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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _____________ to _____________

Qualigen Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-37428

26-3474527

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

5857 Owens Avenue, Suite 300, Carlsbad, California 92008

(Address of principal executive offices) (Zip Code)

(760) 452-8111

(Registrant’s telephone number, including area code)

n/a

(Former name or former address, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock, par value $.001 per share		QLGN		The Nasdaq Capital Market of 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 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 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 an 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 14, 2025, there were 5,160,383 shares of the registrant’s common stock, par value $0.001 per share, outstanding.

TABLE OF CONTENTS

		Page
PART I.	Financial Information

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	3
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statement of Operations	4
	Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit)	5
	Condensed Consolidated Statements of Cash Flow	6
	Notes to Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	33
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	46
Item 4.	Controls and Procedures	46

PART II.	Other Information	47

Item 1.	Legal Proceedings	47
Item 1A.	Risk Factors	47
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	47
Item 3.	Defaults Upon Senior Securities	47
Item 4.	Mine Safety Disclosures	47
Item 5.	Other Information	47
Item 6.	Exhibits	47

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

	(Unaudited)
	September 30,			December 31,
	2025			2024
ASSETS
Current assets
Cash and cash equivalents	$	38,777,166		$	1,174,608
Prepaid expenses and other current assets		343,091			1,499,219
Short-term notes receivable, net of allowance for credit losses of $261,000 at September 30, 2025 and $360,000 at December 31, 2024		4,348,107			2,010,692
Total current assets		43,468,364			4,684,519
Other assets		2,000			2,000
Total Assets	$	43,470,364		$	4,686,519

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable	$	1,282,224		$	1,568,065
Accrued expenses and other current liabilities		41,896			170,243
Warrant liabilities		362,323			269,175
Convertible debt		339,736			—
Promissory notes		2,897,107			—
Total current liabilities		4,923,286			2,007,483
Commitments and Contingencies (Note 10)		-			-
Stockholders’ Equity (Deficit)
Preferred stock, $0.001 par value; 15,000,000 shares authorized; 45,044 and 6,256 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively	$	36,100,334		$	5,716,400
Common stock, $0.001 par value; 225,000,000 shares authorized; 3,056,822 and 736,431 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		67,734			65,314
Additional paid-in capital		131,809,991			119,958,897
Accumulated deficit		(129,430,981	)		(123,061,575	)
Total Stockholders’ Equity (Deficit)		38,547,078			2,679,036
Total Liabilities & Stockholders’ Equity (Deficit)	$	43,470,364		$	4,686,519

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	2025			2024			2025			2024
	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2025			2024			2025			2024
EXPENSES
General and administrative	$	1,891,108		$	1,145,152		$	5,780,572		$	3,186,575
Research and development		105,576			123,429			156,558			1,242,101
Credit loss expense - short-term note receivable		(567,000	)		—			(99,000	)		—
Total expenses		1,429,684			1,268,581			5,838,130			4,428,676

LOSS FROM OPERATIONS		(1,429,684	)		(1,268,581	)		(5,838,130	)		(4,428,676	)

OTHER EXPENSE (INCOME), NET
Loss (Gain) on change in fair value of warrant liabilities		148,346			(1,231	)		93,148			(361,137	)
Loss on change in fair value of derivative liabilities		—			495,693			—			321,080
Loss on change in fair value of convertible debt		197,667			—			159,793			—
Interest expense		455,941			408,359			635,607			808,477
Interest income		(193,819	)		(48,082	)		(449,249	)		(48,082	)
Loss on issuance of convertible debt		—			—			91,943			358,279
Gain on voluntary conversion of convertible debt into common stock		—			27,790			—			(56,010	)
Loss on monthly redemptions of convertible debt into common stock		—			—			—			208,852
Gain on settlements of accounts payable		—			(348,305	)		—			(348,305	)
Other income, net		—			(6,547	)		—			(9,262	)
Total other expense (income), net		608,135			527,677			531,242			873,892

LOSS BEFORE (BENEFIT FROM) PROVISION FOR INCOME TAXES		(2,037,819	)		(1,796,258	)		(6,369,372	)		(5,302,568	)

(BENEFIT FROM) PROVISION FOR INCOME TAXES		—			(2,198	)		35			800

NET LOSS FROM CONTINUING OPERATIONS		(2,037,819	)		(1,794,060	)		(6,369,407	)		(5,303,368	)

DISCONTINUED OPERATIONS
Loss on disposal of discontinued operations, net of tax		—			—			—			(100,000	)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		—			—			—			(100,000	)

NET LOSS		(2,037,819	)		(1,794,060	)		(6,369,407	)		(5,403,368	)

Deemed dividend arising from preferred stock and warrant down-round provision	$	(867,796	)	$	(27,587	)	$	(869,382	)	$	(87,604	)

Net loss attributable to Qualigen Therapeutics, Inc	$	(2,905,615	)	$	(1,821,647	)	$	(7,238,789	)	$	(5,490,972	)

Total net loss per common share, basic and diluted	$	(4.68	)	$	(4.70	)	$	(4.35	)	$	(24.93	)
Weighted-average number of shares outstanding, basic and diluted (after stock split)		620,694			387,878			1,662,223			220,221

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

	Shares			Amount			Shares		Amount		Shares		Amount		Shares		Amount		Capital		Deficit			(Deficit)
	Series A-2						Series A-3				Series B													Total
	Convertible						Convertible				Convertible								Additional					Stockholders’
	Preferred Stock						Preferred Stock				Preferred Stock				Common Stock				Paid-In		Accumulated			Equity
	Shares			Amount			Shares		Amount		Shares		Amount		Shares		Amount		Capital		Deficit			(Deficit)
Balance at December 31, 2024		6,256		$	5,716,400			—	$	—		—	$	—		736,431	$	65,314	$	119,958,897	$	(123,061,575	)	$	2,679,036
Issuance of common stock for the conversion of Series A-2 preferred shares		(3,235	)		(2,893,306	)		—		—		—		—		888,879		889		2,892,417		—			—
Stock-based compensation		—			—			—		—		—		—		—		—		269		—			269
Net loss		—			—			—		—		—		—		—		—		—		(2,646,172	)		(2,646,172	)
Balance at March 31, 2025		3,021			2,823,094			—		—		—		—		1,625,310		66,203		122,851,583		(125,707,745	)		33,134
Issuance of common stock for the conversion of Series A-2 preferred shares		(37	)		(33,087	)		—		—		—		—		10,165		10		33,076		—			—
Net loss		—			—			—		—		—		—		-		—		—		(1,685,417	)		(1,685,417	)
Balance at June 30, 2025		2,984			2,790,007			—		—		—		—		1,635,475		66,213		122,884,659		(127,393,162	)		(1,652,283	)
Issuance of common stock for the conversion of Series A-2 preferred shares		(2,383	)		(2,130,967	)		—		—		—		—		1,023,658		1,024		2,129,945		—			—
Issuance of Series A-3 preferred shares upon closing of private placement		—			—			4,500		4,257,937		—		—		—		—		—		—			4,257,937
Issuance of Series B preferred shares upon closing of private placement		—			—			—		—		39,943		31,183,357		—		—		—		—			31,183,357
Issuance of common stock and warrants upon closing of private placement		—			—			—		—		—		—		497,689		497		6,795,387		—			6,795,885
Net loss		—			—			—		—		—		—		—		—		—		(2,037,819	)		(2,037,819	)
Balance at September 30, 2025		601		$	659,040			4,500	$	4,257,937		39,943	$	31,183,357		3,156,822	$	67,734	$	131,809,991	$	(129,430,981	)	$	38,547,077

	Series A-2				Series A-3				Series B														Total
	Convertible				Convertible				Convertible								Additional						Stockholders’
	Preferred Stock				Preferred Stock				Preferred Stock				Common Stock				Paid-In			Accumulated			Equity
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Capital			Deficit			(Deficit)
Balance at December 31, 2023		—	$	—		—	$	—		—	$	—		107,243	$	43,262	$	114,655,565		$	(116,802,384	)	$	(2,103,557	)
Monthly redemptions of convertible debt into common stock		—		—		—		—		—		—		22,771		1,138		545,094			—			546,232
Fair value of warrant modification for professional services		—		—		—		—		—		—		—		—		9,737			—			9,737
Stock-based compensation		—		—		—		—		—		—		—		—		58,651			—			58,651
Net loss		—		—		—		—		—		—		—		—		—			(2,032,751	)		(2,032,751	)
Balance at March 31, 2024		—		—		—		—		—		—		130,014		44,400		115,269,047			(118,835,135	)		(3,521,688	)
Voluntary conversion of convertible debt into common stock		—		—		—		—		—		—		28,000		1,400		278,801						280,201
Monthly redemptions of convertible debt into common stock		—		—		—		—		—		—		22,726		1,137		355,959			—			357,096
Stock issued upon partial exercise of warrants		—		—		—		—		—		—		11,538		577		149,423			—			150,000
Stock-based compensation		—		—		—		—		—		—		—		—		33,086			—			33,086
Net loss		—		—		—		—		—		—		—		—		—			(1,576,558	)		(1,576,558	)
Balance at June 30, 2024		—		—		—		—		—		—		192,278	$	47,514	$	116,086,316		$	(120,411,693	)	$	(4,277,863	)
Balance		—		—		—		—		—		—		192,278	$	47,514	$	116,086,316		$	(120,411,693	)	$	(4,277,863	)
Issuance of common stock and prefunded warrants in public offering		—		—		—		—		—		—		294,481		14,724		3,038,624			—			3,053,348
Voluntary conversion of convertible debt into common stock		—		—		—		—		—		—		38,222		1,911		452,972			—			454,883
Fair value of warrant modification for professional services		—		—		—		—		—		—		—		—		2,299			—			2,299
Stock issued upon partial exercise of warrants		—		—		—		—		—		—		20,460		1,023		264,958			—			265,981
Restricted share settlements issued to former Board members		—		—		—		—		—		—		2,843		142		142,209			—			142,351
Fair value of warrants reclassified from equity to liabilities		—		—		—		—		—		—		—		—		(14,998	)		—			(14,998	)
Stock-based compensation		—		—		—		—		—		—		—		—		27,208			—			27,208
Net loss		—		—		—		—		—		—		—		—		-			(1,794,060	)		(1,794,060	)
Balance at September 30, 2024		—	$	—		—	$	—		—	$	—		548,284	$	65,314	$	119,999,588		$	(122,205,753	)	$	(2,140,851	)
Balance		—	$	—		—	$	—		—	$	—		548,284	$	65,314	$	119,999,588		$	(122,205,753	)	$	(2,140,851	)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	2025			2024
	For the Nine Months Ended September 30,
	2025			2024
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(6,369,407	)	$	(5,403,368	)
Loss from discontinued operations, net of tax		—			(100,000	)
Loss from continuing operations	$	(6,369,407	)	$	(5,303,368	)
Adjustments to reconcile loss from continuing operations to net cash used in operating activities:
Stock-based compensation		269			118,945
Change in fair value of warrant liabilities		93,148			(361,137	)
Change in fair value of derivative liabilities		—			321,080
Gain on voluntary conversion of convertible debt		—			(56,010	)
Legal expenses deducted from issuance of converftible debt		20,000			—
Issuance of common stock to consultant		325,635			—
Provision for credit losses of short-term note receivable		(99,000	)		—
Accrued interest on short-term note receivable		(428,915	)		(48,082	)
Amortization of penalty on promissory note		635,607			—
Loss on monthly redemptions of convertible debt into common stock		—			208,852
Accretion of discount on convertible debt		—			514,028
Loss on issuance of convertible debt		91,943			358,279
Gain on change in fair value of derivative liabilities		—			—
Loss on change in fair value of convertible debt		159,793			—
Fair value of warrant modification for professional services		—			12,036

Changes in operating assets and liabilities:
Prepaid expenses and other assets		1,156,128			554,685
Accounts payable		(285,841	)		(584,537	)
Accrued expenses and other current liabilities		(128,347	)		207,249
Net cash used in operating activities		(4,828,985	)		(4,057,980	)

CASH FLOWS FROM INVESTING ACTIVITIES:
Issuance of short-term note receivable		(1,809,500	)		(1,250,000	)
Net cash provided by investing activities - discontinued operations		—			350,000
Net cash used in investing activities		(1,809,500	)		(900,000	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the issuance of convertible debt		200,000			1,475,000
Net Proceeds from issuance of common and preferred shares in private placement		41,911,544			—
Proceeds from issuance of common shares and prefunded warrants in public offering		—			3,053,348
Repayment of convertible debt		(132,000	)		—
Repayment of promissory notes		(1,033,500	)		(2,000,000	)
Proceeds from warrant exercises		—			415,981
Proceeds from issuance of promissory notes		3,295,000			2,000,000
Net cash provided by financing activities - continuing operations		44,241,044			4,944,329
Net cash provided by financing activities - discontinued operations		—			—
Net cash provided by financing activities		44,241,044			4,944,329

Net change in cash and cash equivalents		37,602,558			(13,651	)
Cash and cash equivalents - beginning of period		1,174,608			401,803
Cash and cash equivalents- end of period	$	38,777,166		$	388,152

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest	$	—		$	61,020
Taxes	$	—		$	7,864

NONCASH FINANCING AND INVESTING ACTIVITIES:
Voluntary conversion of convertible debt into common stock	$	—		$	735,083
Monthly redemption of convertible debt into common stock	$	—		$	903,329
Deemed dividend arising from warrant down-round provision	$	867,796		$	87,604
Exchange of derivative liability for warrant and convertible debt	$	—		$	675,625
Issuance of warrants to placement agent	$	5,340,491		$	—
Issuance of common stock for the conversion of Series A-2 preferred shares	$	5,057,361		$	—

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

QUALIGEN THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES

Organization

Ritter Pharmaceuticals, Inc. (the Company’s predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc. On May 22, 2020, upon completing a “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals, Inc. was renamed Qualigen Therapeutics, Inc. (the “Company”). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc. was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock of Qualigen, Inc. to Chembio Diagnostics, Inc. (“Chembio”), a wholly-owned subsidiary of Biosynex, S.A. (“Biosynex”). Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 5 – Discontinued Operations).

In 2022, the Company acquired a 52.8% interest in NanoSynex, Ltd. (“NanoSynex”). In 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex Amendment”), which resulted in the Company losing its controlling interest in NanoSynex. (see Note 5 -Discontinued Operations).

Faraday Investment

In September 2025 the Company consummated a Subscription Agreement (the “Subscription Agreement”) with certain investors including Faraday Future Intelligent Electric Inc. (NASDAQ: FFAI)(the “Lead Investor” or “Faraday”) pursuant to which the investors purchased $41.0 million (the “Offering”) of the Company’s common stock and shares of a newly created Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”) (see Note 14 - Stockholders Equity (Deficit)). Up to $6.8 million of the net proceeds from the Offering will be used to pay existing debt and fund the Company’s existing business operations, and the balance of the cash proceeds and contributed currency will be used for the establishment of the Company’s cryptocurrency treasury operations (see Note 16 - Subsequent Events).

Basis of Presentation

Certain information or footnote disclosures normally included in financial statements prepared in accordance with Generally Accepted Accounting Principles (“GAAP”) have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results, and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which contains the audited financial statements and notes thereto. The financial information as of December 31, 2024 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. The interim results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any future periods.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its former wholly-owned and majority owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP. The Company views its operations and manages its business in one operating segment. In general, the functional currency of the Company and its subsidiaries is the U.S. dollar. For NanoSynex, the functional currency was the local currency, New Israeli Shekels (NIS). As there were no transactions between the Company and Nanosynex during 2025 or 2024, there was no activity required to reflect the assets and liabilities for NanoSynex translated into U.S. dollars, with the effects of foreign currency translation adjustments reflected as a component of accumulated other comprehensive loss within the Company’s condensed consolidated statements of changes in stockholders’ equity (deficit).

As of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted for prospectively as an equity method investment.

Discontinued Operations

On July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations for all periods presented herein.

On July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”), a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held by the Company, resulting in the deconsolidation of NanoSynex. The disposition represents a strategic shift that will have a material effect on the Company’s operations and financial results. Accordingly, the business of NanoSynex is classified as discontinued operations for all periods presented herein.

Accounting Estimates

Management uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. The most significant estimates relate to the estimated fair value of convertible debt, warrant liabilities, and determination of the allowance for credit losses. Actual results could vary from the estimates that were used.

Reverse Stock Split

On November 20, 2024, the Company effected a 1-for-50 reverse stock split of its outstanding shares of common stock (the “2024 Reverse Stock Split”). The 2024 Reverse Stock Split reduced the Company’s shares of outstanding common stock, stock options, and warrants to purchase shares of common stock. Fractional shares of common stock that would have otherwise resulted from the 2024 Reverse Stock Split were rounded down to the nearest whole share and cash in lieu of fractional shares was paid to stockholders.

All share and per share data for all periods presented in the accompanying financial statements and the related disclosures have been adjusted retrospectively to reflect the reverse stock split. The number of authorized shares of common stock and the par value per share remains unchanged.

Cash

The Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash equivalents.

The Company maintains the majority of its cash in government money market mutual funds and in accounts at banking institutions in the U.S. that are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits. If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations. As of September 30, 2025, the Company had not experienced losses on these accounts, and management believes the Company is not exposed to significant risk on such accounts.

Segment Reporting

The Company adopted Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, as of January 1, 2024. Operating segments are identified as components of an enterprise about which separate discrete financial information is regularly reviewed for evaluation by the chief operating decision-maker (“CODM”) in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and managed its business as one segment operating primarily within the United States (and in Israel prior to the NanoSynex deconsolidation). The Company is an early stage clinical therapeutics company focused on developing treatments for adult and pediatric cancer. The Company’s operations are organized and reported as a single reportable segment, which includes all activities related to the discovery, development, and commercialization of its products. The Company’s CODM, its chief executive officer, reviews operating results on an aggregate basis and manages the operations as a single operating segment. The accounting policies of the Company’s single operating and reportable segment are the same as those described in the summary of significant accounting policies. The measure of segment assets is reported on the consolidated balance sheets as total assets. The CODM evaluates performance and allocates resources based on consolidated net loss that also is reported on the consolidated statements of operations as net loss, and consolidated cash used in operations. The significant expenses regularly reviewed by the CODM are consistent with those reported on the Company’s consolidated statement of operations, and expenses are not regularly provided to or reviewed on a more disaggregated basis for purposes of assessing segment performance and deciding how to allocate resources.

During the quarter ending September 30, 2025, while there were notable changes to the personnel within the Company’s operating structure, there were no major changes to the operations or structure itself. The Company’s legacy CEO remains responsible for allocating resources to and assessing the performance of the business, including milestone progression of products still in development, as well as cash management. All members of the senior leadership team, many of which include contractors or consultants, report to the legacy CEO. Further, in conjunction with the Offering, FFAI appointed a Co-CEO who is responsible for overseeing the establishment of the Company’s cryptocurrency treasury operations. However, as of September 30, 2025, no substantive activities related to the planned cryptocurrency treasury operations have taken place. As such, there is no change to the CODM during the quarter ended September 30, 2025, which is identified as the legacy CEO.

General and Administrative Expenses

Beginning in December 2024, the Company engaged IR Agency LLC to provide marketing and advertising services to communicate information about the Company to the investment community. During the nine months ended September 30, 2025, expenses related to the work performed by IR Agency LLC totaled million and $1.5 million, or roughly 28% of operating expenses for that period. No expense related to IR Agency LLC was incurred in the three months ended September 30, 2025. The Company deemed this expense necessary to raise additional funding which would provide liquidity to the Company for business operations. This expense is not anticipated to be recurring in future periods.

Research and Development

Except for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including therapeutics license costs.

Patent Costs

The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the condensed consolidated statement of operations.

Derivative Financial Instruments and Warrant Liabilities

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the condensed consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception and subsequent valuation dates. 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 (See Note 8-Warrant Liabilities and Note 9- Convertible Debt).

Fair Value Measurements

The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:

●

Level 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date;

	●	Level 2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active; and

	●	Level 3 - Inputs that are unobservable.

Fair Value of Financial Instruments

Cash, prepaid expenses, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. Short-term notes receivable are valued subject to a current expected credit loss (“CECL”) model (see Note 5 - Short-Term Notes Receivable).

Stock-Based Compensation

Stock-based compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.

Income Taxes

Deferred income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses, and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.

Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income in future years.

Accounting Standards

In December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, which requires more detailed income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is evaluating the disclosure requirements related to the new standard.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income (Subtopic 220-40): Expense Disaggregation Disclosures. This update requires entities to disaggregate operating expenses into specific categories, such as salaries and wages, depreciation, and amortization, to provide enhanced transparency into the nature and function of expenses. Accounting Standards Update 2024-03 is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. Accounting Standards Update 2024-03 may be applied retrospectively or prospectively. The Company is evaluating the disclosure requirements related to the new standard.

The Company does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on our consolidated financial statements or disclosures.

Global Economic Conditions

Ongoing Wars in Ukraine and Israel

In February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the conflict and its impact on regional and global economic conditions.

In October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting the operating environment in Israel. Popular uprisings in various countries in the Middle East over the last few years have also affected the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist activities or political instability involving Israel or other countries in the region could adversely affect the Company’s minority interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 5 – Discontinued Operations).

Inflation and Global Economic Conditions

Beginning in 2022 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary pressures attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition, the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession in the near future. If the global economy slows, the Company’s business may be adversely affected.

NOTE 2 — LIQUIDITY AND GOING CONCERN

As of September 30, 2025, the Company had approximately $38.7 million in cash and an accumulated deficit of $129 million. For the nine months ended September 30, 2025 and year ended December 31, 2024, the Company used cash of $4.8 million and $6.3 million, respectively, in operations.

From January to July 2025, the Company borrowed a total of $3,640,000 from nine investors as short-term borrowings, each due within six months after the date of borrowing. In July 2025, the Company closed a private placement transaction to raise additional funding through the sale of equity, for a net total of $4,258,000. In September 2025, the Company closed a subscription agreement to raise additional funding through the sale of equity for a net total of $37,700,000. While this $37.7 million of cash was received, up to $6.8 million of the net cash proceeds will be used to pay existing debt and fund the Company’s existing research and development operations, and the balance of the cash proceeds will be used for the establishment of the Company’s new cryptocurrency treasury operations, and will therefore not readily be available to fund immediate operations.

Additionally, during the nine months ended September 30, 2025, the Company repaid approximately $1.1 million of outstanding promissory notes.

The Company expects to continue to have net losses and negative cash flow from operations, which will challenge its liquidity . While the Company is establishing cryptocurrency treasury operations, it is newly established and there are no guarantees it will generate revenue. These factors raise substantial doubt about the Company’s ability to continue as a going concern for the one-year period following the date that these financial statements were issued.

There is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ from those reflected in the accompanying financial statements.

NOTE 3 — FAIR VALUE MEASUREMENTS

Below is the summary of our assets and liabilities measured at fair value on a recurring basis and categorized using the fair value hierarchy as of September 30, 2025:

SCHEDULE OF FAIR VALUE MEASUREMENTS

	(Level 1)		(Level 2)		(Level 3)		Total
Assets
Money Market funds	$	38,213,566	$	-	$	-	$	38,213,566
Total Assets	$	38,213,566	$	-	$	-	$	38,213,566
Liabilities
Convertible Debt	$	-	$	-	$	339,736	$	339,736
Warrant Liabilities		—		—		362,323		362,323
Total Liabilities	$	—	$	—	$	702,059	$	702,059

Below is the summary of our assets and liabilities measured at fair value on a recurring basis and categorized using the fair value hierarchy as of December 31, 2024:

	(Level 1)		(Level 2)		(Level 3)		Total
Assets
Money Market funds	$	724,732	$	-	$	-	$	724,732
Total Assets	$	724,732	$	-	$	-	$	724,732
Liabilities
Warrant Liabilities	$	-	$	-	$	269,175	$	269,175
Total Liabilities	$	—	$	—	$	269,175	$	269,175

NOTE 4 — PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following at September 30, 2025 and December 31, 2024:

	September 30,		December 31,
	2025		2024
Prepaid consulting	$	59,044	$	1,241,537
Prepaid insurance		226,156		226,482
Prepaid legal		43,758		—
Other current assets		14,133		31,200
	$	343,091	$	1,499,219

NOTE 5 — SHORT-TERM NOTE RECEIVABLE

Short-term note receivable consisted of the following at September 30, 2025 and December 31, 2024:

SCHEDULE OF SHORT-TERM NOTE RECEIVABLE

	September 30,			December 31,
	2025			2024
Short-term note receivable - Marizyme	$	4,609,107		$	2,370,692
Less allowance for credit losses		(261,000	)		(360,000	)
Short-term notes receivable	$	4,348,107		$	2,010,692

Allowance for credit losses consisted of the following at September 30, 2025 and December 31, 2024:

SCHEDULE OF ALLOWANCE FOR CREDIT LOSSES

	September 30,			December 31,
	2025			2024
Beginning Balance	$	(360,000	)	$	—
Current period provision for expected credit losses		99,000			(360,000	)
Ending Balance	$	(261,000	)	$	(360,000	)

During the nine months ended September 30, 2025, the Company advanced to Marizyme, Inc., $1.8 million, against which Marizyme delivered demand promissory notes to the Company of like principal amounts (the “Marizyme Notes”). As of September 30, 2025, accrued interest related to the Marizyme Notes was $0.5 million. Of this amount, approximately $178,000 and $429,000 was recorded in the three and nine month period ended September 30, 2025, respectively, and was recognized in interest income in the consolidated statement of operations, and the total is included in short-term notes receivable on the consolidated balance sheet. As of December 31, 2024 there was $2,257,400 due to the Company under the Marizyme Notes, as well as $113,292 of accrued interest.

The Marizyme Notes bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of the outstanding principal or interest of the Marizyme Notes at any time and from time to time, in whole or in part, without premium or penalty.

On August 21, 2025, an amendment was made to the original agreement, reclassifying Marizyme’s debt to the Company from junior to senior, therefore changing the assumptions used in our analysis. Additionally, as a result of this amendment the maturity date of the debt changed to August 21, 2026, as there was no previously defined due date.

Under ASC 326-20, known as the CECL model, the Company was required to estimate credit losses expected over the life of an exposure (or pool of exposures) based on historical information, current information, and reasonable and supportable forecasts. The Company is unable to use its historical data to estimate losses as it has no relevant loss history to date. To determine the estimate of expected credit losses, the Company used a probability-weighted approach that incorporates multiple settlement scenarios, including recovery of amounts due upon an acquisition of the debtor, and recovery in different liquidation scenarios, and determines the expected recoverable amount of the loan in each scenario. This model requires management to make certain assumptions including the likelihood of each outcome, the estimated value of the debtor’s assets, and the Company’s expected claim and recovery rate on the debtor’s assets in the event of an insolvency or a liquidation proceeding. As of September 30, 2025, the estimate for expected credit losses on the Marizyme Notes is $261,000. Given the inherently uncertain nature of the debtor’s financial condition and future outcomes, actual credit losses may differ materially from this estimate. The Company will continue to monitor relevant events and conditions and update its assumptions and allowance as necessary.

The Company is also party to a Co-Development Agreement with Marizyme (see Note 13 - Research and License Agreements).

NOTE 6 — DISCONTINUED OPERATIONS

On July 20, 2023, the Company completed the sale of Qualigen, Inc., its formerly wholly-owned subsidiary, to Chembio Diagnostics, Inc. for net cash consideration of $5.4 million, of which $4.9 million was received during the year ended December 31, 2023, and $450,000 was being held in escrow until January 20, 2025 to satisfy certain Company indemnification obligations. On June 4, 2024, the escrow account was settled early by mutual agreement of the Company and the buyer resulting in cash proceeds to the Company of $350,000 and a loss on disposal of discontinued operations of $100,000 for the nine months ended September 30, 2024. There was no activity related to Qualigen, Inc. during the nine months ended September 30, 2025.

There were no assets and liabilities remaining related to Qualigen, Inc. as of September 30, 2025 or December 31, 2024.

NOTE 7 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consisted of the following at September 30, 2025 and December 31, 2024:

	September 30		December 31,
	2025		2024
License fees	$	-	$	14,427
Professional fees		41,896		109,324
Vacation		-		46,492
	$	41,896	$	170,243

NOTE 8 — WARRANT LIABILITIES

On November 20, 2024, the Company closed its private placement transaction resulting in the issuance of newly designated Series A-2 Preferred Stock (see Note 14 – Stockholders Equity (Deficit)). As a result of the issuance of a new class of voting securities, the Company evaluated its equity classified warrants’ respective terms, and concluded that warrants for 68,712 common shares with a weighted average exercise price of $2.00 were required to be reclassified to liabilities, including pre-funded warrants with an exercise price of $0.05 per share. The pre-funded warrants are exercisable upon issuance and will remain exercisable until all the pre-funded warrants are exercised in full. At September 30, 2025, pre-funded warrants for 51,199 common shares remained outstanding. During the three and nine months ended September 30, 2025 the Company recorded a loss on change in fair value of warrant liabilities of $148,347 and $94,119.29, respectively for these warrants. At September 30, 2025 and December 31, 2024, the fair value of these warrants was $362,323 and $269,175, respectively.

In 2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of the reverse recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company. On February 27, 2024, these Series C Warrants were repriced as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debentures described below, from an exercise price of $36.50 per share to an exercise price of $13.00 per share, with 16,473 additional ratchet Series C Warrants issued, resulting in 25,586 Series C Warrants outstanding on March 31, 2024, which expired on June 26, 2024, resulting in a gain recorded in the amount of $187,900. At September 30, 2025 and December 31, 2024 the fair value of these warrants was $0.

The following table summarizes the activity in liability classified warrants for the nine months ended September 30, 2025:

SCHEDULE OF WARRANTS ACTIVITY

	Common Stock Warrants
	Shares			Weighted– Average Exercise Price		Range of Exercise Price		Weighted– Average Remaining Life (Years)
Total outstanding –December 31, 2024		68,712		$	2.00		$0.05 - $7.80		4.32	*
Granted		—			-		—		-
Exercised		—			—		—		—
Reclassified from equity		—			—		—		—
Reclassified to equity		—			—		—		—
Expired		(1,494	)	$	6.50		$6.50 - $6.50		—
Total outstanding – September 30, 2025		67,218		$	1.90		$0.05 - $7.80		3.94	*
		67,218		$	1.90		$0.05 - $7.80		3.94	*

excludes 51,199 pre-funded warrants which have no expiration date.

The following table summarizes the activity in liability classified warrants for the nine months ended September 30, 2024:

	Common Stock Warrants
	Shares			Weighted- Average Exercise Price		Range of Exercise Price		Weighted– Average Remaining Life (Years)
Total outstanding –December 31, 2023		9,113		$	36.50		$36.50 - $36.50		0.49
Granted		52,474		$	10.96		$6.50 - $13.00		4.41
Exercised		—			—		—		—
Reclassified from equity		2,314		$	6.50		$6.50 - $6.50		4.41
Reclassified to equity		—			—		—		—
Expired		(25,586	)	$	13.00		$13.00 - $13.00		—
Total outstanding – September 30, 2024		38,315		$	6.50		$6.50 - $6.50		4.41
Exercisable		38,315		$	6.50		$6.50 - $6.50		4.41

The following table presents the Company’s fair value hierarchy for its warrant liabilities measured at fair value on a recurring basis as of September 30, 2025:

	Quoted
	Market		Significant
	Prices for		Other		Significant
	Identical		Observable		Unobservable
	Assets		Inputs		Inputs
Common Stock Warrant Liabilities	(Level 1)		(Level 2)		(Level 3)		Total
Balance as of December 31, 2024	$	—	$	—	$	269,175	$	269,175
Granted		—		—		—		—
Exercised		—		—		—		—
Loss on change in fair value of warrant liabilities		—		—		93,148		93,148
Balance as of September 30, 2025	$	—	$	—	$	362,323	$	362,323

The following table presents the Company’s fair value hierarchy for its warrant liabilities measured at fair value on a recurring basis as of December 31, 2024:

	Quoted
	Market		Significant
	Prices for		Other		Significant
	Identical		Observable		Unobservable
	Assets		Inputs		Inputs
Common Stock Warrant liabilities	(Level 1)		(Level 2)		(Level 3)			Total
Balance as of December 31, 2023	$	—	$	—	$	54,600		$	54,600
Granted		—		—		565,582			565,582
Exercised		—		—		—			—
Fair value of warrants reclassified from equity		—		—		262,259			262,259
Fair value of warrants reclassified to equity		—		—		(197,456	)		(197,456	)
Gain on change in fair value of warrant liabilities		—		—		(415,810	)		(415,810	)
Balance as of December 31, 2024	$	—	$	—	$	269,175		$	269,175

During the three and nine months ended September 30, 2025, there were no warrants reclassified from equity to liabilities. There were no transfers of financial assets or liabilities between category levels for the three and nine months ended September 30, 2025. During the three and nine months ended September 30, 2024, warrants for 2,314 common shares with an exercise price of $6.50 with a fair value of $14,997 as of September 30, 2024 were reclassified from equity to liabilities.

The value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using the Black-Scholes Model at September 30, 2025, and a Monte-Carlo simulation at September 30, 2024. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher or lower fair value measurements.

The following are the weighted average and the range of assumptions used in estimating the fair value of warrant liabilities (weighted average calculated based on the number of outstanding warrants on each issuance) as of September 30, 2025 and December 31, 2024:

	September 30, 2025						December 31, 2024
	Range			Weighted Average			Range			Weighted Average
Risk-free interest rate		3.66% — 3.71	%		3.71	%		3.79	%		4.24% - 4.38	%
Expected volatility (peer group)		130.0% — 130.0	%		130.00	%		133.50	%		117.5% - 125.0	%
Term of warrants (years)		3.94 — 5.00			4.32			4.2			0.4 - 4.70
Expected dividend yield		0.00	%		0.00	%		0.00	%		0.00	%

NOTE 9 — CONVERTIBLE DEBT

2022 Convertible Debenture (Related party)

On December 22, 2022, the Company issued to Alpha an 8% Senior Convertible Debenture in the aggregate principal amount of $3,300,000 for a purchase price of $3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “2022 Securities Purchase Agreement”). The 2022 Debenture carried a maturity date of December 22, 2025 and was convertible, at any time, at Alpha’s option, into shares of the Company’s common stock (the “Conversion Shares”), at a price initially equal to $66.00 per share, subject to adjustment as described in the 2022 Debenture and other terms and conditions described in the 2022 Debenture. On July 13, 2023, the Company obtained stockholder approval, for purposes of complying with Nasdaq Listing Rule 5635(d), for the issuance to Alpha of more than 20% of our issued and outstanding shares of common stock pursuant to the terms and conditions of the 2022 Debenture, and the common stock purchase warrant dated December 22, 2022 issued by us to Alpha.

Commencing June 1, 2023 the Company was required to redeem $110,000 monthly, plus accrued and unpaid interest in cash, or, subject to the Equity Conditions (as defined in the 2022 Debenture) having been satisfied or waived, in shares of our common stock, based on a conversion price equal to the lesser of (i) the then-effective conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the 2022 Debenture) for the five consecutive trading days ending on the trading day immediately before the applicable monthly redemption date. The 2022 Debenture accrued interest at the rate of 8% per annum beginning on December 1, 2023, and was payable on a monthly or quarterly basis in cash or, subject to the Equity Conditions having been satisfied or waived, shares or a combination thereof at our option.

In December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, the Company entered into a registration rights agreement with Alpha (the “Registration Rights Agreement”), pursuant to which the Company agreed to file one or more registration statements, as necessary, and to the extent permissible, to register under the Securities Act the resale of the remaining shares (underlying the 2022 Debenture and the 2022 Warrant) not otherwise registered under the Company’s registration statement on Form S-3 (File No. 333-266430). The Company filed a resale registration statement on Form S-3 pursuant to the requirements of the Registration Rights Agreement on December 2022 (File Number 333-269088), which registration statement was declared effective by the SEC on January 5, 2023. On September 1, 2023, the Company filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (File No. 333-269088), which Post-Effective Amendment was declared effective by the SEC on September 7, 2023. On May 1, 2024, the Company filed a Post-Effective Amendment No. 2 to Form S-1 on Form S-3 (File No. 333-269088), which Post-Effective Amendment was declared effective by the SEC on May 2, 2024.

The Company evaluated the 2022 Debenture and the 2022 Warrant and determined that the 2022 Warrant is a freestanding financial instrument. Initially, the 2022 Warrant is not considered indexed to the Company’s own stock, because the settlement amount would not equal the difference between the fair value of a fixed number of the Company’s equity shares and a fixed strike price and all of the adjustment features in Section 3(b) of the Alpha Warrant are not down round provisions, as defined in ASU 2017-11. Accordingly, the 2022 Warrant was classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.

In accordance with ASC 470-50, the Company determined that the modified terms of the 2022 Debenture were substantially different when compared to the original terms that existed prior to the SPA Amendment, and thus the event was required to be accounted for as a debt extinguishment. Accordingly, the Company derecognized the net carrying value of the original Debenture, and recorded the new debt instrument at its fair value of $1.4 million, and recorded a $0.6 million loss on debt extinguishment. The difference between the remaining 2022 Debenture principal and its fair value on December 5, 2023 was recorded as a debt discount, which was amortized to interest expense over the expected term of the Debenture using the effective interest method, in accordance with ASC 835-30.

On February 27, 2024, in connection with the issuance of an additional warrant to Alpha with an exercise price of $13.00 per share, and pursuant to certain antidilution provisions in the 2022 Debenture, the Conversion Price of the 2022 Debenture was reduced from $36.50 per share to $13.00 per share.

2024 Alpha Debenture (Related party)

On February 27, 2024, pursuant to a Securities Purchase Agreement executed with Alpha on February 27, 2024 the “2024 Securities Purchase Agreement”, the Company issued to Alpha an 8% Convertible Debenture (the “2024 Alpha Debenture”) with a principal amount of $550,000, for a gross purchase price of $500,000 less expenses. The 2024 Alpha Debenture carries a maturity date of December 31, 2024 and was convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company, at $30.56 per share, subject to adjustment as described in the 2024 Alpha Debenture. Upon the closing of the public offering on September 6, 2024 per the terms of the antidilution provision, the conversion price of the 2024 Alpha Debenture was reduced from $30.56 to $6.50 per share. The 2024 Alpha Debenture accrued interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity. In connection with this issuance, the Company also issued to Alpha a noncompensatory equity classified 5-year common stock purchase warrant (the “2024 Alpha Warrant”) to purchase 18,001 shares of our common stock at an exercise price initially equal to $13.00 per share (see Note 14 - Stockholders Equity (Deficit)).

Pursuant to the 2024 Securities Purchase Agreement, the Company also granted to Alpha an option, exercisable until July 1, 2024, to purchase from us an additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1.1 million (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 36,001 additional warrants) for a purchase price of $1.0 million.

The Company evaluated the terms of the 2024 Securities Purchase Agreement and determined that the 2024 Alpha Warrant and the Option issued to Alpha are each considered freestanding financial instruments. The 2024 Alpha Warrant was further determined to initially (i) be indexed to the Company’s own stock, and (ii) meet all of the additional criteria for permanent equity classification. As the Option required the Company to issue convertible debt with multiple cash settlement alternatives, the Option was classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.

The net proceeds from the issuance of the 2024 Alpha Debenture were allocated first to the liability-classified Option and the bifurcated embedded features in the 2024 Alpha Debenture (conversion option, contingent acceleration upon an Event of Default, and contingent interest upon an Event of Default), with the resulting difference, if any, allocated to the loan host instrument and the equity-classified warrant on a relative fair value basis. The fair value of the Option was estimated to be $0.8 million at issuance, and the suite of bifurcated embedded derivative features was $0.08 million. As the fair value of the liability-classified instruments and features exceeded the net proceeds received, the Company recognized a loss on issuance of convertible debt of $0.4 million, presented in other expenses in the consolidated statements of operations. As a result, the Company recorded a debt discount at the maximum amount equal to the principal of $550,000, which was amortized as additional interest expense over the expected term of the 2024 Alpha Debenture.

During the three and nine months ending September 30, 2024 in connection with the 2024 Alpha Debenture, the Company recorded initial derivative liabilities with a fair value of $858,279, and recorded interest expense of $165,000 and $403,000, respectively, (of which approximately $154,000 and $376,000 was attributable to discount accretion, respectively) in other expenses in the condensed consolidated statements of operations related to the 2024 Alpha Debenture. The Securities Purchase Agreement related to the issuance of 2024 Alpha Debenture resulted in down-round provisions of various warrants being triggered which resulted in reductions of the exercise price of these warrants from $0.73 per share to $0.26 per share.

As of September 30, 2024, the fair value of derivative liabilities related to the 2024 Alpha Debenture was $536,977.

On November 20, 2024, in connection with the closing of the Company’s private placement transaction and issuance of Series A-2 Preferred Stock, the Company repaid the outstanding principal and accrued interest on the Alpha Debenture, in full settlement of the obligation. As of December 31, 2024, there were no amounts outstanding under the 2024 Alpha Debenture.

2024 Convertible Debenture

In April 2024, Alpha assigned the Option to Yi Hua Chen (“Chen”) and Chen exercised the option in full, in exchange for $1,000,000, less expenses, the Company issued to Chen an 8% Convertible Debenture (the “2024 Chen Debenture”) with a principal amount of $1,100,000. In connection with this issuance, the Company also issued to Chen a 5-year liability classified common stock purchase warrant to purchase 36,001 shares of our common stock with a current exercise price of $6.50 per share (see Note 8 - Warrant Liabilities).

In November 2024, in connection with the closing of the Company’s private placement transaction and issuance of Series A-2 Preferred Stock, the Company and Chen executed an Exchange Agreement (the “Exchange Agreement”), agreeing to convert all outstanding principal and accrued interest on the 2024 Chen Debenture totaling approximately $1,154,000, in exchange for 1,154 shares of newly designated Series A-2 Preferred Stock, in full settlement of the Company’s obligations with respect to the Chen Debenture. As of September 30, 2025 and December 31, 2024, there were no amounts outstanding under the 2024 Chen Debenture.

2025 Convertible Note

On April 28, 2025, the Company entered into a Secured Convertible Note (the “2025 Convertible Note”) with Alpha Capital Anstalt (“Alpha”, or “Holder”), pursuant to which the Company issued to Alpha a non-interest-bearing note with a principal of $264,000, and an original issue discount (“OID”) of 20%, or $44,000, in exchange for $220,000 cash, less $20,000 in expenses. The Note is convertible at any time at Alpha’s option, into shares of the Company’s common stock at a price equal to $3.80 per share (the “Conversion Price”), subject to certain adjustments. The Convertible Note bears no interest, and the principal will be due on January 28, 2026 (the “Maturity Date”).

The Company determined the 2025 Convertible Note does not contain a substantial premium and therefore the Company elected to account for the Convertible Note under the fair value option in accordance with ASC 825-10-15-4. The Company determined the fair value of the Convertible Note was $311,943 at issuance. The difference between the $220,000 proceeds received and fair value was recorded as a loss upon issuance in the amount of $91,943. Issuance costs incurred in connection with the transaction were expensed immediately.

On June 4, 2025 the Company paid down $132,000 in principal at the request of Alpha. As of September 30, 2025 the Company reassessed the fair value of the 2025 Convertible Note at $213,367, with a gain on the change in fair value of $71,298 and $33,424 recorded in the three and nine months ended September 30, 2025, respectively.

NOTE 10 — PROMISSORY NOTES

During the nine months ended September 30, 2025 the Company issued short term notes payable totaling $1.0 million for total net proceeds of $1.0 million. The notes are unsecured with a maturity date six months from the original issuance, and include a provision for a penalty in case of default totaling $1.1 million.

In July 2025, the Company repaid three lenders $1.0 million in satisfaction of their outstanding promissory notes. The additional $0.2 million was paid as a premium to the lenders and has been recorded under interest expense.

In August 2025, the Company finalized the terms of the agreements with five investors for the $2.3 million in short-term promissory notes recorded in May 2025. The agreements include a due date six months from when the funding was received as well as a 30% premium due on repayment, meaning we will record an additional $690,000 in principal for the short-term promissory notes for a total due of $3.0 million. Interest expense was recorded for these premiums during the three and nine months ended September 30, 2025 in the amount of $342,231.

There were no promissory notes outstanding at December 31, 2024.

NOTE 11 — EARNINGS (LOSS) PER SHARE

Basic loss per share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding plus unexercised pre-funded warrants. Diluted EPS is computed based on the sum of the weighted-average number of common shares and potentially dilutive common shares outstanding during the period. Potentially dilutive common shares consist of shares issuable from preferred stock, convertible debt, stock options and warrants.

	2025			2024			2025			2024
	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2025			2024			2025			2024
Net loss used for basic earnings per share	$	(2,037,819	)	$	(1,821,627	)	$	(6,369,407	)	$	(5,490,972	)
Basic weighted-average common shares outstanding		620,694			387,878			1,662,223			220,221
Dilutive potential shares issuable from preferred stock, convertible debt, stock options and warrants		—			—			—			—
Diluted weighted-average common shares outstanding		620,694			387,878			1,662,223			220,221

The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2025 and 2024 because their effect would be anti-dilutive:

	As of September 30,
	2025		2024
Shares of common stock subject to outstanding options		1,570		6,740
Shares of common stock subject to outstanding warrants (excluding pre-funded warrants)		1,175,449		90,023
Shares of common stock subject to outstanding preferred stock		20,054,987		—
Shares of common stock subject to outstanding convertible debt		58,771		246,003
Total common stock equivalents		21,290,777		342,766

NOTE 12 — COMMITMENTS AND CONTINGENCIES

Litigation and Other Legal Proceedings

On January 29, 2025, the Company was named as a defendant in an action brought by LifeSci Capital LLC (“LifeSci”) in the U.S. District Court for the Southern District of New York. The complaint alleges that the Company failed to pay $503,483 in connection with offerings of the Company’s common stock that occurred during the tail period of the agreement, pursuant to an engagement under which the Company retained LifeSci to serve as its placement agent and financial advisor.

The Company filed its answer on March 17, 2025, denying the material allegations in the complaint and asserting various affirmative defenses. On October 9, 2025 the matter was settled out of court and the Company agreed to pay Lifesci $75,000 to settle the outstanding claim. As the company had already recorded $35,000 payable to LifeSci, an additional accrual of $40,000 was recorded as of September 30,2025.

NOTE 13 — RESEARCH AND LICENSE AGREEMENTS

UCL Business Limited

In January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for University College London.) The program’s lead compound is now being developed at the Company under the name QN-302 as a candidate for treatment for pancreatic ductal adenocarcinoma, which represents the vast majority of pancreatic cancers. The License Agreement required a $150,000 upfront payment, reimbursement of past patent prosecution expenses (approximately $160,000), and (if and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty sublicensing consideration paid to the Company.

For both the three months ended September 30, 2025 and 2024, there were license costs of $0 and for the nine months ended September 30, 2025 and 2024, there were license costs of approximately $0 an $2,000, respectively, related to this agreement which are included in research and development expenses in the condensed consolidated statements of operations.

QN-302 Phase 1 Study

In June 2023, the Company entered into a Master Clinical Research Services Agreement with Translational Drug Development, LLC (“TD2”) whereby TD2 agreed to perform certain clinical research and development services for the Company including but not limited to trial management, side identification and selection, site monitoring/management, medical monitoring, project management, data collection, statistical programming or analysis, quality assurance auditing, scientific and medical communications, regulatory affairs consulting and submissions, strategic consulting, and/or other related services. From time to time, the Company shall enter into statements of work with TD2 for the performance of specific services under this Master Clinical Research Services Agreement.

In June 2023, the Company entered into a Master Laboratory Services Agreement with MLM Medical Labs, LLC (“MLM”) whereby MLM agreed to perform certain clinical research and development services for the Company including but not limited to laboratory, supply, testing, validation, data management, and storage services. From time to time, the Company shall enter into work orders with MLM for the performance of specific services under this Master Laboratory Services Agreement.

In June 2023, the Company entered into a Master Services Agreement with Clinigen Clinical Supplies Management, Inc. (“Clinigen”) whereby Clinigen agreed to provide certain pharmaceutical products and/or services. From time to time, the Company shall enter into statements of work with Clinigen for the performance of specific services under this Master Services Agreement.

In July 2023, pursuant to the above agreements, the Company entered into work orders and statements of work for clinical trial services for the conduct of the QN-302 Phase 1 study. Given our financial situation, the company slowed the development of the QN-302 Phase 1 Study beginning in the second quarter of 2024.

The University of Louisville Research Foundation

In March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with University of Louisville Research Foundation, Inc. (“ULRF”) for development of several small-molecule RAS interaction inhibitor drug candidates. Under the terms of this agreement, the Company agreed to reimburse ULRF for sponsored research expenses of initially up to $693,000 for this program. This agreement was amended in February 2021, March 2022 and August 2023, with the current term of this agreement expired in December 2023 and the aggregate amount that the Company would reimburse ULRF for sponsored research expenses increased to approximately $2.9 million. In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to July 2020, and (iv) payments ranging from $50,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $50,000 for first dosing in a Phase 1 clinical trial, $100,000 for first dosing in a Phase 2 clinical trial, $150,000 for first dosing in a Phase 3 clinical trial, $300,000 for regulatory marketing approval and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $20,000 to $100,000) for such year.

There were no sponsored research expenses related to these agreements for the three and nine months ended September 30, 2025 and 2024. License costs were approximately $0 and $22,000 related to these agreements for the three months ended September 30, 2025 and 2024, respectively and approximately $0 and $76,000 for the nine months ended September 30, 2025 and 2024, respectively and are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

Between June 2018 and April 2022, the Company entered into license and sponsored research agreements with ULRF for QN-247, a novel aptamer-based compound that has shown promise as an anticancer drug. Under the agreements, the Company took over development, regulatory approval and commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received a $50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s common stock, and the Company agreed to reimburse ULRF for sponsored research expenses of up to approximately $805,000 and prior patent costs of up to $200,000. In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to June 2018, and (iv) payments ranging from $100,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $100,000 for first dosing in a Phase 1 clinical trial, $200,000 for first dosing in a Phase 2 clinical trial, $350,000 for first dosing in a Phase 3 clinical trial, $500,000 for regulatory marketing approval and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales. The Company also agreed to pay another $500,000 milestone payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company must also pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $10,000 to $50,000) for such year.

The sponsored research agreement for QN-247 expired in August 2022 and there were no sponsored research expenses related to these agreements for the three and nine months ended September 30, 2025 and 2024. License costs related to these agreements for the three and nine months ended September 30, 2025 and 2024 were approximately $0 and $1,000, respectively, and are included in research and development expenses in the consolidated statements of operations and other comprehensive loss.

Marizyme

On April 11, 2024, the Company entered into a Co-Development Agreement with Marizyme. Under the Co-Development Agreement (as amended), the Company agreed to pay Marizyme a Funding Payments and an Exclusivity Fee of $200,000. The Exclusivity Fee of $200,000 and a Funding Payment of $500,000 was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The Funding Payments are designed to provide financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery. In return for the Funding Payments the Company will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States. During the nine months ended September 30, 2025 and the year ended December 31, 2024, the Company advanced $1,809,500 and $2,257,400, respectively, to Marizyme, against which Marizyme had previously delivered demand promissory notes to the Company. Accrued interest related to the Marizyme Notes as of September 30, 2025 and December 31, 2024 was $542,207 and $113,292, respectively, and interest income for the three months ended September 30, 2025 in the amount of $177,612 and for the nine months ended September 30, 2025 in the amount of $428,915 was recognized in other income in the consolidated statement of operations, and a $261,000 loan loss reserve was recorded in operations in the consolidated statement of operations (see Note 5 – Short-Term Note Receivable).

NOTE 14 — STOCKHOLDERS’ EQUITY (DEFICIT)

As of September 30, 2025 and December 31, 2024, the Company had two classes of authorized capital stock: common stock and preferred stock.

Common Stock

Holders of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, any remaining assets will be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of any preferred stock upon liquidation, dissolution or winding up of the affairs of the Company. The holders of common stock have no preemptive, subscription or conversion rights and there are no redemption or sinking fund provisions.

At September 30, 2025, the Company has reserved 20,708,447 shares of authorized but unissued common stock for possible future issuance as follows:

SCHEDULE OF RESERVED SHARES


Exercise of issued and future grants of stock options			15,114
Conversion of Series A-2 preferred stock			267,364
Conversion of Series A-3 preferred stock			2,003,562
Conversion of Series B preferred stock			17,784,061
Conversion of convertible debt			58,771
Exercise of stock warrants			579,575
Total			20,708,447

Faraday Subscription Agreement

As described in Note 1 – Organization and Summary of Significant Accounting Policies and Estimates, on September 29, 2025, the Company consummated the Subscription Agreement with certain investors, including Faraday pursuant to which the Company issued and sold 337,432 shares of the Company’s common stock and issued 100,000 to the Company’s legal firm. The purchase price of the common stock was $2.246 per share for an aggregate $0.8 million.

Additionally, in connection with the closing of the Subscription Agreement, the Company issued 60,257 shares of common stock as compensation to its advisor which has been accounted for under ASC 718 Compensation—Stock Compensation. The grant date fair value of these shares of $0.3 million, is included in General and Administrative Expenses on the Company’s Condensed Consolidated Statement of Operations.

Further, in connection with the closing of the Subscription Agreement, 1,087,266 warrants were issued to the placement agent, (the “Placement Agent Warrants”). The Placement Agent Warrants were immediately exercisable and have an initial exercise price of $2.47 per share. At September 30, 2025, 1,087,266 Placement Agent Warrants remain outstanding.

2024 Common Stock Purchase Agreement

On November 19, 2024, the Company entered into a Common Stock Purchase Agreement (the “Common Stock Purchase Agreement”) with Horberg Enterprises LP (the “Investor”), pursuant to which the Company in its sole discretion has the right, but not the obligation, to issue and sell to the Investor up to $10.0 million of the Company’s common stock, from time to time beginning on the Commencement Date, as discussed below, subject to certain limitations and conditions detailed in the Common Stock Purchase Agreement. The Company is not obligated to sell any shares to the Investor under the Common Stock Purchase Agreement; sales and timing of any sales of the Company’s common stock are solely at the Company’s election. In accordance with the terms of the Common Stock Purchase Agreement, the Commencement Date is subject to certain conditions, including the effectiveness of a registration statement on Form S-1 or a similar prospectus permitting the Investor to offer and resell the shares of common stock acquired under the Common Stock Purchase Agreement.

No upfront fees were paid to the Investor at the execution of the arrangement. As of September 30, 2025, no registration statement had been filed and thus the Commencement Date permitting the sale of shares under the Common Stock Purchase Agreement had not yet occurred.

The Company evaluated the Common Stock Purchase Agreement under ASC 815-40 Derivatives and Hedging-Contracts on an Entity’s Own Equity as it represents the right to require the Investor to purchase shares of Common Stock in the future, similar to a put option. The Company concluded the Common Stock Purchase Agreement represents a freestanding derivative instrument that does not qualify for equity classification and therefore requires fair value accounting. The Company analyzed the terms of the contract and concluded the derivative instrument had no value at inception, as of December 31, 2024, or as of September 30, 2025.

Preferred Stock

There are a total of 15,000,000 shares of Preferred Stock authorized , of which 10,000 shares are designated as Series A-2 Preferred Stock, 10,000 shares are designed as Series A-3 Preferred Stock, and to 500,000 shares are designated as Series B Preferred Stock.

As described in Note 1 – Organization and Summary of Significant Accounting Policies and Estimates, on September 29, 2025, the Company consummated the Subscription Agreement pursuant to which the Company issued 39,943 shares of the newly designated Series B Preferred Stock, for $1,000 per share, for aggregate gross proceeds of approximately $39.9 million, before deducting placement agent fees and other offering expenses.

On July 28, 2025, in a private placement transaction, the Company sold and issued to certain institutional and accredited investors 4,500 shares of Series A-3 Convertible Preferred Stock, par value $0.001 per share, (the “Series A-3 Preferred Stock”), at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $4.5 million before deducting placement agent fees and offering expenses.

On November 20, 2024 in a private placement transaction, the Company sold and issued to certain institutional and accredited investors 5,102 shares of the newly designated Series A-2 Convertible Preferred Stock, par value $0.001 per share (the “Series A-2 Preferred Stock” and together with the Series A-3 Preferred Stock, the “Series A Preferred Stock”), at a purchase price of $1,000 per share, for an aggregate purchase price of $5.1 million. The Company also entered into an Exchange Agreement with Yi Hua Chen on November 18, 2024, pursuant to which it issued 1,154 shares of Series A-2 Preferred Stock in full settlement of the outstanding balance of the 2024 Chen Debenture of approximately $1.15 million. At December 31, 2024, the Company had 6,256 shares of Series A-2 Convertible Preferred Stock outstanding which were convertible into 1,718,681 shares of common stock at a Conversion Price of $3.64. During the three and nine months ended September 30, 2025, 2,383 and 5,656 shares respectively, of Series A-2 Convertible Preferred Stock were converted into 1,461,090 and 2,360,134 shares respectively, of common stock at a Conversion Price ranging from $3.64 to $2.246. At September 30, 2025, the Company’s outstanding preferred stock consists of the following:

SCHEDULE OF OUTSTANDING PREFERRED STOCK

	Authorized Shares		Outstanding Shares		Conversion Price		Common Stock Equivalent
Series A-2		10,000		601	$	2.246		267,364
Series A-3		10,000		4,500	$	2.246		2,003,562
Series B		500,000		39,943	$	2.246		17,784,061

The shares of Series A-2 Preferred Stock have the rights, preferences, powers, restrictions and limitations as set forth below.

Conversion Rights – Each share of Preferred Stock is convertible at any time, at the option of the holder, into a number of shares of common stock equal to $1,000 (the “Stated Value”), divided by a conversion price initially equal to $3.64 for each share of Series A-2 Preferred Stock, $2.80 for each share of Series A-3 Preferred stock and $2.246 for each share of Series B Preferred Stock (the “Conversion Shares”), subject to adjustment for any stock splits, stock dividends and similar events (the “Conversion Price”).

The Conversion Prices of the Series A Convertible Preferred Stock are also subject to “ratchet” antidilution adjustments if the Company at any time while the Series A Preferred Stock is outstanding issues common stock or common stock equivalents at a lower effective price per share than the then-effective Conversion Price, in all cases subject to a floor price of $1.82 and $1.40 for the Series A-2 Preferred Stocka and the Series A-3 Preferred Stock, respectively. Conversion of the Series A Preferred Stock will be prohibited if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 4.99% (or 9.99% at the option of the holder) of the total number of shares of the Company’s common stock issued and outstanding.

Liquidation Preference – Upon any voluntary or involuntary liquidation, dissolution or winding-up of the Corporation, the holders of Series A Preferred Stock shall be entitled to an amount equal to the Stated Value for each share of Series A Preferred Stock before any distribution or payment shall be made to the holders of common stock. Upon any voluntary or involuntary liquidation, dissolution or winding-up of the Corporation, the holders of Series B Preferred Stock shall be entitled to an amount equal to the Stated Value, plus any accrued and unpaid dividends thereon before any distribution or payment shall be made to the holders of common stock.

Voting Rights – The holders of Series A Preferred Stock are entitled to vote, together as a single class with the common stock, on all matters presented to the common stockholders for a vote. Each share of Series A Preferred Stock is entitled to a number of votes equal to the number of shares into which such share of Series A Preferred Stock would be convertible, as of the record date for determination of stockholders entitled to vote as to such matter, if the conversion price was equal to the “Minimum Price” (as defined in Nasdaq Listing Rule 5635(d)) as of the original issue date of the Series A Preferred Stock, taking into account for such purposes the beneficial ownership limitation as then in effect. The holders of Series B Preferred stock will vote together with common stock on an as-converted basis.

Dividends – The holders of Series A Preferred Stock and Series B Preferred Stock are entitled to receive dividends, if and when such dividends are paid to holders of common stock, in the same form and at the same time on an as-converted to common stock basis.

Protective Provisions – At all times while the Series A Preferred Stock and Series B Preferred Stock are outstanding, without the consent of the holders of at least 67% of the Stated Value of each series of the then-outstanding Series A Preferred Stock and holders of at least 75% of the Stated Value of the then-outstanding Series B Preferred Stock, (the “Required Consent”), the Company is prohibited from amending its charter documents in any manner that adversely affects the rights of the Series A Preferred Stock and Series B Preferred Stock, repurchase junior securities of the Company, pay cash dividends or distributions on junior securities of the Company, or enter into a material transactions with an affiliate of the Company (unless it is at arm’s length and expressly approved by a majority of the disinterested directors). Without the Required Consent of the Series B-Preferred Stock, the Company is prohibited from entering into, creating, assuming or guaranteeing any new indebtedness or liens of any kind.

In addition, as long as any shares of Series B Preferred Stock are outstanding, the Company shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock directly and/or indirectly (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock or alter or amend this Certificate of Designation, (b) authorize or create any class of stock ranking as to redemption or distribution of assets upon a Liquidation (as defined in Section 5) senior to, or otherwise pari passu with, the Series B Preferred Stock or, authorize or create any class of stock ranking as to dividends senior to, or otherwise pari passu with, the Series B Preferred Stock, (c) amend its Articles of Incorporation or other charter documents in any manner that adversely affects any rights of the holders of the Series B Preferred Stock, (d) increase the number of authorized shares of Series B Preferred Stock, or (e) enter into any agreement with respect to any of the foregoing.

Upon any subsequent issuance by the Company or any of its subsidiaries of common stock or common stock equivalents for cash consideration, indebtedness or a combination of units thereof (a “Subsequent Financing”), holders of Series B Preferred Stock may elect, in its sole discretion, to exchange (in lieu of conversion), if applicable, all or some of the shares of Series B Preferred Stock then held for any securities or units issued in a Subsequent Financing on a $1.00 for $1.00 basis. Additionally, if in such Subsequent Financing there are any contractual provisions or side letters that provide terms more favorable to the investors than the terms previously provided to holders of the Series B Preferred Stock, holders of the Series B Preferred Stock shall become a part of the transaction documents, at their option.

Stock Options and Warrants

Stock Options

The Company recognizes all compensatory share-based payments as compensation expense over the service period, which is generally the vesting period.

In April 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting of incentive or non-statutory common stock options and other types of awards to qualified employees, officers, directors, consultants and other service providers. At September 30, 2025 and December 31, 2024, there were 1,570 and 1,870 outstanding stock options, respectively, under the 2020 Plan and on such dates there were 13,544 and 13,244 shares reserved under the 2020 Plan, respectively, for future grant.

The following represents a summary of the options granted to employees and non-employee service providers that were outstanding at September 30, 2025, and changes during the nine-month period then ended:

SCHEDULE OF STOCK OPTION ACTIVITY

	Shares			Weighted– Average Exercise Price		Range of Exercise Price		Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2024		1,870		$	1,948.41	$	256.80 — $2,565.00		5.93
Granted		—			—		—		—
Expired		—			—		—		—
Forfeited		(300	)	$	1,527.27	$	256.80 — $2,565.00		—
Total outstanding – September 30, 2025		1,570		$	2,028.88	$	256.80 — $2,485.00		5.11
Exercisable (vested)		1,560		$	2,040.24	$	256.80 — $2,485.00		5.09
Non-Exercisable (non-vested)		10		$	256.80	$	256.80 — $256.80		7.02

The following represents a summary of the options granted to employees and non-employee service providers that were outstanding at September 30, 2024, and changes during the nine-month period then ended:

				Weighted–				Weighted–
				Average		Range of		Average
				Exercise		Exercise		Remaining
	Shares			Price		Price		Life (Years)
Total outstanding – December 31, 2023		7,978		$	1,760.26	$	256.80 — $2,565.00		7.06
Granted		—			—		—		—
Expired		—			—		—		—
Forfeited		(1,239	)	$	743.77	$	256.80 — $2,565.00		—
Total outstanding – September 30, 2024		6,739		$	1,947.06	$	256.80 — $2,565.00		6.22
Exercisable (vested)		6,153		$	2,103.52	$	256.80 — $2,565.00		6.08
Non-Exercisable (non-vested)		586		$	305.69	$	256.80 — $620.00		7.71

There were approximately $0 and $27,000 of compensation costs related to outstanding stock options for the three months ended September 30, 2025 and 2024, respectively and approximately $300 and $119,000 of compensation costs related to outstanding stock options for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, there was no unrecognized compensation cost related to unvested stock-based compensation arrangements.

The exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a ten-year period. A forfeiture is recognized as incurred if the option holder does not exercise after 90 days following termination of service.

No stock options were granted or exercised during the nine months ended September 30, 2025 and June 30, 2024.

Fair Value of Equity Awards

The Company utilizes the Black-Scholes option pricing model to value awards under its equity plans. Key valuation assumptions include:

●	Expected dividend yield. The expected dividend is assumed to be zero, as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock.

●	Expected stock-price volatility. The Company’s expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term, because the Company does not have sufficient stock price history over the expected term.

●	Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term.

●	Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options.

The Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations as follows:

	2025		2024		2025		2024
	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
General and administrative	$	—	$	27,208	$	269	$	94,264
Research and development		—		—		—		24,680
Total	$	—	$	27,208	$	269	$	118,944
Share-based compensation expense	$	—	$	27,208	$	269	$	118,944

Equity Classified Compensatory Warrants

As part of the May 2020 reverse recapitalization transaction, the Company issued equity classified compensatory common stock warrants to an advisor and its designees. In addition, various service providers hold equity classified compensatory common stock warrants issued in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase common stock). These are to be differentiated from the Series C Warrants described in Note 8- Warrant Liabilities. As of September 30, 2025, warrants to purchase 164 shares of the Company’s common stock remain outstanding.

On February 27, 2024, as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture, 1,353 warrants were repriced from $36.50 per share exercise price to $13.50 per share exercise price. The increase in fair value of $9,737 for the modification of these warrants was charged to general and administrative expenses in the Company’s condensed consolidated statements of operations. On September 6, 2024 as a result of a down-round provision triggered by shares sold in the public offering, these warrants were repriced again from $13.50 per share exercise price to $6.50 per share exercise price. These warrants were reclassified to warrant liabilities during the year ended December 31, 2024 and expired during the quarter ended September 30, 2025 (See Note 8 – Warrant Liabilities)

No new compensatory warrants were issued during the nine months ended September 30, 2025 or 2024.

The following table summarizes the equity classified compensatory warrant activity for the nine months ended September 30, 2025:

	Common Stock
	Shares			Weighted–Average Exercise Price	Range of Exercise Price	Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2024	509		$	1,270.25	$1,270.25 — $1,270.25	0.69
Exercised	—			—	—	—
Expired	(349	)	$	1,270.25	$1,270.25 — $1,270.25	—
Forfeited	—			—	—	—
Total outstanding – September 30, 2025	160		$	1,270.25	$1,270.25— $1,270.25	1.06
Exercisable	160		$	1,270.25	$1,270.25 — $1,270.25	1.06
Non-Exercisable	—			—	—	—

The following table summarizes the equity classified compensatory warrant activity for the nine months ended September 30, 2024:

	Shares			Weighted–Average Exercise Price		Range of Exercise Price		Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2023		2,381		$	534.44		$66.00 — $1,270.25		1.25
Exercised		—			—		—		—
Expired		(520	)	$	1,033.15		$1,033.15 — $1,033.15		—
Forfeited		—			—		—		—
Total outstanding – September 30, 2024		1,861		$	351.88		$6.50 — $1,270.25		4.50
Exercisable		1,861		$	351.88		$6.50 — $1,270.25		0.72
Non-Exercisable		—			—		—		—

There were no compensation costs related to outstanding equity classified compensatory warrants for the nine months ended September 30, 2025 and $12,000 for the nine months ended September 30, 2024. As of September 30, 2025 and September 30, 2024, there was no unrecognized compensation cost related to nonvested warrants.

Noncompensatory Equity Classified Warrants

On December 22, 2022, in conjunction with the issuance of a debenture to Alpha (see Note 8 – Convertible Debt), the Company issued to Alpha a warrant to purchase 50,000 shares of the Company’s common stock. The exercise price of this warrant was initially $82.50, and may be exercised in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to the related Securities Purchase Agreement, with Alpha. This Amendment reduced the Exercise Price of the December 22, 2022 warrant from $82.50 per share to $36.50 per share. The Amendment also revised certain provisions of the warrant which resulted in reclassification of the warrant from liabilities to equity during the year ended December 31, 2023. During the year ended December 31, 2024 this warrant was partially exercised for 31,998 shares, and as of September 30, 2025 warrants to purchase 18,002 shares of the Company’s common stock remain outstanding.

On February 27, 2024 the Company entered into a new Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture (see Note 8 – Convertible Debt). This Securities Purchase Agreement resulted in the reduction of the exercise price of the December 22, 2022 warrant and the May 2020 warrant from $36.50 per share to $13.00 per share. The company recognized a deemed dividend of $60,017, which represents the incremental fair value of the outstanding warrants as a result of the down-round provision. As the Company has an accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in a net impact of zero to additional paid-in capital in the condensed consolidated statements of changes in stockholders’ equity. In addition, on February 27, 2024, the Company issued to Alpha a warrant to purchase 18,001 shares of the Company’s common stock at an exercise price of $13.00 per share, which may be exercised in whole or in part, at any time before February 27, 2029.

On April 12, 2024, in connection with the issuance of a convertible debenture to Chen (see Note 8 – Convertible Debt), the Company issued a liability classified warrant to Chen to purchase 36,001 shares of common stock, exercisable until February 27, 2029. On September 6, 2024, as a result of a down-round provision triggered by shares sold in a public offering, the warrant was repriced from an exercise price of $13.00 per share to an exercise price of $6.50 per share. The warrant was initially liability classified due to an insufficient number of authorized shares to settle the warrant prior to the receipt of shareholder approval, which was subsequently obtained on October 25, 2024. As of that date, the Company determined that shareholder approval resulted in equity classification for the warrant and accordingly, the Company remeasured the warrant liability to fair value, and reclassified to noncompensatory equity classified warrants.

On September 6, 2024 as a result of the down-round provision triggered by shares sold in a public offering, the above warrants were repriced from $13.00 per share exercise price to $6.50 per share exercise price. The company recognized an additional deemed dividend of $27,587, which represents the incremental fair value of the outstanding warrants as a result of the down-round provision. As the Company has an accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in a net impact of zero to additional paid-in capital.

As a result of a partial voluntary conversion of the 2024 Alpha Debenture on September 9, 2024, the Company no longer had sufficient shares to settle the 2024 Alpha Warrant in full until shareholder approval was obtained, and a portion (2,314 warrant shares with a fair value of $14,997) was reclassified to liabilities (see Note 7 – Warrant Liabilities). Shareholder approval was subsequently obtained on October 25, 2024, and as of that date, the Company determined that shareholder approval resulted in equity classification for the warrant again and, accordingly, the Company remeasured the warrant liability to fair value, and reclassified to noncompensatory equity classified warrants.

On September 6, 2024, upon the closing of a public offering, the Company issued pre-funded warrants to purchase 239,456 common shares at a price of $6.45 per share with an exercise price of $0.05 per share (the “pre-funded warrants”). The pre-funded warrants are exercisable upon issuance and will remain exercisable until all the pre-funded warrants are exercised in full. Pre-funded warrants for 188,257 common shares were exercised during the year ended December 31, 2024. At September 30, 2025 pre-funded warrants for 51,199 common shares remained outstanding.

On September 6, 2024, upon the closing of a public offering, 16,019 warrants were issued to the placement agent. These warrants were not exercisable until March 5, 2025 and expire on September 6, 2029.

On April 28, 2025 as a result of the down-round provision triggered by the issuance of the 2025 Convertible Note (see Note 9 - Convertible Debt), warrants for 54,002 common shares were repriced from $6.50 per share exercise price to $5.82 per share exercise price. The company recognized a deemed dividend of $1,586, which represents the incremental fair value of the outstanding warrants as a result of the down-round provision. As the Company has an accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in a net impact of zero to additional paid-in capital in the condensed consolidated statements of changes in stockholders’ equity (deficit).

As discussed above, on September 29, 2025, 1,087,266 Placement Agent Warrants were issued. The Placement Agent Warrants were immediately exercisable and have an initial exercise price of $2.47 per share. At September 30, 2025, 1,087,266 Placement Agent Warrants remain outstanding.

The following table summarizes the noncompensatory equity classified warrant activity for the nine months ended September 30, 2025:

	Common Stock
	Shares		Weighted– Average Exercise Price		Range of Exercise Price		Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2024		72,004	$	6.50		$6.50 — $6.50		3.99
Granted		1,087,266		2.47		$2.47 — $2.47		5.00
Exercised		—		—		—		—
Expired		—		—		—		—
Forfeited		—		—		—		—
Total outstanding – September 30, 2025		1,159,270	$	2.72		$2.47 — $6.50		4.89
Exercisable		1,159,270	$	2.72		$2.47 — $6.50		4.89
Non-Exercisable		—		—		—		—

The following table summarizes the noncompensatory equity classified warrant activity for the nine months ended September 30, 2024:

	Common Stock
	Shares			Weighted– Average Exercise Price		Range of Exercise Price		Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2023		50,141		$	36.50		$36.50 — $36.50		4.47
Granted		70,021		$	6.81		$6.50 — $7.80		4.54
Pre-funded investor warrants issued		239,456		$	0.05		$0.05 — $0.05		n/a
Exercised		(31,998	)	$	13.00		$13.00 — $13.00		—
Reclassified to liabilities		(2,314	)	$	6.50		$6.50 — $6.50		4.41
Expired		—			—		—		—
Forfeited		—			—		—		—
Total outstanding – September 30, 2024		325,306		$	6.50		$0.00 — $6.50		n/a
Exercisable		309,287		$	6.50		$0.00 — $6.50		n/a
Non-Exercisable		16,019		$	7.80		$7.80 — $7.80		4.94

NOTE 15 — RELATED PARTY TRANSACTIONS

Lead Investor Agreement

In connection with the Subscription Agreement, the Company and Faraday entered into a Lead Investor Agreement (the “Lead Investor Agreement”), pursuant to which, among other things, the Company has agreed to adopt a treasury reserve policy suitable to Faraday and has agreed to certain governance changes including, among other things, the reduction of the size of the Board of Directors, of which two will initially be appointed by Faraday.

Convertible Debt

On December 22, 2022, the Company issued to Alpha, an 8% Senior Convertible Debenture in the aggregate principal amount of $3,300,000 for a purchase price of $3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. As of December 31, 2023, the remaining principal balance was $1,418,922. During the year ended December 31, 2024, the remaining principal balance of this Debenture was converted into 103,876 shares of common stock of the Company, at a weighted average price of $13.66 per share.

On February 27, 2024, the Company issued to Alpha, an 8% Convertible Debenture in the principal amount of $550,000 for a purchase price of $500,000 less expenses pursuant to the terms of a Securities Purchase Agreement dated February 26, 2024. During the year ended December 31, 2024, a principal amount of $50,979 of this Debenture was converted into 7,846 shares of common stock of the Company, at a weighted average price of $6.50 per share. On November 20, 2024 the Company paid to Alpha in cash the remaining principal amount of $499,021 plus outstanding accrued interest of $31,818.

On April 12, 2024, the Company issued to Chen an 8% Convertible Debenture with a principal amount of $1,100,000 for a purchase price of $1,000,000 less expenses pursuant to the terms of a Securities Purchase Agreement dated February 26, 2024. The Company entered into an Exchange Agreement with Yi Hua Chen on November 18, 2024, pursuant to which it issued 1,154 shares of Series A-2 Preferred Stock in full settlement of the outstanding balance of the 2024 Chen Debenture of approximately $1.15 million (see Note 14 — Stockholders’ Equity (Deficit)).

See Note 9 – Convertible Debt for additional information concerning convertible debt – related party transactions.

Warrants

On May 22, 2020, as a commitment fee, the Company issued warrants to Alpha for the purchase of common stock. The remaining warrants expired on May 22, 2025, and as of September 30, 2025, none of these warrants remain outstanding and exercisable. During the nine months ended September 30, 2025 and 2024 there were no exercises of this warrant. This warrant was equity classified as of December 31, 2023 and was reclassified to warrant liabilities during the year ended December 31, 2024 (see Note 8 - Warrant Liabilities).

On December 22, 2022, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha a warrant to purchase 50,000 shares of the Company’s common stock. This warrant may be exercised by Alpha, in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028, subject to certain terms and conditions described in the warrant. During the nine months ended September 30, 2024, Alpha partially exercised this warrant to purchase 5,769 shares respectively, of the Company’s common stock at a weighted average exercise price of $13.00, for total cumulative proceeds to the Company of $300,000. During the nine months ended September 30, 2025, there were no exercises of this warrant. This warrant is included in equity on the Company’s consolidated balance sheets (see Note 14 – Stockholders’ Equity(Deficit)).

On February 27, 2024, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha, a warrant to purchase 18,001 shares of the Company’s common stock, exercisable in whole or in part, until February 27, 2029, subject to certain terms and conditions described in the warrant.

As a result of a partial voluntary conversion of the 2024 Alpha Debenture on September 9, 2024, the Company no longer had sufficient shares to settle the 2024 Alpha Warrant in full until shareholder approval was obtained, and a portion (2,314 warrant shares with a fair value of $14,997) was reclassified to liabilities (see Note 8 – Warrant Liabilities). Shareholder approval was subsequently obtained on October 25, 2024, and as of that date, the Company determined that shareholder approval resulted in equity classification for the warrant again and, accordingly, the Company remeasured the warrant liability to fair value, and reclassified to noncompensatory equity classified warrants.

During the nine months ended September 30, 2025, there were no exercises of this warrant. This warrant is included in equity on the Company’s consolidated balance sheets (see Note 14 – Stockholders’ Equity(Deficit)).

As of September 30, 2025, the exercise price of all of the above warrants issued to Alpha was $6.50.

On April 12, 2024, in connection with the issuance of a debenture to Chen (see Note 9 – Convertible Debt), the Company issued a liability classified warrant to Chen to purchase 36,001 shares of common stock, exercisable until February 27, 2029. On September 6, 2024, as a result of a down-round provision triggered by shares sold in a public offering, the warrant was repriced from an exercise price of $13.00 per share to an exercise price of $6.50 per share. The warrant was initially liability classified due to an insufficient number of authorized shares to settle the warrant prior to the receipt of shareholder approval, which was subsequently obtained on October 25, 2024. As of that date, the Company determined that shareholder approval resulted in equity classification for the warrant and accordingly, the Company remeasured the warrant liability to fair value, and reclassified to noncompensatory equity classified warrants (see Note 14 – Stockholders’ Equity (Deficit)). On April 28, 2025, as a result of the down-round provision triggered by the issuance of the 2025 Convertible Note, the warrant was repriced from an exercise price of $6.50 per share to an exercise price of $5.82 per share.

NOTE 16 — SUBSEQUENT EVENTS

In October 2025, the Company repaid one lender $0.3 million in satisfaction of their outstanding promissory note.

In October 2025, the Company made a payment to settle an outstanding lawsuit. The total payment was $0.1 million, which was accrued as of September 30, 2025. Refer to Note 12 – Commitments and Contingencies.

In October 2025, a total of 3,753 shares of Series A-3 Preferred Stock were converted into 1,662,945 shares of common stock at a conversion price of $2.246 per share.

In October 2025, the Company entered into an agreement with Bitgo to manage the Company’s cryptocurrency portfolio. The Company transferred $20 million to Bitgo to establish a cryptocurrency fund.

In October 2025, an additional $0.1 million was advanced to Marizyme against which Marizyme delivered a demand promissory note to the Company of like principal amount with terms similar to the Marizyme Notes described in Note 5 - Short Term Notes Receivable.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis should be read in conjunction with our interim unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and the audited financial statements and notes thereto as of and for the twelve months ended December 31, 2024, which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on September 30, 2025. As used in this Quarterly Report, unless the context suggests otherwise, “we,” “us,” “our,” or “Qualigen” refer to Qualigen Therapeutics, Inc. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.

Cautionary Note Regarding Forward Looking Statements

This Quarterly Report contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this Report. These statements generally relate to future events or the Company’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” or “continue” or the negative of these words or other similar terms or expressions that concern the Company’s expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among other things, potential future development, testing and launch of products and product candidates. Actual events or results may differ from our expectations due to a number of factors.

Some of the factors that we believe could cause actual results to differ from those anticipated or predicted include:

	●	our ability to procure sufficient working capital to continue and complete the development, testing and launch of our prospective drug products;

	●	our ability to successfully develop any drugs;

	●	our ability to progress our drug candidates through preclinical and clinical development;

	●	our ability to obtain the requisite regulatory approvals for our clinical trials and to begin and complete such trials according to any projected timeline;

	●	our ability to complete enrollment in our clinical trials as contemplated by any projected timeline;

	●	the likelihood that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts;

	●	our ability to successfully commercialize any drugs;

	●	the likelihood that patents will issue on our in-licensed patent applications;

	●	our ability to protect our intellectual property; and

	●	our ability to compete.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate, are consistent in some future periods with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in other future periods. Any forward-looking statement that we make in this Quarterly Report speaks only as of the date of this Quarterly Report, and we disclaim any intent or obligation to update these forward-looking statements beyond the date of this Quarterly Report, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Future filings with the Securities and Exchange Commission (the “SEC”), future press releases and future oral or written statements made by us or with our approval, which are not statements of historical fact, may also contain forward-looking statements. Because such statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.

Overview

We are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our business now consists of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS), and a co-development agreement with Marizyme, Inc. (“Marizyme”).

Our lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells (such as pancreatic cancer). Such binding could, by stabilizing the G4s against DNA “unwinding,” help inhibit cancer cell proliferation.

Our Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor small molecules believed to inhibit or block mutated RAS genes’ proteins from binding to their effector proteins thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. The investigational compounds within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS and NRAS effector pathways.

In addition, under a Co-Development Agreement dated April 11, 2024 with Marizyme, Inc. (“Marizyme”), we are entitled to receive quarterly a 33% payment in the nature of royalties (capped at double the amount of Funding Payment cash we provide to Marizyme) on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States. To date we have provided $700,000 of Funding Payments to Marizyme.

We do not expect to be profitable before products from our therapeutics pipeline are commercialized. To experience losses while therapeutic products are still under development is, of course, typical for biotechnology companies. Given our financial situation, the company slowed the development of the aforementioned therapeutic products beginning in the second quarter of 2024. We have also implemented dramatic expense controls in an effort to stem the rate of losses. Management and the board are strategically reviewing plans on how to best advance our therapeutics pipeline, and will ramp up development when properly funded through either capital markets or strategic partnerships.

Recent Developments

Marizyme

On April 11, 2024, we entered into a Co-Development Agreement with Marizyme. Under the Co-Development Agreement (as amended on August 6, 2024), we agreed to pay Marizyme a Funding Payment of up to $1,750,000 and an Exclusivity Fee of $200,000. The Exclusivity Fee of $200,000 and a Funding Payment of $500,000 was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The Funding Payment is designed to provide financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery. In return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.

In addition, as of September 30, 2025, we have advanced $4,066,900 to Marizyme against which Marizyme had previously delivered its demand promissory notes to us of like principal amounts (the “Marizyme Note”). The Marizyme Note bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of the outstanding principal or interest of the Marizyme Note at any time and from time to time, in whole or in part, without premium or penalty.

Faraday Investment

In September 2025 we consummated a Subscription Agreement (the “Subscription Agreement”) with certain investors including Faraday Future Intelligent Electric Inc. (NASDAQ: FFAI)(the “Lead Investor” or “Faraday”) pursuant to which the investors purchased $41.0 million (the “Offering”) of our common stock and shares of a newly created Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”). Up to $6.8 million of the net proceeds from the Offering will be used to pay existing debt and fund our existing business operations, and the balance of the cash proceeds and contributed currency will be used for the establishment of our cryptocurrency treasury operations, using AlxCrypto. AIxCrypto (AIxC) is committed to building a world-leading ecosystem that integrates Artificial Intelligence (AI) and blockchain, bridging Web2 and Web3. This ecosystem unites a decentralized protocol, distributed network, AI DePIN and EAI RWA value regeneration, and a DeAI Agent product and technology platform designed to achieve optimal trading performance. Its core products include the BesTrade DeAI Agent and the AIxC ecosystem products.

Critical Accounting Policies and Estimates

Our condensed consolidated financial statements historically have not separated our diagnostics-related activities from our therapeutics-related activities. All of our historically reported revenue was diagnostics-related

This discussion and analysis is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to determination of allowance for credit losses, fair value of derivative financial instruments and warrant liabilities, and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 1 to our condensed consolidated financial statements, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations:

	●	Derivative financial instruments and warrant liabilities

	●	Short-term notes receivable

	●	Convertible notes

Derivative Financial Instruments and Warrant Liabilities

On April 12, 2024, in connection with an 8% Convertible Debenture in the principal amount of $1,100,000 issued to Yi Hua Chen (“Chen”) (see Note 7 - Warrant Liabilities), we issued a liability classified warrant to Chen purchase 36,001 shares of our common stock, exercisable until February 27, 2029, which remains outstanding and exercisable as of September 30, 2025.

As a result of a partial voluntary conversion of the 2024 Alpha Debenture on September 9, 2024, as of September 30, 2024 the Company no longer had sufficient shares to settle the 2024 Alpha Warrant in full until shareholder approval was obtained, and a portion (2,314 warrant shares) was reclassified to liabilities (see Note 7 - Warrant Liabilities and Note 12 - Stockholders’ Equity).

The fair value of liability classified warrants will be determined each quarter on a “mark-to-market” basis, it could result in significant variability in our future quarterly and annual consolidated statement of operations and consolidated balance sheets based on changes in our public market common stock price. Pursuant to U.S. GAAP, a quarter-to-quarter increase in our stock price would result in an increase in the fair value of the warrant liabilities and a quarter-to-quarter decrease in our stock price would result in a decrease in the fair value of the warrant liabilities.

Short-Term Notes Receivable

As of September 30, 2025, we had advanced to Marizyme $4,066,900, against which Marizyme delivered demand promissory notes to us of like principal amounts (the “Marizyme Notes”). As of September 30, 2025, accrued interest related to the Marizyme Notes was $542,207. Interest income of $177,611 and $428,915 for the three and nine months ended September 30, 2025, respectively was recognized in other income in the condensed consolidated statement of operations.

The Marizyme Notes bear at interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of the outstanding principal or interest at any time and from time to time, in whole or in part, without premium or penalty.

Under ASC 326-20, known as the current expected credit loss (“CECL”) model, we were required to estimate credit losses expected over the life of an exposure (or pool of exposures) based on historical information, current information, and reasonable and supportable forecasts. We are unable to use our historical data to estimate losses as it has no relevant loss history to date. To determine the estimate of expected credit losses, we used a probability-weighted approach that incorporates multiple settlement scenarios, including recovery of amounts due upon an acquisition of the debtor, and recovery in different liquidation scenarios, and determines the expected recoverable amount of the loan in each scenario. This model requires management to make certain assumptions including the likelihood of each outcome, the estimated value of the debtor’s assets, and our expected claim and recovery rate on the debtor’s assets in the event of an insolvency or a liquidation proceeding. As of September 30, 2025, the estimate for expected credit losses on the Marizyme Notes is $261,000. Given the inherently uncertain nature of the debtor’s financial condition and future outcomes, actual credit losses may differ materially from this estimate. We will continue to monitor relevant events and conditions and update its assumptions and allowance as necessary.

2025 Convertible Note

On April 28, 2025, we entered into a Secured Convertible Note (the “2025 Convertible Note”) with Alpha Capital Anstalt (“Alpha”, or “Holder”), pursuant to which we issued to Alpha a non-interest-bearing note with a principal of $264,000, and an original issue discount (“OID”) of 20%, or $44,000, in exchange for $220,000 cash, less $20,000 in expenses. The Note is convertible at any time at Alpha’s option, into shares of our common stock at a price equal to $3.80 per share (the “Conversion Price”), subject to certain adjustments. The Convertible Note bears no interest, and the principal will be due on January 28, 2026 (the “Maturity Date”).

We determined the 2025 Convertible Note does not contain a substantial premium and therefore we elected to account for the Convertible Note under the fair value option in accordance with ASC 825-10-15-4. We determined the fair value of the Convertible Note was $311,943 at issuance. The difference between the $220,000 proceeds received and fair value was recorded as a loss upon issuance in the amount of $91,943. Issuance costs incurred in connection with the transaction were expensed immediately.

On June 4, 2025 we paid down $132,000 in principal at the request of Alpha. As of September 30, 2025 we reassessed the fair value of the 2025 Convertible Note at $213,367, with a loss on the change in fair value of $71,298 and $33,424 recorded in the three and nine months ended September 30, 2025, respectively.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

	For the Three Months Ended September 30,
	2025			2024
EXPENSES
General and administrative	$	1,891,108		$	1,145,152
Research and development		105,576			123,429
Credit loss expense - short-term note receivable		(567,000	)		-
Total expenses		1,429,684			1,268,581

LOSS FROM OPERATIONS		(1,429,684	)		(1,268,581	)

OTHER EXPENSE (INCOME), NET
Loss (Gain) on change in fair value of warrant liabilities		148,346			(1,231	)
Loss on change in fair value of derivative liabilities		—			495,693
Loss on change in fair value of convertible note		197,667			—
Interest expense		455,941			408,359
Interest income		(193,819	)		(48,082	)
Loss on voluntary conversion of convertible debt into common stock		—			27,790
Gain on settlements of accounts payable		—			(348,305	)
Other income, net		—			(6,547	)
Total other expense (income), net		608,135			527,677
		-			-
LOSS BEFORE (BENEFIT FROM) PROVISION FOR INCOME TAXES		(2,037,819	)		(1,796,258	)

(BENEFIT FROM) PROVISION FOR INCOME TAXES		—			(2,198	)
		-			-
NET LOSS FROM CONTINUING OPERATIONS		(2,037,819	)		(1,794,060	)

DISCONTINUED OPERATIONS
Loss on disposal of discontinued operations, net of tax		—			—
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		—			—

NET LOSS		(2,037,819	)		(1,794,060	)

Deemed dividend arising from warrant down-round provision	$	(867,796	)	$	(27,587	)
		—			—
Weighted-average number of shares outstanding, basic and diluted (after stock split)	$	(2,905,615	)	$	(1,821,647	)

Total net loss per common share, basic and diluted	$	(4.68	)	$	(4.70	)
Weighted-average number of shares outstanding, basic and diluted (after stock split)		620,694			387,878

Expenses

General and Administrative Expenses

General and administrative expenses increased from $1.1 million for the three months ended September 30, 2024, to $1.9 million for the three months ended September 30, 2025, an increase of $0.8 million or 72%. This is primarily due to an increase in professional fees of $1.3 million as we needed more legal and accounting consultants to assist with our audit, offset by a decrease in payroll expenses of $0.3 million resulting from a downsizing of our workforce and a decrease in investor relations expense of $0.2 million resulting from our no longer needing to seek additional investors in the current quarter.

Research and Development Costs

Research and development expenses decreased from approximately $123,000 for the three months ended September 30, 2024, to approximately $105,000 for the three months ended September 30, 2025, a decrease of $18,000 million or 15%. This was primarily due to all research and development being slowed down in 2025, resulting in decreases in QN-302 clinical trail expenses of approximately $97,000 and License Fees of approximately $22,000, offset by increased billing for lab services of approximately $104,000.

Credit Loss Expense – Short-Term Note Receivable

Credit loss expense – short-term note receivable increased from $0 for the three months ended September 30, 2024, to $0.6 million for the three months ended September 30, 2025, an increase of $0.6 million or 100%. This is due to Marizyme notes first being recorded in July 2024, and no assessment being performed until December 31, 2024, therefore no reserve was recorded for the three months ended September 30, 2024.

Other Expense (Income), Net

Gain on Change in Fair Value of Warrant Liabilities

During the three months ended September 30, 2025 and 2024, we experienced a loss of approximately $148,000 and a gain of approximately $1,000, respectively, on change in fair value of warrant liabilities, primarily due to changes in our stock price and expiration of warrants during the prior period, and changes in our stock price in the prior period. Typically, a decline in our stock price would result in a decline in the fair value of our warrant liabilities, generating a gain, while an increase in our stock price would result in an increase in the fair value of our warrant liabilities, generating a loss.

Gain on Change in Fair Value of Derivative Liabilities

During the three months ended September, 2025 we experienced no change in fair value of derivative liabilities, compared to a loss of approximately $496,000 for the three months ended September 30, 2024. We did not hold any derivative liabilities in 2025.

Loss on Change in Fair Value of Convertible Debt

During the three months ended September 30, 2025 we experienced an approximately $198,000 loss on change in fair value of convertible debt, compared to no change for the three months ended September 30, 2024. We did not hold any convertible debt in 2024.

Interest Expense

Interest expense increased from $0.4 million for the three months ended September 30, 2024 to $0.5 million for the three months ended September 30, 2025 due to a $0.4 million decrease for the settlement of convertible debentures in 2024, offset by interest on the amortized penalty on the 2025 Convertible Note and 2025 promissory notes for $0.5 million.

Interest Income

Interest income increased from approximately $48,000 for the three months ended September 30, 2024 to $0.2 million for the three months ended September 30, 2025 due to a $0.1 million increase from the recording of interest on Marizyme notes receivable issued in 2024 and 2025.

Gain on Voluntary Conversions of Convertible Debt into Common Stock

During the three months ended September 30, 2025 we experienced $0 on voluntary conversions of convertible debt into common stock, compared to a gain of $28,000 for the three months ended September 30, 2024. No debt was converted into stock in 2025.

Gain on Settlement of Accounts Payable

There was an approximately $348,000 gain from settlements of accounts payable during the three months ended September 30, 2024, which was generated from the writing off of invoices with several vendors who had previously over billed. There was no gain from settlements of accounts payable in the three months ended September 30, 2025.

Other Income (Net)

There was approximately $7,000 in other income recorded in the three months ended September 30, 2024, as at the time bank interest was being recorded to other income. It is being recorded to interest income in the three months ended September 30, 2025.

Comparison of the Nine months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

	For the Nine Months Ended September 30,
	2025			2024
EXPENSES
General and administrative	$	5,780,572		$	3,186,575
Research and development		156,558			1,242,101
Credit loss expense - short-term note receivable		(99,000	)		-
Total expenses		5,838,130			4,428,676

LOSS FROM OPERATIONS		(5,838,130	)		(4,428,676	)

OTHER EXPENSE (INCOME), NET
Loss (Gain) on change in fair value of warrant liabilities		93,148			(361,137	)
Loss on change in fair value of derivative liabilities		—			321,080
Loss on change in fair value of convertible note		159,793			—
Interest expense		635,607			808,477
Interest income		(449,249	)		(48,082	)
Loss on issuance of convertible debt		91,943			358,279
Gain on voluntary conversion of convertible debt into common stock		—			(56,010	)
Loss on monthly redemptions of convertible debt into common stock		—			208,852
Gain on settlements of accounts payable					(348,305	)
Other income, net					(9,262	)
Total other expense (income), net		531,242			873,892

LOSS BEFORE (BENEFIT FROM) PROVISION FOR INCOME TAXES		(6,369,372	)		(5,302,568	)
		-			-
(BENEFIT FROM) PROVISION FOR INCOME TAXES		35			800

NET LOSS FROM CONTINUING OPERATIONS		(6,369,407	)		(5,303,368	)

DISCONTINUED OPERATIONS
Loss on disposal of discontinued operations, net of tax		—			(100,000	)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		—			(100,000	)
		-
NET LOSS		(6,369,407	)		(5,403,368	)
		-			-
Deemed dividend arising from warrant down-round provision	$	(869,382	)	$	(87,604	)
		—			—
Weighted-average number of shares outstanding, basic and diluted (after stock split)	$	(7,238,789	)	$	(5,490,972	)

Total net loss per common share, basic and diluted	$	(4.35	)	$	(24.93	)
Weighted-average number of shares outstanding, basic and diluted (after stock split)		1,662,223			220,221

Expenses

General and Administrative Expenses

General and administrative expenses increased from $3.2 million for the nine months ended September 30, 2024, to $5.7 million for the nine months ended September 30, 2025, an increase of $2.5 million or 78%. This is primarily due to an increase in investor relation fees of $1.2 million as we paid consultants to help raise capital, plus $2.4 million increase in consultant fees offset by a decrease in payroll expenses of $1.0 million and decrease in insurance expense of $0.2 million.

Research and Development Costs

Research and development expenses decreased from $1.2 million for the nine months ended September 30, 2024, to $0.2 million for the nine months ended September 30, 2025, a decrease of $0.9 million or 81%. This was primarily due to all research and development being slowed down in 2025, resulting in decreases in QN-302 program expenses of approximately $200,000 and a decrease in Marizyme research expense of $700,000.

Credit Loss Expense – Short-Term Note Receivable

Credit loss expense – short-term note receivable increased from $0 for the nine months ended September 30, 2024, to $0.1 million for the nine months ended September 30, 2025, an increase of $0.1 million or 100%. This is due to Marizyme notes first being recorded in July 2024, and no assessment being performed until December 31, 2024, therefore no reserve was required for the nine months ended September 30, 2024.

Other Expense (Income), Net

Gain on Change in Fair Value of Warrant Liabilities

During the nine months ended September 30, 2025 and 2024, we experienced a loss of approximately $0.1 million and a gain of approximately $0.4 million, respectively, on change in fair value of warrant liabilities, primarily due to changes in our stock price and expiration of warrants during the prior period, and changes in our stock price in the prior period. Typically, a decline in our stock price would result in a decline in the fair value of our warrant liabilities, generating a gain, while an increase in our stock price would result in an increase in the fair value of our warrant liabilities, generating a loss.

Gain on Change in Fair Value of Derivative Liabilities

During the nine months ended September 30, 2025 we experienced no change in fair value of derivative liabilities, compared to a loss of approximately $321,000 for the nine months ended September 30, 2024. We did not hold any derivative liabilities in 2025.

Gain on Change in Fair Value of Convertible Debt

During the nine months ended September 30 2025 we experienced an approximately $160,000 loss on change in fair value of convertible debt, compared to no change for the nine months ended September 30, 2024. We did not hold any convertible debt in 2024.

Interest Expense

Interest expense decreased from $0.8 million for the nine months ended September 30, 2024 to $0.6 million for the nine months ended September 30, 2025 due to a decrease in total debt held year over year, as convertible debentures from were settled in 2024 and did not continue to accrue interest.

Interest Income

Interest income increased from $48,000 for the nine months ended September 30, 2024 to $0.4 million for the nine months ended September 30, 2025 due to a $0.3 million increase from the recording of interest on Marizyme notes receivable issued in 2024 and 2025.

Loss on Issuance of Convertible Debt

During the nine months ended September 30, 2024 we incurred a loss on issuance of convertible debt of approximately $358,000 due to the fair value of the 2024 Alpha Debenture and derivative liabilities exceeding the cash proceeds. During the nine months ended September 30, 2025 we incurred a loss on issuance of convertible debt of approximately $92,000 due to the fair value of the 2025 Convertible Note and derivative liabilities exceeding the cash proceeds.

Loss on Monthly Redemptions of Convertible Debt into Common Stock

During the nine months ended September 30, 2025 we experienced $0 on monthly redemptions of convertible debt into common stock, compared to a loss of approximately $209,000 for the nine months ended September 30, 2024. No debt was converted into stock in 2025.

Gain on Voluntary Conversions of Convertible Debt into Common Stock

During the nine months ended September 30, 2025 we experienced $0 on voluntary conversions of convertible debt into common stock, compared to a gain of approximately $56,000 for the nine months ended September 30, 2024. No debt was converted into stock in 2025.

Gain on Settlement of Accounts Payable

There was an approximately $348,000 gain from settlements of accounts payable during the nine months ended September 30, 2024, which was generated from the writing off of invoices with several vendors who had previously over billed. There was no gain from settlements of accounts payable in the nine months ended September 30, 2025.

Other Income (Net)

There was approximately $9,000 in other income recorded in the nine months ended September 30, 2024, as at the time bank interest was being recorded to other income. It is being recorded to interest income in the nine months ended September 30, 2025.

Discontinued Operations

There was a $100,000 loss from discontinued operations during the nine months ended September 30, 2024, which was generated from the early settlement of an escrow account from the sale of Qualigen, Inc. There was no loss from discontinued operations in the nine months ended September 30, 2025 (See Note 5 - Discontinued Operations).

Liquidity and Capital Resources

Our financial position is weak. As of September 30, 2025 we had approximately $38.8 million in cash and net accounts payable of approximately $1.3 million. We are in arrears on accounts payable to important partners. We have incurred recurring losses from operations, and have an accumulated deficit of $129.6 million at September 30, 2025. We expect to continue to incur losses subsequent to the balance sheet date of September 30, 2025. For the nine months ended September 30, 2025 and year ended December 31, 2024, we used cash of $4.8 million and $6.4 million, respectively, in operations.

Our current liabilities at September 30, 2025 include approximately $1.3 million of accounts payable, $3.3 million of short-term debt, and $0.4 million of warrant liabilities.

From January to July 2025, we borrowed a total of $3,640,000 from nine investors as short-term borrowings, each due within six months after the date of borrowing. In July 2025, we closed a private placement transaction to raise additional funding through the sale of equity, for a net total of $4,258,000. In September 2025, we closed a subscription agreement to raise additional funding through the sale of equity for a net total of $37,700,000. While this $37.7 million of cash was received, up to $6.8 million of the net cash proceeds will be used to pay existing debt and fund our existing research and development operations, and the balance of the cash proceeds will be used for the establishment of our new cryptocurrency treasury operations, and will therefore not readily be available to fund immediate operations.

Additionally, during the nine months ended September 30, 2025, we repaid approximately $1.1 million of outstanding promissory notes.

We expect to continue to have net losses and negative cash flow from operations, which will challenge our liquidity. While we are establishing cryptocurrency treasury operations, it is newly established and there are no guarantees it will generate revenue. These factors raise substantial doubt regarding our ability to continue as a going concern for the one-year period following the date that the financial statements in this Quarterly Report were issued.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

Contractual Obligations and Commitments

We have no material contractual obligations that are not fully recorded on our condensed consolidated balance sheets or fully disclosed in the notes to the financial statements.

License and Sponsored Research Agreements

We have obligations under various license and sponsored research agreements to make future payments to third parties that become due and payable on the achievement of certain development, regulatory and commercial milestones (such as the start of a clinical trial, filing for product approval with the FDA or other regulatory agencies, product approval by the FDA or other regulatory agencies, product launch or product sales) or on the sublicense of our rights to another party. We have not included these commitments on our balance sheet because the achievement and timing of these events is not determinable. Certain milestones are in advance of receipt of revenue from the sale of products and, therefore, we may require additional debt or equity capital to make such payments.

We have multiple license agreements with ULRF. Under these agreements, we have taken over development, regulatory approval and commercialization of various drug compounds from ULRF and are responsible for maintenance of the related intellectual property portfolio. Under the terms of these agreements, we are required to make patent maintenance payments and payments based upon development, regulatory and commercial milestones for any products covered by the in-licensed intellectual property. The maximum aggregate milestone payments we may be obligated to make per product are $5 million. We will also be required to pay a royalty on net sales of products covered by the in-licensed intellectual property in the low single digits. The royalty is subject to reduction for any third-party payments required to be made, with a minimum floor in the low single digits. We have the right to sublicense our rights under these agreements, but we will be required to pay ULRF a percentage of any sublicense income.

In January 2022, we entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for University College London.) We are further developing the program’s lead compound under the name QN-302. The License Agreement requires (if and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments, and sharing of a percentage of any non-royalty sublicensing consideration paid to the Company. In November 2023, we became obligated to pay $100,000 to UCL Business Limited upon the first patient dosing of QN-302, which was paid in January 2024.

2022 Convertible Debenture

On December 22, 2022, we issued to Alpha an 8% Senior Convertible Debenture in the aggregate principal amount of $3,300,000 for a purchase price of $3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “2022 Securities Purchase Agreement”). The 2022 Debenture has a maturity date of December 22, 2025 and is convertible, at any time, and from time to time, until the 2022 Debenture is no longer outstanding, at Alpha’s option, into shares of our common stock (the “Conversion Shares”), at a price initially equal to $1.32 per share, subject to adjustment as described in the 2022 Debenture and other terms and conditions described in the 2022 Debenture. On July 13, 2023, we obtained stockholder approval, for purposes of complying with Nasdaq Listing Rule 5635(d), for the issuance to Alpha of more than 20% of our issued and outstanding shares of common stock pursuant to the terms and conditions of (a) the 2022 Debenture, and (b) the common stock purchase warrant dated December 22, 2022 issued by us to Alpha. Between January 9 - 12, 2023, we issued 16,834 shares of common stock upon Alpha’s partial conversion of the 2022 Debenture at $66.00 per share for a total of $1,111,078 in principal. In October and December 2023, we issued 6,193 shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average price of $35.52 per share. During the three and nine months ending September 30, 2024, we issued 30,378 and 103,865 shares of common stock, respectively to Alpha in lieu of cash for monthly redemption payments on and voluntary conversions of the 2022 Debenture at a weighted average conversion price of $13.00 and $13.66 per share, respectively, and a weighted average fair value of $12.97 and $15.19 per share, respectively.

2024 Convertible Debentures

On February 27, 2024, upon our receipt of a cash purchase price payment of $500,000 (less expenses), we issued to Alpha an 8% Convertible Debenture (the “2024 Alpha Debenture”) in the principal amount of $550,000. The 2024 Alpha Debenture matures no later than December 31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company, at $30.56 per share, subject to adjustment as described in the 2024 Alpha Debenture. Except in respect of an Exempt Issuance, the 2024 Alpha Debenture contains a “ratchet” antidilution provision, with a $5.82 per share floor. The 2024 Alpha Debenture accrues interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity. In connection with this issuance, we also issued to Alpha a 5-year common stock purchase warrant to purchase 18,001 shares of our common stock with an exercise price of $6.50 per share as of September 30, 2024.

We also granted to Alpha an option, exercisable until July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 36,002 additional warrants). On April 11, 2024, Alpha assigned this option to Yi Hua Chen, who exercised it in full on April 12, 2024 (see Note 8 - Convertible Debt to the Company’s condensed consolidated financial statements).

2025 Convertible Note

On June 4, 2025 the Company paid down $132,000 in principal at the request of Alpha. As of September 30, 2025 the Company reassessed the fair value of the 2025 Convertible Note at $339,736, with a loss on the change in fair value of $197,667 and $159,793 recorded in the three and nine months ended September 30, 2025, respectively.

Short-Term Promissory Notes

During the nine months ended September 30, 2025 we issued short term notes payable totaling $1.0 million for total net proceeds of $1.0 million. The notes are unsecured with a maturity date six months from the original issuance, and include a provision for a penalty in case of default totaling $1.1 million.

In July 2025, we repaid three lenders $1.2 million in satisfaction of their outstanding promissory notes. The additional $0.2 million was paid as a premium to the lenders and has been recorded under interest expense.

In August 2025, we finalized the terms of the agreements with five investors for the $2.3 million in short-term promissory notes recorded in May 2025. The agreements include a due date six months from when the funding was received as well as a 30% premium due on repayment, meaning we will record an additional $690,000 in principal for the short-term promissory notes for a total due of $3.0 million. Interest expense was recorded for these premiums during the three and nine months ended September 30, 2025 in the amount of $342,231.

Marizyme

On April 11, 2024, we entered into a Co-Development Agreement with Marizyme, Inc. (“Marizyme”). Under the Co-Development Agreement (as amended on August 6, 2024), we agreed to pay Marizyme a Funding Payment of up to $1,750,000 and an Exclusivity Fee of $200,000. The Exclusivity Fee of $200,000 and a Funding Payment of $500,000 was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The Funding Payment is designed to provide financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery. In return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.

On July 15, 2024, the Company advanced to Marizyme $1,250,000 against which Marizyme had previously delivered its demand promissory note to the Company of like principal amount dated July 12, 2024 (the “Marizyme Note”). During the nine month periods ending September 30, 2025 and the year ended December 31, 2024, the Company advanced additional funds of $1.8 million and $2.3 million, respectively. The Marizyme Note bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of the outstanding principal or interest of the Marizyme Note at any time and from time to time, in whole or in part, without premium or penalty.

Other Service Agreements

We enter into contracts in the normal course of business, including with clinical sites, contract research organizations, and other professional service providers for the conduct of clinical trials, contract manufacturers for the production of our product candidates, contract research service providers for preclinical research studies, professional consultants for expert advice and vendors for the sourcing of clinical and laboratory supplies and materials. These contracts generally provide for termination on notice, and therefore are cancelable contracts.

Cash Flows

The following table sets forth the significant sources and uses of cash for the periods set forth below:

	For the Nine Months Ended September 30,
	2025			2024
Net cash (used in) provided by:
Operating activities	$	(4,828,986	)	$	(4,057,980	)
Investing activities		(1,809,500	)		(900,000	)
Financing activities		44,241,044			4,944,329
Net decrease in cash	$	37,602,558		$	(13,651	)

Net Cash Used in Operating Activities

During the nine months ended September 30, 2025, operating activities used $4.8 million of cash, primarily resulting from a loss from continuing operations of $6.5 million. Cash flows from operating activities for the nine months ended September 30, 2025 were positively impacted by adjustments for $0.6 million in amortization of premium on promissory notes, $0.3 million of issuance of common stock to consultants, a $0.4 million loss on change in fair value of warrant liabilities, a $0.2 million loss on change in fair value of convertible debt, a $0.1 million in loss on issuance of convertible debt, and a decrease in prepaid expenses of $1.2 million. Cash flows from operating activities for the nine months ended September 30, 2025 were negatively impacted by adjustments for $99,000 change in provision for credit losses of short-term notes receivable, a $0.4 million increase in accrued interest on short-term notes receivable, a decrease in accrued expenses of $0.1 million and a $0.3 million decrease in accounts payable.

During the nine months ended September 30, 2024, operating activities used $4.1 million of cash, primarily resulting from a loss from continuing operations of $5.3 million. Cash flows from operating activities for the nine months ended September 30, 2024 were positively impacted by adjustments for $0.1 million in stock based compensation, a $0.2 loss on monthly redemptions of convertible debt into common stock, accretion of discount of $0.5 million on convertible debt, a loss on issuance of convertible debt of $0.4 million, a $0.3 million loss on change in fair value of derivative liabilities, a $0.5 million decrease in prepaid expenses, and a $0.2 million increase in accrued expenses and other current liabilities. Cash flows from operating activities for the nine months ended September 30, 2024 were negatively impacted by adjustments for a $0.4 million decrease in fair value of warrant liabilities, a $0.1 million gain on voluntary conversion of convertible debt, a $48,000 increase in accrued interest on short-term notes receivable and a $0.6 million decrease in accounts payable.

Net Cash Provided by (Used in) Investing Activities

During the nine months ended September 30, 2025, net cash used in investing activities resulted from advances to Marizyme of $1.8 million.

During the nine months ended September 30, 2024, net cash provided from investing activities totaled $900,000 resulting from $0.4 million received from settlement of an escrow account for discontinued operations netted against advances to Marizyme of $1.3 million.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was $44.2 million, which resulted from the issuance of short-term debt in the amount of $3.3 million, the issuance of convertible debt in the amount of $0.2 million, the issuance of preferred shares in the amount of $38.8 million, the issuance of common stock and warrants in the amount of $3.1 million, offset by repayment of convertible debt of $0.1 million and the repayment of promissory notes of $1 million.

Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $4.9 million, resulting from the issuance of convertible debt in the amount of $1.5 million, the issuance of common stock and warrants in the amount of $3.1 million, proceeds from warrant exercises of $0.4 million, .

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this Item.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

With the participation of our principal executive officer and principal financial officer, management evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of September 30, 2025. Based on this evaluation, management concluded that our disclosure controls and procedures were not effective at the reasonable assurance level as of that date.

Management identified the following material weaknesses:

	●	An insufficient number of accounting personnel to adequately segregate duties.
	●	Lack of designed and implemented effective Information Technology General Controls (“ITGC”) related to access controls for our financial accounting system.
	●	Absence of formalized documentation of processes and controls that could be evaluated for proper design and implementation.

Due to resource constraints, we are currently unable to employ additional personnel to remediate these material weaknesses. We do not expect remediation until we obtain additional funding to strengthen our accounting department.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

As previously disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, the Company is a party to certain legal proceedings. There have been no material developments with respect to these matters during the quarter ended September 30, 2025. The description of these proceedings set forth in such report is incorporated herein by reference.

From time to time, we could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. The Company is not aware of any pending legal claims, actions, or investigations against it or its properties, other than those described above, that the Company believes would have a material adverse effect on its business, financial condition, or results of operations.

ITEM 1A. RISK FACTORS

The Company’s business, reputation, results of operations and financial condition, as well as the price of its stock, can be affected by a number of factors, whether currently known or unknown, including those described in Part I, Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 under the heading “Risk Factors.” When any one or more of these risks materialize, the Company’s business, reputation, results of operations and financial condition, as well as the price of its stock, can be materially and adversely affected.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Unregistered Sales of Equity Securities

On September 29, 2025, the consummated a Subscription Agreement (the “Subscription Agreement”) with certain investors (the “Subscribers”), including Faraday Future Intelligent Electric Inc. (NASDAQ: FFAI)(the “Lead Investor”) pursuant to which the investors agreed to purchase $41,000,000 in cash (the “Offering”) comprised of 337,432 shares of common stock and 39,943 shares of a newly created Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Stock”). The purchase price of the Common Stock was $2.246 per share and the purchase price for the Series B Stock was $1,000 per share.

In connection with the Offering, on September 29, 2025, the Company entered into a Placement Agency Agreement with Univest Securities LLC (the “Placement Agent”). Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 5.5% of the gross proceeds from the Offering and to issue to the Placement Agent (or its designees) warrants to purchase that number of shares of Common Stock equal to 6% of the securities sold in the Offering, which will be exercisable immediately following the closing date, and have an initial exercise price per share of Common Stock of $2.47 (the “Placement Agent Warrants”). In addition, the Company agreed to reimburse the Placement Agent for up to $150,000 of its fees and expenses.

Also on September 29, 2025, the Company consummated a Capital Market Advisory Agreement (the “Advisory Agreement”) with About Investment Pte. (the “Advisor”). Pursuant to the Advisory Agreement, the Advisor shall provide the Company independent capital markets advisory and consulting in connection with the Offering with the Lead Investor, assisting the Company with structuring and financing and other capital markets advice. In consideration for such services, the Company shall issue to the Advisor approximately 60,257 shares of Common Stock equal to five percent of the Company’s outstanding Common Stock following the Closing.

The securities referred to above were issued without registration under the Securities Act of 1933, as amended (the “Securities Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506(b) of Regulation D promulgated thereunder. None of the foregoing securities as well as common stock issuable upon conversion or exercise of such securities, have been registered under the Securities Act or any other applicable laws and are deemed restricted securities, and unless so registered may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None

ITEM 4. MINE SAFETY DISCLOSURES

Not Applicable

ITEM 5. OTHER INFORMATION

Rule 10b5-1 Trading Arrangement

During the three months ended September 30, 2025, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

ITEM 6. EXHIBITS

Exhibit No.		Description
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 amended.
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 amended.
32.1		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2		Certification of 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 – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL 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 (formatted as Inline XBRL and contained in Exhibit 101).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

November 14, 2025	QUALIGEN THERAPEUTICS, INC.

	By:	/s/ Koti Meka
	Name:	Koti Meka
	Title:	Chief Financial Officer (Principal Financial and Accounting Officer)

Qualigen Therapeutics, Inc. 10-Q