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, 2025
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.)
2569 Wyandotte Street , Suite 101
Mountain View , CA
94043
(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 15, 2025, the registrant had 2,120,053 and 2,120,052 shares of
common stock, $0.001 par value per share, issued and outstanding, respectively.
Table of Contents
INDEX
Page No.
Cautionary Note Regarding Forward-Looking Statements and Industry Data
ii
PART I FINANCIAL INFORMATION
Item 1.
Condensed Consolidated Financial Statements (Unaudited)
1
Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024
1
Condensed Consolidated Statements of Operations for the three months ended March 31, 2025 and 2024
2
Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024
3
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024
5
Notes to Condensed Consolidated Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
49
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
59
Item 4.
Controls and Procedures
59
PART II OTHER INFORMATION
Item 1.
Legal Proceedings
60
Item 1A.
Risk Factors
60
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
64
Item 3.
Defaults Upon Senior Securities
64
Item 4.
Mine Safety Disclosures
64
Item 5.
Other Information
64
Item 6.
Exhibits
65
Signatures
66
i
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;
ii
● 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 shares of convertible preferred stock and warrants and may continue to do so in the future. The conversion
and/or 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;
● 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;
●
while we have entered into a Merger Agreement with Evofem Biosciences, Inc. and an Arrangement Agreement with Appili Therapeutics, Inc., we cannot assure you that such transactions 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 transactions Evofem Biosciences, Inc. and Appili Therapeutics, Inc., which may require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management;
●
we have entered into a Common Stock Purchase Agreement with an equity line investor pursuant to which we may issue and sell up to $150 million of our common stock, which could result in significant dilution;
iii
●
we have entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC pursuant to which we may issue and sell up to $35 million of our common stock, which could result in significant dilution
●
On April 8, 2025, we received a letter from The Nasdaq Stock Market, LLC stating that we had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2). Consequently, the hearing before the Hearings Panel scheduled to take place on April 22, 2025 has been cancelled, however, no assurance can be provided that we will be successful in continuing to remain compliant with the requirements for continued listing on The Nasdaq Capital Market; 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.
iv
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
ADITXT, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31,
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash
$ 476,416
$ 833,031
Accounts receivable, net
42,118
43,435
Inventory
9,057
11,245
Prepaid expenses
62,616
3,379
Subscription receivable
630,105
1,108,751
TOTAL CURRENT ASSETS
1,220,312
1,999,841
Fixed assets, net
1,479,324
1,547,774
Intangible assets, net
5,278
6,111
Deposits
179,846
87,672
Right of use asset
1,060,065
1,225,781
Investment in Evofem
27,277,211
27,277,211
TOTAL ASSETS
$ 31,222,036
$ 32,144,390
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 7,332,793
$ 13,212,239
Mandatorily Redeemable Preferred Stock ( 2,263 and 1,178 shares)
3,956,819
1,354,774
Stock payable
-
2,250,000
Notes payable, related party
-
115,000
Notes payable, net of discount
2,959,166
5,537,860
Financing on fixed assets
147,823
147,823
Deferred rent
94,300
106,075
Lease liability, current
688,474
683,352
TOTAL CURRENT LIABILITIES
15,179,375
23,407,123
Lease liability, long term
277,291
436,354
Derivative liability
1,372
14,517
TOTAL LIABILITIES
15,458,038
23,857,994
COMMITMENTS AND CONTINGENCIES
MEZZANINE EQUITY
Series C-1 Convertible Preferred stock, $ 0.001 par value, 10,853 shares authorized, zero and 8,373 shares issued and outstanding, respectively
-
8,373,000
TOTAL MEZZANINE EQUITY
-
8,373,000
STOCKHOLDERS’ EQUITY (DEFICIT)
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, 22,071 and 22,071 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, 2,689 and 2,689 shares issued and outstanding, respectively
3
3
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
-
-
Series D-1 Preferred stock, $ 0.001 par value, 4,186 shares authorized, zero and zero shares issued and outstanding, respectively
-
-
Common stock, $ 0.001 par value, 1,000,000,000 and 100,000,000 shares authorized, 1,207,931 and 129,680 shares issued and 1,207,930 and 129,679 shares outstanding, respectively
1,208
130
Treasury stock, 1 and 1 shares, respectively
( 201,605 )
( 201,605 )
Additional paid-in capital
190,594,581
168,792,592
Accumulated deficit
( 173,804,878 )
( 168,094,569 )
TOTAL ADITXT, INC. STOCKHOLDERS’ EQUITY (DEFICIT)
16,589,334
496,576
NON-CONTROLLING INTEREST
( 825,336 )
( 583,180 )
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)
15,763,998
( 86,604 )
TOTAL LIABILITIES, MEZZANINE EQUITY, AND STOCKHOLDERS’ EQUITY (DEFICIT)
$ 31,222,036
$ 32,144,390
See accompanying notes to the consolidated financial
statements.
1
ADITXT, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months
Ended
Three Months
Ended
March 31,
2025
March 31,
2024
REVENUE
Sales
$ 1,018
$ 79,680
Cost of goods sold
734
65,799
Gross loss
284
13,881
OPERATING EXPENSES
General and administrative expenses $ 0 and $ 24,573 in stock-based compensation, respectively
4,348,274
3,363,748
Research and development $ 10,000 and $ 6,712,663 in stock-based compensation, respectively
1,209,205
8,145,266
Sales and marketing $ 0 and $ 0 in stock-based compensation, respectively
50,920
40,513
Total operating expenses
5,608,399
11,549,527
NET LOSS FROM OPERATIONS
( 5,608,115 )
( 11,535,646 )
OTHER INCOME (EXPENSE)
Interest expense
( 157,499 )
( 2,489,045 )
Interest income
288
377
Amortization of debt discount
( 200,284 )
( 635,710 )
Gain (loss) on note exchange agreement
-
( 208,670 )
Change in fair value of derivative liability
13,145
-
Total other expense
( 344,350 )
( 3,333,048 )
Net loss before income taxes
( 5,952,465 )
( 14,868,694 )
Income tax provision
-
-
NET LOSS
$ ( 5,952,465 )
$ ( 14,868,694 )
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTEREST
( 242,156 )
( 138,967 )
NET LOSS ATTRIBUTABLE TO ADITXT, INC. & SUBSIDIARIES
$ ( 5,710,309 )
$ ( 14,729,727 )
Net loss per share, basic and diluted
$ ( 8.12 )
$ ( 91,439.43 )
Weighted average number of shares outstanding during the period, basic and diluted
703,666
161
See accompanying notes to the consolidated financial
statements.
2
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY (DEFICIT)
THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Preferred A-1 Shares
Preferred A-1 Shares Par
Preferred B-1 Shares
Preferred B-1 Shares Par
Preferred B-2 Shares
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
Preferred C-1 Shares
Redeemable Preferred C-1
Total Mezzanine Equity
Balance December 31, 2024
22,071
$ 22
2,689
$ 3
2,625
$ 3
129,679
$ 130
$ ( 201,605 )
$ 168,792,592
$ ( 168,094,569 )
$ ( 583,180 )
$ ( 86,604 )
8,373
8,373,000
8,373,000
Issuance of shares for registered direct offering, net of issuance costs
-
-
-
-
-
-
177,883
178
-
4,582,084
-
-
4,582,262
-
-
-
Issuance of shares under ELOC, net of issuance costs
-
-
-
-
-
-
900,116
900
-
18,466,015
-
-
18,466,915
-
-
-
Redemption of C-1 preferred stock
-
-
-
-
-
-
-
-
-
( 917,069
)
-
-
( 917,069
)
( 6,110 )
( 6,110,000 )
( 6,110,000 )
Reclass of C-1 preferred stock to Mandatorily Redeemable Preferred Stock
-
-
-
-
-
-
-
-
-
( 339,041 )
-
-
( 339,041 )
( 2,263 )
( 2,263,000 )
( 2,263,000 )
Acquisition of patent for Pearsanta preferred stock
-
-
-
-
-
-
-
-
-
10,000
-
-
10,000
-
-
-
Rounding from reverse stock split
-
-
-
-
-
-
252
-
-
-
-
-
-
-
-
-
Net loss
-
-
-
-
-
-
-
-
-
-
( 5,710,309 )
( 242,156 )
( 5,952,465 )
-
-
-
Balance March 31, 2025
22,071
$ 22
2,689
$ 3
2,625
$ 3
1,207,930
$ 1,208
$ ( 201,605 )
$ 190,594,581
$ ( 173,804,878 )
$ ( 825,336 )
$ 15,763,998
-
-
-
See accompanying notes to the consolidated
financial statements.
3
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY (DEFICIT)
THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(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
165
$ 11
$ ( 201,605 )
$ 143,999,018
$ ( 127,741,072 )
$ ( 9,608 )
$ 16,046,769
Stock option compensation
-
-
-
-
-
-
-
-
-
24,573
-
-
24,573
MDNA asset purchase
-
-
-
-
-
-
5
1
-
1,008,668
-
-
1,008,669
Brain asset purchase
-
-
6,000
6
-
-
-
-
-
5,970,437
-
-
5,970,443
Issuance of shares for settlement
-
-
-
-
-
-
30
1
-
1,599,999
-
-
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
200
$ 13
$ ( 201,605 )
$ 152,602,695
$ ( 142,470,799 )
$ ( 148,575 )
$ 9,781,760
See accompanying notes to the consolidated financial
statements.
4
ADITXT, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Three Months
Ended
Three Months
Ended
March 31,
2025
March 31,
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 5,952,465 )
$ ( 14,868,694 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation
-
24,573
Stock-based compensation from asset purchase
10,000
6,712,663
Depreciation expense
68,450
142,932
Amortization of intangible assets
833
833
Amortization of debt discount
200,284
635,710
Loss on note exchange agreement
-
208,670
Change in fair value of derivative liability
( 13,145 )
-
Changes in operating assets and liabilities:
Accounts receivable
1,317
( 18,718 )
Prepaid expenses
( 59,237 )
( 239,494 )
Deposits
( 92,174 )
( 26,086 )
Inventory
2,188
122,734
Accounts payable and accrued expenses
( 5,879,446 )
1,343,946
Net cash used in operating activities
( 11,713,395 )
( 5,960,931 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Net cash provided by investing activities
-
-
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from notes payable, related party
-
467,000
Proceeds from notes and convertible notes payable, net of offering costs
-
1,269,950
Repayments of note payable - related party
( 115,000 )
( 375,000 )
Repayments of note payable
( 2,778,978 )
( 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
20,169,072
-
Cash from subscription receivable
1,108,751
5,444,628
Redemptions of C-1 preferred stock
( 7,027,065 )
-
Net cash provided by financing activities
11,356,780
5,952,500
NET INCREASE (DECREASE) IN CASH
( 356,615 )
( 8,431 )
CASH AT BEGINNING OF PERIOD
833,031
97,102
CASH AT END OF PERIOD
$ 476,416
$ 88,671
Supplemental cash flow information:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 1,264,504
$ 622,762
NONCASH INVESTING AND FINANCING ACTIVITIES:
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
ELOC payable
$ 630,105
$ -
Series C-1 redemption payable
$ 1,247,267
$ -
Series C-1 Deemed Dividend
$ 1,354,774
$
ELOC commitment fee stock payable
$ 2,250,000
$ -
See accompanying notes to the consolidated financial
statements.
5
ADITXT, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 – ORGANIZATION AND NATURE OF BUSINESS
Company Background
Overview
Aditxt, Inc. ® is an
innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions,
industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.”
The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address
significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice
is heard and valued, and empowers collective progress.
Reverse Stock Splits
On October 2, 2024, the Company effectuated a 1-for-40
reverse stock split (the “2024 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective
on the Nasdaq Stock Market on October 3, 2024. 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 2024 Reverse Split.
On March 14, 2025, the Company effectuated a 1-for-250
reverse stock split (the “2025 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective
on the Nasdaq Stock Market on March 17, 2025. 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 2025 Reverse Split.
On March 14, 2025, Pearsanta effectuated a 1-for-60
reverse stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of
Pearsanta’s common stock. All Pearsanta share amounts referenced in this report are adjusted to reflect the 2025 Pearsanta Reverse
Split.
6
Offerings
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 “May 2024 Private Placement”) (i) an aggregate of 4,186
shares of the Company’s Series C-1 Convertible Preferred Stock (the “Series C-1 Convertible 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 162 shares of the Company’s common stock.
The May 2024 Private Placement closed on May 6, 2024. The gross proceeds from the May 2024 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 used $ 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. (Note 10)
On August 8, 2024, the Company entered into a
securities purchase agreement (the “Registered Direct Purchase Agreement”) with certain institutional investors, pursuant
to which the Company agreed to sell to such investors 19 shares (the “Registered Direct Shares”) of common stock
of the Company, pre-funded warrants (the “Registered Direct Pre-Funded Warrants”) to purchase up to 95 shares of
common stock of the Company (the “Registered Direct Pre-Funded Warrant Shares”), having an exercise price of $ 400.00 per share,
at a purchase price of $ 10,600 per share of common stock and a purchase price of $ 10,590 per Registered Direct Pre-Funded Warrant
(the “Registered Direct Offering”). The shares of common stock and Registered Direct Pre-Funded Warrants (and shares of common
stock underlying the Registered Direct Pre-Funded Warrants) were offered by the Company pursuant to its shelf registration statement on
Form S-3 (File No. 333-280757), which was declared effective by the Securities and Exchange Commission on August 6, 2024.
The closing of the sales of these securities under
the Registered Direct Purchase Agreement took place on August 9, 2024. The gross proceeds from the offering were approximately $ 1.2 million,
prior to deducting placement agent’s fees and other offering expenses payable by the Company. The Company used $ 500,000 of
the net proceeds from the offering to fund certain obligations under its Amended and Restated Merger Agreement with Evofem Biosciences,
Inc and the remainder for working capital and other general corporate purposes.
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.
7
Nasdaq Notification Letter
On October 3, 2024, the Company was notified (the
“October Notification Letter”) by Nasdaq that it is not in compliance with the minimum bid price requirements set forth in
Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities
to maintain a minimum bid price of $ 1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum
bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price
of the Company’s common stock between August 20, 2024 and October 1, 2024, the Company no longer meets the minimum bid price requirement.
We were notified by the Listing Qualifications
Staff of Nasdaq that it has determined that as of March 6, 2025, the Company’s securities had a closing bid price of $ 0.10 or less
for ten consecutive trading days. As a result, we are subject to the provisions contemplated under Listing Rule 5810(c)(3)A)(iii) and
the Staff has determined to delist our securities from The Nasdaq Capital Market. On March 12, 2025, we filed with the Secretary of State
of the State of Delaware a certificate of amendment to our certificate of incorporation to effect a 1:250 reverse stock split. The reverse
stock split became effective as of 4:01 p.m. Eastern Time on March 14, 2025, and our common stock began trading on a split-adjusted basis
when the Nasdaq Stock Market opened on March 17, 2025. The reverse stock split is primarily intended to bring the Company into compliance
with Nasdaq’s minimum bid price requirement. On March 14, 2025, we submitted an appeal to Nasdaq, which will stay the delisting
and suspension of our securities pending the decision of the Nasdaq Hearings Panel. On April 8, 2025, we received a letter from Nasdaq
stating that we had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as
set forth in Nasdaq Listing Rule 5550(a)(2). Consequently, the hearing before the Hearings Panel scheduled to take place on April 22,
2025 has been cancelled.
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, 2025, the Company had a net loss of $ 5,952,465
and negative cash flow from operating activities of $ 11,713,395 . As of March 31, 2025, the Company’s cash balance was $ 476,416 .
As of March 31, 2025, the Company was subject
to the offering limits in General Instruction I.B.6 of Form S-3 (the “Baby Shelf Limitation”). Thus, the maximum amount of
securities that the Company could offer and sell under its shelf registration statement on Form S-3 as of March 31, 2025 was approximately
$ 11.8 million. Upon the filing of the Company’s annual report on Form 10-K on March 31, 2025, the Company’s aggregate market
value of the voting and non-voting equity held by non-affiliates was below $ 6.0 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 it had regained compliance with the Public Float Rule. On December 29, 2023, the Company received written notice
from Nasdaq that it had regained compliance with the Stockholders’ Equity Rule but will be subject to a Mandatory Panel Monitor
for a period of one year. See Risk Factors and Note 12 for additional details regarding Nasdaq compliance.
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.
8
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, 2025 and 2024. 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, 2024, filed with the
SEC on March 31, 2025. The interim results for the three months ended March 31, 2025 are not necessarily indicative of the results to
be expected for the year ending December 31, 2025 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 value of preferred shares issued and related derivative liability, our investment in Evofem preferred stock and the fair value of
stock options and warrants.
9
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.
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, with the exception of the derivative liability.
The following table provides a summary of financial
instruments that are measured at fair value as of March 31, 2025.
Carrying
Fair Value Measurement Using
Value
Level 1
Level 2
Level 3
Total
Derivative liability
$ 1,372
—
$ 1,372
—
$ 1,372
The following table provides a summary of financial
instruments that are measured at fair value as of December 31, 2024.
Carrying
Fair Value Measurement Using
Value
Level 1
Level 2
Level 3
Total
Derivative liability
$ 14,517
—
$ 14,517
—
$ 14,517
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.
The Company has not experienced any losses in
such accounts and believes it is not exposed to significant concentrations of credit risk on its cash balances on amounts in excess of
federally insured limits due to the financial position of the depository institutions in which these deposits are held.
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.
10
Cash
Cash includes short-term, liquid investments with
maturities less than 90 days.
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, 2025 and December 31, 2024, gross accounts receivable was $ 120,026 and $ 121,582 , respectively. As of March 31, 2025 and
December 31, 2024, there was an allowance for doubtful accounts of $ 77,908 and 78,147 , respectively. Accounts receivable is
made up of billed and unbilled of $ 119,771 and $ 255 as of March 31, 2025, respectively, and $ 120,296 and $ 1,286 as
of December 31, 2024, respectively.
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.
11
Investments
The Evofem investment is included in its own line
item on the Company’s consolidated balance sheets.
Under ASC 321 the Company accounts for equity
investments at fair value. If fair value is not readily determinable or marketable, the Company values at cost less impairment.
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.
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,
2025
As of December 31, 2024
$ 27,277,211
Deposit on acquisition
-
Impairment
-
As of March 31, 2025
$ 27,277,211
The investment in Evofem has been impaired $ 0
to date.
Impairment of long-lived assets
The Company reviews and
evaluates the net carrying value of its long-lived assets at least annually, or upon the occurrence of other events or changes in circumstances
that indicate that the related carrying amounts may not be recoverable. Per ASC 360-10-35-21, a long-lived asset (asset group) shall be
tested for recoverability whenever events or changes in circumstances indicate that its carrying amount may not be recoverable. Per ASC
360-10-35-17, an impairment loss shall be recognized only if the carrying amount of the long-lived asset is not recoverable and exceeds
its fair value. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected
to result from the use and eventual disposition of the asset.
12
Accounts Payable and Accrued Expenses
As of March 31, 2025 and December 31, 2024, accounts payable and accrued
expenses was comprised of:
March 31,
2025
December 31,
2024
Accounts payable
$ 6,654,132
$ 10,192,373
Accrued wages
8,574
1,130,181
Accrued interest
625,216
1,889,527
Other
44,871
158
Total accounts payable and accrued expenses
$ 7,332,793
$ 13,212,239
Derivative Liability
The Company evaluates its options, warrants, other
equity instruments, and other contracts, if any, to determine if those contracts or embedded components of those contracts qualify as
derivatives to be separately accounted for in accordance with ASC 815-10-05-4 and 815-40-25. The result of this accounting treatment is
that the fair value of the embedded derivative is marked-to-market each balance sheet date and recorded as either an asset or a liability.
In the event that the fair value is recorded as a liability, the change in fair value is recorded in the consolidated statements of operations
as other income or expense. Upon conversion, exercise or cancellation of a derivative instrument, the instrument is marked to fair value
at the date of conversion, exercise or cancellation and then the related fair value is reclassified to equity.
The classification of derivative instruments,
including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period.
Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to liability at the
fair value of the instrument on the reclassification date. Derivative instrument liabilities will be classified in the balance sheet as
current or non-current based on whether or not net-cash settlement of the derivative instrument is expected within 12 months of the balance
sheet date.
The Company has determined that a derivative feature
exists on its shares of 22,071 shares of Series A-1 Convertible Preferred Stock, 2,689 shares of Series B-1 Convertible Preferred Stock,
and 2,625 shares of Series B-2 Convertible Preferred Stock. This derivative arose from a conversion feature of these classes of preferred
stock that allows for 50 % additional shares to be issued under certain circumstances, in this case a default on one of the Company’s
leases. (See Note 10)
The Company valued the derivative based on the
conversion formula outlined in the certificate of designation for the preferred stock. Per the formula, the stated value was $ 1,000 , with
an additional premium of 50 %, and alternative conversion amount per share of $ 500 , and a floor price of $ 8,880 for the Series A-1 Convertible
Preferred Stock, $ 8,120 for the Series B-1 Convertible Preferred Stock, and $ 9,420 for the Series B-2 Convertible Preferred Stock.
The following table sets forth a summary of the
fair value of the derivative liability.
March 31,
2025
Fair value of derivative liability of Series A-1 Convertible Preferred Stock
5
Fair value of derivative liability of Series B-1 Convertible Preferred Stock
742
Fair value of derivative liability of Series B-2 Convertible Preferred Stock
625
Total derivative liability
$ 1,372
13
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, 2025 and December 31, 2024, 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.
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 AditxtScore TM 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.
14
Leases
The Company determines if an arrangement is a
lease or implicitly contains a lease as well as if the lease is classified as an operating or finance lease in accordance with ASC 842,
Leases (ASC 842), at inception based on the lease definition. Operating leases are included in operating lease ROU assets and operating
lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying
asset for the lease term. Lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU
assets and lease liabilities are recognized at commencement date or the adoption date for existing leases based on the present value of
lease payments over the lease term using an estimated discount rate.
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.
We have made a policy election regarding our real
estate leases not to separate nonlease components from lease components, to the extent they are fixed. Nonlease components that are not
fixed are expensed as incurred as variable lease expense. Our leases for laboratory and office facilities typically include variable nonlease
components, such as common-area maintenance costs. We have also elected not to record on the consolidated balance sheets a lease that
has a lease term of twelve months or less and does not contain a purchase option that we are reasonably certain to exercise.
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, 2025 and 2024, the Company incurred
patent licensing fees of $ 101,340 and $ 61,666 , 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, 2025 and 2024, the Company incurred research
and development costs of $ 1,209,205 and $ 8,145,266 , respectively.
Sales and Marketing
We incur sales and marketing costs marketing our
technologies. We expense these costs as incurred unless such costs qualify for capitalization under applicable guidance. During the three
months ended March 31, 2025 and 2024, the Company incurred sales and marketing costs of $ 50,920 and $ 40,513 , respectively.
15
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, 2025 and 2024, the Company recognized $ 242,156 and $ 138,967 in net loss attributable to non-controlling interest in
Pearsanta. The Company owns approximately 90.0 % of Pearsanta, Inc., as of March 31, 2025.
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.
Instrument
Quantity
Issued and
Outstanding as
of
March 31,
2025
Standard
Conversion
Common Stock
Equivalent
Liquidation
Amount
Series A Preferred Stock
-
-
$
Series A-1 Convertible Preferred Stock
22,071
2,486
27,588,230
Series B Preferred Stock
-
-
-
Series B-1 Convertible Preferred Stock
2,689
332
3,361,250
Series B-2 Convertible Preferred Stock
2,625
279
3,281,250
Series C Preferred Stock
-
-
-
Series C-1 Convertible Preferred Stock
2,263
87
2,828,750
Series D-1 Preferred Stock
-
-
-
Warrants
2,680
2,680
$ -
Options
59
59
-
Total Common Stock Equivalent
32,387
5,923
37,059,480
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, 2025:
Cost Basis
Accumulated
Depreciation
Net
Computers
$ 378,480
$ ( 376,587 )
$ 1,893
Lab Equipment
2,697,987
( 1,293,565 )
1,404,422
Office Furniture
56,656
( 22,879 )
33,777
Other Fixed Assets
136,939
( 131,493 )
5,446
Leasehold Improvements
120,440
( 86,654 )
33,786
Total Fixed Assets
$ 3,390,502
$ ( 1,911,178 )
$ 1,479,324
16
The Company’s fixed assets include the following
on December 31, 2024
Cost Basis
Accumulated
Depreciation
Net
Computers
$ 378,480
$ ( 374,360 )
$ 4,120
Lab Equipment
2,697,987
( 1,235,236 )
1,462,751
Office Furniture
56,656
( 21,535 )
35,121
Other Fixed Assets
136,939
( 131,278 )
5,661
Leasehold Improvements
120,440
( 80,319 )
40,121
Total Fixed Assets
$ 3,390,502
$ ( 1,842,728 )
$ 1,547,774
Depreciation expense was $ 68,450 and $ 142,932 for
the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025 and December 31, 2024, the fixed assets that serve
as collateral subject to the financed asset liability have a carrying value of $ 622,865 and $ 1,316,830 , respectively.
Fixed asset activity for the three months ended
March 31, 2025 consisted of the following:
For the
three months
ended
March 31,
2025
As of December 31, 2024
$ 3,390,502
Disposals
-
As of March 31, 2025
$ 3,390,502
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, 2025, the Company has four payments 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, 2025, the Company has four payments 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, 2025, the Company has seven payments in arrears.
As of March 31, 2025 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, 2025:
Cost Basis
Accumulated
Amortization
Net
Proprietary Technology
$
321,000
$
( 321,000
)
$
-
Intellectual property
10,000
( 4,722
)
5,278
Total Intangible Assets
$
331,000
$
( 325,722
)
$
5,278
17
The Company’s intangible assets include
the following on December 31, 2024:
Cost Basis
Accumulated
Amortization
Net
Proprietary Technology
$ 321,000
$ ( 321,000 )
$ -
Intellectual property
10,000
( 3,889 )
6,111
Total Intangible Assets
$ 331,000
$ ( 324,889 )
$ 6,111
Amortization expense was $ 833 and $ 833 for
the three months ended March 31, 2025 and 2024, respectively. The Company’s proprietary technology is being amortized over its estimated
useful life of three years .
Intangible asset activity for the months ended
March 31, 2025 consisted of the following:
For the
three months ended
March 31,
2025
As of December 31, 2024
331,000
Additions
-
As of March 31, 2025
$
331,000
NOTE 6 – RELATED PARTY TRANSACTIONS
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. The Albanna Amendment extended
the maturity date of the February 15 th Note to January 31, 2025. As of March 31, 2025, the February 15 th Note was
fully paid off.
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. On September 9, 2024 the Company and Shahrokh Shabahang
entered into the first amendment to the unsecured promissory note which extended the maturity date of the February 29 th Notes
to January 31, 2025. The Albanna Amendment extended the maturity date of the February 29 th Notes to January 31, 2025. As of
March 31, 2025, the February 29 th Notes were was fully paid off.
NOTE 7 – NOTES PAYABLE
November Loan Agreement
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 with an interest rate of 49 %, 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, 2025, the November Loan has an outstanding principal
balance of $ 676,460 , an unamortized debt discount of $ 0 , and accrued interest of $ 61,481 .
18
January Loan Agreement
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 and an interest rate of 49 %, 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, 2025, there was a remaining principal balance of $ 2,282,706 , an unamortized
debt discount of $ 0 , and accrued interest of $ 563,735 .
Sixth Borough Note
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. The Sixth Borough Note was converted into Series
C-1 Convertible Preferred Stock in connection with the Private Placement (as defined below).
On April 10, 2024, Sixth Borough Capital Fund,
LP (“Sixth Borough”) loaned $ 230,000 to Aditxt. 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 accrued interest at the Prime rate of eight and
one-half percent ( 8.5 %) per annum and was due on the earlier of April 19, 2024 or an event of default, as defined therein. $ 200,000 of
the April Sixth Borough Note was converted into 200 shares Series C-1 Convertible Preferred Stock and 200 shares of Series D-1 Convertible
Preferred Stock as part of the May PIPE Purchase Agreement (as defined below) (note 10).
On May 9, 2024, at which point the balance of
the April Sixth Borough Note was $ 35,256 , Sixth Borough loaned an additional $ 20,000 to the Company bringing the balance of the loan
to $ 55,256 . The loan was evidenced by an unsecured promissory note (the “Sixth Borough Upsize Note”). Pursuant to the terms
of the Sixth Borough Upsize Note, it accrued interest at the fifteen percent ( 15.0 %) per annum and was due on the earlier of June 9, 2024
(the “Maturity Date”) or an event of default, as defined therein. As previously reported in a Current Report on Form 8-K filed
by the Company on June 12, 2024, as a result of the Company’s failure to repay the balance on the Maturity Date, the Company was
in default on the Upsize Note.
On June 20, 2024, at which point the balance of
the Sixth Borough Upsize Note was $ 56,187 , Sixth Borough loaned an additional $ 50,000 to the Company and the Company issued a new
note (the “Sixth Borough New Note”) to Sixth Borough in the principal amount of $ 116,806 , which includes an original issue
discount of 10 %. The Sixth Borough New Note is subordinate and junior, in all respects, to those Second May Senior Notes (as defined
below). The Sixth Borough New Note bears interest at a rate of eight percent ( 8.0 %) per annum and is due on the earlier of (i) November
21, 2024 or (ii) at or before the final closing on the next series of public or private financings, totaling $ 750,000 , or more in the
aggregate by the Company, subject to the prior payment in full of all amounts then owing on Second May Senior Notes, (iii) an event of
default. As of March 31, 2025, the Sith Borough New Note was fully paid off.
May 2024 Senior Notes
On May 20, 2024, the Company issued and sold a
senior note (the “First May Senior Note”) to an accredited investor (the “First May Senior Note Holder”) in the
original principal amount of $ 93,919 for a purchase price of $ 75,135 , reflecting an original issue discount of $ 18,784 . Unless earlier
redeemed, the First May Senior Note will mature on August 18, 2024 (the “First May Senior Note Maturity Date”), subject to
extension at the option of the First May Senior Holder in certain circumstances as provided in the First May Senior Note. The First May
Senior Note bears interest at a rate of 8.5 % per annum, which is compounded each calendar month and is payable in arrears on the
First May Senior Maturity Date. The First May Senior Note contains certain standard events of default, as defined in the First May Senior
Note.
19
On May 24, 2024, the Company entered into a Securities
Purchase Agreement (the “Second May Senior Note Securities Purchase Agreement”) with certain accredited investors pursuant
to which the Company issued and sold senior notes in the aggregate principal amount of $ 986,380 (the “Second May Senior Notes”)
maturing on August 22, 2024 , which included the exchange of the First May Senior Note in the principal amount of $ 93,919 . The Company
received cash proceeds of $ 775,000 from the sale of the Second May Senior Notes.
Upon an Event of Default (as defined in the Second
May Senior Notes), the Second May Senior Notes will bear interest at a rate of 14 % per annum and the holder shall have the right
to require the Company to redeem the Note at a redemption premium of 125 %. In connection with the issuance of the Second May Senior
Notes, the Company issued an aggregate of 33 shares of its common stock as a commitment fee to the investors and recorded a
debt discount of $ 662,720 from the issuance of these shares. As of March 31, 2025, the note was fully paid off.
Promissory Notes
On January 24, 2024, an investor entered into a $ 54,870 promissory
note to the Company. Pursuant to the terms of the note, it will accrue interest at a rate of eight and a half percent ( 8.50 %) per annum,
and is due on the earlier of July 25, 2024, or an event of default, as defined therein. As of March 31, 2025, the note was fully paid
off.
On September 8, 2024, an investor entered into
a $ 5,341 promissory note to the Company. Pursuant to the terms of the note, it will accrue interest at a rate of eight and a half
percent ( 8.50 %) per annum, and is due on the earlier of March 9, 2025 or an event of default, as defined therein. As of March 31, 2025,
the note was fully paid off.
September Note
On September 17, 2024, the Company issued and sold a senior note (the
“2024 September Note”) to an accredited investor (the “2024 September Note Holder”) in the original principal
amount of $ 923,077 for a purchase price of $ 600,000 , reflecting an original issue discount of $ 323,077 . The 2024 September Note does not
bear interest and has a maturity date of the earlier of (i) June 18, 2025 and (ii) the initial time of consummation by the Company after
the date hereof of any public or private offering(s), individually or in the aggregate, of securities with gross proceeds of at least
$ 1 million. The Company may prepay any portion of the outstanding principal of the 2024 September Note at any time without penalty. So
long as any amounts remain outstanding under the 2024 September Note, 30 % of the gross proceeds received by the Company on or after the
date hereof from sales of common stock of the Company pursuant to any at-the-market offering, equity-line or other similar transaction
shall be used to repay the 2024 September Note. The 2024 September Note contains certain standard events of default, as defined in the
Note. During the three months ended March 31, 2025, the Company recorded an amortization of debt discount of $ 200,284 . As of March 31,
2025, the 2024 September Note was fully paid off.
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, 2025 and December
31, 2024 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 Mountain
View, California where we lease approximately 5,810 square feet of laboratory and office space. The lease expired in August
31, 2024, subject to extension. As of September 1, 2024, the lease became month to month. As of March 31, 2025 the Company is current
on this lease.
We also lease approximately 25,000 square
feet in Richmond, Virginia. The lease expires on August 31, 2026 , subject to extension. As of March 31, 2025 the Company is current
on this lease.
Additionally, we leased approximately 3,150 square
feet of office space in Melville, New York. 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”). On June 24, 2024 the Company and the
Landlord entered into a surrender and acceptance of lease agreement (the “Surrender Agreement”). Pursuant to the Surrender
Agreement, the Company surrendered to the landlord the lease and term of the estate on June 28, 2024. In consideration of the acceptance
by the Landlord, the Company agreed to pay $ 69,379 (the “Surrender Fee”), which reflected outstanding rent, utilities,
and other charges owed under the lease. Further, upon execution of the agreement, the Landlord released and retained the security deposit
of $ 25,515 . The balance of the Surrender fee, $ 43,864 , was paid in 2024.
20
LS Biotech Eight Default
On May 10, 2024, the Company received written
notice (the “2024 Default Notice”) from LS Biotech Eight, LLC (the “Landlord”), the Landlord of the Company’s
CLIA-certified, CAP accredited, high complexity immune monitoring center in Richmond, Virginia, 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 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 , 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 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. As of March
31, 2025, the Company has made the payment of $ 431,182 . and is current on the Lease.
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.
Lease Costs
Three Months
Ended
March 31,
2025
Three Months
Ended
March 31,
2024
Components of total lease costs:
Operating lease expense
$ 262,206
$ 305,049
Total lease costs
$ 262,206
$ 305,049
Lease Positions as of March 31, 2025 and December
31, 2024
ROU lease assets and lease liabilities for our
operating leases are recorded on the balance sheet as follows:
March 31,
2025
December 31,
2024
Assets
Right of use asset – long term
$ 1,060,065
$ 1,225,781
Total right of use asset
$ 1,060,065
$ 1,225,781
Liabilities
Operating lease liabilities – short term
$ 688,474
$ 683,352
Operating lease liabilities – long term
277,291
436,354
Total lease liability
$ 965,765
$ 1,119,706
Lease Terms and Discount Rate as of March 31,
2025
Weighted average remaining lease term (in years) – operating leases 1.33
Weighted average discount rate – operating leases 8.00 %
21
Maturities of leases are as follows:
2025 (remaining)
$ 536,392
2026
423,930
Total lease payments
$ 960,322
Less imputed interest
5,443
Less current portion
( 688,474 )
Total maturities, due beyond one year
$ 277,291
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 1 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 June 30, 2022; $ 100,000 on September 30, 2024; $ 500,000 on
September 30, 2026; and $ 500,000 on September 30, 2027. In lieu of the $ 175,000 milestone payment due on September 30, 2023,
the Company paid LLU an extension fee of $ 100,000 . The Company did not make the September 30, 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 September 30, 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 September 30, 2023, which will be extended to September 30, 2024 with a payment of a $ 100,000 extension
fee, (ii) the completion of first-in-human (phase I/II) clinical trials by September 30, 2024, which the Company is actively pursuing
an extension, (iii) the completion of Phase III clinical trials by September 30, 2026 and (iv) biologic licensing approval by the FDA
by September 30, 2027. The Company has not initiated clinical trials to date and the Company intends to obtain an extension to commence
human trials by September 30, 2025.
22
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 AditxtScore TM 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 1 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 June 30, 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.
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.
23
In connection with the Merger Agreement the Company assumed $ 13.0 million
in notes payable held by Evofem and assumed a payable for $ 154,480 . These items were capitalized on the Company’s balance sheet
to deposit on acquisition as of March 31, 2025. The Company recognized a debt discount of $ 1,924,276 . As of March 31, 2025, there was
an unamortized discount of $ 0 . During the three months ended March 31, 2025 and 2024, the Company recognized an amortization of debt discount
of $ 0 and $ 571,904 .
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 61 shares of the Company’s common stock, par value $ 0.001 per share; 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 Convertible 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 Convertible 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.
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.
24
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 September 17, 2024 and $ 1,000,000 prior to July 1, 2024 (the “Parent Capital Raise”). (See Note 12)
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.
Amended and Restated Merger Agreement
On July 12, 2024 (the “Execution Date”),
the Company entered into an Amended and Restated Agreement and Plan of Merger (the “Merger Agreement”) with Adifem, Inc. f/k/a
Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”) and 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. The Merger Agreement amended and restated that certain Agreement and Plan of Merger dated as of December 11, 2023 by and
among the Company, Merger Sub and Evofem (as amended, the “Original Agreement”).
Effect on Capital Stock
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 either held by the Company or Merger Sub immediately prior to the Effective Time or which are Dissenting Shares (as hereinafter
defined), will be converted into the right to receive an aggregate of $ 1,800,000 ; and (ii) each issued and outstanding share 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 either held by the Company or Merger Sub immediately prior to the Effective Time or which are Dissenting
Shares, will be converted into the right to receive one (1) share of Series A-2 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-2 Preferred Stock, the form of which is attached as Exhibit C to the Merger Agreement.
25
Any Evofem capital stock outstanding immediately
prior to the Effective Time and held by an Evofem shareholder who has not voted in favor of or consented to the adoption of the Merger
Agreement and who is entitled to demand and has properly demanded appraisal for such Company Capital Stock in accordance with the Delaware
General Corporation Law (“DGCL”), and who, as of the Effective Time, has not effectively withdrawn or lost such appraisal
rights (such Evofem capital Stock, “Dissenting Shares”) shall not be converted into or be exchangeable for the right to receive
a portion of the Merger Consideration and, instead, shall be entitled to only those rights as set forth in the DGCL. If, after the Effective
Time, any such holder fails to perfect or withdraws or loses his, her or its right to appraisal under the DGCL, with respect to any Dissenting
Shares, upon surrender of the certificate(s) representing such Dissenting Shares, such Dissenting Shares shall thereupon be treated as
if they had been converted as of the Effective Time into the right to receive the portion of the merger consideration, if any, to which
such Evofem capital stock is entitled pursuant to the Merger Agreement, without interest.
As a closing condition for the Company, there
shall be no more than 4,141,434 Dissenting Shares that are Evofem Common Stock or 98 Dissenting Shares that are Evofem Preferred Stock.
Treatment of Evofem Options and Employee Stock
Purchase Plan
At the Effective Time, each option outstanding
under the Evofem 2014 Equity Incentive Plan, the Evofem 2018 Inducement Equity Incentive Plan and the Evofem 2019 Employee Stock Purchase
Plan (collectively, the “Evofem Option Plans”), whether or not vested, will be canceled without the right to receive any consideration,
and the board of directors of Evofem shall take such action such that the Evofem Option Plans are cancelled as of the Effective Time.
As soon as practicable following the Execution
Date, Evofem will take all action that may be reasonably necessary to provide that: (i) no new offering period will commence under the
Evofem 2019 Employee Stock Purchase Plan (the “Evofem ESPP”); (ii) participants in the Evofem ESPP as of the Execution Date
shall not be permitted to increase their payroll deductions or make separate non-payroll contributions to the Evofem ESPP; and (iii) no
new participants may commence participation in the Evofem ESPP following the Execution Date. Prior to the Effective Time, Evofem will
take all action that may be reasonably necessary to: (A) cause any offering period or purchase period that otherwise be in progress at
the Effective Time to be the final offering period under the Evofem ESPP and to be terminated no later than five business days prior to
the anticipated closing date (the “Final Exercise Date”); (B) make any pro-rata adjustments that may be necessary to reflect
the shortened offering period or purchase period; (C) cause each participant’s then-outstanding share purchase right under the Evofem
ESPP to be exercised as of the Final Exercise Date; and (D) terminate the Evofem ESPP, as of and contingent upon, the Effective Time.
Representations and Warranties
The parties to the Merger Agreement have agreed
to customary representations and warranties for transactions of this type.
Covenants
The Merger Agreement contains various customary
covenants, including but not limited to, covenants with respect to the conduct of Evofem’s business prior to the Effective Time.
Closing Conditions
Mutual
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 Evofem shareholders;
26
(ii)
the entry into a voting agreement by the Company and certain members of Evofem management;
(iii)
all preferred stock of Evofem other than the Evofem Unconverted Preferred Stock shall have been converted to Evofem Common Stock;
(iv)
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 930,336 shares of Company Preferred Stock;
(v)
Evofem shall have cashed out any other holder of Evofem warrants who has not provided an Evofem Warrant Holder Agreement; and
(vi)
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.
(vii)
The Company shall have received sufficient financing to satisfy its payment obligations under the Merger Agreement.
(viii)
The requisite stockholder approval shall have been obtained by the Company at a Special Meeting of its stockholders to approve the Parent Stock Issuance (as defined in the Merger Agreement) pursuant to the requirements of NASDAQ.
The Company and Merger Sub
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 353 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.
Evofem
The obligations of Evofem 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 be in compliance with the stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1) and shall meet all other applicable criteria for continued listing.
27
Termination
The Merger Agreement may be terminated at any
time prior to the consummation of the Closing by mutual written consent of the Company and Evofem. Either the Company or Evofem may also
terminate the Merger Agreement if (i) the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time on September 30,
2024; (ii) if any judgment, law or order prohibiting the Merger or the Transactions has become final and non-appealable; (iii) the required
vote of Evofem stockholders was not obtained; or (iv) in the event of any Terminable Breach (as defined in the Merger Agreement). The
Company may terminate the Merger Agreement if (i) prior to approval by the required vote of Evofem’s shareholders if the Evofem
board of directors shall have effected a Company Change in Recommendation (as defined in the Merger Agreement); or (ii) in the event that
the Company determines, in its reasonable discretion, that the acquisition of Evofem could result in a material adverse amount of cancellation
of indebtedness income to the Company. Evofem may terminate the Merger Agreement if (i) at any time after there has been a Company Change
of Recommendation; provided, that Evofem has provided the Company ten (10) calendar days’ prior written notice thereof and has negotiated
in good faith with the Company to provide a competing offer; (ii) the Company’s common stock is no longer listed for trading on
Nasdaq; or (iii) any of: (A) the Initial Parent Equity Investment has not been made by the Initial Parent Equity Investment Date, (B)
the Second Parent Equity Investment has not been made by the Second Parent Equity Investment Date, (C) the Third Parent Equity Investment
has not been made by the Third Parent Equity Investment Date or (D) the Fourth Parent Equity Investment has not been made by the Fourth
Parent Equity Investment Date (as all of such terms are defined in the Merger Agreement).
Effect of Termination
If the Merger Agreement is terminated, the Merger
Agreement will become void, and there will be no liability under the Merger Agreement on the part of any party thereto.
Amendments to Evofem Amended and Restated
Merger Agreement
On August 16, 2024, the Company, Merger Sub and
Evofem entered into Amendment No. 1 to the Amended and Restated Merger Agreement (“Amendment No. 1”), pursuant to which the
date by which the Company is to make the Third Parent Equity Investment (as defined under the Amended and Restated Merger Agreement) was
amended to the earlier of September 6, 2024 or five (5) business days of the closing of a public offering by Parent resulting in aggregate
net proceeds to Parent of no less than $ 20,000,000 . Except as set forth herein, the terms and conditions of the Amended and Restated Merger
Agreement have not been modified.
On September 6, 2024, the Company, Merger Sub and Evofem entered into
Amendment No. 2 to the Amended and Restated Merger Agreement (“Amendment No. 2”), pursuant to which the date by which the
Company shall make the Third Parent Equity Investment was amended from September 6, 2024 to September 30, 2024 and adjust the amount of
such investment from $ 2 million to $ 1.5 million, and to extend the date by which Aditxt shall make the Fourth Parent Equity Investment
(as defined under the Amended and Restated Merger Agreement) was amended from September 30, 2024 to October 31, 2024 and adjust the amount
of such investment from $ 1 million to $ 1.5 million.
Third Evofem Amendment & Parent Equity
Investment
On October 2, 2024, the Company, Merger Sub and
Evofem entered into Amendment No. 3 to the Amended and Restated Merger Agreement in order to extend the date by which the Company shall
make the Third Parent Equity Investment to October 2, 2024, reduce the amount of the Third Parent Equity Investment from $ 1.5 million
to $ 720,000 , and increase the amount of the Fourth Parent Equity Investment from $ 1.5 million to $ 2.28 million.
On October 2, 2024 the Company completed the purchase
of 460 shares of Evofem F-1 Preferred Stock for an aggregate purchase price of $ 460,000 .
Evofem Parent Equity Investment
On October 28, 2024, the Company entered into
a Securities Purchase Agreement (the “Series F-1 Securities Purchase Agreement”) with Evofem, pursuant to which the Company
purchased the Fourth Parent Equity Investment of 2,280 shares of Evofem Series F-1 Convertible Preferred Stock for an aggregate purchase
price of $ 2,280,000 .
28
Fifth Amendment to Amended
and Restated Merger Agreement
On March 23, 2025, the Company, Adicure, Inc., and Evofem entered into
Amendment No. 5 to the Amended and Restated Merger Agreement (“Amendment No. 5”), pursuant to which, the parties agreed that
(i) Evofem shall use commercially reasonable efforts to hold the Company Shareholders Meeting (as defined under the A&R Merger Agreement)
no later than September 26, 2025, (ii) the Company shall invest an additional $ 1,500,000 in Evofem no later than April 7, 2025 in exchange
for additional shares of F-1 Preferred Stock and/or, at the Company’s option, senior subordinated notes of Evofem, and (iii) the
End Date shall be extended to September 30, 2025. See Note 12 for the current status of the Evofem transaction.
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.
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) $ 116.75 in cash consideration per share for an aggregate cash payment of $ 5,668,222 (the
“Cash Consideration”) and (ii) 27.45004 of a share of common stock of Aditxt or an aggregate of 34 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).
Appili Amending Agreement
On July 1, 2024, the Company, Adivir and Appili
entered into an Amending Agreement (the “Amending Agreement”), pursuant to which the Parties (as defined in the Arrangement
Agreement) agreed that: (i) the Outside Date (as defined in the Arrangement Agreement) would be changed to August 30, 2024; (ii) Adivir
agreed that it would convene the Company Meeting (as defined in the Arrangement Agreement) no later than August 30, 2024, provided that
Appili shall be under no obligation to convene the Company Meeting prior to the date that is 50 days following the date that Aditxt delivers
to Appili all complete Additional Financial Disclosure (as defined in the Arrangement Agreement) required for inclusion in the Company
Circular (as defined in the Arrangement Agreement); (iii) Aditxt shall use commercially reasonable efforts to complete the Financing (as
defined in the Arrangement Agreement) no later than August 30, 2024; and (iv) Aditxt or Appili may terminate the Arrangement Agreement
if the Financing is not completed by 5:00 p.m. (ET) on August 30, 2024 or such later date as the Parties may agree in writing.
29
On July 18, 2024, the Company, Adivir and Appili
entered into a Second Amending Agreement (the “Second Amending Agreement”), pursuant to which the Arrangement Agreement was
amended to provide that (i) the Outside Date will be extended to September 30, 2024, (ii) the Appili Meeting will be conducted no later
than September 30, 2024, provided that Appili shall be under no obligation to hold the Appili Meting prior to the date that is 50 days
following the date that the Company delivers all complete Additional Financial Disclosure required for inclusion in the circular; (iii)
the Company shall use commercially reasonable efforts to complete the Financing on or prior to September 15, 2024; and (iv) the Company
and Appili may terminate the Arrangement Agreement if the Financing is not completed on or before 5:00 p.m. (ET) on September 15, 2024
or such later date as the Parties may in writing agree.
On August 20, 2024, the Company, Adivir and Appili
entered into a Third Amending Agreement (the “Third Amending Agreement”), pursuant to which the Arrangement Agreement was
amended to provide that (i) the Outside Date will be extended to November 19, 2024, (ii) Appili shall convene an annual and special meeting
in parallel to the Appili Meeting, to approve as promptly as practicable Appili’s continuation from a corporation governed under
the Canada Business Corporations Act to a corporation governed under the Business Corporations Act (Ontario) (the “Continuance”);
(iii) the date by which Appili shall convene the Appili Meeting will be extended to no later than November 6, 2024, provided that Appili
shall be under no obligation to hold the Appili Meeting prior to the date that is 50 days following the date that the Company delivers
all complete Additional Financial Disclosure required for inclusion in the Company Circular; (iv) the Company shall use commercially reasonable
efforts to complete the Financing on or prior to October 18, 2024; and (v) the completion of the Continuance shall be a condition to the
completion of the Arrangement.
Appili Mutual Waiver
On November 11, 2024, the Company, Adivir and
Appili entered into a Mutual Waiver, pursuant to which the parties agreed (i) each party shall waive any termination right it may have
under the Arrangement Agreement until December 15, 2024; (ii) immediately following the completion of the Arrangement, the board of directors
of Adivir will be reconstituted such that it shall consist of the following three (3) directors (with the remaining two directors to be
elected by Adivir at a later date): (a) Shahrokh Shabahang; (b) Madhukar Tanna; and (c) Armand Balboni; and (iii) Adivir shall pay Appili
the sum of $ 115,000 no later than 5:00 p.m. (ET) on November 12, 2024 (the “Waiver Fee”). Adivir paid the Waiver Fee on November
12, 2024.
On January 30, 2025, the Company, Adivir,
and Appili (the “Parties”) entered into a mutual waiver, pursuant to which, among other things, the Parties waived certain
provisions of the Arrangement Agreement relating to the Outside Date not occurring on or before January 31, 2025, such waiver effective
until 5:00pm (ET) on February 28, 2025, in consideration of (i) a payment by Adivir to Appili in the amount of $ 125,000 on or before January
31, 2025, and (ii) a payment by Adivir to Appili in the amount of $ 125,000 not later than February 14, 2025, to the extent the Arrangement
Agreement has not been completed prior to that time.
On February 28, 2025, the Parties entered into
a waiver to waive any termination rights that they may have as a result of the effective time not occurring by February 28, 2025,which
waiver shall expire on March 31, 2025 in consideration of (i) a payment by Adivir to Appili in the amount of $ 125,000 on or before February
28, 2025, and (ii) a payment by Adivir to Appili in the amount of $ 125,000 not later than March 14, 2025, to the extent the Arrangement
Agreement has not been completed prior to that time. The $ 125,000 payment to Appili was completed on March 14, 2025. See Note 12 for additional
amendments.
30
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 34 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 of 225 shares 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.
31
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.
The Company obtained Stockholder Approval at its
Annual Meeting on August 7, 2024. The registration statement covering the ELOC shares was declared effective by the SEC on September 13,
2024.
For the three months ended March 31, 2025, the
Company sold 853,954 shares at an average price of $ 18.99 per share under the ELOC Purchase Agreement. The sales generated gross proceeds
of $ 16,215,915 after paying commissions and related fees. (See Note 10)
In January 2025, the Company issued a total of 46,157 shares to the
ELOC Investor in connection with $ 2,250,000 in commitment fees as defined in the ELOC Purchase Agreement.
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. On October 2, 2024, the Company effectuated a 1-for-40
reverse stock split (the “2024 Reverse Split”). The Company’s stock began trading at the 2024 Reverse Split price
effective on the Nasdaq Stock Market on October 3, 2024. On March 14, 2025, the Company effectuated a 1-for-250 reverse stock split (the
“2025 Reverse Split”). The Company’s stock began trading at the 2024 Reverse Split price effective on the Nasdaq
Stock Market on March 17, 2025.
On March 14, 2025, Pearsanta effectuated a 1-for-60 reverse
stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of Pearsanta’s
common stock. All share amounts referenced in this report are adjusted to reflect the 2025 Pearsanta Reverse Split.
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
former 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 8,334 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 250,000 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 155,334 options, exercisable into shares of Pearsanta common stock under
the Pearsanta Parent Service Provider Plan and the issuance of 66,667 options, exercisable into shares of Pearsanta common stock,
subject to vesting, and 16,667 restricted common stock shares under the Pearsanta Omnibus Incentive Plan.
32
During the three months ended March 31, 2025, the Company issued 177,879 shares
of common stock as part of the ATM (as defined below). During the three months ended March 31, 2025, the Company issued 853,954 shares
of common stock as part of the ELOC (as defined below).
During the three months ended March 31, 2024,
the Company issued 5 shares of common stock as part of the MDNA asset purchase agreement. During the three months ended March
31, 2024, the Company issued 30 shares of common stock as part of a settlement agreement.
Increase in Authorized Capital
On August 8, 2024, the Company filed with the
Secretary of State of Delaware an amendment to the Company’s Certificate of Incorporation, (the “Charter Amendment”)
to increase the number of authorized common stock from 100,000,000 shares to 1,000,000,000 shares. The Charter Amendment
was approved by the Company’s stockholders at the Company’s Annual Meeting of Stockholders held on August 7, 2024.
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 124 shares of the Company’s common stock, par value $ 0.001 at an exercise
price of $ 10.00 per share, and (ii) warrants (the “December Common Warrants”) to purchase up to 248 shares
of the Company’s common stock, at a purchase price of $ 48,500.00 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 $ 46,000.00 per share in consideration for the cash payment by the December Purchaser of
$ 1,250.00 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 8 shares of common stock at an exercise price equal to $ 60,625.00 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.
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 Convertible 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 162 shares of the Company’s common stock.
33
The May PIPE Warrants are exercisable commencing
nine months following the initial issuance date at an initial exercise price of $ 24,700.00 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, issuable upon conversion of the Series C-1 Convertible 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 Convertible 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 used $ 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 of 323 (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 $ 32,437.50 per share commencing nine months following issuance
and have a term of exercise equal to five years from the date of issuance. Per the May PIPE Placement Agent Warrant agreement, the exercise
price of the May PIPE Placement Agent Warrants was reset to $ 5,190.00 .
Registered Direct Offering
On August 8, 2024, the Company entered into a
securities purchase agreement (the “Registered Direct Purchase Agreement”) with certain institutional investors, pursuant
to which the Company agreed to sell to such investors 19 shares (the “Registered Direct Shares”) of common stock
of the Company, pre-funded warrants (the “Registered Direct Pre-Funded Warrants”) to purchase up to 95 shares of
common stock of the Company (the “Registered Direct Pre-Funded Warrant Shares”), having an exercise price of $ 10.00 per
share, at a purchase price of $ 10,600.00 per share of common stock and a purchase price of $ 10,590.00 per Registered Direct
Pre-Funded Warrant (the “Registered Direct Offering”). The shares of common stock and Registered Direct Pre-Funded Warrants
(and shares of common stock underlying the Registered Direct Pre-Funded Warrants) were offered by the Company pursuant to its shelf registration
statement on Form S-3 (File No. 333-280757), which was declared effective by the Securities and Exchange Commission on August 6, 2024.
34
The closing of the sales of these securities under
the Registered Direct Purchase Agreement took place on August 9, 2024. The gross proceeds from the offering were approximately $ 1.2 million,
prior to deducting placement agent’s fees and other offering expenses payable by the Company. The Company used $ 500,000 of
the net proceeds from the offering to fund certain obligations under its Amended and Restated Merger agreement with Evofem Biosciences,
Inc and the remainder for working capital and other general corporate purposes.
At the Market Offering Agreement Amendment
& Activity
For the year ended December 31, 2023, the Company
sold 1 share of common stock at a price of $ 620,500 under the ATM (as defined below). The sale of the share generated proceeds of $ 507,016
after paying commissions and related fees.
On April 20, 2023, the Company entered into an
amendment to the ATM, pursuant to which the Company and the Agent (as defined below) agreed to reduce the aggregate gross sales price
of the shares under the ATM from $ 50,000,000 to zero .
On October 25, 2024 the Company entered into an
amendment to the existing At The Market Offering Agreement (the “ATM”) with H.C. Wainwright & Co., LLC as agent (the “Agent”),
pursuant to which the Company may offer and sell, from time to time through the Agent, shares of the Company’s common stock having
an aggregate offering price of up to $ 35,000,000 (the “ATM Shares”).
During the three months ended March 31, 2025,
the Company sold 177,879 ATM Shares at an average price of $ 25.76 per share under the ATM. The sale of the ATM Shares generated net proceeds
of approximately $ 4,582,262 after paying fees and expenses.
ELOC Activity
During the three months ended March 31, 2025,
the Company sold 853,954 Shares at an average price of $ 18.99 per share under the ELOC Purchase Agreement. The sale of Shares generated
net proceeds of approximately $ 16,216,915 after paying fees and expenses. As of March 31, 2025, the Company had an outstanding subscription
receivable in connection with the ELOC of 115,322 shares in the amount of $ 630,105 . The $ 630,105 was collected subsequent to March 31,
2025.
Preferred Stock
The Company is authorized to issue 3,000,000 shares
of preferred stock, par value $ 0.001 per share. There were 29,648 and 35,758 shares of preferred stock outstanding
as of March 31, 2025 and December 31, 2024, respectively.
All series of the Company’s convertible
preferred stock include alternate conversion provisions. The Company’s convertible preferred stock also contains floor pricing provisions;
the Company has the discretion to issue shares below the floor price.
Aditxt Preferred Share Class
Quantity
Issued and
Outstanding
as of
March 31,
2025
Standard
Conversion
Common
Stock
Equivalent
Liquidation
Amount
Series A Preferred Stock
-
-
$ -
Series A-1 Convertible Preferred Stock
22,071
2,486
27,588,230
Series B Preferred Stock
-
-
-
Series B-1 Convertible Preferred Stock
2,689
332
3,361,250
Series B-2 Convertible Preferred Stock
2,625
279
3,281,250
Series C Preferred Stock
-
-
-
Series C-1 Convertible Preferred Stock
2,263
88
2,828,305
Series D-1 Preferred Stock
-
-
-
Total Aditxt Preferred Shares Outstanding
29,648
3,185
$ 37,059,035
35
Issuance of Series A-1 Convertible 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 61 shares of the Company’s common stock, par value $ 0.001 per share; 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 Convertible 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 Convertible Preferred Stock. See Series A-1 Convertible 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 Convertible 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.
Designation, Amount, and Par Value: The number
of Series A-1 Convertible Preferred Stock designated is 22,280 shares. The shares of Series A-1 Convertible 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 Convertible Preferred
Stock will be convertible into shares of common stock at an initial conversion price of $ 44,400 (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 Convertible 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 Convertible 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) $ 8,880.00 (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.
36
Dividends: Holders of the Series A-1 Convertible
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 Convertible 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 Convertible Preferred Stock would receive if they converted
such share of Series A-1 Convertible 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 Convertible Preferred Stock for cash, at a price per share of Series A-1 Convertible 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 Convertible
Preferred Stock are prohibited from converting shares of Series A-1 Convertible 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 Convertible
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.
37
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.
Issuance of Series B-1 Preferred Stock:
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 “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”).
In connection with the Brain Assignment Agreement,
on January 24, 2024, the Company entered into a Patent Assignment with the Seller, 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.
Series B-1 Convertible Preferred Stock Certificate
of Designation
On January 24, 2024, the Company filed a Certificate
of Designations for its Series B-1 Convertible 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.
Designation, Amount, and Par Value: The number
of Series B-1 Convertible Preferred Stock designated is 6,000 shares. The shares of Series B-1 Convertible 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 Convertible Preferred
Stock will be convertible into shares of common stock at an initial conversion price of $ 40,600.00 (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 Convertible 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
Convertible 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) $ 9,420.00 (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 90 th and 180 th 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.
38
Dividends: Holders of the Series B-1 Convertible
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 Convertible 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 Convertible Preferred Stock would receive
if they converted such share of Series B-1 Convertible 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 Convertible Preferred Stock for cash, at a price per share of Series B-1 Convertible 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 Convertible
Preferred Stock are prohibited from converting shares of Series B-1 Convertible 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 Convertible 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 Convertible Preferred
Stock:
On December 29, 2023, the Company entered into
an Exchange Agreement (the “Note Exchange Agreement”) with the holder (the “Noteholder”) of a secured promissory
note in the principal amount of $ 2,625,000 (the “Note”), 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 Convertible Preferred Stock”). See Series B-2 Convertible 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.
Designation, Amount, and Par Value: The number
of Series B-2 Convertible Preferred Stock designated is 2,625 shares. The shares of Series B-2 Convertible Preferred Stock have
a par value of $ 0.001 per share and a stated value of $ 1,000 per share.
39
Conversion Price: The Series B-2 Convertible Preferred
Stock will be convertible into shares of common stockat an initial conversion price of $ 47,100.00 (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 Convertible 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 Convertible 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) $ 9,420.00 (the “Floor Price”) and (y) 80 % of the lowest volume weighted
average price (“VWAP”) of the common stockduring 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 Convertible
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 Convertible 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 Convertible Preferred Stock would receive if they converted
such share of Series B-2 Convertible 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 Convertible Preferred Stock for cash, at a price per share of Series B-2 Convertible 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 Convertible
Preferred Stock are prohibited from converting shares of Series B-2 Convertible 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 Convertible
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.
40
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.
Series C-1 Convertible Preferred Stock Certificate
of Designation
On May 2, 2024, the Company filed a Certificate
of Designation for its Series C-1 Convertible 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 Convertible Preferred Stock designated is 10,853 shares. The shares of Series C-1 Convertible 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 Convertible Preferred
Stock will be convertible into shares of common stock at an initial conversion price of $ 25,950.00 (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 Convertible 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 Convertible
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) $ 25,950.00 (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.
41
Dividends: Holders of the Series C-1 Convertible
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 Convertible 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 Convertible Preferred Stock would receive if they converted
such share of Series C-1 Convertible 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 Convertible Preferred Stock for cash, at a price per share of Series C-1 Convertible 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 Convertible
Preferred Stock are prohibited from converting shares of Series C-1 Convertible 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 Convertible
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 C-1 Convertible Preferred Stock Redemptions
For the three months ended March 31, 2025, the
Company redeemed approximately 6,110 shares of Series C-1 Convertible Preferred Stock for $ 7,027,070 . As of the date of this report, the
Company has an outstanding redemption payable of 2,263 shares Series C-1 Convertible Preferred Stock of $ 3,956,819 .
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.
42
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.
Pearsanta Acquisition of Assets
On March 24, 2025, Pearsanta, a majority-owned
subsidiary of the Company entered into an Agreement for the Acquisition of Patents (the “Pearsanta Acquisition Agreement”)
with the holders (the “Asset Holders”) of certain patents and intellectual property assets (the “Pearsanta Acquired
Assets”), which are related to the detection of DNA adducts for detection of changes to the DNA that may lead to potentially disease-causing
mutations, pursuant to which Pearsanta acquired the Pearsanta Acquired Assets in consideration of the issuance by Pearsanta to the Asset
Holders of an aggregate of 200 shares of Series B Convertible Preferred Stock, par value $ 0.001 per share (the “Pearsanta Series
B Preferred Stock”). The Pearsanta Series B Preferred Stock valued at $ 50.00 per share resulting in $ 10,000 of patent expenses
being recognized on the statement of operations.
Pursuant to the Certificate of Designation of
Preferences, Rights and Limitations of the Pearsanta Series B Preferred Stock, the Pearsanta Series B Preferred Stock will be mandatorily
and automatically converted, with no further action on the part of the holders thereof, into 1,000 fully paid and nonassessable shares
of common stock (1:1,000) (the “Series B Conversion Ratio”) of Pearsanta upon the consummation of a firm underwritten initial
public offering of the common stock for cash effected pursuant to a registration statement or similar document filed by or on behalf of
Pearsanta under the Securities Act of 1933, as amended (a “Pearsanta Qualifying IPO”), provided, however, that if the value
of such Pearsanta Series B Preferred Stock, on an as-converted basis, at the time of the pricing of the Pearsanta common stock in connection
with the Pearsanta Qualifying IPO does not equal $ 1,000,000 , then the conversion ratio of the Pearsanta Series B Preferred Stock will
be adjusted such that the value of the securities received in the Pearsanta Qualifying IPO by the Asset Holders shall equal $ 1,000,000
in the aggregate.
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.
43
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. An amendment to the 2021 Plan was submitted and approved by the Company’s stockholders at the 2024 annual meeting
of stockholders, increasing the shares of common stock issuable under the plan by 12,500 . A total of 14,000 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, 2025 and
2024, 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, 2024 60 $ 44,395,124.59 8.65
Granted -
-
-
Exercised -
-
-
Expired or forfeited ( 1 ) 150,200,000.00 -
Outstanding March 31, 2025 59 $ 40,808,518.64 6.06
Nonvested Stock Options
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2024
-
$ -
Granted
-
-
Vested
-
-
Forfeited
-
-
Nonvested on March 31, 2025
-
$ -
As of March 31, 2025 there were 59 exercisable
options; these options had a weighted average exercise price $ 40,808,518.64 .
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 250,000 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 155,334 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.
44
During the three months ended March 31, 2025 and
2024, 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, 2024 181,227 $ 1.19 8.84
Granted -
-
-
Exercised -
-
-
Expired or forfeited -
-
-
Rounding in connection with Reverse Split -
-
-
Outstanding March 31, 2025 181,227 $ 1.19 8.38
Nonvested Stock Options
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2024
-
$ -
Granted
-
-
Vested
-
-
Forfeited
-
-
Nonvested on March 31, 2025
-
$ -
As of March 31, 2025, there were 181,227 exercisable
options; these options had a weighted average exercise price $ 1.19 .
The Company recognized stock-based compensation
expense related to all options granted and vesting expense of $ 0 During the three months ended March 31, 2025. The remaining value
to be expensed is $ 0 as of March 31, 2025. The weighted average vesting term is 0 years as of March 31, 2025.
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.
Warrants
45
A summary of warrant issuances are as follows:
Vested and Nonvested Warrants Number Weighted
Average
Exercise
Price Weighted
Average
Remaining
Life
Outstanding December 31, 2024 2,680 $ 659,707.35 4.51
Granted -
-
-
Exercised -
-
-
Expired or forfeited -
-
-
Outstanding March 31, 2025 2,680 $ 659,707.35 4.22
Nonvested Warrants
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2024
-
$ -
Granted
-
-
Vested
-
-
Forfeited
-
-
Nonvested on March 31, 2025
-
$ -
NOTE 11 – INCOME TAXES
The Company has incurred losses since inception.
During the three months ended March 31, 2025, 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, 2025.
As of March 31, 2025, the Company did not have
any amounts recorded pertaining to uncertain tax positions.
NOTE 12 – SUBSEQUENT EVENTS
The Company has evaluated all significant events
or transactions that occurred through May 15, 2025, the date these consolidated financial statements were available to be issued.
Series A-1 Convertible Preferred Stock Redemptions
46
For the period beginning April 1, 2025 through
the date of this report, the Company redeemed approximately 268 shares of Series A-1 Convertible Preferred Stock for $ 308,000 .
Evofem Securities Purchase Agreement &
Waiver
On April 8, 2025, the Company entered into a Securities Purchase Agreement
(the “Evofem April Purchase Agreement”) with Evofem, pursuant to which the Company purchased (i) a senior subordinated convertible
note (the “Evofem April Note”) of Evofem in the principal amount of $ 2,307,692.31 , and (ii) a warrant (the “Evofem April
Warrant”) to purchase 149,850,150 shares of Evofem common stock for a purchase price of $ 1,500,000 . The Company had fully funded
the $ 1,500,000 on April 22, 2025.
The Evofem April Note is a senior subordinate obligation of Evofem
and will accrue interest at a rate of 8 % per annum, which will adjust to 12 % upon an Event of Default (as defined in the Evofem April
Note). The Evofem April Note is initially convertible into shares of common stock of Evofem at a conversion price of $ 0.0154 per share,
subject to adjustment as described therein. The Evofem April Note may not be converted by the Company if, after giving effect to such
conversion, the Company would beneficially own in excess of 9.99 % of Evofem common stock. Unless earlier converted, or redeemed, the Evofem
April Notes will mature on April 8, 2028.
The Evofem April Warrant is exercisable into shares of common stock
of Evofem at an exercise price of $ 0.0154 , subject to adjustment as described therein, and may be exercised on a cashless basis. The Evofem
April Warrant may not be exercised by the Company if, after giving effect to such exercise, the Company would beneficially own in excess
of 9.99 % of Evofem stock. The Evofem April Warrant is exercisable for a term of five years .
In connection with the Evofem April Purchase Agreement,
the Company, Merger Sub and Evofem entered into a Waiver Agreement (the “Evofem April Waiver”), pursuant to which Evofem agreed
to temporarily waive its termination right under the Amended and Restated Merger Agreement until April 16, 2025. Pursuant to the Evofem
April Waiver, in the event that the full purchase price is not received by April 16, 2025, the principal amount of the Evofem April Note
and the number of shares of Evofem common stock issuable upon exercise of the Evofem April Warrant will be adjusted accordingly.
Nasdaq Compliance
On April 8, 2025, the Company received a letter from The Nasdaq Stock
Market, LLC stating that the Company had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq
Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2). Consequently, the hearing before the Hearings Panel scheduled to take
place on April 22, 2025 has been cancelled.
Call Option Agreement
On April 10, 2025, the Company entered into a
Call Option Agreement (the “Option Agreement”) with Adjuvant Global Health Technology Fund, L.P. and Adjuvant Global Health
Technology fund DE, L.P. (collectively, the “Security Holder”) and Evofem, pursuant to which the Security Holder granted the
Company a call option (the “Option”) to purchase, at the sole discretion of the Company, the Evofem Securities (defined below)
for an aggregate purchase price of $ 13 million. The “Evofem Securities” consist of convertible promissory notes of Evofem
in the aggregate principal amount of $ 25 million and certain right to receive common stock agreements issued by Evofem. The Option has
a term commencing on or after the satisfaction in full of the repayment obligations under that certain Securities Purchase and Security
Agreement by and between Evofem, Future Pak, LLC and the designated agent dated April 23, 2020, as amended to date (the “Future
Pak Note”), until 5:00 Pacific time on June 30, 2025 (the “Call Period”). Pursuant to the Option Agreement, the Security
Holder may not transfer the Evofem Securities without the prior written consent of the Company; provided, however, that (i) if the Company
has not provided $ 1.5 million of capital to Evofem by April 30, 2025 (the “Funding Milestone”), the Security Holder may transfer
the Evofem Securities after April 30, 2025 without the prior written consent of the Company; (ii) if the Funding Milestone has not been
satisfied and the Future Pak Note is still held by Future Pak on May 31, 2025, the Security Holder may transfer the Evofem Securities
after May 31, 2025, without the prior written consent of the Company; and (iii) if at any time the repayment obligations of the Future
Pak Note have been satisfied through or by a transaction not associated with either the Company or the transactions contemplated under
the Amended and Restated Agreement and Plan of Merger, as amended to date, by and between the Company, Adifem, Inc. and Evofem, the Security
Holder may transfer the Evofem Securities, without the prior written consent of the Company.
47
Appili Mutual Waiver
On April 2, 2025, the Company, Adivir, and Appili
(the “Parties”) entered into a Mutual Waiver (the “March Waiver”), pursuant to which the Parties waived any termination
rights that they had as a result of the Effective Time not occurring by March 31, 2025, which waiver shall expire on April 30, 2025 in
consideration of a payment by the Company to Appili in the amount of $ 250,000 no later than 5:00 pm (ET) on April 18, 2025, provided that
in the event a Termination Fee becomes payable by the Company or Aditxt pursuant to the Arrangement Agreement, the amount payable by the
Company or Aditxt to Appili shall be reduced by the amount of the Waiver Fee paid by Adivir to Appili. As of the date of this filing,
the $ 250,000 has not been paid.
On May 2, 2025, the Parties entered into a waiver to waive any termination
rights that they may have as a result of the effective time not occurring by April 30, 2025, which waiver shall expire on May 31, 2025
in consideration of a payment by Adivir to Appili in the amount of $ 250,000 on or before May 15, 2025 to the extent the Arrangement Agreement
has not been completed prior to that time. As of the date of this filing, the $ 250,000 has not been paid.
Senior Notes
On April 24, 2025, the Company issued and sold
senior notes (each, a “April Note”) to accredited investors in the aggregate original principal amount of $ 256,250 for a purchase
price of $ 205,000 , reflecting an aggregate original issue discount of $ 51,250 . The April Notes bear interest at a rate of 10 %per annum
and have a maturity date of May 15, 2025 (the “April Notes Maturity Date”). So long as any amounts remain outstanding under
the April Notes, 100 % of the gross proceeds received by the Company on or after the date hereof from sales of common stock of the Company
pursuant to any at-the-market offering, equity-line or other similar transaction shall be used to repay the April Notes. The April Notes
contains certain standard events of default, as defined in the Note. Following the April Maturity Date and until all of the April Notes
have been satisfied, the Company shall be prohibited from taking certain actions, including but not limited to, incurring any additional
indebtedness, redeeming any capital stock or declaring or paying any dividends. As of the date of this filing the April Notes have been
repaid.
May Note
On May 9, 2025, the Company entered into a securities purchase agreement
(the “May Purchase Agreement”) with an accredited investor, pursuant to which the Company issued and sold a 30 % Original Issue
Discount Senior Secured Note (the “May 2025 Note”) to an accredited investor in the original principal amount of $ 3,114,285.71
for a purchase price of $ 2,000,000 . The May 2025 Note bears interest at a rate of 10 % per annum (the “May Note Interest Rate”)
and has a maturity date of May 12, 2025 (the “May Note Maturity Date”). The May 2025 Note contains certain standard events
of default, as defined in the May 2025 Note (each, an “May 2025 Event of Default”). Following any May 2025 Event of Default,
the May 2025 Interest Rate on the May 2025 Note is automatically increased to 20 % per annum to the extent permitted by law.
In connection with the May Purchase Agreement,
the Company entered into forbearance agreements (each, a “Forbearance Agreement”) with the holders (each, a “ Holder ”)
of certain outstanding shares of the Company’s Series A-1 Convertible Preferred Stock and the Company’s Series C-1 Convertible
Preferred Stock (. Pursuant to the Forbearance Agreement, the Company agreed, in consideration of the settlement of the Holder’s
claims and obligations with respect to one or more Triggering Events (as defined in the applicable Certificate of Designation) that: (i)
provided that the Company receives gross proceeds of an aggregate of $ 10 million or more in the Proposed Offerings (as defined in the
Forbearance Agreement), the Company shall concurrently redeem 5,124 of the Series A-1 Preferred Shares allocated pro rata among the holders
of Series A-1 Preferred Shares in a Company Optional Redemption (as defined in the Certificate of Designation of the Series A-1 Preferred
Shares), (ii) provided that the Company receives gross proceeds of $ 20 million or more in the Proposed Offerings, the Company shall concurrently
redeem 8,200 of the Series A-1 Preferred Shares (or, if less, the remaining Series A-1 Preferred Shares then outstanding assuming the
completion of any exercised Reinvestment Right (as defined in the Forbearance Agreement with respect thereto) allocated pro rata among
the holders of Series A-1 Preferred Shares in a Company Optional Redemption, (iii) by no later than the first business day following the
closing of any Additional Offering (as defined in the Forbearance Agreement), the Company shall redeem any remaining Series C-1 Preferred
Shares (after giving effect to any Reinvestment Right with respect thereto) in a Company Optional Redemption, (iv) if the Company sells
any securities pursuant to any VRT Potential Offering (as defined in the Forbearance Agreement), the Company shall apply 30 % of the gross
proceeds thereof to redeem any remaining Series C-1 Preferred Shares and/or any remaining Series A-1 Preferred Shares pro rata among the
holders of Series C-1 Preferred Shares and/or Series A-1 Preferred Shares in a Company Optional Redemption, and (v) if the Company consummates
any EVFM Sale (as defined in the Forbearance Agreement), the Company shall apply 30 % of the gross proceeds thereof to redeem any remaining
Series C-1 Preferred Shares and/or any remaining Series A-1 Preferred Shares pro rata among the holders of Series C-1 Preferred Shares
and/or Series A-1 Preferred Shares in a Company Optional Redemption.
As of the date hereof, the Company is in technical default under the May 2025 Note as no payment has been made. The Company is currently
working with the accredited investor to rectify.
48
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, 2024 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 Mountain View, California. 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 Apoptotic DNA Immunotherapy™ (ADI™) 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,
the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase
(“GAD”), which is implicated in type-1 diabetes, psoriasis, and in many autoimmune diseases of the CNS and has been successfully
tested in several preclinical models (e.g., skin grafting, psoriasis, type 1 diabetes, multiple sclerosis).
All
preclinical studies ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring
durable tolerance over the 10-month duration of the T1D studies both in prevention and treatment study designs. Preclinical safety and
toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs
evaluated. Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness
of the immune system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors.
49
Good
Manufacturing Process (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer. The
clinical grade drug substances are now being prepared for shipment to another contract manufacturer to be formulated into the final drug
product in preparation for stability testing and use in the clinical trials pending required regulatory submissions. Lastly, two remaining
drug product release assays specifically designed for ADI-100 are in the final stages of validation to be used once the final drug product
is ready.
Preclinical
and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to
submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical
trials. Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested.
For
the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process,
including site selection for clinical studies planned in psoriasis and type 1 diabetes. In parallel, Adimune is working with the Mayo
Clinic to prepare the IND package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to
review the package before full submission. 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 and U.S. Food and Drug Administration, a human trial for SPS is expected
get underway in 2025 with enrollment of 10-20 patients, some of whom may also have type 1 diabetes. ADI-100 will initially
be tested for safety and efficacy.
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.
50
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 1 shares of common stock to LLU.
PEARSANTA, INC.
The
best approach may be its early detection. Pearsanta is pioneering the development of molecular tests based on the mitochondrial genome
to develop tests for early detection of cancer. Though further technical development and clinical validation is required to determine
efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of
mitochondrial DNA (mtDNA), and more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease
detection, monitoring, risk assessment, and therapeutic targeting.
Pearsanta
acquired the assets of MDNA Life Sciences Inc. on January 4, 2024. Through the acquisition of these assets, and in particular the Mitomic
Technology platform, patents, and intellectual property, our management believes that the Pearsanta is well positioned for research and
discovery of mitochondrial DNA based biomarkers, and though untested and requiring clinical validation, the development and commercial
application of mitochondrial DNA based biomarkers for a wide spectrum of human diseases.
Pearsanta
is continuing to leverage this technology to discover mitochondrial DNA based biomarkers. Though Pearsanta has no commercially available
FDA or foreign regulator approved products, Pearsanta has two product candidates in develop and hopes to enter the cancer screening market
with these two product candidates, and if proven successful continue to discover mitochondrial DNA based biomarkers and develop a pipeline
of disease screening and diagnostics tests. The current in-development products include a potential product for prostate cancer diagnosis
and a potential product for the detection of endometriosis. Pearsanta has also discovered mitochondrial DNA based biomarkers, which it
believes are associated with ovarian cancer and lung cancer; and Pearsanta intends to pursue the biomarker identification phase of development
for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers.
Licensed Technologies
– AditxtScore TM
We
issued 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).
51
In
collaboration with its partners, the platforms underlying AditxtScore are being further evaluated for evaluating the immune status of
individuals including those with hypersensitivity to certain antigens (e.g., patients with autoimmunity). These tests may become tools
that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens.
Advantages
The
sophistication of the AditxtScore technology includes the following:
● greater
sensitivity/specificity.
● 20-fold
higher dynamic range, greatly reducing signal to noise compared to conventional assays.
● ability
to customize assays and multiplex a large number of analytes with speed and efficiency.
● ability
to test for cellular immune responses (i.e., T and B cells and cytokines).
● 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 AditxtScore TM and securing worldwide exclusivity in all fields of use of the licensed technology.
Acquired Technologies
– Mitomic® Technology Platform
In
January 2024 Pearsanta acquired the assets comprising our Mitomic® Technology platform from MDNA Life Sciences Inc. This platform
seeks to harness the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based
liquid biopsies. Though further technical development and clinical validation is required to determine efficacy in multiple diseases and
disease states, our management believes that the unique structural and functional characteristics of mtDNA, and more specifically mutated
mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic
targeting.
Pearsanta
plans to license distribution rights through various agreements with U.S.-based and international business partners to commercialize our
Mitomic® Technology, should Mitomic® tests be successfully developed and successfully approved by the FDA or a foreign regulator.
We believe our biomarker portfolio covers many high-clinical need cancers, with potential applications outside oncology.
Pearsanta
a state-of-the-art facility located in Richmond VA, that is a high-complexity, CLIA-certified, and CAP-accredited laboratory equipped
to accommodate rapid development and rollout of innovative laboratory tests for the clinical market. Our laboratory facility is optimized
for contamination prevention including dedicated workspaces for key functions; advanced molecular biology capabilities including digital
PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy; and automated and semi-automated (robotic) processes
for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows.
52
Our Mitomic® Products
and Product Candidates
The
Mitomic® Technology targets mutations in mitochondrial DNA to detect disease. Every human cell is home to multiple copies
of mitochondrial DNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer. Though further technical
development and clinical validation is required to determine efficacy, Mitomic® tests are being designed to detect this mutated DNA,
which can accumulate from the very early stages of a disease. If the development of Mitomic® tests is successful and if Mitomic®
tests can achieve their still unproven objective of early disease detection, our Mitomic® Technology presents an opportunity to detect
disease before it presents clinically.
The
Mitomic® Technology platform is designed to identify biomarker targets, develop robust assays, discover new biomarkers, and develop
new products. The biomarker identification program is based on the identification of a new class of molecules generated through a process
associated with mitochondria. The Mitomic® Technology platform has already discovered biomarkers which are believed to be associated
with cancer and has generated an “in-silico” database, which is an experiment that generates thousands of potential biomarkers,
developed through computer software and simulation.
To
date, the Mitomic® Technology biomarker discoveries have identified numerous biomarker targets from the in-silico database and we
plan to use these biomarker targets in its various assay development programs.
Mitomic®
Prostate Test (MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level
of the 3.4kb mitochondrial DNA deletion. Published analytical data for the 3.4kb mitochondrial DNA deletion associated with prostate cancer,
suggests the 3.4kb mitochondrial DNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific
antigen (PSA) grey zone (PSA < 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mitochondrial DNA deletion may be able
to aid in the decision to biopsy. Some of the significant clinical challenges that have not been met for prostate cancer are that up to
50% of men will be ‘over’ diagnosed with cancer that never harms them 1 and the risks associated with treatment
of low-grade cancers (≤ Gleason 6) appear to outweigh the benefits –e.g. urinary incontinence, erectile dysfunction. 1 NIH
National Cancer Institute reports this number is even higher at ~ 75% based on 5-year survival rates. Seer database (https://seer.cancer.gov/statfacts/html/prost.html).
Our
Mitomic® Prostate Test is in development and is being designed with the following objectives:
● Simple
– The test is expected to be completed using a patient’s blood sample and is not expected to require an algorithm.
● Provide
New Information – If ongoing clinical studies support the published analytical data for the 3.4kb mitochondrial DNA deletion, healthcare
providers will be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and
family history.
Mitomic
Endometriosis Test (MET™) is currently in development and is being designed as a blood-based assay that quantifies the
level of one or more mitochondrial DNA deletions which published analytical data suggest are associated with endometriosis – a condition
affecting approximately 1 in 10 women according to Endometriosis World and the World Health Organization. The Mitomic Endometriosis Test
is intended for use in females of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention
is warranted.
Endometriosis
occurs when the tissue of the uterus (endometrium) grows on areas where it does not belong, most often on the ovaries, fallopian tubes,
outer surface of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body. Endometriosis is challenging
to identify, and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe
symptoms.
53
Acquired Technologies – Adductomics
Technology
On
March 21, 2025, Pearsanta acquired certain patents related to the detection and analysis of DNA adducts. DNA adducts are chemically
modified nucleotides that result from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability
and increased cancer risk. The acquired technology includes proprietary mass-tag enhancements designed to improve the sensitivity and
specificity of DNA adduct detection across a full genomic landscape.
Pearsanta
intends to develop this platform to enable a comprehensive, panoramic assessment of DNA adducts using urine, blood, or solid tissue samples.
This approach aims to provide actionable insights into DNA damage before mutations occur, offering the potential to identify environmental
or biological factors that contribute to cancer risk. The development roadmap includes further validation of the technology and the creation
of commercially available diagnostic kits. While still in the early stages, Pearsanta anticipates that additional development over the
next two to three years will advance this platform toward clinical and commercial applications.
ADIVIR, INC.
Formed
in April of 2023, Adivir™, Inc. is a wholly owned subsidiary, dedicated to the clinical and commercial development efforts of innovative
products for population health, including antiviral and other antimicrobial 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;
54
(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.
In
October 2024, the Company received notice that Cellvera was the subject of a liquidation proceeding and that a liquidator had been appointed
by the order of the Eastern Caribbean Supreme Court. As a result, the Company does not presently believe that the proposed acquisition
of Cellvera 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
We
have assembled a team of experts from a variety of scientific fields and commercial backgrounds, with many years of collective experience
that ranges from founding startup biotech companies, to developing and marketing biopharmaceutical products, to designing clinical trials,
and to managing private and public companies.
Going Concern
We were incorporated on
September 28, 2017 and have not generated significant revenues to date. During the three months ended March 31, 2025 we had a net
loss of $5,952,465 and cash of $476,416 as of March 31, 2025.
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, 2025, show a net loss of $5,952,465. 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.
55
Results of Operations
Results of operations for the three months
ended March 31, 2025 and 2024
We generated revenue of $1,018
and $79,680 for the three months ended March 31, 2025 and 2024, respectively. Cost of goods sold for the three months ended March 31,
2025 and 2024 was $734 and $65,799, respectively. The decrease in revenue and costs of goods sold during the three months ended March
31, 2025 compared to the three months ended March 31, 2024 was due to a decrease in AditxtScore TM orders due to decreased
COVID testing being done.
During the three months ended
March 31, 2025, we incurred a loss from operations of $5,608,115. This is due to general and administrative expenses of $4,348,274, which
includes approximately $751,786 in payroll expenses and $1,670,782 in professional fees. Research and development expenses were $1,209,205
which includes $2,250 in consulting expenses. Sales and marketing expenses were $50,920.
During the three months ended
March 31, 2024, we incurred a loss from operations of $11,535,646. 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.
The decrease in expenses during
the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was due to decreased research and development
spend and decreased compensation expense due to reduced headcount.
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, 2025, we
had an accumulated deficit of $173,804,878. We had working capital of $(13,959,063) as of March 31, 2025. During the three months ended
March 31, 2025, we purchased zero in fixed assets.
Our
consolidated financial statements have been prepared assuming that we will continue as a going concern.
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 4 shares of common stock of the Company at a purchase price of $487,600.00 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 $344,000.00 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 1 share of common stock at an exercise price of $600,000.00 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 100 shares of the Company’s common stock at an exercise price of $400.00 per share, and (ii)
warrants (the “Common Warrants”) to purchase up to 100 shares of the Company’s common stock at an exercise price of
$100,000.00 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.
56
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 124 shares of the Company’s common stock, at an
exercise price of $10.00 per share, and (ii) warrants (the “Common Warrants”) to purchase up to 248 shares of the Company’s
common stock, at a purchase price of $48,500.00 per share. The Private Placement closed on January 4, 2024. The net proceeds to the Company
from the Private Placement were approximately $5.5 million, after deducting placement agent fees and expenses and estimated offering expenses
payable by the Company.
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 17 shares of the Company’s Series C-1 Convertible Preferred Stock (the “Series C-1 Convertible Preferred
Stock”), (ii) an aggregate of 17 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 162 shares of the Company’s common 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 used $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.
On
August 8, 2024, the Company entered into a securities purchase agreement (the “Registered Direct Purchase Agreement”) with
certain institutional investors, pursuant to which the Company agreed to sell to such investors 19 shares (the “Registered
Direct Shares”) of common stock of the Company, pre-funded warrants (the “Registered Direct Pre-Funded Warrants”) to
purchase up to 95 shares of common stock of the Company (the “Registered Direct Pre-Funded Warrant Shares”), having
an exercise price of $10.00 per share, at a purchase price of $10,600.00 per share of common stock and a purchase price of $10,590.00 per
Registered Direct Pre-Funded Warrant (the “Registered Direct Offering”). The shares of common stock and Registered Direct
Pre-Funded Warrants (and shares of common stock underlying the Registered Direct Pre-Funded Warrants) were offered by the Company pursuant
to its shelf registration statement on Form S-3 (File No. 333-280757), which was declared effective by the Securities and Exchange Commission
on August 6, 2024.
The
closing of the sales of these securities under the Registered Direct Purchase Agreement took place on August 9, 2024. The gross proceeds
from the offering were approximately $1.0 million, prior to deducting placement agent’s fees and other offering expenses payable
by the Company. The Company used $500,000 of the net proceeds from the offering to fund certain obligations under its Amended and
Restated Merger agreement with Evofem Biosciences, Inc and the remainder for working capital and other general corporate purposes.
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.
57
Contractual Obligations
The following table shows
our contractual obligations as of March 31, 2025:
Payment Due by Year
Total
2025
2026
Lease
$ 960,322
$ 536,392
$ 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.
58
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, 2025.
● 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, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
59
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, 2024
and 2023, the Company had a net loss of $34,446,486 and $32,390,447, respectively. Our condensed consolidated financial statements as
of March 31,2025, show a net loss of $5,952,465. Our cash and cash equivalents were approximately $476,416 as of March 31, 2025. 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.
We are currently over 90 days past due on
a significant amount of vendor obligations. We may not be able to refinance, extend or repay our substantial indebtedness owed to our
secured and unsecured lenders, which would have a material adverse effect on our financial condition and ability to continue as a going
concern.
As of March 31, 2025, we have
approximately $6.7 million in accounts payable with approximately $4.8 million that is over 90 days past due. If we are unable to repay
these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates or refinance
these obligations, we would be in default. We cannot provide any assurances that we will be able to raise the necessary amount of capital
to repay these obligations or that we will be able to extend the maturity dates or otherwise refinance these obligations. Upon a default,
our secured lenders would have the right to exercise their rights and remedies to collect, which would include foreclosing on our assets.
Accordingly, a default would have a material adverse effect on our business, and we would likely be forced to seek bankruptcy protection.
60
We may not be able to effect the transactions
contemplated under the Merger Agreement with Evofem or the Arrangement Agreement with Appili. If we are unable to do so, we will incur
substantial costs associated with withdrawing from the transaction.
In connection with the Merger
Agreement with Evofem and the Arrangement Agreement with Appili, we have incurred substantial costs planning and negotiating the transactions.
These costs include, but are not limited to, costs associated with employing and retaining third-party advisors who perform financial,
auditing and legal services required before we were able to enter into such agreements and which services will continue to be utilized
as we seek to complete such transactions. If, for whatever reason, such transactions fail to close, we will still be responsible for these
costs, which could adversely affect our liquidity and financial results.
We will need to raise substantial additional
capital, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us
to delay, limit or terminate our product development efforts and strategic M&A initiatives, or cease operations.
We do not expect that our
current cash position will be sufficient to fund our current operations for the next 12 months. We also do not presently have sufficient
cash to fund certain obligations under our Merger Agreement with Evofem or our Arrangement Agreement with Appili. In addition, we are
required to complete an equity or debt financing with minimum gross proceeds of at least $20 million in order to close the transactions
contemplated under our Arrangement Agreement with Appili. Our operating plan may change because of many factors currently unknown
to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or
other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements
or a combination of these approaches. In any event, we will require additional capital to obtain regulatory approval for, and to commercialize,
our product candidates. Raising funds in the current economic environment may present additional challenges. Even if we believe we have
sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we
have specific strategic considerations.
Any additional fundraising
efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize
our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable
to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance
of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares
to decline. The sale of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness
would result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations
on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other
operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through
arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to
relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have
a material adverse effect on our business, operating results and prospects.
If we are unable to obtain
funding on a timely basis, we may be required to significantly curtail, delay, or discontinue one or more of our research or development
programs or the commercialization of any product candidate or be unable to expand our operations or otherwise capitalize on our business
opportunities, as desired, which could materially affect our business, financial condition and results of operations.
A significant number of shares of our common
stock may be issued and sold upon the exercise of outstanding options, warrants, and upon the conversion of the Company’s convertible
preferred stock.
As of March 31, 2025, there
were 59 shares of common stock issuable under outstanding options, 2,680 shares of common stock issuable upon exercise of outstanding
warrants at various exercise prices and approximately 0 shares of common stock reserved for issuance upon the standard conversion of outstanding
convertible preferred stock. To the extent that holders of existing options, warrants or convertible preferred stock sell the shares of
common stock issued upon the exercise of options or warrants or conversion of the convertible preferred stock, the market price of our
common stock may decrease due to the additional selling pressure in the market. The risk of dilution from issuances of shares
of common stock underlying existing options, warrants and convertible preferred stock may cause shareholders to sell their common stock,
which could further decline in the market price.
61
We have entered into a Purchase Agreement
with an equity line investor. If we sell shares of our common stock under the Purchase Agreement, our existing stockholders will experience
immediate dilution and, as a result, our stock price may go down.
Pursuant to the Purchase Agreement,
we have agreed to sell up to $150,000,000 of shares of our common stock at our option and subject to certain limitations. In addition,
we may issue up to 225 shares of our common stock as a commitment fee under the Purchase Agreement. As of the date hereof, we have not
issued or sold any shares of our common stock under the Purchase Agreement. The sale of shares of our common stock pursuant to the Purchase
Agreement will have a dilutive impact on our existing stockholders. The equity line investor may resell some or all of the shares we issue
to it under the Purchase Agreement and such sales could cause the market price of our common stock to decline, which decline could be
significant.
Even if we can raise additional funding,
we may be required to do so on terms that are dilutive to you.
The capital markets have been
unpredictable in the past for unprofitable companies such as ours. In addition, it is generally difficult for development stage companies
to raise capital under current market conditions. The amount of capital that a company such as ours is able to raise often depends on
variables that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If we
can consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds are not available
on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued viability will
be materially adversely affected.
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, 2025, approximately $3.9 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.
62
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.
Our
ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
As
previously reported in a Current Report on Form 8-K filed by the Company, on October 3, 2024, the Company was notified (the “October
Notification Letter”) by the staff (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) that it
was not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing
on The Nasdaq Capital Market as the bid price of its securities had closed at less than $1.00 per share over the previous 30
consecutive business days. Therefore, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company was provided 180 calendar days,
or util April 1, 2025, to regain compliance with the rule.
On
March 7, 2025, the Company was notified by the Staff that it has determined that as of March 6, 2025, the Company’s securities had
a closing bid price of $0.10 or less for ten consecutive trading days. As a result, the Company is subject to the provisions contemplated
under Listing Rule 5810(c)(3)A)(iii) and the Staff has determined to delist the Company’s securities from The Nasdaq Capital Market.
On March 12, 2025, the Company effected a 1-for-250 reverse stock split, which became effective as of the open of trading on the Nasdaq
Capital Market on March 17, 2025.
On
March 14, 2025, the Company submitted an appeal to Nasdaq, which will stay the delisting and suspension of the Company’s securities
pending the decision of the Nasdaq Hearings Panel (the “Panel”). The Company’s hearing before the Panel was scheduled
for April 22, 2025.
On
April 8, 2025, the Company received a letter from The Nasdaq Stock Market, LLC stating that the Company had regained compliance with the
minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2). Consequently,
the hearing before the Hearings Panel scheduled to take place on April 22, 2025 has been cancelled. However, no assurance can be
provided that we will be successful in continuing to remain compliant with the requirements for continued listing on The Nasdaq Capital
Market.
63
If
we are delisted from Nasdaq, our common stock may be eligible for trading on an over-the-counter market. If we are not able to obtain
a listing on another stock exchange or quotation service for our common stock, it may be extremely difficult or impossible for stockholders
to sell their shares. We intend to monitor the closing bid price of our common stock and may be required to seek approval from our stockholders
to affect a reverse stock split of the issued and outstanding shares of our common stock, however, under amended Nasdaq
Rule 5810(b)(3)(A)(iv) , we will not be entitled to an additional compliance period if (i) the Company seeks to effect a reverse
stock split within twelve months of our prior reverse stock split in March 2025, or (ii) the proposed reverse split reverse
stock split ratio, when combined with any prior reverse stock splits implements in the prior period of two years would exceed 250-for-1
in the aggregate . Our March 2025 reverse stock split when combined with our October 2024 reverse stock split exceeded 250-for-1
in the aggregate. In addition, there can be no assurance that any future reverse stock split would be approved by our stockholders. Further,
there can be no assurance that the market price per new share of our common stock after the reverse stock split will remain unchanged
or increase in proportion to the reduction in the number of old shares of our common stock outstanding before the reverse stock split.
Even if another reverse stock split is approved by our stockholders, there can be no assurance that we will be able to regain compliance
with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing rules.
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
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the three months ended
March 31, 2025, none of the Company’s directors or officers adopted or terminated any “Rule 10b5-1 trading arrangements”
or any “non-Rule 10b5-1 trading arrangements,” as each term is defined in Item 408 of Regulation S-K.
64
Item 6. Exhibits
Exhibit
Number
Exhibit Description
3.1
Certificate of Amendment to Certificate of Incorporation of Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K fied on March 12, 2025).
31.1*
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104*
Cover Page Interactive Data File (the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 is formatted as Inline XBRL and contained in the Exhibit 101 XBRL Document Set).
*
Filed herewith.
**
Furnished herewith.
65
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 15, 2025
By:
/s/ Amro Albanna
Amro Albanna
Chief Executive Officer
(Principal Executive Officer)
Date: May 15, 2025
By:
/s/ Thomas J. Farley
Thomas J. Farley
Chief Financial Officer
(Principal Financial and Accounting Officer)
66
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.