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 September 30, 2024

☐ 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 November 13, 2024, the registrant had 14,234,212 and 14,234,210 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 September 30, 2024 and December 31, 2023	1
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023	2
	Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2024 and 2023	3
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	51
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	60
Item 4.	Controls and Procedures	60

PART II OTHER INFORMATION
Item 1.	Legal Proceedings	61
Item 1A.	Risk Factors	61
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	66
Item 3.	Defaults Upon Senior Securities	66
Item 4.	Mine Safety Disclosures	66
Item 5.	Other Information	66
Item 6.	Exhibits	67

Signatures		68

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

●

we have generated no significant revenue from commercial sales to date and our future profitability is uncertain;

●

if we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment;

●

our financial situation creates doubt whether we will continue as a going concern;

●

we may need to raise additional funding, which may not be available on acceptable terms, or at all;

●

even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.;

●

the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates, if any;

●

we may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities;

●

if our future pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product candidates on a timely basis or at all;

●

even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their sales, if any, may be limited;

●

adverse events involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results;

●

certain technologies are subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including in the event we do not achieve certain payments and milestone deadlines. Without these licenses, we may not be able to continue to develop our product candidates;

●

if we were to lose our CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business. If we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens from those states;

●

our results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties;

●

we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do;

●

our technologies and products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result;

●

customers may not adopt our products quickly, or at all;

●

the failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively;

●

some of our intellectual property may be subject to “march-in” rights by the U.S. federal government;

●

we do not expect to pay dividends in the foreseeable future;

●

we have issued a significant number of 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;

●

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;

●

while we have entered into a Share Exchange Agreement with Cellvera Global, a Merger Agreement with Evofem Biosciences, Inc. and an Arrangement Agreement with Appili Therapeutics, Inc., we cannot assure you that such transactions will be consummated or, that if one or more of such transactions are consummated, that they will be accretive to stockholder value;

iii

●

we may engage in future acquisitions or strategic transactions, including the transactions with Cellvera Global, Evofem Biosciences and Appili Therapeutics, which will require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management;

●

future sales or issuances of substantial amounts of our common stock, including, potentially as a result of future acquisitions or strategic transactions, including the transactions with Evofem Biosciences, Appili Therapeutics, and Cellvera Global, could result in significant dilution;

●

On December 29, 2023, we received the determination from Nasdaq that we regained compliance with the Nasdaq continued listing requirements, however, we remain subject to a panel monitor of our ongoing compliance until December 29, 2024 and if we fail to comply with such requirements during the panel monitor, it could result in the delisting of our securities by Nasdaq; and

●

exclusive forum provisions in our amended and restated certificate of incorporation and amended and restated bylaws.

All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition, and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes, or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.

This Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles, and surveys. Industry surveys, publications, consultant surveys, and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party sources.

References to Aditxt, Inc.

Throughout this Quarterly Report on Form 10-Q, the “Company,” “Aditxt,” “we,” “us,” and “our” refers to Aditxt, Inc. and “our board of directors” refers to the board of directors of Aditxt, Inc.

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

ADITXT, INC.

CONSOLIDATED BALANCE SHEETS

(unaudited)

	September 30,			December 31,
	2024			2023
ASSETS
CURRENT ASSETS:
Cash	$	328,596		$	97,102
Accounts receivable, net		351,707			408,326
Inventory		88,994			745,502
Prepaid expenses		444,355			217,390
Subscription receivable		874,665			5,444,628
TOTAL CURRENT ASSETS		2,088,317			6,912,948

Fixed assets, net		1,716,307			1,898,243
Intangible assets, net		6,944			9,444
Deposits		102,042			106,410
Right of use asset - long term		1,388,460			2,200,299
Investment in Evofem		24,537,211			22,277,211
Deposit on acquisition		-			11,173,772
TOTAL ASSETS	$	29,839,281		$	44,578,327

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses	$	14,585,212		$	8,554,959
Notes payable - related party		467,000			375,000
Notes payable, net of discount		8,372,685			15,653,477
Financing on fixed assets		147,823			147,823
Deferred rent		117,850			158,612
Lease liability - current		678,332			999,943
TOTAL CURRENT LIABILITIES		24,368,902			25,889,814

Settlement liability		-			1,600,000
Lease liability - long term		592,278			1,041,744
Derivative liability		429,018			-

TOTAL LIABILITIES		25,390,198			28,531,558

COMMITMENTS AND CONTINGENCIES

STOCKHOLDERS’ EQUITY
Preferred stock, $0.001 par value, 3,000,000 shares authorized, zero shares issued and outstanding, respectively		-			-
Series A-1 Convertible Preferred stock, $0.001 par value, 22,280 shares authorized, 22,071 and 22,280 shares issued and outstanding, respectively		22			22
Series B Preferred stock, $0.001 par value, 1 share authorized, zero and zero shares issued and outstanding, respectively		-			-
Series B-1 Convertible Preferred stock, $0.001 par value, 6,000 shares authorized, 4,232 and zero shares issued and outstanding, respectively		5			-
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 C-1 Convertible Preferred Stock, $0.001 par value, 10,853 shares authorized, 10,853 and zero shares issued and outstanding, respectively		11			-
Series D-1 Preferred stock, $0.001 par value, 4,186 shares authorized, 4,186 and zero shares issued and outstanding, respectively		4			-
Common stock, $0.001 par value, 1,000,000,000 and 100,000,000 shares authorized, 531,353 and 32,998 shares issued and 531,351 and 32,996 shares outstanding, respectively		532			35
Treasury stock, 2 and 2 shares, respectively		(201,605	)		(201,605	)
Additional paid-in capital		167,780,688			143,998,994
Accumulated deficit		(162,867,941	)		(127,741,072	)
TOTAL ADITXT, INC. STOCKHOLDERS’ EQUITY		4,711,719			16,056,377

NON-CONTROLLING INTEREST		(262,636	)		(9,608	)

TOTAL STOCKHOLDERS’ EQUITY		4,449,083			16,046,769

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	29,839,281		$	44,578,327

See accompanying notes to the consolidated financial statements.

ADITXT, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

	Three Months Ended			Three Months Ended			Nine Months Ended			Nine Months Ended
	September 30, 2024			September 30, 2023			September 30, 2024			September 30, 2023
REVENUE
Sales	$	6,854		$	124,486		$	130,810		$	563,879
Cost of goods sold		467,536			106,922			556,469			470,969
Gross profit (loss)		(460,682	)		17,564			(425,659	)		92,910

OPERATING EXPENSES
General and administrative expenses $32, $103,031, $28,670, and $484,502 in stock-based compensation, respectively		3,718,804			7,169,863			11,502,097			15,209,789
Research and development $0, $49,209, $6,712,663, and $165,382 in stock-based compensation, respectively		491,552			898,724			10,190,178			2,771,100
Sales and marketing $0, $1,752, $0 and $6,787 in stock-based compensation, respectively		30,000			44,186			94,731			223,562
Total operating expenses		4,240,356			8,112,773			21,787,006			18,204,451

NET LOSS FROM OPERATIONS		(4,701,038	)		(8,095,209	)		(22,212,665	)		(18,111,541	)

OTHER INCOME (EXPENSE)
Interest expense		(570,114	)		(906,104	)		(4,150,727	)		(2,389,627	)
Interest income		376			367			1,131			9,784
Amortization of debt discount		(1,709,537	)		(744,956	)		(2,901,955	)		(921,242	)
Loss on note exchange agreement		-			-			(208,670	)		-
Total other expense		(2,279,275	)	<

10-Q - Aditxt, Inc. (0001726711) (Filer)