NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE
1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Description
of Business
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: and EdgePoint
AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic
Inc., PointR and Edgepoint are collectively called the “Company” or “We”). The Company is currently
developing OT-101 for various cancers and COVID-19, 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.
In
April 2019, Oncotelic completed a merger with Oncotelic Inc., which became a wholly owned subsidiary of Oncotelic. The
merger was treated as a recapitalization and reverse acquisition for financial accounting purposes. Oncotelic Inc. is considered
the acquirer for accounting purposes, and Oncotelic Inc.’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 with the
Securities and Exchange Commission (“SEC”). For more information on this merger, refer to our 2020 Annual Report on
Form 10-K filed with the SEC on April 15, 2021.
In
August 2019, the Company entered into an Agreement and Plan of Merger with PointR Date, Inc. PointR survived the merger as a wholly-owned
subsidiary of the Company. The PointR Merger was intended to create a publicly-traded artificial intelligence (“AI”)
driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas,
pancreatic cancer and melanoma. In November 2019, pursuant to the terms of the PointR Merger Agreement, the Company completed the PointR
Merger. For more information on this merger, refer to our 2020 Annual Report on Form 10-K filed with the SEC on April 15, 2021.
In
February 2020, the Company formed a subsidiary, Edgepoint. Edgepoint was formed as a start-up company, with plans to develop technologies
and IP related to various unmet issues within the pharma and medical device industries. The Company may spin off Edgepoint into a separate
public company in the future.
The
Company is 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 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. Oncotelic Inc.’s
product candidate, 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. Together, the Company 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.
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 developing OT-101 for the various epidemics and pandemics, similar to the current coronavirus (“COVID-19”)
pandemic. In this connection, the Company entered into an agreement and supplemental agreement with Golden Mountain Partners (“GMP”)
for a total of $1.2 million to render services for the development of OT-101. 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.
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, 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 its 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.
Between
October 2021 and March 2022, GMP provided $1.0 million to the Company to fund operations on the way to complete a JV with the Company.
Fundraising
J.H.
Darbie Financing Notes & Issuance of Oncotelic Warrants
Between
July 2020 and March 2021, the Company issued and sold a total of 100 units (“Units”), 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, 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”)
(collectively, the “JH Darbie Financing”).
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 JHDarbie 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. The issuance of the additional warrants
resulted in the Company recording an expense of $2,023,552 in the Company’s statement of operations during the year ended December
31, 2021. No similar expense was recorded in the same period in 2020. Management 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 not
substantially different as of June 30, 2021, and, accounted for the transaction as a debt modification.
In
February 2022, the Company and 99 out of 100 of the Investors agreed to extend the maturity date of the Notes from March 31, 2022, to
March 31, 2023. In addition, the Company issued approximately 33
million Oncotelic Warrants to purchase $50,000
of shares of Common Stock 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 three months ended March 31, 2022. No similar expense was recorded in the same
period in 2020. Management 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 not substantially different as of June 30, 2021, and, accounted
for the transaction as a debt extinguishment.
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 has directed Peak One, on ten occasions, for an aggregate of 3.7 million shares of Common Stock for aggregate net
cash proceeds of approximately $0.4 million.
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.
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. All amounts outstanding under the Notes become due and payable at such time as determined by the holders
of a majority of the Principal Amount of the Notes (the “Majority Holders”), on or after (a) the one-year anniversary
of the Notes, or (b) the occurrence of an Event of Default (as defined in the Note Purchase Agreements) (the “Maturity Date”).
The Company may prepay the Notes at any time. Events of Default under the Notes include, without limitation, (i) failure to make payments
under the Notes within thirty (30) days of the Maturity Date, (ii) breaches of the Note Purchase Agreement or Notes by the Company which
is not cured within thirty (30) days of notice of the breach, (iii) bankruptcy, or (iv) a change in control of the Company (as defined
in the Note Purchase Agreements). The Majority Holders have the right, at any time not more than five 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 Notes. The Notes
may be converted, at the election of the Majority Holders, into shares of the Company’s common stock, par value $0.01 per share
(“Common Stock”), at a fixed conversion price of $0.18 per share.
Joint
Venture with GMP Bio
On March 31, 2022, the Company
formalized a joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology
Limited (“GMP Bio”), both affiliates of GMP. For more information on the JV, refer to Note 6 of the Notes and our
Current Report on Form 8-K filed with the SEC on April 6, 2022.
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.
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 2022 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 September 2021 Note, the October 2021 Note and the January 2022 Note, refer to our 2021 Annual Report on Form
10K filed with the SEC on April 15, 2022.
November/December
2021 Notes
In
November and 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”).
The
Purchase Agreements were entered into as part of a convertible note financing round with aggregate gross proceeds to the Company of up
to $1.25 million (the “Financing”), undertaken by the Company pursuant to that certain Finder’s Fee Agreement between
the Company and JH Darbie & Co., Inc. (“JH Darbie”), dated October 26, 2021 (the “Agreement”). All of the
Purchase Agreements and the Note contain identical terms except with reference to the name of the holders, the use of proceeds, which
include repayment of certain debt, general corporate expenses and payroll, as applicable and the jurisdictions.
In
January 2022, three of the five note holders under the November and 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.
For
more information on the notes, refer to Note 6: November – December 2021 Financing of the Notes to the Unaudited Consolidated Financial
Statements.
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.
Principles
of Consolidation
The
consolidated financial statements include the accounts of Oncotelic, its wholly owned subsidiaries, Oncotelic Inc. and PointR, and Edgepoint
our non-controlled interest entity. Intercompany accounts and transactions have been eliminated in consolidation.
Basis
of Presentation
The
accompanying consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities
and Exchange Commission including Form 10-Q and Regulation S-X. The information furnished herein reflects all adjustments (consisting
of normal recurring accruals and adjustments) which are, in the opinion of management, necessary to fairly state the operating results
for the respective periods. Certain information and footnote disclosures normally present in annual financial statements prepared in
accordance with accounting principles generally accepted in the United States of America (“US GAAP”) have been omitted
pursuant to such rules and regulations.
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 accumulated losses of approximately $35.9
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. The Company also has a negative working capital of approximately $16.7
million at March 31, 2022, of which approximately
$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 three months ended March 31, 2022 of approximately
$1.0
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
additional losses in the foreseeable future and 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 now the product of the JV, to generate sufficient revenues, through either technology transfer or product sales, 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.
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 March 31, 2022 and December 31, 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 March 31, 2022 and December 31, 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
derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), consisted of conversion feature derivatives
at March 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 March 31, 2022 and 2021:
SUMMARY OF CHANGES IN FAIR VALUE OF DERIVATIVE LIABILITIES
| |
| 1 | | |
| 2 | |
| |
March
31, 2022 Conversion Feature | | |
March
31, 2021 Conversion Feature | |
Balance at January 1, 2021 and 2020 | |
$ | 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 | |
| 190,841 | | |
| 536,345 | |
| |
| | | |
| | |
Balance at March 31, 2021 and 2020 | |
$ | 531,131 | | |
$ | 1,168,784 | |
As
of March 31, 2022 and 2021, 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 March 31, 2022 and 2021:
SUMMARY OF ESTIMATE FAIR VALUE OF DERIVATIVE LIABILITIES
| |
March
31, 2022 Key Assumptions for fair value of conversions | | |
March
31, 2021 Key Assumptions for fair value of conversions | |
Risk free interest | |
| 0.17%
to 0.52 | % | |
| 0.07%
to 0.12 | % |
Market price of share | |
$ | 0.22
to 0.36 | | |
$ | 0.36 | |
Life of instrument in years | |
| 0.81
to 1.1 | | |
| 1.06
– 1.35 | |
Volatility | |
| 94.4
to 148.8 | % | |
| 148.79 | % |
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 periods ended March 31, 2022 and March
31, 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 three months ended March 31, 2022
or 2021, respectively.
Net
Loss Per Share
Basic
net loss per common share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the
period. Diluted net 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. The following
number of shares have been excluded from diluted loss since such inclusion would be anti-dilutive:
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
Three
Months Ended March 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Convertible notes | |
| 68,070,034 | | |
| 35,388,901 | |
Stock options | |
| 16,590,261 | | |
| 3,941,301 | |
Warrants | |
| 80,545,259 | | |
| 20,737,500 | |
Potentially dilutive
securities | |
| 165,205,554 | | |
| 60,067,702 | |
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 three months ended March 31, 2022 and the year ended December 31, 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 three months ended
March 31, 2022 and the year ended December 31, 2021, there were no
impairment losses recognized for intangible assets.
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. For the three months ended March 31, 2022 and year ended December
31, 2021, there were no impairment losses recognized for Goodwill.
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 March 31, 2022 and December 31, 2021, the Company identified EdgePoint to
be the Company’s sole VIE. At March 31, 2022 and December 31, 2021, the Company’s ownership percentage of EdgePoint was 29%
and 29%, respectively. The VIE’s net assets were $0.1 million and $0.1 million at March 31, 2022 and December 31, 2021, respectively.
The Company signed a joint venture
agreement (“JVA”) with Dragon to form a joint venture called GMP Biotechnology, LLC, both affiliates of GMP, on March
31, 2022. The JVA prescribes certain requirements to be completed during the three months ended June 30, 2022 to make the
JV fully functional and operational, including issuance of the shares issuable to the Company and Dragon. The Company will evaluate
the accounting for the JV and once these functional and operational activities are completed, the Company will appropriately record the
transactions.
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, 2021, 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 three months ended March 31, 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.
Prior
Period Reclassifications
Certain
amounts in prior periods may have been reclassified to conform with current period presentation.
NOTE
3 - GOODWILL AND INTANGIBLE ASSETS
2019
Reverse Merger with Oncotelic and PointR
The Company completed the 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, 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 $4,879,999. Further, we added goodwill of $16,182,456 upon the completion of the Merger with
PointR. In general, the goodwill is tested on an annual impairment date of December 31. However, as of March 31, 2022, since both assets
are currently being developed for various cancer and COVID-19 therapies, the Company does not believe the there are any factors or indications
that the goodwill is impaired.
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
The
following table summarizes the balances as of March 31, 2022 and December 31, 2021, of the intangible assets acquired, their useful life,
and annual amortization:
SCHEDULE OF INTANGIBLE ASSETS
| |
March
31,
2022 | | |
Remaining Estimated
Useful Life (Years) | |
Intangible asset – Intellectual
Property | |
$ | 819,191 | | |
| 16.75 | |
Intangible asset –
Capitalization of license cost | |
| 190,989 | | |
| 16.75 | |
| |
| 1,010,180 | | |
| | |
Less Accumulated Amortization | |
| (201,180 | ) | |
| | |
Total | |
$ | 809,000 | | |
| | |
| |
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 three months ended March 31, 2022 and 2022 was $12,841 and $12,841, respectively.
The
future yearly amortization expense over the next five years and thereafter are as follows:
SCHEDULE OF AMORTIZATION OF EXPENSE FOR INTANGIBLE ASSETS
For
the years ended December 31, |
| |
| |
2022 | |
$ | 38,524 | |
2023 | |
| 51,365 | |
2024 | |
| 51,365 | |
2025 | |
| 51,365 | |
2026 | |
| 51,365 | |
Thereafter | |
| 577,857 | |
| |
$ | 821,841 | |
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 balance of IPR&D as of March 31, 2022 and December 31, 2021 was
$1,101,760. The following table summarizes the balances as of March 31, 2022 and December 31, 2021 of the IPR&D assets. The Company
evaluates, on an annual basis, for any impairment and records an impairment if identified. The Company identified no impairment to IPR&D
assets during its evaluation.
NOTE
4 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expense consists of the following amounts:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
|
March 31,
2022 | | |
|
December 31,
2021 | |
| |
March 31,
2022 | | |
December 31,
2021 | |
| |
| | |
| |
Accounts payable | |
$ | 1,946,179 | | |
$ | 1,927,749 | |
Accrued expense | |
| 1,578,923 | | |
| 1,164,974 | |
Accounts
payable and accrued liabilities | |
$ | 3,525,102 | | |
$ | 3,092,723 | |
| |
|
March
31,
2022 | | |
|
December 31, 2021 | |
| |
March
31,
2022 | | |
December
31, 2021 | |
| |
| | |
| |
Accounts
payable – related party | |
$ | 358,074 | | |
$ | 403,423 | |
NOTE
5 – CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT
As
of March 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
| |
March
31, 2022 | |
Convertible
debentures | |
| | |
10% Convertible note payable, due
April 23, 2022 – Bridge Investor | |
$ | 34,459 | |
10% Convertible note payable, due April 23,
2022 – Related Party | |
| 159,571 | |
10% Convertible note payable,
due August 6, 2022 – Bridge Investor | |
| 193,325 | |
| |
| 387,355 | |
Fall
2019 Notes | |
| | |
5% Convertible note payable – Stephen
Boesch | |
| 120,208 | |
5% Convertible note payable – Related
Party | |
| 279,358 | |
5% Convertible note payable – Dr. Sanjay
Jha (Through his family trust) | |
| 278,878 | |
5% Convertible note payable – CEO, CTO*
& CFO– Related Parties | |
| 91,382 | |
5% Convertible note payable
– Bridge Investors | |
| 187,222 | |
| |
| 957,048 | |
| |
| | |
August 2021 Convertible
Notes | |
| | |
5% Convertible note – Autotelic Inc–
Related Party | |
| 257,158 | |
5% Convertible note – Bridge investors | |
| 384,193 | |
5% Convertible note –
CFO – Related Party | |
| 77,147 | |
| |
| 718,498 | |
| |
| | |
JH Darbie PPM Debt | |
| | |
16% Convertible Notes - Non-related parties | |
| 2,312,023 | |
16% Convertible Notes – CEO – Related
Party | |
| 121,650 | |
| |
| 2,433,673 | |
| |
| | |
November/December
2021 & March 2022 Notes | |
| | |
12% Convertible Notes
– Accredited Investors | |
| 386,459 | |
| |
| | |
Debt
for Clinical Trials – GMP | |
| | |
2% Convertible
Notes - GMP | |
| 4,591,973 | |
| |
| | |
Other
Debt | |
| | |
Short term debt – Bridge investors | |
| 245,000 | |
Short term debt from CFO – Related Party | |
| 25,050 | |
Short term debt – Autotelic Inc–
Related Party | |
| 20,000 | |
Accrued Interest on Loans | |
| 4,597 | |
| |
| 294,647 | |
Total of convertible
debentures & notes and other debt | |
$ | 9,769,653 | |
For
information on the special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued
interest, if any, as of December 31, 2022, refer to our Annual Report on Form 10-K for the year ended December 31, 2021.
* |
The
CTO was a related party till July 2021, when he resigned as the CTO due to health reasons. |
The
gross principal balances on the convertible debentures listed above totaled $1,000,000 and included initial debt discounts totaling $800,140,
resulting from the recording of the original issue discount, the related financing costs, the beneficial conversion feature (“BCF”)
for the intrinsic value of the non-bifurcated conversion option and the restricted shares issued contemporaneously with the convertible
notes.
Total
amortization expense related to these debt discounts was $22,918 and $54,572 for the three months ended March 31, 2022, and 2021, respectively.
In addition, during the three months ended March 31, 2022, and 2021, we recorded additional and accelerated amortization of debt discounts,
which was created from the bifurcation of the conversion option related the host hybrid instruments, of $0 and $24,491, respectively,
upon the partial and/or full conversion of debt by TFK to shares of the Company’s common stock. The total unamortized debt discount
at March 31, 2022, and December 31, 2021 was approximately $12,646 and $35,564, respectively.
All
the above notes issued to Peak One, TFK, our CEO, and the bridge investors reached the 180 days during the fiscal year ended December
31, 2020. As such, all the note holders had the ability to convert that debt into equity at the variable conversion price of 65% of the
Company’s lowest traded price after the first 180 days or at the lower of the Fixed Price or 55% of the Company’s traded
stock price under certain circumstances. This gave rise to a derivative liability for the debt instrument of approximately $870,000,
since the conversion option attached to certain notes became convertible into a variable number of shares of our common stock, and correspondingly
debited additional debt discounts of approximately $258,000 and interest expense of approximately $612,000.
As
of March 31, 2022, the Company had a derivative liability of approximately $531,000
and a change in fair value of approximately
$191,000.
Bridge
Financings
TFK
Financing
For
information on the special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued
interest, if any, as of December 31, 2022, refer to our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the
SEC on April 15, 2022.
Notes
with Officer and Bridge Investor
In
April 2019, the Company entered into a Securities Purchase Agreement (the “Bridge SPA”) with our CEO and the Bridge
Investor with a commitment to purchase convertible notes in the aggregate of $400,000.
In
April 2019, the Company entered into a convertible note with our Chief Executive Officer, Vuong Trieu, Ph. D. (the “Trieu Note”).
The Trieu Note has a principal balance of $164,444,
including a 10%
OID of $16,444,
resulting in net proceeds of $148,000,
with a maturity date of April
23, 2022. Upon the occurrence of certain events
of default, the Buyer, amongst other remedies, has the right to charge a penalty in a range of 18% to 40% dependent on the specific default event. Amounts due under the Convertible Note may also be converted
into shares (the “Trieu Conversion Shares”) of the Company’s Common Stock at any time, at the option of the
holder, at a conversion price of $0.10 per share (the “Fixed Price”), at the lower of the Fixed Price or 65% of the
Company’s lowest traded price after the 180th day or at the lower of the Fixed Price or 55% of the Company’s traded
stock price under certain circumstances. The Company has agreed to at all times reserve and keep available out of its authorized Common
Stock a number of shares equal to at least two times the full number of Conversion Shares. The Company may redeem the Convertible Note
at rates of 110% to 140% rates over the principal balance dependent on certain events and redeem the value with accrued interest thereon,
if any.
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 $14,620 and $18,058 for the three months ended March 31, 2022, and 2021.
Total unamortized discount on this note was approximately $4,900 and $19,000 as of March 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. Tranche #1 has a principal balance of $35,556, an OID of $3,556, resulting in net proceeds of $32,000, with a maturity
date of April 23, 2022. Upon the occurrence of certain events of default, the Buyer, among other remedies, has the right to charge a
penalty in a range of 18% to 40% dependent on the specific default event. Amounts due under Tranche #1 may also be converted into shares
(the “Bridge SPA Conversion Shares”) of the Company’s Common Stock at any time, at (i) a conversion price, during
the first 180 days, of $0.10 per share (the “Fixed Price”), and then (2) at the lower of the Fixed Price or 65% of
the Company’s lowest traded price after the first 180 days or at the lower of the Fixed Price or 55% of the Company’s traded
stock price under certain circumstances. The Company may redeem the Convertible Note at rates of 110% to 140% rates over the principal
balance dependent on certain events and redeem the value with accrued interest thereon, if any.
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 $3,300 and $4,100 for the three months March 31, 2022, and 2021, respectively. Total unamortized discount
on this note was approximately $1,100 and $4,400 as of March 31, 2022, and December 31, 2021.
On
August 6, 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #2 (“Tranche #2”) with
the Bridge Investor. Tranche #2 has a principal balance of $200,000, an OID of $20,000 and debt issuance costs of $5,000, resulting in
net proceeds of $175,000, with a maturity date of August 6, 2022. Upon the occurrence of certain events of default, the Buyer, among
other remedies, has the right to charge a penalty in a range of 18% to 40% dependent on the specific default event. Amounts due under
Tranche #1 may also be converted into Bridge Conversion Shares of the Company’s Common Stock at any time, at the option of the
holder, at a conversion price equal to the Fixed Price, at the lower of the Fixed Price or 65% of the Company’s lowest traded price
after the 180th day or at the lower of the Fixed Price or 55% of the Company’s traded stock price under certain circumstances.
The Company may redeem the Convertible Note at rates of 110% to 140% rates over the principal balance dependent on certain events and
redeem the value with accrued interest thereon, if any.
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 $5,000 and $4,900 for the three months ended March 31, 2022, and March 31, 2021, respectively. Total unamortized
discount on this note was $6,700 and $12,000 as of March 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 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 debt. The Company also issued the
Fall 2019 Notes of $168,000 to two accredited investors.
The
Company repaid $0 and $50,000 of principal in the three months ended March 31, 2022, and 2021, respectively. The total unamortized principal
amount of the Fall 2019 Notes was $850,000 as of March 31, 2022, and December 31, 2021, respectively.
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 the default in the maturity of the Fall 2019 Notes and as such there is no event of
default. 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 three months ended March 31, 2022, and 2021.Total
unamortized discount on this note was $0 as of March 31, 2022, and December 31, 2021.
Further,
the Company recorded interest expense of $10,625 and approximately $11,460 on these Fall 2019 Notes for the three months ended March
31, 2022, and 2021, respectively. The total amount outstanding under the Fall 2019 Notes, net of discounts and including accrued interest
thereon, as of March 31, 2022, and December 31, 2021, was $957,048 and $946,424, respectively.
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 June 30, 2022. 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 March 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 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. As of March 31, 2022, GMP was invoiced by the clinical research organization for $0.5
million. 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.
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.
The
GMP Note 2, the October 2021 Note and the January 2022 Note carries an interest rate of 2%
per annum and matures 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). The GMP Note 2, the October 2021 Note and the January
2022 Note contains a voluntary conversion mechanism whereby GMP may convert the outstanding principal and accrued interest under the
terms of the GMP Note 2, the October 2021 Note and the January 2022 Note 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 Note 2, the October 2021 Note and the January 2022 Note 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 Note 2, the October 2021 Note and the January 2022 Note, plus accrued but unpaid interest, will become immediately due and
payable in cash. The October Purchase Agreement and the January Purchase Agreement requires the Company to use of the proceeds received
under the October 2021 Note and January 2022 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 all the GMP notes, inclusive of accrued interest, was $4,569,781
and $4,069,781
as of March 31, 2022, and December 31,
2021, respectively.
Geneva
Roth Remark Notes
For
information on the special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued
interest, if any, as of December 31, 2022, refer to our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the
SEC on April 15, 2022.
Paycheck
Protection Program
For
information on the special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued
interest, if any, as of December 31, 2022, refer to our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the
SEC on April 15, 2022.
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 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.
As
of March 31, 2022, and December 31, 2021, the August 2021 convertible notes, net of debt discount, consist of the following amounts:
SCHEDULE
OF CONVERTIBLE NOTES, NET OF DISCOUNT
| |
|
March 31, 2022 | | |
|
December 31, 2021 | |
| |
March 31, 2022 | | |
December 31, 2021 | |
| |
| | |
| |
Autotelic Related party convertible note, 5% coupon August 2022 | |
$ | 257,158 | | |
$ | 256,634 | |
CFO Related party convertible note, 5% coupon August 2022 | |
| 77,147 | | |
| 76,531 | |
Accredited investors convertible note, 5% coupon August 2022 | |
| 384,193 | | |
| 381,123 | |
Total | |
$ | 718,498 | | |
$ | 714,288 | |
During
the three months ended March 31, 2022, and 2021, the Company recognized approximately $5,700 and $0 of interest, respectively. At March
31, 2022, and December 31, 2021, accrued interests on these convertible notes totaled approximately $20,000 and $14,260, respectively.
November
– December 2021 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 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 shares at a strike price of
$0.13 up to five years after issuance. The Placement agent was also granted a total amount of 961,540 as part of a finder’s fee
agreement.
In January 2022,
three of the five investors made a cashless exercise for their warrants. In this connection, the Company issued approximately 3 million
shares of the Common Stock in exchange of approximately 5.8 million warrants.
As
of March 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
| |
|
March 31,
2022 | | |
|
December 31,
2021 | |
| |
March 31,
2022 | | |
December 31,
2021 | |
| |
| | |
| |
Mast Hill Convertible note, 12% coupon November 21 | |
$ | 250,000 | | |
$ | 250,000 | |
Talos Victory Convertible note, 12% coupon November 2021 | |
| 250,000 | | |
| 250,000 | |
First Fire Global Opportunities LLC Convertible note, 12% coupon, December 2021 | |
| 250,000 | | |
| 250,000 | |
Blue Lake Partners LLC Convertible note, 12% coupon, December 2021 | |
| 250,000 | | |
| 250,000 | |
Fourth Man LLC Convertible note, 12% coupon December 2021 | |
| 250,000 | | |
| 250,000 | |
Convertible notes, gross | |
$ | 1,250,000 | | |
$ | 1,250,000 | |
Less Debt discount recorded | |
| (1,250,000 | ) | |
| (1,250,000 | ) |
Amortization debt discount | |
| 386,459 | | |
| 76,994 | |
Convertible notes, net | |
$ | 386,459 | | |
$ | 76,994 | |
The
Company recognized approximately $48,000 and $0 of accrued interest during the three months ended March 31, 2022, and 2021, respectively.
The Company recognized approximately $309,500 and $0 of interest expense attributable to the amortization of the debt discount from the
original debt discount, deferred financing costs, fair value allocated to the warrants and the beneficial conversion feature during the
three months ended March 31, 2022, and 2021, respectively.
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. The Company recognized amortization expense related
to the debt discount and debt issuance costs of approximately $0.3 million for the three months ended March 31, 2022, which is included
in interest expense in the consolidated statements of operations.
Other
short-term advances
As
of March 31, 2022 compared to December 31, 2021, other short-term advances consist of the following amounts obtained from various employees
and related parties:
SCHEDULE OF SHORT-TERM LOANS
Other Advances | |
|
March 31,
2022 | | |
|
December 31,
2021 | |
Other Advances | |
March 31,
2022 | | |
December 31,
2021 | |
Short term advance from CEO – Related Party | |
$ | - | | |
$ | 20,000 | |
Short term advances – bridge investors | |
| 245,000 | | |
| 265,000 | |
Short term advances from CFO – Related Party | |
| 25,050 | | |
| 45,050 | |
Short term advance – Autotelic Inc. – Related Party | |
| 20,000 | | |
| 20,000 | |
Accrued Interest on advances | |
| 5,003 | | |
| 9,212 | |
Total | |
$ | 295,053 | | |
$ | 359,262 | |
During
the year ended December 31, 2020, the Company’s CEO provided additional funding of $70,000
to the Company, of which $50,000
was repaid before December 31, 2020. Further,
during the three months ended March 31, 2022, $20,000
repaid
to the Company’s CEO. As such, $0
and $20,000
was outstanding at March 31, 2022 and December
31, 2021, respectively.
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, and as such, $20,000 was outstanding and payable to Autotelic
at March 31, 2022 a December 31, 2021, respectively.
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 during the three months ended March 31, 2022. As such approximately $25,000 and
$45,000 was outstanding at March 31, 2022 and December 31, 2021, respectively.
NOTE
6 – JOINT VENTURE WITH GMP AFFILIATES
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 $11,320,237.25,
for an aggregate of $22,640,474.50.
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 $27,671,691, 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 is currently evaluating the estimated
impact the accounting for the JV will have on its financial statements upon completion of the formation.
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
March 31, 2022 and December 31, 2021 funds received under the JH Darbie Financing, net of debt discount, consist of the following amounts:
SCHEDULE OF FUNDS RECEIVED UNDER THE SUBSCRIPTION AGREEMENT
| |
|
March 31,
2022 | | |
|
December 31,
2021 | |
| |
March 31,
2022 | | |
December 31,
2021 | |
Convertible promissory notes | |
| | | |
| | |
Subscription agreements - accredited investors | |
$ | 2,312,023 | | |
$ | 1,520,720 | |
Subscription agreements – related party | |
| 121,650 | | |
| 85,664 | |
Total convertible promissory notes | |
$ | 2,433,673 | | |
$ | 1,606,384 | |
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.
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.
The
terms of convertible notes are summarized as follows:
|
■ |
Term:
Through March 31, 2022. |
|
■ |
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 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 non-controlling interests of approximately
$1.8
million in Edgepoint between July 2020
and March 2021. 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 three months ended March 31, 2021, under the private placement memorandum with JH
Darbie, the estimated grant date fair value of approximately $0.20 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 | % |
As
of the multiple closings of the Company through December 31, 2020, under the private placement memorandum with JH Darbie, the estimated
grant date fair value of approximately $0.20 per share associated with the warrants to purchase up to 3,465,000 shares of common stock
issued in this offering, or a total of approximately $0.4 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.
The
Company recorded an initial debt discount of approximately $0.7 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.
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 March 31, 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 as of March 31, 2022:
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 $30,775
and $373,949
for the three months ended March 31, 2022
and March 31, 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 entered into a Master Service Agreement (the “MSA”) with Autotelic Inc., a related party that
is partly-owned by the Company’s CEO Vuong Trieu, Ph.D. 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 $66,000 for the three months ended March 31, 2022 as compared to approximately $77,000 for the
same period of 2021.
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. In exchange for the rights granted to Oncotelic,
Autotelic would be entitled to earn the following milestone payments (collectively, the “Milestone Payments”).
SCHEDULE
OF RELATED PARTY LICENSE AGREEMENT
Milestones |
|
Transaction
Value |
|
Actions |
|
|
|
|
|
Tranche
1 |
|
$ |
1,000,000 |
|
Upon
the earlier to occur of: (i) the Company receiving an investment of at least $20 million, and (ii) the uplisting of the Company’s
common stock to any NASDAQ market or the New York Stock Exchange. |
|
|
|
|
|
|
Tranche
2 |
|
$ |
2,000,000 |
|
Upon
approval by the United States Food and Drug Administration of the Company’s 505(b)2 application for purposes of treating PD. |
|
|
|
|
|
|
Tranche
3 |
|
$ |
2,000,000 |
|
Upon
first patient in (“FPI”) for any clinical trial supporting the use of AL-101 for the treatment of PD or ED. |
|
|
|
|
|
|
Tranche
4 |
|
$ |
2,500,000 |
|
Upon
FPI for phase 2 clinical trials supporting the use of AL-101 to treat FSD. |
|
|
|
|
|
|
Tranche
5 |
|
$ |
2,500,000 |
|
Upon
FPI for phase 3 clinical trials supporting the use of AL-101 to treat FSD |
|
|
|
|
|
|
Tranche
6 |
|
$ |
10,000,000 |
|
Upon
Marketing approval for the use of AL-101 to treat PD. |
|
|
|
|
|
|
Tranche
7 |
|
$ |
10,000,000 |
|
Upon
Marketing approval for the use of AL-101 to treat ED. |
|
|
|
|
|
|
Tranche
8 |
|
$ |
10,000,000 |
|
Upon
Marketing approval for the use of AL-101 to treat FSD |
|
|
|
|
|
|
Tranche
9 |
|
$ |
10,000,000 |
|
Upon
the earlier of: (i) the Company entering into a licensing agreement with a third party for the use of AL-101 for the treatment of
PD, ED or FSD with an aggregate licensing value of at least $50 million; and (ii) the Company’s gross revenue derived from
sales of AL-101 for the treatment of PD, ED or FSD reaches at least $50.0 million. |
In
addition to the Milestone Payments, Autotelic will be entitled to 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.
Note
Payable and Short Term Loan – Related Parties
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. 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. Further, the Company repaid $20,000 to Dr. Trieu for the balance
of his short term loan of $20,000. 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 2021, Autotelic Inc provided a short term loans of $270,000, of which $250,000 was converted into the August
2021 loan and the balance of $20,000 continues to be a short term loan. During the three months ended March 31, 2021, Autotelic Inc,
provided a short-term loan of $120,000 to the Company. Such loan was repaid in April 2021. No loans or repayments were made to Autotelic
Inc. during the same period in 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”). 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 formation
of a new business unit to develop AI and Blockchain Driven Vision Systems (“EdgePoint AI”), for which Mr. King is 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 2017 Equity Incentive Plan, 148,837 restricted shares of the Company’s common stock, par value
$.01 per share (“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 Effective Date. The Artius Agreement
will automatically renew one year from the Effective Date, unless the Parties agree to terminate the Artius Agreement at that time.
No
expense was recorded during the three months ended March 31, 2022 or March 31, 2021 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.
Pursuant
to the terms of the Maida Agreement, the Company granted to Dr. Maida 400,000 restricted shares of the Company’s Common Stock to
vest on May 5, 2021. The Company will also pay Dr. Maida $15,000 per month for a minimum of 20 hours per week, in in addition to reimbursement
of reasonable and necessary expenses incurred by Dr. Maida in connection with his services to the Company.
Either
the Company or Dr. Maida may terminate the Maida Agreement, for any reason, upon 30 days advance written notice.
The
Company recorded an expense of $75,000 during the three months ended March 31, 2022 as compared to $45,000 during the three months ended
March 31, 2021 related to this Agreement.
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”). Under the terms of the EPL, the Company
issued 250,000 shares of Common Stock to Peak One. Further, under the terms of the EPL, Peak One agreed to purchase from the Company
up to $10,000,000 of the Company’s Common Stock upon effectiveness of a registration statement on Form S-1 filed with the U.S.
Securities and Exchange Commission and subject to certain limitations and conditions set forth in the Equity Purchase Agreement. The
Registration Rights Agreement provided that the Company would (i) file the Registration Statement with the SEC by July 2, 2021; and (ii)
use its best efforts to have the Registration Statement declared effective by the Commission at the earliest possible date (in any event,
within 90 days after the execution date of the definitive agreements). The Company filed a Registration Statement on Form S-1 with the
Commission on May 24, 2021, and the Form S-1 was declared effective on June 2, 2021.
Following
effectiveness of the Registration Statement, and subject to certain limitations and conditions set forth in the Equity Purchase Agreement,
the Company shall have the discretion to deliver put notices to the Investor and the Investor will be obligated to purchase shares of
the Company’s Common Stock based on the investment amount specified in each put notice. The minimum amount that the Company shall
be entitled to put to the Investor in each put notice is $20,000 and the maximum amount is up to the lesser of $1.0 million or two hundred
fifty percent (250%) of the average daily trading volume of the Company’s Common Stock defined as the average trading volume of
the Company’s Common Stock in the ten (10) days preceding the date on the put notice multiplied by the lowest closing bid price
in the ten (10) immediately preceding the date of the put notice. Pursuant to the Equity Purchase Agreement, the Investor will not be
permitted to purchase, and the Company may not put shares of the Company’s Common Stock to the Investor that would result in the
Investor’s beneficial ownership of the Company’s outstanding Common Stock exceeding 4.99%. The price of each put share shall
be equal to ninety one percent (91%) of the market price, which is defined as the lesser of (i) closing bid price of the Common stock
on the trading date immediately preceding the respective put date, or (ii) the lowest closing bid price of the Common Stock during the
seven (7) trading days immediately following the clearing date associated with the applicable put notice.
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.
.
In
connection with the EPL, the Company issued 250,000 shares of Common Stock to Peak One and recorded a fair value in lieu of service of
approximately $70,000.
During
the three months ended March 31, 2022, the Company sold a total of 300,000
shares of Common Stock at price of $0.21
for total gross proceeds of approximately $65,500
and approximately $51,800, net of issuance costs.
No similar sales were recorded during the three months ended March 31, 2021.
NOTE
10 - STOCKHOLDERS’ EQUITY
The
following transactions affected the Company’s Stockholders’ Equity:
Issuance
of Common Stock during the three months ended March 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.
Issuance
of Common Stock during the three months ended March 31, 2021
In
January 2021, the Company issued 657,200 shares of its common stock to TFK in connection with the part conversion of their convertible
notes payable.
In
March 2021, the Company converted 278,188 shares of our Series A Preferred Stock to 278,187,847 shares of its common stock.
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.
As
of March 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, in aggregate, 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 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 for the three months ended March 31, 2022 is summarized as follows:
SCHEDULE
OF COMPENSATION BASED STOCK OPTION ACTIVITY
| |
| | |
Weighted | |
For the three months ended March 31, 2022 | |
| | |
Average | |
| |
Shares | | |
Exercise Price | |
Outstanding at January 1, 2022 | |
| 16,592,620 | | |
$ | 0.30 | |
Expired or cancelled | |
| (2,359 | ) | |
| 11.88 | |
Outstanding at March 31, 2022 | |
| 16,590,261 | | |
$ | 0.30 | |
Information
on compensation-based stock option activity for qualified and unqualified stock options for the year ended December 31, 2021 can be found
in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on April 15, 2022.
The
following table summarizes information about options to purchase shares of the Company’s Common Stock outstanding and exercisable
at March 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 | |
| | |
| | |
| | |
| | |
| |
$ | 0.14 | | |
| 7,150,000 | | |
| 9.43 | | |
$ | 0.14 | | |
| 3,707,500 | |
| 0.16 | | |
| 5,502,761 | | |
| 9.27 | | |
| 0.16 | | |
| 5,502,761 | |
| 0.22 | | |
| 1,750,000 | | |
| 4.09 | | |
| 0.22 | | |
| 1,750,000 | |
| 0.38 | | |
| 900,000 | | |
| 3.41 | | |
| 0.38 | | |
| 900,000 | |
| 0.73 | | |
| 762,500 | | |
| 3.04 | | |
| 0.73 | | |
| 762,500 | |
| 1.37 | | |
| 150,000 | | |
| 1.25 | | |
| 1.37 | | |
| 150,000 | |
| 1.43 | | |
| 300,000 | | |
| 3.16 | | |
| 1.43 | | |
| 300,000 | |
| 15.00 | | |
| 75,000 | | |
| 3.16 | | |
| 15.00 | | |
| 75,000 | |
| | | |
| 16,590,261 | | |
| 7.97 | | |
$ | 0.30 | | |
| 13,147,761 | |
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 $1.0
million and was based on the Company’s
closing stock price of $0.23
as of March 31, 2022, which would have been received
by the option holders had all option holders exercised their options as of that date. Information on the aggregate intrinsic value
for the year ended December 31, 2021 can be found in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the
SEC on April 15, 2022.
The
Company amortized approximately $297,000 of stock compensation expense during the three months ended March 31, 2022 on the grants of
certain milestone driven options that were granted during the year ended December 31, 2021. No similar expense was recorded during the
same period of 2021.
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. Details of the agreements and the incentive compensation is described in detail
in Note 11 – Commitments & Contingencies under “Employment Agreements”. The incentive stock options or the restricted
stock awards granted to the Company’s executive officers have not been granted as of the date of this filing.
Warrants
Pursuant
to the Merger, the Company’s Common Stock and corresponding outstanding warrants survived. The below information represents the
Company’s associated warrant activity.
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 approximately 33
million
Oncotelic Warrants at a price of $0.15
per
share of Company’s Common Stock. 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 as of March 31, 2022:
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
issuance of warrants to purchase shares of the Company’s Common Stock, including those attributed to debt issuances, as of March
31, 2022 are summarized as follows:
SCHEDULE
OF WARRANTS ACTIVITY
For the three months ended March 31, 2022 | |
| | |
Average | |
| |
Shares | | |
Exercise Price | |
Outstanding at January 1, 2022 | |
| 53,314,424 | | |
$ | 0.20 | |
Issued during the three months ended March 31, 2022 | |
| 33,000,066 | | |
| 0.15-0.20 | |
Exercised / cancelled during the three months ended March 31, 2022 | |
| (5,769,231 | ) | |
| 0.13 | |
Outstanding at December 31, 2021 | |
| 80,545,259 | | |
$ | 0.18 | |
Information on
warrants for the year ended December 31, 2022 can be found in our Annual Report on Form 10-K for the year ended December 31, 2021 filed
with the SEC on April 15, 2022.
The
following table summarizes information about warrants outstanding and exercisable at March 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 | | |
| 1.00 | | |
$ | 0.20 | | |
| 4,237,500 | |
| 0.13 | | |
| 4,807,693 | | |
| 5.00 | | |
| 0.13 | | |
| 4,807,693 | |
| 0.15 | | |
| 33,000,066 | | |
| 2.00 | | |
| 0.15 | | |
| 33,000,066 | |
| | | |
| 80,545,259 | | |
| 2.15 | | |
$ | 0.18 | | |
| 80,545,259 | |
In January 2022, three of
the five November/December accredited investors made a cashless exercise for their warrants. In this connection, the Company issued 3,041,958 shares of Common Stock in exchange of approximately 5,769,231
million warrants.
NOTE
12 – INCOME TAXES
The Company had gross
deferred tax assets, which primarily relate to net operating loss carryforwards. As
of December 31, 2021, the Company had gross federal and state net operating loss carryforwards of approximately $236.1 million
and $76.3 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 less likely
than not. Information on our deferred tax assets and liabilities can be found in our Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC on April 15, 2022.
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. as a result 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 of $17,831,427 represented the consideration transferred from the Company in the PointR Merger 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 can
increase to $15 million of contingent consideration, upon achievement of certain milestones. The $2,625,000 of contingent consideration
of shares issuable to PointR shareholders 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 and as of March 31, 2022 or December 31, 2021, respectively.
NOTE
14 – SUBSEQUENT EVENTS
March
2022 – Fourth Man Financing
In
March 2022, the Company entered into a securities purchase agreement with an accredited investor, whereby the Company issued a promissory
note in the aggregate principal amount of $250,000
convertible into shares of common stock of the
Company. The convertible note carries a twelve (12%)
percent coupon and a default coupon of 16%
and mature one year from issuance. 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 also 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. As the funds
for the Note were received in April 2022, the Company will record the transaction during the six months ended June 30, 2022.
Peak
One Equity Purchase Agreement
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 6 May, 2022. The Company filed the prospectus in this connection on May 11, 2022.
Appointments
of Chief Medical Officer and Chief Regulatory Officer
The
Company appointed Dr. Fatih Uckun and Dr. Seymour Fein as its Consulting Chief Medical Officer and Chief Regulatory Officer in May 2022.
For more information on the appointments of Drs. Uckun and Fein, refer to our Current Report on form 8-K filed with the SEC on
May 6, 2022.
Cashless exercise of warrants
On May 13, 2022, the Company received a request
from one of the November/December 2021 note holders for a cashless exercise of their warrants. The Company will issue 1,403,326 shares
of Common Stock to the debt holder in lieu of 1,923,077 warrants.