint
will automatically create a shopping list from standard templates and alert supply chain personnel to collect and deliver a list of raw
materials to manufacturing. TrustPoint will track personnel authorized to collect materials of the shelves in compliance with picklist
and generate alerts if the wrong materials are picked. It will commit the data to an immutable block chain ledger for later retrieval
in case of compliance issues. Blockchain records are irrefutable and can be reproduced to trace with fidelity operating activities, e.g.,
authorized personnel, what they picked, who they delivered to with date and timestamps of each action.
Market
Human
labor costs represent the most expensive element in drug manufacturing. In the $70.0 billion CDMO (contract development manufacturing
operations) industry, personnel costs of $30 billion are ripe for computer automation. Until now, computer technologies like MRP and
ERP created more problems than resolved. The labor problem is compounded by the cost of personnel onboarding and turnover. It takes 6-9
months to train a quality control employee only to lose them to a competitor.
The
market is large. Approximately 10,000 drug manufacturing facilities worldwide are FDA and EMA (European FDA) registered, representing
a significant addressable market for EdgePoint. Many such facilities run on paper-based, handwritten forms ripe for modernization by
the TrustPoint product. The $70.0 billion CDMO industry is poised to grow to $123.0 billion by 2025 according to industry experts. EdgePoint
has the first mover advantage and expects to lead the industry’s transition. It expects to garner a significant share
of the labor automation market. Addressing the $30.0 billion labor market and more specifically the $12.0 billion supply-chain segment,
EdgePoint expects to improve efficiencies and create additional value for shareholders. EdgePoint intends to address the $12.0 billion
market with AI Vision, BlockChain and NLP.
Go-to-Market:
The
Company’s go-to-market plan is to execute a proof-of-concept project, possibly through a planned CDMO by the JV. As part
of the JV Agreement, the JV has acquired a non-exclusive license for the AI platform developed by PointR/EdgePoint for implementation
in a planned CDMO.
The
expected outcome is a potential re-sellable product for materials release deployed with production level data to attract a rich
pipeline of paying customers. EdgePoint is looking to address an unsolved problem with a proprietary technology and first
mover advantage to capture a significant share of the GMP manufacturing market. The product is a novel and potentially disruptive application
of AI neural networks and block-chain to ensure compliance with drug sponsors and the FDA while ensuring ROI for manufacturers by slashing
labor costs. The side benefit is that it brings this industry into the fourth industrial revolution which includes AI, cloud computing,
blockchain, and IoT sensor fusion.
In
addition to ARTIVeda™ / PulmoHeal™ AI application, the Company has also developed and launched
a mobile application called ArtiHealth and a post marketing survey that have been included with ArtiVeda, which along with ArtiHealth
is called PulmoHeal™. PulmoHeal™ is a full evaluation package of drug and assessment platforms for
COVID-19, and other respiratory disease patients. Further, the Company recently announced the development of its Pet2DAO infrastructure
development and chatbots that are planned to help the shareholders and other users to easier access to useful information. This is driven
by AI built by our internal resources and is planned to be launched by Pet2DAO.
Our
Strategy and Development Plan
We
have been operating with significant capital constraints since the reverse merger between the Company and Oncotelic Inc, and for this
time period we have been seeking to secure sufficient funding to continue our operations while we simultaneously seek to advance our
all our investigational drugs for the treatment of cancer, coronaviruses, AI technology and more recently for PD, ED and FSD. Subject
to our ability to secure additional capital, we would seek to further develop our product candidates. However, our inability to access
capital historically has and may significantly impairs our ability to develop these compounds. If we are able to advance any or all of
our drug candidates, we would seek to develop them till commercialization, however, there is no guarantee that we would be able to fully
develop our products, obtain regulatory approvals and successfully commercialize them.
We
continue to discuss collaboration opportunities with other biopharmaceutical companies, although to date have not secured any agreements
with companies that are willing to purchase the products from us or license the development and commercialization rights. We intend to
continue to seek a partner to acquire the marketing rights to our product candidates and to finance further clinical studies and will
seek to complete a transaction if we are able to reach mutual agreement on terms. We were in discussions with GMP to further the development
of OT-101, primarily for oncology indications and COVID-19, as well as CA4P and Oxi4503. In March 2022, the Company entered into a
JV with Dragon to form GMP Bio. Both entities are affiliates of GMP. GMP Bio and the Company will work together to further the development
of OT-101, wherein the Company would provide the technology and technical expertise and GMP Bio would fund the development expenses.
In
addition to entering into a transaction that would provide funding for the further development of our product candidates, other elements
of our development strategy would currently include:
|
● |
Initiating
clinical trials of OT-101 in various cancers: We have yet to initiate any trials, but we are evaluating conducting such trials
in the US as well as other countries like China in conjunction with GMP Bio. We are looking to conduct such trials in combination
with other drugs like checkpoint inhibitors. We have filed the protocols for some of the trials being planned and we hope to be
able to get acceptance from the FDA and be able to initiate the trials shortly thereafter. |
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● |
Conducting follow up clinical trials
of OT-101 for COVID-19: A Phase 2 C001 Covid Study: “A Double-Blind, Randomized, Placebo
Controlled, Multi-Center Study of OT-101 in Hospitalized COVID-19 Subjects” was completed
for OT-101 in South America. That study can expand into a Phase 3 trial if the data supports
the safety of the drug in the event there is a resurgent in COVID-19. We are currently conducting
an observational study, with OT-101 for long COVID-19, in conjunction with BARDA. |
|
● |
We have completed
a 120-patient trial for Artemisinin. We plan to continue to further develop Artemisinin as
pharmaceutic against respiratory viral infections, especially in the event there is a resurgence
in COVID-19. |
|
|
|
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Initiating
a clinical trial of CA4P in combination with an immuno-oncology agent: Based on preclinical data generated to date and support of
two well-known immuno-oncology clinical investigators, we have developed a protocol for a clinical trial that would be the first
human clinical trial combining CA4P and an approved immuno-oncology agent. This trial is designed to make initial determinations
of whether the combination results in improved patient outcomes, including safety, overall survival, progression free survival, objective
response rate, tumor size and other parameters. |
|
● |
Continuing
to evaluate OXi4503 in a clinical trial: We have completed six ascending dose cohorts of OXi4503 in combination with cytarabine in
Study OX1222 in patients with relapsed/refractory AML and/or MDS. In the highest dose cohort, the sixth cohort of the study, we observed
potential safety signals which triggered stopping rules for the study and resulted in a partial clinical hold from the FDA until
we and the FDA assess additional safety data, particularly at the fifth dose cohort level. In the fifth dose cohort of OX1222, we
have observed the best potential signs of efficacy to date in the trial and believe treatment of additional patients would provide
additional evidence regarding the efficacy of OXi4503 in these indications |
|
|
|
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Ramping
up the apomorphine development program and initiating noninferiority trial comparing AL-101 against subcutaneous apomorphine for
the treatment of PD. We are also considering ramping up the apomorphine development programs for ED and FSD/HSDD. |
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The Company formed Pet2DAO, as
a wholly owned subsidiary. Pet2DAO is a DAO technology company, integrating the strong governance
of traditional corporations with the innovative DAO architecture looking to engage stakeholders, to build value through the DAO,
while maintaining the rigor of traditional corporations, including governance, compliance, and accountability through a team of veterans
in public companies with innovators in AI, blockchain and Web3. Pet2DAO will initially be looking to develop products for
the animal health space. |
Regulatory
Matters
Government
Regulation and Product Approval
Government
authorities in the United States and other countries extensively regulate, among other things, the research, development, testing, manufacture,
quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and
import of products such as those we are developing. Our drug candidates must be approved by the FDA through the New Drug Application
(“NDA”), process before they may be legally marketed in the United States.
U.S.
Drug Development Process
In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and implementing
regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and
foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable
United States requirements at any time during the product development process, approval process or after approval, may subject an applicant
to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to review or approve pending applications,
withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production
or distribution injunctions, fines, refusal of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency
or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a drug may be marketed
in the United States generally involves the following:
|
● |
completion
of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (“GLP”)
or other applicable regulations; |
|
● |
submission
to the FDA of an Investigational New Drug Application, or IND, which must be first approved by the FDA before human clinical trials
may begin; |
|
● |
performance
of adequate and well-controlled human clinical trials according to Good Clinical Practices (“GCP”) to establish
the safety and efficacy of the proposed drug for its intended use; |
|
● |
submission
to the FDA of an NDA; |
|
● |
satisfactory
completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with
current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s
identity, strength, quality and purity; |
|
● |
satisfactory
completion of FDA inspections of clinical sites and GLP toxicology studies; and |
|
● |
FDA
review and approval of the NDA. |
The
testing and approval process require substantial time, effort and financial resources, and we cannot be certain that any approvals for
our product candidates will be granted on a timely basis, if at all.
Once
a pharmaceutical candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory
evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the
preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. The sponsor will also
include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety,
and the effectiveness criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. Preclinical testing continues
even after the IND is submitted. The IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period,
places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before
the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety
concerns or non-compliance.
All
clinical trials must be conducted under the supervision of qualified investigators in accordance with GCP regulations. These regulations
include the requirement that all research subjects provide informed consent. Further, an institutional review board, or IRB, must review
and approve the plan for any clinical trial before it commences at any institution. An IRB considers, among other things, whether the
risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves
the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal representative
and must monitor the clinical trial until completed.
Each
new clinical protocol must be submitted to the IND for FDA review, and to the IRBs for approval. Protocols detail, among other things,
the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor
subject safety and efficacy in Phase 2 and 3 clinical trials.
Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:
|
● |
Phase
1: The drug is initially introduced into human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution
and excretion. |
|
● |
Phase
2: Involves clinical trials in a limited patient population to identify possible adverse effects and safety risks, to evaluate preliminary
efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. |
|
● |
Phase
3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population. These
studies are intended to establish the overall risk-benefit ratio of the product and provide, if appropriate, an adequate basis for
product labeling. |
Progress
reports detailing the results of the clinical trials must be submitted at least annually to the FDA. IND Safety Reports must be submitted
to the FDA, IRBs and the investigators for (a) any suspected adverse reaction that is both serious and unexpected; (b) any findings from
epidemiological studies, pooled analysis of multiple trials, or clinical trials (other than those already reported in (a)); (c) any findings
from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to
the drug, such as reports of mutagenicity, teratogenicity, or carcinogenicity or reports of significant organ toxicity at or near the
expected human exposure; and (d) any clinically important increase in the rate of a serious suspected adverse reaction over that listed
in the protocol or investigator brochure. Phase 1, phase 2, and phase 3 testing may not be completed successfully within any specified
period, if at all. The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research
subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical
trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug
has been associated with unexpected serious harm to patients.
Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry
and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate
and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product
candidate does not undergo unacceptable deterioration over its shelf life.
U.S.
Review and Approval Processes
The
results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical
tests conducted on the chemistry of the drug, proposed labeling, and other relevant information are submitted to the FDA as part of an
NDA requesting approval to market the product. The submission of an NDA is subject to the payment of user fees; a waiver of such fees
may be obtained under certain limited circumstances, which may include orphan drug status and the first NDA application for a company.
In
addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA must contain data to assess the safety and
effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration
for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant deferrals for submission of data or full
or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation
has been granted.
The
FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing.
The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the
additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission
is accepted for filing, the FDA begins an in-depth substantive review. The FDA also may refer the NDA to an advisory committee for review,
evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the
recommendation of an advisory committee, but it generally follows such recommendations. The approval process is lengthy and difficult
and the FDA may refuse to approve an NDA at its discretion or the FDA may require additional clinical or other data and information.
Even if such additional data and information are submitted, the FDA may ultimately decide that the NDA does not satisfy its criteria
for approval. Data obtained from clinical trials are not always conclusive, and the FDA may interpret data differently than we or others
may interpret the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose
other conditions that must be met in order to obtain approval of the NDA. The FDA reviews an NDA to determine, among other things, whether
a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s
identity, strength, quality and purity. Before approving an NDA, the FDA will generally inspect the facility or facilities where the
product is manufactured. The FDA will also generally inspect selected clinical sites that participated in the clinical studies and may
inspect the testing facilities that performed the GLP toxicology studies cited in the NDA.
NDAs
receive either standard or priority review. A drug representing a significant improvement in treatment, prevention or diagnosis of disease
may receive priority review. In addition, products studied for their safety and effectiveness in treating serious or life-threatening
illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved
on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint
that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible
morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and
well-controlled post-marketing clinical trials. Priority review and accelerated approval do not change the standards for approval but
may expedite the approval process.
If
a product receives regulatory approval, the approval may be limited to specific diseases or patient subpopulations and dosages or the
indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, approval by the
FDA may include a requirement for phase 4 testing, which involves clinical trials designed to further assess a drug’s safety and
effectiveness, and the FDA may require testing and surveillance programs to monitor the safety of approved products which have been commercialized.
Orphan
Drug Designation
Under
the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally
a disease or condition that affects fewer than 200,000 individuals in the United States. After the FDA grants orphan drug designation,
the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not
convey any advantage in or shorten the duration of the regulatory review and approval process.
If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation,
the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the
same drug for the same indication for seven years, except in very limited circumstances.
In
the European Union and Japan, orphan drug exclusivity regulations provide for 10 years of market exclusivity.
CA4P
has been awarded orphan drug status by the FDA for the treatment of anaplastic, medullary, Stage IV papillary and Stage IV follicular
thyroid cancers, ovarian cancer, neuroendocrine tumors and glioma. OXi4503 has been awarded orphan drug status by the FDA for the treatment
of acute myelogenous leukemia. CA4P has been awarded orphan drug status by the FDA for the treatment of pancreatic cancer, melanoma,
and glioblastoma.
CA4P
has also been awarded orphan drug status by the European Commission in the European Union for the treatment of anaplastic thyroid cancer,
ovarian cancer and neuroendocrine tumors. OXi4503 has been awarded orphan drug status by the European Commission in the European Union
for the treatment of acute myelogenous leukemia. OT-101 has been awarded orphan drug status by European Commission in the European Union
for the treatment of pancreatic cancer, melanoma, and glioblastoma.
Rare
Pediatric Disease Designation
The
FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people
aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA’s Rare Pediatric Disease Priority
Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for
the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review
for any subsequent marketing application and may be sold or transferred. Such vouchers can be valued at several millions of dollars,
sometimes in excess of $100 million.
The
FDA granted Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of DIPG as a drug for a rare pediatric disease.
The
FDA granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin tromethamine for the treatment of stage IIB–IV melanoma
due to genetic mutations that disproportionately affect pediatric patients as a drug.
The
FDA granted Rare Pediatric Disease Designation for Oxi4503 for the treatment of AML as a drug for a rare pediatric disease.
Expedited
Review and Approval
The
FDA has various programs, including Fast Track, priority review, accelerated approval and breakthrough therapy, which are intended to
expedite or simplify the process for reviewing drugs, and/or provide for approval on the basis of surrogate endpoints. Even if a drug
qualifies for one or more of these programs, the FDA may subsequently decide the drug no longer meets the conditions for qualification
or the FDA may not shorten the review or approval time period. Generally, drugs that may be eligible for these programs are those for
serious or life-threatening conditions, those with the potential to address unmet medical needs, and those that offer meaningful benefits
over existing treatments. Fast Track designation applies to the combination of the product and the specific indication for which it is
being studied. Although Fast Track and priority review do not affect the standards for approval, the FDA will attempt to facilitate early
and frequent meetings with a sponsor of a Fast-Track designated drug and expedite review of the application for a drug designated for
priority review. Drugs that receive an accelerated approval may be approved on the basis of adequate and well-controlled clinical trials
establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on
the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may
require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trials.
OXi4503
has been awarded Fast Track designation for the treatment of AML.
Foreign
Regulation
In
addition to regulations in the United States, we are subject to a variety of foreign regulations governing clinical trials and if any
of our product candidates are approved, we will be subject to additional regulations regarding commercial sales and distribution. Whether
or not we obtain FDA approval to test a product candidate in the United States, we must obtain approval by the comparable regulatory
authorities of foreign countries before we can commence testing any product candidate in those countries. Likewise, whether or not we
obtain FDA approval to market a product, we must obtain approval by the comparable regulatory authorities of foreign countries before
we can commence marketing of any product candidate in those countries. The approval process varies from country to country and the time
may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing,
pricing and reimbursement vary greatly from country to country.
Under
European Union regulatory systems, a company may submit marketing authorization applications, or MAAs, either under a centralized or
decentralized procedure. The centralized procedure, which is compulsory for medicines produced by biotechnology or those medicines intended
to treat AIDS, cancer, neurodegenerative disorders or diabetes and optional for those medicines which are highly innovative, provides
for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure provides
for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit
an application to the remaining member states. Within 90 days of receiving the applications and assessments report, each member state
must decide whether to recognize approval. If a member state does not recognize the marketing authorization, the disputed points are
eventually referred to the European Commission, whose decision is binding on all member states.
As
in the United States, the European Medicines Agency, or EMA, may grant orphan drug status for specific indications if the request is
made before an MAA is submitted. The EMA considers an orphan medicinal product to be one that affects less than five of every 10,000
people in the European Union. A company whose application for orphan drug designation in the European Union is approved is eligible to
receive, among other benefits, regulatory assistance in preparing the marketing application, protocol assistance and reduced application
fees. Orphan drugs in the European Union receive up to ten years of market exclusivity for the approved indication.
Reimbursement
Sales
of any of our product candidates, if approved, will depend, in part, on the extent to which the costs of the products will be covered
by third-party payors, including government health programs such as Medicare and Medicaid, commercial health insurers and managed care
organizations. These third-party payors are increasingly challenging the prices charged for health care products and services. The U.S.
government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including
price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption or application of price
controls and cost-containment measures could limit our revenue. If third-party payors do not consider our products to be cost-effective,
they may not pay for our products even if we receive approval, or their level of payment may not be sufficient to allow us to sell our
products on a profitable basis.
The
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, imposes requirements for the distribution and pricing
of prescription drugs for Medicare beneficiaries. Under Part D (the Medicare prescription drug benefit), Medicare beneficiaries may enroll
in prescription drug plans offered by private entities that provide coverage of outpatient prescription drugs not covered under Medicare
Part B. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs. Each drug plan can develop its own
drug formulary that identifies which drugs it will cover and at what tier or level. Federal regulations require Part D prescription drug
formularies to include drugs within each therapeutic category and class of covered Part D drugs, although not necessarily all the drugs
in each category or class.
In
general, government payment for some of the costs of prescription drugs may increase demand for products for which we receive marketing
approval. However, any negotiated prices for our products covered by a Part D prescription drug plan will likely be lower than the prices
we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow
Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA
or other Medicare regulations may result in a similar reduction in payments from non-governmental payors.
The
Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively,
the “Affordable Care Act” or “ACA”) mandated prescription drug coverage as one of ten essential
health benefits that most health plans must offer, requiring coverage of at least one drug in every category and class. The ACA increased
in the number of individuals covered by insurance and as a result commercial insurers and government programs have increased their emphasis
on cost controls to reduce overall spending. A number of federal government leaders have expressed their intentions to repeal and replace
the ACA. If full or partial repeal is enacted, many if not all of the provisions of the ACA may no longer apply to prescription drugs.
As a result, we expect that there will continue to be uncertainty regarding drug product pricing, reimbursement and other factors impacting
the revenue we may receive if our product candidates are ultimately approved, which could have a material adverse effect on our business,
financial condition and results of operations.
In
addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements
governing drug pricing vary widely from country to country. For example, the European Union provides options for its member states to
restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices
of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a
system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no
assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement
and pricing arrangements for any of our products. Historically, products launched in the European Union do not follow price structures
of the United States and tend to be significantly lower.
Patents
and Proprietary Rights
We
actively seek to protect the proprietary technology that we consider important to our business, including chemical species, compositions
and forms, their methods of use and processes for their manufacture, as well as modified forms of naturally-expressed receptors, in the
United States and other jurisdictions internationally that we consider key pharmaceutical markets. We also rely upon trade secrets and
contracts to protect our proprietary information.
As
of May 12, 2020, we were the exclusive licensee, sole assignee or co-assignee of fifteen granted U.S. patents, one pending U.S. patent
application, and granted patents and/or pending applications in several other major markets, including the European Union, Canada and
Japan. Our policy is to file U.S. and foreign patent applications to protect technology, inventions and improvements to inventions that
are commercially important to the development of our business. There can be no assurance that any of these patent applications will result
in the grant of a patent either in the United States or elsewhere, or that any patents granted will be valid and enforceable, or will
provide a competitive advantage or will afford protection against competitors with similar technologies. We also intend to rely upon
trade secret rights to protect other technologies that may be used to discover and validate targets and that may be used to identify
and develop novel drugs. We seek protection, in part, through confidentiality and proprietary information agreements.
We
consider the following U.S. patents and applications owned by or exclusively licensed to us to be particularly important to the protection
of our most advanced product candidates.
Product
Candidate |
|
Patent
Scope |
|
Patent
Expiration |
CA4P |
|
Use
of VDAs to Enhance Immunomodulating Therapies Against Tumors** |
|
August
2036 |
|
|
|
|
|
OXi4503 |
|
Method
of Treating Myeloid Neoplasm by Administering OXi4503 |
|
November
2028 |
|
|
|
|
|
OT-101 |
|
Combination
of A Chemotherapeutic Agent and An Inhibitor of the TGF-β System |
|
July
2030 |
|
|
Combination
Therapy for Treatment of Pancreatic Cancer |
|
February
2036 |
|
|
Compositions
and Methods for Treating Cancer |
|
February
2036 |
In
addition to these patents, for some of our product candidates, we have patents and/or applications that cover a particular form or composition,
use for a particular indication, use as part of combination therapy or method of preparation or use, as well as other pending patent
applications. These issued patents, including any patents that issue from pending applications, could provide additional or a longer
period of protection. We also have patent applications pending that seek equivalent or substantially comparable protection for our product
candidates in jurisdictions internationally that we consider key pharmaceutical markets.
The
patent expiration dates referenced above do not reflect any potential patent term extension that we may receive under the federal Drug
Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. The Hatch-Waxman Act generally permits a patent
extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. Patent extension cannot
extend the remaining term of a patent beyond a total of 14 years. The patent term restoration period is generally one-half of the time
between the effective date of an investigational new drug application, or IND, and the submission date of a new drug application, or
NDA, plus the time between the submission date and approval date of an NDA. Only one patent applicable to an approved drug is eligible
for the extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trademark Office,
in consultation with the FDA, reviews and approves applications for patent term extension.
As
previously noted, the FDA and European Union have granted CA4P and OXi4503 orphan drug status for certain indications. We are also pursuing,
and may continue to in the future to pursue, orphan drug status for other product candidates and indications. Our ability to obtain and
maintain the exclusivity for our products and product candidates by virtue of their orphan drug status is an important part of our intellectual
property strategy. Also as previously noted, we emphasizing on Rare Pediatric Designation to leverage on the regulatory exclusivity and
voucher program associated with these designations.
Competition
The
industry in which we are engaged is characterized by rapidly evolving technology and intense competition. Our competitors include, among
others, major pharmaceutical, biopharmaceutical and biotechnology companies, nearly all of which have financial, technical and marketing
resources significantly greater than ours. In addition, many of the small companies in our industry have also formed collaborative relationships
with large, established companies to support research, development and commercialization of products that may be competitive with ours.
Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities
and patenting new technologies in our line of business and any of these entities may commercialize products that may be competitive with
ours.
We
expect that, if any of our products gain regulatory approval for sale, they will compete primarily on the basis of product efficacy,
safety, patient convenience, reliability, price and patent protection. Our competitive position will also depend on our ability to attract
and retain qualified scientific and other personnel, develop effective proprietary products and implement joint ventures or other alliances
with large pharmaceutical companies in order to jointly market and manufacture our products.
Employees
We
had twenty-two full-time employees and consultants as of April 12, 2023 however, all the employees and consultants,
other than Dr. Maida who was partially compensated through the Company upto March 2022, were compensated from our JV from February 2022
onwards. We rely on external consultants or outsource nearly all our research, development, preclinical testing and clinical trial
activity, although we maintain managerial and quality control over our clinical trials. We also rely on external consultants for various
administrative tasks that are required for a public company. We expect to continue to rely on external service providers and to maintain
a small number of executives and other employees. Our relations with our employees are good and we do not have any unions for the Company.
Costs
of Compliance with Environmental Regulations
We
have not incurred any costs associated with compliance with environmental regulations, nor do we anticipate any future costs associated
with environmental compliance; however, no assurances can be given that we will not incur such costs in the future.
DESCRIPTION
OF PROPERTY
Our
office is located in Agoura Hills, California, where we lease about 2,000 square feet of general office space. The lease for this office
is on a month-to-month basis. We consider our office space to be adequate for our current needs. We believe that other suitable office
space would be available if we move to a different location upon the expiration of our current lease.
LEGAL
PROCEEDINGS
From
time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Historically, the outcome of
all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial condition, results of
operations or liquidity. Other than as set forth below, there are no additional pending or threatened legal proceedings at this time.
One
of the Company’s ex-employees has made a breach of employment contract claim against the Company. The Company and its legal counsel
are evaluating the validity of the claim, as the Company believes that such claim has limited merits and is hopeful to attain a positive
outcome for such claim. Since the Company and its legal counsel are still evaluating the claim, we are unable to quantify the amount
such claim would be settled at, if at all settled.
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
The
Company’s common stock trades on the OTCQB market, operated by OTC Markets, under the symbol “OTLC”.
Holders
As of April 12, 2023, there were
approximately 79 stockholders of record of the 392,871,880 outstanding shares of the Company’s common stock.
Dividends
The
Company has not declared or paid any cash dividends on its common stock since its inception in 1988 and does not intend to pay cash dividends
in the foreseeable future. The Company presently intends to retain future earnings, if any, to finance the growth and development of
its business.
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following table provides certain aggregate information with respect to all of the Company’s equity compensation plans in effect
as of December 31, 2022.
Plan Category | |
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights | | |
Weighted-Average Exercise Price of Outstanding Options | | |
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) | |
Equity compensation plans approved by security holders | |
| 24,042,620 | | |
$ | 0.22 | | |
| 3,205,021 | |
Equity compensation plans not approved by security holders | |
| 1,650,000 | | |
| 0.30 | | |
| 350,000 | |
| |
| | | |
| | | |
| | |
Total | |
| 25,692,620 | | |
$ | 0.23 | | |
| 3,555,021 | |
In
August 2020, the shareholders of the Company approved the expansion of the number of securities to be issued upon exercise of outstanding
options, warrants, restricted stock units and warrants by 20 million. The amendment to the 2015 Plan was completed in March 2021 and
as such the pool under the 2015 Plan is now 27,250,000.
Brief
Description of equity compensation plan not approved by security holders
In
January 2017, the Board of Directors adopted and approved the 2017 Plan. The 2017 Plan allows the Company, under the direction of the
Compensation Committee, to make grants of stock options, restricted and unrestricted stock awards, and other stock-based awards to employees,
consultants and directors. The purpose of these awards is to attract and retain key individuals, further align employee and stockholder
interests, and provide additional incentive for them to promote our success. The 2017 Plan provides for the issuance of up to 2,000,000
shares of the Company’s common stock. Any stock options granted under the 2017 Plan must be non-qualified stock options, which
are not intended to meet the requirements of Section 422 of the Internal Revenue code. Options generally vest over a period of time,
may not be exercised unless they are vested, and no option may be exercised after the end of the term set forth in the award agreement.
Unregistered
Sales of Securities
No
unregistered securities were issued during the fiscal year that were not previously reported in an Annual Report on Form 10-K, Quarterly
Report on Form 10-Q or Current Report on Form 8-K.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Note
Regarding Forward-Looking Statements
This
Registration Statement on Form S-1 (the “Registration Statement” or “Statement”) includes a number
of forward-looking statements that reflect management’s current views with respect to future events and financial performance.
Forward-looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify
forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue”
or the negative of these terms or other comparable terminology. Those statements include statements regarding the intent, belief or current
expectations of us and members of our management team, as well as the assumptions on which such statements are based. For a more detailed
discussion on our forward-looking statements, kindly refer to “Forward Looking Statements” prior to Item 1: Part I: Business
contained in this Registration Statement.
Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
of activity, or performance. These statements are only predictions and involve known and unknown risks, uncertainties and other factors.
Some of these risks are included in the section entitled “Risk Factors” set forth in this Registration Statement and in other
reports that we file with the SEC. The occurrence of any of these risks, or others of which we are currently unaware, may cause our company’s
actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity,
performance or achievements expressed or implied by these forward-looking statements. These risks include, by way of example and without
limitation:
● |
our
ability to successfully commercialize our products and services on a large enough scale to generate profitable operations; |
|
|
● |
our
ability to maintain and develop relationships with customers and suppliers; |
|
|
● |
our
ability to successfully integrate acquired businesses or new products, or to realize anticipated synergies in connection with acquisitions
of businesses or products; |
|
|
● |
expectations
concerning our ability to raise additional funding and to continue as a going concern; |
|
|
● |
our
ability to successfully implement our business plan; |
|
|
● |
our ability to successfully operate GMP Biotechnology
Limited (“GMP Bio”), our joint venture with Dragon Overseas Limited (“Dragon”), to develop our product portfolio,
or to have a successful IPO for GMP Bio as planned; |
● |
our
ability to avoid, or to adequately address any intellectual property claims brought by third parties; and |
|
|
● |
the
anticipated impact of any changes in industry regulation. |
|
|
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building and the success of our nanoparticle platform
and the related success of launching the platform |
|
|
● |
the success of the launch of a company with a DAO infrastructure,
the success of the entity and the plans surrounding the pet and animal health, the ability for the Company to register the tokens
of Pet2Dao, the actual filing of a registration statement and approval of the tokens as registrable securities with the SEC through
a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable. |
Readers
are urged to carefully review and consider the various disclosures made by us in this Annual Report and in our other reports
filed with the SEC. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence
of unanticipated events or changes in the future operating results over time except as required by law. We believe that our assumptions
are based upon reasonable data derived from and known about our business and operations. No assurances are made that the actual
results of operations or the results of our future activities will not differ materially from our assumptions.
Corporate
History
Oncotelic
Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) (“Oncotelic”), was formed in the State of New York in 1988 as
OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic
Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly-owned subsidiaries, Oncotelic,
Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO Inc., a Delaware corporation
and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic,
Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”).
The Company completed a reverse merger with Oncotelic Inc in April 2019, a merger with PointR in November 2019 and formed a
subsidiary Edgepoint in February 2020. For more information on these mergers, refer to our 2022 Annual Report on Form 10-K filed with
the SEC on April 14, 2023.
Amendments
to Certificate of Incorporation
In
March 2021, the Company received approval from the Financial Industry Regulatory Authority on its notice of corporate action to
change the name of the Company from Mateon Therapeutics, Inc. to Oncotelic Therapeutics, Inc, and the Company’s ticker symbol
has changed from “MATN” to “OTLC”.
In
January 2021, the Company filed an additional amendment to its Certificate of Incorporation, as amended (the “Charter Amendment”),
with the Secretary of State for the State of Delaware, which Charter Amendment went effective immediately upon acceptance by the Secretary
of State for the State of Delaware. The Charter Amendment increased the number of authorized shares of Common Stock from 150,000,000
shares to 750,000,000 shares.
In
addition, the Company registered an additional total of 20,000,000 shares of its Common Stock, which may be issued pursuant to the Company’s
Amended and Restated 2015 Equity Incentive Plan (the “Plan”). As such, the total number of shares of the Company’s
Common Stock available for issuance under the 2015 plan is 27,250,000.
Recent
Events
Peak
One Equity Purchase Agreement
In
May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the
“Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to
which the Company shall have the right, but not the obligation, to direct Peak One, to purchase up to $10.0 million (the “Maximum
Commitment Amount”) in shares of the Company’s Common Stock. Under the EPL and subject to the Maximum Commitment Amount,
the Company has the right, but not the obligation, to submit Put Notices (as defined in the EPL) to Peak One (i) in a minimum amount
not less than $20,000.00, and (ii) in a maximum amount up to the lesser of (a) $1.0 million or (b) 250% of the Average Daily Trading
Value (as defined in the EPL). In exchange for Peak One entering into the EPL, the Company agreed, among other things, to (A) issue Peak
One and Peak One Investments, LLC, an aggregate of 250,000 shares of Common Stock, and (B) file a registration statement registering
the Common Stock issued or issuable to Peak One under the EPL for resale (the “Registration Statement”) with the SEC
within 60 calendar days of the date of the EPL, as more specifically set forth in the Registration Rights Agreement. The obligation of
Peak One to purchase the Company’s Common Stock shall begin on the date of the EPL, and ending on the earlier of (i) the date on
which Peak One shall have purchased Common Stock pursuant to the EPL equal to the Maximum Commitment Amount, (ii) twenty four (24) months
after the initial effectiveness of the Registration Statement, (iii) written notice of termination by the Company to Peak One (subject
to certain restrictions set forth in the EPL), (iv) the Registration Statement is no longer effective after the initial effective date
of the Registration Statement, or (v) the date that the Company commences a voluntary case or any person commences a proceeding against
the Company, a custodian is appointed for the Company or for all or substantially all of its property or the Company makes a general
assignment for the benefit of its creditors (the “Commitment Period”). During the Commitment Period, the purchase
price to be paid by Peak One for the Common Stock under the EPL shall be 91% of the Market Price, which is defined as the lesser of the
(i) closing bid price of the Common Stock on the trading day immediately preceding the respective Put Date (as defined in the EPL), or
(ii) lowest closing bid price of the Common Stock during the Valuation Period (as defined in the EPL), in each case as reported by Bloomberg
Finance L.P or other reputable source designated by Peak One.
The
Company filed a post-effective amendment to reregister
the EPL on April 26, 2022 and the post-effective amendment was found effective by the SEC on May 6, 2022. Since the EPL was made effective
in June 2021 till December 31, 2022, the Company has directed Peak One, on multiple occasions, for an aggregate of 4.7
million shares of Common Stock for aggregate net cash proceeds of approximately $0.6 million.
Company
Overview
We
are a clinical stage biopharmaceutical company developing drugs for the treatment of cancer. Our goal is to advance our drug candidates
into late-stage pivotal clinical trials and either sell marketing rights to a larger pharmaceutical company or seek FDA approval ourselves.
The
Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”)
and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”),
for various cancers and COVID-19, Artemisinin for COVID-19 and AI technologies for clinical development and manufacturing. The Company
is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for
that platform. The Company has acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual dysfunction.
In addition, the Company is evaluating the further development of its product candidates OXi4503 as a treatment for acute myeloid leukemia
and myelodysplastic syndromes and CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma.
In
2020, the Company had entered into an agreement and supplemental agreement with GMP for a total of $1.2 million to render services for
the development of OT-101 for COVID-19 and such amount was recorded as revenue upon completion of all performance obligations under the
agreement. Further, In June 2020, the Company secured $2 million in debt financing from GMP to conduct a clinical trial evaluating OT-101
against COVID-19. The Company discontinued enrollment in its OT-101 clinical trial in patients with COVID-19 in June 2021. In September
2021, the Company secured a further $1.5 million in debt from GMP to complete the study. The trial completed randomization of 32 out
of 36 patients planned, on an intent to treat basis. The discontinuance of the trial was due to the continuing rise of more severe variants
in Latin America, leading to exhaustion of medical care infrastructure in Latin America.
In
2020 and 2021, the Company was developing Artemisinin
as a potential therapy for COVID-19. Artemisinin, purified from a plant Artemisia annua. It can inhibit TGF-β activity and
is able to neutralize COVID-19. The Company initially conducted a study and the test results during an in vitro study at Utah State University
showed Artemisinin having an EC50 of 0.45 ug/ml, and a Safety Index of 140. For more information on the development of Artemisinin,
refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
Between
October 2021 and January 2022, GMP provided a further $1.0 million to the Company to fund operations on the way to complete a JV. In
March 2022, the Company formalized a JV with Dragon to form GMP Bio. For more information on the JV, refer to Note 6 of the Notes to
the Audited Consolidated Financial Statements for this Annual Report.
In
November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO, Inc. (“Pet2DAO”),
as a wholly owned subsidiary. A DAO is an emerging form of legal structure, that has no central
governing body, and whose members share a common goal to act in the best interest of the entity. Pet2DAO is a DAO technology company,
integrating the strong governance of traditional corporations with the innovative DAO architecture. The Company will look to engage stakeholders,
to build value through the DAO, while maintaining the rigor of traditional corporations, including governance, compliance, and accountability
through a team of veterans in public companies with innovators in AI, blockchain and Web3. Pet2DAO will initially be looking to
develop products for the animal health space. The Company will initially issue regular tokens and non-fungible tokens (“NFT”
and cumulatively “Tokens”) of Pet2DAO called PDAO to its employees, shareholders and key opinion leaders (“KOLs’)
and use the Tokens to propose and vote on various animal health related programs. In the future, the Company will evaluate and plan to
register these tokens with the SEC to make such Tokens freely tradable at a future point in time.
Since
April 2019, we have been operating under significant capital constraints, which has curtailed our ability to achieve meaningful progress
in either of the Company’s two clinical programs – one of which is developing OXi4503 as a treatment for acute myeloid leukemia
and myelodysplastic syndromes and the other of which is developing CA4P in combination with a checkpoint inhibitor for the treatment
of advanced metastatic melanoma. We believe that the merger of Oncotelic and Oncotelic Inc. creates a combined company that has potential
to generate shareholder value through a promising pipeline of next generation immunotherapies targeting several significant cancer markets
where there is a lack of therapeutic options and lack of an effective immunotherapy protocol.
Research
Service Agreement between Golden Mountain Partners LLC (“GMP”) and the Company.
When
COVID-19 emerged in China, the Company and GMP contemplated a collaboration to develop drug candidates for COVID-19. Oncotelic Inc. and
GMP entered into a research and services agreement (the “GMP Research Agreement”) on February 3, 2020 memorializing
their collaborative efforts to develop and test COVID-19 antisense therapeutics (the “GMP Agreement Product”). In
March 2020, the Company reported the anti-viral activity of OT-101 – its lead drug candidate currently in phase 3 testing in pancreatic
cancer and glioblastoma. In an in vitro antiviral testing performed by an independent laboratory, OT-101 had an 50% effective concentration
(EC50) of 7.6 µg/mL and is not toxic at the highest dose of 1000 µg/mL giving a safety index (SI) value of >130, which is
considered highly active. Further in March 2020, the Company and GMP entered into a supplement to the GMP Research Agreement (the “GMP
Research Supplement”) to confirm the inclusion of OT-101 within the scope of the GMP Research Agreement as a GMP Agreement
Product, pending positive confirmatory testing against COVID-19. In April 2020, the Company announced that it had delivered the requisite
testing results to GMP confirming the applicability and potential use of OT-101 for the treatment of COVID-19. OT-101 exhibited potent
activity against both COVID-19 and SARS with a robust safety index of >500. Also, the Company has submitted a Pre-Investigational
New Drug application package to the Food and Drug Administration.
In consideration for the financial support
provided to GMP for the research, pursuant to the terms of the GMP Research Agreement (as amended by the GMP Research Supplement), GMP
was entitled to obtain certain exclusive rights to the use of the GMP Agreement Product in the COVID Field on a global basis, and an
economic interest in the use of the GMP Agreement Product in the COVID-19 Field including profit sharing to be decided. For more information
on the collaborations with GMP, refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023. In March 2022, the
Company entered into a JV transaction with Dragon to form GMP Bio, both entities being affiliates of GMP. Dragon and the Company will
own in a / ratio, respectively, and its principal activities shall be to research, develop, bring to market and commercialize: (i)
the GMP Agreement Products in the COVID-19 Field on a global basis, (ii) the GMP Agreement Products in the OT-101 Oncology Field in the
territory set forth above, and if GMP so decides to include (iii) OXi4503 in the territory set forth above; and (iv) CA4P in the territory
set forth above.
In June 2020, the Company secured a
$2 million in debt financing, evidenced by a one-year secured convertible note (the “GMP Note”) from GMP, to conduct
a clinical trial evaluating OT-101 against COVID-19 bearing 2% annual interest, and is personally guaranteed by Dr. Vuong Trieu, the
Chief Executive Officer of the Company. The GMP Note was convertible into the Company’s Common Stock upon the GMP Note’s
maturity one year from the date of the GMP Note, at the Company’s Common Stock price on the date of conversion with no discount.
GMP does not have the option to convert prior to the GMP Note’s maturity at the end of one year. GMP has extended the maturity
of the GMP Note to December 31, 2023 with no concessions granted to GMP for such extension. Such financing was utilized solely
to fund the clinical trial.
In
September 2021, the Company secured a further $1.5 million in debt financing, evidenced by a one-year unsecured convertible note
(the “GMP Note 2”) from GMP, bearing 2% annual interest, to fund the same clinical trial evaluating OT-101
against COVID-19. All the terms of the GMP Notes 2 are the same as the GMP Note. Such financing will be utilized solely to fund
the COVID-19 clinical trial. As of December 31, 2022, GMP was invoiced by the clinical research organization for $1.5 million.
GMP paid the clinical trial organization $1.0 million against the billing. GMP has extended the maturity of the GMP Note
2 to December 31, 2023 with no concessions granted to GMP for such extension. Such financing was utilized solely to fund the clinical
trial.
In
October 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “October Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “October
2021 Note”), bearing 2% annual interest, which October 2021 Note is convertible into shares of the Company’s Common
Stock. The terms of all the notes are identical to the GMP Note 2. GMP has extended the maturity of the October 2021
Note to December 31, 2023 with no concessions granted to GMP for such extension. Such financing was utilized solely to fund the clinical
trial.
In
January 2022, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “ January Purchase
Agreement”) with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount
of $0.5 million (the “January 2022 Note”), bearing 2% annual interest, which January 2022
Note is convertible into shares of the Company’s Common Stock. The terms of all the notes are identical to the
GMP Note 2. GMP has extended the maturity of the January 2022 Note to December 31, 2023 with no concessions granted to GMP
for such extension. Such financing was utilized solely to fund the clinical trial.
Cumulatively,
the GMP Note, GMP Note 2, October 2021 Note and January 2022 Note are referred to as the “GMP Notes”.
Joint
Venture
On
March 31, 2022, the Company entered into (i) a JV agreement with Dragon and GMP Bio (and the Company, Dragon and GMP Bio are collectively
called the “Parties”) (the “JVA”), (ii) a license agreement for rights to OT-101 (the “US
License Agreement”) for the territory within the United States of America (the “US”) with Sapu Holdings,
LLC, a subsidiary of GMP Bio and (iii) a license agreement for rights to OT-101 for the rest of the world with GMP Bio (the “Ex-US
Rights Agreement”, and the US License Agreement and the Ex-US License Agreement are collectively called the “Agreements”).
The
Company determined that the arrangement does not meet the accounting definition of a joint venture. Subsequently, we analyzed our investment
and determined that such investment was not considered a VIE, which would require consolidation. Besides, the Company does not have the
power to direct the activities that most significantly impact the economic performance of the JV. The Company does not control the JV
through majority ownership interest or Board participation. As such, the Company followed the guidance in ASC 610-20 regarding the sale
of nonfinancial assets to noncustomers when retaining a non-controlling ownership interest in such assets. The Company is deemed to have
substantially transferred the actual intellectual property related to OT-101 as the investee can benefit from the risk and rewards of
ownership of such intellectual property. This resulted in the derecognition of the carrying amount of our intangible assets for approximately
$0.8 million and goodwill for $4.9 million for an aggregate amount of approximately $5.7 million, recorded its initial investment at
its fair value for approximately $22.6 million and which resulted in a non-cash gain on non-financial asset disposal of approximately
$17 million, which was reported in other income in the condensed consolidated statements of operations during the year ended December
31, 2022. The Company elected the fair value option under subsection of Section 825-10-15 to account for its equity-method investment
as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option
is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are
not appropriately reflected in the market value or reflective of the true value of the development activities of the company.
This
JV is a significant milestone in the history of the Company. It permits the Company to monetize and develop the assets it holds, by minimal
to no shareholder dilution. This transaction allows us to unburden the Company of the high cost of drug development, which the JV will
be responsible for, while the Company will participate in its upside through appreciation in the value of its shares in the JV and up
to a potential of $50 million on the sale of the RPD voucher following marketing approval of OT-101 for DIPG. Dragon has agreed to invest
cash and other assets with a value of approximately $27.6 million for 55% ownership of the JV; and Oncotelic has granted the License
to the JV for 45% ownership in the JV for a fair value of about $22.6 million. The cash contributions by Dragon will allow the JV to
commence the development of OT-101.
For
information on the JV, refer to Note 6 – Joint Venture and GMP of the Notes to the Consolidated Financial Statements below.
License
Agreement with Autotelic, Inc.
On
September 30, 2021, Oncotelic Therapeutics,
Inc. (the “Company”) entered into an exclusive License Agreement (the “License Agreement”) with
Autotelic, Inc. (“Autotelic”), pursuant to which Autotelic granted Oncotelic the exclusive right and license to certain
Autotelic Patents (as defined in the Agreement) and Autotelic Know-How (as defined in the License Agreement) and a right of first refusal
to acquire at least a majority of the outstanding capital stock of Autotelic. For more information on the License Agreement, refer
to our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
Private
Placement through JH Darbie & Co., Inc.
Between
July 2020 and March 2021, the Company offered and sold certain units (“Units”) in a private placement through JH Darbie
& Co., Inc. (“JH Darbie”), with each unit consisting of: (i) 25,000 shares of Edgepoint common stock, par value
$0.01 per share (“Edgepoint Common Stock”), for a price of $1.00 per share of Edgepoint Common Stock; (ii) one convertible
promissory note issued by the Company (the “Unit Note”), convertible into up to 25,000 shares of EdgePoint Common
Stock at a conversion price of $1.00 per share, or up to 138,889 shares of the Company’s Common Stock, at a conversion price of
$0.18 per share; and (iii) 100,000 warrants (the “Warrants”), consisting of (a) 50,000 warrants to purchase an equivalent
number of shares of EdgePoint Common Stock at $1.00 per share (“Edgepoint Warrant”), and (b) 50,000 warrants to purchase
an equivalent number of shares of Company Common Stock at $0.20 per share (“Oncotelic Warrant”) (the sale of Units
is hereinafter, the “JH Darbie Financing”). In total, as of December 31, 2021, the Company had issued and sold a total
of 100 Units, resulting in gross proceeds of $5 million to the Company. JH Darbie earned $0.65 million and 10 Units as
fees as the private placement agent.
In
June 2021, the Company and the Investors agreed to extend the maturity date of the Notes from June 30, 2021, to March 31, 2022. In
addition, the Company and JH Darbie identified an error in the Oncotelic Warrants and JH Darbie Financing documents which intended
to have the investors to purchase $50,000 of shares of Common Stock or Edgepoint Common Stock. However, the Company only issued
50,000 Oncotelic Warrants, with an aggregate exercise price of $10,000. The error was corrected by the Company and the Company
issued to the Investors an aggregate of 20.0 million additional Oncotelic Warrants, and 2.0 million additional Oncotelic Warrants to
J.H. Darbie, as placement agent. Each Investor was entitled to receive 200,000 additional Oncotelic Warrants for each Unit
purchased.
In
February 2022, the Company and 99 out of 100 of the Investors agreed to extend the maturity date of the notes connected to the Units
from March 31, 2022, to March 31, 2023. In addition, the Company issued approximately 33 million warrants to purchase $50,000 of shares
of common stock of the Company in connection with agreeing to extend the maturity date by one year. The 99 units were outstanding as
of December 31, 2022.
Peak
One Equity Purchase Agreement
In
May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the
“Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to
which the Company shall have the right, but not the obligation, to direct Peak One, to purchase up to $10.0 million (the “Maximum
Commitment Amount”) in shares of the Company’s Common Stock. For more information for the EPL, refer to our 2022 Annual
Report on Form 10-K filed with the SEC on April 14, 2023.
The
Company filed a post-effective amendment to reregister the EPL on April 26, 2022, and the post-effective amendment was found effective
by the SEC on May 6, 2022. Since the EPL was made effective in June 2021 till December 31, 2022, the Company has directed Peak One,
on multiple occasions, for an aggregate of 4.7 million shares of Common Stock for aggregate net cash proceeds of approximately $0.6 million.
Paycheck
Protection Program
In
April 2020, the Company received loan proceeds in the amount of $250,000 under the Paycheck Protection Program (“1st
PPP”) which was established under the Coronavirus Aid, Relief and Economic Security (“CARES”) Act and
is administered by the Small Business Administration (“SBA”).
The
Company met the 1st PPP loan forgiveness requirements and applied for forgiveness; and the Company received the 1st
PPP loan forgiveness approval in August 2021 from the lender and wrote off the loan outstanding amount inclusive of interest
accrued, in the amount of approximately $0.25 million.
In
July 2021, the Company’s wholly owned subsidiary, PointR, received loan proceeds in the amount of $92,995 under the PPP (“2nd
PPP”). The 2nd PPP was at terms similar to the 1st PPP. The Company met the 2nd PPP
loan forgiveness requirements and received the 2nd PPP loan forgiveness approval from the lender on December 8, 2021 and wrote
off the loan outstanding amount inclusive of interest accrued, in the amount of approximately $0.1 million. For more information on
the PPP loans, refer to Note 5 of the Notes to the Consolidated Financial Statements.
August
2021 Notes
In
August 2021, the Company entered into Note Purchase Agreements with Autotelic, the Company’s CFO, and certain other accredited
investors. Under the terms of the Note Purchase Agreements, the Company issued an aggregate of $698,500 (the “Principal Amount”)
in debt in the form of unsecured convertible promissory notes (collectively, the “August 2021 Notes”). For more
information on the August 2021 Notes, refer to Note 5 of the current Notes to the Consolidated Financial Statements.
November
/ December 2021 and March 2022 Financing
In
November and December 2021, the Company entered into securities purchase agreement with five institutional investors, whereby the Company
issued five convertible notes in the aggregate principal amount of $1,250,000 convertible into shares of common stock of the Company.
The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance
or upon event of default. Investors have the right at any time following issuance date to convert all or any part of the outstanding
and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.07. As
of December 31, 2022, these notes are in default and payable immediately. However, the Company has not received notification of default
from the lender. The Company granted a total number of 9,615,385 warrants convertible into an equivalent number of the Company common
shares at a strike price of $0.13 up to five years after issuance. The Placement agent was also granted a total amount of 125,000 warrants
as part of a finder’s fee agreement.
In
January 2022, three of the five note holders under the November / December 2021 Notes exercised their warrants
to purchase shares of Common Stock of the Company on a cashless basis. As such, the Company issued the note holders 3,041,958 shares
of Common Stock.
In
March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible
promissory note in the aggregate principal amount of $0.25 million, which Note is convertible into shares of the
Company’s Common Stock. As of December 31, 2022, this note is in technical
default due to cross default provision contained in November / December 2021 Notes. This Note was undertaken by
the Company pursuant to the Darbie Agreement.
In June 2022, Mast fully converted their November 2021 Note, for which the company
issued 4,025,000 shares of Common Stock.
In
August 2022, the Company converted $140,000 of
Fourth Man Note into 2,025,000 shares of common stock.
In
September 2022, the Company converted $68,250 of Blue Lake note into 1,428,571 shares of common stock.
In
October 2022, Fourth Man exercised their warrants to purchase shares of Common Stock of the Company on a cashless basis. As such, the
Company issued the note holder 912,162 shares of Common Stock.
In
December 2022, the Company partially converted $50,000
of Fourth Man Note into 739,285 shares of Common Stock.
In
February 2023, the Company partially converted $ 71,750 of Blue Lake Note into 1,025,000 shares of Common Stock.
May
2022 Note
In
May 2022, the Company entered into a Securities Purchase Agreement with Mast, pursuant to which the Company issued convertible
promissory notes in the aggregate principal amount of $0.6 million, which note is convertible into shares of the Company’s
Common Stock. As of December 31, 2022, this note is in technical default due to cross default
provision contained in November / December 2021 Notes. As of December 31, 2022, this note is in technical default due to cross
default provision contained in November / December 2021 Notes. This note was used to fully repay November 2021 Talos note and
the December 2021 First Fire note. $35,000 of the First Fire Note was converted into 500,000 shares of Common Stock and the balance
was repaid in cash
June
2022 Note
In
June 2022, the Company entered into a Securities Purchase Agreement with Blue Lake, pursuant to which the Company issued convertible
promissory notes in the aggregate principal amount of $0.34 million, which note is convertible into shares of the Company’s Common
Stock. As of December 31, 2022, this note is in technical default due to cross default provision
contained in November / December 2021 Notes. This note was utilized for corporate expenses.
Short-term
loans
During
the year ended December 31, 2021, the Company’s CFO, a related Party, provided short term advances of approximately $45,000. $20,000
was repaid to the CFO in January 2022. As such approximately $25,000 was outstanding at December 31, 2022.
During
the fourth quarter of the year ended December 31, 2020, the Company’s CFO and the Bridge Investor provided short term loans of
$25,000 and $50,000, respectively to the Company. Such loans were repaid as of March 31, 2021. During the year ended December 31, 2021,
the CFO provided a total of approximately $120,000, of which $75,000 was converted into the August 2021 Notes. During the year ended
December 31, 2021, the Company received approximately $630,000 primarily from two bridge investors, of which $373,500 was converted into
the August 2021 Notes, and $20,000 was repaid. Approximately $243,000 was outstanding as short-term advances to bridge investors
as of December 31, 2022.
During
the year ended December 31, 2021, Autotelic Inc. provided a short-term funding of $120,000 to the Company, which was repaid in 2021.
In May 2021, Autotelic provided an additional short-term funding of $250,000 to the Company, which was converted into the August 2021
Notes. Autotelic provided an additional $20,000 short-term loan to the Company. During the year ended December 31, 2022, Autotelic provided
an additional $100,000 short term loan to the company and as such, $120,000 was outstanding and payable to Autotelic at December 31,
2022.
Pet2DAO
In
November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO, Inc. (“Pet2DAO”),
as a wholly owned subsidiary. A DAO is an emerging form of legal structure, that has no central governing body, and whose members share
a common goal to act in the best interest of the entity. Pet2DAO is a DAO technology company, integrating the strong governance of traditional
corporations with the innovative DAO architecture. The Company will look to engage stakeholders, to build value through the DAO, while
maintaining the rigor of traditional corporations, including governance, compliance, and accountability through a team of veterans in
public companies with innovators in AI, blockchain and Web3. Pet2DAO will initially be looking to develop products for the animal health
space. The Company will initially issue regular tokens and non-fungible tokens (“NFT” and cumulatively “Tokens”)
of Pet2DAO, called PDAO, to its employees, shareholders and key opinion leaders (“KOLs’) and use the Tokens to propose
and vote on various animal health related programs. In the future, the Company will evaluate and plan to register these tokens with the
SEC to make such Tokens freely tradable at a future point in time.
Critical
Accounting Policies and Significant Judgments and Estimates
The
preparation of financial statements in accordance with U.S. generally accepted accounting principles requires us to make estimates and
assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the
date of the financial statements, as well as the reported revenues and expense during the reporting periods. We base our estimates on
historical experience and on various other assumptions that we believe to be reasonable under the circumstances at the time we make such
estimates. Actual results and outcomes may differ materially from our estimates, judgments and assumptions. We periodically review our
estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in
the financial statements prospectively from the date of the change in estimate. Our significant accounting policies are more fully described
in Note 2 to our financial statements included elsewhere in this Registration Statement.
We
define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about
matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as
the specific manner in which we apply those principles. We believe the critical accounting policies used in the preparation of our financial
statements that require significant estimates and judgments are the following:
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the
forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined
to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets
of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature
of the assets.
Intangible
Assets
The
Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews
the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not
that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating
performance, competition, sale or disposition of a significant portion of the business, or other factors.
Goodwill
Goodwill
represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired.
Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events
or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative
assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more
likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment
would not be required. Otherwise, goodwill impairment is tested using a two-step approach.
The
first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is
determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined
to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves
calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill,
of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in
this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of
the goodwill, an impairment loss equivalent to the difference is recorded.
Convertible
Instruments
The
Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives
and Hedging”.
ASC
815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and
account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic
characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and
risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is
not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported
in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered
a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional
as defined under professional standards.
The
Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from
their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly,
the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments
based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the
effective conversion price embedded in the note. Original issue discounts under these arrangements are amortized over the term of the
related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of
conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the
commitment date of the note transaction and the effective conversion price embedded in the note.
ASC
815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally,
if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an
asset or a liability
Derivative
Financial Instruments Indexed to the Company’s Common Stock
We
have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms
of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations
include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding,
do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However,
if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are
met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity
offerings, we must estimate the fair value of the warrants, which is as inherently subjective as it is for stock options, and for similar
reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we
report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.
Variable
Interest Entity (VIE) Accounting
We
evaluate our ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests,
whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations
can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information,
among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is
consolidated into the financial statements.
Investments
- Equity Method
The
Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses,
which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary
declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an
asset may not be recoverable.
The
Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to
ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares are included in the result from continuing operations. Refer to
Note 6 of these Notes to the Consolidated Financial Statements.
Joint
Venture agreement
We
have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization,
including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract
development and manufacturing organization (CDMO) facilities and capabilities. The Company first review the arrangement to determine
if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture,
the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii)
the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity
investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition
of a joint venture
We
consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures
to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity
investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether
there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection
against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf
of an investor with disproportionately few voting rights in making this VIE determination.
To
the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic
performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant
to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests
in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary
beneficiary.
To
the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests
or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights.
Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets
of the joint venture without the consent of the non-managing entity and the inability of the non-managing entity to remove us from our
role as the managing entity.
We
use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the
equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and
liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.
When
we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize
the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria
are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value.
As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.
When
circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is
other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at
fair value.
The
Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment.
Research
and Development Expense
Research
and development expense consists of costs we incur for the development of our investigational drugs and, to a lesser extent, for preclinical
research activities. Research and development costs are expensed as incurred. Research and development expense includes clinical trial
costs, salaries and benefits of employees, including associated stock-based compensation, payments to clinical investigators, drug manufacturing
costs, laboratory supplies and facility costs. Clinical trial costs are a significant component of our research and development expense,
and these can be difficult to accurately estimate. Included in clinical trial costs are fees paid to other entities that conduct certain
research and development activities on our behalf, such as clinical research organizations, or CROs. We estimate clinical trial expense
based on the services performed pursuant to contracts with research institutions such as CROs and the actual clinical investigators.
These estimates are based on actual time and expenses incurred by the CRO and the clinical investigators. Also included in clinical trial
expense are costs based on the level of patient enrollment into the clinical trial and the actual services performed under the related
clinical trial agreement. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of
screening failures, patient drop-out rates, number and nature of adverse event reports and the total number of patients enrolled can
impact the average and expected cost per patient and the overall cost of the clinical trial. Based on patient enrollment reports and
services provided, we may periodically adjust estimates for the clinical trial costs. If we do not identify costs that we have begun
to incur or if we underestimate or overestimate the level of services performed, the length of time for these services or the costs of
these services, our actual expenses could differ from our estimates.
Share-Based
Compensation
We
record the estimated fair value of all share-based payments issued to employees and other service providers. Our share-based payments
consist primarily of stock options. The valuation of stock options is an inherently subjective process, since market values are not available
for any stock options in our equity securities. Market values are also not available on long-term, non-transferable stock options in
other equity securities. With no market values on options to trade in our common stock and no comparable market values on any long-term
non-transferable stock options, the process of valuing our stock options is even more uncertain and subjective. Accordingly, we use a
Black-Scholes option pricing model to derive an estimated fair value of the stock options which we issue. The Black-Scholes option pricing
model requires certain input assumptions, including the expected term of the options and the expected volatility of our common stock.
Changes in these assumptions could have a material impact on the estimated fair value that we record for share-based payments that we
issue. We determine the term of the options based on the simplified method, which averages the vesting period and the contractual life
of the stock option. We determine the expected volatility based on the historical volatility of our common stock over a period commensurate
with the option’s expected term. The Black-Scholes option pricing model also requires assumptions for risk-free interest rates
and the expected dividend yield of our common stock, but we feel that these values are more objective and note that changes in these
values do not have a significant impact on the estimated value of the options when compared to the volatility and term assumptions.
Results
of Operations
Comparison
of the Results of Operations for the Year Ended December 31, 2022 to the Year Ended December 31, 2021
A
comparison of the Company’s operating results for the year ended December 31, 2022 and 2021, respectively, is as follows.
| |
2022 | | |
2021 | | |
Variance | |
Operating expense: | |
| | | |
| | | |
| | |
Research and development | |
$ | 756,910 | | |
$ | 3,658,617 | | |
$ | (2,901,707 | ) |
General and administrative | |
| 4,853,664 | | |
| 5,467,266 | | |
| (613,602 | ) |
Goodwill impairment | |
| 4,111,079 | | |
| - | | |
| 4,111,079 | |
Total operating expense | |
| 9,721,653 | | |
| 9,125,883 | | |
| (595.770 | ) |
Loss from operations | |
| (9,721,653 | ) | |
| (9,125,883 | ) | |
| 595,770 | |
Interest expense, net | |
| (2,971,046 | ) | |
| (2,002,813 | ) | |
| (968,233 | ) |
PPP loan forgiveness | |
| - | | |
| 346,761 | | |
| (346,761 | ) |
Reimbursement for expenses – related
party | |
| 533,485 | | |
| - | | |
| 533,485 | |
Gain on derecognition of non-financial asset | |
| 16,951,477 | | |
| - | | |
| 16,951,477 | |
Loss on debt conversion | |
| (257,810 | ) | |
| (27,504 | ) | |
| (230,306 | ) |
Change in the value
of derivatives on debt | |
| 142,150 | | |
| 292,149 | | |
| (149,999 | ) |
Net income (loss)
before controlling interests | |
$ | 4,676,603 | | |
$ | (10,517,290 | ) | |
$ | 15,193,894 | |
Net
Loss
We
recorded a net income of approximately $4.7 million for the year ended December 31, 2022, compared to a net loss of approximately
$10.5 million for the same period in 2021. The lower loss of approximately $15.2 million for the year ended December
31, 2022, as compared to the same period of 2021 was primarily due to recording a non-cash gain of $16.9 million in connection
with derecognition of non-financial asset related to the JV, reimbursement for expenses from a related party of $0.5 million,
lower operational expenses of approximately $3.5 million, excluding goodwill impairment, and lower change in value of derivatives
on debt. This gain was offset by recording an impairment of approximately $4.1 million on goodwill, which was created upon the acquisition
of PointR due the lower market capitalization of our Company as compared to our net assets (see Notes 2 and 3 to the Consolidated
Financial Statements), higher interest expense by approximately $1.0 million, lower PPP loan forgiveness of approximately
$0.3 million and approximately $0.2 million of a higher loss recorded on conversion of debt.
Research
and Development Expense
Research
and Development (“R&D”) expense decreased by approximately $2.9 million, to approximately $0.76
million for the year ended December 31, 2022 as compared to approximately $3.7 million for the year ended December 31, 2021.
The reduction in the R&D activities cost is primarily due to reduced clinical trial costs of $1.8 million for
the trials for OT-101 and Artemisinin, decreased compensation cost of approximately $1 million and $0.17 million for lower
operational costs as these costs have been borne by our JV.
Now
that we have formed a joint venture with GMP Bio, whereby we are able to transfer the responsibility of our drug development program
to the JV, we expect to increase research and development activities related to apomorphine, including the initiation of
new clinical trials for our other oncology indications as well continuing or expanding on the trials and development of AI based tools
and applications for OT-101 and Artemisinin for COVID-19 and other epidemics, and therefore believe that research and development expense
may increase in the future, subject to our continuing ability to secure sufficient funding to continue planned operations.
General
and Administrative Expense
General
and administrative (“G&A”) expense decreased by approximately $0.6 million, to approximately
$4.8 million for the year ended December 31, 2022 as compared to approximately $5.5 million for the same period of
2021. The decrease in G&A expenses was primarily due to an increase of approximately $0.7 million of non-cash
stock-compensation expenses, offset by lower compensation costs of approximately $0.8 million and lower legal and
professional costs of approximately $0.5 million.
Now
that we have formed a joint venture with GMP Bio, we may be able to transfer the responsibility of some or most of our G&A expenses
to the joint venture, we may see an increase in G&A expenses, subject to our continuing ability to secure sufficient funding to continue
planned operations.
Goodwill
Impairment
We
recorded a goodwill impairment of approximately $4.1 million on the approximately $16.2 million goodwill, which we recorded upon our
acquisition of PointR, for the year ended December
31, 2022. No similar impairment was recorded for the same period of 2021.
During
the third and fourth quarters of 2022, we concluded
that the steep decline of our stock price, the market capitalization of our Company, and the general economic conditions, which adversely
impacted the majority of the pharmaceutical and biotechnology industry, were indicative of a potential impairment of our goodwill. While
we evaluated and concluded that the AI technologies related to the PointR acquisition are not adversely impacted, and the Company
continues to develop other AI technologies, the significant reduction of our market capitalization required us to record an impairment
on the goodwill to the extent of the difference between the net assets of the Company over the fair value based on the market
capitalization.
Interest
Expense
We
recorded interest expense, including amortization of debt costs, of approximately $3.0 million for the year ended December
31, 2022 in connection with debt raised from the various convertible notes and a private placement memorandum as compared to
$2.0 million on convertible notes and a portion of the private placement memorandum for the same period of 2021.
PPP
Loan Forgiveness
During
the year ended December 31, 2021, we recorded a PPP Loan Forgiveness of approximately $0.35 million. No similar forgiveness was recorded
during the year ended December 31, 2022.
Reimbursement
of expenses
The
Company was reimbursed approximately $0.5 million, by Autotelic Inc. a related party, during the year ended December 31, 2022 for expenses
incurred by the Company on behalf of our JV. No similar reimbursement was made during the year ended December 31, 2021.
Gain
on Derecognition of Non-financial Asset
During
the year ended December 31, 2022, we recorded a gain of approximately $16.9 million on the sale of our non-financial asset upon the transfer
of OT-101 as our capital contribution for the JV. We adopted the fair value measurements under the equity method and the gain was net
of the fair value of the asset of approximately $22.6 million as reduced by the removal of the value of the intangibles of approximately
$0.8 million for OT-101 and the value of the goodwill of $4.9 million recorded at the time of the 2019 Merger with Oncotelic Inc. No
similar gain was recorded during the year ended December 31, 2021.
Loss
on Conversion of Debt
During
the year ended December 31, 2022, we recorded a loss on conversion of debt of approximately $0.3 million related to the difference in
fair value to the price at which the debt was converted. We had recorded a similar loss of $28 thousand for the debt conversion by Peak
One and TFK in 2021.
Change
in value of derivatives
During
the year ended December 31, 2022, we recorded a gain of $0.1 million due to the change in value of derivatives on the notes issued to
our CEO and the bridge investors. Correspondingly, during the year ended December 31, 2021, we recorded a gain of $0.3 million due to
the change in value of derivatives on the notes issued to our CEO and the bridge investors.
Liquidity,
Financial Condition and Capital Resources ($s in ‘000’s)
| |
December
31, 2022 | | |
December
31, 2021 | |
Cash, including restricted cash | |
$ | 261 | | |
$ | 589 | |
Working capital | |
| (16,620 | ) | |
| (14,828 | ) |
Stockholders’ Equity | |
| 19,193 | | |
| 8,158 | |
The
Company has experienced net losses every year since inception and as of December 31, 2022 had an accumulated deficit of approximately
$25.9 million, including approximately $4.1 million goodwill impairment recorded during the fourth quarter of 2022. As of December
31, 2022, the Company had approximately $0.3 million in cash and current liabilities of approximately $16.9 million,
of which approximately $1.3 million are net assumed liabilities of the Company as part of the Oncotelic Inc. reverse merger, $4.1 million
of debt related to debt for conducting clinical trials for OT-101 from GMP and $2.6 million is contingent liability to issue common shares
of the Company to PointR shareholders upon achievement of certain milestones. The Company does not expect to generate any meaningful
revenue from product sales or licensing in the near future, and expects to incur additional operating losses over the next several years,
primarily as a result of the Company’s plans to continue clinical trials for its investigational drugs. Since the Company successfully formed the joint venture with Dragon Overseas and GMP Bio, all
costs associated with developing the assets licensed to the JV and a substantial portion of the G&A expenses will shift over to the
JV and hence the Company may be able to reduce its expenses. The Company’s limited capital resources, history of recurring losses
and uncertainties as to whether the Company’s operations will become profitable raise substantial doubt about its ability to continue
as a going concern. The financial statements contained in this report do not include any adjustments related to the recoverability of
assets or classifications of liabilities that might be necessary should the Company be unable to continue as a going concern.
The
principal source of the Company’s working capital deficit to date has been the issuance of convertible notes, a substantial part
of which has been provided by officers and certain insiders. The Company will need to raise additional capital in order to fund its operations
and continue development of product candidates. The Company is evaluating the options to further the development of the Company’s
lead product candidate, Apomorphine for Parkinsons Disease, erectile dysfunction and female sexual dysfunction; OT-101 for both cancer
and COVID-19, Artemisinin for COVID-19, developing AI technologies to support the COVID-19 therapies; in addition to evaluating the development
pathway of its product candidates; OXi4503 and/or CA4P.
The
Company anticipates raising substantial additional capital through the sale of equity securities and/or debt, but no new financing arrangements
are in place at this time.
If
the Company is unable to access additional funds when needed, it may not be able to continue the development of these investigational
drugs and the Company could be required to delay, scale back or eliminate some or all of its development programs and operations. Any
additional equity financing, if available, would be dilutive to the current stockholders and may not be available on favorable terms.
Additional debt financing, if available, may involve restrictive covenants and could also be dilutive. The Company’s ability to
access capital is not assured and, if access is not achieved on a timely basis, would materially harm the Company’s financial condition,
the value of its common stock and its business prospects.
Cash
Flows ($s in ‘000s)
| |
Year
ended December 31, | |
| |
2022 | | |
2021 | |
Net cash used in operating activities | |
$ | (1,453 | ) | |
$ | (4,434 | ) |
Net cash provided by
financing activities | |
| 1,125 | | |
| 4,529 | |
Increase in cash | |
$ | (327 | ) | |
$ | 95 | |
Operating
Activities
Net
cash used in operating activities was approximately $1.5 million for the year ended December 31, 2022. This was due to the net income
of approximately $4.7 million, primarily reduced by approximately $17 million due to a non-cash gain recorded upon the derecognition
of our non-financial assets and approximately $0.1 million due to a change in fair value of derivatives, and primarily increased by approximately
$4.1 million of goodwill impairment, approximately $2.0 million of amortization of debt and finance discounts, approximately $2.9 million
of non-cash stock based expense on issuance of warrants, approximately $0.9 million of stock compensation, approximately $0.3 million
of loss on conversion of debt and approximately $0.8 million due to changes in operating assets and liabilities.
Net
cash used in operating activities was approximately $4.4 million for the year ended December 31, 2021. This was due to the net
loss of approximately $10.5 million, which was partially offset by a $1.5 million of R&D cost paid through debt from GMP, non-cash
amortization of debt discounts and deferred financing costs of $1.4 million, non-cash stock-based compensation of $0.8 million, amortization
and depreciation of intangibles and development equipment of $0.1 million, non-cash gain on conversion of debt and change in fair value
of derivatives of $0.3 million, forgiveness of the PPP Loan of $0.3 million and changes in operating assets and liabilities of approximately
$0.2 million.
Financing
Activities
For
the year ended December 31, 2022, net cash provided by financing activities was approximately $1.1 million. Net cash provided was due
to approximately $0.2 million raised from sale of common stock under the equity purchase agreement with Peak One and approximately $1.0
million raised through issuance of convertible debt.
For
the year ended December 31, 2021, net cash provided by financing activities was approximately $4.5 million. Net cash provided
was due to approximately $1.6 million raised from the JH Darbie Financing, $0.1 million received under the Payroll Protection Plan, $0.4
million raised from sale of common stock under the equity purchase agreement with Peak One, $2.8 million raised through issuance of convertible
debt, repayment of $0.4 million of convertible debt due to Geneva and repayment of $0.2 million of other notes.
Off-Balance
Sheet Arrangements
We
have no off-balance sheet arrangements.
Effects
of Inflation
We
do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented.
Contractual
Obligations
Our
current drug development programs are based on a series of compounds called combretastatins, which we have exclusively licensed from
Arizona State University, or ASU. If our current drug candidates are approved, we will be required to pay low to mid-single-digit royalties
on future net sales of products associated with the ASU patent rights until these patent rights expire.
We
also have an exclusive license from Bristol-Myers Squibb, or BMS, for certain patent rights to particular combretastatins, including
CA4P. If CA4P is approved, we will be required to pay low-single-digit royalties on future net sales of products associated with the
BMS patent rights until these patent rights expire.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
following table sets forth certain information about our current directors and executive officers followed by individual biographies
of the directors and executive officers of the Company, including their business experience and other relevant information as of December
31, 2022.
Name |
|
Age |
|
Position |
Vuong
Trieu, Ph. D. |
|
57 |
|
Chairman
of the Board and Chief Executive Officer |
Amit
Shah |
|
55 |
|
Chief
Financial Officer |
Saran
Saund |
|
64 |
|
Chief
Business Officer |
Anthony
E. Maida III |
|
69 |
|
Chief
Medical Officer – Translation Medicine (Consultant) & Director |
Steven
W. King |
|
57 |
|
Director
and Consultant |
Fatih Uckun M.D, Ph. D. |
|
64 |
|
Chief Medical Officer (Consultant), resigned February 2023 |
Seymour Fein, M.D. |
|
73 |
|
Chief Regulatory Officer and Chief Medical Officer (Consultant) |
Vuong
Trieu, Ph.D. was the founder and Chairman of the Board of Directors of Oncotelic Inc., having served in such capacity since 2014,
and now serves as the Company’s Chief Executive Officer and Chairman of the Board of Directors. Dr. Trieu has been involved in
drug discovery, development, and commercialization for over 25 years, including his contributions as co-inventor of Abraxane®. He
previously served as Executive Chairman and Interim CEO of Marina Biotech, Inc. from 2016 to 2018. Marina Biotech was a developer of
tkRNA for the treatment of FAP/CRC (Familial adenomatous polyposis/ Colorectal Cancer). Prior to that, he also served as President and
CEO of IgDraSol, Inc.- a developer of a 2nd generation Abraxane—beginning in 2012 until its acquisition by Sorrento Therapeutics,
Inc. in 2013. He served as Chief Scientific Officer for Sorrento Therapeutics, Inc. and a member of that company’s board of directors
from 2013 until 2014. Previously, Dr. Trieu was Senior Director of Pharmacology/Biology at Abraxis Bioscience/Celgene, where he led the
preclinical, clinical and PK/biomarker development of Abraxane, and was the co-inventor of the intellectual property covering Abraxane.
Earlier in his career, Dr. Trieu held positions at Genetic Therapy/Sandoz (leading the adenoviral gene therapy program against atherosclerosis),
Applied Molecular Evolution (AME)/Lily (leading the expression, purification, and preclinical testing of mAb therapeutics) and Parker
Hughes Institute (Director of Cardiovascular Biology program that evaluated a series of small molecules and biologics against preclinical
models of atherosclerosis, dyslipidemia, stroke, ALS, and restenosis). Dr. Trieu holds a PhD in Microbiology, BS in Microbiology and
Botany. He is a member of ENDO, ASCO, AACR, and many other professional organizations. Dr. Trieu is published widely in oncology, cardiovascular,
and drug development.
Dr.
Trieu has over 100 patent applications and 39 issued U.S. patents.
The
Board believes that Dr. Trieu’s extensive experience as an executive at various biotechnology and biopharmaceutical companies as
well as his service on private and public company boards qualifies him to serve on the Board.
Amit
Shah was appointed as our Chief Financial Officer effective in July 2019. Mr. Shah has served as a senior financial officer for a
number of life science companies, including Chief Financial Officer at Marina Biotech, Inc., a publicly traded biotechnology company
from 2017 to 2018; Vice President of Finance & Accounting Insightra Medical Inc. from 2014 to 2015, Acting Chief Financial Officer
of Insightra Medical Inc. in 2015; VP Finance and Acting Chief Financial Officer at IgDraSol Inc. in 2013; Corporate Controller &
Director of Finance at ISTA Pharmaceuticals from 2010 to 2012; Corporate Controller at Spectrum Pharmaceuticals from 2007 to 2010: and
as Controller / Senior Manager Internal Audits at Caraco Pharmaceuticals Laboratories from 2000 to 2007. In addition to his work with
life sciences companies, Mr. Shah served as the Chief Financial Officer at Eagle Business Performance Services, a management consulting
and business advisory firm from end of 2018 through March 2019 and as a consultant and ultimately Senior Director of Finance –
ERP, at Young’s Market Company from 2015 to 2017. Mr. Shah received a Bachelor’s of Commerce degree from the University of
Mumbai, and is an Associate Chartered Accountant from The Institute of Chartered Accountants of India. Mr. Shah is also an inactive CPA
from Colorado, USA.
Saran
Saund has served as the Chief Business Officer of the Company since November 2019. Prior to that, he was the Chief Executive Officer
and Founder of PointR Data Inc. from 2016 to 2019 where the revenue generating startup developed an innovative AI for cashier-less automated
retail stores. From 2013 to 2016 Saran Saund served as managing partner of Astralync LLC that specialized in open-source AI frameworks
and developed an industry consortium. Previously, Saran Saund held positions as General Manager, founder and CEO at various companies,
including Cambridge Silicon Radio (acquired by Qualcomm), Marvell Semiconductors Inc., and PicoMobile Inc (acquired by Marvell). Mr.
Saund received his MSc. Tech in Computer Science from BITS Pilani (India) and MS Computer Science from Penn State University.
Anthony
E. Maida III, Ph.D., M.A., M.B.A. was appointed to the Board in May 2020. Dr, Maida was also appointed as a consultant Chief Medical
Officer of the Company in April 2020. Dr. Maida has been involved in the clinical development of immunotherapy for over 27 years in various
executive management positions. Since June 2010, Dr. Maida has served as Senior Vice President, Clinical Research for Northwest Biotherapeutics,
Inc., a cancer vaccine company focused on therapy for patients with glioblastoma multiforme and prostate cancer. From June 2009 through
June 2010, Dr. Maida served as Vice President of Clinical Research and General Manager, Oncology, Worldwide for PharmaNet, Inc., a clinical
research organization. From 1997 through 2010, Dr. Maida served as Chairman, Founder and Director of BioConsul Drug Development Corporation
and Principal of Anthony Maida Consulting International, advising pharmaceutical and investment firms, in the clinical development of
therapeutic products and product/company acquisitions. From 1992 to September of 1999, Dr. Maida was President and Chief Executive Officer
of Jenner Biotherapies, Inc., an immunotherapy company. Dr. Maida is currently a member of the board of directors and audit chair of
Spectrum Pharmaceuticals, Inc. and Vitality Biopharma, Inc. (OTCQB: VBIO) and was formerly a member of the board of directors and audit
chair of OncoSec Medical Inc. (OTCQB: ONCS). Dr. Maida holds a B.A. in Biology and History, an M.B.A., an M.A. in Toxicology and a Ph.D.
in Immunology. He is a member of the American Society of Clinical Oncology, the American Association for Cancer Research, the Society
of Neuro-Oncology, and the International Society for Biological Therapy of Cancer and the American Chemical Society.
The
Board believes that Dr. Maida is qualified to serve on the Board and as the Chief Medical Officer due to his extensive experience as
an executive at various biotechnology and biopharmaceutical companies as well as his service on private and public company boards.
Steven
W. King was appointed to the Board in May 2020. He previously served as the CEO of Peregrine Pharmaceuticals, Inc. and its wholly
owned biomanufacturing subsidiary Avid Bioservices, Inc., during which time the company advanced its lead compound through Phase 3 development,
while growing revenues to over $55 million. Prior to joining Peregrine, Mr. King was employed at Vascular Targeting Technologies, Inc.,
which was acquired by Peregrine in 1997. Mr. King served in a variety of executive roles at Peregrine, including Director of Research
and Development from 1997 to 2000; Vice President Technology and Product Development from 2000 to 2002; Chief Operating Officer from
2002 to 2003; and Chief Executive Officer from 2003 to 2017. Mr. King served on the board of directors of Peregrine from 2003 until 2017.
Mr. King previously worked at the University of Texas Southwestern Medical Center and is co-inventor on over 40 U.S. and foreign patents
and patent applications in the vascular targeting agent field. Mr. King received his Bachelor’s and Master’s degrees from
Texas Tech University in Cell and Molecular Biology.
The
Board believes Mr. King is qualified to serve as a director because of his extensive scientific understanding of technologies in development
and expertise in developing and manufacturing biologics, combined with the perspective and experience he brings from having previously
served on the boards of public companies.
Fatih
Uckun, M.D., Ph.D. was appointed in May 2022 as a Consulting Chief Medical Officer (“CMO”) for the Company.
Prior to joining Oncotelic, Dr. Uckun served as Chief Medical Officer and Chief Scientific Officer of Reven Pharmaceuticals from 2020
to 2022, Chief Medical Officer of Ares Pharmaceuticals from 2017 to 2022, Chief Clinical Advisor of Aptevo Therapeutics in 2021, Vice
President and Clinical Strategy Lead, Oncology-Hematology of Worldwide Clinical Trials in 2020, Chief Medical Officer of Mateon and Oncotelic
from 2019 to 2020, and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health from 2017 to 2018.
Prior to this, he was Vice President of Research and Clinical Development at Nantkwest, Chief Scientific Officer of Jupiter Research
Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm
Pharmaceuticals, and the Children’s Cancer Study Group. From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group
and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer. From 2009 to 2015 he was
a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood
Diseases at the University of Southern California. During his tenure at the University of Minnesota from 1986 to 1997, Dr. Uckun worked
as a Professor of Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute
at the University of Minnesota, where he became the first recipient of the Endowed Hughes Chair in Biotherapy. Dr. Uckun is an elected
Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of
several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion
proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial
Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar. He has published more than 500 peer-reviewed
papers, authored numerous review articles and book chapters and is an inventor on numerous patents. Dr Uckun resigned from his position
as CMO on February 28, 2023.
Seymour
Fein, M.D. was appointed to in May 2022 as the
Company’s Consulting Chief Regulatory Officer. Dr. Fein has been managing partner of the clinical and regulatory consulting organization,
CNF Pharma, LLC for the last 20 years and in that capacity has worked closely with numerous new drug reviewing divisions at the FDA including
the divisions of oncologic drug products. Dr. Fein’s professional activities have been focused on drug development research for
over 35 years. He has been extensively involved in the successful development of numerous drugs, biologics and medical devices during
this time leading to FDA approvals for over 20 drugs (NDAs, sNDAs, BLAs) and devices (PMAs). Dr. Fein began his career at Hoffmann-La
Roche Ltd. as a senior research physician and was responsible for a clinical development program that led to U.S. Food and Drug Administration
(FDA) approval of recombinant interferon-alpha for cancer treatment. Dr. Fein was also the medical director of Bayer Healthcare Pharmaceuticals
(U.S.) where he was responsible for therapeutic areas including gastroenterology, oncology, and cardiology. He later served as medical
director for Rorer Group (now part of Sanofi) and Ohmeda (now part of Baxter). Dr. Fein founded and has been managing partner of a clinical
and regulatory consulting organization and has worked closely with the numerous new drug review divisions at the FDA including the divisions
of oncologic drug products. Dr. Fein has successfully overseen entrepreneurial drug development leading to the FDA approval of two orphan
drug products in the field of gastroenterology and the first drug approved for the treatment of nocturia in the field of urology. Dr.
Fein received his B.A. degree from the University of Pennsylvania and his M.D. degree with honors from New York Medical College. He completed
a three-year residency in internal medicine at Dartmouth and a three-year fellowship in medical oncology and hematology at Harvard Medical
School, where he served as an instructor of medicine during his final fellowship year. Dr. Fein is board-certified in both oncology and
internal medicine.
The
Board had three standing committees, which
consisted of the Audit Committee, the Compensation Committee and the Nominating and Corporate Governance Committee (collectively,
the “Committees”), We discontinued all the Committees since July 2021 and since that date, the full Board serves
in lieu of all Committees. Once we engage new directors to the Board, we will restart the Committees, and the members will
serve on these committees until their resignation or as otherwise determined by our Board.
Audit
Committee
For
the year ended December 2022, the full Board acted in lieu of an Audit Committee. The full Board met four times during the year ended
December 31, 2022 in lieu of the Audit Committee.
Our
Audit Committee had the authority to retain and terminate the services of our independent registered public accounting firm, reviews
our annual financial statements, considers matters relating to accounting policy and internal controls, and reviews the scope of our
annual audits. Such functions are currently being managed by our full Board.
The
Board had adopted a charter for the Audit Committee, which is to be reviewed and reassessed annually by the Audit Committee. Due to a
lack of the Committee, such review and evaluation has not been done. A copy of the Audit Committee’s written charter is publicly
available on our website at www.oncotelic.com.
Compensation
Committee
For
the year ended December 2022, the full
Board acted in lieu of Compensation Committee. The full Board met once during the year ended December 31, 2022.
The
Compensation Committee’s responsibilities include making recommendations to the Board regarding the compensation philosophy and
compensation guidelines for our executives, the role and performance of our executive officers, and appropriate compensation levels for
our CEO, which are determined without the CEO present, and other executives based on a comparative review of compensation practices of
similarly situated businesses. The Compensation Committee also makes recommendations to the Board regarding the design and implementation
of our compensation plans and the establishment of criteria and the approval of performance results relative to our incentive plans.
Our Compensation Committee also administers our 2005 Stock Plan, our 2015 Equity Incentive Plan and our 2017 Equity Incentive Plan. Each
member of the Compensation Committee qualifies as independent under the definition promulgated by The NASDAQ Stock Market and qualifies
as a “Non-Employee Director” within the meaning of Rule 16b-3 under the Exchange Act.
The
Compensation Committee reviews and assesses the three main components of each named executive officer’s compensation: base salary,
incentive compensation, and equity compensation. Adjustments to base salary are generally only made when there has been a change in the
scope of the responsibilities of the named executive officer or when, based on a review of the base salary component of executive officers
in companies of a similar size and stage of development, the Compensation Committee members believe that an adjustment is warranted in
order to remain competitive. The executive management of the Company determines and agrees with the Compensation Committee on its corporate
goals and objectives for the ensuing year. At the end of each year, the attainment of each objective is assessed and incentive awards
may be made to each executive based on his or her contribution to achieving the objectives. Awards are made based on either provision
of an executive’s employment agreement, or an assessment of each executive’s equity compensation position relative to the
Company’s other executives.
The
Compensation Committee also typically reviews our director compensation on at least an annual basis. The Compensation Committee has the
authority to directly retain the services of independent consultants and other experts to assist in fulfilling its responsibilities.
Currently there are no independent compensation consultants retained by the Company.
Nominating
and Governance Committee
For
the year ended December 2022, the Company
had no Nominating and Governance Committee. The full Board acted in lieu of Nominating and Governance Compensation Committee.
The full board did not meet in lieu of the Nominating Committee.
The
Nominating and Governance Committee’s responsibilities include making recommendations to the full Board as to the size and composition
of the Board and making recommendations as to particular nominees to the Board. All members of the Nominating and Governance Committee
qualify as independent under the definition promulgated by The NASDAQ Stock Market.
Board
Attendance at Board of Directors, Committee and Stockholder Meetings
Our
Board met 4 times, which included in lieu of the Audit Committee, approved certain corporate actions by unanimous written
consents three times during the fiscal year ended December 31, 2022. Each of our directors serving during fiscal 2022 attended
all the meetings of the Board and in lieu of the Committees of the Board upon which such director served and that
were held during the year ended December 31, 2022.
Although
we do not have a formal policy regarding attendance by members of the Board at our annual meeting of stockholders, directors are encouraged
to attend.
Board
Leadership Structure
Our
Board has the discretion to determine whether to separate or combine the roles of Chair of the Board and Chief Executive Officer. Dr.
Trieu has served in both roles since his appointment to the Board after the reverse merger with Oncotelic and our Board continues to
believe that his combined role is most advantageous to the Company and its stockholders. Dr. Trieu possesses in-depth knowledge of the
issues, opportunities and risks facing us, our business and our industry and is best positioned to fulfill the Board Chair’s responsibility
to develop meeting agendas that focus the Board’s time and attention on critical matters and to facilitate constructive dialogue
among Board members on strategic issues.
In
addition to Dr. Trieu’s leadership, the Board maintains effective independent oversight through a number of governance practices,
including, open and direct communication with management, input on meeting agendas, and regular executive sessions.
Risk
Oversight
Our
Board oversees a company-wide approach to risk management, determines the appropriate risk level for us generally, and assesses the specific
risks faced by us to reviews the steps taken by management to mitigate those risks. Although our Board has ultimate oversight responsibility
for the risk management process, its committees oversee risk in certain specified areas.
Specifically,
our Compensation Committee is responsible for overseeing the management of risks relating to our executive compensation plans and arrangements,
and the incentives created by the compensation awards it administers and our Audit Committee oversees management of enterprise risks
and financial risks, as well as potential conflicts of interests. The Board will be responsible for overseeing the management of risks
associated with the independence of our Board.
Compensation
Committee Interlocks and Insider Participation
None
of our executive officers, except Dr. Trieu, served
as a member of the Board or Compensation Committee, or other committee serving an equivalent function, of any entity that has an executive
officer and who serves on our Board or Compensation Committee since 2019. After the merger of the Company with Oncotelic Inc.,
our Chief Executive Officer, Dr. Trieu has been identified and is a control person of Autotelic, Inc.
Also,
Mr. Steven King, was the CEO of Edgepoint Inc., an AI company that is a non-controlling interest subsidiary of the Company. Dr. Maida
is currently consulting as the Chief Medical Officer with the Company in regards to its planned trials for OT-101 for COVID-19 and other
oncology indications.
Corporate
Code of Ethics
We
have adopted a Corporate Code of Conduct and Ethics (the “Code of Conduct”) that applies to all of our employees,
including our CEO and CFO. The text of the Code of Conduct has been filed as an exhibit to our Annual Report on Form 10-K for the year
ended December 31, 2014, and is posted on our website at www.oncotelic.com. Disclosure regarding any amendments to, or waivers from provisions
of the code of conduct and ethics that apply to our directors and principal executive and financial officers will be included in a Current
Report on Form 8-K within four business days following the date of the amendment or waiver.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Exchange Act requires our directors, executive officers and persons who own more than 10% of our common stock to file with
the SEC and us initial reports of beneficial ownership and reports of changes in beneficial ownership of our common stock and other equity
securities. For these purposes, the term “other equity securities” would include options granted under the Company’s
2005 Stock Plan (the “2005 Stock Plan”), the Company’s 2015 Equity Incentive Plan (the “2015 Plan”)
and the Company’s 2017 Equity Incentive Plan (the “2017 Plan”). To our knowledge, based solely on a review of
the forms and written representations received by us from our Section 16 reporting persons, during the fiscal year ended December 31,
2019, all Section 16(a) filing requirements applicable to the reporting persons were properly and timely satisfied.
EXECUTIVE
COMPENSATION
Summary
Compensation Table
The
following table provides information regarding the compensation paid during the years ended December 31, 2022 and 2021
to our principal executive officer, principal financial officer and certain of our other executive officers, who are collectively referred
to as “named executive officers” elsewhere in this Annual Report.
Name and Principal Position | |
Year | | |
Salary $(1) | | |
Bonus $ | | |
Stock Awards $(2) | | |
All Other Compensation $ | | |
Total $ | |
Vuong Trieu, Ph. D. | |
| 2022 | | |
| 38,003 | | |
| | | |
| 53,832 | | |
| 37,500 | | |
| 129,335 | |
President and Chief Executive Officer | |
| 2021 | | |
| 189,990 | | |
| — | | |
| 48,341 | | |
| 18,750 | (3) | |
| 257,081 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Anthony E. Maida III, Ph. D., M.D. MBA | |
| 2022 | | |
| — | | |
| — | | |
| 53,832 | | |
| 75,000 | | |
| 128,832 | |
Chief Medical Officer (May 2020) Consultant | |
| 2021 | | |
| — | | |
| — | | |
| 100,164 | | |
| 205,000 | (4) | |
| 305,164 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Saran Saund | |
| 2022 | | |
| 19.531 | | |
| — | | |
| 58,832 | | |
| 15,898 | | |
| 89,261 | |
Chief Business Officer | |
| 2021 | | |
| 188,791 | | |
| — | | |
| 77,652 | | |
| 33,809 | (3) | |
| 300,252 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Amit Shah | |
| 2022 | | |
| 27,105 | | |
| — | | |
| 58,832 | | |
| 13,333 | | |
| 94,270 | |
Chief Financial Officer | |
| 2021 | | |
| 230,716 | (3) | |
| — | | |
| 26,948 | | |
| 13,333 | (3) | |
| 270,997 | |
(1)
Includes cost of healthcare benefits paid by the Company. Effective February 1, 2022, the cash compensation and benefits for all the
Officers, except Dr. Maida who was compensated till March 2022, has been borne by the JV. As the JV financials are not consolidated into
those of the Company, the Company has not included such compensation in this table. Going forward, and assuming the continuation of the
cash compensation and benefits will continue to be borne by the JV, the Company will not report such compensation information as part
of the Company’s Executive Compensation.
(2)
During the 2022 fiscal year, the Company granted 1 million stock awards to each of Dr. Trieu, Dr. Maida, Mr Saund
and Mr. Shah. The Company recorded stock-based compensation as the fair value of the awards using a Black Scholes valuation model using
the following input values
Expected Term | |
| 1
year | |
Expected volatility | |
| 95.5 | % |
Risk-free interest rates | |
| 3.12 | % |
Dividend yields | |
| 0.00 | % |
During
the 2021 fiscal year, the Company granted certain stock awards to Dr. Trieu, Dr. Maida, Mr. Saund and Mr. Shah. The Company had recorded
stock-based compensation as the fair value of the awards using a Black Scholes valuation model using the following input values.
Expected Term | |
| 2.18
to 2.28 years | |
Expected volatility | |
| 129.9
to 131.40 | % |
Risk-free interest rates | |
| 0.22
to 0.27 | % |
Dividend yields | |
| 0.00 | % |
The
values of stock option grants shown in the table represent the full estimated Black-Scholes option value at the grant date, pursuant
to compensation disclosure rules of the SEC. The Black-Scholes valuation for the options and stock awards for Messrs. Trieu, Maida, Park,
Saund and Shah were estimated based on the date on which the options and awards were granted to the officers. However, the stock option
grants in the table vest over one to ten years, and the values shown do not take into account subsequent increases or decreases in actual
value to the recipient. See the Narrative Disclosure below for information regarding the number of shares granted to each of the named
executive officers. See Note 11 to our Financial Statements included in this Annual Report on Form 10-K for the year ended December 31,
2021, for additional information regarding the assumptions used to determine the fair value of each of the option awards in this table.
See also our discussion of stock-based compensation under “Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our current Annual Report
on Form 10-K for the year ended December 31, 2021.
(3)
Represents other compensations paid to Messrs. Trieu, Saund and Shah in lieu of salary and for services rendered to the Company and its
subsidiaries.
(4)
Represents compensation paid to Dr. Maida in lieu of services rendered to the Company.
(5)
Drs. Uckun, as the Chief Medical Officer, and Fein, as the Chief Regulatory Officer, were compensated for their services by the JV
and hence are not reportable. Further, Dr. Uckun resigned from the position of Chief Medical Officer effective February 2023 and Dr.
Fein was appointed to that position effective the same date.
Narrative
Disclosure to Summary Compensation Table
Vuong
Trieu, Ph. D., Saran Saund and Amit Shah
Commencing
April 2019, Drs. Trieu and Park were appointed as Executive Officers and commenced earning compensation based on the table below. Mr.
Shah was appointed as a consulting CFO in July 2019 and became an Executive Officer and employee in August 2019. Subsequently, in August
2019, the Company entered into Employment Agreements and incentive compensation arrangements with each of its executive officers. The
Employment Agreements provide for annual base salaries for each year of the term, subject to review and adjustment by the Board or the
Compensation Committee from time to time. Each Employment Agreement provides that the executive shall be eligible for an annual discretionary
cash bonus expressed as a percentage the executive’s base salary, subject to their achievement of performance targets and goals
established by the Board or the Compensation Committee. Mr. Saund was appointed as an Executive Officer in November 2019 after the PointR
merger. Dr. Maida was appointed as our consultant Chief Medical Officer – Translation Medicine in May 2020 and does not
have an Employment Agreement. Each of the executive officers entered into the Company’s standard form of indemnification agreement.
Drs.
Uckun, as the Chief Medical Officer, and Fein, as the Chief Regulatory Officer, were appointed to their offices in May 2022. Further,
Dr. Uckun resigned from the position of Chief Medical Officer effective February 2023 and Dr. Fein was appointed to that position effective
the same date.
The
initial base salaries and discretionary cash bonus amounts have been set for the executives as follows:
Executive | |
Title | |
Initial
Base
Salary | | |
Discretionary
Bonus
(% of Base) | |
Vuong Trieu | |
Chief Executive Officer | |
$ | 450,000 | | |
| 50 | % |
Amit Shah | |
Chief Financial Officer | |
$ | 320,000 | | |
| 40 | % |
Saran Saund | |
Chief Business Officer | |
$ | 230,000 | | |
| 40 | % |
Anthony E. Maida III(1) | |
Chief Medical Officer | |
$ | 180,000 | | |
| NA | |
(1) |
Dr.
Maida is a consultant to the Company and currently does not have an Employment Agreement. |
For
more information on the executive compensations to the Executive Officers, refer to our 2022 Annual Report on form 10-K filed with the
SEC on April 14, 2023.
The Company did not grant any increases in cash compensation to any of its Executive Officers during the years
ended December 31, 2022 or 2021 due to the financial condition of the Company. In lieu of the financial condition, the Company granted
stock awards to the executives, including all other employees, during the year ended December 31,2022 and 2021 as under:
December
31, 2022
Executive | |
Title | |
Stock Options |
Vuong Trieu | |
Chief Executive Officer | |
1,000,000 |
Amit Shah | |
Chief Financial Officer | |
1,000,000 |
Saran Saund | |
Chief Business Officer | |
1,000,000 |
Anthony E. Maida III | |
Consulting Chief Medical Officer | |
1,000,000 |
20%
of the stock option awards vested immediately and 80% were to vest upon achievement of certain performance milestones by the Officers.
The Company has not completed its evaluation of whether such milestones have been met or not as of the date of this Report. However,
for the purposes of this Report and compensatory tables, the stock compensation expense has been reported as though such awards have
been earned by the Officers.
December
31, 2021
Executive | |
Title | |
Restricted
Stock | | |
Stock
Options | |
Vuong Trieu(1) | |
Chief Executive Officer | |
| 50,000 | | |
| 425,000 | |
Amit Shah | |
Chief Financial Officer | |
| 50,000 | | |
| 200,000 | |
Saran Saund | |
Chief Business Officer | |
| 25,000 | | |
| 775,000 | |
Anthony E. Maida III (2) | |
Consulting Chief Medical Officer | |
| - | | |
| 600,000 | |
(1)
Granted 225,000 stock options in his capacity as a member of the Board of Directors
(2)
Granted in his capacity as a member of the Board of Directors and not his capacity as the Consulting Chief Medical Officer – Translation
Medicine.
The
stock-based compensation on the issuance the RSUs and stock options has been reported under Summary Compensation Table above.
Outstanding
Equity Awards at Fiscal Year-End
The
following table shows all outstanding grants of stock options as of December 31, 2022 to each of the executive officers named
in the Summary Compensation Table. The table below reflects the options and restricted shares that are issuable to Messrs. Trieu, Maida,
Saund and Shah.
| |
| |
Option Awards |
Name | |
Type | |
Number of Securities Underlying
Unexercised Options Exercisable | | |
Number of Securities Underlying
Unexercised Options Unexercisable | | |
Option Exercise Price | | |
Option Expiration Date |
Vuong Trieu, Ph. D. (1) | |
| |
| | | |
| | | |
| | | |
|
Chief Executive Officer & President-
2022 | |
ISO | |
| 200,000 | | |
| 800,000 | | |
| 0.10 | | |
7/22/2032 |
2021 | |
ISO | |
| 360,000 | | |
| — | | |
| 0.1398 | | |
7/8/2031 |
2021 | |
ISO | |
| 200,000 | | |
| — | | |
| 0.1626 | | |
9/3/2031 |
| |
| |
| | | |
| | | |
| | | |
|
Saran Saund (1) | |
| |
| | | |
| | | |
| | | |
|
Chief Business Officer- 2022 | |
ISO | |
| 200,000 | | |
| 800,000 | | |
| 0.10 | | |
7/22/2032 |
2021 | |
ISO | |
| 675,000 | | |
| — | | |
| 0.1398 | | |
7/8/2031 |
2021 | |
ISO | |
| 100,000 | | |
| — | | |
| 0.1626 | | |
9/3/2031 |
| |
| |
| | | |
| | | |
| | | |
|
Anthony Maida (1) 2022 | |
| |
| | | |
| | | |
| | | |
|
Chief Medical Officer – Consultant- 2022 | |
ISO | |
| 200,000 | | |
| 800,000 | | |
$ | 0.10 | | |
7/22/2032 |
2021 | |
NQSO | |
| 400,000 | | |
| — | | |
$ | 0.1398 | | |
7/8/2031 |
2021 | |
NQSO | |
| 400,000 | | |
| — | | |
$ | 0.1626 | | |
9/3/2031 |
| |
| |
| | | |
| | | |
| | | |
|
Amit Shah (1) | |
| |
| | | |
| | | |
| | | |
|
Chief Financial Officer- 2022 | |
ISO | |
| 200,000 | | |
| 800,000 | | |
$ | 0.10 | | |
7/22/2031 |
2021 | |
ISO | |
| 400,000 | | |
| — | | |
$ | 0.1626 | | |
7/8/2031 |
(1) |
The
stock awards have been approved by the board. The stock compensation thereon has been computed and expensed when granted and reported
in the Summary Compensation Table. |
Pension
Benefits
We
do not have any qualified or non-qualified defined benefit plans.
Nonqualified
Deferred Compensation
We
do not have any non-qualified defined contribution plans or other deferred compensation plans.
Potential
Payments upon Termination or Change-In-Control
We
have entered into certain agreements and maintain certain plans that may require us to make certain payments and/or provide certain benefits
to Dr. Trieu, Mr. Saund and Mr. Shah in the event of a termination of their employment or a change of control of the Company.
The following table summarizes the potential payments to Drs. Trieu and Messrs. Saund and Shah assuming that one of the described
termination events occurs. The table assumes that the event occurred on December 31, 2022, the last day of our fiscal year and
that each of the named officers were eligible to earn the full initial base compensation. On the final trading day of our fiscal year
the closing price of our common stock on OTCQB Market was $0.05 per share.
The
Employment Agreements each have a term that continues until terminated by the Company or the executive. In the event that the Company
terminates an executive for “Cause”, or an executive voluntarily resigns his employment, on termination the executive will
be entitled to receive all accrued and unpaid base salary, any accrued and unused paid time off, and reimbursement of outstanding business
expenses. If the Employment Agreements are terminated by the Company without “Cause” or the executive resigns for “Good
Reason” (each as defined in the Employment Agreement) then the executive will be entitled to additional severance benefits including:
(a) a lump sum payment equal to 12 months’ of the executive’s then current base salary (18 months in the case of Dr. Trieu);
(b) accelerated vesting of all outstanding stock options and incentive compensation awards, and (c) insurance benefits or COBRA coverage
for 12 months (18 months in the case of Dr. Trieu) in addition to payment of accrued and unpaid.
Vuong
N. Trieu, Ph. D.
Executive
Benefits and Payments Upon Termination | |
Termination
within 12 months Following
Change in Control | | |
Voluntary
Termination by Executive or Death | | |
Involuntary
Not for
Cause Termination or
Termination by Executive with Good Reason | | |
For Cause
Termination | | |
Disability | |
Base Salary | |
$ | 675,000 | | |
$ | — | | |
$ | 675,000 | | |
$ | — | | |
$ | — | |
Annual
Bonus
(50% of Base Salary) | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | | |
| N/A | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | |
Acceleration of Vesting of Equity | |
| 100 | % | |
| 0 | % | |
| 100 | % | |
| 0 | % | |
| 0 | % |
Stock Options: | |
| | | |
| | | |
| | | |
| | | |
| | |
Number of Stock Option | |
| 1,998,255 | | |
| — | | |
| 1,998,255 | | |
| — | | |
| — | |
Value upon Termination* | |
$ | 99,913 | | |
$ | — | | |
$ | 99,913 | | |
$ | — | | |
$ | — | |
Vested Stock / Received: | |
| | | |
| | | |
| | | |
| | | |
| | |
Number of Shares | |
| 1,198,255 | | |
| — | | |
| 1,198,255 | | |
| — | | |
| — | |
Value upon Termination* | |
$ | 59,913 | | |
$ | — | | |
$ | 59,193 | | |
$ | — | | |
$ | — | |
Relocation Reimbursement | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Deferred Compensation Payout | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Post-Term Health Care | |
| Up
to 18 months | | |
| N/A | | |
| Up
to 18 months | | |
| N/A | | |
| N/A | |
| |
$ | 18,964 | | |
$ | — | | |
$ | 18,964 | | |
$ | — | | |
$ | — | |
Excise Tax Gross Up | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Saran
Saund
Executive
Benefits and Payments Upon Termination | |
Termination
within 12 months Following Change in Control | | |
Voluntary
Termination by Executive or Death | | |
Involuntary
Not for Cause Termination or Termination by Executive with Good Reason | | |
For Cause
Termination | | |
Disability | |
Base Salary | |
$ | 320,000 | | |
$ | — | | |
$ | 320,000 | | |
$ | — | | |
$ | — | |
Annual
Bonus
(40% of Base Salary) | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | | |
| N/A | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year if earned and not
already paid | |
Acceleration of Vesting of Equity | |
| 100 | % | |
| 0 | % | |
| 100 | % | |
| 0 | % | |
| 0 | % |
Stock Options: | |
| | | |
| | | |
| | | |
| | | |
| | |
Number of Stock Options (1) | |
| 1,993,798 | | |
| — | | |
| 1,993,798 | | |
| — | | |
| — | |
Value upon Termination* | |
$ | 99,690 | | |
$ | — | | |
$ | 99,690 | | |
$ | — | | |
$ | — | |
Vested Stock Received: | |
| | | |
| | | |
| | | |
| | | |
| | |
Number of Shares (1) | |
| 1,193,798 | | |
| — | | |
| 1,193,798 | | |
| — | | |
| — | |
Value upon Termination* | |
$ | 59,690 | | |
$ | — | | |
$ | 59,690 | | |
$ | — | | |
$ | — | |
Relocation Reimbursement | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Deferred Compensation Payout | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Post-Term Health Care | |
| Up
to 12 months | | |
| N/A | | |
| Up
to 12 months | | |
| N/A | | |
| N/A | |
| |
$ | 5,671 | | |
$ | — | | |
$ | 5,671 | | |
$ | — | | |
$ | — | |
Excise Tax Gross Up | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Amit
Shah
Executive
Benefits and Payments Upon Termination | |
Termination
within 12 months Following Change in Control | | |
Voluntary
Termination by Executive or Death | | |
Involuntary
Not for Cause Termination or Termination by Executive with Good Reason | | |
For
Cause Termination | | |
Disability | |
Base Salary | |
$ | 320,000 | | |
$ | — | | |
$ | 320,000 | | |
$ | — | | |
$ | — | |
Annual
Bonus (50%
of Base Salary) | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year
if earned and not already paid | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year
if earned and not already paid | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year
if earned and not already paid | | |
| N/A | | |
| Executive
entitled to Annual Bonus related to most recently completed calendar year
if earned and not already paid | |
Acceleration of Vesting of Equity | |
| 100 | % | |
| 0 | % | |
| 100 | % | |
| 0 | % | |
| 0 | % |
Stock Options: | |
| | | |
| | | |
| | | |
| | | |
| | |
Number
of Stock Options (1) | |
| 1,997,093 | | |
| — | | |
| 1,997,093 | | |
| — | | |
| — | |
Value upon Termination* | |
$ | 99,855 | | |
$ | — | | |
$ | 99,855 | | |
$ | — | | |
$ | — | |
Vested Stock Received: | |
| | | |
| | | |
| | | |
| | | |
| | |
Number of Shares (1) | |
| 1,197,093 | | |
| — | | |
| 1,197,093 | | |
| — | | |
| — | |
Value upon Termination* | |
$ | 59,855 | | |
$ | — | | |
$ | 59,855 | | |
$ | — | | |
$ | — | |
Relocation Reimbursement | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Deferred Compensation Payout | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
Post-Term Health Care | |
| Up
to 12 months | | |
| N/A | | |
| Up
to 12 months | | |
| N/A | | |
| N/A | |
| |
$ | 11,208 | | |
$ | — | | |
$ | 11,208 | | |
$ | — | | |
$ | — | |
Excise Tax Gross Up | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | | |
| N/A | |
*Based
on the stock price of the Company as of December 31, 2022, of $0.05 and assuming the number of shares granted are vested
and earned.
Dr.
Maida is a consultant Chief Medical Officer and is not subject to potential payments upon termination or change-in-control, and as such
his information has not been compiled for this table.
The
information set forth above is described in more detail in the Narrative Disclosure to the Summary Compensation Table.
As
defined in the employment agreements, a “Change in Control” means the following during the employment term:
(1) |
any
“Person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the “Beneficial Owner”
(as defined in Rule 13d-3 under said Act), directly or indirectly, of securities of the Company representing more than fifty percent
of the total voting power represented by the Company’s then outstanding voting securities (excluding for this purpose any such
voting securities held by the Company or its affiliates or by any employee benefit plan of the Company) pursuant to a transaction
or a series of related transactions which the Board of Directors does not approve; or |
|
|
(2) |
a
merger or consolidation of the Company whether or not approved by the Board of Directors, other than a merger or consolidation which
would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining
outstanding or by being converted into voting securities of the surviving entity or the parent of such corporation) at least fifty
percent of the total voting power represented by the voting securities of the Company or such surviving entity or parent of such
corporation, as the case may be, outstanding immediately after such merger or consolidation; or |
|
|
(3) |
the
stockholders of the Company approve an agreement for the sale or disposition by the Company of all or substantially all of its assets;
or |
|
|
(4) |
a
change in the composition of the Board of Directors, as a result of which fewer than a majority of the directors are Incumbent Directors,
and provided in each such case the Change in Control also meets the requirements of a “Change in Control Event” within
the meaning of Section 409A(a)(2)(A)(v) of the Code and Treasury Regulation Section 1.409A-3(i)(5). “Incumbent Directors”
mean the directors who either (A) are directors of the Company as of the date of this Agreement, or (B) are elected, or nominated
for election, to the Board of Directors with the affirmative votes of at least a majority of the Incumbent Directors at the time
of such election or nomination (but shall not include an individual whose election or nomination is in connection with an actual
or threatened proxy contest relating to the election of directors to the Company). |
In
each such case the Change of Control must also meet the requirements of a “Change of Control Event” within the meaning of
Section 409(a)(2)(A)(v) of the Code.
Each
of Drs. Trieu, Saund and Mr. Shah will be entitled to certain benefits as described in the table above if his employment is terminated
by the Company for reasons other than cause or by him with good reason. “Cause,” as defined in the employment agreements,
means:
(1) |
Substantial
failure to perform any of his duties or to follow reasonable, lawful directions of the Board or any officer to whom the party reports; |
|
|
(2) |
willful
misconduct or willful malfeasance in connection with his employment; |
(3) |
commission
of, conviction of, or plea of nolo contendere to, any crime constituting a felony under the laws of the United States or any state
thereof, or any other crime involving moral turpitude; |
|
|
(4) |
material
breach of any provision of the employment agreement, the By-laws or any other written agreement with the Company; |
|
|
(5) |
engaging
in misconduct that causes significant injury to the Company, financial or otherwise, or to its reputation; or |
|
|
(6) |
any
act, omission or circumstance constituting cause under the law governing the employment agreement. |
“Good
Reason,” as defined in the employment agreements, means the Company:
(1) |
materially
reduces the officer’s title or responsibilities; |
|
|
(2) |
relocates
its headquarters more than sixty (60) miles from their current location (unless the relocation results in the headquarters being
closer to the officer’s residence); |
(3) |
materially
reduces the officer’s base salary; or |
|
|
(4) |
breaches
a material term of the officer’s employment agreement. |
Good
Reason must also meet the requirements for a good reason termination in accordance with Code Section 409A, and any successor statute,
regulation and guidance thereto.
Director
Compensation
For
the year ended December 31, 2022, and 2021, one of the non-employee directors was paid the following in cash and stock
awards
| |
Fees
Earned or Paid in | | |
| |
| |
Cash(1) | | |
Option
Awards(2) | | |
Total | |
Steven King – 2021/22 | |
$ | - | | |
$ | 86,065 | | |
$ | 86,065 | |
David Diamond - 2021 | |
$ | 31,875 | | |
$ | 27,106 | | |
$ | 58,981 | |
For
2021/22, Mr. King was compensated in stock for his
services to the Board. Drs. Trieu and Maida were granted stock options as Board members but have been reported in the Summary
Compensation Table above.
We
granted Mr. King 500,000 options for his services
through the end of fiscal year 2022. Although the initial terms of the options, when granted, provide that they vest one year subsequent
to grant, pursuant to rules of the SEC the fair market value for the options granted represents the full value at the grant date only
and the values do not take into account subsequent increases or decreases in actual value to the recipient. See also our discussion of
stock-based compensation under “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical
Accounting Policies and Significant Judgments and Estimates” in the Form 10-K.
For
the period Mr. Diamond served during the year ended December 31, 2021, the Company paid Mr. Diamond for his services to the Board and
Committees. Further, or for the year ended December 31, 2021, we granted Mr. Diamond 251,467 options. Although the initial terms of the
options, when granted, provide that they vest one year subsequent to grant, pursuant to rules of the SEC the fair market value for the
options granted represents the full value at the grant date only and the values do not take into account subsequent increases or decreases
in actual value to the recipient. See also our discussion of stock-based compensation under “Management’s Discussion and
Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates”
in the Form 10-K.
The
grant date fair values of stock option grants shown in the table represent the full estimated Black-Scholes option value at the grant
date, pursuant to compensation disclosure rules of the SEC. The Company recorded stock-based compensation as the fair value of the awards
using a Black Scholes valuation model using the following input values.
Expected Term | |
| 2.18
to 2.28 years | |
Expected volatility | |
| 129.9
to 131.40 | % |
Risk-free interest rates | |
| 0.22
to 0.27 | % |
Dividend yields | |
| 0.00 | % |
The
following is a description of the standard compensation arrangements under which our non-employee directors have been compensated for
their service as directors, including as members of the various Committees of our Board.
Fees.
In
October 2016, the Board amended and restated its director compensation policy. For more details on the Fees, kindly refer to our form
2022 Annual Report on 10-K filed with the SEC on April 14, 2023. However, since the departure of Mr. Diamond, we have discontinued
cash compensations for the independent Board Members or Committee members.
The
Board intends to re-evaluate compensation, including non-employee director compensation, following the reconstitution of its Compensation
Committee.
Equity
Grants.
In
October 2016, the Board amended and restated its director compensation policy.
The
Board intends to re-evaluate compensation, including non-employee director compensation, following the reconstitution of its Compensation
Committee. For more information on our prior policy, please refer to our 2022 Annual Report on Form 10-K filed with the SEC on
April 14, 2023
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED
STOCKHOLDER MATTERS
Security
Ownership of Certain Beneficial Owners and Management
The
following table sets forth information, as of April 14, 2023, regarding the beneficial ownership of our common stock by:
|
● |
each
of our directors and our director nominees; |
|
|
|
|
● |
each
of our executive officers; |
|
|
|
|
● |
our
directors and executive officers as a group; and |
|
|
|
|
● |
each
person known to us to beneficially own more than 5% of our common stock. |
The
address for each beneficial owner listed is c/o Oncotelic Therapeutics, Inc. 29397 Agoura Road, Suite 107, Agoura Hills, California,
91301. Each of the stockholders listed has sole voting and investment power with respect to the shares beneficially owned by the stockholder,
subject to community property laws where applicable.
In
accordance with applicable SEC rules, the number of shares reflected as beneficially owned by each entity, person, director or executive
officer is determined in accordance with the rules of the SEC. Under those rules, beneficial ownership includes any shares over which
the individual has sole or shared voting power or investment power as well as any shares that the individual has the right to acquire
within 60 days after the Record Date through the exercise of any stock option, warrants or other rights.
We
have computed the percentage of shares beneficially owned on the basis of 392,871,880 shares of our Common Stock outstanding as
of April 14, 2023. Shares of our Common Stock that a person has the right to acquire within 60 days after the Record Date through
other means, such as a stock option or warrant, are deemed outstanding for purposes of computing the percentage ownership of the person
holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person (other than
the percentage ownership of all directors and executive officers as a group).
Name of Beneficial Owner | |
Common
Stock Beneficially Owned | | |
Percentage
of Common Stock | |
Directors and Officers: | |
| | | |
| | |
Vuong Trieu | |
| 122,770,303 | (1) | |
| 31.3 | % |
Steven W. King | |
| 4,188,059 | (2) | |
| 1.1 | % |
Anthony E. Maida III | |
| 3,137,314 | (3) | |
| 0.8 | % |
Amit Shah | |
| 2,584,871 | (4) | |
| 0.7 | % |
Saran Saund | |
| 18,347,759 | (5) | |
| 4.7 | % |
All officers and directors as a group (7 persons) | |
| 151,028,306 | (6) | |
| 38.1 | % |
| |
| | | |
| | |
Beneficial owners of more
than 5% | |
| | | |
| | |
Vuong Trieu | |
| 122,770,303 | (1) | |
| 31.3 | % |
Balaji Bhakta | |
| 43,575,256 | (7) | |
| 11.1 | % |
Larn Hwang | |
| 25,714,323 | (8) | |
| 6.6 | % |
Chao Hsiao | |
| 22,406,942 | (9) | |
| 5.7 | % |
*
< 1%
(1) |
Includes:
(a) 90,817,329 shares owned directly and beneficially by the reporting person; 3,922,219 shares of common shares issuable
upon conversion of debt, 1,738,953 shares issuable upon exercise of stock options and 1,250,000 shares of common shares issuable
upon exercise of warrants; (b) 16,780,384 shares registered in the name of Autotelic, Inc., and 1,388,889 shares issuable upon conversion
of debt, and (c) 6,872,529 shares registered in the name of Dr. Trieu’s spouse. Dr. Trieu is the Chief Executive Officer of
Autotelic, Inc. and in that capacity has the sole authority to control the voting and the disposition of Common Stock and Preferred
Stock owned by Autotelic, Inc. Dr. Trieu disclaims beneficial ownership of the shares held by Autotelic, Inc., except to the extent
of his pecuniaIy interest therein. |
|
|
(2) |
Shares
held in the name of Artius Bioconsulting, LLC, consists of (i) 3,330,647 shares of Common Stock and (ii) 857,412 shares issuable
upon exercise of stock options granted to Mr. King. |
|
|
(3) |
Consists
of (i) 1,137,314 shares of Common Stock and (ii) 2,000,000 shares issuable upon exercise of stock options. |
(4) |
Consists
of (i) 358,837 shares of Common Stock, (ii) 527,778 shares of common stock issuable upon conversion of debt and (iii) 1,698,256
shares of common stock upon exercise of options. |
|
|
(5) |
Consists
of (i) 16,456,480 shares of Common Stock, and (ii) 1,891,279 shares issuable upon exercise of stock options. |
|
|
(6) |
Consists
of (i) 135,753,521 shares of Common Stock, (ii) 5,838,885 shares issuable upon conversion of debt, (iii) 8,185,900
shares issuable upon exercise of options and (iv) 1,250,000 shares issuable upon exercise of warrants. |
|
|
(7) |
Consists
of (i) 41,630,811 shares of Common Stock, (ii) (iii) 694,445 shares of common stock upon conversion of debt and 1,250,000 upon conversion of warrants. |
|
|
(8) |
Consists
of (i) 23,455,990 shares of Common Stock, (ii) 1,208,333 shares of common stock issuable upon conversion of debt and (iii) 1,050,000
shares of common stock upon exercise of options. |
|
|
(9) |
Consists
of (i) 17,073,604 shares of Common Stock, (ii) 3,744,449 shares of common stock issuable upon conversion of debt, (iii) 1,200,000
shares of common stock upon exercise of options, and (iv) 388,889 shares issuable upon exercise of PPM debt and warrants. |
Equity
Compensation Plan Information
The
following table provides certain aggregate information with respect to all of the Company’s equity compensation plans in effect
as of December 31, 2022.
Plan
Category | |
Number
of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights | | |
Weighted-Average
Exercise Price of Outstanding Options | | |
Number
of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected
in Column (a)) | |
Equity compensation plans approved
by security holders | |
| 24,042,620 | | |
$ | 0.22 | | |
| 3,205,021 | |
Equity compensation
plans not approved by security holders | |
| 1,650,000 | | |
| 0.30 | | |
| 350,000 | |
| |
| | | |
| | | |
| | |
Total | |
| 25,692,620 | | |
$ | 0.23 | | |
| 3,555,021 | |
In
August 2020, the shareholders of the Company approved the expansion of the number of securities to be issued upon exercise of outstanding
options, warrants, restricted stock units and warrants by 20 million. The amendment to the 2015 Plan was completed in March 2021 and
as such the pool under the 2015 Plan is now 27,250,000.
Brief
Description of equity compensation plan not approved by security holders
In
January 2017, the Board of Directors adopted and approved the 2017 Plan. The 2017 Plan allows the Company, under the direction of the
Compensation Committee, to make grants of stock options, restricted and unrestricted stock awards, and other stock-based awards to employees,
consultants and directors. The purpose of these awards is to attract and retain key individuals, further align employee and stockholder
interests, and provide additional incentive for them to promote our success. The 2017 Plan provides for the issuance of up to 2,000,000
shares of the Company’s common stock. Any stock options granted under the 2017 Plan must be non-qualified stock options, which
are not intended to meet the requirements of Section 422 of the Internal Revenue code. Options generally vest over a period of time,
may not be exercised unless they are vested, and no option may be exercised after the end of the term set forth in the award agreement.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Our
Audit Committee reviews and approves in advance all related person transactions.
Our
Board of Directors has reviewed the materiality of any relationship that each of our directors has with the Company, either directly
or indirectly. Based upon this review, our Board has determined that none of the directors, qualify as “independent directors”
as defined under the OTC Market Rules for U.S. Companies.
Master
Service Agreement with Autotelic Inc.
In
October 2015, Oncotelic Inc. entered into a Master Service Agreement (the “MSA”) with Autotelic Inc., a related party
that is partly owned by Dr. Trieu. Dr. Trieu, a related party, is a control person in Autotelic Inc. Autotelic Inc. currently owns less
than 10% of the Company. The MSA stated that Autotelic Inc. will provide business functions and services to the Company and allowed Autotelic
Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time
incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of
the Company. The MSA requires a 90-day written termination notice in the event either party requires to terminate such services.
Expenses
related to the MSA were approximately $60,000 and $280,000 for the years ended December 31, 2022, and 2021,
respectively. Amounts outstanding at the end of the year 2022 and 2021 were approximately $225,000 and $270,000,
respectively.
In
September 2021, the Company entered into an exclusive License Agreement (the “Agreement”) with Autotelic, pursuant to which
Autotelic granted Oncotelic, among other things: (i) the exclusive right and license to certain Autotelic Patents (as defined in the
Agreement) and Autotelic Know-How (as defined in the Agreement); and (ii) a right of first refusal to acquire at least a majority of
the outstanding capital stock of Autotelic prior to Autotelic entering into any transaction that is a financing collaboration, distribution
revenues, earn-outs, sales, out-licensing, purchases, debt, royalties, merger acquisition, change of control, transfer of cash or non-cash
assets, disposition of capital stock by way of tender or exchange offer, partnership or any other joint or collaborative venture, research
collaboration, material transfer, sponsored research or similar transaction or agreements. For more information on the Agreement,
refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
Notes
Payable and Short-Term Loans
In
April 2019, the Company issued a convertible note to Dr. Trieu totaling $164,444, including OID of $16,444, receiving net proceeds of
$148,000, which was used by the Company for working capital and general corporate purposes (See Note 6). The Company issued a Fall 2019
Note to Dr. Trieu in the principal amount of $250,000. Dr. Trieu also offset certain amounts due to him in the amount of $35,000 and
was converted into the Fall 2019 debt. Further during the year ended December 31, 2022, $20,000 was repaid to Dr Trieu.
As such the Company owed $0 for the short-term loan as of December 31, 2022.
During
the year ended December 31, 2021, Autotelic Inc. provided a short-term funding of $120,000 to the Company, which was repaid
in 2021. In May 2021, Autotelic provided an additional short-term funding of $250,000 to the Company, which was
converted into the August 2021 Notes. Autotelic provided an additional $20,000 and $100,000 short-terms loan to the Company, and as
such, $120,000 was outstanding and payable to Autotelic at December 31, 2022 and $0 at December 31, 2021, respectively.
Artius
Consulting Agreement
On
March 9, 2020, the Company and Artius Bioconsulting, LLC (“Artius”), for which Mr. Steven King, our Board and Committee
member, is the Managing Member, entered into an amendment to that certain Consulting Agreement dated December 1, 2018 (the “Artius
Agreement”), under which Artius agreed to serve as a consultant to the Company for services related to the Company’s
business from time to time, effective December 1, 2019 (the “Artius Agreement Effective Date”). In connection with
the Artius Agreement, Mr. King also agreed to assist the Company with strategic advisory services with respect to transactional and operational
contracts, budgetary input, among other matters in connection with the development EdgePoint AI’s Artificial Intelligence and Blockchain
Driven Vision Systems, for which Mr. King served as Chief Executive Officer.
Under
the terms of the Artius Agreement, the Company agreed to grant to Artius, subject to approval by the Company’s Board of Directors
and pursuant to the Company’s 2015 or 2017 Equity Incentive Plan, 148,837 restricted shares of the Company’s Common Stock,
in addition to a 30% pre-financing ownership stake in EdgePoint AI. The Artius Agreement contemplates that Mr. King will generally provide
his services at a rate of $237 per hour, not to exceed 44 hours per month and payable monthly, and to reimburse Mr. King for reasonable
and necessary expenses incurred by him or Artius in connection with providing services to the Company.
Either
the Company or Artius may terminate the Artius Agreement at any time, for any reason following the Artius Agreement Effective Date. The
Artius Agreement will automatically renew one year from the Artius Agreement Effective Date, unless the Parties agree to terminate the
Artius Agreement at that time.
The
Company recorded $0 and $0 as expense during the year ended December 31, 2022, and 2021, respectively, related to this
Agreement.
Maida
Consulting Agreement
Effective
May 5, 2020, the Company and Dr. Maida entered into an independent consulting agreement, commencing April 1, 2020 (the “Maida
Agreement”), under which Dr. Maida will assist the Company in providing medical expertise and advice from time to time in the
design, conduct and oversight of the Company’s existing and future clinical trials.
For
more information on this Agreement, refer to
our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
The
Company recorded an expense of $75,000 during the year ended December 31, 2022, related to this Agreement as compared
to $215,000 during the same period in 2021. Effective April 1, 2022, Dr Maida’s compensation is being by the JVA with GMP
Bio.
SHARES
ELIGIBLE FOR FUTURE SALES
Prior
to this offering, there has been a limited public market for our common stock. Future sales of substantial amounts of common stock in
the public market could adversely affect market prices prevailing from time to time. Furthermore, since only a limited number of shares
will be available for sale shortly after this offering because of certain restrictions on resale, sales of substantial amounts of our
common stock in the public market after the restrictions lapse could adversely affect the prevailing market price and our ability to
raise equity capital in the future.
Upon
completion of this offering and assuming all 29,878,445 being registered are purchased by the Selling Stockholders, we may have outstanding
an aggregate of up to 422,750,325 issued and outstanding. These shares being registered and purchased by the Selling Stockholders
will be freely tradable without restriction or further registration under the Securities Act, unless such shares are purchased by individuals
who become “affiliates” as that term is defined in Rule 144 under the Securities Act, as the result of the securities they
acquire in this offering which provide them, directly or indirectly, with control or the capacity to control us. Our officers and directors
will not be purchasing shares in this offering. The remaining shares of common stock held by our existing stockholders are “restricted
securities” as that term is defined in Rule 144 under the Securities Act. Restricted shares may be sold in the public market only
if registered or if they qualify for an exemption from registration under Rule 144 and or Section 4(a)(1). As a result of these provisions
of Rules 144, additional shares will be available for sale in the public market as follows:
●no
restricted shares will be eligible for immediate sale on the date of this prospectus; and
●the
remainder of the restricted shares will be eligible for sale from time to time pursuant to available exemptions, subject to restrictions
on such sales by affiliates.
Sales
pursuant to Rule 144 are subject to certain requirements relating to the availability of current public information about us. A person
(or persons whose shares are aggregated) who is not deemed to have been an affiliate of Oncotelic Therapeutics, Inc. at any time during
the 90 days immediately preceding the sale and who has beneficially owned restricted shares for at least six months is entitled to sell
such shares under Rule 144 without regard to the resale limitations.
The
SEC has adopted rules that regulate broker-dealer practices in connection with transactions in “penny stocks.” Penny stocks
generally are equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges
or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is
provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise
exempt from the rules, to deliver to the prospective purchaser a standardized risk disclosure document prepared by the Securities and
Exchange Commission that provides information about penny stocks and the nature and level of risks in the penny stock market. In addition,
the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from such rules; the broker-dealer must
make a special written determination that the penny stock is a suitable investment for the prospective purchaser and receive the purchaser’s
written agreement to the transaction. Furthermore, subsequent to a transaction in a penny stock, the broker-dealer will be required to
deliver monthly or quarterly statements containing specific information about the penny stock. It is anticipated that our common stock
will be traded on an OTC market at a price of less than $5.00. In this event, broker-dealers would be required to comply with the disclosure
requirements mandated by the penny stock rules.
These
disclosure requirements will likely make it more difficult for investors in this offering to sell their common stock in the secondary
market.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Baker
Tilly US, LLP resigned from the position of our Auditors in November 2021. We appointed Rose, Snyder and Jacobs, LLP as our auditors.
We have no disagreements with our accountants on accounting and financial disclosure.
Oncotelic
Therapeutics, Inc. (Formerly Mateon Theapeutics, Inc.)
Oncotelic
Therapeutics, Inc. (Formerly Mateon Theapeutics, Inc.)
Index
to Financial Statements
The
following financial statements of Oncotelic Therapeutics, Inc.:
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders of
Oncotelic
Therapeutics, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Oncotelic Therapeutics, Inc. and Subsidiaries (the Company) as of December
31, 2022 and 2021, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the
years in the two-year period ended December 31, 2022, and the related notes (collectively referred to as the consolidated financial statements).
In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of
the Company as of December 31, 2022 and 2021, and the consolidated results of its operations and its cash flows for each of the years
in the two-year period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Going
Concern Uncertainty
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations and has an accumulated
deficit and a working capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management’s
plans regarding these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance
with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material
to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication
of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are
not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or
disclosures to which it relates.
Convertible
Debt Accounting
Description
of the Matter
As
described in Notes 6 and 7 to the consolidated financial statements, the Company entered into various capital raising transactions whereby
it issued convertible debt with other instruments, including warrants and shares of common stock.
We
identified the accounting for the issuance of these convertible notes as a critical audit matter. Accounting for the issuance of convertible
debt was complex due to the evaluation of the terms of the agreements as well as the inherent estimation uncertainty in the Company’s
valuation of the beneficial conversion feature, note agreements and warrants. The Company allocated the proceeds among the freestanding
financial instruments that were issued in the respective transactions using the relative fair value method, which affects the determination
of each financial instruments’ initial carrying amount. The Company utilized the relative fair value method as none of the freestanding
financial instruments issued as part of the transactions are measured at fair value. Under the relative fair value method, the Company
made separate estimates of the fair value of each freestanding financial instrument and then allocated the proceeds in proportion to
those fair value amounts.
How
We Addressed the Matter in our Audit
The
primary procedures we performed to address this critical audit matter included:
|
● |
Obtaining
an understanding of the Company’s process to account for the issuance of convertible notes, warrants and shares of common stock |
|
● |
Reviewing
the underlying agreements associated with these transactions |
|
● |
Reviewing
the Company’s position papers addressing the accounting for these transactions and assessing the appropriateness of the positions |
|
● |
Testing
the completeness and accuracy of the underlying data used in the assessment of relative fair values |
Evaluation
of Goodwill for Impairment
Description
of the Matter
As
discussed in Note 2 and 3 to the consolidated financial statements, reporting unit goodwill is tested for impairment at least annually
or when events or circumstances indicate the fair value of a reporting unit may be below its carrying value. This analysis involves comparing
events and circumstances such as general macroeconomic conditions, conditions specific to the industry and market and whether there has
been sustained declines in share price. These fair value estimates are sensitive to significant assumptions and judgments, such as projections
of operating expenditures, discount rates, and future economic conditions.
During
the third and fourth quarters of 2022, the Company experienced a sustained decrease in its share price, and as of December 31, 2022,
the Company’s market capitalization and uncertain economic conditions, which adversely impacted the pharmaceutical and biotechnology
industry, were indicative of an impairment. Pursuant to current accounting guidance, management performed a quantitative analysis and
concluded that goodwill was impaired and the Company recorded an impairment charge of $4.1M during the year ended December 31, 2022.
At December 31, 2022, the Company’s goodwill balance was $12M.
Auditing
management’s annual impairment tests for goodwill was complex because of the significant judgement required to evaluate the management
assumptions described above used to determine the fair value of the reporting units.
How
We Addressed the Matter in our Audit
Our
audit procedures related to the evaluation of goodwill for impairment included the following, among others:
|
a. |
We
considered the design and operating effectiveness of certain controls over the Company’s annual impairment assessments of intangible
assets and goodwill. We considered the material weaknesses related to management’s internal controls in determining the nature,
timing and extent of the audit tests applied in our audit. |
|
b. |
We
evaluated managements significant accounting policies related to the impairment of goodwill and indefinite-lived intangible assets
for reasonableness. |
|
c. |
We
evaluated management’s assessment of qualitative factors relating to the goodwill valuation by reviewing information regarding
economic growth forecast, industry outlook, and business environment, as well as accumulating our understanding of the Company’s
reporting unit’s performance. |
|
d. |
With
respect to the Company’s valuation of its sole reporting unit: |
|
1. |
We
assessed the qualifications and competence of management |
|
2. |
We
evaluated the methodologies used to determine the fair value of the Company’s reporting unit |
|
3. |
We
reperformed management’s quantitative analysis to assess the impact of goodwill impairment |
|
e. |
We
assessed the adequacy of the Company’s disclosures regarding impairment assessments included in Note 2 and Note 3. |
Rose,
Snyder & Jacobs LLP |
|
|
|
We
have served as the Company’s auditor since 2021. |
|
|
|
Encino,
CA |
|
|
|
April
14, 2023 |
|
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
The
accompanying footnotes are an integral part of these consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
The
accompanying footnotes are an integral part of these consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY FOR THE YEAR ENDED DECEMBER 31, 2022
The
accompanying footnotes are an integral part of these consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY FOR THE YEAR ENDED DECEMBER 31, 2021
| |
Preferred
Stock | | |
Common
Stock | | |
Additional
Paid-in | | |
Accumulated | | |
Non controlling | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Interests | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at January 1, 2021 | |
| 278,188 | | |
$ | 2,782 | | |
| 90,601,912 | | |
$ | 906,019 | | |
$ | 32,493,086 | | |
$ | (21,630,008 | ) | |
$ | 708,954 | | |
$ | 12,480,833 | |
Balance | |
| 278,188 | | |
$ | 2,782 | | |
| 90,601,912 | | |
$ | 906,019 | | |
$ | 32,493,086 | | |
$ | (21,630,008 | ) | |
$ | 708,954 | | |
$ | 12,480,833 | |
Common shares issued upon conversion of Preferred Stock | |
| (278,188 | ) | |
| (2,782 | ) | |
| 278,187,847 | | |
| 2,781,878 | | |
| (2,779,096 | ) | |
| - | | |
| - | | |
| - | |
Common shares issued upon conversion of debt | |
| - | | |
| - | | |
| 657,200 | | |
| 6,572 | | |
| 203,729 | | |
| - | | |
| - | | |
| 210,301 | |
Common shares issued in lieu of restricted stock units | |
| - | | |
| - | | |
| 1,257,952 | | |
| 12,580 | | |
| 213,852 | | |
| - | | |
| - | | |
| 226,432 | |
Common shares issued for services | |
| - | | |
| - | | |
| 1,148,235 | | |
| 11,482 | | |
| 182,159 | | |
| - | | |
| - | | |
| 193,641 | |
Common shares issued for cash | |
| - | | |
| - | | |
| 3,435,000 | | |
| 34,350 | | |
| 385,952 | | |
| - | | |
| - | | |
| 420,302 | |
Beneficial Conversion Feature on convertible debt | |
| - | | |
| - | | |
| - | | |
| - | | |
| 969,754 | | |
| - | | |
| - | | |
| 969,754 | |
Warrants issued in connection with private placement | |
| - | | |
| - | | |
| - | | |
| - | | |
| 2,190,127 | | |
| - | | |
| - | | |
| 2,190,127 | |
Warrants issued in connection with debt issuance | |
| - | | |
| - | | |
| - | | |
| - | | |
| 600,965 | | |
| - | | |
| - | | |
| 600,965 | |
Stock compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 763,314 | | |
| - | | |
| - | | |
| 763,314 | |
Increase in non-controlling interest from issuance of additional Edgepoint
stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 620,052 | | |
| 620,052 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (9,391,042 | ) | |
| (1,126,248 | ) | |
| (10,517,290 | ) |
Net Income (loss) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (9,391,042 | ) | |
| (1,126,248 | ) | |
| (10,517,290 | ) |
Balance as of December 31, 2021 | |
| - | | |
$ | - | | |
| 375,288,146 | | |
$ | 3,752,881 | | |
$ | 35,223,842 | | |
$ | (31,021,050 | ) | |
$ | 202,758 | | |
$ | 8,158,431 | |
Balance | |
| - | | |
$ | - | | |
| 375,288,146 | | |
$ | 3,752,881 | | |
$ | 35,223,842 | | |
$ | (31,021,050 | ) | |
$ | 202,758 | | |
$ | 8,158,431 | |
The
accompanying footnotes are an integral part of these consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
The
accompanying footnotes are an integral part of these consolidated financial statements.
ONCOTELIC
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Description
of Business
Oncotelic
Therapeutics, Inc. (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated
in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November
2020. Oncotelic conducts business activities through Oncotelic and its wholly owned subsidiaries, Oncotelic, Inc., a Delaware corporation,
PointR Data, Inc. (“PointR”), a Delaware corporation; Pet2DAO, Inc (“Pet2DAO”) and EdgePoint AI, Inc. (“Edgepoint”), a Delaware
Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the
“Company” or “We”). The Company completed a reverse merger with Oncotelic Inc in April 2019, a
merger with PointR in November 2019 and formed a subsidiary Edgepoint in February 2020. For more information on these mergers, refer
to our 2020 Annual Report on Form 10-K filed with the SEC on April 15, 2021.
The
Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”)
and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”),
for various cancers and COVID-19, Artemisinin for COVID-19 and AI technologies for clinical development and manufacturing. The Company
is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for
that platform. The Company has acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual dysfunction.
In addition, the Company is evaluating the further development of its product candidates OXi4503 as a treatment for acute myeloid leukemia
and myelodysplastic syndromes and CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma.
The
Company is primarily a cancer immunotherapy company dedicated to the development of first in class self-immunization protocol (“SIP™”)
candidates for difficult to treat cancers. The Company’s proprietary SIP™ candidates are expected to offer advantages over
other immunotherapies because they do not require extraction of the tumor or isolation of the antigens, and they have the potential for
broad-spectrum applicability for multiple cancer types. The Company’s proprietary product candidates have shown promising clinical
activity in phase 2 trials for the treatment of gliomas and pancreatic cancers. The Company aims to translate its unique insights, which
span more than three decades of original work using RNA therapeutics, into the deployment of antisense as a RNA therapeutic for diseases
which are caused by TGF-β overexpression, starting with cancer and expanding to Duchenne Muscular Dystrophy (“DMD”)
and others. OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard
cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers. The JV plans to initiate
phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer, and any other indications that may evolve, for human
pharmaceutical needs. The Company is evaluating the further development of its product candidates OXi4503 as a treatment for acute myeloid
leukemia and myelodysplastic syndromes and CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma.
The JV is also developing OT-101 for the various epidemics and pandemics, similar to the current corona virus (“COVID-19”)
pandemic. In this connection, the Company entered into an agreement and supplemental agreement with GMP for a total of $1.2 million to
render services and was paid for the development of OT-101. In 2020 and 2021, the Company was developing Artemisinin as a potential therapy
for COVID-19. Artemisinin, purified from a plant Artemisia annua. For more information on GMP and Artemisinin, refer to our 2021
Annual report on Form 10-K filed with the SEC on April 15, 2022.
Amendments
to Certificate of Incorporation
In
March 2021, the Company received approval from the Financial Industry regulatory Authority (“FINRA”) on its notice
of corporate action to change the name of the Company from Mateon Therapeutics, Inc. to Oncotelic Therapeutics, Inc, and the Company’s
ticker symbol has changed from “MATN” to “OTLC”.
In
January 2021, the Company filed an additional amendment to its Certificate of Incorporation, as amended (the “Charter Amendment”),
with the Secretary of State for the State of Delaware, which Charter Amendment went effective immediately upon acceptance by the Secretary
of State for the State of Delaware. The Charter Amendment increased the number of authorized shares of Common Stock from 150,000,000
shares to 750,000,000 shares.
In
addition, the Company registered an additional total of 20,000,000 shares of its Common Stock, which may be issued pursuant to the Company’s
Amended and Restated 2015 Equity Incentive Plan (the “Plan”). As such, the total number of shares of the Company’s
Common Stock available for issuance under the 2015 plan is 27,250,000.
Fundraising
J.H.
Darbie Financing Notes & Issuance of Oncotelic Warrants
In
February 2022, the Company and 99 out of 100 of the Investors agreed to extend the maturity date of the notes connected to the Units
from March 31, 2022 to March 31, 2023. In addition, the Company issued approximately 33 million warrants to purchase $50,000 of shares
of common stock of the Company in connection with agreeing to extend the maturity date by one year. The issuance of the additional warrants
resulted in the Company recording an expense of approximately $2.9 million in the Company’s statement of operations during the
year ended December 31, 2022. For more information on the JD Darbie financing, refer to Note 7 of the Notes to the Consolidated Financial
Statements.
Equity
Purchase Agreement
In
May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the
“Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to
which the Company shall have the right, but not the obligation, to direct Peak One to purchase up to $10.0
million (the “Maximum Commitment Amount”)
in shares of the common stock, par value $0.01
per share (“Common Stock”)
in multiple tranches. The Company filed a post-effective amendment to reregister the EPL on April 26, 2022 and the post-effective amendment
was found effective by the SEC on May 6, 2022. Since the EPL was made effective in June 2021 till December 31, 2022, the Company
has directed Peak One, on multiple occasions, for an aggregate of 4.7
million shares of Common Stock for aggregate
net cash proceeds of approximately $0.6
million. For more information on the EPL, refer
to Note 9 of the Notes to the Consolidated Financial Statements.
Geneva
Roth Remark Notes
In
May 2021, the Company consummated the closing of a private placement transaction whereby, pursuant to a Securities Purchase Agreement
(the “Geneva Agreement”) entered into with Geneva Roth Remark (“Geneva”), the Company issued a
convertible promissory note in the aggregate principal amount of $203,750 (the “Note 1”). Further in June 2021, the
Company issued an additional convertible promissory note in the aggregate principal amount of $103,750 (“Note 2”,
and collectively with Note 1, the “Notes”). For more information on the debt financing of the Company, refer to Note
5 of the Notes to the Consolidated Financial Statements.
August
2021 Notes
In
August 2021, the Company issued Note Purchase Agreements with Autotelic Inc., the Company’s Chief Financial Officer (“CFO”),
and certain other accredited investors. Under the terms of the Note Purchase Agreements, the Company issued an aggregate of $698,500
(the “Principal Amount”) in debt in the form of unsecured convertible promissory notes (collectively, the “Notes”).
The Notes are unsecured, and provide for interest at the rate of 5% per annum. Such Notes were issued against some of the short-term
debt due as of June 30, 2021. For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated
Financial Statements.
November/December
2021 Notes
In
November / December 2021, the Company entered into various Securities Purchase Agreements with Talos Victory Fund, LLC (the
(“Talos”), Mast Hill Fund, LP (“Mast”), FirstFire Global Opportunities Fund, LLC (“FirstFire”),
Blue Lake Partners, LLC (“Blue Lake”) and Fourth Man, LLC (“Fourth Man”), pursuant to which the Company
issued convertible promissory notes in the aggregate principal amount of $0.25
million each, aggregating gross $1.25
million (the “Notes”), which Notes are convertible into shares of the Company’s common stock, par value $0.01
per share (“Common Stock”).
In
January 2022, three of the five note holders under the November / December 2021 Notes exercised their warrants to purchase shares of
Common Stock of the Company on a cashless basis. As such, the Company issued the note holders 3,041,958
shares of Common Stock.
In
March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the pursuant to which the
Company issued convertible promissory note in the aggregate principal amount of $0.25
million, which Note is convertible into shares of the Company’s Common Stock. As of
December 31, 2022, this note is in technical default and available for conversion to OTLC shares due to cross default provision
contained in November / December 2021 Notes. This Note was undertaken by the Company
pursuant to the Darbie Agreement.
In
August 2022, the Company converted $140,000 of Fourth
Man Note into 2,025,000 shares of common stock. Further in September 2022, the Company converted $68,250 of Blue Lake note into 1,428,571
shares of common stock.
In
October 2022, Fourth Man exercised their warrants to purchase shares of Common Stock of the Company on a cashless basis. As such, the
Company issued the note holder 912,162 shares of Common Stock.
In
December 2022, the Company partially converted $50,000
of Fourth Man Note into 739,285 shares of common stock.
For
more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.
May
2022 Note
In
May 2022, the Company entered into a Securities Purchase Agreement with Mast, pursuant to which the Company issued convertible
promissory notes in the aggregate principal amount of $0.6
million, which note is convertible into shares of the Company’s Common Stock. As of
December 31, 2022, this note is in technical default and available for conversion to OTLC shares due to cross default provision
contained in November / December 2021 Notes. This note was used to fully repay November 2021 Talos note and the December
2021 First Fire note. $35,000
of the First Fire Note was converted into 500,000
shares of Common Stock and the balance was repaid in cash
In
June 2022, Mast fully converted their November 2021 Note, for which the company issued 4,025,000 shares of Common Stock.
For
more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.
June
2022 Note
In
June 2022, the Company entered into a Securities Purchase Agreement with Blue Lake, pursuant to which the Company issued convertible
promissory notes in the aggregate principal amount of $0.34
million, which note is convertible into shares of the Company’s Common Stock. As of
December 31, 2022, this note is in technical default and available for conversion to OTLC shares due to cross default provision
contained in November / December 2021 Notes. This note was utilized for corporate expenses.
For
more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.
GMP
Note purchase agreements and unsecured notes
In
August 2021 the Company, the Company’s Chief Executive Officer (the “CEO”), and GMP executed a letter of intent and
a non-binding term sheet (the “Term Sheet”), which Term Sheet included certain binding terms relating to a standstill
agreement and the issuance of a convertible promissory note (as more fully described below).
In
September 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $1.5 million (the “September
2021 Note”), which September 2021 Note is convertible into shares of the Company’s Common Stock.
In
October 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “October Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “October
2021 Note”), which October 2021 Note is convertible into shares of the Company’s Common Stock.
In
January 2022, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “January Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “January
2022 Note”), which January 2022 Note is convertible into shares of the Company’s Common Stock.
For
more information on the GMP debt financing, refer to Note 5 of the Notes to the Consolidated Financial Statements.
Joint
Venture with GMP Bio
In
March 2022, the Company formalized a joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”)
and GMP Biotechnology Limited (“GMP Bio”), both affiliates of GMP. Although no assurances can be given, the Company
and GMP currently intend to conduct an initial public offering of the JV, at a future date, on either the Hong Kong Exchange or other
stock exchange.
For
more information on the JV, refer to Note 6 of the Notes to the Consolidated Financial Statements.
Pet2DAO
In
November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO LLC (“Pet2DAO”),
as a wholly owned subsidiary. A DAO is an emerging form of legal structure, that has no central
governing body, and whose members share a common goal to act in the best interest of the entity. Pet2DAO is a DAO technology company,
integrating the strong governance of traditional corporations with the innovative DAO architecture. The Company will look to engage stakeholders,
to build value through the DAO, while maintaining the rigor of traditional corporations, including governance, compliance, and accountability
through a team of veterans in public companies with innovators in AI, blockchain and Web3. Pet2DAO will initially be looking to
develop products for the animal health space. The Company will initially issue regular tokens and non-fungible tokens (“NFT”
and cumulatively “Tokens”) of Pet2DAO called PDAO to its employees, shareholders and key opinion leaders (“KOLs’)
and use the Tokens to propose and vote on various animal health related programs. In the future, the Company will evaluate and plan to
register these tokens with the SEC to make such Tokens freely tradable at a future point in time.
Licensing
Agreement with Autotelic Inc.
In
September 2021, the Company entered into an exclusive License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”),
pursuant to which Autotelic granted Oncotelic, among other things: (i) the exclusive right and license to certain Autotelic Patents (as
defined in the Agreement) and Autotelic Know-How (as defined in the Agreement); and (ii) a right of first refusal to acquire at least
a majority of the outstanding capital stock of Autotelic prior to Autotelic entering into any transaction that is a financing collaboration,
distribution revenues, earn-outs, sales, out-licensing, purchases, debt, royalties, merger acquisition, change of control, transfer of
cash or non-cash assets, disposition of capital stock by way of tender or exchange offer, partnership or any other joint or collaborative
venture, research collaboration, material transfer, sponsored research or similar transaction or agreements. In exchange for the rights
granted to Oncotelic, Autotelic will be entitled to earn the milestone payments of up to $50 million upon achievement of certain financial,
development and regulatory milestones. In addition to the milestone payments, Autotelic would be entitled to earn royalties equal to
15% of the net sales of any products that incorporate the Autotelic Patents or Autotelic Know-How. The Agreement contains representations,
warranties and indemnification provisions of each of the parties thereto that are customary for transactions of this type. For more information
on the Agreement, refer to our 2021 Annual Report on form 10-K filed with the SEC on April 15, 2022.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Oncotelic, PointR and Edgepoint
for which there are non-controlling interests. Intercompany accounts and transactions have been eliminated in consolidation.
Liquidity
and Going Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company
has incurred net losses of approximately $25.9
million since inception of Oncotelic Inc. as
the Company’s historical financial statements before the Merger have been replaced with the historical financial statements of
Oncotelic Inc. prior to the Merger in the financial statements and filings. The Company also has a negative working capital of $16.96
million at December 31, 2022, of which approximately
$1.3
million is attributable to assumed negative working
capital of the Company and $2.6
million contingent liability of issuance of common
shares of the Company to PointR shareholders upon achievement of certain milestones in accordance with the PointR Merger Agreement. The
Company has negative cash flows from operations for the year ended December 31, 2022 of approximately $1.5
million. These conditions raise substantial doubt
about the Company’s ability to continue as a going concern for a period of one year from the date of this filing. Management expects
to incur significantly lower costs and losses in the foreseeable future, as a majority of the costs related with the development of OT-101
will be incurred by the JV, but the Company also recognizes the need to raise capital to remain viable. The accompanying consolidated
financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.
The
Company’s long-term plans include continued development of its current pipeline of products, in addition to continue the development
of OT-101 which is exclusively out-licensed to the JV and the JV will be responsible for the funding required to support the development
in entirety, to generate sufficient revenues, through either technology transfer or product sales, or raise additional financing to cover
its anticipated expenses. Until the Company is able to generate sufficient revenues from its current pipeline, the Company plans on funding
its operations through the sale of equity and/or the issuance of debt, combined with or without warrants or other equity instruments.
Between
July 2020 and March 2021, the Company raised gross proceeds of $5 million, through JH Darbie Financing. The Company incurred $0.7 million
of costs associated with the raise, of which $0.65 million was paid as direct placement fees to JH Darbie. JH Darbie and the Company
are parties to a placement agent agreement, dated February 25, 2020 pursuant to which JH Darbie has the right to sell a minimum of 40
Units and a maximum of 100 Units on a best-efforts basis. Concurrently with the sale of the Units, JH Darbie was granted, a warrant,
exercisable over a five-year period, to purchase 10% of the number of Units sold in the JH Darbie Financing. As such, the Company granted
10 Units to JH Darbie pursuant to the JH Darbie Placement Agreement.
In
addition to the JH Darbie Financing, the Company raised approximately $0.2 million from the Equity Purchase Agreement with Peak One,
$0.5 million from Note Agreements with GMP, approximately $0.1 million from from Autotelic Inc., a related party, and $1.1 million from
various investors in Notes from March 2022, May 2022 and June 2022 financing.
Although
no assurances can be given as to the Company’s ability to deliver on its revenue plans, or that unforeseen expenses may arise,
management believes that the potential equity and debt financing or other potential financing will provide the necessary funding for
the Company to continue as a going concern. Also, management cannot guarantee any potential debt or equity financing will be available
on favorable terms or at all. As such, management does not believe the Company has sufficient cash for 12 months from the date of this
report. If adequate funds are not available on acceptable terms, or at all, the Company will need to curtail operations, or cease operations
completely.
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates
The
preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets, liabilities, equity-based transactions and disclosure of contingent liabilities at the date of the financial
statements and revenues and expense during the reporting period. Actual results could materially differ from those estimates.
The
Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation
of the financial statements. Significant estimates include the valuation of goodwill and intangible assets for impairment, deferred tax
asset and valuation allowance, and fair value of financial instruments.
Cash
As
of December 31, 2022 and 2021, respectively, the Company held all its cash in banks in the United States of America. The Company considers
investments in highly liquid instruments with a maturity of three months or less to be cash equivalents. The Company did not have any
cash equivalents as of December 31, 2022 and 2021, respectively. Restricted cash consists of certificates of deposits held at banks as
collateral for various purposes.
Debt
issuance Costs and Debt discount
Issuance
costs are specific incremental costs that are (1) paid to third parties and (2) directly attributable to the issuance of a debt or equity
instrument. The issuance costs attributable to the initial sale of the instrument are offset against the associated proceeds in the determination
of the instrument’s initial net carrying amount.
Debt
issuance costs and debt discounts are being amortized over the lives of the related financings on a basis that approximates the effective
interest method. Costs and discounts are presented as a reduction of the related debt in the accompanying balance sheets if related to
the issuance of debt or presented as a reduction of additional paid in capital if related to the issuance of an equity instrument. The
Company applies the relative fair value to allocate the issuance costs among freestanding instruments that form part of the same transaction.
If
the Company amends the terms of its convertible notes, the Company reviews and applies the guidance per ASC 470-60 Troubled debt restructurings
and ASC 470-50 Debt-Modifications and Extinguishments, evaluates and concludes whether the terms of the agreements were or
were not substantially different as of a particular reporting date and accounts the transaction as a debt modification or a troubled
debt restructuring.
Fair
Value of Financial Instruments
The
carrying value of cash, accounts payable and accrued expense approximate their fair values based on the short-term maturity of these
instruments. As defined in ASC 820, “Fair Value Measurements and Disclosures,” fair value is the price that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit
price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including
assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market
corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair
value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level
1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at
both initial and subsequent measurement.
The
three levels of the fair value hierarchy defined by ASC 820 are as follows:
● |
Level
1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets
are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information
on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities
and listed equities. |
|
|
● |
Level
2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly
observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation
methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices
for commodities, time value, volatility factors and current market and contractual prices for the underlying instruments, as well
as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full
term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed
in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest
rate swaps, options and collars. |
|
|
● |
Level
3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be
used with internally developed methodologies that result in management’s best estimate of fair value. |
The
Company did not have any Level 1 or Level 2 assets and liabilities at December 31, 2022 and 2021.
Investment
in equity securities
The
following table summarizes the cumulative gross unrealized gains and losses and fair values for long-term investments accounted for at
fair value under the fair value option, with the unrealized gains and losses reported within earnings on the Condensed Consolidated Statements
of Operation as of December 31, 2022. No similar investments were held by the Company at December 31, 2021:
SCHEDULE
OF UNREALIZED GAINS AND LOSSES
| |
Initial Book Value | | |
Cumulative Gross Unrealized Gains | | |
Cumulative Gross Unrealized Losses | | |
Fair Value | |
December 31, 2022 | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Investment in GMP Bio (equity securities) | |
$ | 22,640,519 | | |
$ | - | | |
$ | - | | |
$ | 22,640,519 | |
Total | |
$ | 22,640,519 | | |
$ | - | | |
$ | - | | |
$ | 22,640,519 | |
The
table below sets forth a summary of the recording of the initial value of the long-term value of investment in equity securities of GMP
Bio, based on a third-party valuation report, and changes in the fair value of such equity securities, if such change occurs, as a Level
3 fair value as of December 31, 2022. The Company did not own similar long-term investments as of December 31, 2021:
SUMMARY OF CHANGES
IN FAIR VALUE OF LONG-TERM INVESTMENT IN EQUITY SECURITIES
| |
December 31, 2022 Fair Value | |
Balance at January 1, 2022 | |
$ | - | |
Contribution at cost basis | |
| 5,689,042 | |
Gain on derecognition of non-financial asset | |
| 16,951,477 | |
Change in fair value | |
| - | |
| |
| | |
Balance at December, 2022 | |
$ | 22,640,519 | |
Derivative
Liability
The
Company has certain derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), consisted of conversion
feature derivatives at December 31, 2022 and 2021, are Level 3 fair value measurements.
The
table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3
as of December 31, 2022 and 2021:
SUMMARY
OF CHANGES IN FAIR VALUE OF DERIVATIVE LIABILITIES
| |
December 31, 2022 Conversion Feature | | |
December 31, 2021 Conversion Feature | |
Balance at beginning of the year ended | |
$ | 340,290 | | |
$ | 777,024 | |
New derivative liability | |
| - | | |
| - | |
Reclassification to additional paid in capital from conversion of debt to common stock | |
| - | | |
| (144,585 | ) |
Change in fair value | |
| (142,150 | ) | |
| (292,149 | ) |
| |
| | | |
| | |
Balance at the end of the year ended | |
$ | 198,140 | | |
$ | 340,290 | |
At
December 31, 2022 and 2021, respectively, the Company estimated the fair value of the conversion feature derivatives embedded in the
convertible debentures based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consists, in
part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected
volatility of the Company’s Common Stock all as of the measurement dates. The Company used the following assumptions to estimate
fair value of the derivatives as of December 31, 2022 and 2021:
SUMMARY
OF ESTIMATE FAIR VALUE OF DERIVATIVE LIABILITIES
| |
December 31, 2022 | | |
December 31, 2021 | |
Risk free interest | |
| 0.17%
- 4.0 | % | |
| 0.3 | % |
Market price of share | |
$ | 0.05 - 0.23 | | |
$ | 0.17 | |
Life of instrument in years | |
| 0.01 - 0.33 | | |
| 0.31 | |
Volatility | |
| 99.80% - 116.51 % | | |
| 140 | % |
Dividend yield | |
| 0 | % | |
| 0 | % |
When
the Company changes its valuation inputs for measuring financial liabilities at fair value, either due to changes in current market conditions
or other factors, it may need to transfer those liabilities to another level in the hierarchy based on the new inputs used. The Company
recognizes these transfers at the end of the reporting period that the transfers occur. For the years ended December 31, 2022 and 2021,
there were no transfers of financial assets or financial liabilities between the hierarchy levels.
The
$2,625,000 of contingent consideration, of shares issuable to PointR shareholders which was recorded and associated with the PointR Merger,
is also classified as Level 3 fair value measurements. The Company initially recorded the contingency based on a valuation conducted
by a third-party valuation expert. The valuation was based on a probability of the completion of certain milestones by PointR for the
shareholders to earn additional shares. The Company evaluated the probability of the earning of the milestones and concluded that the
probability of achievement of the milestones had not changed, primarily due to the shifting of focus by the Company to develop AI technologies
for the COVID-19 pandemic. As such, the Company did not record any change to the valuation during the years ended December 31, 2022 or
2021, respectively; and as of December 31, 2022 and 2021, respectively.
Net
Income (Loss) Per Share
Basic
net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding
during the period. Diluted net income (loss) per share includes the effect of Common Stock equivalents (notes convertible into Common
Stock, stock options and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be
dilutive. Approximately 156 million equivalent shares of Common Stock have been excluded in the computation of the dilutive income per
share for the year ended December 31, 2022. No similar equivalent shares of the Common Stock were excluded during the year
ended December 31, 2021, as the Company had a loss and addition of such stock equivalents in the computation would have been anti-dilutive.
The
table below sets forth a reconciliation of the basic weighted average common stock outstanding to the diluted weighted average common
stock outstanding of the Company as of December 31, 2022:
SCHEDULE OF BASIC AND DILUTED WEIGHTED AVERAGE COMMON STOCK OUTSTANDING
| |
December 31, 2022 | |
Basic weighted average common stock outstanding | |
| 384,075,369 | |
Add: Dilutive common stock equivalents | |
| | |
Stock options outstanding | |
| 2,606,054 | |
Warrants outstanding | |
| 68,681 | |
Convertible debt, convertible into common stock | |
| 70,549,786 | |
| |
| | |
Diluted weighted average common stock outstanding | |
| 457,299,890 | |
Stock-Based
Compensation
The
Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement
and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options,
in the statements of operations.
For
stock options issued, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The
use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option,
the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend
yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the
Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over
the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being
estimated at the time of grant and revised.
For
warrants issued in connection with fund raising activities, the Company estimates the grant date fair value of each warrant using the
Black-Scholes pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to
the expected term of the warrant, the expected volatility of the Common Stock consistent with the expected life of the warrant, risk-free
interest rates and expected dividend yields of the Common Stock. If the warrants are issued upon termination or cancellation of prior
issued warrants, then the Company estimates the grant date fair value of the new warrants using the Black-Scholes pricing model and evaluates
whether the new warrants are deemed as equity instruments or liability instruments. If the warrants are deemed to be equity instruments,
the Company records stock compensation expense and an addition to additional paid in capital. If however, the warrants are deemed to
be liability instruments, then the fair value is treated as a deemed dividend and credited to additional paid in capital.
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the
forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined
to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets
of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature
of the assets. For the years ended December 31, 2022 and 2021, there were no impairment losses recognized for long-lived assets.
Intangible
Assets
The
Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews
the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not
that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating
performance, competition, sale or disposition of a significant portion of the business, or other factors. If the review indicates the
impairment, an impairment loss would be recorded for the difference of the value recorded and the new value. For the years ended December
31, 2022 and 2021, there were no impairment losses recognized for intangible assets. When we sell or contribute properties to unconsolidated
arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received
and the carrying amount of the asset sold or contributed. For the year ended December 31, 2022, we derecognized the intangibles of $0.8
million associated with OT-101 upon the transfer of our non-financial asset as a capital contribution for our 45% ownership in the JV.
Goodwill
Goodwill
represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired.
Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events
or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative
assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more
likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment
would not be required. Otherwise, goodwill impairment is tested using a two-step approach.
The
first step involves comparing the fair value of the reporting unit to its carrying amount. The Company has always operated as a
single unit. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment.
If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to
measure the amount of impairment, if any. The second step involves calculating the implied fair value of goodwill by deducting the
fair value of all tangible and intangible assets, excluding goodwill, of the reporting unit from the fair value of the reporting
unit as determined in step one. The implied fair value of the goodwill in this step is compared to the carrying value of goodwill.
If the implied fair value of the goodwill is less than the carrying value of the goodwill, an impairment loss equivalent to the
difference is recorded. When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership
interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or
contributed. For the year ended December 31, 2022, we recorded an impairment loss of approximately $4.1 million on our goodwill,
based on the difference between the carrying value of our goodwill as against the market capitalization of the Company. No similar
loss was recorded during the year ended December 31, 2021. Further, for the year ended December 31, 2022, we derecognized the
goodwill of $4.8 million
associated with OT-101 upon the transfer of our non-financial asset as a capital contribution for our 45%
ownership in the JV. For more information on goodwill and impairment, refer to Note 3 to these Notes to the Consolidated Financial Statements.
Derivative
Financial Instruments Indexed to the Company’s Common Stock
We
have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms
of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations
include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding,
do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However,
if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are
met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity
offerings, we must estimate the fair value of the warrants, which is as inherently subjective as it is for stock options, and for similar
reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we
report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.
Convertible
Instruments
The
Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives
and Hedging”.
ASC
815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments
and account for them as free standing derivative financial instruments. These three criteria include circumstances in which (a) the
economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic
characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and
the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes
in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative
instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host
instrument is deemed to be conventional as defined under professional standards as “The Meaning of Conventional Convertible
Debt Instrument.”
The
Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from
their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly,
the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments
based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the
effective conversion price embedded in the note. Original issue discounts (“OID”) under these arrangements are amortized
over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for
the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying
Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note.
ASC
815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally,
if an event occurs that is not within the entity’s control could or would require net cash settlement, then the contract shall
be classified as an asset or a liability.
Variable
Interest Entity (VIE) Accounting
The
Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the
interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations.
These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical
information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE,
the entity is consolidated into the financial statements. At December 31, 2022 and 2021, the Company identified EdgePoint to be the Company’s
sole VIE. At December 31, 2022, and 2021, the Company’s ownership percentage of EdgePoint was 29% each, respectively. The VIE’s
net assets were less than approximately $0.1 million and approximately $0.1 million at December 31, 2022 and December 31, 2021, respectively.
Investments
- Equity Method
The
Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses,
which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary
declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an
asset may not be recoverable. The Investment in GMP Bio represents the investment into equity securities for which the Company elected
the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares shall be included in the result
from other income. Refer to Note 6 to these Notes to the Consolidated Financial Statements.
Joint
Venture agreement
We
have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization,
including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract
development and manufacturing organization (“CDMO”) facilities and capabilities. The Company first reviews the arrangement
to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of
a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal
entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through
their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with
the definition of a joint venture.
We
consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures
to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity
investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether
there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection
against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf
of an investor with disproportionately few voting rights in making this VIE determination.
To
the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic
performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant
to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests
in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary
beneficiary.
To
the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests
or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights.
Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets
of the joint venture without the consent of the non-managing entity and the inability of the non-managing entity to remove us from our
role as the managing entity.
We
use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the
equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and
liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.
When
we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize
the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria
are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value.
As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.
When
circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is
other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at
fair value.
The
Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment
as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option
is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are
not appropriately reflected in the market value or reflective of the true value of the development activities of the company
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers.
Under
ASC 606, the Company recognizes revenue when its customers obtain control of the promised good or services, in an amount that reflects
the consideration which the Company expects to receive in exchange for those goods or services. The Company applies the following five-step
process: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the
transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when
(or as) the Company satisfies a performance obligation.
At
contract inception, once the contract is determined to be within the scope of ASC 606, the Company identifies the performance obligation(s)
in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue
for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation
is satisfied.
The
Company anticipates generating revenues from rendering services to other third party customers for the development of certain drug products
and/or in connection with certain out-licensing agreements. In the case of services rendered for development of the drugs, revenue is
recognized upon the achievement of the performance obligations or over time on a straight-line basis over the extended service period.
In the case of out-licensing contracts, the Company records revenues either (i) upon achievement of certain pre-defined milestones when
there is no obligation of the Company achieve any performance obligations in connection with the said pre-defined milestones, or (ii)
upon achievement of the performance obligations if the milestones require the Company to provide the performance obligations.
The
Company occasionally collects advance payments from customers toward commitments to provide services or performance obligations, in which
case the advance payment is recorded as a liability until the obligations are fulfilled and revenue is recognized.
Research
& Development Costs
In
accordance with ASC 730-10-25 “Research and Development”, research and development costs are charged to expense as and when
incurred.
Recent
Accounting Pronouncements
In
August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible
instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for
convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible
for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2023, including interim
periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The
Company has not adopted ASU 2020-06 during the year 2022 and is evaluating the impact of implementation on its financial statements,
if any.
All
other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.
NOTE
3 - ACQUISITIONS, GOODWILL AND INTANGIBLE ASSETS
Goodwill
from 2019 Reverse Merger with Oncotelic and Merger with PointR
The
Company completed the reverse merger with Oncotelic Inc. (“Merger”) in April 2019. The Company completed the merger with
PointR Data Inc (“PointR Merger”) in November 2019. For more details on the two mergers, refer to our 2020 Annual Report
on Form 10-K for the year ended December 31, 2020 filed by the Company on April 15, 2021.
The
Oncotelic merger gave rise to Goodwill of approximately $4.9
million. Upon the non-financial sale of our asset as contribution to our equity method investment, we derecognized the balance of the
carrying value of our goodwill of approximately $4.9
million from the Oncotelic Merger in accordance with our policy and authoritative accounting guidance.
Further,
we added goodwill of $16,182,456 upon the completion of the Merger with PointR.
We
have one operating segment and reporting unit. Accordingly, our review of goodwill impairment indicators was performed at the entity-wide
level. In performing our annual impairment assessment, we determined if we should qualitatively assess whether it was more likely than
not the fair value of goodwill was less than its carrying amount (the qualitative impairment test). The factors we considered in the
assessment included our market capitalization, general macroeconomic conditions, conditions specific to the industry and market and whether
there had been sustained declines in our share price. If we concluded, it was more likely than not, the fair value of the reporting unit
was less than its carrying amount, or elected not to use the qualitative impairment test, a quantitative impairment test would be performed.
We
used our market capitalization as an indicator of fair value. While we believe the fair value measurement need not be based solely on
the quoted market price of an individual share of our Common Stock, and that we also could consider the impact of a control premium in
measuring the fair value of its reporting unit. In the absence of any other valuation metrics, the Company believed using a control premium
utilized would not be appropriate under the current circumstances. We also considered some other market comparables, trends in our stock
price as well as the industry over a period of two successive quarters and prospective quarter to evaluate whether the fair value of
our reporting unit was greater than our carrying amount. As such, we performed a quantitative impairment assessment of goodwill for our
single reporting unit at the end of 2022, due to a sustained decline in our market capitalization and an increase in negative economic
outlook for biotech markets We estimated and reconciled the fair value of our reporting unit utilizing our market capitalization based
on the stock price of our Common Stock as of December 31, 2022. Before completing our goodwill impairment test, we first tested our indefinite-lived
intangible asset then our remaining long-lived assets for impairment. We concluded our indefinite-lived intangible assets were not impaired.
Based on the market capitalization, we further concluded the fair value of our single reporting unit was less than its carrying value
and therefore recognized an impairment charge of $4.1
million during the year ended December
31, 2022. The calculation of the impairment charge included substantial fact-based determinations and estimates. The goodwill impairment
charge is reflected as goodwill impairment in the consolidated statements of operations for the year ended December 31, 2021.
A
summary of our goodwill as of December 31, 2022 and 2021 is shown below:
SUMMARY
OF GOODWILL
| |
December 31, 2022 | | |
December 31, 2021 | |
Balance at beginning of the year ended | |
$ | 21,062,455 | | |
$ | 21,062,455 | |
Less: Derecognition upon recording of gain on non-financial asset | |
| (4,880,000 | ) | |
| - | |
Less; Goodwill impairment due to market capitalization | |
| (4,111,079 | ) | |
| - | |
| |
| | | |
| | |
Balance at the end of the year ended | |
$ | 12,071,376 | | |
$ | 21,062,455 | |
In
general, the goodwill is tested on an annual impairment date of December 31, unless we observe any further deterioration in our market capitalization, in which case we may, depending on the
materiality of the impairment, record an impairment at the end of other reporting periods.
Assignment
and Assumption Agreement with Autotelic, Inc.
In
April 2018, Oncotelic Inc. entered into an Assignment and Assumption Agreement (the “Assignment Agreement”) with Autotelic
Inc., an affiliate company, and Autotelic LLC, an affiliate company, pursuant to which Oncotelic acquired the rights to all intellectual
property (“IP”) related to a patented product. As consideration for the Assignment Agreement, Oncotelic Inc. issued
204,798 shares of its Common Stock for a value of $819,191. The Assignment Agreement also provides that Oncotelic Inc. shall be responsible
for all costs related to the IP, including development and maintenance, going forward.
Intangible
Asset Summary
In
April 2018, Oncotelic Inc. entered into an Assignment and Assumption Agreement (the “Assignment Agreement”) with Autotelic
Inc., an affiliate company, and Autotelic LLC, an affiliate company, pursuant to which Oncotelic acquired the rights to all intellectual
property (“IP”) related to a patented product. As consideration for the Assignment Agreement, Oncotelic Inc. issued
204,798 shares of its Common Stock for a value of $819,191. The Assignment Agreement also provides that Oncotelic Inc. shall be responsible
for all costs related to the IP, including development and maintenance, going forward.
The
following table summarizes the balances as of December 31, 2022 and 2021, respectively, of the intangible assets acquired, their useful
life, and annual amortization:
SCHEDULE
OF INTANGIBLE ASSETS
| |
December 31, 2022 | | |
Remaining Estimated Useful Life (Years) | |
Intangible asset – Intellectual property | |
$ | 819,191 | | |
| 16.00 | |
Intangible asset – Capitalization of license cost | |
| 190,989 | | |
| 16.00 | |
| |
| 1,010,180 | | |
| | |
Less Accumulated Amortization | |
| (201,180 | ) | |
| | |
Less: Derecognition of carrying value upon transfer of non-financial asset | |
| (809,000 | ) | |
| | |
Total | |
$ | - | | |
| | |
| |
December 31, 2021 | | |
Remaining Estimated Useful Life (Years) | |
Intangible asset – Intellectual property | |
$ | 819,191 | | |
| 17.00 | |
Intangible asset – Capitalization of license cost | |
| 190,989 | | |
| 17.00 | |
| |
| 1,010,180 | | |
| | |
Less Accumulated Amortization | |
| (188,339 | ) | |
| | |
Total | |
$ | 821,841 | | |
| | |
Amortization
of identifiable intangible assets for the year ended December 31, 2022 and 2021 was $12,841 and $51,365, respectively. Upon the non-financial
sale of our asset as contribution to our equity method investment of approximately $0.8 million, we derecognized the balance of the carrying
value of our intangibles in accordance with our policy and authoritative accounting guidance.
There
will be no future yearly amortization expense related to our intangibles.
In-Process
Research & Development (“IPR&D”) Summary
The
IPR&D assets were acquired in the PointR Merger during the year ended December 31, 2019. Since January 2021, the Company has determined
that the IPR&D should be reported as an indefinitely lived asset and therefore will evaluate, on an annual basis, for any impairment
on the IPR&D and will record an impairment if identified. The Company evaluated the qualitative conditions to see if the asset was impaired and concluded that the assets were
not impaired. The balance of IPR&D as of December 31, 2022 and December 31, 2021
was $1,101,760. For more information on the IPR&D, please refer to our 2021 Annual Report on Form 10-K filed with the SEC on April
15, 2022.
NOTE
4 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expense consists of the following amounts:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
December 31, 2022 | | |
December 31, 2021 | |
| |
| | |
| |
Accounts payable | |
$ | 1,735,764 | | |
$ | 1,927,749 | |
Accrued expenses | |
| 775,100 | | |
| 1,164,974 | |
Accounts payable and
accrued liabilities, current | |
$ | 2,510,864 | | |
$ | 3,092,723 | |
|
|
December
31,
2022 |
|
|
December
31,
2021 |
|
|
|
|
|
|
|
|
|
|
Accounts
payable – related party |
|
$ |
332,432 |
|
|
$ |
403,423 |
|
NOTE
5 – CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT
As
of December 31, 2022, special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued
interest, if any, consist of the following amounts:
SCHEDULE
OF CONVERTIBLE DEBENTURES AND NOTES, NET OF DISCOUNT
| |
December 31, | | |
December 31, | |
| |
2022 | | |
2021 | |
Convertible debentures | |
| | | |
| | |
10% Convertible note payable, due April 23, 2022 – Bridge Investor | |
$ | 35,556 | | |
$ | 31,167 | |
10% Convertible note payable, due April 23, 2022 – Related Party | |
| 164,444 | | |
| 144,951 | |
10% Convertible note payable, due August 6, 2022 – Bridge Investor | |
| 200,000 | | |
| 188,319 | |
| |
| 400,000 | | |
| 364,437 | |
Fall 2019 Notes | |
| | | |
| | |
5% Convertible note payable – Stephen Boesch | |
| 123,958 | | |
| 118,958 | |
5% Convertible note payable – Related Party | |
| 288,733 | | |
| 276,233 | |
5% Convertible note payable – Dr. Sanjay Jha (Through his family trust) | |
| 288,253 | | |
| 275,753 | |
5% Convertible note payable – CEO, CTO* & CFO – Related Parties | |
| 94,457 | | |
| 90,357 | |
5% Convertible note payable – Bridge Investors | |
| 193,522 | | |
| 185,122 | |
| |
| 988,923 | | |
| 946,423 | |
| |
| | | |
| | |
August 2021 Convertible Notes | |
| | | |
| | |
5% Convertible note – Autotelic Inc– Related Party | |
| 267,553 | | |
| 256,634 | |
5% Convertible note – Bridge investors | |
| 399,722 | | |
| 381,123 | |
5% Convertible note – CFO – Related Party | |
| 80,266 | | |
| 76,531 | |
| |
| 747,541 | | |
| 714,288 | |
| |
| | | |
| | |
JH Darbie PPM Debt | |
| | | |
| | |
16% Convertible Notes - Non-related parties | |
| 2,441,471 | | |
| - | |
16% Convertible Notes – CEO – Related Party | |
| 124,547 | | |
| - | |
| |
| 2,566,018 | | |
| - | |
| |
| | | |
| | |
November/December 2021 & March 2022 Notes | |
| | | |
| | |
12% Convertible Notes – Accredited Investors | |
| 619,345 | | |
| - | |
| |
| | | |
| | |
Debt for Clinical Trials – GMP | |
| | | |
| | |
2% Convertible Notes – GMP | |
| 4,659,782 | | |
| - | |
| |
| | | |
| | |
May and June 2022 Note | |
| | | |
| | |
12% Convertible Notes – Accredited Investors | |
| 885,312 | | |
| - | |
| |
| | | |
| | |
Other Debt | |
| | | |
| | |
Short term debt – CEO | |
| - | | |
| 20,000 | |
Short term debt – Bridge investors | |
| 245,000 | | |
| 265,000 | |
Short term debt from CFO – Related Party | |
| 25,050 | | |
| 45,050 | |
Short term debt – Autotelic Inc– Related Party | |
| 120,000 | | |
| 20,000 | |
| |
| 390,050 | | |
| 350,050 | |
Accrued interest | |
| - | | |
| 9,212 | |
Total of convertible debentures & notes and other debt | |
$ | 11,256,971 | | |
| 2,384,410 | |
Convertible
Debentures
As
of December 31, 2022, the Company had a derivative liability of approximately $200,000 and recorded a change in fair value of approximately
$140,000 on the Convertible Debentures issued in 2019 to our CEO and a bridge investor.
Bridge
Financing
Notes
with Officer and Bridge Investor
In
April 2019, the Company entered into a Securities Purchase Agreement (the “Bridge SPA”) with our CEO (the “Trieu
Note”) and a Bridge Investor with a commitment to purchase convertible notes in the aggregate of $400,000. For more information
on the Bridge SPA, refer to our Annual Report on Form 10-K filed with the SEC on April 15, 2022.
The
issuance of the Trieu Note resulted in a discount from the beneficial conversion feature totaling $131,555 related to the conversion
feature. Total amortization of the OID and the discount totaled approximately $19,500 and $75,100 for the years ended December
31, 2022, and 2021, respectively. Total unamortized discount on this note was approximately $0 and $19,500 as of December 31,
2022, and December 31, 2021, respectively.
In
April 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #1 (“Tranche #1”) with the
Bridge Investor. For more information on Tranche #1, refer to our Annual Report on Form 10-K filed with the SEC on April 15, 2022.
The
issuance of the note resulted in a discount from the beneficial conversion feature totaling $28,445. Total amortization of the OID and
discount totaled approximately $4,400 and $16,900 for the years ended December 31, 2022, and 2021, respectively. Total unamortized
discount on this note was approximately $0 and $4,400 as of December 31, 2022, and December 31, 2021.
In
August 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #2 (“Tranche #2”) with the
Bridge Investor. For more information on Tranche #2, refer to our Annual Report on Form 10-K filed with the SEC on April 15, 2022.
The
issuance of the note resulted in a discount from the beneficial conversion feature totaling $175,000. Total amortization of the OID and
discount totaled approximately $11,700 and $19,900 for the years ended December 31, 2022, and 2021, respectively. Total unamortized
discount on this note was $0 and $11,700 as of December 31, 2022, and December 31, 2021.
Fall
2019 Debt Financing
In
December 2019, the Company closed its Fall 2019 Debt Financing, raising an additional $500,000 bringing the gross proceeds of all debt
financings under the Fall 2019 Debt Financing to $1,000,000. The Company entered into those certain Note Purchase Agreements (the “Fall
2019 Note Purchase Agreements”) with certain accredited investors and the officers of the Company for the sale of convertible
promissory notes (the “Fall 2019 Notes”). The Company completed the initial closing under the Fall 2019 Note Purchase
Agreements in November 2019. The Company issued Fall 2019 Notes in the principal amount of $250,000 to each of Dr. Vuong Trieu, the Company’s
Chief Executive Officer, and Stephen Boesch, in exchange for gross proceeds of $500,000. In connection with the second and final closing
of the Fall 2019 Debt Financing, the Company issued Fall 2019 Notes to additional investors including $250,000 to Dr. Sanjay Jha, through
his family trust, the former CEO of Motorola and COO/President of Qualcomm. The Company also offset certain amounts due to Dr. Vuong
Trieu, the Company’s Chief Executive Officer, Chulho Park, the Company’s then Chief Technology Officer, and Amit Shah, the
Company’s Chief Financial Officer, all related parties as Officers of the Company, and converted such amounts due into the Fall
2019 Notes. $35,000 due to Dr. Vuong Trieu, $27,000 due to Chulho Park and $20,000 due to Amit Shah were converted into convertible debt
under the Fall 2019 Notes. The Company also issued the Fall 2019 Notes of $168,000 to two accredited investors. The Company repaid $0
and $100,000 of principal for the years ended December 31, 2022, and December 31, 2021, respectively. The total unamortized principal
amount of the Fall 2019 Notes was $850,000 as of December 31, 2022, and 2021.
All
the Fall 2019 Notes provided for interest at the rate of 5% per annum and are unsecured. All amounts outstanding under the Fall 2019
Notes became due and payable upon the approval of the holders of a majority of the principal amount of outstanding Fall 2019 Notes (the
“Majority Holders”) on or after (a) November 23, 2020, or (b) the occurrence of an event of default (either, the “Maturity
Date”). The Majority Holders have waived any default in the maturity of the Fall 2019 Notes and as such there is no event of
default as of December 31, 2022. The Company had the option to prepay the Fall 2019 Notes at any time. Events of default under the Fall
2019 Notes included failure to make payments under the Fall 2019 Notes within thirty (30) days of the date due, failure to observe of
the Fall 2019 Note Purchase Agreement or Fall 2019 Notes which is not cured within thirty (30) days of notice of the breach, bankruptcy,
or a change in control of the Company (as defined in the Fall 2019 Note Purchase Agreement).
The
Majority Holders had the right, at any time not more than five (5) days following the Maturity Date, to elect to convert all, and not
less than all, of the outstanding accrued and unpaid interest and principal on the Fall 2019 Notes. The Fall 2019 Notes may be converted,
at the election of the Majority Holders, either (a) into shares of the Company’s Common Stock at a conversion price of $0.18 per
share, or (b) into shares of common stock of the Edgepoint, at a conversion price of $5.00 (based on a $5.0 million pre-money valuation)
of Edgepoint and 1,000,000 shares outstanding. The issuance of the Fall 2019 notes resulted in a discount from the BCF totaling $222,222
related to the conversion feature. Total amortization of the discount totaled $0 for the years ended December 31, 2022, and 2021. Total
unamortized discount on this note was $0 as of December 31, 2022, and 2021.
Further,
the Company recorded interest expense of $42,500 and $43,412 on these Fall 2019 Notes for the year ended December 31, 2022, and 2021.
The total amount outstanding under the Fall 2019 Notes, net of discounts and including accrued interest thereon, as of December 31, 2022,
and 2021 was $988,924 and $946,424, respectively.
Geneva
Roth Remark Notes
In
May and June 2021, the Company entered into Securities Purchase Agreement with Geneva Roth Remark Holdings Inc. (“Geneva”),
whereby the Company issued two convertible notes in the aggregate principal amount of $307,500 convertible into shares of common stock
of the Company.
The
notes were prepaid in December 2021 and the Company recorded interest expense, including prepayment penalty of approximately $0.1 million.
There was no similar expense recorded in 2022. For more information on the Geneva Roth Remark Notes, refer to our 2021 Annual Report
on Form 10-K filed with the SEC on April 15, 2022.
Paycheck
Protection Program
In
April 2020, the Company received loan proceeds in the amount of $250,000 under the Paycheck Protection Program (“1st PPP”)
which was established under the Coronavirus Aid, Relief and Economic Security (“CARES”) Act and is administered by
the Small Business Administration (“SBA”).
The
Company met the 1st PPP loan forgiveness requirements and on August 7, 2021, applied for forgiveness. On Aug 17, 2021, the
Company received the 1st PPP loan forgiveness approval from the lender and wrote off the loan outstanding amount inclusive
of interest accrued, in the amount of $253,347.
In
July 2021, the Company’s wholly owned subsidiary, PointR, received loan proceeds in the amount of $92,995 under the PPP (“2nd
PPP”). The 2nd PPP was at terms similar to the 1st PPP. The Company met the 2nd PPP
loan forgiveness requirements and received the 2nd PPP loan forgiveness approval from the lender on December 8, 2021 and wrote
off the loan outstanding amount inclusive of interest accrued, in the amount of $93,413. For more information on PPP, refer to our Annual
Report on Form 10-K filed with the SEC on April 15, 2022.
The
SBA reserves the right to audit any PPP loan, regardless of size. These audits may occur after the forgiveness has been granted. In accordance
with the CARES Act, all borrowers are required to maintain their PPP loan documentation for six years after the loan was forgiven or
repaid in full and to provide that documentation to the SBA upon request.
GMP
Notes
In
June 2020, the Company secured $2
million in debt financing, evidenced by a one-year
convertible note (the “GMP Note”) from GMP, to conduct a clinical trial evaluating OT-101 against COVID-19 bearing
2%
annual interest, and is personally guaranteed by Dr. Vuong Trieu, the Chief Executive Officer of the Company. The GMP Note is convertible
into the Company’s Common Stock upon the GMP Note’s maturity of the GMP Note, at the Company’s Common Stock price on
the date of conversion with no discount. GMP has waived the default in the maturity of the GMP Note and as such there is no event of
default and also agreed to extend the date of maturity of the GMP Note to December 31, 2023. GMP does not have the option to convert
prior to the GMP Note’s maturity. Such financing will be utilized solely to fund the clinical trial. The Company’s liability
under GMP Note commenced to accrue when GMP first began to pay for services related to the clinical trial to our third-party clinical
research organization, up to a maximum of $2
million. GMP has been invoiced by the clinical
research organization for the full $2 million as of December 31, 2022, and as such the Company has recognized the liability as a convertible
debt.
In
September 2021, the Company secured a further $1.5
million in debt financing, evidenced by a one-year
convertible note (the “GMP Note 2”) from GMP, to fund the same clinical trial evaluating OT-101 against COVID-19 bearing
2%
annual interest. The GMP Note is convertible into the Company’s Common Stock upon the GMP Note 2’s maturity one year from
the date of the GMP Note 2, at the Company’s Common Stock price on the date of conversion with no discount. GMP has waived the
default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the
GMP Note to December 31, 2023. GMP does not have the option to convert prior to the GMP Note 2’s maturity at the end of
one year. Such financing was to be utilized solely to fund the clinical trial. GMP was invoiced by the clinical research organization
for $0.5 million
and. GMP paid the clinical trial organization the first tranche of $0.5 million
in October 2021.
In
October 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “October Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5
million (the “October 2021 Note”),
which October 2021 Note is convertible into shares of the Company’s Common Stock. GMP has waived the default in the maturity of
the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31,
2023.
In
January 2022, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “January Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million
(the “January 2022 Note”), which January 2022 Note is convertible into shares of the Company’s Common Stock.
GMP agreed to extend the date of maturity of the January 2022 Note to December 31, 2023.
Cumulatively,
the GMP Note, GMP Note 2, October 2021 Note and the January 2022 Notes are referred to as the “GMP Notes”.
The
GMP Notes carry an interest rate of 2% per annum and mature on the earlier of (a) the one-year anniversary of the date of the Purchase
Agreement, or (b) the acceleration of the maturity by GMP upon occurrence of an Event of Default (as defined below). All Notes contain
a voluntary conversion mechanism whereby GMP may convert the outstanding principal and accrued interest under the terms of all the GMP
Notes into shares of Common Stock (the “Conversion Shares”), at the consolidated closing bid price of the Company’s
Common Stock on the applicable OTC Market as of the date the Company receives a Notice of Conversion from GMP. Prepayment of the GMP
Notes may be made at any time by payment of the outstanding principal amount plus accrued and unpaid interest. The October Note contains
customary events of default (each an “Event of Default”). If an Event of Default occurs, at GMP’s election,
the outstanding principal amount of the GMP Notes, plus accrued but unpaid interest, will become immediately due and payable in cash.
The October Purchase Agreement requires the Company to use of the proceeds received under the October 2021 Note to support the clinical
development of OT-101, including payroll and has been made in continuation of the relationship between the Company and GMP.
The
total principal outstanding on GMP Notes, inclusive of accrued interest, was $4,659,781 and $4,069,781 as of December 31, 2022 and 2021,
respectively.
August
2021 Notes
In
August 2021, the Company entered into Note Purchase Agreements with Autotelic - a related party, our CFO – a related party, and
certain accredited investors (the “August 2021 investors”), whereby the Company issued four convertible notes in the aggregate
principal amount of $698,500 convertible into shares of common stock of the Company for net proceeds of $690,825. The convertible notes
carry a five (5%) percent coupon and mature one year from issuance. The majority of the August 2021 investors have the right, but not
the obligation, not more than five days following the maturity date, to convert all, but not less than all, the outstanding and unpaid
principal plus accrued interest into the Company’s common stock, at a conversion price of $0.18. The August 2021 Note Holders has
waived the default in the maturity of the August 2021 Notes and as such there is no event of default and also agreed to extend the date
of maturity of the August 2021 Notes to December 31, 2023.The Company determined that the economic characteristics and risks of the embedded
conversion option are not clearly and closely related to the economic characteristics and risks of the debt host instrument. Further,
the Company determined that the embedded conversion feature meets the definition of a derivative but met the scope exception to the derivative
accounting required under ASC 815 for certain contracts involving a reporting entity’s own equity.
During
the year ended December 31, 2022, the Company recognized approximately $34,800 of interest expense on the August 2021 Investors notes
of which approximately $16,000 are attributable to related parties. During the year ended December 31, 2021, the Company recognized approximately
$16,000 of interest expense on the August 2021 Investors notes of which approximately $6,600 are attributable to related parties.
At
December 31, 2022, and December 31, 2021, accrued interests on these convertible notes totaled approximately $49,040 and $14,260, respectively.
The
outstanding balance on the note for the year ended December 31, 2022 was $747,539 including related party balance of $347,817. The outstanding
balance on the note for the year ended December 31, 2021 was $714,288, including related party balance of $333,615.
November
/ December 2021 and March 2022 Financing
In
November / December 2021, the Company entered into securities purchase agreement with five institutional investors, whereby the
Company issued five convertible notes in the aggregate principal amount of $1,250,000
convertible into shares of common stock of the Company. The convertible notes carry a twelve (12%)
percent coupon and a default coupon of 16%
and mature at the earliest of one year from issuance or upon event of default. Investors has the right at any time following
issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a
conversion price established at a fixed rate of $0.07.
The Company granted a total number of 9,615,385
warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13
up to five years after issuance. The Placement agent was also granted a total of 961,540
warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13
up to five years after issuance, as part of a finder’s fee agreement.
Further,
in March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible
promissory note in the aggregate principal amount of $0.25 million, convertible into shares of common stock of the Company. The
convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from
issuance or upon event of default. As of December 31, 2022, this note is in Investors have the right at any time following issuance date
to convert all or any part of the outstanding and unpaid amount of the note into the Company’s Common Stock at a conversion price
established at a fixed rate of $0.10. The Company granted a total number of 1,250,000 warrants convertible into an equivalent
number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted
a total of 125,000 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up
to five years after issuance, as part of a finder’s fee agreement.
During
the year ended December 31, 2022, the Company converted the Mast Hill convertible note into 4,025,000 shares of the Company’s
Common Stock, which fully retired the convertible note during the second fiscal quarter of 2022. Such conversion resulted in a loss from
debt conversion of approximately $0.1 million, which was recorded in other expense in the Company’s consolidated statements
of operations.
During
the year ended December 31, 2022, the Company repaid the Talos Victory and First Fire convertible notes with the proceeds from the May
2022 Mast Hill convertible note. Such repayment resulted in a loss from debt extinguishment of approximately $258,100, which was recorded
in other expense in the Company’s consolidated statements of operations.
During
the year ended December 31, 2022, the Company converted $68,250 of Blue Lake note and $30,000 of accrued interest into 1,428,571 shares
of Common Stock and converted $190,000 of Fourth Man note into 2,764,286 shares of common stock.
As
of December 31, 2022, and December 31, 2021, convertible notes under the November-December 2021 Financing, net of debt discount, consist
of the following amounts:
SCHEDULE
OF CONVERTIBLE NOTES, NET OF DISCOUNT
| |
December 31, 2022 | | |
December 31, 2021 | |
| |
| | |
| |
Mast Hill Convertible note, 12% coupon November 21 | |
$ | - | | |
$ | 250,000 | |
Talos Victory Convertible note, 12% coupon November 2021 | |
| - | | |
| 250,000 | |
First Fire Global Opportunities LLC Convertible note, 12% coupon, December 2021 | |
| - | | |
| 250,000 | |
Blue Lake Partners LLC Convertible note, 12% coupon, December 2021, inclusive of accrued interest | |
| 227,187 | | |
| 250,000 | |
Fourth Man LLC Convertible note, 12% coupon December 2021, inclusive of accrued interest | |
| 112,500 | | |
| 250,000 | |
Convertible notes, gross | |
$ | 339,687 | | |
$ | 1,250,000 | |
Less: Debt discounts recorded | |
| (500,000 | ) | |
| (1,250,000 | ) |
Amortization of debt discounts | |
| 500,000 | | |
| 76,994 | |
Convertible notes, net of discounts | |
$ | 339,687 | | |
| 76,994 | |
The
Company recorded amortization expense related to interest, debt discount, debt issuance costs, fair value allocated to the warrants and
the beneficial conversion feature of approximately $1
million and $87,000
during the fiscal year ended December 31, 2022,
and 2021, respectively. This expense included accrued interest of approximately $150,000
and $10,000
during the years ended December 31, 2022, and
2021, respectively. As of December 31, 2022, the Blue Lake and Fourth Man Notes are in default and, per the terms of the Notes, payable
in cash. However, the Company has not received notification of default from the lender. The cross-default provision requires the accrual
of a default penalty of 25%
of the outstanding principal plus accrued interest. The Company has recorded an estimated default penalty of $68,000
on the unpaid notes and accrued interest thereon.
The Company recorded an initial debt discount of approximately $0.4 million
representing the intrinsic value of the conversion option embedded in the convertible debt instrument based upon the difference between
the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded
in the note.
As
of December 31, 2022, and December 31, 2021, Fourth Man convertible note, net of debt discount, consist of the following amounts:
The
Company recorded amortization expense related to interest, debt discount, debt issuance costs, fair value allocated to the warrants and
the beneficial conversion feature of approximately $250,000
and $0 during
the year ended December 31, 2022, and 2021, respectively. This expense included accrued interest of approximately $90,000
and $0
during the years ended December 31, 2022, and
2021, respectively. As of December 31, 2022, these notes were in technical default, due to cross default provision contained in the November
/ December 2021 Notes and payable in cash. As of the date of this Report, these notes are in default. However, the Company has not received
notification of default from the lender. The cross-default provision requires the accrual of a default penalty of 25%
of the outstanding principal plus accrued interest. The Company has recorded an estimated default penalty of approximately $68,000.
May
2022 Mast Financing
In
May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible
note in the aggregate principal amount of $605,000 convertible into shares of common stock of the Company (“May 2022 Mast
Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of
one year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part
of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate
of $0.10. The Company granted a total number of 3,025,000 warrants convertible into an equivalent number of Company common
shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 302,500
warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance,
as part of a finder’s fee agreement. A portion of the proceeds were used to retire some of the November/December 2021 notes.
The extinguishment of existing notes resulted in the recognition of approximately $258,100 in loss on extinguishment of debt in the consolidated
statement of operations in the year ended December 31, 2022.
As
of December 31, 2022, and December 31, 2021, convertible note under the May 2022 Mast Financing, net of debt discount, consist of the
following amounts:
The
Company recorded amortization expense related to interest, debt discount, debt issuance costs, fair value allocated to the warrants and
the beneficial conversion feature of approximately $500,000
during the years ended December 31, 2022, and
2021, respectively, including the guaranteed twelve-month coupon and earned in full at issuance date. This expense included accrued interest
of approximately $240,000
and $0
during the years ended December 31, 2022, and
2021, respectively. As of December 31, 2022, and as of the date of this Report, these notes are in technical default due to the cross-default
provision contained in the November / December 2021 Notes and payable in cash. However, the Company has not received notification of
default from the lender. The cross-default provision requires the accrual of a default penalty of 25%
of the outstanding principal plus accrued interest. The Company has recorded an estimated default penalty of approximately $169,000.
June
2022 Mast Financing
In
June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible
note in the aggregate principal amount of $335,000 convertible into shares of common stock of the Company (“June 2022 Blue
Lake Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest
of one year from issuance or upon event of default. The investor has the right at any time following issuance date to convert all or any
part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed
rate of $0.10. The Company granted a total number of 837,500 warrants convertible into an equivalent number of the Company
common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 83,750 warrants
convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as
part of a finder’s fee agreement. A portion of the proceeds were used to retire some of the November/December 2021 notes.
As
of December 31, 2022, and December 31, 2021, convertible note under the June 2022 Blue Lake Financing, net of debt discount, consist
of the following amounts:
The
Company recorded amortization expense related to interest, debt discount, debt issuance costs, fair value allocated to the warrants and
the beneficial conversion feature of approximately $270,000 and
$0 during
the years ended December 31, 2022, and 2021, respectively, including the guaranteed twelve-month coupon and earned in full at issuance
date. This expense included accrued interest of approximately $134,000 and
$0 during
the years ended December 31, 2022, and 2021, respectively. As of December 31, 2022, these notes are in technical default due to cross
default provision contained in November/December 2021 Notes and payable immediately. However, the Company has not received notification
of default from the lender. The cross-default provision in the November / December 2021 and March 2022 notes requires the accrual of
a default penalty of 25%
of the outstanding principal plus accrued interest. The Company has recorded an estimated default penalty of approximately $94,000.
Other
short-term advances
As
of December 31, 2022, other short-term advances consist of the following amounts obtained from various employees and related parties:
SCHEDULE
OF SHORT-TERM LOANS
Other Advances | |
December 31, 2022 | |
Short term advances from CFO – Related Party | |
$ | 25,050 | |
Short term advances – bridge investors & others | |
| 245,000 | |
Short term advance – Autotelic Inc. – Related Party | |
| 120,000 | |
Total | |
$ | 390,050 | |
During
the year ended December 31, 2021, the Company’s CFO, a related Party, provided short term advances of approximately $45,000. During
the year ended December 31, 2020, the Company’s CFO had provided a short-term advance of $25,000, which was repaid during the year
ended December 31, 2021. $20,000 was repaid to the CFO in January 2022. As such approximately $25,000 was outstanding at December 31,
2022.
During
the fourth quarter of the year ended December 31, 2020, the Company’s CFO and the Bridge Investor provided short term loans of
$25,000
and $50,000,
respectively to the Company. Such loans were repaid as of March 31, 2021. During the year ended December 31, 2021, the CFO provided a
total of approximately $120,000,
of which $75,000
was converted into the August 2021 Notes. During
the year ended December 31, 2021, the Company received approximately $630,000
primarily from two bridge investors, of which
$373,500
was converted into the August 2021 Notes, and
$20,000
was repaid. Approximately $245,000
was outstanding as short-term advances to
bridge investors as of December 31, 2022.
During
the year ended December 31, 2021, Autotelic Inc. provided a short-term funding of $120,000 to the Company, which was repaid in 2021.
In May 2021, Autotelic provided an additional short-term funding of $250,000 to the Company, which was converted into the August 2021
Notes. Autotelic provided an additional $20,000 short-term loan to the Company. During the year ended December 31, 2022, Autotelic provided
an additional $100,000 short term loan to the company and as such, $120,000 was outstanding and payable to Autotelic at December 31,
2022.
NOTE
6 - JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT
On
March 31, 2022, the Company entered into (i) a joint venture (the “JV”) agreement with Dragon and GMP Bio, both affiliates
of GMP, (and the Company, Dragon and GMP Bio are collectively called the “Parties”) (the “JVA”),
(ii) a license agreement for rights to OT-101 (the “US License Agreement”) for the territory within the United States
of America (the “US”) with Sapu Holdings, LLC, a subsidiary of GMP Bio and (iii) a license agreement for rights to
OT-101 for the rest of the world with GMP Bio (the “Ex-US Rights Agreement”, and the US License Agreement and the
Ex-US License Agreement are collectively called the “Agreements”).
Dragon
and the Company entered into the JVA to regulate their relationship and the operation and management of the JV. The JVA contains provisions
for the licensed products and licensed technologies related to OT-101 (the “Licensed products and technologies”).
Pursuant to the JVA the Company is required to transfer to GMP Bio all of the Company’s rights and obligations under the research
and development agreement dated 3 February 2020 between the Company and Golden Mountain Partners, LLC (“GMP”), an
affiliate of Dragon, as amended, varied and/or supplemented by a supplement to research and Services Agreement dated 23 March 2020 between
the Company, Mateon Therapeutics, Inc. (subsequently renamed the Company) and GMP (the “R&D Agreement”). The
JVA permits GMP to seek conversion of certain convertible promissory notes entered into between the Company and GMP (see reference to
Purchase Agreements and Notes below) into shares of the Common Stock of the Company within 15 business days of the execution of the JVA
at a price of $0.2242 per Common Share, the closing price of the Common Share as traded on the OTCQB the day prior to the execution of
the JVA, or the closing price of the Common Stock prior to the date of conversion if not within 15 business days of the JVA. Upon the
execution of the JVA, Dragon will pay for and hold 55 shares of GMP Bio and the Company will pay for and hold 45 shares of GMP Bio, both
to be acquired at $1.00 per share of GMP Bio. Such shares of GMP Bio were issued shortly after the date of the JVA. The
JVA required the entering into of the Agreements on or before the execution of the JVA. The JVA defines the valuation of the Agreements
(taking into account the transfer of the Company’s rights and obligations under the R&D Agreement) each at approximately $11.3
million, for an aggregate of approximately $22.7
million. The
Parties also agreed that if a Rare Pediatric Disease (“RPD”) Priority Review Voucher, upon clinical approval of OT-101
Technologies for treatment of diffuse intrinsic pontine glioma (the “DIPG Voucher”), is issued to GMP Bio and GMP
Bio, or a subsidiary thereof, sells the DIPG Voucher to a non-GMP subsidiary, then the Company shall be eligible to receive up to 50%
of the net sales proceeds or $50 million, whichever is less. Dragon shall fund the JVA, for a total of approximately $27.7 million, based
on the conditions contained in the JVA, and the Company will input the licenses under the Agreements into the JV. The Company is obligated
to (i) (A) rectify the chain of legal title such that the Company is the sole legal owner of such rights, (B) complete registration as
the sole owner of all the Company’s Patent Rights and (C) provide evidence of such registration that is satisfactory to Dragon;
(ii) provide Dragon with copies of official documents issued by the relevant patent offices in the relevant countries evidencing the
Company’s legal ownership of all the Company’s Patents Rights; and (iii) reflect the Company’s legal ownership of all
the Company’s Patent Rights in the relevant online registers of the relevant patent offices in the relevant countries. The JVA
intends to raise funding for the JVA through a Series A round of financing of not less than $20 million. Dragon
can suspend funding the JVA if the Series A round of financing is not successfully completed by August 31, 2022, in which case Dragon’s
funding obligation would be restricted to $250,000
per month to GMP Bio. If Dragon decides to terminate
the JVA, the licenses granted under the Agreements shall be terminated and the OT-101 assets licensed by the Company will revert back
to the Company. The rest of the JVA deals with the conduct of the JV, the board of directors of GMP Bio and other administrative matters.
Dragon shall nominate up to three directors of their choosing to the board of directors of GMP Bio, two of whom are already nominated
as “A” Directors and the Company shall nominate up to two directors of their choosing to the board of directors of GMP Bio,
one of whom is already nominated as a “B” Director. The JVA defines how the board of directors will operate as well as the
general management and operations of the JV. Other standard terms on shareholder rights, indemnification etc. are also defined in the
JVA. Also included are the other terms with relation to insurance, indemnification, jurisdiction and other customary terms and conditions.
The
Agreements include terms of an exclusive, irrevocable, perpetual, royalty-free, sublicensable license under the Licensed Technology to
manufacture, have manufactured, use, import, sell, offer for sale or otherwise exploit the Licensed Products, which is OT-101, in the
Field, which is all therapeutic uses in humans, and in the Territories, which is the US and the rest of the world. In addition, the Company
grants a non-exclusive, irrevocable, perpetual, royalty-free, non-sublicensable license for its sole use of the Company’s Vision
Grid system for monitoring process, man flow, equipment flow, and material flow in contract development and manufacturing organization
operations. These have been granted to GMP Bio and Sapu Holdings, LLC as the capital contribution by the Company to GMP Bio. The Agreements
include the contributions by the key employees, as defined and included in the Agreements, standard representations and warranties, intellectual
property protection, insurance, indemnification, jurisdiction and other customary terms and conditions.
The
Company determined that the arrangement does not meet the accounting definition of a joint venture. Subsequently, we analyzed our investment
and determined that such investment was not considered a VIE, which would require consolidation because the Company does not have the
power to direct the activities that most significantly impact the economic performance of the JV. The Company does not control the JV
through majority ownership interest or Board participation. As such, the Company followed the guidance in ASC 610-20 regarding the sale
of nonfinancial assets to noncustomers when retaining a non-controlling ownership interest in such assets. The Company is deemed to have
substantially transferred the actual intellectual property related to OT-101 as the investee can benefit from the risk and rewards of
ownership of such intellectual property. This resulted in the derecognition of the carrying amount of our intangible assets for approximately
$0.8
million and goodwill for $4.9
million for an aggregate amount of approximately
$5.7
million, recorded its initial investment at its
fair value for approximately $22.6
million and which resulted in a non-cash gain
on non-financial asset disposal of approximately $17
million, which was reported in other income in
the consolidated statements of operations during the year ended December 31, 2022.
As
of the effective date of the formation of the JV, the combined enterprise value of GMP Bio was approximately $50.4
million, comprising of the fair value of the Company’s investment in GMP Bio of approximately $22.7
million and the total original capital contributions by Dragon Overseas of approximately $27.7
million. As of December 31, 2022, the JV had approximately $22.8
million in assets, not including GMP Bio’s capital subscriptions of approximately $23
million; recorded approximately $1.0
million in liabilities and incurred approximately $5.6
million in operational expenses. The Company elected the fair value option under subsection of Section 825-10-15 to account for its
equity-method investment as the Company believes that it the most appropriate method to properly value the Company and record a
change in value when and upon conducting a fair value assessment. As of December 31, 2022, the Company does not believe the fair
value of the JV has changed and hence has not recorded a change in value.
For
information on the various notes from GMP, refer to Note 5 – GMP Notes of the Notes to the Consolidated Financial Statements
above.
NOTE
7 - PRIVATE PLACEMENT AND JH DARBIE FINANCING
During
the period from July 2020 to March 2021, the Company entered into subscription agreements with certain accredited investors pursuant
to the JH Darbie Financing, whereby the Company issued and sold a total of 100 Units, for total gross proceeds of approximately $5 million,
pursuant to the JH Darbie Placement Agreement, with each Unit consisting of:
|
■ |
25,000
shares of Edgepoint Common Stock for a price of $1.00 per share of Edgepoint Common Stock. |
|
■ |
One
convertible promissory note, convertible into up to 25,000 shares of Edgepoint Common Stock, at a conversion price of $1.00 per share
or up to 138,889 shares of the Company’s Common Stock, at a conversion price of $0.18 per share. |
|
■ |
50,000
warrants to purchase an equivalent number of shares of Edgepoint Common Stock at $1.00 per share or an equivalent number of shares
of the Company’s Common Stock at $0.20 per share with a three-year expiration date. |
As
of December 31, 2022, and 2021, debt recorded under the JH Darbie Financing, net of debt discounts, consist of the following amounts:
SCHEDULE
OF FUNDS RECEIVED UNDER THE SUBSCRIPTION AGREEMENT
| |
December 31, 2022 | | |
December 31, 2021 | |
Convertible promissory notes | |
| | | |
| | |
Subscription agreements - accredited investors | |
$ | 2,342,064 | | |
$ | 2,353,253 | |
Subscription agreements – related party | |
| 125,547 | | |
| 109,046 | |
Total convertible promissory notes | |
$ | 2,466,611 | | |
$ | 2,462,299 | |
Convertible promissory notes | |
$ | 2,466,611 | | |
$ | 2,462,299 | |
The
Company incurred approximately $0.64 million of issuance costs, including legal costs of approximately $39,000, that are incremental
costs directly related to the issuance of the various instruments bundled in the offering. As of the date of this Report, the PPM notes are in default.
Concurrently
with the sale of the Units, JH Darbie was granted, for nominal consideration, a warrant, exercisable over a five-year period, to purchase
10% of the number of Units sold in the JH Darbie Financing. As such, the Company granted 10 Units to JH Darbie pursuant to the JH Darbie
Placement Agreement.
The
terms of convertible notes are summarized as follows:
|
■ |
Term:
Through March 31, 2023. |
|
■ |
Coupon:
16%. |
|
■ |
Convertible
at the option of the holder at any time in the Company’s Common Stock or Edgepoint Common Stock. |
|
■ |
The
conversion price is initially set at $0.18 per share for the Company’s Common Stock or $1.00 for Edgepoint Common Stock, subject
to adjustment. |
The
Company allocated the proceeds among the freestanding financial instruments that were issued in the single transaction using the relative
fair value method, which affects the determination of each financial instrument’s initial carrying amount. The Company utilized the relative
fair value method as none of the freestanding financial instruments issued as part of the single transaction are measured at fair value.
Under the relative fair value method, the Company made separate estimates of the fair value of each freestanding financial instrument
and then allocated the proceeds in proportion to those fair value amounts. The Company recorded aggregate non-controlling interests of
approximately $1 million in Edgepoint. Non-controlling interests represent the portion of net assets in consolidated entities that are
not owned by the Company and are reported as a component of equity in the consolidated balance sheets.
As
of the multiple closings of the Company, during the six months ended June 30, 2021, under the private placement memorandum with JH Darbie,
the estimated volume weighted grant date fair value of approximately $0.21 per share associated with the warrants to purchase up to 2,035,000
shares of common stock issued in this offering, or a total of approximately $0.7 million, was recorded to additional paid-in capital
on a relative fair value basis. All warrants sold in this offering had an exercise price of $0.20 per share of the Company stock or $1.00
per share of Edge Point, subject to adjustment, are exercisable immediately and expire three years from the date of issuance. The fair
value of the warrants was estimated using a Black Scholes valuation models using the following input values:
SCHEDULE
OF FAIR VALUE WARRANTS ESTIMATED USING BLACK SCHOLES VALUATION MODEL
Expected Term | |
1.5 years | |
Expected volatility | |
| 152.3%-164.8 | % |
Risk-free interest rates | |
| 0.09%-0.11 | % |
Dividend yields | |
| 0.00 | % |
In
February 2022, the Company and all except one of the Investors agreed to extend the maturity date of the Notes from March 31, 2022, to
March 31, 2023. In consideration for the extension of the Notes, the Company issued to the Investors an aggregate of 33,000,066 Oncotelic
Warrants at a price of $0.15 per share of Company’s Common Stock. Each Investor will be entitled to receive 333,334 Oncotelic
Warrants for each Unit purchased. Upon the amendment of the terms of the convertible notes under the private placement memorandum. As
incentive to extend the maturity date, approximately 33 million warrants were issued to the Unit Holders who participated in the amendment,
The Company repaid the 1-unit holder who did not participate in the amendment shortly after March 31, 2022.
The
Company reviewed the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments
and concluded that the terms of the agreements were substantially different as of September 30, 2022, and, accounted for the transaction
as a debt extinguishment. The loss is recognized equal to the difference between the net carrying amount of the original debt and the
fair value of the modified debt instrument.
At
March 31, 2022, the Company estimated the fair value of the warrants issued in conjunction with the amendment of the private placement
under the JH Darbie financing based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consists,
in part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected
volatility of the Company’s Common Stock all as of the measurement date. The Company used the following assumptions to estimate
fair value of the warrants:
All
the warrants issued in conjunction with the amendment #5 had an exercise price of $0.15 per share and are immediately exercisable
and expire two years from the date of issuance or February 9, 2024. The warrants resulted in an aggregate fair value of approximately
$2.9 million.
The
Company recognized amortization expense related to the debt discount and debt issuance costs of $90,737 and $1,229,865 for
the fiscal years ended December 31, 2022, and 2021 respectively, which is included in interest expense in the statements of operations.
NOTE
8 - RELATED PARTY TRANSACTIONS
Master
Service Agreement with Autotelic Inc.
In
October 2015, Oncotelic Inc. entered into a Master Service Agreement (the “MSA”) with Autotelic Inc. (“Autotelic”),
a related party that is partly owned by Dr. Trieu. Dr. Trieu, a related party, is a control person in Autotelic. Autotelic currently
owns less than 10% of the Company. The MSA stated that Autotelic will provide business functions and services to the Company and allowed
Autotelic to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of
time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf
of the Company. The MSA requires a 90-day written termination notice in the event either party requires to terminate such services.
Expenses
related to the MSA were approximately $60,000 and $280,000 for the years ended December 31, 2022 and 2021, respectively. Amounts outstanding
at the end of the year 2022 and 2021 were approximately $225,000 and $270,000, respectively.
License
Agreement with Autotelic Inc.
In
September 2021, the Company entered into an exclusive License Agreement with Autotelic. For more information on the exclusive license
Agreement with Autotelic, refer to our 2021 Annual Report on Form 10-K filed with SEC on April 15, 2022
Notes
Payable and Short-Term Loan – Related Party
In
April 2019, the Company issued a convertible note to Dr. Trieu totaling $164,444,
including OID of $16,444,
receiving net proceeds of $148,000,
which was used by the Company for working capital and general corporate purposes (See Note 6). The Company issued a Fall 2019 Note
to Dr. Trieu in the principal amount of $250,000.
Dr. Trieu also offset certain amounts due to him in the amount of $35,000
and was converted into the Fall 2019 debt. During the year ended December 31, 2020, Dr. Trieu provided additional short-term funding
of $70,000
to the Company, of which the Company repaid $50,000
prior to December 31, 2020. As such the Company owed $20,000
for the short term loan as of December 31, 2021. During the year ended December 31, 2020, Dr. Trieu purchased a total of 5
Units under the private placement for a gross total of $250,000.
During
the year ended December 31, 2021, Autotelic Inc. provided a short-term funding of $120,000 to the Company, which was repaid in 2021.
In May 2021, Autotelic provided an additional short-term funding of $250,000 to the Company, which was converted into the August 2021
Notes. Autotelic provided an additional $20,000 short-term loan to the Company. During the year ended December 31, 2022, Autotelic provided
an additional $100,000 short term loan to the company and as such, $120,000 was outstanding and payable to Autotelic at December 31,
2022.
Artius
Consulting Agreement
On
March 9, 2020, the Company and Artius Bioconsulting, LLC (“Artius”), for which Mr. King is the Managing Member, entered
into an amendment to the Consulting Agreement dated December 1, 2018, under which Artius agreed to serve as a consultant to the Company
for services related to the Company’s business from time to time, effective December 1, 2019 (the “Effective Date”)
(the “Artius Agreement”). For more information on this Agreement, refer to our 2021 Annual Report on Form 10-K filed
with the SEC on April 15, 2022.
No
expense was recorded during the year ended December 31, 2022, or 2021, respectively, related to this Agreement.
Maida
Consulting Agreement
Effective
May 5, 2020, the Company and Dr. Maida entered into an independent consulting agreement, commencing April 1, 2020 (the “Maida Agreement”),
under which Dr. Maida will assist the Company in providing medical expertise and advice from time to time in the design, conduct and
oversight of the Company’s existing and future clinical trials. For more information on this Agreement, refer to our 2021 Annual
Report on Form 10-K filed with the SEC on April 15, 2022.
The
Company recorded an expense of $75,000 during the year ended December 31, 2022 related to this Agreement as compared to $215,000 during
the same period in 2021. Effective April 1, 2022, Dr Maida’s compensation is being borne by the JVA with GMP Bio.
NOTE
9 - EQUITY PURCHASE AGREEMENT AND REGISTRATION RIGHTS AGREEMENT
On
May 3, 2021, the Company entered into an Equity Purchase Agreement (“EPL”) and Registration Rights Agreement with
Peak One Opportunity Fund LP (“Peak One” or the “Investor”). For further information on EPL, refer
to our 2021 Annual Report on Form 10-K filed with the SEC on April 15, 2022.
The
Company filed a post-effective amendment Registration Statement on Form S-1 with the Commission on April 26, 2022, and the Form S-1 was
declared effective on May 6, 2022. The Company filed the prospectus in this connection on May 11, 2022.
During
the year ended December 31, 2022, the Company sold a total of 1,300,000 shares of Common Stock at prices ranging from $0.09 and $0.25
for total gross proceeds of approximately $0.2 million, net of issuance costs.
During
the year ended December 31, 2021, the Company sold a total of 3,435,000 shares of Common Stock at prices ranging from $0.09 and $0.23
for total net proceeds of approximately $420,000.
NOTE
10 – STOCKHOLDERS’ EQUITY
The
following transactions affected the Company’s Stockholders’ Equity:
Issuance
of Common Stock during the year ended December 31, 2022
In
January 2022, three of the five investors from the November/December 2021 financing made a cashless exercise for their warrants. In connection
with this exercise, the Company issued 3,041,958 shares of Common Stock in exchange of approximately 5,769,231 million warrants.
In
March 2022, the Company sold 300,000 shares of its Common Stock to Peak One under the EPL for net proceeds of approximately $52 thousand.
In
May 2022, Blue Lake made a cashless exercise for their warrants. In connection with this exercise, the Company issued 1,403,326 shares
of Common Stock in exchange of 1,923,077 warrants.
In
June 2022, the Company sold 300,000 shares of its Common Stock to Peak One under the EPL for net proceeds of approximately $47 thousand.
In
June 2022, Mast Hill converted their debt of approximately $0.28 million. In connection with the Note conversion, the Company issued
4,025,000 shares of Common Stock to Mast Hill.
In
June 2022, Company issued 500,000 shares of Common Stock to First Fire under partial repayment of convertible debt of $35,000.
In
June 2022, First Fire made a cashless exercise for their warrants. In connection with this exercise, the Company issued 1,183,400 shares
of Common Stock in exchange for 1,923,077 warrants.
In
July 2022, the Company sold 400,000 shares of its Common Stock to Peak One under the EPL for net proceeds of approximately $38 thousand.
In
August 2022, the Company sold 300,000 shares of its Common Stock to Peak One under the EPL for net proceeds of approximately $23 thousand.
In
August 2022, Fourth Man converted $0.14 million of their debt of approximately $0.28 million. In connection with the Note conversion,
the Company issued 2,025,000 shares of Common Stock to Fourth Man.
In
September 2022, Blue Lake converted $0.1 million of their debt of approximately $0.1 million. In connection with the Note conversion,
the Company issued 1,428,571 shares of Common Stock to Blue Lake.
In
December 2022, Fourth Man converted $0.05 million of their debt of approximately $0.1 million. In connection with the Note conversion,
the Company issued 1,428,571 shares of Common Stock to Fourth Man.
Issuance
of Common Stock during the year ended December 31, 2021
During
the year ended December 31, 2021, the Company issued 657,200 shares of its Common Stock to TFK in connection with the partial but final
conversion of their convertible notes payable. As such, the debt outstanding to TFK at December 31, 2021 was $0.
During
the year ended December 31, 2021, the Company issued a total of 1,148,235 shares of its Common Stock to various service providers for
services rendered. A total cost of approximately $194,000 was recorded for such services.
During
the year ended December 31, 2021, the Company sold 3,435,000 shares of its Common Stock in connection with the EPL for cash at prices
ranging from $0.09 to $0.23 per share of Common Stock. The Company received a total of approximately $420,000 against such sale of its
Common Stock.
During
the third quarter of 2021, the Company issued 1,257,952 shares of Common Stock to its employees in lieu of fully vested restricted stock
units (“RSUs”) under the 2015 Equity Incentive Plan. The Company recorded a stock-based compensation cost of $226,431
related to such issuance.
In
connection with the fully vested RSUs, the Company estimated the fair value using the stock price as of the date of issuance as the RSUs
were fully vested and issued as Common Stock of the Company. As such, there were no unvested RSUs as of December 31, 2021.
NOTE
11 – STOCK-BASED COMPENSATION
Options
Pursuant
to the Merger, the Company’s Common Stock and corresponding outstanding options survived. The below information details the Company’s
associated option activity pre and post-merger.
As
of December 31, 2022, options to purchase Common Stock were outstanding under three stock option plans – the 2017 Equity Incentive
Plan (the “2017 Plan”), the 2015 Equity Incentive Plan (the “2015 Plan”) and the 2005 Stock Plan
(the “2005 Plan”). Under the 2017 Plan, up to 2,000,000 shares of the Company’s Common Stock may be issued pursuant
to awards granted in the form of nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards.
Under the 2015 and 2005 Plans, taken together, up to 7,250,000 shares of the Company’s Common Stock may be issued pursuant to awards
granted in the form of incentive stock options, nonqualified stock options, restricted and unrestricted stock awards, and other stock-based
awards.
Employees,
consultants, and directors are eligible for awards granted under the 2017 and 2015 Plans. The Company registered an additional total
of 20,000,000 shares of its Common Stock, which may be issued pursuant to the Registrant’s Amended and Restated 2015 Equity Incentive
Plan (the “Plan”). Such additional shares were approved by the shareholders of the Company on August 10, 2020 and
as reported to the Securities and Exchange Commission (the “SEC”) vide a Current Report on Form 8-K on August 14,
2020. As such, the total number of shares of the Company’s Common Stock available for issuance under the 2015 plan is 27,250,000.
Since the adoption of the 2015 Plan, no further awards may be granted under the 2005 Plan, although options previously granted remain
outstanding in accordance with their terms.
Compensation
based stock option activity for qualified and unqualified stock options are summarized as follows:
SCHEDULE
OF COMPENSATION BASED STOCK OPTION ACTIVITY
| |
| | |
Weighted | |
For the year ended December 31, 2022 | |
| | |
Average | |
| |
Shares | | |
Exercise Price | |
Outstanding at January 1, 2022 | |
| 16,592,620 | | |
$ | 0.30 | |
Expired or cancelled | |
| (2,359 | ) | |
| 11.88 | |
Granted and vested during the year* | |
| 9,100,000 | | |
| 0.10 | |
Outstanding and exercisable at December 31, 2022 | |
| 25,690,261 | | |
$ | 0.23 | |
* | Includes 7,280,000 options that have been considered as vested, pending approval by the Board of
Directors of the Company. |
| |
| | |
Weighted | |
For the year ended December 31, 2021 | |
| | |
Average | |
| |
Shares | | |
Exercise Price | |
Outstanding at January 1, 2021 | |
| 3,941,301 | | |
$ | 0.78 | |
Granted during the year, fully vested | |
| 12,652,761 | | |
| 0.15 | |
Expired or cancelled | |
| (1,442 | ) | |
| 19.80 | |
Outstanding at December 31, 2021 | |
| 16,592,620 | | |
$ | 0.30 | |
The
following table summarizes information about options to purchase shares of the Company’s Common Stock outstanding and exercisable
at December 31, 2022:
SCHEDULE OF OPTIONS TO PURCHASE SHARES OF COMMON STOCK OUTSTANDING AND EXERCISABLE
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
|
Outstanding |
|
|
Remaining
Life |
|
|
Exercise |
|
|
Number |
|
Exercise
prices |
|
|
Options |
|
|
In
Years |
|
|
Price |
|
|
Exercisable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.01
to 0.15 |
|
|
|
16,250,000 |
|
|
|
9.16 |
|
|
$ |
0.12 |
|
|
|
6,057,500 |
|
|
0.16 |
|
|
|
5,502,761 |
|
|
|
8.5 |
|
|
|
0.16 |
|
|
|
5,502,761 |
|
|
0.22 |
|
|
|
1,750,000 |
|
|
|
3.3 |
|
|
|
0.22 |
|
|
|
1,750,000 |
|
|
0.38 |
|
|
|
900,000 |
|
|
|
2.6 |
|
|
|
0.38 |
|
|
|
900,000 |
|
|
0.73 |
|
|
|
762,500 |
|
|
|
2.3 |
|
|
|
0.73 |
|
|
|
762,500 |
|
|
1.37 |
|
|
|
150,000 |
|
|
|
0.5 |
|
|
|
1.37 |
|
|
|
150,000 |
|
|
1.43 |
|
|
|
300,000 |
|
|
|
2.4 |
|
|
|
1.43 |
|
|
|
300,000 |
|
|
15.00 |
|
|
|
75,000 |
|
|
|
2.4 |
|
|
|
15.00 |
|
|
|
75,000 |
|
|
|
|
|
|
25,690,261 |
|
|
|
8.0 |
|
|
$ |
0.30 |
|
|
|
15,497,761 |
|
The
compensation expense attributed to the issuance of the options is recognized as they are vested.
The
employee stock option plan stock options are generally exercisable for ten years from the grant date and vest over various terms from
the grant date to three years.
The
aggregate intrinsic value totaled approximately $0 and was based on the Company’s closing stock price of $0.05 as of December 31,
2022, which would have been received by the option holders had all option holders exercised their options as of that date.
As
of December 31, 2022, there was no
unamortized stock compensation cost related to the stock options granted during the year as the stock options granted during the year ended December 31, 2022 are considered vested. The vesting criteria
for 7,280,000 options is still being evaluated as on the date of this Report, as those options are subject to individual milestone achievements.
In
August 2019, the Company entered into Employment Agreements and incentive compensation arrangements with each of its executive officers,
including Dr. Vuong Trieu, the Chief Executive Officer; Dr. Fatih Uckun, the Chief Medical Officer; Dr. Chulho Park, its Chief Technology
Officer; and Mr. Amit Shah, the Chief Financial Officer. The incentive stock options and the restricted stock awards approved for the
Company’s executive officers were granted and issued in July 2021. The Company issued an aggregate of 1,257,952 of its common shares
in lieu of fully vested restricted stock units and 4,244,809 incentive and non-qualified stock options to purchase its Common Stock to
all its employees, including the awards due to the CEO, CFO, the prior CTO and Saran Saund, the Chief Business Officer of the Company.
Further, the Company issued all its employees, including the CEO and CBO and consultants 4,325,000 performance-based stock options that
would vest over two tranches subject to certain corporate goals being achieved, of which none have vested as of December 31, 2021. In
addition, the Company granted its Board of Directors and certain consultants, 2,825,000 stock options, which for the Board of Directors
vest over 5 quarters commencing the quarter ended September 30, 2021. All the options granted to the Board members have vested as of
December 31, 2022.
The
Company granted 9.1 million stock options to its employees during the year ended December 31, 2022. 20% of the options vested immediately
and the balance shall vest upon achievement of certain corporate and individual milestones, which are currently being evaluated. At December
31, 2022, the Company estimated the fair value of the options issued based on assumptions used in the Black-Scholes valuation model.
The options resulted in an aggregate fair value of approximately $0.5 million. The key valuation assumptions used of the price of the
Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected volatility of the Company’s
Common Stock all as of the measurement date. The Company used the following assumptions to estimate fair value of the warrants:
SCHEDULE
OF ASSUMPTIONS TO ESTIMATE FAIR VALUE OF THE WARRANTS
Strike price | |
$ | 0.10 | |
Expected Term | |
| 1 year | |
Expected volatility | |
| 95.5 | % |
Risk-free interest rates | |
| 3.12 | % |
Dividend yields | |
| 0.00 | % |
The
Company amortized approximately $0.9 million of stock compensation expense during the year ended December 31, 2022 on the 2021 and 2022
grants. The Company recorded $0.9 million of similar expense during the same periods of 2021 respectively.
Warrants
During
the year ended December 31, 2020, the Company offered to cancel to all the prior warrants of the warrant holders from the 2018 debt financing
and offered to reissue new warrants to such warrant holders. Out of all the warrant holders, holders of 13,750,000 warrants opted to
participate in the reissuance. In addition, the Company issued 3,465,000 new warrants to certain accredited investors in connection with
the financing through JH Darbie (See note 7).
During
the year ended December 31, 2021, 2,035,000 warrants were issued in connection with the financing through JH Darbie (See note 7). The
fair value of these warrants on issue date amounted to $467,637 as calculated using a Black Scholes valuation model. The Company also
issued 22,000,000 warrants in connection with the financing through JH Darbie (See note 7). The fair value of these warrants on the issue
date amounted to $2,190,127 as calculated using a Black Scholes valuation model. Further, the Company issued 10,576,924 warrants related
to the November/December 2021 Notes (See Note 6). The fair value of these warrants on issue date amounted to $1,172,753 as calculated
using a Black Scholes valuation model.
The
issuance of warrants to purchase shares of the Company’s Common Stock, including those attributed to debt issuances, for the years
ended December 31, 2022 and 2021, respectively are summarized as follows:
SCHEDULE OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted Exercise Price | |
Outstanding at January 1, 2022 | |
| 53,314,424 | | |
$ | 0.20 | |
Issued during the year ended December 31, 2022 | |
| 38,623,816 | | |
| 0.15-0.20 | |
Exercised / cancelled during the year ended December 31, 2022 | |
| (10,865,385 | ) | |
| 0.13-0.20 | |
Outstanding at December 31, 2022 | |
| 81,072,855 | | |
$ | 0.18 | |
|
|
|
|
|
Weighted- |
|
For
the year ended December 31, 2021 |
|
|
|
|
Average |
|
|
|
Shares |
|
|
Exercise
Price |
|
Outstanding
at January 1, 2021 |
|
|
18,702,500 |
|
|
$ |
0.20 |
|
Issued
during the year ended December 31, 2021 |
|
|
34,611,924 |
|
|
|
0.13-0.20 |
|
Outstanding
at December 31, 2021 |
|
|
53,314,424 |
|
|
$ |
0.20 |
|
The
following table summarizes information about warrants outstanding and exercisable at December 31, 2022:
SCHEDULE
OF WARRANTS OUTSTANDING AND EXERCISABLE
|
|
|
Outstanding
and exercisable |
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
|
Number |
|
|
Remaining
Life |
|
|
Exercise |
|
|
Number |
|
Exercise
Price |
|
|
Outstanding |
|
|
in
Years |
|
|
Price |
|
|
Exercisable |
|
$ |
0.20 |
|
|
|
42,737,500 |
|
|
|
0.25 |
|
|
$ |
0.20 |
|
|
|
42,737,500 |
|
|
0.13 |
|
|
|
961,539 |
|
|
|
3.90 |
|
|
|
0.13 |
|
|
|
961,539 |
|
|
0.15 |
|
|
|
33,000,066 |
|
|
|
1.25 |
|
|
|
0.15 |
|
|
|
33,000,066 |
|
|
0.20 |
|
|
|
4,373,750 |
|
|
|
4.24-4.48 |
|
|
|
0.20 |
|
|
|
4,373,750 |
|
|
|
|
|
|
81,072,855 |
|
|
|
0.92 |
|
|
$ |
0.18 |
|
|
|
81,072,855 |
|
NOTE
12 – INCOME TAXES
Significant
components of the Company’s deferred tax assets and liabilities for federal and state income taxes as of December 31, 2022 and
2021 are as follows in thousands:
SCHEDULE OF COMPONENTS OF NET DEFERRED TAX ASSETS AND LIABILITIES
| |
December 31, 2022 | | |
December 31, 2021 | |
Deferred tax assets: | |
| | | |
| | |
Stock-based compensation | |
$ | 2,575 | | |
$ | 1,164 | |
Assets | |
| 2,752 | | |
| 5,736 | |
Liability accruals | |
| 323 | | |
| 361 | |
R&D Credit | |
| 1,372 | | |
| 4,792 | |
Capital Loss | |
| 528 | | |
| 528 | |
Deferred state tax | |
| (2,146 | ) | |
| (2,246 | ) |
Net operating loss carry forward | |
| 53,456 | | |
| 57,343 | |
Total gross deferred tax assets | |
| 58,860 | | |
| 67,678 | |
Less - valuation allowance | |
| (58,860 | ) | |
| (67,678 | ) |
Net deferred tax assets | |
$ | - | | |
$ | - | |
The
Company had gross deferred tax assets of approximately $58.9
million and $67.7
million as of December 31, 2022 and 2021, respectively,
which primarily relate to net operating loss carryforwards.
As
of December 31, 2022 and 2021, the Company had gross federal net operating loss carryforwards of approximately $222.1
million and $236.1
million, respectively, which are available to
offset future taxable income, if any. The Company recorded a valuation allowance in the full amount of its net deferred tax assets since
realization of such tax benefits has been determined by our management to be unlikely.
At
December 31, 2022 and 2021, the Company had California state gross operating loss carry-forwards of approximately $77.2
and $76.3
million,
which will expire
in various amounts from 2028 through 2040.
At December 31, 2022, all the Company’s federal research and development tax credits of approximately $3.3 million, from prior
years, expired in 2021 and California state research and development tax credits of approximately $1.4 million which have no expiration
date.
The
Company identified its federal and California state tax returns as “major” tax jurisdictions. The periods our income tax
returns are subject to examination for these jurisdictions are 2018 through 2021. We believe our income tax filing positions and deductions
will be sustained on audit, and we do not anticipate any adjustments that would result in a material change to our financial position.
Therefore, no liabilities for uncertain income tax positions have been recorded.
Portions
of these carryforwards will expire through 2038, if not otherwise utilized. The Company’s utilization of net operating loss carryforwards
could be subject to an annual limitation because of certain past or future events, such as stock sales or other equity events constituting
a “change in ownership” under the provisions of Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and
similar state provisions. The annual limitations could result in the expiration of net operating loss carryforwards and tax credits before
they can be utilized. We have not performed a formal analysis, but we believe our ability to use such net operating losses and tax credit
carryforwards will be subject to annual limitations, due to change of ownership control provisions under Section 382 and 383 of the Internal
Revenue Code, which would significantly impact our ability to realize these deferred tax assets.
NOTE
13 – COMMITMENTS AND CONTINGENCIES
Leases
Currently,
the Company is leasing the office located at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 on a month-to-month basis until such
time a new office is identified. The Company believes the office is sufficient for its current operations.
Legal
Claims
From
time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. The Company is not presently
a party to any legal proceedings that it currently believes, if determined adversely to the Company, would individually or taken together
have a material adverse effect on the Company’s business, operating results, financial condition or cash flows.
PointR
Merger Consideration
The
total purchase price in the PointR Merger of $17,831,427
represented the consideration transferred from
the Company and was calculated based on the number of shares of Common Stock plus the preferred shares outstanding but convertible into
Common Stock outstanding at the date of the PointR Merger and included $2,625,000
of contingent consideration of shares issuable
to PointR shareholders, which could increase to $15
million of contingent consideration, upon achievement
of certain milestones. For more information on the PointR Merger Contingent Consideration, refer to our 2021 Annual Report on Form 10-K
filed with the SEC on April 15, 2022.
Other
claims
From
time to time, the Company may become involved in certain claims arising in the ordinary course of business. One of the Company’s
ex-employees has made a breach of employment contract claim against the Company. The Company and its legal counsel are evaluating the
validity of the claim, as the Company believes that such claim has limited merits and is hopeful to attain a positive outcome for such
claim. Since the Company and its legal counsel are still evaluating the claim, we are unable to quantify the amount such claim would
be settled at, if at all settled.
NOTE
14 – SUBSEQUENT EVENTS
Blue
Lake conversion
In
February 2023, the Company partially converted $ 71,750 of Blue Lake Note into 1,025,000 shares of Common Stock.
March
2022 Note
As
of the date of this Report, the March 2022 Note with Fourth Man is in default, as it was due to be paid at the end of March 2023. As
such, the May and June 2022 Notes with Mast Hill and Blue Lake are also in technical default due to the cross-default provisions contained
in those Notes. These are now available for conversion to shares of Common Stock of the Company.
J.
H. Darbie PPM Notes
As
of the date of this Report, the JH Darbie PPM Notes are in default as these notes were to be paid at the end of March 2023.The Company
is in discussion with JH Darbie to close out these notes. The Company is fairly confident a resolution should be reached to resolve the
matter.
Claim
The
Company is disputing a judgement of $20,000 for a non-payment to a service provider. The Company considers the claim to be immaterial
to the financial position of the Company.
ONCOTELIC
THERAPEUTICS, INC.
33,863,445
SHARES OF COMMON STOCK
PROSPECTUS
YOU
SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS DOCUMENT OR THAT WE HAVE REFERRED YOU TO. WE HAVE NOT AUTHORIZED ANYONE TO PROVIDE
YOU WITH INFORMATION THAT IS DIFFERENT. THIS PROSPECTUS IS NOT AN OFFER TO SELL COMMON STOCK AND IS NOT SOLICITING AN OFFER TO BUY COMMON
STOCK IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
The
date of this Prospectus is April 14, 2023
PART
II
INFORMATION
NOT REQUIRED IN THE PROSPECTUS
Other
Estimated Expenses of Issuance and Distribution
Securities and Exchange Commission registration fee | |
$ | 1,099 | |
Legal fees | |
| 10,000 | |
Accounting fees and expenses | |
$ | 20,000 | |
| |
| | |
Total | |
$ | 31,099 | |
All
amounts are estimates other than the Commission’s registration fee. We are paying all expenses of the Offering listed above. No
portion of these expenses will be borne by the Selling Shareholders. The Selling Shareholders, however, will pay any other expenses incurred
in selling their Common Stock, including any brokerage commissions or costs of sale.
Indemnification
of Directors and Officers
Section
145 of the Delaware General Corporation Law permits a corporation to indemnify any director or officer of the corporation against expenses
(including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with
any action, suit or proceeding brought by reason of the fact that such person is or was a director or officer of the corporation, if
such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of
the corporation, and, with respect to any criminal action or proceeding, if he or she had no reason to believe his or her conduct was
unlawful. In a derivative action, one brought by or on behalf of the corporation), indemnification may be provided only for expenses
actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action or suit if
such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of
the corporation, except that no indemnification shall be provided if such person shall have been adjudged to be liable to the corporation,
unless and only to the extent that the court in which the action or suit was brought shall determine that the defendant is fairly and
reasonably entitled to indemnity for such expenses despite such adjudication of liability.
Our
Articles of Incorporation contain a provision that no director or officer will be personally liable to us or our stockholders for damages
regarding breaches of fiduciary duty. This limitation on liability may reduce the likelihood of derivative litigation against our officers
and directors and may discourage or deter our stockholders from suing our officers and directors based upon breaches of their duties
to our Company.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons
of the Company pursuant to the foregoing provisions, or otherwise, the Company has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other than the payment by the Company of expenses incurred or
paid by a director, officer or controlling person of the Company in the successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with the securities being registered, the Company will, unless in the opinion
of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication
of such issue.
Recent
Sales of Unregistered Securities
No
unregistered securities were issued during the fiscal year that were not previously reported in a Quarterly Report on Form 10-Q or Current
Report on Form 8-K
Exhibits
and Financial Statement Schedules
|
|
|
|
Incorporated by Reference |
Exhibit
Number |
|
Description |
|
Form |
|
Filing
Date |
|
Exhibit
Number |
|
Filed
Herewith |
|
|
|
|
|
|
|
|
|
|
|
2.1 |
|
Agreement and Plan of Merger, dated as of April 17, 2019, by and among the Company, Oncotelic and Oncotelic Acquisition Corporation. |
|
8-K |
|
4/18/2019 |
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
2.2 |
|
Agreement and Plan of Merger, dated as of April 17, 2019, by and among the Company, Oncotelic and Oncotelic Acquisition Corporation. |
|
8-K |
|
4/25/2019 |
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
2.3 |
|
Agreement and Plan of Merger, dated as of August 17, 2019, by and among the Company, PointR and Paris Acquisition Corporation. |
|
8-K |
|
8/21/2019 |
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
2.4 |
|
Agreement and Plan of Merger, dated as of August 17, 2019, by and among the Company, PointR Data, Inc. and Paris Acquisition Corp. |
|
8-K |
|
11/12/2019 |
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
2.5 |
|
Amendment No. 1 to Agreement and Plan of Merger, dated as of November 1, 2019, by and among the Company, PointR Data, Inc. and Paris Acquisition Corp. |
|
8-K |
|
11/12/2019 |
|
2.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.1 |
|
Amended and Restated By-Laws of the Registrant. |
|
8-K |
|
6/17/2016 |
|
3.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.2 |
|
Restated Certificate of Incorporation of the Registrant, as amended by Certificates of Amendment dated June 22, 1995, November 15, 1996, July 14, 2005, June 2, 2009, February 8, 2010, August 5, 2010, February 22, 2011, May 29, 2012, December 27, 2012, July 17, 2013, June 16, 2016 and June 20, 2018. |
|
10-Q |
|
8/14/2018 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.3 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company. |
|
8-K |
|
4/25/2019 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.4 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company. |
|
8-K |
|
11/12/2019 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.5 |
|
Certificate of Amendment to the Certificate of Incorporation dated September 24, 2020. |
|
10-K |
|
04/15/2021 |
|
3.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.1 |
|
Form of Series A/B Common Stock Purchase Warrant. |
|
8-K |
|
4/11/2013 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.2 |
|
Form of Common Stock Purchase Warrant. |
|
8-K |
|
9/20/2013 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.3 |
|
Form of Common Stock Purchase Warrant. |
|
S-1/A |
|
1/31/2014 |
|
4.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.4 |
|
Form of Placement Agent Purchase Warrant. |
|
S-1/A |
|
1/31/2014 |
|
4.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.5 |
|
Form of Common Stock Purchase Warrant. |
|
8-K |
|
2/14/2014 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.6 |
|
Form of Placement Agent Purchase Warrant. |
|
8-K |
|
2/14/2014 |
|
4.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.7 |
|
Form of Common Stock Purchase Warrant. |
|
8-K |
|
5/23/2014 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.8 |
|
Form of Common Stock Purchase Warrant. |
|
8-K |
|
3/20/2015 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.9 |
|
Specimen Common Stock Certificate. * |
|
10-Q |
|
8/2/2016 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.10 |
|
Form of Series A Warrant to purchase Common Stock. |
|
8-K |
|
4/16/2018 |
|
4.1 |
|
|
4.11 |
|
Form of Series B Warrant to purchase Common Stock |
|
8-K |
|
4/16/2018 |
|
4.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.12 |
|
Form of Placement Agent Purchase Warrant. |
|
S-1 |
|
6/13/2018 |
|
4.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.13 |
|
Form of Debenture, issued by the Company to PeakOne. |
|
8-K |
|
4/18/2019 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.14 |
|
Form of Debenture, issued by the Company to the Bridge Investors. |
|
8-K |
|
4/18/2019 |
|
4.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.15 |
|
Form of Debenture, issued by the Company to Peak One Opportunity Fund, L.P. and TFK Investments, LLC Ex. 4.1 Form of Debenture, issued by the Company to the Bridge Investors. |
|
8-K |
|
4/25/2019 |
|
4.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.16 |
|
Form of Debenture, issued by the Company to Peak One Opportunity Fund, L.P. and TFK Investments, LLC. |
|
8-K |
|
6/20/2019 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.17 |
|
Convertible Promissory Note between Mateon Therapeutics, Inc. and PointR Data Inc. dated July 22, 2019. |
|
8-K |
|
7/24/2019 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.18 |
|
Form of Note Purchase Agreement, dated as of November 23, 2019, by and among the Company and the investors identified therein. |
|
8-K |
|
11/25/2019 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
5.1 |
|
Opinion of JDT Legal, PLLC |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
10.1 |
|
Technology Development Agreement, dated as of May 27, 1997, between the Registrant and the Arizona Board of Regents, acting for and on behalf of Arizona State University. |
|
10-K |
|
4/15/1998 |
|
10.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2 |
|
Research Collaboration and License Agreement, dated as of December 15, 1999, between OXiGENE Europe AB and Bristol-Myers Squibb Company. * |
|
8-K |
|
12/28/1999 |
|
99.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.3 |
|
Amendment and Confirmation of License Agreement No. 206-01.LIC, dated as of June 10, 2002, between the Registrant and the Arizona Board of Regents, acting for and on behalf of Arizona State University. |
|
10-Q |
|
8/14/2002 |
|
10.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.4 |
|
Termination Agreement by and between OXiGENE Europe AB and Bristol-Myers Squibb Company dated as of February 15, 2002. |
|
10-Q |
|
8/14/2002 |
|
10.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.5 |
|
License Agreement No. 206-01.LIC by and between the Arizona Board of Regents, acting on behalf of and for Arizona State University, and OXiGENE Europe AB, dated August 2, 1999. |
|
10-K/A |
|
8/12/2003 |
|
10.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.6 |
|
Research and License Agreement between the Registrant and Baylor University, dated June 1, 1999. |
|
10-K/A |
|
8/12/2003 |
|
10.28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.7 |
|
Agreement to Amend Research and License Agreement between the Registrant and Baylor University, dated April 23, 2002. |
|
10-K/A |
|
8/12/2003 |
|
10.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.8 |
|
Addendum to Research and License Agreement between the Registrant and Baylor University, dated April 14, 2003. |
|
10-K/A |
|
8/12/2003 |
|
10.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.9 |
|
Form of Incentive Stock Option Agreement under Mateon’s 2005 Stock Plan. + |
|
10-K |
|
3/14/2006 |
|
10.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.10 |
|
Form of Non-Qualified Stock Option Agreement under Mateon’s 2005 Stock Plan. + |
|
10-K |
|
3/14/2006 |
|
10.30 |
|
|
10.11 |
|
Form of Restricted Stock Agreement under Mateon’s 2005 Stock Plan. + |
|
10-K |
|
3/14/2006 |
|
10.31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.12 |
|
Lease between Broadway 701 Gateway Fee LLC, a Delaware Limited Liability Company, as Landlord, and the Registrant, as Tenant, dated October 10, 2008. |
|
10-K |
|
3/30/2009 |
|
10.59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.13 |
|
Form of Indemnification Agreement. + |
|
10-Q |
|
8/13/2012 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.14 |
|
Third Amendment to Lease, dated as of April 1, 2013, by and between the Registrant and DWF III Gateway, LLC, a Delaware limited liability company. |
|
10-Q |
|
5/9/2013 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.15 |
|
Fourth Amendment to Lease, dated April 28, 2014, by and between the Registrant and DWF III Gateway, LLC. |
|
10-Q |
|
5/8/2014 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.16 |
|
Employment Agreement by and between the Registrant and William D. Schwieterman, dated as of May 12, 2015. + |
|
10-Q |
|
8/6/2015 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.17 |
|
Employment Agreement by and between the Registrant and Matthew M. Loar, dated as of July 20, 2015. + |
|
10-Q |
|
8/6/2015 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.18 |
|
Form of Option Agreement under Mateon’s 2015 Equity Incentive Plan. + |
|
10-Q |
|
8/6/2015 |
|
10.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.19 |
|
Amendment No. 1 to Employment Agreement by and between William D. Schwieterman, dated as of July 31, 2015. + |
|
10-Q |
|
8/6/2015 |
|
10.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.20 |
|
Second Amended and Restated Employment Agreement by and between the Registrant and David J. Chaplin, effective as of January 1, 2017. + |
|
8-K |
|
10/28/2016 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.21 |
|
Mateon Therapeutics, Inc. Amended and Restated Non-Employee Director Compensation Policy, effective October 25, 2016. + |
|
8-K |
|
10/28/2016 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.22 |
|
Mateon Therapeutics, Inc. 2017 Equity Incentive Plan. + |
|
8-K |
|
1/13/2017 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.23 |
|
Form of Option Agreement under Mateon’s 2017 Equity Incentive Plan. + |
|
8-K |
|
1/13/2017 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.24 |
|
Mateon Therapeutics, Inc. 2005 Stock Plan (as amended and restated on January 12, 2017). + |
|
8-K |
|
1/13/2017 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.25 |
|
Amendment No. 2 to Employment Agreement by and between the Registrant and William D. Schwieterman, dated as of October 2, 2017. + |
|
10-Q |
|
11/14/2017 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.26 |
|
Amendment No. 1 to Employment Agreement by and between the Registrant and Matthew M. Loar, dated as of October 2, 2017. + |
|
10-Q |
|
11/14/2017 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.27 |
|
Amendment No. 1 to Second Amended and Restated Employment Agreement by and between the Registrant and David J. Chaplin, dated as of October 2, 2017. + |
|
10-Q |
|
11/14/2017 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.28 |
|
Mateon Therapeutics, Inc. 2015 Equity Incentive Plan (as amended and restated on May 24, 2018). + |
|
Definitive
Proxy Statement on Schedule 14A |
|
05/07/2018 |
|
Appendix
A |
|
|
10.29 |
|
Form of Subscription Agreement for private placement transaction entered into on April 12, 2018. |
|
8-K |
|
4/16/2018 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.30 |
|
Form of Registration Rights Agreement for private placement transaction entered into on April 12, 2018. |
|
8-K |
|
4/16/2018 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.31 |
|
Engagement Letter, dated February 7, 2018, by and between the Registrant and Divine Capital Markets LLC. |
|
8-K |
|
4/16/2018 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.32 |
|
Separation and Release Agreement, dated April 17, 2019 by and between the Company and William D. Schwieterman, M.D. |
|
8-K |
|
4/18/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.33 |
|
Form of Securities Purchase Agreement, dated as of April 17, 2019, by and among the Company and Peak One |
|
8-K |
|
4/18/2019 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.34 |
|
Form of Securities Purchase Agreement, dated as of April 17, 2019, by and among the Company and the Bridge Investors. |
|
8-K |
|
4/18/2019 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.35 |
|
Contingent Value Rights Agreement, dated April 17, 2019, by and among the Company, Oncotelic and American Stock Transfer and Trust Company LLC |
|
8-K |
|
4/25/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.36 |
|
Form of Securities Purchase Agreement, dated as of April 17, 2019, by and among the Company and Peak One Opportunity Fund, L.P. and TFK Investments, LLC. |
|
8-K |
|
4/25/2019 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.37 |
|
Form of Securities Purchase Agreement, dated as of April 17, 2019, by and among the Company and the Bridge Investors |
|
8-K |
|
4/25/2019 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.38 |
|
Form of Securities Purchase Agreement, dated as of April 17, 2019, by and among the Company and Peak One Opportunity Fund, L.P. and TFK Investments, LLC. |
|
8-K |
|
6/20/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.39 |
|
Amendment to Securities Purchase Agreement dated as of June 12, 2019 by and between the Company and Peak One Opportunity Fund, L.P. |
|
8-K |
|
6/20/2019 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.40 |
|
Separation Agreement dated as of July 1, 2019 by and between the Company and Matthew M. Loar Ex. |
|
8-K |
|
7/5/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.41 |
|
Note Purchase Agreement between Mateon Therapeutics, Inc. and PointR Data Inc. dated July 22, 2019. |
|
8-K |
|
7/24/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.42 |
|
Employment Agreement dated August 23, 2019 between the Company and Dr. Vuong Trieu. |
|
8-K |
|
8/29/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.43 |
|
Employment Agreement dated August 23, 2019 between the Company and Dr. Fatih Uckun. |
|
8-K/A |
|
11/25/2019 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.44 |
|
Employment Agreement dated August 23, 2019 between the Company and Dr. Chulho Park. |
|
8-K |
|
8/29/2019 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.45 |
|
Employment Agreement dated August 23, 2019 between the Company and Mr. Amit Shah. |
|
8-K |
|
8/29/2019 |
|
10.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.46 |
|
Investigational Product Supply and Use Authorization Agreement for OT-101 U.S. Expanded Access (IPSUA) dated September 5, 2019, between WideTrial and Oncotelic. |
|
8-K |
|
9/10/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.47 |
|
Agreement for Delivery and Licensed Use of Data Generated from OT-101 U.S. Expanded Access (Data License 1) dated September 5, 2019 between WideTrial and Oncotelic. |
|
8-K |
|
9/10/2019 |
|
10.2 |
|
|
10.48 |
|
Agreement for Delivery and Licensed Use of WideTrial Bonus Dataset (Data License 2 Agreement) dated September 5, 2019 between WideTrial and Oncotelic. |
|
8-K |
|
9/10/2019 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.49 |
|
Form of Convertible Promissory Note, issued by the Company under the Note Purchase Agreement dated as of November 23, 2019. |
|
8-K |
|
11/25/2019 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.50 |
|
Research and Services Agreement. |
|
8-K |
|
3/23/2020 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.51 |
|
Supplement Research and Services Agreement. |
|
8-K |
|
3/23/2020 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.52 |
|
Paycheck Protection Program Promissory Note dated April 21, 2020 between Mateon Therapeutics, Inc. and Silicon Valley Bank. |
|
8-K |
|
4/27/2020 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.53 |
|
Form of Series A Warrant to purchase Common Stock. |
|
10-Q |
|
06/12/2020 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.54 |
|
Agreement between Oncotelic Inc, Autotelic Inc. and Autotelic BIO. |
|
8-K |
|
6/16/2020 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.55 |
|
Consulting Agreement by Between the Company and Artius, dated March 9, 2020 |
|
8-K/A |
|
6/22/2020 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.56 |
|
Consulting Agreement by Between the Company and Dr. Maida, dated May 5, 2020 |
|
8-K/A |
|
6/22/2020 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.57 |
|
Loan, Secured Convertible Note Purchase, and Security Agreement between the Company and Golden Mountain Partners, LLC dated June 27, 2020 |
|
10-Q |
|
11/16/2020 |
|
10.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.58 |
|
Secured Convertible Promissory Note between the Company and Golden Mountain Partners, LLC dated June 27, 2020 |
|
10-Q |
|
11/16/2020 |
|
10.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.59 |
|
License, Development and Commercialization Agreement between Mateon Therapeutics, Inc. and Windlas Biotech Private Limited dated November 10, 2020 |
|
10-Q |
|
11/16/2020 |
|
10.59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.60 |
|
Equity Purchase Agreement (Peak One) filed herewith |
|
8-K |
|
05/07/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.61 |
|
Registration Rights Agreement (Peak One) filed herewith |
|
8-K |
|
05/07/2021 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.62 |
|
Amendment to the Oncotelic Therapeutics, Inc. 2015 Equity Incentive Plan |
|
S-8 |
|
04/16/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.63 |
|
Equity Purchase Agreement by and between the Company and Peak One Opportunity Fund L.P dated May 3, 2021 |
|
8-K |
|
05/07/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.64 |
|
Form for Registration of Securities |
|
S-1 |
|
05/24/2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.65 |
|
Form of Securities Purchase Agreement by and between the Company and Geneva Roth Remark Holding, Inc dated May 25, 2021 |
|
8-K |
|
06/01/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.66 |
|
Form of Securities Purchase Agreement and by and between the Company and Geneva Roth Remark Holding, Inc dated Jube 28, 2021 |
|
8-K |
|
07/02/2021
|
|
10.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.67 |
|
Form of Note Purchase Agreement by and between the Company and Autotelic Inc. dated August 4, 2021 |
|
8-K |
|
08/05/2021 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.68 |
|
Licensing Agreement by and between the Company and Autotelic Inc dated August 31, 2021 |
|
8-K |
|
09/03/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.69 |
|
Unsecured Convertible Note Purchase Agreement by and between the Company and Golden Mountain Partners LLC dated September 21, 2021 |
|
8-K |
|
09/27/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.70 |
|
Licensing Agreement by and between the Company and Autotelic Inc dated September 30, 2021 |
|
8-K |
|
10/04/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.71 |
|
Unsecured Convertible Note Purchase Agreement by and between the Company and Golden Mountain Partners LLC dated October 25, 2021 |
|
8-K |
|
10/28/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.72 |
|
Form of Securities Purchase Agreement by and between the Company and certain accredited investors |
|
8-K |
|
12/01/2021 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.73 |
|
Form of Convertible Notes by and between the Company certain accredited investors |
|
8-K |
|
12/01/2021 |
|
10.1 |
|
|
10.74 |
|
Form of Unsecured Convertible Note Purchase Agreement between the Company and Golden Mountain Partners dated January 31, 2022 |
|
8-K |
|
02/02/2022 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.75 |
|
Form of Convertible Promissory Note issued by the Company dated January 31, 2022 |
|
8-K |
|
02/02/2022 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.76 |
|
Form of Warrants issued by the Company to certain Investors, under the extension of Notes dated February 9, 2022 of the Note Purchase Agreement dated July 23, 2020 |
|
8-K |
|
02/15/2022 |
|
10.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.77 |
|
Form of Securities Purchase Agreement by and between the Company and certain accredited investors dated March 29, 2022 |
|
8-K |
|
04/04/2022 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.78 |
|
Form of Joint Venture Agreement between the Company and Dragon Overseas Capital Limited dated March 31, 2022 |
|
8-K |
|
04/06/2022 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.79 |
|
License Agreement between Oncotelic Therapeutics, Inc. and GMP Biotechnology Limited dated March 31, 2022 |
|
8-K |
|
04/06/2022 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.80 |
|
License Agreement between Oncotelic Therapeutics, Inc. and Sapu Holdings, LLC dated March 31, 2022 |
|
8-K |
|
04/06/2022 |
|
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.81 |
|
Independent consulting agreement between Oncotelic Therapeutics, Inc. and Fatih Uckun, MD, Ph.D. dated May 1, 2022 |
|
8-K |
|
5/6/2022 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.82 |
|
Independent consulting agreement between Oncotelic Therapeutics, Inc. and Seymour Fein, MD dated May 1, 2022 |
|
8-K |
|
5/6/2022 |
|
10.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.83 |
|
Securities Purchase Agreement between Oncotelic Therapeutics Inc. and certain accredited investors dated May 27, 2022 |
|
8-K |
|
6/3/2022 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.84 |
|
Securities Purchase Agreement between Oncotelic Therapeutics Inc. and certain accredited investors dated June 22, 2022 |
|
8-K |
|
6/27/2022 |
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
23.1 |
|
Consent of the Independent Registered Accounting Firm |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
23.2 |
|
Consent of Counsel to the Offering (included in Exhibit 5.1) |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
107 |
|
Filing Fees Exhibit |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.INS |
|
Inline XBRL
Instance Document |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.SCH |
|
Inline XBRL
Taxonomy Extension Schema |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.CAL |
|
Inline XBRL
Taxonomy Extension Calculation Linkbase |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.DEF |
|
Inline XBRL
Taxonomy Extension Definition Linkbase |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.LAB |
|
Inline XBRL
Taxonomy Extension Label Linkbase |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.PRE |
|
Inline XBRL
Taxonomy Extension Presentation Linkbase |
|
|
|
|
|
|
|
X |
* |
Confidential
treatment has been granted for portions of this Exhibit. Redacted portions filed separately with the Securities and Exchange Commission. |
|
|
+ |
Management
contract or compensatory plan or arrangement. |
Undertakings
|
A. |
The
undersigned registrant hereby undertakes: |
|
|
|
|
|
|
|
(1) |
To
file, during any period in which offers, or sales are being made, a post-effective amendment to this registration statement: |
|
|
|
|
|
|
|
|
|
|
i. |
To
include any Prospectus required by Section 10(a)(3) of the Securities Act of 1933. |
|
|
|
|
|
|
|
|
|
|
ii. |
To
reflect in the Prospectus any facts or events arising after the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if
the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end
of the estimated maximum offering range may be reflected in the form of Prospectus filed with the Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set
forth in the “Calculation of Registration Fee” table in the effective registration statement. |
|
|
|
|
|
|
|
|
|
|
iii. |
To
include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement. |
|
|
|
|
|
|
|
|
(2) |
That,
for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof. |
|
|
|
|
|
|
|
|
(3) |
To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the
termination of the offering. |
|
|
|
|
|
|
|
|
(4) |
That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each Prospectus filed pursuant to Rule
424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other
than Prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of
the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or Prospectus
that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration
statement or Prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior
to such first use, supersede or modify any statement that was made in the registration statement or Prospectus that was part of the
registration statement or made in any such document immediately prior to such date of first use. |
|
B. |
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons
of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid
by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the
final adjudication of such issue |
|
C. |
That,
for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution
of the securities: |
The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
|
i. |
Any
preliminary Prospectus or Prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule
424 (Section 230.424 of this chapter); |
|
|
|
|
ii. |
Any
free writing Prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by
the undersigned registrant; |
|
|
|
|
iii. |
The
portion of any other free writing Prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and |
|
|
|
|
iv. |
Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
SIGNATURES
Pursuant
to the requirement of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement on Form S-1
to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Agoura Hills, California, on April 19,
2023
|
Oncotelic
Therapeutics, Inc. |
|
(Formerly
Mateon Therapeutics, Inc.) |
|
|
|
|
/s/
VUONG TRIEU |
|
By: |
VUONG
TRIEU, PH. D. |
|
|
Chief
Executive Officer |
In
accordance with the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons
in the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
VUONG TRIEU |
|
President,
Chief Executive Officer and Chairman of the |
|
April
19, 2023 |
Vuong
Trieu, Ph. D. |
|
Board
and Director (Principal executive officer) |
|
|
|
|
|
|
|
/s/
AMIT SHAH |
|
Chief
Financial Officer (Principal financial |
|
April
19, 2023 |
Amit
Shah |
|
and
accounting officer) |
|
|
|
|
|
|
|
/s/
STEVEN KING |
|
Director |
|
April
19, 2023 |
Steven
King |
|
|
|
|
|
|
|
|
|
/s/
ANTHONY MAIDA |
|
Director |
|
April
19, 2023 |
Anthony
Maida, M.D., Ph. D. |
|
|
|
|
Oncotelic Therapeutics (QB) (USOTC:OTLC)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024
Oncotelic Therapeutics (QB) (USOTC:OTLC)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024