UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2024
or
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________________
to ________________
Commission File Number: 001-39336
Aditxt, Inc.
(Exact name of registrant as specified in its charter)
Delaware | | 82-3204328 |
(State or other jurisdiction of
incorporation or organization) | | (I.R.S. Employer
Identification No.) |
737 N. Fifth Street, Suite 200 Richmond, VA | | 23219 |
(Address of principal executive offices) | | (Zip Code) |
(650) 870-1200
(Registrant’s telephone number, including
area code)
Not applicable
(Former name, former address and former fiscal
year, if changed since last report)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | | ADTX | | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☒ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 17, 2024, the registrant had 1,665,265
and 1,665,214 shares of common stock, $0.001 par value per share, issued and outstanding, respectively.
Table of Contents
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
AND INDUSTRY DATA
This Quarterly Report on Form
10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of
1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,”
“intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements
are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results
or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed
in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed
in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties,
including the risks and uncertainties inherent in our statements regarding:
|
● |
we have generated no significant revenue from commercial sales to date and our future profitability is uncertain; |
|
● |
if we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment; |
|
● |
our financial situation creates doubt whether we will continue as a going concern; |
|
● |
we may need to raise additional funding, which may not be available on acceptable terms, or at all; |
|
● |
even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.; |
|
● |
the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates, if any; |
|
● |
we may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities; |
|
● |
if our future pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product candidates on a timely basis or at all; |
|
● |
even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their sales, if any, may be limited; |
|
● |
adverse events involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results; |
|
● |
certain technologies are subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including in the event we do not achieve certain payments and milestone deadlines. Without these licenses, we may not be able to continue to develop our product candidates; |
|
● |
if we were to lose our CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business. If we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens from those states; |
|
● |
our results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties; |
|
● |
we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do; |
|
● |
our technologies and products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result; |
|
● |
customers may not adopt our products quickly, or at all; |
|
● |
the failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively; |
|
● |
some of our intellectual property may be subject to “march-in” rights by the U.S. federal government; |
|
● |
we do not expect to pay dividends in the foreseeable future; |
|
● |
we have issued a significant number of restricted stock awards, restricted stock units, options and warrants and may continue to do so in the future. The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock; |
|
● |
future sales or issuances of substantial amounts of our common stock, including, potentially as a result of future acquisitions or strategic transactions, including the transaction with Cellvera Global, could result in significant dilution; |
|
● |
while we have entered into a Share Exchange Agreement with Cellvera Global, we cannot assure you that the transaction contemplated by the Share Exchange Agreement will be consummated or, that if such transaction is consummated, that it will be accretive to stockholder value; |
|
● |
we may engage in future acquisitions or strategic transactions, including the transaction with Cellvera Global, which may require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management; |
|
● |
we received the determination from Nasdaq that we regained compliance with the Nasdaq continued listing requirements, however, we remain subject to a panel monitor of our ongoing compliance until December 29, 2024 and if we fail to comply with such requirements during the panel monitor, it could result in the delisting of our securities by Nasdaq; and |
|
● |
exclusive forum provisions in our amended and restated certificate of incorporation and amended and restated bylaws. |
All of our forward-looking
statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such
forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An
occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly
Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with
or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business,
prospects, financial condition, and results of operations. Except as required by law, we do not undertake or plan to update or revise
any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances
affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes,
or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following
this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form
10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.
This Quarterly Report on Form
10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research,
consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles, and surveys.
Industry surveys, publications, consultant surveys, and forecasts generally state that the information contained therein has been obtained
from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such
studies and publications are reliable, we have not independently verified market and industry data from third-party sources.
References to Aditxt, Inc.
Throughout this Quarterly
Report on Form 10-Q, the “Company,” “Aditxt,” “we,” “us,” and “our” refers
to Aditxt, Inc. and “our board of directors” refers to the board of directors of Aditxt, Inc.
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
ADITXT, INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | |
| |
CURRENT ASSETS: | |
| | |
| |
Cash | |
$ | 88,671 | | |
$ | 97,102 | |
Accounts receivable, net | |
| 427,044 | | |
| 408,326 | |
Inventory | |
| 622,768 | | |
| 745,502 | |
Prepaid expenses | |
| 456,884 | | |
| 217,390 | |
Subscription receivable | |
| - | | |
| 5,444,628 | |
TOTAL CURRENT ASSETS | |
| 1,595,367 | | |
| 6,912,948 | |
| |
| | | |
| | |
Fixed assets, net | |
| 2,021,760 | | |
| 1,898,243 | |
Intangible assets, net | |
| 8,611 | | |
| 9,444 | |
Deposits | |
| 132,496 | | |
| 106,410 | |
Right of use asset - long term | |
| 1,940,076 | | |
| 2,200,299 | |
Investment in Evofem | |
| 22,277,211 | | |
| 22,277,211 | |
Deposit on acquisition | |
| - | | |
| 11,173,772 | |
TOTAL ASSETS | |
$ | 27,975,521 | | |
$ | 44,578,327 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 9,360,680 | | |
$ | 8,554,959 | |
Notes payable - related party | |
| 467,000 | | |
| 375,000 | |
Notes payable, net of discount | |
| 5,678,182 | | |
| 15,653,477 | |
Financing on fixed assets | |
| 147,823 | | |
| 147,823 | |
Deferred rent | |
| 147,350 | | |
| 158,612 | |
Lease liability - current | |
| 900,979 | | |
| 999,943 | |
Advance on private placement | |
| 600,000 | | |
| - | |
TOTAL CURRENT LIABILITIES | |
| 17,302,014 | | |
| 25,889,814 | |
| |
| | | |
| | |
Settlement liability | |
| - | | |
| 1,600,000 | |
Lease liability - long term | |
| 891,747 | | |
| 1,041,744 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 18,193,761 | | |
| 28,531,558 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Preferred stock, $0.001 par value, 3,000,000 shares authorized, zero shares issued and outstanding, respectively | |
| - | | |
| - | |
Series A-1 Convertible Preferred stock, $0.001 par value, 22,280 shares authorized, 22,280 and 22,280 shares issued and outstanding, respectively | |
| 22 | | |
| 22 | |
Series B Preferred stock, $0.001 par value, 1 share authorized, zero and zero shares issued and outstanding, respectively | |
| - | | |
| - | |
Series B-1 Convertible Preferred stock, $0.001 par value, 6,000 shares authorized, 6,000 and zero shares issued and outstanding, respectively | |
| 6 | | |
| - | |
Series B-2 Convertible Preferred stock, $0.001 par value, 2,625 shares authorized, 2,625 and 2,625 shares issued and outstanding, respectively | |
| 3 | | |
| 3 | |
Series C Preferred stock, $0.001 par value, 1 share authorized, zero and zero shares issued and outstanding, respectively | |
| - | | |
| - | |
Common stock, $0.001 par value, 100,000,000 shares authorized, 1,665,265 and 1,318,968 shares issued and 1,665,214 and 1,318,918 shares outstanding, respectively | |
| 1,665 | | |
| 1,319 | |
Treasury stock, 51 and 51 shares, respectively | |
| (201,605 | ) | |
| (201,605 | ) |
Additional paid-in capital | |
| 152,601,043 | | |
| 143,997,710 | |
Accumulated deficit | |
| (142,470,799 | ) | |
| (127,741,072 | ) |
TOTAL ADITXT, INC. STOCKHOLDERS’ EQUITY | |
| 9,930,335 | | |
| 16,056,377 | |
| |
| | | |
| | |
NON-CONTROLLING INTEREST | |
| (148,575 | ) | |
| (9,608 | ) |
| |
| | | |
| | |
TOTAL STOCKHOLDERS’ EQUITY | |
| 9,781,760 | | |
| 16,046,769 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 27,975,521 | | |
$ | 44,578,327 | |
See accompanying notes to the consolidated financial
statements.
ADITXT, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
| |
Three Months Ended | | |
Three Months Ended | |
| |
March 31, 2024 | | |
March 31, 2023 | |
REVENUE | |
| | |
| |
Sales | |
$ | 79,680 | | |
$ | 218,415 | |
Cost of goods sold | |
| 65,799 | | |
| 178,309 | |
Gross profit (loss) | |
| 13,881 | | |
| 40,106 | |
| |
| | | |
| | |
OPERATING EXPENSES | |
| | | |
| | |
General and administrative expenses, includes $24,573, and $274,315 in stock-based compensation, respectively | |
| 3,363,748 | | |
| 4,368,843 | |
Research and development, includes $6,712,663, and $62,633 in stock-based compensation, respectively | |
| 8,145,266 | | |
| 1,387,541 | |
Sales and marketing $0, and $2,503 in stock-based compensation, respectively | |
| 40,513 | | |
| 65,617 | |
Total operating expenses | |
| 11,549,527 | | |
| 5,822,001 | |
| |
| | | |
| | |
NET LOSS FROM OPERATIONS | |
| (11,535,646 | ) | |
| (5,781,895 | ) |
| |
| | | |
| | |
OTHER EXPENSE | |
| | | |
| | |
Interest expense | |
| (2,489,045 | ) | |
| (198,492 | ) |
Interest income | |
| 377 | | |
| 9,074 | |
Amortization of debt discount | |
| (635,710 | ) | |
| (13,393 | ) |
Loss on note exchange agreement | |
| (208,670 | ) | |
| - | |
Total other expense | |
| (3,333,048 | ) | |
| (202,811 | ) |
| |
| | | |
| | |
Net loss before income taxes | |
| (14,868,694 | ) | |
| (5,984,706 | ) |
Income tax provision | |
| - | | |
| - | |
| |
| | | |
| | |
NET LOSS | |
$ | (14,868,694 | ) | |
$ | (5,984,706 | ) |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTEREST | |
| (138,967 | ) | |
| - | |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO ADITXT, INC. & SUBSIDIARIES | |
$ | (14,729,727 | ) | |
$ | (5,984,706 | ) |
| |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (9.14 | ) | |
$ | (52.46 | ) |
| |
| | | |
| | |
Weighted average number of shares outstanding during the period - basic and diluted | |
| 1,610,872 | | |
| 114,072 | |
See accompanying notes to the consolidated financial
statements.
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
THREE MONTHS ENDED MARCH 31, 2024 AND 2023
(unaudited)
| |
Preferred
A-1 Shares Outstanding | | |
Preferred
A-1
Shares Par | | |
Preferred
B-1
Shares Outstanding | | |
Preferred
B-1
Shares Par | | |
Preferred
B-2
Shares Outstanding | | |
Preferred
B-2
Shares Par | | |
Common Shares
Outstanding | | |
Common Shares
Par | | |
Treasury Stock | | |
Additional
Paid-in Capital | | |
Accumulated
Deficit | | |
Non-
Controlling
Interest | | |
Total Stockholders’
Equity | |
Balance December 31, 2023 | |
| 22,280 | | |
$ | 22 | | |
| - | | |
$ | - | | |
| 2,625 | | |
$ | 3 | | |
| 1,318,918 | | |
$ | 1,319 | | |
$ | (201,605 | ) | |
$ | 143,997,710 | | |
$ | (127,741,072 | ) | |
$ | (9,608 | ) | |
$ | 16,046,769 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock option compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 24,573 | | |
| - | | |
| - | | |
| 24,573 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
MDNA asset purchase | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 50,000 | | |
| 50 | | |
| - | | |
| 1,008,619 | | |
| - | | |
| - | | |
| 1,008,669 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Brain asset purchase | |
| - | | |
| - | | |
| 6,000 | | |
| 6 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,970,437 | | |
| - | | |
| - | | |
| 5,970,443 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of shares for settlement | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 296,296 | | |
| 296 | | |
| - | | |
| 1,599,704 | | |
| - | | |
| - | | |
| 1,600,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (14,729,727 | ) | |
| (138,967 | ) | |
| (14,868,694 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance March 31, 2024 | |
| 22,280 | | |
$ | 22 | | |
| 6,000 | | |
$ | 6 | | |
| 2,625 | | |
$ | 3 | | |
| 1,665,214 | | |
$ | 1,665 | | |
$ | (201,605 | ) | |
$ | 152,601,043 | | |
$ | (142,470,799 | ) | |
$ | (148,575 | ) | |
$ | 9,781,760 | |
See accompanying notes to the consolidated
financial statements.
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
THREE MONTHS ENDED MARCH 31, 2024 AND 2023
(unaudited)
| |
Preferred
A-1 Shares Outstanding | | |
Preferred
A-1 Shares Par | | |
Preferred
B-1 Shares Outstanding | | |
Preferred
B-1 Shares Par | | |
Preferred
B-2 Shares Outstanding | | |
Preferred
B-2 Shares Par | | |
Common
Shares Outstanding | | |
Common
Shares Par | | |
Treasury
Stock | | |
Additional
Paid-in Capital | | |
Accumulated
Deficit | | |
Non-
Controlling
Interest | | |
Total
Stockholders’ Equity | |
Balance December 31, 2022 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 107,647 | | |
$ | 108 | | |
$ | (201,605 | ) | |
$ | 100,448,166 | | |
$ | (95,040,362 | ) | |
$ | - | | |
$ | 5,206,307 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock option compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 59,964 | | |
| - | | |
| - | | |
| 59,964 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Restricted stock unit compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 111,187 | | |
| - | | |
| - | | |
| 111,187 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of restricted stock
units for compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 44 | | |
| 1 | | |
| - | | |
| (1 | ) | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Sale of common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 8,463 | | |
| 9 | | |
| - | | |
| 507,007 | | |
| - | | |
| - | | |
| 507,016 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of shares for services | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 4,675 | | |
| 5 | | |
| | | |
| 168,295 | | |
| | | |
| | | |
| 168,300 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,984,706 | ) | |
| - | | |
| (5,984,706 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance March 31, 2023 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 120,829 | | |
$ | 123 | | |
$ | (201,605 | ) | |
$ | 101,294,618 | | |
$ | (101,025,068 | ) | |
$ | - | | |
$ | 68,068 | |
See accompanying notes to the consolidated financial
statements.
ADITXT, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| |
Three Months Ended | | |
Three Months Ended | |
| |
March 31, 2024 | | |
March 31, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss | |
$ | (14,868,694 | ) | |
$ | (5,984,706 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Stock-based compensation | |
| 24,573 | | |
| 339,451 | |
Stock-based compensation from asset purchase | |
| 6,712,663 | | |
| - | |
Depreciation expense | |
| 142,932 | | |
| 109,896 | |
Amortization of intangible assets | |
| 833 | | |
| 26,750 | |
Amortization of debt discount | |
| 635,710 | | |
| - | |
Loss on note exchange agreement | |
| 208,670 | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (18,718 | ) | |
| 198,940 | |
Prepaid expenses | |
| (239,494 | ) | |
| (51,533 | ) |
Deposits | |
| (26,086 | ) | |
| (54,940 | ) |
Inventory | |
| 122,734 | | |
| 186,563 | |
Accounts payable and accrued expenses | |
| 1,343,946 | | |
| 1,277,788 | |
Net cash used in operating activities | |
| (5,960,931 | ) | |
| (3,951,791 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchase of fixed assets | |
| - | | |
| (5,049 | ) |
Net cash used in investing activities | |
| - | | |
| (5,049 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from notes - related party | |
| 467,000 | | |
| - | |
Proceeds from notes and convertible notes payable, net of offering costs | |
| 1,269,950 | | |
| 1,245,853 | |
Repayments of note payable - related party | |
| (375,000 | ) | |
| - | |
Repayments of note payable | |
| (1,906,052 | ) | |
| - | |
New principal from extension of notes, net of debt discount | |
| 451,974 | | |
| - | |
Advance on private placement | |
| 600,000 | | |
| - | |
Common stock and warrants issued for cash, net of issuance costs | |
| - | | |
| 507,016 | |
Cash from subscription receivable | |
| 5,444,628 | | |
| - | |
Payments on financing on fixed asset | |
| - | | |
| (262,160 | ) |
Net cash provided by financing activities | |
| 5,952,500 | | |
| 1,490,709 | |
| |
| | | |
| | |
NET INCREASE IN CASH | |
| (8,431 | ) | |
| (2,466,131 | ) |
| |
| | | |
| | |
CASH AT BEGINNING OF PERIOD | |
| 97,102 | | |
| 2,768,640 | |
| |
| | | |
| | |
CASH AT END OF PERIOD | |
$ | 88,671 | | |
$ | 302,509 | |
| |
| | | |
| | |
Supplemental cash flow information: | |
| | | |
| | |
Cash paid for income taxes | |
$ | - | | |
$ | - | |
Cash paid for interest expense | |
$ | 622,762 | | |
$ | 193,175 | |
| |
| | | |
| | |
Issuance of shares in asset purchase | |
$ | 266,448 | | |
$ | - | |
Shares issued for settlement | |
$ | 1,600,000 | | |
$ | - | |
Return of notes payable from Evofem merger agreement | |
$ | 11,174,426 | | |
$ | - | |
Accrued interest rolled into notes payable | |
$ | 538,223 | | |
$ | - | |
See accompanying notes to the consolidated financial
statements.
ADITXT, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND NATURE OF BUSINESS
Company Background
Overview
We are a biotech innovation company with a mission
of prolonging life and enhancing its quality by improving the health of the immune system. We are an innovation company developing and
commercializing technologies with a focus on monitoring and modulating the immune system. Our immune reprogramming technologies are currently
at the pre-clinical stage and are designed to retrain the immune system to induce tolerance with an objective of addressing rejection
of transplanted organs, autoimmune diseases, and allergies. Our immune monitoring technologies are designed to provide a personalized
comprehensive profile of the immune system and we plan to utilize them in our upcoming reprogramming clinical trials to monitor subjects’
immune response before, during and after drug administration.
On January 1, 2023, the Company formed Adimune,
Inc., a Delaware wholly owned subsidiary.
On January 1, 2023, the Company formed Pearsanta,
Inc., a Delaware majority owned subsidiary.
On April 13, 2023, the Company formed Adivir,
Inc., a Delaware wholly owned subsidiary.
On August 24, 2023, the Company formed Adivue,
Inc., a Delaware wholly owned subsidiary.
On October 16, 2023, the Company formed Adicure,
Inc., which was renamed Adifem, Inc., a Delaware wholly owned subsidiary.
Reverse Stock Split
On August 17, 2023, the Company effectuated a
1 for 40 reverse stock split (the “2023 Reverse Split”). The Company’s stock began trading on a split-adjusted
basis effective on the Nasdaq Stock Market on August 18, 2023. There was no change to the number of authorized shares of the Company’s
common stock. All share amounts referenced in this report are adjusted to reflect the 2023 Reverse Split.
Offerings
On August 31, 2021, the Company completed a registered
direct offering (“August 2021 Offering”). In connection therewith, the Company issued 2,292 shares of common stock,
at a purchase price of $4,800.00 per share, resulting in gross proceeds of approximately $11.0 million. In a concurrent private
placement, the Company issued warrants to purchase up to 2,292 shares. The warrants have an exercise price of $5,060.00 per
share and are exercisable for a five-year period commencing months from the date of issuance. The warrants exercise price
was subsequently repriced to $3,000.00. In addition, the Company issued a warrant to the placement agent to purchase up to 115 shares
of common stock at an exercise price of $6,000.00 per share.
On October 18, 2021, the Company entered into
an underwriting agreement with Revere Securities LLC, relating to the public offering (the “October 2021 Offering”) of 1,417 shares
of the Company’s common stock (the “Shares”) by the Company. The Shares were offered, issued, and sold at a price to
the public of $3,000.00 per share under a prospectus supplement and accompanying prospectus filed with the SEC pursuant to an effective
shelf registration statement filed with the SEC on Form S-3 (File No. 333-257645), which was declared effective by the SEC on July 13,
2021. The October 2021 Offering closed on October 20, 2021 for gross proceeds of $4.25 million. The Company utilized a portion of
the proceeds, net of underwriting discounts of approximately $3.91 million from the October 2021 Offering to fund certain obligations
of the Company.
On December 6, 2021, the Company completed a public
offering for net proceeds of $16.0 million (the “December 2021 Offering”). As part of the December 2021 Offering, we
issued 4,123 units consisting of shares of the Company’s common stock and warrant to purchase shares of the Company’s
common stock and 4,164 prefunded warrants. The warrant issued as part of the units had an exercise price of $2,300.00 and
the prefunded warrants had an exercise price of $0.04. On June 15, 2022, the Company entered an agreement with a holder of certain warrants
in the December 2021 Offering. (See Note 10)
On September 20, 2022, the Company completed a
public offering for net proceeds of $17.2 million (the “September 2022 Offering”). As part of the September 2022 Offering,
we issued 30,608 of shares of the Company’s common stock, pre-funded warrants to purchase 52,725 shares of common
stock, and warrants to purchase 83,333 shares of the Company’s common stock. The warrants had an exercise price of $240.00 and
the pre-funded warrants had an exercise price of $0.04.
On April 20, 2023, the Company entered into a
securities purchase agreement (the “April Purchase Agreement”) with an institutional investor, pursuant to which the Company
agreed to sell to such investor pre-funded warrants (the “April Pre-Funded Warrants”) to purchase up to 39,634 shares
of common stock of the Company (the “Common Stock”) at a purchase price of $48.76 per April Pre-Funded Warrant. The April
Pre-Funded Warrants (and shares of common stock underlying the April Pre-Funded Warrants) were offered by the Company pursuant to its
shelf registration statement on Form S-3 (File No. 333-257645), which was declared effective by the Securities and Exchange Commission
on July 13, 2021. Concurrently with the sale of the April Pre-Funded Warrants, pursuant to the Purchase Agreement in a concurrent
private placement, for each April Pre-Funded Warrant purchased by the investor, such investor received from the Company an unregistered
warrant (the “Warrant”) to purchase two shares of Common Stock. The warrants have an exercise price of $34.40 per
share, and are exercisable for a three year period. In addition, the Company issued a warrant to the placement agent to purchase
up to 2,378 shares of common stock at an exercise price of $61.00 per share. The closing of the sales of these securities under the April
Purchase Agreement took place on April 24, 2023. The gross proceeds from the offering were approximately $1.9 million, prior to deducting
placement agent’s fees and other offering expenses payable by the Company.
On August 31, 2023, the “Company entered
into a securities purchase agreement (the “August Purchase Agreement”) with an institutional investor for the issuance
and sale in a private placement (the “Private Placement”) of (i) pre-funded warrants (the “August Pre-Funded Warrants”)
to purchase up to 1,000,000 shares of the Company’s common stock at an exercise price of $0.001 per share, and (ii) warrants (the
“Common Warrants”) to purchase up to 1,000,000 shares of the Company’s Common Stock at an exercise price of $10.00 per
share. The Private Placement closed on September 6, 2023. The net proceeds to the Company from the Private Placement were approximately
$9 million, after deducting placement agent fees and expenses and estimated offering expenses payable by the Company. The Company used
the net proceeds received from the Private Placement for (i) the payment of approximately $3.1 million in outstanding obligations, (ii)
the repayment of approximately $0.4 million of outstanding debt, and (iii) the balance for continuing operating expenses and working capital.
On December 29, 2023, the Company entered into
a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (“the “Purchaser”)
for the issuance and sale in a private placement (the “Private Placement”) of (i) pre-funded warrants (the “Pre-Funded
Warrants”) to purchase up to 1,237,114 shares of the Company’s common stock, par value $0.001 (the “Common Stock”)
at an exercise price of $0.001 per share, and (ii) warrants (the “Common Warrants”) to purchase up to 2,474,228 shares of
the Company’s Common Stock, at a purchase price of $4.85 per share. The Private Placement closed and the funds were received on
January 4, 2024. The net proceeds to the Company from the Private Placement were approximately $5.4 million, after deducting placement
agent fees and expenses and estimated offering expenses payable by the Company. The Company intends to use the net proceeds received from
the Private Placement for continuing operating expenses and working capital.
Risks and Uncertainties
The Company has a limited operating history and
is in the very early stages of generating revenue from intended operations. The Company’s business and operations are sensitive
to general business and economic conditions in the U.S. and worldwide along with local, state, and federal governmental policy decisions.
A host of factors beyond the Company’s control could cause fluctuations in these conditions. Adverse conditions may include: changes
in the biotechnology regulatory environment, technological advances that render our technologies obsolete, availability of resources for
clinical trials, acceptance of technologies into the medical community, and competition from larger, more well-funded companies. These
adverse conditions could affect the Company’s financial condition and the results of its operations.
NOTE 2 – GOING CONCERN ANALYSIS
Management Plans
The Company was incorporated on September
28, 2017 and has not generated significant revenues to date. During the three months ended March 31, 2024, the Company had a net
loss of $14,868,694 and negative cash flow from operating activities of $5,960,931. As of March 31, 2024, the Company’s cash
balance was $88,671.
As of March 31, 2024, the Company had approximately
$1.8 million of availability to sell under its shelf registration statement on Form S-3. Upon the filing of the Company’s annual
report on Form 10-K on April 16, 2024, the Company’s aggregate market value of the voting and non-voting equity held by non-affiliates
was below $3.0 million. As a result, the maximum amount that the Company can sell under its shelf registration statement on Form
S-3 during any 12 month period is equal to one-third of the aggregate market value of the voting and non-voting equity held by non-affiliates
of the Company.
On November 21, 2023, the Company received written
notice from Nasdaq that we had regained compliance with the Public Float Rule. On December 29, 2023, the Company received written notice
from Nasdaq that we had regained compliance with the Stockholders’ Equity Rule but will be subject to a Mandatory Panel Monitor
for a period of one year.
If we are delisted from Nasdaq, but obtain a substitute
listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility
than experienced on Nasdaq. Stockholders may not be able to sell their shares of common stock on any such substitute market in the quantities,
at the times, or at the prices that could potentially be available on a more liquid trading market. As a result of these factors, if our
common stock is delisted from Nasdaq, the value and liquidity of our common stock, warrants and pre-funded warrants would likely be significantly
adversely affected. A delisting of our common stock from Nasdaq could also adversely affect our ability to obtain financing for our operations
and/or result in a loss of confidence by investors, employees and/or business partners.
The Company continues to actively pursue numerous
capital raising transactions with the objective of obtaining sufficient bridge funding to meet the Company’s existing capital needs
as well as more substantial capital raises to meet the Company’s longer-term needs.
In addition, factors such as stock price, volatility,
trading volume, market conditions, demand and regulatory requirements may adversely affect the Company’s ability to raise capital
in an efficient manner. Because of these factors, the Company believes that this creates substantial doubt with the Company’s ability
to continue as a going concern.
In addition to the shelf registration, the Company
has the ability to raise capital from equity or debt through private placements or public offerings pursuant to a registration statement
on Form S-1. We may also secure loans from related parties.
The financial statements included in this report
do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the matters discussed herein. The Company’s ability to continue as a going
concern is dependent upon the ability to complete clinical studies and implement the business plan, generate sufficient revenues and to
control operating expenses. In addition, the Company is consistently focused on raising capital, strategic acquisitions and alliances,
and other initiatives to strengthen the Company.
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
The accompanying
unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in
the United States of America (“U.S. GAAP”) for interim financial information and the rules and regulations of the Securities
and Exchange Commission (“SEC”). In the opinion of the Company’s management, the accompanying condensed consolidated
financial statements reflect all adjustments, consisting of normal, recurring adjustments, considered necessary for a fair presentation
of the results for the interim periods ended March 31, 2024 and March 31, 2023. Although management believes that the disclosures in these
unaudited condensed consolidated financial statements are adequate to make the information presented not misleading, certain information
and footnote disclosures normally included in condensed consolidated financial statements that have been prepared in accordance U.S. GAAP
have been omitted pursuant to the rules and regulations of the SEC.
The accompanying
unaudited condensed consolidated financial statements should be read in conjunction with the Company’s financial statements and
notes related thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the
SEC on April 16, 2024. The interim results for the three months ended March 31, 2024 are not necessarily indicative of the results to
be expected for the year ended December 31, 2024 or for any future interim periods.
Principles of Consolidation
The consolidated financial statements include
the accounts of Aditxt, Inc., its wholly owned subsidiaries and, one majority owned subsidiary. All significant intercompany balances
and transactions have been eliminated in the consolidated financial statements.
Use of Estimates
The preparation of financial statements in conformity
with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the
reporting period. Actual results could differ from those estimates. Significant estimates underlying the financial statements include
the collectability of notes receivable, the reserve on insurance billing, value of preferred shares issued, our investments in preferred
shares, estimation of discounts on non-interest bearing borrowing, and the fair value of stock options and warrants.
Fair Value Measurements and Fair Value of
Financial Instruments
The Company adopted Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements. ASC Topic 820 clarifies
the definition of fair value, prescribes methods for measuring fair value, and establishes a fair value hierarchy to classify the inputs
used in measuring fair value as follows:
|
Level 1 |
- |
Inputs are unadjusted quoted prices in active markets for identical assets or liabilities available at the measurement date. |
|
Level 2 |
- |
Inputs are unadjusted quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, inputs other than quoted prices that are observable, and inputs derived from or corroborated by observable market data. |
|
Level 3 |
- |
Inputs are unobservable inputs which reflect the reporting entity’s own assumptions on what assumptions the market participants would use in pricing the asset or liability based on the best available information. |
The Company did not identify any assets or liabilities
that are required to be presented on the balance sheets at fair value in accordance with ASC Topic 820.
Due to the short-term nature of all financial
assets and liabilities, their carrying value approximates their fair value as of the balance sheet dates. (See Note 9)
Concentrations of Credit Risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable.
The Company maintains its cash accounts at financial
institutions which are insured by the Federal Deposit Insurance Corporation. At times, the Company may have deposits in excess of federally
insured limits.
Substantially all the Company’s accounts
receivable are with companies in the healthcare industry, individuals, and the U.S. government. However, concentration of credit risk
is mitigated due to the Company’s number of customers. In addition, for receivables due from U.S. government agencies, the Company
does not believe the receivables represent a credit risk as these are related to healthcare programs funded by the U.S. government and
payment is primarily dependent upon submitting the appropriate documentation.
Cash and Cash Equivalents
Cash and cash equivalents include short-term,
liquid investments.
Inventory
Inventory consists of laboratory materials and
supplies used in laboratory analysis. We capitalize inventory when purchased. Inventory is valued at the lower of cost or net realizable
value on a first-in, first-out basis. We periodically perform obsolescence assessments and write off any inventory that is no longer usable.
Fixed Assets
Fixed assets are stated at cost less accumulated
depreciation. Cost includes expenditures for furniture, office equipment, laboratory equipment, and other assets. Maintenance and repairs
are charged to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation are
removed from the accounts and any resulting gain or loss is reflected in operations. The costs of fixed assets are depreciated using the
straight-line method over the estimated useful lives or lease life of the related assets.
Useful lives assigned to fixed assets are as follows:
Computers | |
Three years to five years |
Lab Equipment | |
Seven to ten years |
Office Furniture | |
Five to ten years |
Other fixed assets | |
Five to ten years |
Leasehold Improvements | |
Shorter of estimated useful life or remaining lease term |
Intangible Assets
Intangible assets are stated at cost less accumulated
amortization. For intangible assets that have finite lives, the assets are amortized using the straight-line method over the estimated
useful lives of the related assets. For intangible assets with indefinite lives, the assets are tested periodically for impairment.
Investments
The following table sets forth a summary of the
changes in equity investments. This investment has been recorded at cost in accordance with ASC 321.
| |
For the
three months
ended
March 31, 2024 | |
| |
| |
As of December 31, 2023 | |
| 22,711,221 | |
Purchase of equity investments | |
| - | |
Unrealized gains | |
| - | |
As of March 31, 2024 | |
$ | 22,711,221 | |
This investment is included in its own line item
on the Company’s consolidated balance sheets.
Non-marketable equity investments (for which we
do not have significant influence or control) are investments without readily determinable fair values that are recorded based on initial
cost minus impairment, if any, plus or minus adjustments resulting from observable price changes in orderly transactions for identical
or similar securities, if any. All gains and losses on investments in non-marketable equity securities, realized and unrealized, are recognized
in investment and other income (expense), net.
We monitor equity method and non-marketable equity
investments for events or circumstances that could indicate the investments are impaired, such as a deterioration in the investee’s
financial condition and business forecasts and lower valuations in recently completed or anticipated financings, and recognize a charge
to investment and other income (expense), net for the difference between the estimated fair value and the carrying value. For equity method
investments, we record impairment losses in earnings only when impairments are considered other-than-temporary.
Accounts Receivable and Allowance for Doubtful
Accounts
Accounts receivable are stated at the amount management
expects to collect from outstanding balances. The Company generally does not require collateral to support customer receivables. The Company
determines if receivables are past due based on days outstanding, and amounts are written off when determined to be uncollectible by management.
As of March 31, 2024 and December 31, 2023, there was an allowance for doubtful accounts of zero and zero, respectively.
Accounts receivable is made up of billed and unbilled of $273,802 and $153,242 as of March 31, 2024 and $236,605 and $171,721 as of December
31, 2023, respectively.
Income Taxes
Deferred
tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred
tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized
in income in the period that includes the enactment date. At March 31, 2024 and December 31, 2023, the Company had a full valuation allowance
against its deferred tax assets.
Offering Costs
Offering costs incurred in connection with equity
are recorded as a reduction of equity and offering costs incurred in connection with debt are recorded as a reduction of debt as a debt
discount. Equity instruments issued as offering costs have zero net effect on the Company’s equity.
Revenue Recognition
In accordance with ASC 606 (Revenue From Contracts
with Customers), revenue is recognized when a customer obtains control of promised services. The amount of revenue recognized reflects
the consideration to which the Company expects to be entitled to receive in exchange for these services. To achieve this core principle,
the Company applies the following five steps:
|
1) |
Identify the contract with a customer |
|
2) |
Identify the performance obligations in the contract |
|
3) |
Determine the transaction price |
|
4) |
Allocate the transaction price to performance obligations in the contract |
|
5) |
Recognize revenue when or as the Company satisfies a performance obligation |
Revenues reported from services relating to the
AditxtScore™ are recognized when the AditxtScoreTM report is delivered to the customer. The services performed include
the analysis of specimens received in the Company’s CLIA laboratory and the generation of results which are then delivered upon
completion.
The Company recognizes revenue in the following
manner for the following types of customers:
Client Payers:
Client payers include physicians or other entities
for which services are billed based on negotiated fee schedules. The Company principally estimates the allowance for credit losses for
client payers based on historical collection experience and the period of time the receivable has been outstanding.
Cash Pay:
Customers are billed based on established patient
fee schedules or fees negotiated with physicians on behalf of their patients. Collection of billings is subject to credit risk and the
ability of the patients to pay.
Insurance:
Reimbursements from healthcare insurers are based
on fee for service schedules. Net revenues recognized consist of amounts billed net of contractual allowances for differences between
amounts billed and the estimated consideration the Company expects to receive from such payers, collection experience, and the terms of
the Company’s contractual arrangements.
Leases
Under Topic 842 (Leases), operating lease expense
is generally recognized evenly over the term of the lease. The Company has operating leases consisting of office space, laboratory space,
and lab equipment.
Leases with an initial term of twelve months or
less are not recorded on the balance sheet. We combine the lease and non-lease components in determining the lease liabilities and right
of use (“ROU”) assets.
Stock-Based Compensation
The Company accounts for stock-based compensation
costs under the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation
expense related to the fair value of stock-based compensation awards that are ultimately expected to vest. Stock-based compensation expense
recognized includes the compensation cost for all stock-based payments granted to employees, officers, and directors based on the grant
date fair value estimated in accordance with the provisions of ASC 718. ASC 718 is also applied to awards modified, repurchased, or cancelled
during the periods reported. Stock-based compensation is recognized as expense over the employee’s requisite vesting period and
over the nonemployee’s period of providing goods or services.
Patents
The Company incurs fees from patent licenses,
which are reflected in research and development expenses, and are expensed as incurred. During the three months ended March 31, 2024 and
2023, the Company incurred patent licensing fees of $61,666 and $60,000, respectively.
Research and Development
We incur research and development costs during the process of researching
and developing our technologies and future offerings. We expense these costs as incurred unless such costs qualify for capitalization
under applicable guidance. During the three months ended March 31, 2024 and 2023, the Company incurred research and development costs
of $8,145,266 and $1,387,541, respectively.
Non-controlling
Interest in Subsidiary
Non-controlling
interests represent the Company’s subsidiary’s cumulative results of operations and changes in deficit attributable to non-controlling
shareholders. During the three months ended March 31, 2024 and 2023, the Company recognized
$138,967 and $0 in net loss attributable to non-controlling interest in Pearsanta. The Company owns approximately 90.2% of Pearsanta,
Inc., as of March 31, 2024.
Basic and Diluted Net Loss per Common Share
Basic loss per common share is computed by dividing
the net loss by the weighted average number of shares of common stock outstanding for each period. Diluted loss per share is computed
by dividing the net loss attributable of common stockholders by the weighted average number of shares of common stock outstanding plus
the dilutive effect of shares issuable through the common stock equivalents. The weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive. As of March 31, 2024, 45,572 stock options, 0 unvested restricted
stock units, 5,097,080 warrants, 22,280 shares of preferred series A-1 stock, 6,000 shares of preferred series B-1, and 2,625 shares of
preferred series B-2 stock were excluded from dilutive earnings per share as their effects were anti-dilutive.
Instrument | |
Quantity Issued and Outstanding as of March 31,
2024 | | |
Common Stock Equivalent | |
Series A Preferred Stock | |
| - | | |
| - | |
Preferred Series A-1 Stock | |
| 22,280 | | |
| 5,018,019 | |
Series B Preferred Stock | |
| - | | |
| - | |
Preferred Series B-1 Stock | |
| 6,000 | | |
| 1,477,833 | |
Preferred Series B-2 Stock | |
| 2,625 | | |
| 557,325 | |
Series C Preferred Stock | |
| - | | |
| - | |
Warrants | |
| 5,097,080 | | |
| 5,097,080 | |
Options | |
| 45,572 | | |
| 45,572 | |
Total Common Stock Equivalent | |
| | | |
| 12,195,829 | |
As of March 31, 2023, 44,710 stock options,
4,267 unvested restricted stock units, and 5,079,348 warrants were excluded from dilutive earnings per share as their effects were anti-dilutive.
Recent Accounting Pronouncements
The FASB issues ASUs to amend the authoritative
literature in ASC. There have been several ASUs to date, including those above, that amend the original text of ASC. Management believes
that those issued to date either (i) provide supplemental guidance, (ii) are technical corrections, (iii) are not applicable to us or
(iv) are not expected to have a significant impact on our financial statements.
NOTE 4 – FIXED ASSETS
The Company’s fixed assets include the following
on March 31, 2024:
| |
Cost Basis | | |
Accumulated Depreciation | | |
Net | |
Computers | |
$ | 378,480 | | |
$ | (342,303 | ) | |
$ | 36,177 | |
Lab Equipment | |
| 2,711,525 | | |
| (949,414 | ) | |
| 1,762,111 | |
Office Furniture | |
| 56,656 | | |
| (15,282 | ) | |
| 41,374 | |
Other Fixed Assets | |
| 148,605 | | |
| (25,632 | ) | |
| 122,973 | |
Leasehold Improvements | |
| 120,440 | | |
| (61,315 | ) | |
| 59,125 | |
Total Fixed Assets | |
$ | 3,415,706 | | |
$ | (1,393,946 | ) | |
$ | 2,021,760 | |
The Company’s fixed assets include the following
on December 31, 2023
| |
Cost Basis | | |
Accumulated Depreciation | | |
Net | |
Computers | |
$ | 378,480 | | |
$ | (320,473 | ) | |
$ | 58,007 | |
Lab Equipment | |
| 2,585,077 | | |
| (859,612 | ) | |
| 1,725,465 | |
Office Furniture | |
| 56,656 | | |
| (13,866 | ) | |
| 42,790 | |
Other Fixed Assets | |
| 8,605 | | |
| (2,084 | ) | |
| 6,521 | |
Leasehold Improvements | |
| 120,440 | | |
| (54,980 | ) | |
| 65,460 | |
Total Fixed Assets | |
$ | 3,149,258 | | |
$ | (1,251,015 | ) | |
$ | 1,898,243 | |
Depreciation expense was $142,932 and $109,896
for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, the fixed assets that serve
as collateral subject to the financed asset liability have a carrying value of $1,006,741 and $1,316,830, respectively.
Fixed asset activity for the three months ended
March 31, 2024 consisted of the following:
| |
For the
three months
ended
March 31, 2024 | |
As of December 31, 2023 | |
| 3,149,258 | |
Brain Scientific Asset Purchase | |
| 266,448 | |
Additions | |
| - | |
As of March 31, 2024 | |
$ | 3,415,706 | |
Financed Assets:
In October 2020, the Company purchased two pieces
of lab equipment and financed them for a period of twenty-four months with a monthly payment of $19,487, with an interest rate of 8%.
As of March 31, 2024, the Company has one payment in arrears.
In January of 2021, the Company purchased one
piece of lab equipment and financed it for a period of twenty-four months with a monthly payment of $9,733, with an interest rate of 8%.
As of March 31, 2024, the Company has one payment in arrears.
In March of 2021, the Company purchased five
pieces of lab equipment and financed them for a period of twenty-four months with a monthly payment of $37,171, with an interest rate
of 8%. As of March 31, 2024, the Company has four payments in arrears.
As of March 31, 2024, all lab equipment financing
agreements have matured and are in default status.
NOTE 5 – INTANGIBLE ASSETS
The Company’s intangible assets include
the following on March 31, 2024:
| |
Cost Basis | | |
Accumulated Amortization | | |
Net | |
Proprietary Technology | |
$ | 321,000 | | |
$ | (321,000 | ) | |
$ | - | |
Intellectual property | |
| 10,000 | | |
| (1,389 | ) | |
| 8,611 | |
Total Intangible Assets | |
$ | 331,000 | | |
$ | (322,389 | ) | |
$ | 8,611 | |
The Company’s intangible assets include
the following on December 31, 2023:
| |
Cost Basis | | |
Accumulated Amortization | | |
Net | |
Proprietary Technology | |
$ | 321,000 | | |
$ | (321,000 | ) | |
$ | - | |
Intellectual property | |
| 10,000 | | |
| (556 | ) | |
| 9,444 | |
Total Intangible Assets | |
$ | 331,000 | | |
$ | (321,556 | ) | |
$ | 9,444 | |
Amortization expense was $833 and
$26,750 for the three months ended March 31, 2024 and 2023, respectively. The Company’s proprietary technology is being
amortized over its estimated useful life of three years.
| |
For the three months ended March 31, 2024 | |
As of December 31, 2023 | |
| 321,000 | |
Additions | |
| - | |
As of March 31, 2024 | |
$ | 321,000 | |
NOTE 6 – RELATED PARTY TRANSACTIONS
On November 30, 2023, Amro Albanna, the Chief
Executive Officer of the Company, loaned $10,000 to the Company. The loan was evidenced by an unsecured promissory note (the “November
Note”). Pursuant to the terms of the November Note, it will accrue interest at a rate of eight and a half percent (8.50%) per annum,
the Prime rate on the date of signing, and is due on the earlier of May 30, 2024 or an event of default, as defined therein. As of March
31, 2024, the note was fully paid off.
On December 6, 2023, Amro Albanna, the Chief Executive
Officer of the Company, loaned $200,000 to the Company. The loan was evidenced by an unsecured promissory note (the “First December
Note”). Pursuant to the terms of the First December Note, it will accrue interest at a rate of eight and a half percent (8.50%)
per annum, the Prime rate on the date of signing, and is due on the earlier of June 6, 2024 or an event of default, as defined therein.
As of March 31, 2024, the note was fully paid off.
On December 20, 2023, Amro Albanna, the Chief
Executive Officer of the Company, loaned $165,000 to the Company. The loan was evidenced by an unsecured promissory note (the “Second
December Note”). Pursuant to the terms of the Second December Note, it will accrue interest at a rate of eight and a half percent
(8.50%) per annum, the Prime rate on the date of signing, and is due on the earlier of June 20, 2024 or an event of default, as defined
therein. As of March 31, 2024, the note was fully paid off.
On February 7, 2024, Amro Albanna, the Chief Executive
Officer of the Company loaned $30,000 to the Company. The loan was evidenced by an unsecured promissory note (the “February 7th
Note”). Pursuant to the terms of the February 7th Note, it will accrue interest at the Prime rate of eight and one-half percent
(8.5%) per annum and is due on the earlier of August 7, 2024 or an event of default, as defined therein. As of March 31, 2024 the note
has an outstanding principal balance of $30,000.
On February 15, 2024, Amro Albanna, the Chief
Executive Officer of the Company loaned $205,000 to the Company. The loan was evidenced by an unsecured promissory note (the “February
15th Note”). Pursuant to the terms of the February 15th Note, it will accrue interest at the Prime rate of eight and one-half percent
(8.5%) per annum and is due on the earlier of August 15, 2024 or an event of default, as defined therein. As of March 31, 2024 the note
has an outstanding principal balance of $205,000.
On February 29, 2024, Amro Albanna, the Chief
Executive Officer of the Company, and Shahrokh Shabahang, the Chief Innovation Officer of the Company, loaned $117,000 and $115,000, respectively,
to the Company. The loans were evidenced by an unsecured promissory note (the “February 29th Notes”). Pursuant to the terms
of the February 29th Notes, it will accrue interest at the Prime rate of eight and one-half percent (8.5%) per annum and is due on the
earlier of August 29, 2024 or an event of default, as defined therein. As of March 31, 2024 these notes have an outstanding principal
balance of $232,000.
See Note 12 for additional loans incurred or
paid subsequent to March 31, 2024.
NOTE 7 – NOTES PAYABLE
On October 5, 2023, the Company entered into an
Agreement for the Purchase and Sale of Future Receipts (the “October MCA Agreement”) pursuant to which the existing funder
(the “Funder”) increased the existing outstanding amount to $4,470,000 (the “October MCA Purchased Amount”) for
gross proceeds to the Company of $3,000,000, less origination fees of $240,000 and the outstanding balance under the existing agreement
of $1,234,461, resulting in net proceeds to the Company of $1,525,539. Pursuant to the October MCA Agreement, the Company granted the
Funder a security interest in all of the Company’s present and future accounts receivable in an amount not to exceed the October
MCA Purchased Amount. The October MCA Purchased Amount shall be repaid by the Company in 30 weekly installments of $149,000. The October
Purchased Amount may be prepaid by the Company via a payment of $3,870,000 if repaid within 30 days, $4,110,000 if repaid within 60 days
and $4,230,000 if repaid within 90 days. On January 24, 2024, the October MCA Agreement was restructured in connection with the January
Loan Agreement, as defined below.
On November 7, 2023, the Company entered into
a Business Loan and Security Agreement (the “November Loan Agreement”) with the lender (the “Lender”), pursuant
to which the Company obtained a loan from the Lender in the principal amount of $2,100,000, which satisfied the outstanding balance on
the August Loan of $1,089,000 and includes origination fees of $140,000 (the “November Loan”). Pursuant to the November Loan
Agreement, the Company granted the Lender a continuing secondary security interest in certain collateral (as defined in the November Loan
Agreement). The total amount of interest and fees payable by us to the Lender under the November Loan will be $3,129,000, which will be
repaid in 34 weekly installments ranging from $69,000 - $99,000. As of March 31, 2024 the November Loan has an outstanding principal balance
of $1,752,827, an unamortized debt discount of $57,647, and accrued interest of $469,892. As of December 31, 2023 the November Loan has
an outstanding principal balance of $1,990,699. The November Loan Agreement is currently in default status.
On November 24, 2023, the Company entered into
a loan with a principal of $53,099. The loan was evidenced by an unsecured promissory note (the “Second November Note”). Pursuant
to the terms of the Second November Note, it will accrue interest at a rate of eight and a half percent (8.50%) per annum, the Prime rate
on the date of signing, and is due on the earlier of May 24, 2024 or an event of default, as defined therein. As of March 31, 2024, the
note was fully paid off. As of December 31, 2023, there was a remaining principal balance of $53,099 on the Second December Loan and accrued
interest of $458.
On January 24, 2024, the Company entered
into a Business Loan and Security Agreement (the “January Loan Agreement”) with a commercial funding source (the “Lender”),
pursuant to which the Company obtained a loan from the Lender in the principal amount of $3,600,000, which includes origination fees of
$252,000 (the “January Loan”). Pursuant to the January Loan Agreement, the Company granted the Lender a continuing secondary
security interest in certain collateral (as defined in the January Loan Agreement). The total amount of interest and fees payable by the
Company to the Lender under the January Loan will be $5,364,000, which will be repayable by the Company in 30 weekly installments of $178,800.
The Company received net proceeds from the January Loan of $814,900 following repayment of the outstanding balance on the October Purchased
Amount of $2,533,100. As of March 31, 2024, there was a remaining principal balance of $3,519,577, an unamortized debt discount of $176,400,
and accrued interest of $714,826. The January Loan Agreement is currently in default status.
On March 7, 2024, Sixth Borough Capital Fund,
LP loaned $300,000 to the Company. The loan was evidenced by an unsecured promissory note (the “Sixth Borough Note”). Pursuant
to the terms of the Sixth Borough Note, it will accrue interest at the Prime rate of eight and one-half percent (8.5%) per annum and is
due on the earlier of March 31, 2024 or an event of default, as defined therein. As of March 31, 2024 the note has an outstanding principal
balance of $300,000. The Sixth Borough Note was subsequently converted into Series C-1 Preferred Stock in connection with the Private
Placement (as defined below). (See note 12)
Evofem Merger
In connection with the Agreement and Plan of Merger
(the “Merger Agreement”) with Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger
Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”), the Company, Evofem and the holders (the “Holders”)
of certain senior indebtedness (the “Notes”) entered into an Assignment Agreement dated December 11, 2023 (the “Assignment
Agreement”), pursuant to which the Holders assigned the Notes to the Company in consideration for the issuance by the Company of
(i) an aggregate principal amount of $5 million in secured notes of the Company due on January 2, 2024 (the “January 2024 Secured
Notes”), (ii) an aggregate principal amount of $8 million in secured notes of the Company due on September 30, 2024 (the “September
2024 Secured Notes”), (iii) an aggregate principal amount of $5 million in ten-year unsecured notes (the “Unsecured Notes”),
and (iv) payment of $154,480 in respect of net sales of Phexxi in respect of the calendar quarter ended September 30, 2023, which amount
is due and payable on December 14, 2023. The January 2024 Secured Notes are secured by certain intellectual property assets of the Company
and its subsidiaries pursuant to an Intellectual Property Security Agreement (the “IP Security Agreement”) entered into in
connection with the Assignment Agreement. The September 2024 Secured Notes are secured by the Notes and certain associated security documents
pursuant to a Security Agreement (the “Security Agreement”) entered into in connection with the Assignment Agreement. As of
March 31, 2024, there was a remaining principal balance of $250,000 on the Notes.
Subject to the terms and conditions set forth
in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares
of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common Stock
held by the Company or Merger Sub immediately prior to the Effective Time, will be converted into the right to receive an aggregate of
610,000 shares of the Company’s common stock, par value $0.001 per share (“Company Common Stock”); and (ii) all issued
and outstanding shares of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred Stock”),
other than any shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior to the Effective Time,
will be converted into the right to receive an aggregate of 2,327 shares of Series A-1 Preferred Stock, par value $0.001 of the Company
(the “Company Preferred Stock”), having such rights, powers, and preferences set forth in the form of Certificate of Designation
of Series A-1 Preferred Stock, the form of which is attached as Exhibit C to the Merger Agreement.
The respective obligations of each of the Company,
Merger Sub and Evofem to consummate the closing of the Merger (the “Closing”) are subject to the satisfaction or waiver, at
or prior to the closing of certain conditions, including but not limited to, the following:
|
(i) |
approval by the Company’s shareholders and Evofem shareholders; |
|
(ii) |
the registration statement on Form S-4 pursuant to which the shares of the Company Common Stock issuable in the Merger being declared effective by the U.S. Securities and Exchange Commission; |
|
(iii) |
the entry into a voting agreement by the Company and certain members of Evofem management; |
|
(iv) |
all preferred stock of Evofem other than the Evofem Unconverted Preferred Stock shall have been converted to Evofem Common Stock; |
|
(v) |
Evofem shall have received agreements (the “Evofem Warrant Holder Agreements”) from all holders of Evofem warrants which provide: |
a. waivers with respect to any fundamental
transaction, change in control or other similar rights that such warrant holder may have under any such Evofem warrants, and (b) an agreement
to such Evofem warrants to exchange such warrants for not more than an aggregate (for all holders of Evofem warrants) of 551 shares of
Company Preferred Stock;
|
(vi) |
Evofem shall have cashed out any other holder of Evofem warrants who has not provided an Evofem Warrant Holder Agreement; and |
|
(vii) |
Evofem shall have obtained waivers from the holders of the convertible notes of Evofem (the “Evofem Convertible Notes”) with respect to any fundamental transaction rights that such holder may have under the Evofem Convertible Notes, including any right to vote, consent, or otherwise approve or veto any of the transactions contemplated under the Merger Agreement. |
The obligations of the Company and Merger Sub
to consummate the Closing are subject to the satisfaction or waiver, at or prior to the Closing of certain conditions, including but not
limited to, the following:
| (i) | the Company shall have obtained agreements from the holders of Evofem Convertible Notes and purchase rights they hold to exchange such Convertible Notes and purchase rights for not more than an aggregate (for all holders of Evofem Convertible Notes) of 86,153 shares of Company Preferred Stock; |
|
(ii) |
the Company shall have received waivers form the holders of certain of the Company’s securities which contain prohibitions on variable rate transactions; and |
|
(iii) |
the Company, Merger Sub and Evofem shall work together between the Execution Date and the Effective Time to determine the tax treatment of the Merger and the other transactions contemplated by the Merger Agreement. |
The obligations of the Company to consummate the
Closing are subject to the satisfaction or waiver, at or prior to the Closing of certain conditions, including but not limited to, the
following:
|
(i) |
the Company shall have regained compliance with the stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1) and shall meet all other applicable criteria for continued listing, subject to any panel monitor imposed by Nasdaq. |
As the January 2024 Secured Notes and September
2024 Secured Notes did not contain a stated interest rate, the Company calculated an imputed interest rate of 26.7% based on the Company’s
weighted average cost of capital for the period in which the January 2024 Secured Notes and September 2024 Secured Notes were outstanding.
This amounted to approximately $1.8 million which was recorded as a discount to be amortized over the life of the January 2024 Secured
Notes and September 2024 Secured Notes.
Secured Notes Amendments and Assignment
On January 2, 2024, the Company and certain holders
of the secured notes (the “Holders”) entered into amendments to the January 2024 Secured Notes (“Amendment No. 1 to
January 2024 Secured Notes”), pursuant to which the maturity date of the January 2024 Notes was extended to January 5, 2024.
On January 5, 2024, the Company and the Holders
entered into amendments to the January 2024 Secured Notes (“Amendment No. 2 to January 2024 Secured Notes”) and amendments
to the September 2024 Secured Notes (“Amendment No. 1 to September 2024 Secured Notes”), pursuant to which the Company and
the Holders agreed that in consideration of a principal payment in the aggregate amount of $1 million on the January 2024 Secured Notes
and in increase in the aggregate principal balance of $250,000 on the September 2024 Secured Notes, that the maturity date of the January
2024 Secured Notes would be further extended to January 31, 2024.
On January 31, 2024, the Company and the Holders
entered into amendments to the January 2024 Secured Notes (“Amendment No. 3 to January 2024 Secured Notes”), pursuant to which
the maturity date of the January 2024 Notes was extended to February 29, 2024. In addition, on January 31, 2024, the Company and the Holders
entered into amendments to the September 2024 Secured Notes (“Amendment No. 2 to September 2024 Secured Notes”), pursuant
to which the Company and the Holders agreed that in consideration of a principal payment in the aggregate amount of $1.25 million on the
January 2024 Secured Notes and in increase in the aggregate principal balance of $300,000 on the September 2024 Secured Notes.
Pursuant to Amendment No. 3 to the January 2024
Secured Notes, the Company was required to make the Additional Consideration payment no later than February 9, 2024. As a result of the
Company’s failure to make the Additional Consideration payment by February 9, 2023, the January 2024 Secured Notes and the September
2024 Secured Notes were in default and the entire principal balance of the January 2024 Secured Notes and the September 2024 Secured Notes,
without demand or notice, were due and payable.
As a result of the defaults on the January 2024
Secured Notes and the September 2024 Secured Notes, the Company was in default on the Business Loan and Security Agreement dated January
24, 2024 (the January Business Loan”), which had a current balance of approximately $5.2 million, and the Business Loan and Security
Agreement dated November 7, 2023 (the “November Business Loan”) which had a current balance of approximately $2.7 million.
On February 26, 2024, the Company and the Holders
entered into an Assignment Agreement (the “February Assignment Agreement”), pursuant to which the Company assigned all remaining
amounts due under the January 2024 Secured Notes, the September 2024 Secured Notes and the Unsecured Notes (collectively, the “Notes”)
back to the Holders. The Company recognized a $208,670 loss on the transfer of these notes. In connection with the February Assignment
Agreement, the Company and the Holders entered into a payoff letter (the “Payoff Letter”) and amendments to the January 2024
Secured Notes (“Amendment No. 4 to January 2024 Secured Notes”), pursuant to which the maturity date of the January 2024 Secured
Notes was extended to March 31, 2024 and the outstanding balance under the Notes, after giving effect to the transactions contemplated
by the February Assignment Agreement as applied pursuant to the Payoff Letter, was adjusted to $250,000. On April 15, 2024, the Company
repaid the $250,000.
NOTE 8 – LEASES
Our lease agreements generally do not provide
an implicit borrowing rate; therefore, an internal incremental borrowing rate is determined based on information available at lease commencement
date for purposes of determining the present value of lease payments. We used the incremental borrowing rate on March 31, 2024 and December
31, 2023 for all leases that commenced prior to that date. In determining this rate, which is used to determine the present value of future
lease payments, we estimate the rate of interest we would pay on a collateralized basis, with similar payment terms as the lease and in
a similar economic environment.
Our corporate headquarters is located in Richmond,
Virginia, where we lease approximately 25,000 square feet. The lease expires in August 31, 2026, subject to extension.
As of March 31, 2024 the Company is 4.75 months in arrears on this lease.
On March 6, 2024, the Company received correspondence
from 532 Realty Associates, LLC (the “Landlord”) that the Company is in default under that certain Agreement of Lease dated
November 3, 2021 by and between the Landlord and the Company (the “New York Lease”) for failure to pay Basic Rent and Additional
Rent (as each term is defined in the New York Lease) in the aggregate amount of $40,707 (the “Past Due Rent”).
We also lease approximately 5,810 square
feet of laboratory and office space in Mountain View, California. The lease expires in August 31, 2024, subject to extension. As
of March 31, 2024 the Company is 4 months in arrears on this lease.
Additionally, we lease approximately 3,150 square
feet of office space in Melville, New York. The lease expires in December 31, 2025, subject to extension. As of March 31, 2024 the
Company is 4 months in arrears on this lease.
The overdue amounts represent a payable of $413,300
which are included in accounts payable and accrued liabilities on the Company’s condensed consolidated balance sheet.
Lease Costs
| |
Three Months Ended
March 31, 2024 | | |
Three Months Ended
March 31, 2023 | |
Components of total lease costs: | |
| | |
| |
Operating lease expense | |
$ | 305,049 | | |
$ | 297,091 | |
Total lease costs | |
$ | 305,049 | | |
$ | 297,091 | |
Lease Positions as of March 31, 2024 and December
31, 2023
ROU lease assets and lease liabilities for our
operating leases are recorded on the balance sheet as follows:
| |
March 31, 2024 | | |
December 31, 2023 | |
Assets | |
| | |
| |
Right of use asset – long term | |
$ | 1,940,076 | | |
$ | 2,200,299 | |
Total right of use asset | |
$ | 1,940,076 | | |
$ | 2,200,299 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Operating lease liabilities – short term | |
$ | 900,979 | | |
$ | 999,943 | |
Operating lease liabilities – long term | |
| 891,747 | | |
| 1,041,744 | |
Total lease liability | |
$ | 1,792,726 | | |
$ | 2,041,687 | |
Lease Terms and Discount Rate as of March 31,
2024
Weighted average remaining lease term (in years) – operating leases | |
| 1.79 | |
Weighted average discount rate – operating leases | |
| 8.00 | % |
Maturities of leases are as follows:
2024 (remaining) | |
$ | 718,751 | |
2025 | |
| 710,546 | |
2026 | |
| 423,930 | |
Total lease payments | |
$ | 1,853,227 | |
Less imputed interest | |
| (60,501 | ) |
Less current portion | |
| (900,979 | ) |
Total maturities, due beyond one year | |
$ | 891,747 | |
NOTE 9 – COMMITMENTS & CONTINGENCIES
License Agreement with Loma Linda University
On March 15, 2018, as amended on July 1, 2020,
we entered into a LLU License Agreement directly with Loma Linda University.
Pursuant to the LLU License Agreement, we obtained
the exclusive royalty-bearing worldwide license in and to all intellectual property, including patents, technical information, trade secrets,
proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or any of its affiliates
(the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases (the ADI™
technology). In consideration for the LLU License Agreement, we issued 13 shares of common stock to LLU.
Pursuant to the LLU License Agreement, we
are required to pay an annual license fee to LLU. Also, we paid LLU $455,000 in July 2020 for outstanding milestone payments and
license fees. We are also required to pay to LLU milestone payments in connection with certain development milestones. Specifically,
we are required to make the following milestone payments to LLU: $175,000 on March 31, 2022; $100,000 on March 31, 2024; $500,000 on
March 31, 2026; and $500,000 on March 31, 2027. In lieu of the $175,000 milestone payment due on March 31, 2023, the Company paid
LLU an extension fee of $100,000. The Company did not make the March 31, 2024 payment; the Company intends to obtain an extension
for this payment. Upon payment of this extension fee, an additional year will be added for the March 31, 2023 milestone.
Additionally, as consideration for prior expenses incurred by LLU to prosecute, maintain and defend the LLU Patent and Technology
Rights, we made the following payments to LLU: $70,000 at the end of December 2018, and a final payment of $60,000 at the end of
March 2019. We are required to defend the LLU Patent and Technology Rights during the term of the LLU License Agreement.
Additionally, we will owe royalty payments of (i) 1.5% of Net Product Sales (as such terms are defined under the LLU License
Agreement) and Net Service Sales on any Licensed Products (defined as any finished pharmaceutical products which utilizes the LLU
Patent and Technology Rights in its development, manufacture or supply), and (ii) 0.75% of Net Product Sales and Net Service Sales
for Licensed Products and Licensed Services (as such terms are defined under the LLU License Agreement) not covered by a valid
patent claim for technology rights and know-how for a three (3) year period beyond the expiration of all valid patent claims. We
also are required to produce a written progress report to LLU, discussing our development and commercialization efforts, within 45
days following the end of each year. All intellectual property rights in and to LLU Patent and Technology Rights shall remain with
LLU (other than improvements developed by or on our behalf).
The LLU License Agreement shall terminate on
the last day that a patent granted to us by LLU is valid and enforceable or the day that the last patent application licensed to us is
abandoned. The LLU License Agreement may be terminated by mutual agreement or by us upon 90 days written notice to LLU. LLU may terminate
the LLU License Agreement in the event of (i) non-payments or late payments of royalty, milestone and license maintenance fees not cured
within 90 days after delivery of written notice by LLU, (ii) a breach of any non-payment provision (including the provision that requires
us to meet certain deadlines for milestone events (each, a “Milestone Deadline”)) not cured within 90 days after delivery
of written notice by LLU and (iii) LLU delivers notice to us of three or more actual breaches of the LLU License Agreement by us in any
12-month period. Additional Milestone Deadlines include: (i) the requirement to have regulatory approval of an IND application to initiate
first-in-human clinical trials on or before March 31, 2023, which will be extended to March 31, 2024 with a payment of a $100,000 extension
fee, (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii) the completion of Phase III clinical
trials by March 31, 2026 and (iv) biologic licensing approval by the FDA by March 31, 2027. The Company has not initiated clinical trials to date and the Company intends to obtain an extension to commence human trials by March
31, 2025.
License Agreement with Leland Stanford Junior University
On February 3, 2020, we entered into an exclusive
license agreement (the “February 2020 License Agreement”) with Stanford regarding a patent concerning a method for detection
and measurement of specific cellular responses. Pursuant to the February 2020 License Agreement, we received an exclusive worldwide license
to Stanford’s patent regarding use, import, offer, and sale of Licensed Products (as defined in the agreement). The license to the
patented technology is exclusive, including the right to sublicense, beginning on the effective date of the agreement, and ending when
the patent expires. Under the exclusivity agreement, we acknowledged that Stanford had already granted a non-exclusive license in the
Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory (as those terms are defined
in the February 2020 License Agreement”). However, Stanford agreed to not grant further licenses under the Licensed Patents in the
Licensed Field of Use in the Licensed Territory. On December 29, 2021, we entered into an amendment to the February 2020 License Agreement
which extended our exclusive right to license the technology deployed in AditxtScoreTM and securing worldwide exclusivity
in all fields of use of the licensed technology.
We were obligated to pay and paid a fee of $25,000
to Stanford within 60 days of February 3, 2020. We also issued 10 shares of the Company’s common stock to Stanford.
An annual licensing maintenance fee is payable by us on the first anniversary of the February 2020 License Agreement in the amount of
$40,000 for 2021 through 2024 and $60,000 starting in 2025 until the license expires upon the expiration of the patent. The Company is
required to pay and has paid $25,000 for the issuances of certain patents. The Company will pay milestone fees of $50,000 on the first
commercial sales of a licensed product and $25,000 at the beginning of any clinical study for regulatory clearance of an in vitro diagnostic
product developed and a potential licensed product. The Company paid a milestone fee for a clinical study for regulatory clearance of
an in vitro diagnostic product developed and a potential licensed product of $25,000 in March of 2022. We are also required to: (i) provide
a listing of the management team or a schedule for the recruitment of key management positions by March 31, 2020 (which has been completed),
(ii) provide a business plan covering projected product development, markets and sales forecasts, manufacturing and operations, and financial
forecasts until at least $10,000,000 in revenue by June 30, 2020 (which has been completed), (iii) conduct validation studies by September
30, 2020 (which has been completed), (iv) hold a pre-submission meeting with the FDA by September 30, 2020 (which has been completed),
(iv) submit a 510(k) application to the FDA, Emergency Use Authorization (“EUA”), or a Laboratory Developed Test (“LDT”)
by March 31, 2021 (which has been completed), (vi) develop a prototype assay for human profiling by December 31, 2021 (which has been
completed), (vii) execute at least one partnership for use of the technology for transplant, autoimmunity, or infectious disease purposes
by March 31, 2022 (which has been completed) and (viii) provided further development and commercialization milestones for specific fields
of use in writing prior to December 31, 2022.
In addition to the annual license maintenance
fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined in the February 2020 License Agreement) during
the of the term of the agreement as follows: 4% when Net Sales are below or equal to $5 million annually or 6% when Net Sales are above
$5 million annually. The February 2020 License Agreement may be terminated upon our election on at least 30 days advance notice to Stanford,
or by Stanford if we: (i) are delinquent on any report or payment; (ii) are not diligently developing and commercializing Licensed Product;
(iii) miss certain performance milestones; (iv) are in breach of any provision of the February 2020 License Agreement; or (v) provide
any false report to Stanford. Should any events in the preceding sentence occur, we have a thirty (30) day cure period to remedy such
violation.
Asset Purchase Agreement
MDNA Lifesciences, Inc.
On January 4, 2024 (the “Closing Date”),
the Company completed its acquisition of certain assets and issued to MDNA Lifesciences, Inc. (“MDNA”): 50,000 shares of the
Company’s Common Stock, 50,000 shares of the Company’s Warrants, and 5,000 shares of the Pearsanta Preferred Stock. The Company
accounted for this transaction as an asset acquisition.
On January 4, 2024, the Company, Pearsanta and
MDNA entered into a First Amendment to Asset Purchase Agreement (the “First Amendment to Asset Purchase Agreement”), pursuant
to which the parties agreed to: (i) the removal of an upfront working capital payment, (ii) the removal of a Closing Working Capital Payment
(as defined in the Purchase Agreement”), and (iii) to increase the maximum amount of payments to be made by Aditxt under the Transition
Services Agreement (as defined below) from $2.2 million to $3.2 million.
On January 4, 2024, Pearsanta and MDNA entered
into a Transition Services Agreement (the “Transition Services Agreement”), pursuant to which MDNA agreed that it would perform,
or cause certain of its affiliates or third parties to perform, certain services as described in the Transition Services Agreement for
a term of three months in consideration for the payment by Pearsanta of certain fees as provided in the Transition Services Agreement,
in an amount not to exceed $3.2 million.
As part of this transaction, the Company acquired
$1,008,669 in patents which was expensed to R&D. The fair market value of this transaction was determined by the purchase price paid
in the transaction of 50,000 shares of the Company’s Common Stock which had a value of $256,000 based on the trading price of the
common stock, 50,000 shares of the Company’s Warrants which had a value of $252,669 using a Black Sholes valuation, and 5,000 shares
of the Pearsanta Preferred Stock which had a value of $500,000 based on the stated value of Pearsanta’s Preferred Stock of $5,000
per share.
Brain Scientific, Inc.
On January 24, 2024, the Company entered into
an Assignment and Assumption Agreement (the “Brain Assignment Agreement”) with the agent (the “Agent”) of certain
secured creditors (the “Brain Creditors”) of Brain Scientific, Inc., a Nevada corporation (“Brain Scientific”)
and Philip J. von Kahle (the “Brain Seller”), as assignee of Brain Scientific and certain affiliated entities (collectively,
the “Brain Companies”) under an assignment for the benefit of creditors pursuant to Chapter 727 of the Florida Statutes. Pursuant
to the Brain Assignment Agreement, the Agent assigned its rights under that certain Asset Purchase and Settlement Agreement dated October
31, 2023 between the Seller and the Agent (the “Brain Asset Purchase Agreement”) to the Company in consideration for the issuance
by the Company of an aggregate of 6,000 shares of a new series of convertible preferred stock of the Company, designated as Series B-1
Convertible Preferred Stock, $0.001 par value (the “Series B-1 Preferred Stock”). The shares of Series B-1 Preferred Stock
were issued pursuant to a Securities Purchase Agreement entered into by and between the Company and each of the purchasers signatory thereto
(the “Brain Purchase Agreement”). (See Note 10)
In connection with the Brain Assignment Agreement,
on January 24, 2024, the Company entered into a Patent Assignment with the Brain Seller (the “Brain Patent Assignment”), pursuant
to which the Seller assigned all of its rights, titles and interests in certain patents and patent applications that were previously held
by the Brain Companies to the Company.
As part of this transaction, the Company acquired
$5,703,995 in patents which was expensed to R&D and $266,448 in fixed assets. The fair market value of this transaction was determined
by the purchase price paid in the transaction of 6,000 shares of the Company’s Series B-1 Preferred Stock which had a value of $5,970,443
based on stated value of the Series B-1 Preferred Stock of $1,000 per share.
Contingent Liability
On September 7, 2023, the Company received a demand
letter from the holder of certain warrants issued by the Company in April 2023. The demand letter alleged that the investor suffered more
than $2 million in damages as a result of the Company failing to register the shares of the Company’s common stock underlying the
warrants as required under the securities purchase agreement.
On January 3, 2024, the Company entered into a
settlement agreement and general release with an investor (the “Settlement Agreement”), pursuant to which the Company and
the investor agreed to settle an action filed in the United States District Court in the Southern District of New York by an investor
against the Company (the “Action”) in consideration of the issuance by the Company of shares of the Company’s Common
Stock (the “Settlement Shares”). The number of Settlement Shares to be issued will be equal to $1.6 million divided by the
closing price of the Company’s Common Stock on the day prior to court approval of the joint motion. Following the issuance of the
Settlement Shares, the Investor will file a dismissal stipulation in the Action.
On January 17, 2024, the Company issued 296,296
Settlement Shares to the investor. The Settlement Shares were issued pursuant to an exemption from registration pursuant to Section 3(a)(10)
under the Securities Act of 1933, as amended.
EvoFem Merger Agreement
On December 11, 2023 (the “Execution Date”),
Aditxt, Inc., a Delaware corporation (the “Company”) entered into an Agreement and Plan of Merger (the “Merger Agreement”)
with Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”) and Evofem Biosciences,
Inc., a Delaware corporation (“Evofem”), pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”),
with Evofem surviving the Merger as a wholly owned subsidiary of the Company.
In connection with the Merger Agreement the Company
assumed $13.0 million in notes payable held by Evofem (see Note 7) and assumed a payable for $154,480 (see Note 7). These items were capitalized
on the Company’s balance sheet to deposit on acquisition as of March 31, 2024. The Company recognized a debt discount of $1,826,250.
As of March 31, 2024, there was an unamortized discount of $0. During the three months ended March 31, 2024 and 2023, the Company recognized
an amortization of debt discount of $571,904 and $0.
Subject to the terms and conditions set forth
in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares
of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common Stock
held by the Company or Merger Sub immediately prior to the Effective Time, will be converted into the right to receive an aggregate of
610,000 shares of the Company’s common stock, par value $0.001 per share (“Company Common Stock”); and (ii) all issued
and outstanding shares of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred Stock”),
other than any shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior to the Effective Time,
will be converted into the right to receive an aggregate of 2,327 shares of Series A-1 Preferred Stock, par value $0.001 of the Company
(the “Company Preferred Stock”), having such rights, powers, and preferences set forth in the form of Certificate of Designation
of Series A-1 Preferred Stock.
On December 11, 2023 the Company entered into
an Agreement and Plan of Merger (the “Merger Agreement”) with Adicure, Inc., a Delaware corporation and wholly owned subsidiary
of the Company (“Merger Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”), pursuant to which,
Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary
of the Company.
On January 8, 2024, the Company, Adicure, Inc.,
a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”), and Evofem Biosciences, Inc., a Delaware
corporation (“Evofem”) entered into the First Amendment (the “First Amendment to Merger Agreement”), to the Agreement
and Plan of Merger (the “Merger Agreement”) pursuant to which the parties agreed to extend the date by which the joint proxy
statement would be filed with the SEC until February 14, 2024.
On January 30, 2024, the Company, Adicure and
Evofem entered into the Second Amendment to the Merger Agreement (the “Second Amendment to Merger Agreement”) to amend (i)
the date of the Parent Loan (as defined in the Merger Agreement) to Evofem to be February 29, 2024, (ii) to change the date by which Evofem
may terminate the Merger Agreement for failure to receive the Parent Loan to be February 29, 2024, and (iii) to change the filing date
for the Joint Proxy Statement (as defined in the Merger Agreement) to April 1, 2024.
On February 29, 2024, the Company, Adicure and
Evofem entered into the Third Amendment to the Merger Agreement (the “Third Amendment to Merger Agreement”) in order to (i)
make certain conforming changes to the Merger Agreement regarding the Notes, (ii) extend the date by which the Company and Evofem will
file the joint proxy statement until April 30, 2024, and (iii) remove the requirement that the Company make the Parent Loan (as defined
in the Merger Agreement) by February 29, 2024 and replace it with the requirement that the Company make an equity investment into Evofem
consisting of (a) a purchase of 2,000 shares of Evofem Series F-1 Preferred Stock for an aggregate purchase price of $2.0 million on or
prior to April 1, 2024, and (b) a purchase of 1,500 shares of Evofem Series F-1 Preferred Stock for an aggregate purchase price of $1.5
million on or prior to April 30, 2024. As of the date of this filing the Company has not purchased the 2,000 shares of EvoFem Series F-1
Preferred Stock.
Engagement Letter with Dawson James Securities,
Inc.
On February 16, 2024, the “Company”
entered into an engagement letter (the “Dawson Engagement Letter”) with Dawson James Securities, Inc.(“Dawson”),
pursuant to which the Company engaged Dawson to serve as financial advisor with respect to one or more potential business combinations
involving the Company for a term of twelve months. Pursuant to the Dawson Engagement Letter, the Company agreed to pay Dawson an initial
fee of $1.85 million (the “Dawson Initial Fee”), which amount is payable on the later of (i) the closing of an offering resulting
in gross proceeds to the Company of greater than $4.9 million, or (ii) five days after the execution of the Dawson Engagement Letter.
At the Company’s option, the Dawson Initial Fee may be paid in securities of the Company. In addition, with respect to any business
combination (i) that either is introduced to the Company by Dawson following the date of the Dawson Engagement Letter or (ii) that with
respect to which the Company hereafter requests Dawson to provide M&A advisory services, the Company shall compensate Dawson in an
amount equal to 5% of the Total Transaction Value (as defined in the Engagement Letter) with respect to the first $20.0 million in Total
Transaction Value plus 10.0% of the Total Transaction Value that is in excess of $20.0 million (the “Transaction Fee”). The
Transaction Fee is payable upon the closing of a business combination transaction.
Advance on Private Placement
On March 5, 2024, the Company received a $1,000,000
deposit for an ongoing Private Placement (as defined below), of which $400,000 was attributed to offering costs in connection with the
Private Placement. As of March 31, 2024 the Private Placement had not yet closed. The Private Placement closed subsequent to the quarter
and the net advance amount was converted into Series C-1 Preferred Stock. (See note 12)
NOTE 10 – STOCKHOLDERS’ EQUITY
Common Stock
On May 24, 2021, the Company increased the number
of authorized shares of the Company’s common stock, par value $0.001 per share, from 27,000,000 to 100,000,000 (the
“Authorized Shares Increase”) by filing a Certificate of Amendment (the “Certificate of Amendment”) to its Amended
and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. In accordance with the General Corporation
Law of the State of Delaware, the Authorized Shares Increase and the Certificate of Amendment were approved by the stockholders of the
Company at the Company’s Annual Meeting of Stockholders on May 19, 2021. On September 13, 2022, the Company effectuated a 1
for 50 reverse stock split (the “2022 Reverse Split”). The Company’s stock began trading at the 2022 Reverse Split
price effective on the Nasdaq Stock Market on September 14, 2022. There was no change to the number of authorized shares of the Company’s
common stock. On August 17, 2023, the Company effectuated a 1 for 40 reverse stock split (the “2023 Reverse Split”). The
Company’s stock began trading at the 2023 Reverse Split price effective on the Nasdaq Stock Market on August 17, 2023. There was
no change to the number of authorized shares of the Company’s common stock.
Formed in January 2023, our majority owned subsidiary
Pearsanta™, Inc. (“Pearsanta”) seeks to take personalized medicine to a new level by delivering “Health by the
Numbers.” On November 22, 2023, Pearsanta entered into an assignment agreement with FirstVitals LLC, an entity controlled by Pearsanta’s
CEO, Ernie Lee (“FirstVitals”), pursuant to which FirstVitals assigned its rights in certain intellectual property and website
domain to Pearsanta in consideration of the issuance of 500,000 shares of Pearsanta common stock to FirstVitals. On December 18, 2023,
the board of directors of Pearsanta adopted the Pearsanta 2023 Omnibus Equity Incentive Plan (the “Pearsanta Omnibus Incentive Plan”),
pursuant to which it reserved 15 million shares of common stock of Pearsanta for future issuance under the Pearsanta Omnibus Incentive
Plan and the Pearsanta 2023 Parent Service Provider Equity Incentive Plan (the “Pearsanta Parent Service Provider Plan”) and
approved the issuance of 9.32 million options, exercisable into shares of Pearsanta common stock under the Pearsanta Parent Service Provider
Plan and the issuance of 4.0 million options, exercisable into shares of Pearsanta common stock, subject to vesting, and 1.0 million restricted
common stock shares under the Pearsanta Omnibus Incentive Plan.
During the three months ended March 31, 2024,
the Company issued 50,000 shares of common stock as part of the MDNA asset purchase agreement. (See Note 9) During the three
months ended March 31, 2024, the Company issued 296,296 shares of common stock as part of a settlement agreement. (See Note 9)
During the three months ended March 31, 2023,
the Company issued 4,675 shares of common stock and recognized expense of $168,300 in stock-based compensation for consulting
services. The stock-based compensation for consulting services is calculated by the number shares multiplied by the closing price on the
effective date of the contract. During the three months ended March 31, 2023, 44 Restricted Stock Units vested which resulted
in the issuance of shares. The Company recognized expense of $111,187 in stock-based compensation for the three months ended March
31, 2023. The stock-based compensation for shares issued or RSU’s granted during the period were valued based on the fair market
value on the date of grant.
Closing of Private Placement
On December 29, 2023, the Company entered into
a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (“the “December Purchaser”)
for the issuance and sale in a private placement (the “December Private Placement”) of (i) pre-funded warrants (the “December
Pre-Funded Warrants”) to purchase up to 1,237,114 shares of the Company’s Common Stock, par value $0.001 at an exercise price
of $0.001 per share, and (ii) warrants (the “December Common Warrants”) to purchase up to 2,474,228 shares of the Company’s
Common Stock, at a purchase price of $4.85 per share.
Pursuant to the Purchase Agreement, the Company
agreed to reduce the exercise price of certain outstanding warrants to purchase Common Stock of the Company (“Certain Outstanding
Warrants”) held by the Purchaser to $4.60 per share in consideration for the cash payment by the December Purchaser of $0.125 per
share of Common Stock underlying the Certain Outstanding Warrants, effective immediately.
The December Private Placement closed on January
4, 2024. The net proceeds to the Company from the December Private Placement were approximately $5.5 million, after deducting placement
agent fees and expenses and estimated offering expenses payable by the Company.
In addition, the Company agreed to pay H.C. Wainwright
& Co., LLC (“Wainwright”) certain expenses and issued to Wainwright or its designees warrants (the “December Placement
Agent Warrants”) to purchase up to an aggregate of 74,227 shares of Common Stock at an exercise price equal to $6.0625 per share.
The December Placement Agent Warrants are exercisable immediately upon issuance and have a term of exercise equal to three years from
the date of issuance.
Preferred Stock
The Company is authorized to issue 3,000,000 shares
of preferred stock, par value $0.001 per share. There were 30,905 and 24,905 shares of preferred stock outstanding as of
March 31, 2024 and December 31, 2023, respectively.
Aditxt Preferred Share Class | |
Quantity
Issued and
Outstanding
as of
March 31,
2024 | |
Series A Preferred Stock | |
| - | |
Series A-1 Convertible Preferred Stock | |
| 22,280 | |
Series B Preferred Stock | |
| - | |
Series B-1 Convertible Preferred Stock | |
| 6,000 | |
Series B-2 Convertible Preferred Stock | |
| 2,625 | |
Series C Preferred Stock | |
| - | |
Total Aditxt Preferred Shares Outstanding | |
| 30,905 | |
Issuance of Series A-1 Preferred Stock:
On December 11, 2023 (the “Execution Date”),
the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Adicure, Inc., a Delaware corporation
and wholly owned subsidiary of the Company (“Merger Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”),
pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly
owned subsidiary of the Company.
Subject to the terms and conditions set forth
in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares
of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common Stock
held by the Company or Merger Sub immediately prior to the Effective Time, will be converted into the right to receive an aggregate of
610,000 shares of the Company’s common stock, par value $0.001 per share (“Company Common Stock”); and (ii) all issued
and outstanding shares of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred Stock”),
other than any shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior to the Effective Time,
will be converted into the right to receive an aggregate of 2,327 shares of Series A-1 Preferred Stock, par value $0.001 of the Company
(the “Company Preferred Stock”), having such rights, powers, and preferences set forth in the form of Certificate of Designation
of Series A-1 Preferred Stock. See Series A-1 Preferred Stock certificate of designation incorporated by reference to this document.
On December 22, 2023, the Company entered into
an Exchange Agreement (the “Exchange Agreement”) with the holders (the “Holders”) of an aggregate of 22,280 shares
of Series F-1 Convertible Preferred Stock of Evofem (the “Evofem Series F-1 Preferred Stock”) agreed to exchange their respective
shares of Evofem Series F-1 Preferred Stock for an aggregate of 22,280 shares of a new series of convertible preferred stock of the Company
designated as Series A-1 Convertible Preferred Stock, $0.001 par value, (the “Series A-1 Preferred Stock”).
The following is only a summary of the Series
A-1 Certificate of Designations, and is qualified in its entirety by reference to the full text of the Series A-1 Certificate of Designations,
a copy of which is filed as Exhibit 3.1 to our Current Report on Form 8-K filed on December 26, 2023 and is incorporated by reference
herein.
Designation, Amount, and Par Value: The number
of Series A-1 Preferred Stock designated is 22,280 shares. The shares of Series A-1 Preferred Stock have a par value of $0.001 per share
and a stated value of $1,000 per share.
Conversion Price: The Series A-1 Preferred Stock
will be convertible into shares of Common Stock at an initial conversion price of $4.44 (subject to adjustment pursuant to the Series
A-1 Certificate of Designations) (the “Conversion Price”). The Certificate of Designations also provides that in the event
of certain Triggering Events (as defined below) any holder may, at any time, convert any or all of such holder’s Series A-1 Preferred
Stock at an alternate conversion rate equal to the product of (i) the Alternate Conversion Price (as defined below) and (ii) the quotient
of (x) the 25% redemption premium multiplied by (y) the amount of Series A-1 Preferred Stock subject to such conversion. “Triggering
Events” include, among others, (i) a suspension of trading or the failure to be traded or listed on an eligible market for five
consecutive days or more, (ii) the failure to remove restrictive legends when required, (iii) the Company’s default in payment of
indebtedness in an aggregate amount of $500,000 or more (the Company is currently in default for payments greater than $500,000), (iv)
proceedings for a bankruptcy, insolvency, reorganization or liquidation, which are not dismissed with 30 days, (v) commencement of a voluntary
bankruptcy proceeding, and (viii) final judgments against the Company for the payment of money in excess of $100,000. “Alternate
Conversion Price” means the lowest of (i) the applicable conversion price the in effect, (ii) the greater of (x) $0.888 (the “Floor
Price”) and (y) 80% of the volume weighted average price (“VWAP”) of the Common Stock on the trading day immediately
preceding the delivery of the applicable conversion notice. Further, the Series A-1 Certificate of Designations provides that if on any
of the 90th and 180th day after each of the occurrence of any Stock Combination Event (as defined in the Series A-1 Certificate of Designations)
and the Applicable Date (as defined in the Series A-1 Certificate of Designations), the conversion price then in effect is greater than
the market price then in effect (the “Adjustment Price”), on such date then the conversion price shall automatically lower
to the Adjustment Price.
Dividends: Holders of the Series A-1 Preferred
Stock shall be entitled to receive dividends when and as declared by the Board, from time to time, in its sole discretion, which Dividends
shall be paid by the Company out of funds legally available therefor, payable, subject to the conditions and other terms hereof, in cash,
in securities of the Company or any other entity, or using assets as determined by the Board on the Stated Value of such Preferred Share.
Liquidation: In the event of a Liquidation Event
(as defined in the Series A-1 Certificate of Designation), the holders the Series A-1 Preferred Stock shall be entitled to receive in
cash out of the assets of the Company, before any amount shall be paid to the holders of any other shares of capital stock of the Company,
equal to the greater of (A) 125% of the Conversion Amount (as defined in the Series A-1 Certificate of Designation) on the date of such
payment and (B) the amount per share such holder of Series A-1 Preferred Stock would receive if they converted such share of Series A-1
Preferred Stock into Common Stock immediately prior to the date of such payment
Company Redemption: The Company may redeem all,
or any portion, of the Series A-1 Preferred Stock for cash, at a price per share of Series A-1 Preferred Stock equal to 115% of the greater
of (i) the Conversion Amount (as defined in the Series A-1 Certificate of Designation)being redeemed as of the Company Optional Redemption
Date (as defined in the Series A-1 Certificate of Designation) and (ii) the product of (1) the Conversion Rate (as defined in the Series
A-1 Certificate of Designation) with respect to the Conversion Amount being redeemed as of the Company Optional Redemption Date multiplied
by (2) the greatest Closing Sale Price (as defined in the Certificate of Designation) of the Common Stock on any Trading Day during the
period commencing on the date immediately preceding such Company Optional Redemption Notice Date (as defined in the Certificate of Designation)
and ending on the Trading Day immediately prior to the date the Company makes the entire payment required to be made under the Certification
of Designation.
Maximum Percentage: Holders of Series A-1 Preferred
Stock are prohibited from converting shares of Series A-1 Preferred Stock into shares of Common Stock if, as a result of such conversion,
such holder, together with its affiliates, would beneficially own in excess of 4.99% (the “Maximum Percentage”) of the total
number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
Voting Rights: The holders of the Series A-1 Preferred
Stock shall have no voting power and no right to vote on any matter at any time, either as a separate series or class or together with
any other series or class of share of capital stock, and shall not be entitled to call a meeting of such holders for any purpose nor shall
they be entitled to participate in any meeting of the holders of Common Stock, except as expressly provided in the Certificate of Designations
and where required by the DGCL.
Issuance of Series B Preferred Stock:
On July 19, 2022, the Company entered into a Subscription
and Investment Representation Agreement with its Chief Executive Officer (the “Purchaser”), pursuant to which the Company
agreed to issue and sell one (1) share of the Company’s Series B Preferred Stock (the “Preferred Stock”),
par value $0.001 per share, to the Purchaser for $20,000 in cash.
On July 19, 2022, the Company filed a certificate
of designation (the “Certificate of Designation”) with the Secretary of State of Delaware, effective as of the time of filing,
designating the rights, preferences, privileges and restrictions of the share of Preferred Stock. The Certificate of Designation provides
that the share of Preferred Stock will have 250,000,000 votes and will vote together with the outstanding shares of the Company’s
common stock as a single class exclusively with respect to any proposal to amend the Company’s Restated Certificate of Incorporation
to effect a reverse stock split of the Company’s common stock. The Preferred Stock will be voted, without action by the holder,
on any such proposal in the same proportion as shares of common stock are voted. The Preferred Stock otherwise has no voting rights except
as otherwise required by the General Corporation Law of the State of Delaware.
The Preferred Stock is not convertible into, or
exchangeable for, shares of any other class or series of stock or other securities of the Company. The Preferred Stock has no rights with
respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale,
dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Preferred Stock will not be entitled
to receive dividends of any kind. See Series B Preferred Stock certificate of designation incorporated by reference to this document.
The outstanding share of Preferred Stock shall
be redeemed in whole, but not in part, at any time (i) if such redemption is ordered by the Board of Directors in its sole discretion
or (ii) automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing a reverse stock split.
Upon such redemption, the holder of the Preferred Stock will receive consideration of $20,000 in cash.
Redemption of Series B Preferred Stock
On October 7, 2022, the Company paid $20,000 in
consideration for the one share of Preferred Stock which was redeemed on September 13, 2022.
Series B-1 Preferred Stock Certificate of Designation
On January 24, 2024,
the Company filed a Certificate of Designations for its Series B-1 Preferred Stock with the Secretary of State of Delaware (the “Series
B-1 Certificate of Designations”). The following is only a summary of the Series B-1 Certificate of Designations, and is qualified
in its entirety by reference to the full text of the Series B-1 Certificate of Designations, a copy of which is filed as Exhibit 3.1 to
this Current Report on Form 8-K and is incorporated by reference herein.
Designation, Amount,
and Par Value: The number of Series B-1 Preferred Stock designated is 6,000 shares. The shares of Series B-1 Preferred Stock have
a par value of $0.001 per share and a stated value of $1,000 per share.
Conversion Price: The
Series B-1 Preferred Stock will be convertible into shares of Common Stock at an initial conversion price of $4.06 (subject to adjustment
pursuant to the Series B-1 Certificate of Designations) (the “Conversion Price”). The
Series B-1 Certificate of Designations also provides that in the event of certain Triggering Events (as defined below) any holder may,
at any time, convert any or all of such holder’s Series B-1 Preferred Stock
at an alternate conversion rate equal to the product of (i) the Alternate Conversion Price (as defined below) and (ii) the quotient of
(x) the 125% redemption premium multiplied by (y) the amount of Series B-1 Preferred
Stock subject to such conversion. “Triggering Events” include, among others, (i) a suspension of trading or the failure to
be traded or listed on an eligible market for five consecutive days or more, (ii) the failure to remove restrictive legends when required,
(iii) the Company’s default in payment of indebtedness in an aggregate amount of $500,000 or more, (iv) proceedings for a bankruptcy,
insolvency, reorganization or liquidation, which are not dismissed with 30 days, (v) commencement of a voluntary bankruptcy proceeding,
and (viii) final judgments against the Company for the payment of money in excess of $500,000. “Alternate Conversion Price”
means the lowest of (i) the applicable conversion price the in effect, (ii) the greater of (x) $0.9420 (the “Floor Price”)
and (y) 80% of the lowest volume weighted average price (“VWAP”) of the Common Stock during the five consecutive trading day
period ending and including the trading day immediately preceding the delivery of the applicable conversion notice. Further, the Series B-1 Certificate
of Designations provides that if on any of the 90th and 180th day after each of the occurrence of any Stock
Combination Event (as defined in the Series B-1 Certificate of Designations) and
the Applicable Date (as defined in the Series B-1 Certificate of Designations),
the conversion price then in effect is greater than the market price then in effect (the “Adjustment Price”), on such date
then the conversion price shall automatically lower to the Adjustment Price.
Dividends: Holders of
the Series B-1 Preferred Stock shall be entitled to receive dividends when and as declared by the Board, from time to time, in its sole
discretion, which Dividends shall be paid by the Company out of funds legally available therefor, payable, subject to the conditions and
other terms hereof, in cash, in securities of the Company or any other entity, or using assets as determined by the Board on the Stated
Value of such Preferred Share.
Liquidation: In
the event of a Liquidation Event (as defined in the Series B-1 Certificate of Designations), the holders the Series B-1 Preferred Stock
shall be entitled to receive in cash out of the assets of the Company, before any amount shall be paid to the holders of any other shares
of capital stock of the Company, equal to the greater of (A) 125% of the Conversion Amount (as defined in the Series B-1 Certificate of
Designation) on the date of such payment and (B) the amount per share such holder of Series B-1 Preferred Stock would receive if they
converted such share of Series B-1 Preferred Stock into Common Stock immediately prior to the date of such payment.
Company Redemption: The
Company may redeem all, or any portion, of the Series B-1 Preferred Stock for cash, at a price per share of Series B-1 Preferred Stock
equal to 115% of the greater of (i) the Conversion Amount (as defined in the Series B-1 Certificate of Designations) being redeemed as
of the Company Optional Redemption Date (as defined in the Series B-1 Certificate of Designations) and (ii) the product of (1) the Conversion
Rate (as defined in the Series B-1 Certificate of Designations) with respect to the Conversion Amount being redeemed as of the Company
Optional Redemption Date multiplied by (2) the greatest Closing Sale Price (as defined in the Series B-1 Certificate of Designations)
of the Common Stock on any Trading Day during the period commencing on the date immediately preceding such Company Optional Redemption
Notice Date (as defined in the Series B-1 Certificate of Designations) and ending on the Trading Day immediately prior to the date the
Company makes the entire payment required to be made under the Certification of Designation.
Maximum Percentage: Holders
of Series B-1 Preferred Stock are prohibited from converting shares of Series B-1 Preferred Stock into shares of Common Stock if, as a
result of such conversion, such holder, together with its affiliates, would beneficially own in excess of 4.99% (the “Maximum Percentage”)
of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
Voting Rights: The
holders of the Series B-1 Preferred Stock shall have no voting power and no right to vote on any matter at any time, either as a separate
series or class or together with any other series or class of share of capital stock, and shall not be entitled to call a meeting of such
holders for any purpose nor shall they be entitled to participate in any meeting of the holders of Common Stock, except as expressly provided
in the Series B-1 Certificate of Designations and where required by the DGCL.
Issuance of Series B-2 Preferred Stock:
On December 29, 2023, the Company entered into
an Exchange Agreement (the “Note Exchange Agreement”) with the Noteholder, pursuant to which the Noteholder agreed, subject
to the terms and conditions set forth therein, to exchange the Note, including all accrued but unpaid interest thereon, for an aggregate
of 2,625 shares of a new series of convertible preferred stock of the Company, designated as Series B-2 Convertible Preferred Stock, $0.001
par value (the “Series B-2 Preferred Stock”). See Series B-2 Preferred Stock certificate of designation incorporated by reference
to this document.
The following is only a summary of the Series
B-2 Certificate of Designations, and is qualified in its entirety by reference to the full text of the Series B-2 Certificate of Designations,
a copy of which is filed as an exhibit to our Current Report on Form 8-K filed with the SEC on January 2, 2024.
Designation, Amount, and Par Value: The number
of Series B-2 Preferred Stock designated is 2,625 shares. The shares of Series B-2 Preferred Stock have a par value of $0.001 per share
and a stated value of $1,000 per share.
Conversion Price: The Series B-2 Preferred Stock
will be convertible into shares of Common Stock at an initial conversion price of $4.71 (subject to adjustment pursuant to the Series
B-2 Certificate of Designations) (the “Conversion Price”). The Series B-2 Certificate of Designations also provides that in
the event of certain Triggering Events (as defined below) any holder may, at any time, convert any or all of such holder’s Series
B-2 Preferred Stock at an alternate conversion rate equal to the product of (i) the Alternate Conversion Price (as defined below) and
(ii) the quotient of (x) the 125% redemption premium multiplied by (y) the amount of Series B-2 Preferred Stock subject to such conversion.
“Triggering Events” include, among others, (i) a suspension of trading or the failure to be traded or listed on an eligible
market for five consecutive days or more, (ii) the failure to remove restrictive legends when required, (iii) the Company’s default
in payment of indebtedness in an aggregate amount of $500,000 or more(the Company is currently in default for payments greater than $500,000),
(iv) proceedings for a bankruptcy, insolvency, reorganization or liquidation, which are not dismissed with 30 days, (v) commencement of
a voluntary bankruptcy proceeding, and (viii) final judgments against the Company for the payment of money in excess of $500,000. “Alternate
Conversion Price” means the lowest of (i) the applicable conversion price the in effect, (ii) the greater of (x) $0.9420 (the “Floor
Price”) and (y) 80% of the lowest volume weighted average price (“VWAP”) of the Common Stock during the five consecutive
trading day period ending and including the trading day immediately preceding the delivery of the applicable conversion notice. Further,
the Series B-2 Certificate of Designations provides that if on any of the 90th and 180th day after each of the occurrence of any Stock
Combination Event (as defined in the Series B-2 Certificate of Designations) and the Applicable Date (as defined in the Series B-2 Certificate
of Designations), the conversion price then in effect is greater than the market price then in effect (the “Adjustment Price”),
on such date then the conversion price shall automatically lower to the Adjustment Price.
Dividends: Holders of the Series B-2 Preferred
Stock shall be entitled to receive dividends when and as declared by the Board, from time to time, in its sole discretion, which Dividends
shall be paid by the Company out of funds legally available therefor, payable, subject to the conditions and other terms hereof, in cash,
in securities of the Company or any other entity, or using assets as determined by the Board on the Stated Value of such Preferred Share.
Liquidation: In the event of a Liquidation Event
(as defined in the Series B-2 Certificate of Designations), the holders the Series B-2 Preferred Stock shall be entitled to receive in
cash out of the assets of the Company, before any amount shall be paid to the holders of any other shares of capital stock of the Company,
equal to the greater of (A) 125% of the Conversion Amount (as defined in the Series B-2 Certificate of Designation) on the date of such
payment and (B) the amount per share such holder of Series B-2 Preferred Stock would receive if they converted such share of Series B-2
Preferred Stock into Common Stock immediately prior to the date of such payment.
Company Redemption: The Company may redeem all,
or any portion, of the Series B-2 Preferred Stock for cash, at a price per share of Series B-2 Preferred Stock equal to 115% of the greater
of (i) the Conversion Amount (as defined in the Series B-2 Certificate of Designations) being redeemed as of the Company Optional Redemption
Date (as defined in the Series B-2 Certificate of Designations) and (ii) the product of (1) the Conversion Rate (as defined in the Series
B-2 Certificate of Designations) with respect to the Conversion Amount being redeemed as of the Company Optional Redemption Date multiplied
by (2) the greatest Closing Sale Price (as defined in the Series B-2 Certificate of Designations) of the Common Stock on any Trading Day
during the period commencing on the date immediately preceding such Company Optional Redemption Notice Date (as defined in the Series
B-2 Certificate of Designations) and ending on the Trading Day immediately prior to the date the Company makes the entire payment required
to be made under the Certification of Designation.
Maximum Percentage: Holders of Series B-2 Preferred
Stock are prohibited from converting shares of Series B-2 Preferred Stock into shares of Common Stock if, as a result of such conversion,
such holder, together with its affiliates, would beneficially own in excess of 4.99% (the “Maximum Percentage”) of the total
number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
Voting Rights: The holders of the Series B-2 Preferred Stock shall
have no voting power and no right to vote on any matter at any time, either as a separate series or class or together with any other series
or class of share of capital stock, and shall not be entitled to call a meeting of such holders for any purpose nor shall they be entitled
to participate in any meeting of the holders of Common Stock, except as expressly provided in the Series B-2 Certificate of Designations
and where required by the DGCL.
Series C Preferred Stock
On July 11, 2023, the Company filed a certificate
of designation (the “Certificate of Designation”) with the Secretary of State of Delaware, effective as of the time of filing,
designating the rights, preferences, privileges and restrictions of the share of Preferred Stock. The Certificate of Designation provides
that the share of Preferred Stock will have 250,000,000 votes and will vote together with the outstanding shares of the Company’s
common stock as a single class exclusively with respect to any proposal to amend the Company’s Amended and Restated Certificate
of Incorporation to effect a reverse stock split of the Company’s common stock. The Preferred Stock will be voted, without action
by the holder, on any such proposal in the same proportion as shares of common stock are voted. The Preferred Stock otherwise has no voting
rights except as otherwise required by the General Corporation Law of the State of Delaware.
The Preferred Stock is not convertible into, or
exchangeable for, shares of any other class or series of stock or other securities of the Company. The Preferred Stock has no rights with
respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale,
dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Preferred Stock will not be entitled
to receive dividends of any kind.
The outstanding share of Preferred Stock shall
be redeemed in whole, but not in part, at any time (i) if such redemption is ordered by the Board of Directors in its sole discretion
or (ii) automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing a reverse stock split.
Upon such redemption, the holder of the Preferred Stock will receive consideration of $1,000 in cash. As of December 31, 2023, the share
has been redeemed and the consideration has been paid.
On July 11, 2023, the Company entered into a Subscription
and Investment Representation Agreement (the “Subscription Agreement”) with Amro Albanna, its Chief Executive Officer, who
is an accredited investor (the “Purchaser”), pursuant to which the Company agreed to issue and sell one (1) share of the Company’s
Series C Preferred Stock, par value $0.001 per share (the “Preferred Stock”), to the Purchaser for $1,000 in cash. The sale
closed on July 11, 2023. The Subscription Agreement contains customary representations and warranties and certain indemnification rights
and obligations of the parties. See Series C Preferred Stock certificate of designation incorporated by reference to this document. On
August 17, 2023, the share was redeemed.
Stock-Based Compensation
In October 2017, our Board of Directors adopted
the Aditx Therapeutics, Inc. 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provides for the grant of equity
awards to directors, employees, and consultants. The Company is authorized to issue up to 2,500,000 shares of our common
stock pursuant to awards granted under the 2017 Plan. The 2017 Plan is administered by our Board of Directors, and expires ten years after
adoption, unless terminated earlier by the Board of Directors. All shares of our common stock pursuant to awards under the 2017 Plan
have been awarded.
On February 24, 2021, our Board of Directors adopted
the Aditx Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). The 2021 Plan provides for grants of nonqualified
stock options, incentive stock options, stock appreciation rights, restricted stock and restricted stock units, and other stock-based
awards (collectively, the “Awards”). Eligible recipients of Awards include employees, directors or independent contractors
of the Company or any affiliate of the Company. The Compensation Committee of the Board of Directors (the “Committee”) administers
the 2021 Plan. A total of 60,000 shares of common stock, par value $0.001 per share, of the Company may be issued pursuant
to Awards granted under the 2021 Plan. The exercise price per share for the shares to be issued pursuant to an exercise of a stock option
will be no less than one hundred percent (100%) of the Fair Market Value (as defined in the 2021 Plan) of a share of Common Stock on the
date of grant. The 2021 Plan was submitted and approved by the Company’s stockholders at the 2021 annual meeting of stockholders,
held on May 19, 2021.
During the three months ended March 31, 2024 and
2023, the Company granted no new options.
The Company recognizes option
forfeitures as they occur, as there is insufficient historical data to accurately determine future forfeitures rates.
The following is an analysis of the stock option
grant activity under the Plan:
Vested and Nonvested Stock Options | | Number | | | Weighted Average Exercise Price | | | Weighted Average Remaining Life | |
Outstanding December 31, 2023 | | | 45,572 | | | $ | 173.12 | | | | 9.74 | |
Granted | | | - | | | | - | | | | - | |
Exercised | | | - | | | | - | | | | - | |
Expired or forfeited | | | - | | | | - | | | | - | |
Outstanding March 31, 2024 | | | 45,572 | | | $ | 173.12 | | | | 9.49 | |
Nonvested Stock Options | |
Number | | |
Weighted- Average Exercise Price | |
Nonvested on December 31, 2023 | |
| - | | |
$ | - | |
Granted | |
| - | | |
| - | |
Vested | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Nonvested on March 31, 2024 | |
| - | | |
$ | - | |
As of March 31, 2024 there were 45,572 exercisable
options; these options had a weighted average exercise price $173.12.
On December 18, 2023, our Board of Directors adopted
the Pearsanta, Inc. 2023 Omnibus Equity Incentive Plan (the “Pearsanta 2023 Plan”) and the 2023 Parent Service Provider Equity
Incentive Plan (the “Pearsanta Parent 2023 Plan”), collectively (the “Pearsanta Plans”). The Pearsanta Plans provides
for grants of nonqualified stock options, incentive stock options, stock appreciation rights, restricted stock and restricted stock units,
and other stock-based awards (collectively, the “Pearsanta Awards”). Eligible recipients of Pearsanta Awards include employees,
directors or independent contractors of the Company or any affiliate of the Company. The Board of Directors administers the Pearsanta
Plans. The Pearsanta 2023 Plan consists of a total of 15,000,000 shares of Pearsanta common stock, par value $0.001 per
share, which may be issued pursuant to Pearsanta Awards granted under the Pearsanta 2023 Plan. The Pearsanta Parent 2023 Plan consists
of a total of 9,320,000 shares of Pearsanta common stock, par value $0.001 per share, which may be issued pursuant to Pearsanta
Awards granted under the Pearsanta Parent 2023 Plan. The exercise price per share for the shares to be issued pursuant to an exercise
of a stock option will be no less than one hundred percent (100%) of the Fair Market Value (as defined in the Pearsanta Plans) of a share
of Common Stock on the date of grant.
During the three months ended March 31, 2024 and
2023, Pearsanta granted no new options under the Pearsanta 2023 Plan.
The following is an analysis of the stock option
grant activity under the Pearsanta Plans:
Vested and Nonvested Stock Options | |
Number | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Life | |
Outstanding December 31, 2023 | |
| 13,320,000 | | |
$ | 0.02 | | |
| 9.97 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired or forfeited | |
| - | | |
| - | | |
| - | |
Outstanding March 31, 2024 | |
| 13,320,000 | | |
$ | 0.02 | | |
| 9.72 | |
Nonvested Stock Options | |
Number | | |
Weighted- Average Exercise Price | |
Nonvested on December 31, 2023 | |
| 4,000,000- | | |
$ | 0.02 | |
Granted | |
| - | | |
| - | |
Vested | |
| (1,334,000 | ) | |
| 0.02 | |
Forfeited | |
| - | | |
| - | |
Nonvested on March 31, 2024 | |
| 2,666,000 | | |
$ | 0.02 | |
As of March 31, 2024, there were 10,654,000 exercisable
options; these options had a weighted average exercise price $0.02.
The Company recognized stock-based compensation
expense related to all options granted and vesting expense of $24,572 during the three months ended March 31, 2024, of which $24,572 is
included in general and administrative expenses in the accompanying statements of operations. The remaining value to be expensed is $53,240 as
of March 31, 2024. The weighted average vesting term is 1.92 years as of March 31, 2024. The Company recognized stock-based
compensation expense related to all options granted and vesting expense of $59,964 during the three months ended March 31, 2023,
of which $24,429 is included in general and administrative expenses and $35,535 is included in research and development expenses in the
accompanying statements of operations.
Warrants
For the
three months ended March 31, 2024, the fair value of each warrant granted was estimated using
the assumption and/or factors in the Black-Scholes Model as follows:
Exercise price | |
$ | 5.23 | |
Expected dividend yield | |
| 0 | % |
Risk free interest rate | |
| 3.97 | % |
Expected life in years | |
| 5.0 | |
Expected volatility | |
| 219 | % |
The risk-free interest rate assumption for warrants
granted is based upon observed interest rates on the United States Government Bond Equivalent Yield appropriate for the expected term
of warrants.
The Company determined the expected volatility
assumption for warrants granted using the historical volatility of comparable public companies’ common stock. The Company will continue
to monitor peer companies and other relevant factors used to measure expected volatility for future warrant grants, until such time that
the Company’s common stock has enough market history to use historical volatility.
The dividend yield assumption for warrants granted
is based on the Company’s history and expectation of dividend payouts. The Company has never declared nor paid any cash dividends
on its common stock, and the Company does not anticipate paying any cash dividends in the foreseeable future.
The Company recognizes warrant forfeitures as
they occur, as there is insufficient historical data to accurately determine future forfeitures rates.
A summary of warrant issuances are as follows:
Vested and Nonvested Warrants | |
Number | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Life | |
Outstanding December 31, 2023 | |
| 5,047,450 | | |
$ | 14.11 | | |
| 2.73 | |
Granted | |
| 50,000 | | |
| 5.23 | | |
| 4.77 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired or forfeited | |
| (400 | ) | |
| 400.00 | | |
| - | |
Outstanding March 31, 2024 | |
| 5,097,050 | | |
$ | 13.63 | | |
| 2.56 | |
Nonvested Warrants | |
Number | | |
Weighted- Average Exercise Price | |
Nonvested on December 31, 2023 | |
| - | | |
$ | - | |
Granted | |
| 50,000 | | |
| 5.23 | |
Vested | |
| (50,000 | ) | |
| 5.23 | |
Forfeited | |
| - | | |
| - | |
Nonvested on March 31, 2024 | |
| - | | |
$ | - | |
Restricted Stock Units
A summary of Restricted Stock Units (“RSUs”)
issuances are as follows:
Nonvested RSUs | |
Number | | |
Weighted Average Price | |
Nonvested December 31, 2023 | |
| - | | |
$ | - | |
Granted | |
| - | | |
| - | |
Vested | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Nonvested March 31, 2024 | |
| - | | |
$ | - | |
The Company recognized stock-based compensation
expense related to RSUs granted and vesting expense of zero and $111,187 during the three months ended March 31, 2024 and March 31,
2023, respectively. Of the $111,187, $81,586 is included in general and administrative, $27,098 is included in research and
development, and $2,503 is included in sales and marketing in the accompanying Statements of Operations. The remaining value to be expensed
is $0 with a weighted average vesting term of 0 years as of March 31, 2024.
During the three months ended March 31, 2024,
the Company granted a total of zero RSUs. During the three months ended March 31, 2023, 44 RSUs vested and the Company
issued 44 shares of common stock for the 44 vested RSUs.
NOTE 11 – INCOME TAXES
The Company
has incurred losses since inception. During the three months ended March 31, 2023, the Company did not provide any provision for income
taxes as the Company incurred losses during such period. The Company accounts for income taxes using the asset and liability method in
accordance with ASC 740, “Accounting for Income Taxes”. The asset and liability method provides that deferred tax assets and
liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases
of assets and liabilities and for operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using
the currently enacted tax rates and laws that will be in effect when the differences are expected to reverse. In assessing the need for
a valuation allowance, the Company has considered both positive and negative evidence related to the likelihood of realization of deferred
tax assets using a “more likely than not” standard. In making such assessment, more weight was given to evidence that could
be objectively verified, including recent cumulative losses. Based on the Company’s review of this evidence, the Company has recorded
a full valuation allowance for its net deferred tax assets as of March 31, 2023.
As of March
31, 2023, the Company did not have any amounts recorded pertaining to uncertain tax positions.
NOTE 12 – SUBSEQUENT EVENTS
Appili Arrangement Agreement
On April 1, 2024 (the “Execution Date”),
the Company, entered into an Arrangement Agreement (the “Arrangement Agreement”), subject to various closing conditions, with
Adivir, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Adivir” or the “Buyer”), and
Appili Therapeutics, Inc., a Canadian corporation (“Appili”), pursuant to which, Adivir will acquire all of the issued and
outstanding Class A common shares of Appili (the “Appili Shares”) on the terms and subject to the conditions set forth therein.
The acquisition of the Appili Shares (the “Arrangement”) will be completed by way of a statutory plan of arrangement under
the Canada Business Corporation Act.
At the effective time of the Arrangement (the
“Effective Time”), each Appili Share outstanding immediately prior to the Effective Time (other than Appili Shares held by
a registered holder of Appili Shares who has validly exercised such holder’s dissent rights) will be deemed to be assigned and transferred
by the holder thereof to the Buyer in exchange for (i) $0.0467 in cash consideration per share for an aggregate cash payment of $5,668,222
(the “Cash Consideration”) and (ii) 0.002745004 of a share of common stock of Aditxt or an aggregate of 332,876 shares (the
“Consideration Shares” and together with the Cash Consideration, the “Transaction Consideration”). In connection
with the transaction, each outstanding option and warrant of Appili will be cashed-out based on the implied in-the-money value of the
Transaction Consideration, which is expected to result in an additional aggregate cash payment of approximately $341,000 (based on the
number of issued and outstanding options and warrants and exchange rates as of the date of the Arrangement Agreement).
Promissory Note
On
April 10, 2024, Sixth Borough Capital Fund, LP (“Sixth Borough) loaned $230,000 to the Company. The loan was evidenced by an unsecured
promissory note (the “April Sixth Borough Note”). Pursuant to the terms of the April Sixth Borough Note, it will accrue interest
at the Prime rate of eight and one-half percent (8.5%) per annum and is due on the earlier of April 19, 2024 or an event of default, as
defined therein.
On
May 9, 2024, at which point the balance of the loan was $35,256, Sixth Borough loaned an additional $20,000 to the Company bringing the
balance of the loan to $55,256.03. Additionally, the maturity date of the April Sixth Borough Note was extended to June 9, 2024.
EvoFem
Reinstatement and Fourth Amendment to the Merger Agreement
On April 26, 2024, the
Company received notice from Evofem (the “Termination Notice”) that Evofem was exercising its right to terminate the Merger
Agreement as a result of the Company’s failure to provide the Initial Parent Equity Investment (as defined in the Merger Agreement,
as amended).
On May 2, 2024, the Company,
Adifem, Inc. f/k/a Adicure, Inc. and Evofem Biosciences, Inc. (“Evofem”) entered into the Reinstatement and Fourth Amendment
to the Merger Agreement (the “Fourth Amendment”) in order to waive and amend, among other things, the several provisions listed
below.
Amendments to Article
VI: Covenants and Agreement
Article VI of the Merger
Agreement is amended to:
| ● | reinstate the Merger Agreement, as amended by the Fourth Amendment,
as if never terminated; |
| | |
| ● | reflect the Company’s payment to Evofem, in the amount
of $1,000,000 (the “Initial Payment”), via wire initiated by May 2, 2024; |
| | |
| ● | delete Section 6.3, which effectively eliminates the “no
shop” provision, and the several defined terms used therein; |
| ● | add a new defined term “Company Change of Recommendation;”
and |
| | |
| ● | revise section 6.10 of the Merger Agreement such that, after
the Initial Payment, and upon the closing of each subsequent capital raise by the Company (each a “Parent Subsequent Capital Raise”),
the Company shall purchase that number of shares of Evofem’s Series F-1 Preferred Stock, par value $0.0001 per share (the “Series
F-1 Preferred Stock”), equal to forty percent (40%) of the gross proceeds of such Parent Subsequent Capital Raise divided by 1,000,
up to a maximum aggregate amount of $2,500,000 or 2,500 shares of Series F-1 Preferred Stock. A maximum of$1,500,000 shall be raised
prior to June 17, 2024 and $1,000,000 prior to July 1, 2024 (the “Parent Capital Raise”). |
Amendments to Article
VIII: Termination
Article VIII of the Merger
Agreement is amended to:
| ● | extend the date after which either party may terminate from
May 8, 2024 to July 15, 2024; |
| ● | revise Section 8.1(d) in its entirety to allow Company to terminate
at any time after there has been a Company Change of Recommendation, provided that Aditxt must receive ten day written notice and have
the opportunity to negotiate a competing offer in good faith; and |
| ● | amend and restate Section 8.1(f) in its entirety, granting the
Company the right to terminate the agreement if (a) the full $1,000,000 Initial Payment required by the Fourth Amendment has not been
paid in full by May 3, 2024 (b) $1,500,000 of the Parent Capital Raise Amount has not been paid to the Company by June 17, 2024, (c)
$1,000,000 of the Parent Capital Raise Amount has not been paid to the Company by July 1, 2024, or (d) Aditxt does not pay any portion
of the Parent Equity Investment within five calendar days after each closing of a Parent Subsequent Capital Raise. |
Equity Line of Credit
On May 2, 2024, the Company
entered into a Common Stock Purchase Agreement (the “ELOC Purchase Agreement”) with an equity line investor (the “ELOC
Investor”), pursuant to which the ELOC Investor has agreed to purchase from the Company, at the Company’s direction from time
to time, in its sole discretion, from and after the date effective date of the Registration Statement (as defined below) and until the
termination of the ELOC Purchase Agreement in accordance with the terms thereof, shares of the Company’s common stock having a total
maximum aggregate purchase price of $150,000,000 (the “ELOC Purchase Shares”), upon the terms and subject to the conditions
and limitations set forth in the ELOC Purchase Agreement.
In connection with the
ELOC Purchase Agreement, the Company also entered into a Registration Rights Agreement with the Investor (the “ELOC Registration
Rights Agreement”), pursuant to which the Company agreed to file a registration statement with the Securities and Exchange Commission
covering the resale of the shares of common stock issued to the ELOC Investor pursuant to the ELOC Purchase Agreement (the “Registration
Statement”) by the later of (i) the 30th calendar day following the closing date, and (ii) the second business day following Stockholder
Approval (defined below).
The Company may, from
time to time and at its sole discretion, direct the ELOC Investor to purchase shares of its common stock upon the satisfaction of certain
conditions set forth in the ELOC Purchase Agreement at a purchase price per share based on the market price of the Company’s common
stock at the time of sale as computed under the ELOC Purchase Agreement. There is no upper limit on the price per share that the ELOC
Investor could be obligated to pay for common stock under the ELOC Purchase Agreement. The Company will control the timing and amount
of any sales of its common stock to the ELOC Investor, and the ELOC Investor has no right to require us to sell any shares to it under
the ELOC Purchase Agreement. Actual sales of shares of common stock to the ELOC Investor under the ELOC Purchase Agreement will depend
on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price
of its common stock and determinations by the Company as to available and appropriate sources of funding for the Company and its operations.
The ELOC Investor may not assign or transfer its rights and obligations under the ELOC Purchase Agreement.
Under the applicable
Nasdaq rules, in no event may the Company issue to the ELOC Investor under the ELOC Purchase Agreement more than 332,876 shares of common
stock, which number of shares is equal to 19.99% of the shares of the common stock outstanding immediately prior to the execution of the
ELOC Purchase Agreement (the “Exchange Cap”), unless (i) the Company obtains stockholder approval to issue shares of common
stock in excess of the Exchange Cap in accordance with applicable Nasdaq rules (“Stockholder Approval”), or (ii) the average
price per share paid by the Investor for all of the shares of common stock that the Company directs the ELOC Investor to purchase from
the Company pursuant to the ELOC Purchase Agreement, if any, equals or exceeds the official closing sale price on the Nasdaq Capital Market
immediately preceding the delivery of the applicable purchase notice to the Investor and (B) the average of the closing sale prices of
the Company’s common stock on the Nasdaq Capital market for the five business days immediately preceding the delivery of such purchase
notice.
In all cases, the Company
may not issue or sell any shares of common stock to the ELOC Investor under the ELOC Purchase Agreement which, when aggregated with all
other shares of the Company’s common stock then beneficially owned by the ELOC Investor and its affiliates, would result in the
ELOC Investor beneficially owning more than 4.99% of the outstanding shares of the Company’s common stock.
The net proceeds under
the ELOC Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to the
ELOC Investor. The Company expects that any proceeds received by it from such sales to the Investor will be used for working capital and
general corporate purposes.
As consideration for
the ELOC Investor’s commitment to purchase shares of common stock at the Company’s direction upon the terms and subject to
the conditions set forth in the ELOC Purchase Agreement, the Company shall pay the Investor a commitment fee as outlined in the ELOC Purchase
Agreement, which is payable on the later of (i) January 2, 2025 and (ii) the trading day following the date on which Stockholder Approval
is obtained.
The ELOC Purchase Agreement
contains customary representations, warranties and agreements of the Company and the ELOC Investor, limitations and conditions regarding
sales of ELOC Purchase Shares, indemnification rights and other obligations of the parties.
There are no restrictions
on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the ELOC Purchase Agreement other
than a prohibition (with certain limited exceptions) on entering into a dilutive securities transaction during certain periods when the
Company is selling common stock to the ELOC Investor under the Purchase Agreement. The ELOC Investor has agreed that it will not engage
in or effect, directly or indirectly, for its own account or for the account of any of its affiliates, any short sales of the Company’s
common stock or hedging transaction that establishes a net short position in the Company’s common stock during the term of the ELOC
Purchase Agreement.
The Company has the right
to terminate the ELOC Purchase Agreement at any time after the Commencement Date (as defined in the ELOC Purchase Agreement), at no cost
or penalty, upon three trading days’ prior written notice to the Investor. The Company and the ELOC Investor may also agree to terminate
the ELOC Purchase Agreement by mutual written consent, provided that no termination of the ELOC Purchase Agreement will be effective during
the pendency of any purchase that has not then fully settled in accordance with the ELOC Purchase Agreement. Neither the Company nor the
ELOC Investor may assign or transfer the Company’s respective rights and obligations under the ELOC Purchase Agreement.
May Private Placement
On May 2, 2024, the Company
entered into a Securities Purchase Agreement (the “May PIPE Purchase Agreement”) with certain accredited investors, pursuant
to which the Company agreed to issue and sell to such investors in a private placement (the “Private Placement”) (i) an aggregate
of 4,186 shares of the Company’s Series C-1 Convertible Preferred Stock (the “Series C-1 Preferred Stock”), (ii) an
aggregate of 4,186 shares of the Company’s Series D-1 Preferred Stock (the “Series D-1 Preferred Stock”), and (iii)
warrants (the “May PIPE Warrants”) to purchase up to an aggregate of 1,613,092 shares of the Company’s common stock.
The May PIPE Warrants
are exercisable commencing six months following the initial issuance date at an initial exercise price of $2.47 per share and expire five
years from the date of issuance.
On May 2, 2024, in connection
with the Purchase Agreement, the Company entered into a Registration Rights Agreement with the investors (the “May PIPE Registration
Rights Agreement”), pursuant to which the Company agreed to prepare and file with the Securities and Exchange Commission (the “SEC”)
a registration statement on Form S-3 (the “May PIPE Registration Statement”) covering the resale of the shares of the Company’s
common stock, par value $0.001 (the “Common Stock”) issuable upon conversion of the Series C-1 Preferred Stock (the “Conversion
Shares”) and upon exercise of the May PIPE Warrants (the “May PIPE Warrant Shares”) (i) on the later of (x) the 30th
calendar day after the closing date, or (y) the 2nd business day following the Stockholder Approval Date (as defined in the May PIPE Purchase
Agreement), with respect to the initial registration statement and (ii) on the date on which the Company is required to file any additional
May PIPE Registration Statement pursuant to the terms of the May PIPE Registration Rights Agreement with respect to any additional Registration
Statements that may be required to be filed by the Company (the “Filing Deadline”). Pursuant to the Registration Rights Agreement,
the Company is required to have the initial May PIPE Registration Statement declared effective by the SEC on the earlier of (x) the 60th
calendar day after the Filing Deadline (or the 90th calendar day after the Filing Deadline if subject to a full review by the SEC), and
(y) the 2nd business day after the date the Company is notified by the SEC that such May PIPE Registration Statement will not be reviewed.
In the event that the Company fails to file the May PIPE Registration Statement by the Filing Deadline, have it declared effective by
the Effectiveness Deadline, or the prospectus contained therein is not available for use or the investor is not otherwise able to sell
its May PIPE Warrant Shares pursuant to Rule 144, the Company shall be required to pay the investor an amount equal to 2% of such investor’s
Purchase Price (as defined in the May PIPE Purchase Agreement) on the date of such failure and on every thirty date anniversary until
such failure is cured.
In connection with the
Private Placement, the Sixth Borough Note (Note 7) was converted into Series C-1 Preferred Stock.
The Private Placement
closed on May 6, 2024. The gross proceeds from the Private Placement were approximately $4.2 million, prior to deducting the placement
agent’s fees and other offering expenses payable by the Company. The Company intends to use $1.0 million of the net proceeds to
fund certain obligations under its merger agreement with Evofem Biosciences, Inc. and the remainder of the net proceeds from the offering
for working capital and other general corporate purposes.
Dawson James Securities
(“Dawson James”) served as the Company’s exclusive placement agent in connection with the Private Placement, pursuant
to that certain engagement letter, dated as of May 2, 2024, between the Company and Dawson James (the “Engagement Letter”).
Pursuant to the Engagement Letter, the Company paid Dawson James (i) a total cash fee equal to 7% of the aggregate gross proceeds of the
Private Placement. In addition, the Company agreed to pay Dawson James certain expenses and issued to Dawson James or its designees warrants
(the “May PIPE Placement Agent Warrants”) to purchase 5% of the number of securities sold in the Private Placement. The May
PIPE Placement Agent Warrants are exercisable at an exercise price of $3.24375 per share commencing six months following issuance and
have a term of exercise equal to five years from the date of issuance.
Series C-1 Preferred
Stock Certificate of Designation
On May 2, 2024, the Company
filed a Certificate of Designation for its Series C-1 Preferred Stock with the Secretary of State of Delaware (the “Series C-1 Certificate
of Designations”). The following is only a summary of the Series C-1 Certificate of Designations, and is qualified in its entirety
by reference to the full text of the Series C-1 Certificate of Designations.
Designation, Amount,
and Par Value. The number of Series C-1 Preferred Stock designated is 10,853 shares. The shares of Series C-1 Preferred Stock have a par
value of $0.001 per share and a stated value of $1,000 per share.
Conversion Price: The
Series C-1 Preferred Stock will be convertible into shares of Common Stock at an initial conversion price of $2.595 (subject to adjustment
pursuant to the Series C-1 Certificate of Designations) (the “Series C-1 Conversion Price”). The Series C-1 Certificate of
Designations also provides that in the event of certain Triggering Events (as defined below) any holder may, at any time, convert any
or all of such holder’s Series C-1 Preferred Stock at an alternate conversion rate equal to the product of (i) the Alternate Conversion
Price (as defined below) and (ii) the quotient of (x) the 25% redemption premium multiplied by (y) the amount of Series C-1 Preferred
Stock subject to such conversion. “Triggering Events” include, among others, (i) a suspension of trading or the failure to
be traded or listed on an eligible market for five consecutive days or more, (ii) the failure to remove restrictive legends when required,
(iii) the Company’s default in payment of indebtedness in an aggregate amount of $500,000 or more, (iv) proceedings for a bankruptcy,
insolvency, reorganization or liquidation, which are not dismissed with 30 days, (v) commencement of a voluntary bankruptcy proceeding,
and (viii) final judgments against the Company for the payment of money in excess of $500,000. “Alternate Conversion Price”
means the lowest of (i) the applicable conversion price the in effect, (ii) the greater of (x) $0.519 (the “Floor Price”)
and (y) 80% of the volume weighted average price (“VWAP”) of the Common Stock on the trading day immediately preceding the
delivery of the applicable conversion notice. Further, the Series C-1 Certificate of Designations provides that if on any of the 90th
and 180th day after each of the occurrence of any Stock Combination Event (as defined in the Series C-1 Certificate of Designations) and
the Applicable Date (as defined in the Series C-1 Certificate of Designations), the conversion price then in effect is greater than the
market price then in effect (the “Adjustment Price”), on such date then the conversion price shall automatically lower to
the Adjustment Price.
Dividends: Holders of
the Series C-1 Preferred Stock shall be entitled to receive dividends when and as declared by the Board, from time to time, in its sole
discretion, which Dividends shall be paid by the Company out of funds legally available therefor, payable, subject to the conditions and
other terms hereof, in cash, in securities of the Company or any other entity, or using assets as determined by the Board on the Stated
Value of such Preferred Share.
Liquidation: In the event
of a Liquidation Event (as defined in the Series C-1 Certificate of Designation), the holders the Series C-1 Preferred Stock shall be
entitled to receive in cash out of the assets of the Company, before any amount shall be paid to the holders of any other shares of capital
stock of the Company, equal to the greater of (A) 125% of the Conversion Amount (as defined in the Series C-1 Certificate of Designation)
on the date of such payment and (B) the amount per share such holder of Series C-1 Preferred Stock would receive if they converted such
share of Series C-1 Preferred Stock into Common Stock immediately prior to the date of such payment
Company Redemption: The
Company may redeem all, or any portion, of the Series C-1 Preferred Stock for cash, at a price per share of Series C-1 Preferred Stock
equal to 115% of the greater of (i) the Conversion Amount (as defined in the Series C-1 Certificate of Designations) being redeemed as
of the Company Optional Redemption Date (as defined in the Series C-1 Certificate of Designation) and (ii) the product of (1) the Conversion
Rate (as defined in the Series C-1 Certificate of Designation) with respect to the Conversion Amount being redeemed as of the Company
Optional Redemption Date multiplied by (2) the greatest Closing Sale Price (as defined in the Certificate of Designation) of the Common
Stock on any Trading Day during the period commencing on the date immediately preceding such Company Optional Redemption Notice Date (as
defined in the Certificate of Designation) and ending on the Trading Day immediately prior to the date the Company makes the entire payment
required to be made under the Certification of Designation.
Maximum Percentage: Holders
of Series C-1 Preferred Stock are prohibited from converting shares of Series C-1 Preferred Stock into shares of Common Stock if, as a
result of such conversion, such holder, together with its affiliates, would beneficially own in excess of 4.99% (the “Maximum Percentage”)
of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
Voting Rights. The holders
of the Series C-1 Preferred Stock shall have no voting power and no right to vote on any matter at any time, either as a separate series
or class or together with any other series or class of share of capital stock, and shall not be entitled to call a meeting of such holders
for any purpose nor shall they be entitled to participate in any meeting of the holders of Common Stock, except as expressly provided
in the Certificate of Designations and where required by the General Corporation Law of the State of Delaware (the “DGCL”).
Series D-1 Preferred
Stock Certificate of Designation
On May 2, 2024, the Company
filed a Certificate of Designation for its Series D-1 Preferred Stock with the Secretary of State of Delaware (the “Series D-1 Certificate
of Designations”). The following is only a summary of the Series D-1 Certificate of Designations, and is qualified in its entirety
by reference to the full text of the Series D-1 Certificate of Designations, a copy of which is filed as Exhibit 3.1 to this Current Report
on Form 8-K and is incorporated by reference herein.
The Series D-1 Certificate
of Designations provides that the share of Preferred Stock will have 418,600,000 votes and will vote together with the outstanding shares
of the Company’s Common Stock as a single class exclusively with respect to any proposal to amend the Company’s Amended and
Restated Certificate of Incorporation to increase the number of shares of Common Stock that the Company is authorized to issue. The Series
D-1Preferred Stock will be voted, without action by the holder, on any such proposal in the same proportion as shares of the Company’s
Common Stock are voted. The Series D-1 Preferred Stock otherwise has no voting rights except as otherwise required by the DGCL.
The Series D-1 Preferred
Stock is not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The
Series D-1 Preferred Stock has no rights with respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy,
reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily. The holders
of Series D-1 Preferred Stock will not be entitled to receive dividends of any kind.
The outstanding share
of Series D-1 Preferred Stock shall be redeemed in whole, but not in part, at any time (i) if such redemption is ordered by the Board
of Directors in its sole discretion or (ii) automatically upon the effectiveness of the amendment to increase the number of shares of
Common Stock that the Company is authorized to issue. Upon such redemption, the holder of the Preferred Stock will receive consideration
of $0.01 per share in cash.
LS Biotech Eight Default
On May 10, 2024, the
Company received written notice (the “2024 Default Notice”) from LS Biotech Eight, LLC (the “Landlord”) that the
Company was in violation of its obligation to (i) pay Base Rent (as defined in the Lease) and Additional Rent (as defined in the Lease)
in the amount of $431,182.31 in the aggregate, together with administrative charges and interest, as well as (ii) replenish the Security
Deposit (as defined in the Lease) in the amount of $159,375.00, all as required under that certain Lease Agreement dated as of May 4,
2021 by and between the Landlord and the Company (the “Lease”). Pursuant to the Notice, the Landlord has demanded that a payment
of $590,557.31 plus administrative charges and interest, which shall accrue at the Default Rate (as defined in the Lease) be made no later
than May 17, 2024.
The
Company is working with the Landlord to come to an amicable resolution. However, no assurance can be given that the parties will reach
an amicable resolution on a timely basis, on favorable terms, or at all.
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
The following discussion
and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial
statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial statements and related
notes for the year ended December 31, 2023 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission,
or SEC. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties,
and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain
factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Quarterly Report
on Form 10-Q, including those factors set forth in the section entitled “Cautionary Note Regarding Forward-Looking Statements and
Industry Data” and in the section entitled “Risk Factors” in Part II, Item 1A.
Overview and Mission
We believe the world needs—and
deserves—a new approach to innovating that harnesses the power of large groups of stakeholders who work together to ensure that
the most promising innovations make it into the hands of people who need them most.
We were incorporated in the
State of Delaware on September 28, 2017, and our headquarters are in Richmond, Virginia. The company was founded with a mission of bringing
stakeholders together, to transform promising innovations into products and services that could address some of the most challenging needs.
The socialization of innovation through engaging stakeholders in every aspect of it, is key to transforming more innovations, more rapidly,
and more efficiently.
At inception, the first innovation
we took on was an immune modulation technology titled ADI/Adimune with a focus on prolonging life and enhancing life quality of patients
that have undergone organ transplants. Since then, we expanded our portfolio of innovations, and we continue to evaluate a variety of
promising health innovations.
ADIMUNE, INC.
Formed in January 2023, Adimune™,
Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs. Adimune’s proprietary immune modulation
product candidate, ADI-100™, based on the Apoptotic DNA Immunotherapy™ platform technology, utilizes a novel approach that
mimics the way our bodies naturally induce tolerance to our own tissues. It includes two DNA molecules designed to deliver signals to
induce tolerance. ADI-100 has been successfully tested in several preclinical models (e.g., skin grafting, psoriasis, type 1 diabetes,
multiple sclerosis).
In May 2023, Adimune entered
into a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system
(“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome (“SPS”).
According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS is unknown; however, one estimate places
the incidence at approximately one in one million individuals in the general population.
Pending approval by the International
Review Board, a human trial for SPS is expected get underway in the first half of 2024 with enrollment of up to 20 patients, some of whom
may also have type 1 diabetes. ADI-100 will initially be tested for safety and efficacy. ADI-100 is designed to tolerize against an antigen
known as glutamic acid decarboxylase (“GAD”), which is implicated in type-1 diabetes, psoriasis, stiff person syndrome, and
in many autoimmune diseases of the CNS.
Background
The
discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible life-saving organ transplantation
procedures and blocking of unwanted immune responses in autoimmune diseases. However, immune suppression leads to significant undesirable
side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses
immune function throughout the body. While the use of these drugs has been justifiable because they prevent or delay organ rejection,
their use for treatment of autoimmune diseases and allergies may not be acceptable because of the aforementioned side effects. Furthermore,
often transplanted organs ultimately fail despite the use of immune suppression, and about 40% of transplanted organs survive no more
than five years.
Through
Aditxt, Adimune has the right of use to the exclusive worldwide license for commercializing ADI nucleic acid-based technology (which is
currently at the pre-clinical stage) from Loma Linda University. ADI uses a novel approach that mimics the way the body naturally induces
tolerance to our own tissues (“therapeutically induced immune tolerance”). While immune suppression requires continuous administration
to prevent rejection of a transplanted organ, induction of tolerance has the potential to retrain the immune system to accept the organ
for longer periods of time. ADI may allow patients to live with transplanted organs with significantly reduced immune suppression. ADI
is a technology platform which we believe can be engineered to address a wide variety of indications.
Advantages
ADI™
is a nucleic acid-based technology (e.g., DNA-based), which we believe selectively suppresses only those immune cells involved
in attacking or rejecting self and transplanted tissues and organs. It does so by tapping into the body’s natural process of cell
turnover (i.e., apoptosis) to retrain the immune system to stop unwanted attacks on self or transplanted tissues. Apoptosis is a natural
process used by the body to clear dying cells and to allow recognition and tolerance to self-tissues. ADI triggers this process by enabling
the cells of the immune system to recognize the targeted tissues as “self.” Conceptually, it is designed to retrain the immune
system to accept the tissues, similar to how natural apoptosis reminds our immune system to be tolerant to our own “self”
tissues.
While
various groups have promoted tolerance through cell therapies and ex vivo manipulation of patient cells (i.e., takes
place outside the body), to our knowledge, we will be unique in our approach of using in-body induction of apoptosis to promote tolerance
to specific tissues. In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute
amounts of the therapeutic drug into the skin.
Moreover,
preclinical studies have demonstrated that ADI treatment significantly and substantially prolongs graft survival, in addition to successfully
“reversing” other established immune-mediated inflammatory processes.
License Agreement with Loma Linda University
(“LLU”)
On March 15, 2018, we entered
into a License Agreement with LLU, which was subsequently amended on July 1, 2020. Pursuant to the LLU License Agreement, we obtained
the exclusive royalty-bearing worldwide license to all intellectual property, including patents, technical information, trade secrets,
proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or any of its affiliates
(the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases (the ADI™
technology). In consideration for the LLU License Agreement, we issued 25,000 shares of common stock to LLU.
PEARSANTA, INC.
Formed in January 2023, our
subsidiary Pearsanta™, Inc. (“Pearsanta”) seeks to take personalized medicine to a whole new level by delivering “Health
by the Numbers.” Since its founding, Pearsanta has been building the platform for enabling our vision of lab quality testing, anytime,
anywhere. Our plan for Pearsanta’s platform is for it to be the transactional backbone for sample collection, sample processing
(on- and off-site), and reporting. This will require the development and convergence of multiple components developed by Pearsanta, or
through transactions with third parties, including collection devices, “lab-on-a-chip” technologies, Lab Developed Test (LDT)
assays, a data-driven analysis engine, and telemedicine. According to a comprehensive research report by Market Research Future, the clinical
and consumer diagnostic market is estimated to hit $429.3 billion by 2030.
We believe that timely and
personalized testing enables far more informed treatment decisions. Pearsanta’s platform is being developed as a seamless digital
healthcare solution. This platform will integrate at-location sample collection, Point-of-Care (“POC”) and LDT assays, and
an analytical reporting engine, with telemedicine-enabled visits with licensed physicians to review test results and, if necessary, order
a prescription. Pearsanta’s goal of extending its platform to enable consumers to monitor their health more proactively as the goal
is to provide a more complete picture about someone’s dynamic health status, factoring in genetic makeup and their response to medication.
The POC component of Pearsanta would enable diagnostic testing at-home, at work, in pharmacies, and more to generate results quickly so
that an individual can access necessary treatment faster. With certain infections, prescribing the most effective treatment according
to one’s numbers can prevent hospital emergency room admissions and potentially life-threatening consequences.
Examples of indication-focused
tests for the Test2Treat platform will include the evaluation for advanced urinary tract infections (“UTIs”), COVID-19/flu/respiratory
syncytial virus, sexually transmitted infections, gut health, pharmacogenomics (i.e., how your genes affect the way your body responds
to certain therapeutics), and sepsis. We believe that these offerings are novel and needed as the current standard of care using broad
spectrum antibiotic treatment can be ineffective and potentially life-threatening. For example, improperly prescribed antibiotics may
approach 50% of outpatient cases. Further, according to an article published in Physician’s Weekly, only 1% of board-certified critical
care medicine physicians are trained in infectious disease.
Licensed Technologies – AditxtScoreTM
We
intend to sublicense to Pearsanta an exclusive worldwide sub-license for commercializing the AditxtScore™ technology which provides
a personalized comprehensive profile of the immune system. AditxtScore is intended to detect individual immune responses to viruses, bacteria,
peptides, drugs, supplements, bone marrow and solid organ transplants, and cancer. It has broad applicability to many other agents of
clinical interest impacting the immune system, including those not yet identified such as emerging infectious agents.
AditxtScore
is being designed to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles and to
stay informed about attacks on or by their immune system. We believe AditxtScore can also assist the medical community and individuals
by being able to anticipate the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as
transplanted organs. This technology may be able to serve as a warning signal, thereby allowing for more time to respond appropriately.
Its advantages include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine the
immune status with respect to several factors simultaneously, in approximately 3-16 hours. In addition, it can determine and differentiate
between distinct types of cellular and humoral immune responses (e.g., T and B cells and other cell types). It also provides for simultaneous
monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).
We
are actively involved in the regulatory approval process for AditxtScore assays for clinical use and securing manufacturing, marketing,
and distribution partnerships for application in the various markets. To obtain regulatory approval to use AditxtScore as a clinical assay,
we have conducted validation studies to evaluate its performance in detection of antibodies and plan to continue conducting additional
validation studies for new applications in autoimmune diseases.
Advantages
The
sophistication of the AditxtScore technology includes the following:
|
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greater sensitivity/specificity. |
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20-fold higher dynamic range, greatly reducing signal to noise compared to conventional assays. |
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ability to customize assays and multiplex a large number of analytes with speed and efficiency. |
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ability to test for cellular immune responses (i.e., T and B cells and cytokines). |
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proprietary reporting algorithm. |
License Agreement with Leland Stanford Junior
University (“Stanford”)
On February 3, 2020, we entered
into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with regard to a patent concerning
a method for detection and measurement of specific cellular responses. Pursuant to the February 2020 License Agreement, we received an
exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed Products (as defined in
the agreement). The license to the patented technology is exclusive, including the right to sublicense, beginning on the effective date
of the agreement, and ending when the patent expires. Under the exclusivity agreement, we acknowledged that Stanford had already granted
a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory
(as those terms are defined in the “February 2020 License Agreement”). However, Stanford agreed not to grant further licenses
under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. On December 29, 2021, we entered into an amendment
to the February 2020 License Agreement which extended our exclusive right to license the technology deployed in AditxtScoreTM and
securing worldwide exclusivity in all fields of use of the licensed technology.
ADIVIR, INC.
Formed in April of 2023, Adivir™,
Inc., is Aditxt’s most recently formed wholly owned subsidiary, dedicated to the clinical and commercial development efforts of
innovative antiviral products, which have the potential to address a wide range of infectious diseases, including those that currently
lack viable treatment options.
Background
On
April 18, 2023, we entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Cellvera Global Holdings
LLC (“Cellvera Global”), Cellvera Holdings Ltd. (“BVI Holdco”), Cellvera, Ltd. (“Cellvera Ltd.”),
Cellvera Development LLC (“Cellvera Development” and together with Cellvera Global, BVI Holdco, Cellvera Ltd. and Cellvera
Development (the “Sellers”), AiPharma Group Ltd. (“Seller Owner” and collectively with the Sellers, “Cellvera”),
and the legal representative of Cellvera, pursuant to which, the Company will purchase Cellvera’s 50% ownership interest in G Response
Aid FZE (“GRA”), certain other intellectual property and all goodwill related thereto (the “Acquired Assets”). Unless
expressly stated otherwise herein, capitalized terms used but not defined herein have the meanings ascribed to them in the Asset Purchase
Agreement. Pursuant to the Asset Purchase Agreement, the consideration for the Acquired Assets consists of (A) $24.5 million, comprised
of: (i) the forgiveness of the Company’s $14.5 million loan to Cellvera Global, and (ii) approximately $10 million in cash, and
(B) future revenue sharing payments for a term of seven years. GRA holds an exclusive, worldwide license for the antiviral medication,
Avigan® 200mg, excluding Japan, China and Russia. The other 50% interest in GRA is held by Agility, Inc. (“Agility”).
Additionally,
upon the closing, the Share Exchange Agreement previously entered into as of December 28, 2021, between Cellvera Global Holdings, LLC
f/k/a AiPharma Global Holdings, LLC (together with other affiliates and subsidiaries) and the Company, and all other related agreements
will be terminated.
The
obligations of the Company to consummate the Closing under the Asset Purchase Agreement are subject to the satisfaction or waiver, at
or prior to the Closing of certain conditions, including but not limited to, the following:
|
(i) |
Satisfactory completion of due diligence; |
|
(ii) |
Completion by the Company of financing sufficient to consummate the transactions contemplated by the Asset Purchase Agreement; |
|
(iii) |
Receipt by the Company of all required Consents from Governmental Bodies for the Acquisition, including but not limited to, any consents required to complete the transfer and assignment of Cellvera’s membership interests in GRA; |
|
(iv) |
Receipt of executed payoff letters reflecting the amount required to be fully pay all of each of Seller’s and Seller Owner’s Debt to be paid at Closing; |
|
(v) |
Receipt by the Company of a release from Agility; |
|
(vi) |
Execution of an agreement acceptable to the Company with respect to the acquisition by the Company of certain intellectual property presently held by a third party; |
|
(vii) |
Execution of an amendment to an asset purchase agreement previously entered into by Cellvera with a third party that effectively grants the Company the rights to acquire the intellectual property from the third party under such agreement; |
|
(viii) |
Receipt of a fairness opinion by the Company with respect to the transactions contemplated by the Asset Purchase Agreement; and |
|
(ix) |
Receipt by the Company from the Seller Owner of written consent, whether through its official liquidator or the Board of Directors of Seller Owner, to the sale and purchase of the Acquired Assets and Assumed Liabilities pursuant to the Assert Purchase Agreement. |
There can be no assurance
that the conditions to closing will be satisfied or that the proposed acquisition will be completed as proposed or at all.
Our commitment to building
our antiviral portfolio is strategic and timely. We believe that there has never has there been a more important time to address the growing
global need to uncover new treatments or commercialize existing ones that treat life-threatening global viral infections.
Our Team
Aditxt has assembled an entrepreneurial
team of experts from a variety of different business, engineering, and scientific fields, and commercial backgrounds, with collective
experience that ranges from founding startup innovation companies, to developing and marketing biopharmaceutical and diagnostic products,
to designing clinical trials, and management of private and public companies. We have deep experience in identifying and accessing promising
health innovations and developing them into products and services with the ability to scale. We understand the capital markets, both public
and private, as well as M&A and facilitating complex IPOs.
Going Concern
We were incorporated on
September 28, 2017 and have not generated significant revenues to date. During the three months ended March 31, 2024 we had a net
loss of $14,868,694 and cash of $88,671 as of March 31, 2024.
We are currently over 90 days past due on a significant number of
vendor obligations. The Company will require significant additional capital to operate in the normal course of business and fund
clinical studies in the long-term. We believe our remaining funds on hand will not be sufficient to fund our operations for the next
12 months and such creates substantial doubt about our ability to continue as a going concern beyond one year.
Financial
Results
We have a limited operating history. Therefore, there is limited historical
financial information upon which to base an evaluation of our performance. Our prospects must be considered in light of the uncertainties,
risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Our condensed consolidated
financial statements as of March 31, 2024, show a net loss of $14,868,694. We expect to incur additional net expenses over the next several
years as we continue to maintain and expand our existing operations. The amount of future losses and when, if ever, we will achieve profitability
are uncertain.
Results of Operations
Results of operations for the three months
ended March 31, 2024 and 2023
We generated revenue of $79,680
and $218,415 for the three months ended March 31, 2024 and 2023, respectively. Cost of for the three months ended March 31, 2024 and 2023
was $65,799 and $178,309, respectively.
During the three months ended
March 31, 2024, we incurred a loss from operations of $11,549,527. This is due to general and administrative expenses of $3,363,748, which
includes approximately $1,214,004 in payroll expenses, $1,145,679 in professional fees, and $20,477 in stock-based compensation. Research
and development expenses were $8,145,266, which includes $201,579 in consulting expenses and $6,712,663 in stock-based compensation. Sales
and marketing expenses were $40,513.
During the three months ended
March 31, 2023, we incurred a loss from operations of $5,822,001. This is due to general and administrative expenses of $4,368,843, which
includes $274,315 in stock-based compensation, research and development of $1,387,541, which includes $62,633 in stock-based compensation,
and sales and marketing expenses of negative $65,617, which includes $2,503 in stock-based compensation. The $1,387,541 in research and
development is mainly comprised of $415,429 in consulting expenses, $673,377 in compensation and $62,633 in stock-based compensation.
Sales and marketing expenses were $65,617 which includes $2,503 in stock-based compensation.
The decrease in expenses during
the three months ended March 31, 2024 compared to the three months ended March 31, 2023 was due to decreased research and development
spend and the termination of a sales and marketing vendor.
Liquidity and Capital Resources
We have incurred substantial operating losses since inception and expect
to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of March 31, 2024, we
had an accumulated deficit of $142,575,090. We had working capital of $(15,706,647) as of March 31, 2024. During the three months ended
March 31, 2024, we purchased zero in fixed assets.
Our condensed consolidated
financial statements have been prepared assuming that we will continue as a going concern.
We have funded our operations
from proceeds from the sale of equity and debt securities. On July 2, 2020, we completed our IPO and raised approximately $9.5 million
in net proceeds. At the time of the IPO, we believed that these funds would be sufficient to fund our operations for the foreseeable future.
On September 10, 2020, we
completed a follow-on public offering. In connection therewith, we issued 1,200 units, or Follow-On Units, excluding the underwriters’
option to cover overallotments, at an offering price of $8,000.00 per Follow-On Unit, resulting in gross proceeds of approximately $9.6
million.
On January 25, 2021, the Company
entered into a securities purchase agreement with an institutional accredited investor (the “Investor”) for the sale of a
$6,000,000 senior secured convertible note (the “Convertible Note”). The Convertible Note had a term of 24 months, was originally
convertible at a price of $8,000.00 per share and was issued at an original issuance discount of $1,000,000. On August 30, 2021, the Company
entered into a defeasance and waiver agreement with the Investor, pursuant to which the Noteholder has agreed in exchange for (a) a cash
payment by the Company to the Investor of $1.2 million (the Cash Payment”), (b) a waiver, in part of the conversion price adjustment
provision such that the January 2021 Note shall be convertible into 2,401 shares of common stock (without giving effect to the conversion
notice received by the company form the Noteholder prior to the date hereof totaling (503 shares) (the “Shares”), and (c)
a voluntary and permanent reduction by the Company of the exercise price of the warrant to purchase 400 shares of the common stock of
the Company (the “January 2021 Warrant”) to $5,060 per share. As of December 31, 2022, the outstanding principle of the convertible
note had been converted to 2,401 shares of common stock.
On August 30, 2021, the Company
completed a registered direct offering and raised approximately $10.1 million in net proceeds.
On October 20, 2021, the Company
completed a public offering for net proceeds of $3.8 million. As part of this offering, we issued 1,417 shares of the Company’s
common stock
On December 6, 2021, the Company
completed a public offering for net proceeds of $16.0 million. As part of this offering, we issued 4,123 units consisting of shares of
the Company’s common stock and warrant to purchase shares of the Company’s common stock and 4,164 pre-funded warrants. The
warrant issued as part of the units had an exercise price of $2,300.00 and the prefunded warrants had an exercise price of $0.001.
On September 20, 2022, the
Company completed a public offering for net proceeds of $18.1 million (the “September 2022 Offering”). As part of the
September 2022 Offering, we issued 30,608 of shares of the Company’s common stock, pre-funded warrants to purchase 52,725 shares
of the Company’s common stock and warrants to purchase 83,333 shares of the Company’s common stock. The warrants have
an exercise price of $240.00 and the pre-funded warrants have an exercise price of $0.004.
On April 20, 2023, the Company
entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor, pursuant to which
the Company agreed to sell to such investor pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 39,634 shares
of common stock of the Company (the “Common Stock”) at a purchase price of $48.76 per Pre-Funded Warrant. Concurrently with
the sale of the Pre-Funded Warrants, pursuant to the Purchase Agreement in a concurrent private placement, for each Pre-Funded Warrant
purchased by the investor, such investor received from the Company an unregistered warrant (the “Warrant”) to purchase two
shares of Common Stock. The warrants have an exercise price of $34.40 per share and are exercisable for a three-year period. In addition,
the Company issued a warrant to the placement agent to purchase up to 2,378 shares of common stock at an exercise price of $61.00 per
share.
On August 31, 2023, the Company
entered into a securities purchase agreement (the “August Purchase Agreement”) with an institutional investor for the
issuance and sale in a private placement (the “Private Placement”) of (i) pre-funded warrants (the “Pre-Funded Warrants”)
to purchase up to 1,000,000 shares of the Company’s common stock at an exercise price of $0.001 per share, and (ii) warrants (the
“Common Warrants”) to purchase up to 1,000,000 shares of the Company’s Common Stock at an exercise price of $10.00 per
share. The Private Placement closed on September 6, 2023. The net proceeds to the Company from the Private Placement were approximately
$9 million, after deducting placement agent fees and expenses and estimated offering expenses payable by the Company. The Company utilized
net proceeds received from the Private Placement for (i) payment of approximately $3.1 million in outstanding obligations, (ii) repayment
of approximately $0.4 million of outstanding debt, and (iii) continuing operating expenses and working capital.
On December 29, 2023, the
Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (“the
“December Purchaser”) for the issuance and sale in a private placement (the “December Private Placement”) of (i)
pre-funded warrants (the “December Pre-Funded Warrants”) to purchase up to 1,237,114 shares of the Company’s Common
Stock, par value $0.001 at an exercise price of $0.001 per share, and (ii) warrants (the “December Common Warrants”) to purchase
up to 2,474,228 shares of the Company’s Common Stock, at a purchase price of $4.85 per share.
Pursuant to the Purchase Agreement,
the Company agreed to reduce the exercise price of certain outstanding warrants to purchase Common Stock of the Company (“Certain
Outstanding Warrants”) held by the Purchaser to $4.60 per share in consideration for the cash payment by the December Purchaser
of $0.125 per share of Common Stock underlying the Certain Outstanding Warrants, effective immediately.
The December Private Placement
closed on January 4, 2024. The net proceeds to the Company from the December Private Placement were approximately $5.5 million, after
deducting placement agent fees and expenses and estimated offering expenses payable by the Company.
In addition, the Company agreed
to pay H.C. Wainwright & Co., LLC (“Wainwright”) certain expenses and issued to Wainwright or its designees warrants (the
“December Placement Agent Warrants”) to purchase up to an aggregate of 74,227 shares of Common Stock at an exercise price
equal to $6.0625 per share. The December Placement Agent Warrants are exercisable immediately upon issuance and have a term of exercise
equal to three years from the date of issuance.
We will need significant additional
capital to continue to fund our operations and the clinical trials for our product candidates. We may seek to sell common stock, preferred
stock or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing.
In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible
debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common
shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities, or other debt financing, these
securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require
us to relinquish valuable rights.
The source, timing, and availability
of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development
program. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us to, among
other things, delay, scale back or eliminate expenses including some or all our planned development, including our clinical trials. While
we may need to raise funds in the future, we believe the current cash reserves should be sufficient to fund our operation for the foreseeable
future. Because of these factors, we believe that this creates doubt about our ability to continue as a going concern.
Contractual Obligations
The following table shows
our contractual obligations as of March 31, 2024:
| |
Payment Due by Year | |
| |
Total | | |
2024 | | |
2025 | | |
2026 | |
Lease | |
$ | 1,853,227 | | |
$ | 718,751 | | |
$ | 710,546 | | |
$ | 423,930 | |
Critical Accounting Polices and Estimates
Our condensed consolidated
financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of
our condensed consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that
affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. We believe that our critical
accounting policies described under the heading “Management’s Discussion and Analysis of Financial Condition and Plan of Operations—Critical
Accounting Policies” in our Prospectus, dated September 1, 2020, filed with the SEC pursuant to Rule 424(b), are critical to fully
understanding and evaluating our financial condition and results of operations. The following involve the most judgment and complexity:
|
● |
Research and development |
|
● |
Stock-based compensation expense |
Accordingly, we believe the
policies set forth above are critical to fully understanding and evaluating our financial condition and results of operations. If actual
results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported
financial condition and results of operations could be materially affected.
Off-Balance Sheet Arrangements
We did not have during the
periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
JOBS Act
On April 5, 2012, the
JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the
extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.
In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards
would otherwise apply to private companies.
When favorable, we have chosen to take advantage
of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting
standards until those standards would otherwise apply to private companies provided under the JOBS Act.
We are in the process of evaluating
the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain
conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including
without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the
date of the completion of our IPO (December 31, 2025); (iii) the date on which we have issued more than $1 billion in nonconvertible
debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of
the SEC.
Recently Issued and Adopted Accounting Pronouncements
See Note 3 - Summary of Significant
Accounting Policies to the accompanying condensed consolidated financial statements for a description of other accounting policies and
recently issued accounting pronouncements.
Recent Developments
See Note 12 – Subsequent
Event to the accompanying condensed consolidated financial statements for a description of material recent developments.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
We are not required to provide
the information required by this Item as we are a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
In accordance with Rules 13a-15(b)
and 15d-15(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we, under the supervision and with
the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act) as of the
end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our Chief Executive Officer and Chief Financial
Officer concluded that our disclosure controls and procedures have not materially changed since the Company determined that we did not
maintain effective internal controls over financial reporting and the following weaknesses still exist as of March 31,2024.
| ● | We did not maintain adequate controls over the documentation of accounting and financial reporting policies
and procedures. Specifically, we did not maintain policies and procedures to ensure account reconciliations were adequately prepared and
reviewed by management. |
| ● | We did not retain individuals and/or entities with extensive knowledge to recognize and record technical
and complex accounting issues. |
| ● | We did not maintain the sufficient procedures for the identification
and cutoff of accounts payable. |
These material weaknesses resulted in material
misstatements to the financial statements, which were corrected. There were no changes to previously released financial results. We are
in the process of remediating these material weaknesses.
Change in Internal Control Over Financial Reporting
No change occurred in our internal
control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) during the quarter ended March 31, 2024
that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may
become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is subject
to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
Item 1A. Risk Factors
Our business, financial
condition, results of operations, and cash flows may be impacted by a number of factors, many of which are beyond our control, including
those set forth below and in our most recent Annual Report on Form 10-K and in our other filings with the SEC, the occurrence of any one
of which could have a material adverse effect on our actual results.
Our financial situation
creates doubt whether we will continue as a going concern.
The
Company was incorporated on September 28, 2017 and through the date of this report has generated no significant revenues. For the years
ended December 31, 2023 and 2022, the Company had a net loss of $32,390,447 and $27,649,876, respectively. Our condensed consolidated
financial statements as of March 31, 2024, show a net loss of $14,868,694. Our cash and cash equivalents were approximately $88,671 as
of March 31, 2024. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash
flow from operations or additional financing through private placements, public offerings and/or bank financing necessary to support our
working capital requirements. To the extent that funds generated from any private placements, public offerings and/or bank financing are
insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available,
or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern.
If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire
investment.
If we fail to obtain the capital necessary
to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.
We will need to continue to
seek capital from time to time to continue development of our lead drug candidate beyond our initial combined Phase I/IIa clinical trial
and to acquire and develop other product candidates. Once approved for commercialization, we cannot provide any assurances that any revenues
it may generate in the future will be sufficient to fund our ongoing operations.
Our business or operations
may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required
to maintain operations, fund expansion, develop new or enhance products, acquire complementary products, business or technologies, or
otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred
treatment modalities. In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently
envisioned, and this would require additional capital. However, we may not be able to secure funding when we need it or on favorable terms.
We may not be able to raise sufficient funds to commercialize the product candidates we intend to develop.
If we cannot raise adequate
funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical
studies, or future operations. We may also be required to obtain funds through arrangements with collaborators, which arrangements may
require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights
to future product candidates or certain major geographic markets. This could result in sharing revenues which we might otherwise retain
for ourselves. Any of these actions may harm our business, financial condition, and results of operations.
The amount of capital we may
need depends on many factors, including the progress, timing and scope of our product development programs; the progress, timing and scope
of our preclinical studies and clinical trials; the time and cost necessary to obtain regulatory approvals; the time and cost necessary
to further develop manufacturing processes and arrange for contract manufacturing; our ability to enter into and maintain collaborative,
licensing and other commercial relationships; and our partners’ commitment of time and resources to the development and commercialization
of our products.
Our obligations
to certain of our creditors are secured by security interests in our assets, so if we default on those obligations, our creditors could
foreclose on some or all of our assets.
Our
obligations to certain of our creditors are secured by security interests in our assets. As of March 31, 2024, approximately $5.2 million
was owed to such secured creditors. Under such agreements, we are required to pay $277,800 on a weekly basis to such creditors. If we
default on our obligations under these agreements, our secured creditors could foreclose on its security interests and liquidate some
or all of these assets, which would harm our financial condition and results of operations and would require us to reduce or cease operations
and possibly seek Bankruptcy Protection.
In the event we
pursue Bankruptcy Protection, we will be subject to the risks and uncertainties associated with such proceedings.
In the event we file for relief
under the United States Bankruptcy Code, our operations, our ability to develop and execute our business plan and our continuation as
a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings, including, among others: our ability
to execute, confirm and consummate a plan of reorganization; the additional, significant costs of bankruptcy proceedings and related fees;
our ability to obtain sufficient financing to allow us to emerge from bankruptcy and execute our business plan post-emergence, and our
ability to comply with terms and conditions of that financing; our ability to continue our operations in the ordinary course; our ability
to maintain our relationships with our consumers, business partners, counterparties, employees and other third parties; our ability to
obtain, maintain or renew contracts that are critical to our operations on reasonably acceptable terms and conditions; our ability to
attract, motivate and retain key employees; the ability of third parties to use certain limited safe harbor provisions of the United States
Bankruptcy Code to terminate contracts without first seeking Bankruptcy Court approval; the ability of third parties to force us to into
Chapter 7 proceedings rather than Chapter 11 proceedings and the actions and decisions of our stakeholders and other third parties who
have interests in our bankruptcy proceedings that may be inconsistent with our operational and strategic plans. Any delays in our bankruptcy
proceedings would increase the risks of our being unable to reorganize our business and emerge from bankruptcy proceedings and may increase
our costs associated with the bankruptcy process or result in prolonged operational disruption for us. Also, we would need the prior approval
of the bankruptcy court for transactions outside the ordinary course of business during the course of any bankruptcy proceedings, which
may limit our ability to respond timely to certain events or take advantage of certain opportunities. Because of the risks and uncertainties
associated with any bankruptcy proceedings, we cannot accurately predict or quantify the ultimate impact of events that could occur during
any such proceedings. There can be no guarantees that if we seek Bankruptcy Protection we will emerge from Bankruptcy Protection as a
going concern or that holders of our common stock will receive any recovery from any bankruptcy proceedings.
In the event we
are unable to pursue Bankruptcy Protection under Chapter 11 of the United States Bankruptcy Code, or, if pursued, successfully emerge
from such proceedings, it may be necessary to pursue Bankruptcy Protection under Chapter 7 of the United States Bankruptcy Code for all
or a part of our businesses.
In the event we are unable
to pursue Bankruptcy Protection under Chapter 11 of the United States Bankruptcy Code, or, if pursued, successfully emerge from such proceedings,
it may be necessary for us to pursue Bankruptcy Protection under Chapter 7 of the United States Bankruptcy Code for all or a part of our
businesses. In such event, a Chapter 7 trustee would be appointed or elected to liquidate our assets for distribution in accordance with
the priorities established by the United States Bankruptcy Code. We believe that liquidation under Chapter 7 would result in significantly
smaller distributions being made to our stakeholders than those we might obtain under Chapter 11 primarily because of the likelihood that
the assets would have to be sold or otherwise disposed of in a distressed fashion over a short period of time rather than in a controlled
manner and as a going concern.
We received a written notice from Nasdaq
that we have failed to comply with certain listing requirements of the Nasdaq Stock Market, which could result in our Common Stock being
delisted from the Nasdaq Stock Market.
On May 23, 2023, we received
written notice from Nasdaq that, based upon the stockholders equity reported by the Company in its Form 10-Q for the period ended
March 31, 2023, and as of March 31, 2023, the Company was no longer in compliance with Nasdaq Listing Rule 5550(b)(1), which requires
a company to maintain a minimum of $2,500,000 in stockholders’ equity, a market value of listed securities of at least $35 million,
or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed
fiscal years (the “Continued Listing Requirements”). The May notification letter further provided that the Company has 45
calendar days, or until July 7, 2023, to submit a plan to regain compliance and if the plan is accepted by Nasdaq, an extension of up
to 180 calendar days, or until November 19, 2023 to evidence compliance. On June 22, 2023, we received a letter from Nasdaq notifying
the Company that it has failed to maintain compliance with the minimum bid price rule in Nasdaq Listing Rule 5550(a)(2) (the “Minimum
Bid Price Rule”) as the closing price of Company’s common stock has remained below $1.00 for over 30 consecutive trading days.
On June 29, 2023, we submitted an appeal to Nasdaq, which stays the delisting and suspension of our securities pending the decision of
the Nasdaq Hearings Panel (the “Panel”). At the hearing, which was held on August 31, 2023, which represented the tenth trading
day that the closing of the Company’s common stock was above $1.00 per share. At the hearing, the Company also presented its plans
to regain compliance with the Equity Rule to the Panel. In addition, on September 15, 2023, the Company received a written notice form
Nasdaq that it no longer meets the minimum 500,000 publicly held shares requirement for The Nasdaq Capital Market and it no longer complies
with Nasdaq Listing Rule 5550(a)(4) (the “Public Float Rule”). The September notification letter stated that the Panel will
consider this matter in their decision regarding the Company’s continued listing on The Nasdaq Capital Market.
On September 29, 2023, the
Company received a written notice from Nasdaq that the Panel had granted the Company an exception through December 26, 2023, to allow
the Company to complete its compliance with the Equity Rule. The October notification letter also confirmed that the Company had demonstrated
compliance with the Minimum Bid Price Rule and granted the Company an exception through December 26, 2023 to allow the Company to demonstrate
compliance with the Public Float Rule. On December 29, 2023, the Company received written notice
from Nasdaq that we had regained compliance with the Stockholders’ Equity Rule, but will be subject to a Mandatory Panel Monitor
for a period of one year.
If we are delisted from Nasdaq,
but obtain a substitute listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially
more price volatility than experienced on Nasdaq. Stockholders may not be able to sell their shares of common stock on any such substitute
market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result
of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our common stock, warrants and pre-funded warrants
would likely be significantly adversely affected. A delisting of our common stock from Nasdaq could also adversely affect our ability
to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners.
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds
(a) Sales of Unregistered Securities
On March 17, 2023, the Company
issued a consultant 4,675 shares of common stock for services rendered.
The issuance above was made
pursuant to an exemption from registration under the Securities Act of 1933, as amended, pursuant to Section 4(a)(2) thereof.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
* |
Filed herewith. |
** |
Furnished herewith. |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
Aditxt, Inc. |
|
|
|
Date: May 20, 2024 |
By: |
/s/ Amro Albanna |
|
|
Amro Albanna |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
Date: May 20, 2024 |
By: |
/s/ Thomas J. Farley |
|
|
Thomas J. Farley |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
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compsci:item
I, Thomas J. Farley, certify that:
In connection with the Quarterly Report of Aditxt,
Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2024, as filed with the Securities and Exchange Commission
on the date hereof (the “Report”), each of Amro Albanna, Chief Executive Officer of the Company and Thomas J. Farley, Chief
Financial Officer, certify, pursuant to 18 U.S.C. § 1350, as enacted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: