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 June 30, 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 August 13, 2025, the registrant had 4,976,556 and 4,976,555 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 June 30, 2025 and December 31, 2024
1
Condensed
Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024
2
Condensed
Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2025 and 2024
3
Condensed
Consolidated Statements of Cash Flows for the six months ended June 30, 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
30
Item
3.
Quantitative
and Qualitative Disclosures About Market Risk
39
Item
4.
Controls
and Procedures
39
PART II
OTHER INFORMATION
Item 1.
Legal
Proceedings
40
Item 1A.
Risk Factors
40
Item 2.
Unregistered
Sales of Equity Securities and Use of Proceeds
42
Item 3.
Defaults
Upon Senior Securities
42
Item 4.
Mine Safety
Disclosures
42
Item 5.
Other
Information
42
Item 6.
Exhibits
42
Signatures
43
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;
ii
●
if we were to lose our
CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer
be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business. If
we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to
test specimens from those states;
●
our results of operations
will be affected by the level of royalty and milestone payments that we are required to pay to third parties;
●
we face substantial competition,
which may result in others discovering, developing or commercializing products before or more successfully than we do;
●
our technologies and products
under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant
revenues as a result;
●
customers may not adopt
our products quickly, or at all;
●
the failure to obtain or
maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively;
●
some of our intellectual
property may be subject to “march-in” rights by the U.S. federal government;
●
we do not expect to pay
dividends in the foreseeable future;
●
we have issued a significant
number of 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., 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., which may require us to seek additional financing or financial commitments, increase our expenses
and/or present significant distractions to our management;
iii
●
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;
●
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)
June 30,
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash
$ 323,679
$ 833,031
Accounts receivable, net
39,743
43,435
Inventory
7,617
11,245
Prepaid expenses
62,616
3,379
Subscription receivable
-
1,108,751
TOTAL CURRENT ASSETS
433,655
1,999,841
Fixed assets, net
1,412,276
1,547,774
Intangible assets, net
4,444
6,111
Deposits
215,946
87,672
Right of use asset
886,014
1,225,781
Notes receivable, related party, net of discount
2,196,826
-
Investment in Evofem
27,542,071
27,277,211
TOTAL ASSETS
$ 32,691,232
$ 32,144,390
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 10,660,226
$ 13,212,239
Mandatorily Redeemable A-1 Preferred Stock ( 450 and 0 shares)
517,445
-
Mandatorily Redeemable C-1 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
4,527,649
5,537,860
Financing on fixed assets
147,823
147,823
Deferred rent
79,044
106,075
Lease liability, current
693,613
683,352
TOTAL CURRENT LIABILITIES
20,582,619
23,407,123
Lease liability, long term
113,357
436,354
Derivative liability
392
14,517
TOTAL LIABILITIES
20,696,368
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
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, 21,353 and 22,071 shares issued and outstanding, respectively
21
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, 3,176,929 and 129,680 shares issued and 3,176,929 and 129,679 shares outstanding, respectively
3,177
130
Treasury stock, 1 and 1 shares, respectively
( 201,605 )
( 201,605 )
Additional paid-in capital
194,219,137
168,792,592
Accumulated deficit
( 181,061,686 )
( 168,094,569 )
TOTAL ADITXT, INC. STOCKHOLDERS’ EQUITY
12,959,050
496,576
NON-CONTROLLING INTEREST
( 964,186 )
( 583,180 )
TOTAL STOCKHOLDERS’ EQUITY
11,994,864
( 86,604 )
TOTAL LIABILITIES, MEZZANINE EQUITY, AND STOCKHOLDERS’ EQUITY
$ 32,691,232
$ 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
Six Months
Ended
Six Months
Ended
June 30,
2025
June 30,
2024
June 30,
2025
June 30,
2024
REVENUE
Sales
$ 1,004
$ 44,276
$ 2,022
$ 123,956
Cost of goods sold
1,005
23,134
1,739
88,933
Gross profit (loss)
( 1 )
21,142
283
35,023
OPERATING EXPENSES
General and administrative expenses $ 0 , $ 4,097 , $ 0 , and $ 28,670 in stock-based compensation, respectively
5,039,036
4,419,545
9,387,310
7,783,293
Research and development $ 0 , $ 1,000,000 , $ 10,000 and $ 6,712,663 in stock-based compensation, respectively
764,327
1,553,360
1,973,532
9,698,626
Sales and marketing $ 473,311 , $ 0 , $ 473,311 , and $ 0 in stock-based compensation, respectively
349,031
24,218
399,951
64,731
Total operating expenses
6,152,394
5,997,123
11,760,793
17,546,650
NET LOSS FROM OPERATIONS
( 6,152,395 )
( 5,975,981 )
( 11,760,510 )
( 17,511,627 )
OTHER INCOME (EXPENSE)
Interest expense
( 47,352 )
( 1,091,568 )
( 204,851 )
( 3,580,613 )
Interest income
78,566
378
78,854
755
Amortization of debt discount
( 1,212,246 )
( 556,708 )
( 1,412,530 )
( 1,192,418 )
Gain (loss) on note exchange agreement
-
-
-
( 208,670 )
Change in fair value of derivative liability
980
-
14,125
-
Change in fair value of Evofem warrants
( 63,211 )
-
( 63,211 )
-
Total other expense
( 1,243,263 )
( 1,647,898 )
( 1,587,613 )
( 4,980,946 )
Net loss before income taxes
( 7,395,658 )
( 7,623,879 )
( 13,348,123 )
( 22,492,573 )
Income tax provision
-
-
-
-
NET LOSS
$ ( 7,395,658 )
$ ( 7,623,879 )
$ ( 13,348,123 )
$ ( 22,492,573 )
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTEREST
( 138,850 )
( 74,260 )
( 381,006 )
( 213,227 )
NET LOSS ATTRIBUTABLE TO ADITXT, INC. & SUBSIDIARIES
$ ( 7,256,808 )
$ ( 7,549,619 )
$ ( 12,967,117 )
$ ( 22,279,346 )
Net loss per share, basic and diluted
$ ( 3.45 )
$ ( 1,047.17 )
$ ( 9.22 )
$ ( 3,262.64 )
Weighted average number of shares outstanding during the period, basic and diluted
2,101,701
7,210
1,406,545
6,829
See accompanying notes to the consolidated financial
statements.
2
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY (DEFICIT)
SIX MONTHS ENDED JUNE 30, 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
(Deficit)
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
-
-
-
Issuance of shares for registered
direct offering, net of issuance costs
-
-
-
-
-
-
1,870,119
1,870
-
3,976,788
-
-
3,978,658
-
-
-
Redemption of A-1 preferred
stock
( 268 )
-
-
-
-
-
-
-
-
( 308,000 )
-
-
( 308,000 )
-
-
-
Reclassification of A-1 preferred
stock to Mandatorily Redeemable Preferred Stock
( 450 )
( 1 )
-
-
-
-
-
-
-
( 517,444 )
-
-
( 517,445 )
-
-
-
Warrants issued for services
-
-
-
-
-
-
-
-
-
473,311
-
-
473,311
-
-
-
Rounding from reverse stock
split
-
-
-
-
-
-
98,880
99
-
( 99 )
-
-
-
-
-
-
Net
loss
-
-
-
-
-
-
-
-
-
-
( 7,256,808 )
( 138,850 )
( 7,395,658 )
-
-
-
Balance June 30, 2025
21,353
$ 21
2,689
$ 3
2,625
$ 3
3,176,929
$ 3,177
$ ( 201,605 )
$ 194,219,137
$ ( 181,061,686 )
$ ( 964,186 )
$ 11,994,864
-
-
-
See accompanying notes to the consolidated
financial statements.
3
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY (DEFICIT)
SIX MONTHS ENDED JUNE 30, 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
Preferred
C-1
Shares
Preferred
C-1
Shares
Par
Preferred
D-1
Shares
Preferred
D-1
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
-
$ -
-
$ -
-
$ -
-
$ -
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
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
6,000
$ 6
-
$ -
-
$ -
200
$ 13
$ ( 201,605 )
$ 152,602,695
$ ( 142,470,799 )
$ ( 148,575 )
$ 9,781,760
Stock
option compensation
-
-
-
-
-
-
-
-
-
-
-
-
-
4,095
-
-
4,095
Restricted
stock unit compensation
-
-
-
-
-
-
-
-
-
-
1
-
-
2
-
-
2
Issuance
of shares for offering, net of issuance costs
-
-
-
-
-
-
4,186
4
4,186
4
-
-
-
3,518,559
-
-
3,518,567
Issuance
of shares for debt issuance costs
-
-
-
-
-
-
-
-
-
-
33
1
-
662,717
-
-
662,718
Modification
of warrants
-
-
-
-
-
-
-
-
-
-
-
-
-
4,137
( 4,137 )
-
-
Net
loss
-
-
-
-
-
-
-
-
-
-
-
-
-
( 7,549,619 )
( 74,260 )
( 7,623,879 )
Balance
June 30, 2024 (unaudited)
22,280
$ 22
6,000
$ 6
6,000
$ 6
2,625
$ 4
2,625
$ 4
234
$ 14
$ ( 201,605 )
$ 156,791,985
$ ( 150,024,555 )
$ ( 222,835 )
$ 6,343,263
See accompanying notes to the consolidated financial
statements.
4
ADITXT, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months
Ended
Six Months
Ended
June 30,
2025
June 30,
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 13,348,123 )
$ ( 22,492,573 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation
473,311
28,670
Stock-based compensation from asset purchase
10,000
6,712,663
Depreciation expense
135,498
300,129
Amortization of intangible assets
1,667
1,666
Amortization of debt discount - note payable
1,412,530
1,192,418
Amortization of debt discount - note receivable, related party
( 99,897 )
-
Loss on note exchange agreement
-
208,670
Change in fair value of derivative liability
( 14,125 )
-
Change in fair value of Evofem warrants
63,211
-
Changes in operating assets and liabilities:
Accounts receivable
3,692
1,732
Prepaid expenses
( 59,237 )
( 225,898 )
Deposits
( 128,274 )
( 572 )
Inventory
3,628
180,001
Accounts payable and accrued expenses
( 2,552,013 )
5,122,287
Settlement liability
-
720,000
Net cash used in operating activities
( 14,098,132 )
( 8,250,807 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Investment in notes receivable and warrants, related party
( 2,425,000 )
-
Investment in Evofem preferred stock
-
( 1,000,000 )
Net cash provided by investing activities
( 2,425,000 )
( 1,000,000 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from notes payable, related party
493,000
467,000
Proceeds from notes and convertible notes payable, net of offering costs
1,504,019
2,393,811
Repayments of note payable, related party
( 608,000 )
( 375,000 )
Repayments of note payable
( 3,926,760 )
( 2,156,052 )
New principal from extension of notes, net of debt discount
-
451,974
Common stock and warrants issued for cash, net of issuance costs
24,777,835
3,018,567
Cash from subscription receivable
1,108,751
5,444,628
Redemptions of A-1 preferred stock
( 308,000 )
-
Redemptions of C-1 preferred stock
( 7,027,065 )
-
Net cash provided by financing activities
16,013,780
9,244,928
NET DECREASE IN CASH
( 509,352 )
( 5,879 )
CASH AT BEGINNING OF PERIOD
833,031
97,102
CASH AT END OF PERIOD
$ 323,679
$ 91,223
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 for the conversion of notes payable
$ -
$ 500,000
Debt discount from shares issued as inducement for note payable
$ -
$ 662,718
Warrant modification
$ -
$ 4,137
Issuance of shares in asset purchase
$ -
$ 266,448
Shares issued for settlement
$ -
$ 160,000
Return of notes payable from Evofem merger agreement
$ -
$ 11,174,246
Accrued interest rolled into notes payable
$ -
$ 583,223
ELOC payable
$ 630,105
$ -
Series C-1 redemption payable
$ 2,602,045
$ -
ELOC commitment fee stock payable
$ 2,250,000
$ -
Loan in escrow
$ 2,000,000
$ -
Reclassification of series A-1 preferred shares to liabilities
$ 517,444
$ -
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.
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.
6
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.
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 six months ended June 30, 2025, the Company had a net loss of $ 13,348,123 and negative cash flow
from operating activities of $ 14,098,132 . As of June 30, 2025, the Company’s cash balance was $ 323,679 .
As of June 30, 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 June 30, 2025 was $ 0 . 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.
If we are delisted from Nasdaq, but obtain a
substitute listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially more
price volatility than experienced on Nasdaq. Stockholders may not be able to sell their shares of common stock on any such substitute
market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result
of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our common stock, warrants and pre-funded warrants
would likely be significantly adversely affected. A delisting of our common stock from Nasdaq could also adversely affect our ability
to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners.
The Company continues to actively pursue numerous
capital raising transactions with the objective of obtaining sufficient bridge funding to meet the Company’s existing capital needs
as well as more substantial capital raises to meet the Company’s longer-term needs.
In addition, factors such as stock price, volatility,
trading volume, market conditions, demand and regulatory requirements may adversely affect the Company’s ability to raise capital
in an efficient manner. Because of these factors, the Company believes that this creates substantial doubt with the Company’s ability
to continue as a going concern.
7
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
June 30, 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 six months ended June 30, 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.
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.
8
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 June 30, 2025.
Carrying
Fair Value Measurement Using
Value
Level 1
Level 2
Level 3
Total
Derivative liability
$ 392
—
$ 392
—
$ 392
Investment in Evofem warrants
264,860
—
264,860
—
264,860
Total
$ 265,252
—
265,252
—
$ 265,252
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.
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 June 30, 2025 and December 31, 2024, gross accounts receivable was $ 117,651 and $ 121,582 , respectively. As of June 30, 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 $ 117,328 and $ 323 as of June 30, 2025, respectively, and $ 120,296 and $ 1,286 as of December 31, 2024, respectively.
9
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.
Notes Receivable
The Company accounts for its notes receivable
in accordance with the FASB Accounting Standards Codification 320, Investments – Debt and Equity Securities (“ASC 320”).
The notes receivable are classified as held for maturity.
Amortization of discount or premium as well as loan origination, commitment,
and other fees and costs recognized as an adjustment of the effective interest rate are to be included in interest income. The notes receivable
are presented as the carrying value net of any impairment.
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.
10
The Evofem F-1 Preferred Stock is recorded at
cost less impairment and the Evofem warrants are recorded at fair value. The Evofem F-1 Preferred Stock is recorded as cost due to it
being a non-marketable equity investment. The Evofem warrants are valued at fair market value due to having a readily determinable fair
value.
The following table sets forth a summary of the
components in equity investments.
June 30,
2025
Evofem warrants
$ 264,860
Evofem F-1 Preferred Stock
27,277,211
As of June 30, 2025
$ 27,542,071
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 shares of Evofem F-1 Preferred
Stock and fair value for the Evofem warrants.
For the
six months
ended
June 30,
2025
As of December 31, 2024
$ 27,277,211
Evofem warrants
328,071
Impairment
-
Change in fair value of Evofem Warrants
( 63,211 )
As of June 30, 2025
$ 27,542,071
The investment in Evofem F-1 Preferred Stock has been impaired $ 0 to
date. During the three and six months ended June 30, 2025, the Company recorded a change in the fair value of the Evofem warrants of $ 63,211 .
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.
Accounts Payable and Accrued Expenses
As of June 30, 2025 and December 31, 2024, accounts payable and accrued
expenses was comprised of:
June 30,
2025
December 31,
2024
Accounts payable
$ 9,680,600
$ 10,192,373
Accrued wages
233,639
1,130,181
Accrued interest
669,545
1,889,527
Other
76,442
158
Total accounts payable and accrued expenses
$ 10,660,226
$ 13,212,239
11
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 21,353 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.
June 30,
2025
Fair value of derivative liability of Series A-1 Convertible Preferred Stock
1
Fair value of derivative liability of Series B-1 Convertible Preferred Stock
212
Fair value of derivative liability of Series B-2 Convertible Preferred Stock
179
Total derivative liability
$ 392
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 June 30, 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.
12
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.
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.
13
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 six months ended June 30, 2025 and
2024, the Company incurred patent licensing fees of $ 108,519 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 six months ended June 30, 2025 and 2024, the Company incurred research
and development costs of $ 1,973,532 and $ 9,698,626 , 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 six
months ended June 30, 2025 and 2024, the Company incurred sales and marketing costs of $ 399,951 and $ 64,731 , respectively.
Non-controlling Interest in Subsidiary
Non-controlling interests represent the Company’s
subsidiary’s cumulative results of operations and changes in deficit attributable to non-controlling shareholders. During the six
months ended June 30, 2025 and 2024, the Company recognized $ 381,006 and $ 213,227 in net loss attributable to non-controlling
interest in Pearsanta. The Company owns approximately 90.0 % of Pearsanta, Inc., as of June 30, 2025.
Basic and Diluted Net Loss per Common Share
Basic loss per common share is computed by dividing the net loss, less
any deemed dividends, 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 to 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
June 30,
2025
Standard
Conversion
Common
Stock
Equivalent
Liquidation
Amount
Series A Preferred Stock
-
-
$
Series A-1 Convertible Preferred Stock
21,803
2,456
27,253,448
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
-
-
-
Warrants
602,680
602,680
-
Options
59
59
-
Total Common Stock Equivalent
632,119
605,894
$ 36,724,253
14
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 June 30, 2025:
Cost Basis
Accumulated
Depreciation
Net
Computers
$ 378,480
$ ( 377,411 )
$ 1,069
Lab Equipment
2,697,987
( 1,351,895 )
1,346,092
Office Furniture
56,656
( 24,223 )
32,433
Other Fixed Assets
136,939
( 131,708 )
5,231
Leasehold Improvements
120,440
( 92,989 )
27,451
Total Fixed Assets
$ 3,390,502
$ ( 1,978,226 )
$ 1,412,276
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 $ 67,047 and $ 157,197 for
the three months ended June 30, 2025 and 2024, respectively. Depreciation expense was $ 135,498 and $ 300,129 for the six months
ended June 30, 2025 and 2024, respectively. As of June 30, 2025 and December 31, 2024, the fixed assets that serve as collateral subject
to the financed asset liability have a carrying value of $ 936,486 and $ 1,898,243 , respectively.
Fixed asset activity for the six months ended
June 30, 2025 consisted of the following:
For the
six months
ended
June 30,
2025
As of December 31, 2024
$ 3,390,502
Disposals
-
As of June 30, 2025
$ 3,390,502
15
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 June 30, 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 June 30, 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 June 30, 2025, the Company has seven payments in arrears.
As of June 30, 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 June 30, 2025:
Cost Basis
Accumulated
Amortization
Net
Proprietary Technology
$ 321,000
$ ( 321,000 )
$ -
Intellectual property
10,000
( 5,556 )
4,444
Total Intangible Assets
$ 331,000
$ ( 326,556 )
$ 4,444
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 $ 834 and $ 833 for
the three months ended June 30, 2025 and 2024, respectively. Amortization expense was $ 1,667 and $ 1,666 for the six months ended
June 30, 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
June 30, 2025 consisted of the following:
For the
six months
ended
June 30,
2025
As of December 31, 2024
331,000
Additions
-
As of June 30, 2025
$ 331,000
16
NOTE 6 – RELATED PARTY TRANSACTIONS
On May 22, 2025, Amro Albanna, the Chief Executive
Officer of the Company loaned $ 233,000 to the Company. The loan was evidenced by an unsecured promissory note (the “May 22nd
Note”). Pursuant to the terms of the May 22nd Note, it will accrue interest at the Prime rate of seven and one-half percent ( 7.5 %)
per annum and is due on the earlier of November 22, 2025 or an event of default, as defined therein. As of June 30, 2025, the May 22nd
Note was fully paid off.
On June 6, 2025, Shahrokh Shabahang, the Chief
Innovation Officer of the Company loaned $ 70,000 to the Company. The loan was evidenced by an unsecured promissory note (the “June
5th Note”). Pursuant to the terms of the June 5th Note, it will accrue interest at the Prime rate of seven and one-half percent
( 7.5 %) per annum and is due on the earlier of December 5, 2025 or an event of default, as defined therein. As of June 30, 2025, the June
5th Note was fully paid off.
On June 20, 2025, Amro Albanna, the Chief Executive Officer of the
Company, and Shahrokh Shabahang, the Chief Innovation Officer of the Company, loaned $ 90,000 and $ 100,000 , respectively, to the Company.
The loans were evidenced by an unsecured promissory note (the “June 20th Notes”). Pursuant to the terms of the June 20th Notes,
it will accrue interest at the Prime rate of seven and one-half percent ( 7.5 %) per annum and is due on the earlier of July 20, 2025 or
an event of default, as defined therein. As of June 30, 2025, the June 20th Notes were fully paid off.
Evofem
Evofem is a related party of the Company due to
the Chief Executive Officer of Evofem being a member of the Company’s Board of Directors.
Notes Receivable
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 , 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 Evofem April Warrant is
exercisable into shares of common stock of Evofem at an exercise price of $ 0.0154 , subject to adjustment 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 an exercise, the Company would beneficially
own in excess of 9.99 % of Evofem stock. The fair value of the Evofem April Warrant was $ 235,389 . The Evofem April Warrant is exercisable
for a term of five years. 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 Company recorded an original issuance discount of $ 807,692 , recorded
a debt discount of $ 235,389 from the fair value of the warrants, and paid $ 1,500,000 . The value of the warrants was being treated as a
debt discount on the note. The debt discount from both the warrants and the original issuance discount are being amortized using the effective
interest method.
17
As of June 30, 2025, the Evofem April Note has
an outstanding principal balance of $ 2,307,692 , an unamortized debt discount of $ 955,677 , and accrued interest of $ 41,981 .
On June 26, 2025, the Company entered into a Securities Purchase Agreement
(the “Evofem June Purchase Agreement”) with Evofem, pursuant to which the Company purchased (i) a senior subordinated convertible
note (the “Evofem June Note”) of Evofem in the principal amount of $ 1,423,077 , and (ii) a warrant (the “Evofem June
Warrant”) to purchase 92,407,592 shares of Evofem common stock for a purchase price of $ 925,000 . The Evofem June Warrant is exercisable
into shares of common stock of Evofem at an exercise price of $ 0.0154 , subject to adjustment and may be exercised on a cashless basis.
The Evofem June Warrant may not be exercised by the Company if, after giving effect to such an exercise, the Company would beneficially
own in excess of 9.99 % of Evofem stock. The fair value of the Evofem June Warrant was $ 92,682 . The Evofem June Warrant is exercisable
for a term of five years. The Company had fully funded the $ 925,000 on June 26, 2025.
The Evofem June 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
June Note). The Evofem June 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 June 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 June Notes
will mature on June 26, 2028.
The Company recorded an original issuance discount of $ 498,077 , recorded
a debt discount of $ 92,682 from the fair value of the warrants, and paid $ 925,000 . The value of the warrants was is being treated as a
debt discount on the note. The debt discount from both the warrants and the original issuance discount are being amortized using the effective
interest method.
As of June 30, 2025, the Evofem June Note has an outstanding principal
balance of $ 1,423,077 , an unamortized debt discount of $ 578,266 , and accrued interest of $ 1,248 .
For the period ended June 30, 2025, the fair value
of each warrant granted with the notes receivable was estimated using the assumption and/or factors in the Black-Scholes Model as follows:
Exercise price
$ 0.0154
Expected dividend yield
0 %
Risk free interest rate
7.79 - 3.88 %
Expected life in years
0.50 - 0.73
Expected volatility
175 - 180 %
The risk-free interest rate assumption for warrants
granted is based upon observed interest rates on the United States Government Bond Equivalent Yield appropriate for the expected term
of warrants.
The Company determined the expected volatility
assumption for warrants granted using the historical volatility of Evofem’s common stock.
The dividend yield assumption for warrants granted
is based on the Evofems’s history and expectation of dividend payouts. Evofem has never declared nor paid any cash dividends on
its common stock.
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 13 for the current status of the Evofem transaction.
18
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 . The November Loan Agreement had
an original maturity date of July 2, 2024. As of June 30, 2025, the November Loan has an outstanding principal balance of $ 560,268 , an
unamortized debt discount of $ 0 , and accrued interest of $ 28,991 . As of June 30, 2025, the November Loan Agreement is in default status.
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 “January
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 January 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 January Loan Agreement had an original maturity date of August
12, 2024. 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 June 30, 2025, there was a remaining principal balance of $ 2,000,336 , an unamortized debt
discount of $ 0 , and accrued interest of $ 597,393 . As of June 30, 2025, the January Loan Agreement is in default status.
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 was repaid in February 2025.
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 June 30, 2025, April Notes have been repaid.
19
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. The May 2025 Note is secured by the assets of the Company.
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. The Forbearance Agreement has an expiration date of August 7, 2025.
The Company applied $ 517,445 of the gross proceeds of the ATM as a payable to redeem approximately 450 of the Series A-1 Preferred Shares
in a mandatory redemption. The remaining Series A-1 Preferred Shares are not contingently redeemable.
As of June 30, 2025, there was a remaining principal
balance of $ 1,114,286 , an unamortized debt discount of $0 , and accrued interest of $ 41,855 . The May 2025 Note is in default status as
of June 30, 2025.
Promissory Note
On June 7, 2025, an investor entered into a $ 44,396 promissory
note to the Company (the “June 2025 Promissory Note”). Pursuant to the terms of the note, it will accrue interest at a rate
of seven and a half percent ( 7.50 %) per annum, and is due on the earlier of December 5, 2025, or an event of default, as defined therein.
As of June 30, 2025, there was a remaining principal balance of $ 44,396 and accrued interest of $ 210 . Subsequent to June 30, 2025 this
note was repaid. (Note 13)
June Senior Notes
On June 26, 2025, the Company issued and sold
senior notes (each, a “June Note”) to accredited investors in the aggregate original principal amount of $ 1,000,000 for a
purchase price of $ 800,000 , reflecting an aggregate original issue discount of $ 100,000 . The original issuance discount is being straight
line amortized over the life of the notes. The June Notes bear interest at a rate of 10%per annum and have a maturity date of September
30, 2025 (the “June Notes Maturity Date”). So long as any amounts remain outstanding under the June 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 June Notes. The June Notes contains certain standard events of default,
as defined in the Note. Following the June Maturity Date and until all of the June 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 June 30, 2025, there was a remaining principal balance of $ 1,000,000 , an unamortized debt discount of $ 191,667 ,
and accrued interest of $ 1,096 . During the three and six months ended June 30, 2025, the Company recognized $ 8,333 and $ 8,333 in amortization
of debt discount. The proceeds of the June Notes were used in connection with the Evofem June Purchase Agreement. (Note 6)
20
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 June 30, 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 June 30, 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 June 30, 2025 the Company is two months
in arrears on this lease.
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 June
30, 2025, the Company has made the payment of $ 431,182 and is currently two months in arrears 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
Six Months
Ended
June 30,
2025
Six Months
Ended
June 30,
2024
Components of total lease costs:
Operating lease expense
$ 556,026
$ 603,072
Total lease costs
$ 556,026
$ 603,072
21
Lease Positions as of June 30, 2025 and December
31, 2024
ROU lease assets and lease liabilities for our
operating leases are recorded on the balance sheet as follows:
June 30,
2025
December 31,
2024
Assets
Right of use asset – long term
$ 886,014
$ 1,225,781
Total right of use asset
$ 886,014
$ 1,225,781
Liabilities
Operating lease liabilities – short term
$ 693,613
$ 683,352
Operating lease liabilities – long term
113,357
436,354
Total lease liability
$ 806,970
$ 1,119,706
Lease Terms and Discount Rate as of June 30,
2025
Weighted average remaining lease term (in years) – operating leases 1.08
Weighted average discount rate – operating leases 8.00 %
Maturities of leases are as follows:
2025 (remaining)
$ 358,756
2026
423,930
Total lease payments
$ 782,686
Less imputed interest
24,284
Less current portion
( 693,613 )
Total maturities, due beyond one year
$ 113,357
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).
22
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.
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.
23
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. As of June 30, 2025, the Option was not exercised.
Appili Mutual Waiver
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, which was paid, and (ii) a payment by Adivir to Appili in the amount of $ 125,000 not later than February 14, 2025, which was
paid, 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 June 30, 2025 in consideration of (i) a payment by Adivir to Appili in the amount of $ 125,000 on
or before February 28, 2025, which was paid, and (ii) a payment by Adivir to Appili in the amount of $ 125,000 not later than March
14, 2025 (collectively the “February Appili Waiver Payments”), which was paid, to the extent the Arrangement Agreement
has not been completed prior to that time.
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.
Appili Termination
The Parties terminated the Arrangement Agreement effective May 31,
2025. In connection with the termination of the Arrangement Agreement, the Company is required to pay a $ 1,250,000 termination fee (the
“Appili Termination Fee”). The February Appili Waiver Payments of $ 250,000 has been applied to the Appili Termination fee.
As of June 30, 2025 there is $ 1,000,000 remaining of the Appili Termination Fee. The Appili Termination Fee is recorded in general and
administrative expenses.
24
NOTE 10 – STOCKHOLDERS’ EQUITY
Common Stock
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 2025 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.
During the six months ended June 30, 2024, the
Company issued 5 shares of common stock as part of the MDNA asset purchase agreement. During the six months ended June 30, 2024,
the Company issued 30 shares of common stock as part of a settlement agreement.
At the Market Offering Agreement Amendment
& Activity
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 six months ended June 30, 2025, the
Company sold 2,048,002 ATM Shares at an average price of $ 4.18 per share under the ATM. The sale of the ATM Shares generated net proceeds
of approximately $ 8,560,920 after paying fees and expenses.
ELOC Activity
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 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.
During the six months ended June 30, 2025, the Company sold 853,959
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.
Preferred Stock
The Company is authorized to issue 3,000,000 shares
of preferred stock, par value $ 0.001 per share. There were 29,380 and 35,758 shares of preferred stock outstanding
as of June 30, 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
June 30,
2025
Standard
Conversion
Common
Stock
Equivalent
Liquidation
Amount
Series A Preferred Stock
-
-
$ -
Series A-1 Convertible Preferred Stock
21,803
2,456
27,253,448
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
29,380
3,155
$ 36,724,253
25
Series A-1 Convertible Preferred Stock Redemptions
During the six months ended June 30, 2025, the
Company redeemed approximately 268 shares of Series A-1 Convertible Preferred Stock for $ 308,000 .
In connection with the May Purchase Agreement,
the Company applied $ 517,445 of the gross proceeds of the ATM as a payable to redeem approximately 450 of the Series A-1 Preferred Shares
in a mandatory redemption. As of June 30, 2025, the remaining Series A-1 Preferred Shares are contingently redeemable until the
Forbearance Agreement expiration date of August 7, 2025. (Note 7)
Series C-1 Convertible Preferred Stock Redemptions
For the six months ended June 30, 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 .
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.
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 six months ended June 30, 2025 and
2024, the Company granted no new options.
26
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 6.10
Granted -
-
-
Exercised -
-
-
Expired or forfeited ( 1 ) 150,200,000.00 -
Outstanding June 30, 2025 59 $ 40,808,518.64 5.81
Nonvested Stock Options
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2024
-
$ -
Granted
-
-
Vested
-
-
Forfeited
-
-
Nonvested on June 30, 2025
-
$ -
As of June 30, 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.
During the six months ended June 30, 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 June 30, 2025 181,227 $ 1.19 8.34
27
Nonvested Stock Options
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2024
-
$ -
Granted
-
-
Vested
-
-
Forfeited
-
-
Nonvested on June 30, 2025
-
$ -
As of June 30, 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 June 30, 2025. The Company recognized
stock-based compensation expense related to all options granted and vesting expense of $ 0 during the six months ended June 30, 2025.
The remaining value to be expensed is $ 0 as of June 30, 2025. The weighted average vesting term is 0 years as of June
30, 2025.
The Company recognized stock-based compensation
expense related to all options granted and vesting expense of $ 4,095 during the three months ended June 30, 2024, of which $ 4,095 is included
in general and administrative expenses in the accompanying statements of operations. The Company recognized stock-based compensation expense
related to all options granted and vesting expense of $ 28,668 during the six months ended June 30, 2024, of which $ 28,688 is included
in general and administrative expenses in the accompanying statements of operations.
Warrants
For the year ended December 31, 2024, the fair
value of each warrant granted was estimated using the assumption and/or factors in the Black-Scholes Model as follows:
Exercise price $ 2.00
Expected dividend yield 0 %
Risk free interest rate 3.75 %
Expected life in years 1.0
Expected volatility 190 %
The risk-free interest rate assumption for warrants
granted is based upon observed interest rates on the United States Government Bond Equivalent Yield appropriate for the expected term
of warrants.
The Company determined the expected volatility
assumption for warrants granted using the historical volatility of comparable public companies’ common stock. The Company will continue
to monitor peer companies and other relevant factors used to measure expected volatility for future warrant grants, until such time that
the Company’s common stock has enough market history to use historical volatility.
The dividend yield assumption for warrants granted
is based on the Company’s history and expectation of dividend payouts. The Company has never declared nor paid any cash dividends
on its common stock, and the Company does not anticipate paying any cash dividends in the foreseeable future.
The Company recognizes warrant forfeitures as
they occur, as there is insufficient historical data to accurately determine future forfeitures rates.
28
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 600,000 2.00 1.98
Exercised -
-
-
Expired or forfeited -
-
-
Outstanding June 30, 2025 602,680 $ 2,935.58 1.99
Nonvested Warrants
Number
Weighted-
Average
Exercise
Price
Nonvested on December 31, 2024
-
$ -
Granted
600,000
2.00
Vested
( 600,000 )
2.00
Forfeited
-
-
Nonvested on June 30, 2025
-
$ -
The Company recognized stock-based compensation
expense related to all warrants granted and vesting expense of $ 473,311 during the three months ended June 30, 2025. The Company
recognized stock-based compensation expense related to all options granted and vesting expense of $ 473,311 during the six months
ended June 30, 2025. The remaining value to be expensed is $ 0 as of June 30, 2025. The weighted average vesting term is 0 years
as of June 30, 2025.
NOTE 11 – INCOME TAXES
The Company has incurred losses since inception.
During the six months ended June 30, 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 June 30, 2025.
As of June 30, 2025, the Company did not have
any amounts recorded pertaining to uncertain tax positions.
NOTE 12 – SEGMENT REPORTING
The Company operates in one operating
segment, and therefore one reportable segment, and is focused on the discovery and development of biopharmaceutical products. The Company’s
business activities are managed on a consolidated basis through the development and potential commercialization of biopharmaceutical products,
which are aimed at the global market in the event that products are successful in receiving regulatory approvals. Our determination that
we operate as a single operating segment is consistent with the financial information regularly reviewed by the chief operating decision
makers for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting
for future periods. Our chief operating decision makers is the Chief Executive Officer and Chief Financial Officer.
The accounting policies for
our single operating segment are the same as those described in the summary of significant accounting policies. Our single operating segment
incurs expenses from the development of biopharmaceutical products.
For the segment, the chief
operating decision makers use net loss, that also is reported on the consolidated statements of operations as consolidated net loss, to
allocate resources. The chief operating decision maker also uses consolidated net loss, along with non-financial inputs and qualitative
information, to evaluate our performance, establish compensation, monitor budget versus actual results, and decide the allocation of funds
in our various research activities.
NOTE 13 – SUBSEQUENT EVENTS
The Company has evaluated all significant events
or transactions that occurred through August XX, 2025, the date these consolidated financial statements were available to be issued.
Series C-1 Convertible Preferred Stock Redemptions
For the period beginning July 1, 2025 through
the date of this report, the Company redeemed approximately 275 shares of Series C-1 Convertible Preferred Stock for $ 316,632 .
Promissory Note Repayment
On July 3, 2025, the Company repaid the June 2025
Promissory Note.
Promissory Notes
On August 13, 2025, Amro Albanna, the Chief Executive Officer of the
Company, and Shahrokh Shabahang, the Chief Innovation Officer of the Company, loaned $ 95,000 and $ 95,000 , respectively, to the Company.
The loans were evidenced by an unsecured promissory note (the “August 13 th Notes”). Pursuant to the terms of the
August 13 th Notes, it will accrue interest at the Prime rate of seven and one-half percent ( 7.5 %) per annum and is due on the
earlier of February 13, 2025 or an event of default, as defined therein.
ELOC Activity
For the period beginning July 1, 2025 through
the date of this report, the Company sold 1,569,021 shares at an average price of $ 1.01 per share under the ELOC. The sale of shares generated
net proceeds of approximately $ 1,586,996 after paying fees and expenses.
At the Market Activity
For the period beginning July 1, 2025 through
the date of this report, the Company sold 230,605 shares at an average price of $ 1.34 per share under the ATM. The sale of ATM shares
generated net proceeds of approximately $ 293,450 after paying fees and expenses.
29
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.
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.
30
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.
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.
31
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).
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.
32
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.
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.
33
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.
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.
34
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;
(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;
35
(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 six months ended June 30, 2025 we had a net loss of $13,348,123 and cash of $323,679 as of June 30, 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 June 30, 2025, show a net loss of $13,348,123. We expect to incur additional net expenses over the next several
years as we continue to maintain and expand our existing operations. The amount of future losses and when, if ever, we will achieve profitability
are uncertain.
Results of Operations
Results of operations for the three months
ended June 30, 2025 and 2024
We generated revenue of $1,004
and $44,276 for the three months ended June 30, 2025 and 2024, respectively. Cost of goods sold for the three months ended June 30, 2025
and 2024 was $1,005 and $23,134, respectively. The decrease in revenue and costs of goods sold during the three months ended June 30,
2025 compared to the three months ended June 30, 2024 was due to a decrease in AditxtScore TM orders due to decreased COVID
testing being done.
36
During the three months ended
June 30, 2025, we incurred a loss from operations of $6,152,395. This is due to general and administrative expenses of $5,039,036, which
includes approximately $1,121,252 in payroll expenses and $2,918,727 in professional fees. Research and development expenses were $764,327
which includes $2,250 in consulting expenses. Sales and marketing expenses were $349,031.
During the three months ended
June 30, 2024, we incurred a loss from operations of $5,975,981. This is due to general and administrative expenses of $4,419,545, which
includes approximately $1,484,996 in payroll expenses, $1,183,992 in professional fees, and $4,097 in stock-based compensation. Research
and development expenses were $1,553,360, which includes $978,012 in consulting expenses. Sales and marketing expenses were $24,218.
The increase in expenses during
the three months ended June 30, 2025 compared to the three months ended June 30, 2024 was due to decreased research and development spend.
Results of operations for the six months
ended June 30, 2025 and 2024
We generated revenue of $2,022
and $123,956 for the six months ended June 30, 2025 and 2024, respectively. Cost of goods sold for the six months ended June 30, 2025
and 2024 was $1,739 and $88,933, respectively. The decrease in revenue and costs of goods sold during the six months ended June 30, 2025
compared to the six months ended June 30, 2024 was due to a decrease in AditxtScore TM orders due to decreased COVID testing
being done.
During the six months ended
June 30, 2025, we incurred a loss from operations of $11,760,510. This is due to general and administrative expenses of $9,387,310, which
includes approximately $1,793,945 in payroll expenses and $4,589,509 in professional fees. Research and development expenses were $1,973,532
which includes $62,963 in consulting expenses. Sales and marketing expenses were $399,951.
During the six months ended
June 30, 2024, we incurred a loss from operations of $17,511,627. This is due to general and administrative expenses of $7,783,293, which
includes approximately $2,958,585 in payroll expenses, $2,329,671 in professional fees, and $28,670 in stock-based compensation. Research
and development expenses were $9,698,626, which includes $1,179,591 in consulting expenses and $6,712,663 in stock-based compensation.
Sales and marketing expenses were $64,731.
The decrease in expenses during
the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due to decreased research and development spend.
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 June 30, 2025, we
had an accumulated deficit of $181,061,686. We had working capital of $(20,148,964) as of June 30, 2025. During the six months ended June
30, 2025, we purchased zero in fixed assets.
Our
consolidated financial statements have been prepared assuming that we will continue as a going concern.
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.
37
The
source, timing, and availability of any future financing will depend principally upon market conditions, and, more specifically, on the
progress of our clinical development program. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of
necessary funds may require us to, among other things, delay, scale back or eliminate expenses including some or all our planned development,
including our clinical trials. While we may need to raise funds in the future, we believe the current cash reserves should be sufficient
to fund our operation for the foreseeable future. Because of these factors, we believe that this creates doubt about our ability to continue
as a going concern.
Contractual Obligations
The following table shows
our contractual obligations as of June 30, 2025:
Payment Due by Year
Total
2025
2026
Lease
$ 782,686
$ 358,756
$ 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.
38
We are in the process of evaluating
the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain
conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including
without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the
date of the completion of our IPO (December 31, 2025); (iii) the date on which we have issued more than $1 billion in nonconvertible
debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of
the SEC.
Recently Issued and Adopted Accounting Pronouncements
See Note 3 - Summary of Significant
Accounting Policies to the accompanying condensed consolidated financial statements for a description of other accounting policies and
recently issued accounting pronouncements.
Recent Developments
See Note 13 – 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 June 30, 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 June
30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
39
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 June 30, 2025, show a net loss of
$13,348,123. Our cash and cash equivalents were approximately $323,679 as of June 30, 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.
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 June 30, 2025, we have
approximately $9.7 million in accounts payable with approximately $5.7 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.
40
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 June 30, 2025, there
were 59 shares of common stock issuable under outstanding options, 602,680 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.
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 June 30, 2025, approximately $3.2 million was owed to such secured
creditors. Under such agreements, we are required to pay $277,800 on a weekly basis to such creditors. If we default on our obligations
under these agreements, our secured creditors could foreclose on its security interests and liquidate some or all of these assets, which
would harm our financial condition and results of operations and would require us to reduce or cease operations and possibly seek Bankruptcy
Protection.
Our
ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
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.
41
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 six months ended
June 30, 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.
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.
42
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: August 14, 2025
By:
/s/ Amro Albanna
Amro Albanna
Chief Executive Officer
(Principal Executive Officer)
Date: August 14, 2025
By:
/s/ Thomas J. Farley
Thomas J. Farley
Chief Financial Officer
(Principal Financial and Accounting Officer)
43
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.