QLGN Qualigen Therapeutics Inc

 

 

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, 2024

 

Or

 

☐ 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 12, 2024, there were 736,431 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 as of September 30, 2024 and December 31, 2023		3
	Condensed Consolidated Statements of Operations and Other Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023		4
	Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2024 and 2023		5
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023		6
	Notes to Condensed Consolidated Financial Statements		7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		27
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		38
Item 4.	Controls and Procedures		38
PART II.	Other Information		39
Item 1.	Legal Proceedings		39
Item 1A.	Risk Factors		39
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds		39
Item 3.	Defaults Upon Senior Securities		39
Item 4.	Mine Safety Disclosures		39
Item 5.	Other Information		39
Item 6.	Exhibits		40

 

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

		September 30,				December 31,
		2024				2023
ASSETS
Current assets
Cash and cash equivalents		$	388,152			$	401,803
Prepaid expenses and other current assets			626,760				764,964
Short-term note receivable - Marizyme			1,298,082				—
Total current assets			2,312,994				1,166,767
Other assets			—				866,481
Total Assets		$	2,312,994			$	2,033,248
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities
Accounts payable		$	1,638,447			$	2,222,983
Accrued expenses and other current liabilities			570,148				560,006
Warrant liabilities			274,042				54,600
Convertible debt			1,090,002				—
Convertible debt - related party			344,229				1,299,216
Convertible debt			344,229				1,299,216
Derivative liabilities			368,288				—
Derivative liabilities - related party			168,689				—
Derivative liabilities			168,689				—
Total current liabilities			4,453,845				4,136,805
Commitments and Contingencies (Note 10)			-				-
Stockholders’ Deficit
Qualigen Therapeutics, Inc. stockholders’ equity (deficit):
Common stock, $0.001 par value; 225,000,000 shares authorized; 548,284 and 107,243 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively			65,314				43,262
Additional paid-in capital			119,999,588				114,655,565
Accumulated deficit			(122,205,753	)			(116,802,384	)
Total Stockholders’ Deficit			(2,140,851	)			(2,103,557	)
Total Liabilities & Stockholders’ Deficit		$	2,312,994			$	2,033,248

 

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

 

 

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS

(Unaudited)

 

		2024				2023				2024				2023
		For the Three Months Ended September 30,								For the Nine Months Ended September 30,
		2024				2023				2024				2023
EXPENSES
General and administrative		$	1,145,152			$	1,336,765			$	3,186,575			$	5,132,834
Research and development			123,429				1,441,598				1,242,101				3,898,061
Total expenses			1,268,581				2,778,363				4,428,676				9,030,895
LOSS FROM OPERATIONS			(1,268,581	)			(2,778,363	)			(4,428,676	)			(9,030,895	)
OTHER EXPENSE (INCOME), NET
(Gain) loss on change in fair value of warrant liabilities			(1,231	)			101,112				(361,137	)			(1,377,855	)
Loss on change in fair value of derivative liabilities			495,693				—				321,080				—
Interest expense			408,359				367,257				808,477				1,288,908
Interest income			(48,082	)			—				(48,082	)			—
Loss on issuance of convertible debt			—				—				358,279				—
(Gain) loss on voluntary conversion of convertible debt into common stock			27,790				—				(56,010	)			1,077,287
Loss on monthly redemptions of convertible debt into common stock			—				—				208,852				—
Gain on settlements of accounts payable			(348,305	)			—				(348,305	)			—
Loss on fixed asset disposal			—				21,747				—				21,747
Other income, net			(6,547	)			(33,454	)			(9,262	)			(33,534	)
Total other expense (income), net			527,677				456,662				873,892				976,553
LOSS BEFORE PROVISION FOR INCOME TAXES			(1,796,258	)			(3,235,025	)			(5,302,568	)			(10,007,448	)
(BENEFIT) PROVISION FOR INCOME TAXES			(2,198	)			—				800				—
NET LOSS FROM CONTINUING OPERATIONS			(1,794,060	)			(3,235,025	)			(5,303,368	)			(10,007,448	)
DISCONTINUED OPERATIONS
Income (loss) from discontinued operations, net of tax			—				159,507				—				(683,008	)
Loss on disposal of discontinued operations, net of tax			—				(619,545	)			(100,000	)			(619,545	)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS			—				(460,038	)			(100,000	)			(1,302,553	)
NET LOSS			(1,794,060	)			(3,695,063	)			(5,403,368	)			(11,310,001	)
Net loss attributable to non-controlling interest from discontinued operations			—				(38,526	)			—				(343,038	)
Net loss available to Qualigen Therapeutics, Inc.		$	(1,794,060	)		$	(3,656,537	)		$	(5,403,368	)		$	(10,966,963	)
Deemed dividend arising from warrant down-round provision		$	(27,587	)		$	—			$	(87,604	)		$	—
Net loss attributable to Qualigen Therapeutics, Inc		$	(1,821,647	)		$	(3,656,537	)		$	(5,490,972	)		$	(10,966,963	)
Net loss per common share, basic and diluted - continuing operations		$	(4.70	)		$	(32.01	)		$	(24.48	)		$	(99.64	)
Net income (loss) per common share, basic and diluted - discontinued operations		$	—			$	(4.17	)		$	(0.45	)		$	(9.55	)
Total net loss per common share, basic and diluted		$	(4.70	)		$	(36.18	)		$	(24.93	)		$	(109.19	)
Weighted-average number of shares outstanding, basic and diluted			387,878				101,049				220,221				100,434
Other comprehensive loss, net of tax
Net loss		$	(1,794,060	)		$	(3,695,063	)		$	(5,403,368	)		$	(11,310,001	)
Foreign currency translation adjustment from discontinued operations			—				—				—				(50,721	)
Other comprehensive loss			(1,794,060	)			(3,695,063	)			(5,403,368	)			(11,360,722	)
Comprehensive loss attributable to noncontrolling interest from discontinued operations			—				(38,526	)			—				(343,038	)
Comprehensive loss attributable to Qualigen Therapeutics, Inc.		$	(1,794,060	)		$	(3,656,537	)		$	(5,403,368	)		$	(11,017,684	)

 

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				Capital				Deficit					Deficit
		Common Stock								Additional Paid-In				Accumulated					Total Stockholders’
		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			130,013			$	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	)
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	)

 

										Additional				Accumulated Other								Total Qualigen Therapeutics, Inc.								Total
		Common Stock								Additional Paid-In				Accumulated Other Comprehensive				Accumulated				Total Qualigen Therapeutics, Inc. Stockholders’				Noncontrolling				Total Stockholders’
		Shares				Amount				Capital				Income				Deficit				Equity				Interest				Equity
Balance at December 31, 2022			84,215			$	42,110			$	110,528,050			$	50,721			$	(103,385,172	)		$	7,235,709			$	1,530,881			$	8,766,590
Voluntary conversion of convertible debt into common stock			16,835				842				1,111,740				—				—				1,112,582				—				1,112,582
Stock-based compensation			—				—				247,657				—				—				247,657				4,569				252,226
Foreign currency translation adjustment			—				—				—				119,723				—				119,723				56,497				176,220
Net loss			—				—				—				—				(3,846,221	)			(3,846,221	)			(261,028	)			(4,107,249	)
Balance at March 31, 2023			101,049			$	42,952			$	111,887,447			$	170,444			$	(107,231,393	)		$	4,869,450			$	1,330,919			$	6,200,369
Balance			101,049			$	42,952			$	111,887,447			$	170,444			$	(107,231,393	)		$	4,869,450			$	1,330,919			$	6,200,369
Stock-based compensation			—				—				667,383				—				—				667,383				4,728				672,111
Foreign currency translation adjustment			—				—				—				(38,553)				—				(38,553)				(18,194)				(56,747)
Net loss			—				—				—				—				(3,464,205	)			(3,464,205	)			(43,484	)			(3,507,689	)
Balance at June 30, 2023			101,049			$	42,952			$	112,554,830			$	131,891			$	(110,695,598	)		$	2,034,075			$	1,273,969			$	3,308,044
Stock-based compensation			—				—				113,801				—				—				113,801				—				113,801
Net loss			—				—				—				—				(3,656,537	)			(3,656,537	)			(38,526	)			(3,695,063	)
Deconsolidation of discontinued operations			—				—				—				(131,891	)			—				(131,891	)			(1,235,443	)			(1,367,334	)
Balance at September 30, 2023			101,049			$	42,952			$	112,668,631			$	—			$	(114,352,135	)		$	(1,640,552	)		$	—			$	(1,640,552	)
Balance			101,049			$	42,952			$	112,668,631			$	—			$	(114,352,135	)		$	(1,640,552	)		$	—			$	(1,640,552	)

 

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

 

 

QUALIGEN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

		2024				2023
		For the Nine Months Ended September 30,
		2024				2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss		$	(5,403,368	)		$	(11,310,001	)
Loss from discontinued operations, net of tax			(100,000	)			(1,302,553	)
Loss from continuing operations			(5,303,368	)			(10,007,448	)
Adjustments to reconcile loss from continuing operations to net cash used in operating activities:
Stock-based compensation			118,945				1,028,841
Change in fair value of warrant liabilities			(361,137	)			(1,377,855	)
Change in fair value of derivative liabilities			321,080				—
Accrued interest on short-term note receivable - Marizyme			(48,082	)			—
(Gain) loss on voluntary conversion of convertible debt			(56,010	)			1,077,287
Loss on monthly redemptions of convertible debt into common stock			208,852				—
Accretion of discount on convertible debt			514,028				1,247,198
Loss on issuance of convertible debt			358,279				—
Loss on disposal of fixed assets			—				21,747
Fair value of warrant modification for professional services			12,036				—
Changes in operating assets and liabilities:
Prepaid expenses and other assets			554,685				(640,105	)
Accounts payable			(584,537	)			952,269
Accrued expenses and other current liabilities			207,249				443,330
Net cash used in operating activities - continuing operations			(4,057,980	)			(7,254,736	)
Net cash used in operating activities - discontinued operations			—				2,622,059
Net cash used in operating activities			(4,057,980	)			(4,632,677	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Issuance of short-term note receivable - Marizyme			(1,250,000	)			—
Net cash provided by investing activities - discontinued operations			350,000				3,980,541
Net cash provided by (used in) investing activities			(900,000	)			3,980,541
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from the issuance of convertible notes payable			1,475,000				(440,000	)
Proceeds from issuance of common shares and prefunded warrants in public offering			3,053,348				—
Net proceeds from issuance of short term debt			2,000,000				—
Proceeds from warrant exercises			415,981				—
Payments on short term debt			(2,000,000	)			—
Net cash provided by (used in) financing activities - continuing operations			4,944,329				(440,000	)
Net cash provided by (used in) financing activities - discontinued operations			—				—
Net cash provided by (used in) financing activities			4,944,329				(440,000	)
Net change in cash and cash equivalents			(13,651	)			(1,092,136	)
Cash and cash equivalents from continuing operations- beginning of period			401,803				3,165,985
Cash and cash equivalents from continuing operations - end of period		$	388,152			$	2,073,849
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid during the year for:
Interest		$	61,020			$	—
Taxes		$	7,864			$	4,900
NONCASH FINANCING AND INVESTING ACTIVITIES:
Monthly redemptions of convertible debt into common stock		$	903,329			$	—
Voluntary conversion of convertible debt into common stock		$	735,083			$	1,112,582
Deemed dividend arising from warrant down-round provision		$	87,604			$	—
Exchange of derivative liability for warrant and convertible debt		$	675,625			$	—
Net transfers to equipment held for lease from inventory		$	—			$	83,271

 

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).

 

On May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha Capital Anstalt (“Alpha”), a related party, in exchange for 7,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase 6,629 reverse split adjusted shares of the Company’s common stock at an exercise price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, with NanoSynex (the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex, and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted in the Company acquiring a 52.8% interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex (see Note 5 -Discontinued Operations).

 

Reverse Stock Split

 

On October 28, 2024, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended (the “Amendment”) with the Secretary of State of Delaware to effect a 1-for-50 Reverse Stock Split of the Company’s common stock, which became effective on November 5, 2024. The Amendment did not reduce the number of authorized shares of common stock, which remains at 225,000,000, and did not change the par value of the common stock, which remains at $0.0001 per share. As a result of the Reverse Stock Split, every fifty shares of the common stock were combined into one issued and outstanding share of common stock and no fractional shares were issued. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof.

 

All share and per share information shown herein has been retroactively adjusted to reflect the effect of the Reverse Stock Split Amendment for all periods presented.

 

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, 2023, which contains the audited financial statements and notes thereto. The financial information as of December 31, 2023 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The interim results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 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 such, assets and liabilities for NanoSynex were 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. See Note 5 – Discontinued Operations for further information.

 

7

 

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.

 

See Note 5 - Discontinued Operations for further information.

 

Equity Method Investments

 

Following deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods. See Note 5 – Discontinued Operations for further information.

 

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 warrant liabilities, convertible debentures, derivative liabilities, and stock-based compensation. Actual results could materially vary from the estimates that were used.

 

Cash and Cash Equivalents

 

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. In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect the Company’s business and financial position.

 

Impairment of Long-Lived Assets

 

The Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between the net book value of the assets and their estimated fair values. During the nine months ended September 30, 2024 and 2023, no such impairment losses have been recorded.

 

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker 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).

 

8

 

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 7-Warrant Liabilities and Note 8- 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, accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

 

Comprehensive Loss

 

Comprehensive loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements of stockholders’ equity (deficit) for all periods presented.

 

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.

 

9

 

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.

 

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.

 

Foreign Currency Translation

 

The functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).

 

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

 

During the year ended 2023 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.

 

Impact of COVID-19 Pandemic

 

The COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned subsidiary, to Chembio (see Note 5 - Discontinued Operations).

 

10

 

Accounting Standards

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The update, among other things, requires disclosure of certain significant segment expenses. We will adopt the updated accounting guidance in our Annual Report on Form 10-K for the year ending December 31, 2024. We do not expect the adoption of the new accounting guidance will have a material impact to our consolidated financial statements.

 

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.

 

We do 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.

 

NOTE 2 — LIQUIDITY AND GOING CONCERN

 

As of September 30, 2024, we had approximately $388,000 in cash and an accumulated deficit of $122.2 million. For the nine months ended September 30, 2024 and year ended December 31, 2023, we used cash of $4.0 million and $11 million, respectively, in operations.

 

The Company’s cash balances as of the date that these financial statements were issued, without additional financing, are expected to fund operations through the fourth quarter of 2024. The Company expects to continue to have net losses and negative cash flow from operations, which will challenge its liquidity. 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.

 

Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt. Between February 2024 and April 2024 the Company raised $1.5 million from the sale of Convertible Debentures (see Note 8 - Convertible Debt - Related Party). In July 2024 the Company raised an additional $2.0 million from the sale of a nonconvertible 18% Senior Note, which was subsequently repaid in September 2024. In September 2024, the Company raised additional net proceeds of approximately $3.1 million from the sale of common stock and prefunded warrants in a public offering. There can be no assurance that further financing can be obtained on favorable terms, or at all. If the Company is unable to obtain funding, the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect the Company’s business prospects.

 

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 — PREPAID EXPENSES AND OTHER CURRENT ASSETS

 

Prepaid expenses and other current assets consisted of the following at September 30, 2024 and December 31, 2023:

 SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

		September 30,				December 31,
		2024				2023
Prepaid insurance		$	313,703			$	566,011
Other prepaid expenses			63,057				25,053
Prepaid consulting			250,000				—
Prepaid research and development expenses			—				173,900
Prepaid expenses and other current assets		$	626,760			$	764,964

 

11

 

NOTE 4 — SHORT-TERM NOTE RECEIVABLE - MARIZYME

 

Other current assets consisted of the following at September 30, 2024 and December 31, 2023:

 SCHEDULE OF SHORT-TERM NOTE RECEIVABLE

		September 30,				December 31,
		2024				2023
Short-term note receivable - Marizyme		$	1,298,082			$	—
Total		$	1,298,082			$	—

 

On July 15, 2024, the Company advanced to Marizyme, Inc., $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”). 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.

 

Under ASC 326-20, known as the current expected credit loss ("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 conclusion was that if the Company were to demand repayment of the loan mentioned above, management expects that the Company would be able to recover substantially all of its investment in a presumed liquidation of Marizyme’s assets, as the Company has seniority in any future bankruptcy or insolvency proceeding. As such, management estimates the expected credit losses on the Marizyme Note to be zero as of September 30, 2024.

 

The Company is also party to a Co-Development Agreement with Marizyme (see Note 11 - Research and License Agreements).

 

NOTE 5 — DISCONTINUED OPERATIONS

 

The summary of gain (loss) from discontinued operations, net of tax, for the three and nine months ended September 30, 2024 are as follows:

SCHEDULE OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS 

		Qualigen, Inc.				NanoSynex				Total				Qualigen, Inc.				NanoSynex				Total				Qualigen, Inc.				NanoSynex				Total				Qualigen, Inc.				NanoSynex				Total
						Three Months Ended September 30, 2024												Nine Months Ended September 30, 2024												Three Months Ended September 30, 2023												Nine Months Ended September 30, 2023
		Qualigen, Inc.				NanoSynex				Total				Qualigen, Inc.				NanoSynex				Total				Qualigen, Inc.				NanoSynex				Total				Qualigen, Inc.				NanoSynex				Total
Loss on disposal of discontinued operations, net of tax		$	—			$	—			$	—			$	—			$	—			$	—			$	90,778			$	68,729			$	159,507			$	(171,701	)		$	(511,307	)		$	(683,008	)
Income (loss) from discontinued operations, net of tax			—				—				—				(100,000	)			—				(100,000	)			3,859,465				(4,479,010	)			(619,545	)			3,859,465				(4,479,010	)			(619,545	)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		$	—			$	—			$	—			$	(100,000	)		$	—			$	(100,000	)		$	3,950,243			$	(4,410,281	)		$	(460,038	)		$	3,687,764			$	(4,990,317	)		$	(1,302,553	)

 

Sale of Qualigen Inc.

 

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 ending September 30, 2024. There was no other activity related to Qualigen, Inc. during the three and nine months ended September 30, 2024.

 

There were no assets and liabilities remaining related to Qualigen, Inc. as of September 30, 2024 or December 31, 2023.

 

12

 

The Company reclassified the following statement of operations items to discontinued operations for the three and nine months ended September 30, 2023:

 SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS

		For the Three Months Ended September 30,				For the Nine Months September 30,
		2023				2023
REVENUES
Net product sales		$	426,920			$	3,661,121
Total revenues			426,920				3,661,121
EXPENSES
Cost of product sales			269,747				2,551,114
General and administrative			26,346				610,559
Research and development			2,612				206,819
Sales and marketing			37,288				405,626
Total expenses			335,993				3,774,118
OTHER EXPENSE (INCOME), NET
Loss on disposal of equipment held for lease			—				63,302
Other expense (income), net			149				(4,898	)
Loss on fixed asset disposal			—				300
Total other expense (income), net			149				58,704
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.			90,778				(171,701	)
Gain on sale of Qualigen, Inc.			3,859,465				3,859,465
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.		$	3,950,243			$	3,687,764

 

Amendment and Settlement Agreement with NanoSynex Ltd.

 

On July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, reducing its ownership from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex, and deconsolidation of the subsidiary. On November 22, 2023, the Company further agreed to eliminate the Company’s obligations to lend additional funds to NanoSynex by surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced the Company’s ownership in NanoSynex voting equity from approximately 49.97% to 39.90%.

 

On the date of deconsolidation, the Company recognized its retained investment at fair value, which during the preparation of these financial statements was determined to be de minimis based on various economic, industry, and other factors. As a result, the Company has discontinued recognition of its proportionate share of equity method losses following the date of initial recognition. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods.

 

There were no assets and liabilities recognized related to NanoSynex as of September 30, 2024 or December 31, 2023.

 

13

 

There was no activity related to NanoSynex during the three and nine months ended September 30, 2024. The Company reclassified the following statement of operations items to discontinued operations for the three and nine months ended September 30, 2023:

 SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS

		For the Three Months Ended September 30,				For the Nine Months September 30,
		2023				2023
EXPENSES
Research and development		$	81,640			$	869,064
Total expenses			81,640				869,064
Loss on disposal of discontinued operations			4,479,010				4,479,010
(BENEFIT) PROVISION FOR INCOME TAXES			(150,369	)			(357,757	)
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.			(4,410,281	)			(4,990,317	)
Loss attributable to noncontrolling interest			(1,276,969	)			(1,578,481	)
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS		$	(3,133,312	)		$	(3,411,836	)

 

NOTE 6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 

Accrued expenses and other current liabilities consisted of the following at September 30, 2024 and December 31, 2023:

 SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

		September 30,				December 31,
		2024				2023
Board compensation		$	97,597			$	129,499
Interest (Convertible debt)			68,318				10,004
License fees			4,907				32,975
Payroll			3,173				1,215
Professional fees			163,270				121,775
Research and development			61,515				104,402
Vacation			164,095				151,286
Other			7,273				8,850
Accrued expenses and other current liabilities		$	570,148			$	560,006

 

NOTE 7 — WARRANT LIABILITIES

 

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. The Series C Warrants were determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, based on the inclusion of a leveraged ratchet provision for subsequent dilutive issuances. As of December 31, 2022 there were 26,995 Series C Warrants outstanding with an exercise price of $66.00 per share.

 

On December 22, 2022, in conjunction with the issuance of the 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 “Alpha Warrant”). The exercise price of the Alpha Warrant was $82.50 (equal to 125% of the conversion price of the Debenture on the closing date). The Alpha 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 Alpha Warrant. The fair value of this Alpha Warrant was included in Warrant liabilities-related party on the Company’s consolidated balance sheet as of December 31, 2022. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to a Securities Purchase Agreement, with Alpha. This Amendment eliminated certain adjustment provisions of the Warrant. The Company determined the event resulted in equity classification for the Warrant and, accordingly, the Company remeasured the warrant liabilities to fair value, and reclassified to noncompensatory equity classified warrants (see Note 12 - Stockholders Equity).

 

On November 24, 2023, 21,952 Series C Warrants expired, and on December 5, 2023 the remaining Series C Warrants were repriced from an exercise price of $66.00 per share to an exercise price of $36.50 per share, with 4,074 additional ratchet Series C Warrants issued, resulting in 9,113 of these Series C Warrants outstanding and exercisable as of December 31, 2023.

 

14

 

On February 27, 2024, these Series C Warrants were repriced again as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture, 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 of these Series C Warrants outstanding and exercisable, and on June 26, 2024 these remaining 25,586 Series C Warrants expired.

 

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 8 – Convertible Debt), we issued a liability classified warrant to Chen purchase 36,001 shares of our common stock, exercisable until February 27, 2029. 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 warrant remains outstanding and exercisable and was liability classified as of September 30, 2024 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. The fair value of the warrant was $565,582 on the issuance date and $257,492 at September 30, 2024. During the three and nine months ended September 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of $2,784 and $308,090 for this warrant.

 

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 12 - Stockholders’ Equity).

 

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

 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, 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
Expired			(25,586	)		$	13.00			$	13.00 - $13.00				—
Forfeited			—				—				—				—
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 summarizes the activity in liability classified warrants for the nine months ended September 30, 2023:

 

		Common Stock Warrants
		Shares				Weighted– Average Exercise Price				Range of Exercise Price				Weighted– Average Remaining Life (Years)
Total outstanding –December 31, 2022			76,992			$	76.72			$	66.00 - $82.50				3.9
Granted			—				—				—				—
Exercised			—				—				—				—
Expired			—				—				—				—
Forfeited			—				—				—				—
Total outstanding – September 30, 2023			76,992			$	76.72			$	66.00 - $82.50				3.16
Exercisable			76,992			$	76.72			$	66.00 - $82.50				3.16

 

15

 

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, 2024:

 SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES 

		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			—				—				—				—
Reclassified from equity			—				—				14,997				14,997
Gain on change in fair value of warrant liabilities			—				—				(361,137	)			(361,137	)
Balance as of September 30, 2024		$	—			$	—			$	274,042			$	274,042

 

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. There were no transfers of financial assets or liabilities between category levels for the three and nine months ended September 30, 2023.

 

The value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo simulation. 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, 2024 and 2023:

 SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES 

		September 30, 2024								September 30, 2023
		Actual				Weighted Average				Range				Weighted Average
Risk-free interest rate			3.61% — 3.61	%			3.61	%			4.523% — 5.401	%			4.83	%
Expected volatility (peer group)			119.5% — 119.5	%			119.5	%			57.9% — 134.5	%			108.41	%
Term of warrants (years)			4.41 — 4.41				4.41				0.14 — 4.73				3.16
Expected dividend yield			0.00	%			0.00	%			0.00	%			0.00	%

 

16

 

NOTE 8 — CONVERTIBLE DEBT

 

2022 Convertible Debenture (Related party)

 

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 $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, 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 and 12, 2023, we issued 16,832 shares of common stock upon Alpha’s partial voluntary conversion of the 2022 Debenture at a conversion price of $66.00 per share for a total of $1,111,078 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.

 

During the three and nine months ending September 30, 2023, we issued 0 and 16,832 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 $0 and $66.00 per share, respectively, and a weighted average fair value of $0 and $66.09 per share, respectively.

 

Commencing June 1, 2023 (the “Initial Monthly Redemption Date”) and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a “Monthly Redemption Date”), we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022 Debenture (the “Monthly Redemption Amount”). The Monthly Redemption Amount must be paid in cash; provided that after the first two monthly redemptions, we may elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i) the then 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 that is immediately before the applicable Monthly Redemption Date, subject to the Equity Conditions (as defined in the 2022 Debenture) having been satisfied or waived.

 

The 2022 Debenture accrued interest at the rate of 8% per annum, which did not begin accruing until December 1, 2023, and was payable on a monthly or quarterly basis. Interest may be paid in cash or shares of our common stock or a combination thereof at our option; provided that interest may only be paid in shares if the Equity Conditions have been satisfied or waived.

 

In December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, we entered into a registration rights agreement with Alpha (the “Registration Rights Agreement”), pursuant to which we 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 Registration Rights Agreement requires that the Company file, within 30 days after signing, a resale registration statement and use commercially reasonable efforts to cause the resale registration statement to be declared effective by the SEC on or before the 60^th calendar day following the date of signing of the Registration Rights Agreement (or 120 days if such registration statement is subject to full review by the SEC). We 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, we 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, we 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.

 

The proceeds from the 2022 Debenture were allocated to the initial fair value of the 2022 Warrant, with the residual balance allocated to the initial carrying value of the 2022 Debenture. The Company has not elected the fair value option for the 2022 Debenture. The 2022 Debenture was recognized as proceeds received after allocating the proceeds to the 2022 Warrant, and then allocating remaining proceeds to a suite of bifurcated embedded derivative features (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. The suite of derivative features was measured and determined to have no fair value.

 

The original issue discount of $0.3 million, the initial fair value of the 2022 Warrant of $2.8 million, the initial fair value of the suite of bifurcated embedded derivative features of $0, and the fees and costs paid to Alpha and other third parties of $0.1 million comprised the debt discount upon issuance. The debt discount is amortized to interest expense over the expected term of the 2022 Debenture using the effective interest method, in accordance with ASC 835-30. The debt host instrument of the 2022 Debenture will subsequently be measured at amortized cost using the effective interest method to accrete interest over its term to bring the 2022 Debenture’s initial carrying value to the principal balance at maturity.

 

17

 

On December 5, 2023, the Company and Alpha executed Amendment No. 1 with regard to Securities Purchase Agreement (the “SPA Amendment”), pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the 2022 Debenture from $66.00 per share to $36.50 per share and reduce the exercise price of the 2022 Warrant from $82.50 per share to $36.50 per share, in each case subject to certain adjustments. In addition, the SPA Amendment revised certain provisions of the 2022 Warrant to (i) limit the circumstances which would trigger a potential adjustment to the exercise price of the 2022 Warrant and (ii) clarify the treatment of the 2022 Warrant upon a Fundamental Transaction. The purpose of these revisions was to remove the terms that caused the 2022 Warrant to be liability-classified under U.S. GAAP. The Company performed an assessment and concluded that all remaining adjustment features in the revised language meet the FASB’s definition of a down-round feature. In addition, the 2022 Warrant was determined to meet all of the additional requirements for equity classification. Accordingly, as of December 5, 2023, the Company remeasured the 2022 Warrant to its fair value immediately prior to the modification and recognized the change in fair value in earnings. The incremental fair value impact from the 2022 Warrant modification of $0.09 million was included in the Company’s evaluation of the 2022 Debenture modification under ASC 470, discussed further below. The Company then reclassified the 2022 Warrant liability to equity at its post-modification fair value of $1.6 million.

 

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 and will be amortized to interest expense over the expected term of the Debenture using the effective interest method, in accordance with ASC 835-30.

 

During the three and nine months ended September 30, 2024, the Company recognized a gain of approximately $1,000, and a loss of approximately $124,000 respectively, upon debenture share redemptions, and recorded interest expense of approximately $28,000 and $162,000 (of which approximately $28,000 and $120,000 was attributable to discount accretion, respectively) for the three and nine months ended September 30, 2024 respectively, in other expenses in the condensed consolidated statements of operations related to the 2022 Debenture. As of September 30, 2024 and December 31, 2023, the fair value of the suite of bifurcated embedded derivative features related to the 2022 Debenture was $0.

 

During the three and nine months ended September 30, 2023, the Company recorded interest of approximately $368,000 and$1.3 million, respectively (of which approximately $350,000 and $1.2 million was attributable to discount amortization, respectively) in other expenses in the condensed consolidated statements of operations. As of September 30, 2023, the fair value of the Alpha Warrant was approximately $2.2 million, and the fair value of the suite of bifurcated embedded derivative features was $0.

 

On July 3, 2024 and July 5, 2024 Alpha voluntarily converted the remainder of the 2022 Debenture.

 

2024 Convertible Debenture (Related party)

 

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 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. Except in respect of an Exempt Issuance, the 2024 Alpha Debenture contains a “ratchet” antidilution provision, with a $5.82 per share floor. 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 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 noncompensatory equity classified 5-year common stock purchase warrant to purchase (at $13.00 per share) 18,001 shares of our common stock (see Note 12 - Stockholders Equity (Deficit)).

 

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 36,001 additional warrants).

 

On September 9, 2024 we issued 7,842 shares of common stock upon Alpha’s partial voluntary conversion of the 2024 Alpha Debenture at a conversion price of $6.50 per share for a total of $50,979 principal.

 

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 interest expense of approximately $165,000 and $403,000, respectively (of which approximately $154,000 and $376,000, respectively was attributable to discount accretion), and loss (gain) on change in derivative liabilities of approximately $151,000 and ($14,000), respectively in other expenses in the condensed consolidated statements of operations. As of September 30, 2024, the fair value of the suite of bifurcated embedded derivative features related to the 2024 Alpha Debenture was approximately $169,000.

 

 

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 $36.50 per share to $6.50 per share (see Note 7 - Warrant Liabilities and Note 12 - Stockholders Equity (Deficit).

 

18

 

2024 Convertible Debenture

 

In April 2024, Alpha assigned its option to Chen and Chen exercised the option in full, in exchange for $1,000,000, less expenses, we issued to Chen an 8% Convertible Debenture (the “2024 Chen Debenture”) with a principal amount of $1,100,000. The 2024 Chen Debenture matures no later than December 31, 2024 and was convertible, at any time, and from time to time, at Chen’s option, into shares of common stock of the Company, at $30.56 per share, subject to adjustment as described in the 2024 Chen Debenture. Except in respect of an Exempt Issuance, the 2024 Chen Debenture contains a “ratchet” antidilution provision, with a $5.82 per share floor. Upon the closing of the public offering on September 6, 2024 per the terms of the antidilution provision, the conversion price of the 2024 Chen Debenture was reduced from $30.56 to $6.50 per share. The 2024 Chen 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 Chen a 5-year liability classified common stock purchase warrant to purchase 36,001 shares of our common stock at $6.50 per share with an initial fair value of $565,582 (see Note 7 - Warrant Liabilities).

 

During the three and nine months ending September 30, 2024 in connection with the 2024 Chen Debenture, the Company recorded initial derivative liabilities with a fair value of $33,243, and recorded interest expense of approximately $32,000 and $60,000, respectively (of which approximately $10,000 and $18,000, respectively was attributable to discount accretion), and loss on change in derivative liabilities of approximately $345,000 and $335,000, respectively in other expenses in other expenses in the condensed consolidated statements of operations. As of September 30, 2024, the fair value of the suite of bifurcated embedded derivative features related to the 2024 Alpha Debenture was approximately $368,000. The fair value of the warrant issued in connection with the 2024 Chen Debenture was approximately $257,000 at September 30, 2024, and during the three and nine months ended September 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of approximately $2,784 and $308,090 for this warrant.

 

Convertible debt is comprised of the following as of September 30, 2024 and December 31, 2023:

 SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT 

		September 30, 2024				December 31, 2023
Convertible debt		$	1,100,000			$	—
Discount on convertible debt			(9,998	)			—
Total convertible debt		$	1,090,002			$	—

 

		September 30, 2024				December 31, 2023
Convertible debt - related party			499,021				1,418,922
Convertible debt			499,021				1,418,922
Discount on convertible debt - related party			(154,792	)			(119,706	)
Discount on convertible debt			(154,792	)			(119,706	)
Total convertible debt - related party		$	344,229			$	1,299,216
Total convertible debt		$	344,229			$	1,299,216

 

As of September 30, 2024, there were no events of default or violation of any covenants under our financing obligations.

 

The following table presents the Company’s fair value hierarchy for its derivative liabilities arising from the issuance of convertible debt measured at fair value on a recurring basis as of September 30, 2024:

 

 SCHEDULE OF DERIVATIVE LIABILITIES

Derivative Liabilities Arising From Issuance of Convertible Debt			Quoted Market Prices for Identical Assets (Level 1)				Significant Other Observable Inputs (Level 2)				Significant Unobservable Inputs (Level 3)				Total
Balance as of December 31, 2023		$	—			$	—			$	—			$	—
Granted			—				—				215,897				215,897
Loss on change in fair value of derivative liabilities			—				—				321,080				321,080
Balance as of September 30, 2024		$	—			$	—			$	536,977			$	536,977

 

The following are the weighted average and the range of assumptions used in estimating the fair value of derivative liabilities arising from the issuance of convertible debt as of September 30, 2024:

 

SCHEDULE OF RANGE OF ASSUMPTIONS USED IN ESTIMATING THE FAIR VALUE OF DERIVATIVE LIABILITIES

		September 30, 2024
		Actual				Weighted Average
Risk-free interest rate			4.79% — 4.79	%			4.79	%
Expected volatility (peer group)			139.5% — 139.5	%			139.5	%
Remaining term (years)			0.25 — 0.25				0.25
Expected dividend yield			0.00	%			0.00	%

 

NOTE 9 — EARNINGS (LOSS) PER SHARE

 

Basic loss per share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding. 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 stock options and warrants. The Company has included pre-funded warrants in its computation of basic net loss per share based on the nominal exercise price.

 

The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2024 and 2023 because their effect would be anti-dilutive:

 SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE 

		As of September 30,
		2024				2023
Shares of common stock subject to outstanding options			6,740				8,324
Shares of common stock subject to outstanding warrants			90,023				81,199
Shares of common stock subject to outstanding convertible debt			246,003				—
Total common stock equivalents			342,766				89,523

 

19

 

NOTE 10 — COMMITMENTS AND CONTINGENCIES

 

Litigation and Other Legal Proceedings

 

From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of September 30, 2024, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the results of the Company’s operations.

 

NOTE 11 — 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 of 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, 2024 and 2023, there were license costs of $0 and $12,000, and for the nine months ended September 30, 2024 and 2023, there were license costs of approximately $2,000 and $28,000, respectively, related to this agreement which are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

 

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.

 

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.

 

20

 

Sponsored research expenses related to these agreements for the three months ended September 30, 2024 and 2023 were $0 and $101,000, and for the nine months ended September 30, 2024 and 2023 were $0 and $657,000. License costs were approximately $22,000 and $18,000 related to these agreements for the three months ended September 30, 2024 and 2023, respectively, and approximately $76,000 and $47,000 related to these agreements for the nine months ended September 30, 2024 and 2023, 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.

 

Sponsored research expenses related to these agreements for the three months ended September 30, 2024 and 2023 were both $0, and for the nine months ended September 30, 2024 and 2023 were both $0, and are recorded in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs related to these agreements for the three months ended September 30, 2024 and 2023 were both $0, and for the nine months ended September 30, 2024 and 2023 were approximately $1,000 and $22,000, respectively, and are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.

 

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, on July 15, 2024, the Company advanced $1,250,000 to Marizyme, against which Marizyme had previously delivered a demand promissory note to the Company (see Note 4 - Short Term Note Receivable - Marizyme).

 

21

 

NOTE 12 — STOCKHOLDERS’ EQUITY

 

As of September 30, 2024 and December 31, 2023, 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, 2024, the Company has reserved 590,597 shares of authorized but unissued common stock for possible future issuance. At September 30, 2024, shares were reserved in connection with the following:

 SCHEDULE OF RESERVED SHARES 

Exercise of issued and future grants of stock options			15,114
Conversion of convertible debt			246,004
Exercise of stock warrants			329,479
Total			590,597

 

Preferred Stock

 

At September 30, 2024 and December 31, 2023, there were no shares of preferred stock outstanding.

 

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, 2024 and December 31, 2023, there were 6,739 and 7,978 outstanding stock options, respectively, under the 2020 Plan and on such dates there were 8,375 and 7,136 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, 2024, 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, 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 was approximately $119,000 and $1.0 million of compensation cost related to outstanding stock options for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, there was approximately $19,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 0.58 years.

 

22

 

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.

 

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:

 SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE 

		2024				2023				2024				2023
		For the Three Months Ended September 30,								For the Nine Months Ended September 30,
		2024				2023				2024				2023
General and administrative		$	27,208			$	73,384			$	94,264			$	881,365
Research and development			—				40,417				24,680				140,674
Total		$	27,208			$	113,801			$	118,944			$	1,022,039

 

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 7- Warrant Liabilities.

 

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 and comprehensive loss. On September 6, 2024 as a result of a down-round provision triggered by shares sold in the public offering, these 1,353 warrants were repriced again from $13.50 per share exercise price to $6.50 per share exercise price. The increase in fair value of $2,299 for the modification of these warrants was charged to general and administrative expenses in the Company’s condensed consolidated statements of operations and comprehensive loss.

 

23

 

No compensatory warrants were issued during the three and nine months ended September 30, 2024 and September 30, 2023.

 

The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2024:

 SCHEDULE OF COMPENSATORY WARRANT ACTIVITY 

		Common Stock
		Shares				Weighted– Average Exercise Price				Range of Exercise Price				Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2023			2,381			$	534.44			$	36.50—$1,270.25				1.25
Granted			—				—				—				—
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			—				—				—				—

 

The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2023:

 

		Common Stock
		Shares				Weighted– Average Exercise Price				Range of Exercise Price				Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2022			3,581			$	455.88			$	66.00 — $1,270.25				1.73
Exercised			—				—				—				—
Expired			(1,200	)		$	300.00			$	300.00 — $300.00				—
Forfeited			—				—				—				—
Total outstanding – September 30, 2023			2,381			$	534.44			$	66.00 — $1,270.25				1.50
Exercisable			2,381			$	534.44			$	66.00 — $1,270.25				1.50
Non-Exercisable			—				—				—				—

 

There was approximately $2,000 and $12,000 in compensation cost related to outstanding equity classified compensatory warrants for the three and nine months ended September 30, 2024 respectively, and $0 for both the three and nine months ended September 30, 2023. As of September 30, 2024 and September 30, 2023, there was no unrecognized compensation cost related to nonvested warrants.

 

Noncompensatory Equity Classified Warrants

 

On May 22, 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha (a related party) for the purchase of common stock. 141 of these warrants remain outstanding and exercisable as of September 30, 2024 and may be exercised in whole or in part, at any time before May 22, 2025. 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.

 

24

 

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 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 in the condensed consolidated statements of changes in stockholders’ equity.

 

On September 6, 2024, upon the closing of a public offering, the Company issued pre-funded warrants to purchase 239,456 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. No pre-funded warrants were exercised during the three or nine months ending September 30, 2024.

 

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

 

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).

 

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

 SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY 

		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

 

25

 

The following table summarizes the non compensatory equity classified warrant activity for the nine months ended September 30, 2023:

 

		Common Stock
		Shares				Weighted– Average Exercise Price				Range of Exercise Price				Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2022			10,941			$	987.97			$	66.00 — $1,000.00				0.33
Granted			—				—				—				—
Exercised			—				—				—				—
Expired			(9,114	)		$	1,000.00			$	1,000.00 — $1,000.00				—
Forfeited			—				—				—				—
Total outstanding – September 30, 2023			1,827			$	927.91			$	66.00—$1,000.00				0.33
Exercisable			1,827			$	927.91			$	66.00—$1,000.00				0.33
Non-Exercisable			—				—				—				—

 

NOTE 13 — RELATED PARTY TRANSACTIONS

 

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 nine months ended September 30, 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 nine months ended September 30, 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. As of September 30, 2024 this Debenture had a remaining principal balance of $499,021, and was convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company, at a price equal to $6.50 per share, subject to adjustment as described in the Debenture and other terms and conditions described in the Debenture.

 

See Note 8 – 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. As of September 30, 2024, 141 of these warrants remain outstanding and exercisable, and may be exercised in whole or in part, at any time before May 22, 2025. During the three and nine months ended September 30, 2024 and September 30, 2023, there were no exercises of this warrant.

 

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. As of September 30, 2024, the exercise price of this warrant was $6.50. 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 three and nine months ended September 30, 2024, Alpha partially exercised this warrant to purchase 20,460 and 31,998 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 $416,000. During the three and nine months ended September 30, 2023, there were no exercises of this warrant.

 

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. This warrant may be exercised by Alpha, in whole or in part, at any time before February 27, 2029, subject to certain terms and conditions described in the warrant. During the three and nine months ended September 30, 2024, there were no exercises of this warrant.

 

As of September 30, 2024, the exercise price of all of the above warrants issued to Alpha was $6.50.

 

The above warrants are included in equity on the Company’s condensed consolidated balance sheets (see Note 12 – Stockholders’ Equity (Deficit)), except for 2,314 shares of the warrant issued on February 27, 2024, which was reclassified to liabilities as of September 30, 2024, until shareholder approval is obtained for the company to issue the shares (see Note 7 - Warrant Liabilities).

 

NOTE 14 — SUBSEQUENT EVENTS

 

Annual Shareholder Meeting

 

On October 9, 2024, the nominating committee of the Board of Directors (the “Board”) nominated Braeden Lichti as a board member. At the Annual Shareholder Meeting on October 27, 2024, Mr. Lichti along with all other board member nominees was elected to serve as a director until the Company’s annual meeting of stockholders in 2025, or until such person’s successor is duly elected and qualified or until such person’s earlier resignation, death, or removal. All other proposals in the Company’s proxy were also approved.

 

Reverse Stock Split

 

On October 28, 2024, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended with the Secretary of State of the State of Delaware to effect a 1-for-50 reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding Common Stock, effective November 5, 2024 at 12:01 a.m., Eastern Time (the “Effective Time”). The Reverse Stock Split was approved by the Company’s stockholders at the Company’s reconvened annual meeting of stockholders held on October 25, 2024, at a ratio of not less than 1-for-10 and not greater than 1-for-50, with the exact ratio, if approved and effected at all, to be set within that range at the discretion of the board of directors. On October 25, 2024, the Board of Directors approved a ratio of 1-for-50 for the Reverse Stock Split. The Amendment provides that at the Effective Time, every 50 shares of the Company’s issued and outstanding Common Stock immediately prior to the Effective Time, will automatically be reclassified, without any action on the part of the holder thereof, into one share of Common Stock. No fractional shares will be issued as a result of the Reverse Stock Split. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof. Equiniti Trust Company is acting as exchange agent for the Reverse Stock Split and will send instructions to stockholders of record who hold stock certificates regarding the exchange of certificates for Common Stock, should they wish to do so. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take any action to effect the exchange of their shares. Commencing on November 5, 2024, trading of the Company’s Common Stock will continue on the Nasdaq Capital Stock Market on a reverse stock split-adjusted basis. The new CUSIP number for the Company’s Common Stock following the Reverse Stock Split is 74754R301.

 

New Chairperson of the Audit Committee and Independent Member of the Board

 

On October 8, 2024, the Board of Directors (the “Board”) appointed Braeden Lichti as an independent member of the Board, effective immediately. On October 8, 2024, the Board appointed Robert Lim as the chairperson of the Audit Committee, effective immediately.

 

 

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, 2023, which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on April 5, 2024. 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).

 

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. QN-302 is undergoing a Phase 1a clinical trial at START Midwest in Grand Rapids, Michigan, and HonorHealth in Scottsdale, Arizona.

 

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.

 

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.

 

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 $1,750,000 of Funding Payments to Marizyme (inclusive of a $1,250,000 demand promissory note dated July 15, 2024 which bears interest at 18% per annum).

 

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 entitles 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 $1,250,000 to Marizyme, Inc., a Nevada corporation (“Marizyme”), against which Marizyme had previously delivered its demand promissory note to the Company of like principal amount dated July 12, 2024 (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.

 

 

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. Before the third quarter of 2023, our reported expenses represented the total of our diagnostics-related and therapeutics-related expenses. In this Quarterly Report, all diagnostics-related revenues and expenses have been reclassified to discontinued operations (See Note 5 - Discontinued Operations).

 

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 impairment of goodwill and other intangible assets, fair value of 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:

 

	●	Research and development
	●	Discontinued operations
	●	Derivative financial instruments and warrant liabilities
	●	Stock-based compensation
	●	Income taxes

 

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, 2024.

 

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.

 

 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2024 and 2023

 

The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:

 

		For the Three Months September 30,
		2024				2023
EXPENSES
General and administrative		$	1,145,152			$	1,336,765
Research and development			123,429				1,441,598
Total expenses			1,268,581				2,778,363
LOSS FROM OPERATIONS			(1,268,581	)			(2,778,363	)
OTHER EXPENSE (INCOME), NET
(Gain) loss on change in fair value of warrant liabilities			(1,231	)			101,112
Loss on change in fair value of derivative liabilities			495,693				—
Interest expense			408,359				367,257
Interest income			(48,082	)			—
Loss on voluntary conversion of convertible debt into common stock			27,790				—
Gain on settlements of accounts payable			(348,305	)			—
Loss on fixed asset disposal			—				21,747
Other income, net			(6,547	)			(33,454	)
Total other expense (income), net			527,677				456,662
LOSS BEFORE PROVISION FOR INCOME TAXES			(1,796,258	)			(3,235,025	)
(BENEFIT) PROVISION FOR INCOME TAXES			(2,198	)			—
NET LOSS FROM CONTINUING OPERATIONS			(1,794,060	)			(3,235,025	)
DISCONTINUED OPERATIONS
Income from discontinued operations, net of tax			—				159,507
Loss on disposal of discontinued operations, net of tax							(619,545	)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS			—				(460,038	)
NET LOSS			(1,794,060	)			(3,695,063	)
Net loss attributable to non-controlling interest from discontinued operations			—				(38,526	)
Net loss available to Qualigen Therapeutics, Inc.		$	(1,794,060	)		$	(3,656,537	)
Deemed dividend arising from warrant down-round provision		$	(27,587	)		$	—
Net loss attributable to Qualigen Therapeutics, Inc			(1,821,647	)			(3,656,537	)
Net loss per common share, basic and diluted - continuing operations		$	(4.70	)		$	(32.01	)
Net loss per common share, basic and diluted - discontinued operations		$	—			$	(4.17	)
Total net loss per common share, basic and diluted		$	(4.70	)		$	(36.18	)
Weighted—average number of shares outstanding, basic and diluted			387,878				101,049
Other comprehensive loss, net of tax
Net loss		$	(1,794,060	)		$	(3,695,063	)
Foreign currency translation adjustment from discontinued operations			—				(56,747	)
Other comprehensive loss			(1,794,060	)			(3,751,810	)
Comprehensive loss attributable to noncontrolling interest from discontinued operations			—				(38,526	)
Comprehensive loss attributable to Qualigen Therapeutics, Inc.		$	(1,794,060	)		$	(3,713,284	)

 

 

Expenses

 

General and Administrative Expenses

 

General and administrative expenses decreased from $1.3 million for the three months ended September 30, 2023, to $1.1 million for the three months ended September 30, 2024, a decrease of $0.2 million or 15%. This is primarily due to decreases in payroll of $0.2 million, professional fees of $0.1 million and insurance of $0.1 million offset by an increase in investor relations expenses of $0.2 million.

 

Research and Development Costs

 

Research and development expenses decreased from $1.4 million for the three months ended September 30, 2023, to $0.1 million for the three months ended September 30, 2024, a decrease of $1.3 million or 91%. This was primarily due to decreases in QN-302 program expenses of $0.8 million, a decrease in RAS program expenses of $0.2 million, a decrease in payroll of $0.2 million and a decrease in stock-based compensation of $0.1 million.

 

Other Expense (Income), Net

 

Gain on Change in Fair Value of Warrant Liabilities

 

During the three months ended September 30, 2024 and 2023, we experienced a gain of approximately $1,000 and a loss of approximately $0.1 million, respectively, on change in fair value of warrant liabilities, primarily due to changes in our stock price and expiration of warrants during the current 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 30, 2024 we experienced a gain of approximately $0.5 million on change in fair value of derivative liabilities, compared to $0 for the three months ended September 30, 2023. The fair value of derivative liabilities declined during the current period due to changes in our stock price and a reduction in the remaining term of the underlying instruments. Derivative liabilities in the prior period had no fair value.

 

Interest Expense, Net

 

Interest expense during the three months ended September 30, 2024 and September 30, 2023 remained the same.

 

Loss on Voluntary Conversion of Convertible Debt Into Common Stock

 

During the three months ended September 30, 2024, we issued 30,378 shares of common stock with a fair value of approximately $394,000, upon Alpha’s partial voluntary conversion of the 2022 Alpha Debenture at a weighted average share price of $13.00. Upon conversion to shares, we recognized a gain on voluntary conversion of convertible debt into common stock of approximately $1,000.

 

In addition, we issued 7,842 shares of common stock with a fair value of approximately $61,000, upon Alpha’s partial voluntary conversion of the 2024 Alpha Debenture at a weighted average share price of $6.50. Upon conversion to shares, we recognized a loss on voluntary conversion of convertible debt into common stock of approximately $29,000.

 

There were no voluntary conversions of convertible debt for the three months ended September 30, 2023.

 

Gain on Settlements of Accounts Payable

 

During the three months ended September 30, 2024, we settled $395,000 of our outstanding accounts payable for a gain of $348,000. No such events in 2023.

 

Other Income, Net

 

Other income, net was immaterial during the three months ended September 30, 2024 and 2023.

 

 

Discontinued Operations

 

Income from discontinued operations during the three months ended September 30, 2024 was $0 compared to loss from discontinued operations of approximately $160,000 during the three months ended September 30, 2023. Of the $160,000 income from discontinued operations during the three months ended September 30, 2023, approximately $91,000 was due to net income from our former Qualigen, Inc. subsidiary, and $69,000 in income from NanoSynex, inclusive of a $150,000 benefit in provision for income taxes. The $912,000 loss from discontinued operations during the three months ended September 30, 2022 consisted of approximately $422,000 from our former Qualigen, Inc. subsidiary and approximately $489,000 from NanoSynex.

 

In addition, the Company recorded a loss of approximately $0.6 million on disposal of discontinued operations during the three months ended September 30, 2023, and $0 during the three months ended September 30, 2024. The loss during the three months ended September 30, 2023 consisted of approximately $4.5 million from deconsolidation of NanoSynex, offset by a gain of approximately $3.9 million from the sale of the Company’s former Qualigen, Inc. subsidiary.

 

Comparison of the Nine Months Ended September 30, 2024 and 2023

 

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

 

Expenses

 

		For the Nine Months September 30,
		2024				2023
EXPENSES
General and administrative		$	3,186,575			$	5,132,834
Research and development			1,242,101				3,898,061
Total expenses			4,428,676				9,030,895
LOSS FROM OPERATIONS			(4,428,676	)			(9,030,895	)
OTHER EXPENSE (INCOME), NET
Gain on change in fair value of warrant liabilities			(361,137	)			(1,377,855	)
Loss on change in fair value of derivative liabilities			321,080				—
Interest expense			808,477				1,288,908
Interest income			(48,082	)			—
Loss on issuance of convertible debt			358,279				—
(Gain) loss on voluntary conversion of convertible debt into common stock			(56,010	)			1,077,287
Loss on monthly redemptions of convertible debt into common stock			208,852				—
Gain on settlements of accounts payable			(348,305	)			—
Loss on fixed asset disposal			—				21,747
Other income, net			(9,262	)			(33,534	)
Total other expense (income), net			873,891				976,553
LOSS BEFORE PROVISION FOR INCOME TAXES			(5,302,568	)			(10,007,448	)
(BENEFIT) PROVISION FOR INCOME TAXES			800				—
NET LOSS FROM CONTINUING OPERATIONS			(5,303,368	)			(10,007,448	)
DISCONTINUED OPERATIONS
Loss from discontinued operations, net of tax			—				(683,008	)
Loss on disposal from discontinued operations, net of tax			(100,000	)			(619,545	)
LOSS FROM DISCONTINUED OPERATIONS			(100,000	)			(1,302,553	)
NET LOSS			(5,403,368	)			(11,310,001	)
Net loss attributable to non-controlling interest from discontinued operations			—				(343,038	)
Net loss available to Qualigen Therapeutics, Inc.		$	(5,403,368	)		$	(10,966,963	)
Deemed dividend arising from warrant down-round provision		$	(87,604	)		$	—
Net loss attributable to Qualigen Therapeutics, Inc			(5,490,972	)			(10,966,963	)
Net loss per common share, basic and diluted - continuing operations		$	(24.48	)		$	(99.64	)
Net loss per common share, basic and diluted - discontinued operations		$	(0.45	)		$	(9.55	)
Total net loss per common share, basic and diluted		$	(24.93	)		$	(109.19	)
Weighted—average number of shares outstanding, basic and diluted			220,221				100,434
Other comprehensive loss, net of tax
Net loss		$	(5,403,368	)		$	(11,310,001	)
Foreign currency translation adjustment from discontinued operations			—				(50,721	)
Other comprehensive loss			—				(11,360,722	)
Comprehensive loss attributable to noncontrolling interest from discontinued operations			(5,403,368	)			(343,038	)
Comprehensive loss attributable to Qualigen Therapeutics, Inc.		$	—			$	(11,017,684	)

 

 

General and Administrative Expenses

 

General and administrative expenses decreased from approximately $5.1 million, during the nine months ended September 30, 2023 to approximately $3.2 million during the nine months ended September 30, 2024, a decrease of approximately $1.9 million or 38%. This decrease was primarily due to a $0.8 million decrease in stock-based compensation expense, $0.7 million decrease in payroll expenses, a $0.5 million decrease in professional fees, and a $0.1 million decrease in insurance, offset by an increase in investor relations expenses of $0.2 million.

 

Research and Development Costs

 

Research and development expenses decreased from approximately $3.9 million for the nine months ended September 30, 2023, to approximately $1.2 million for the nine months ended September 30, 2024, a decrease of $2.7 million or 68%. This was primarily due to an decrease in QN-302 program costs of $2.0 million, a decrease in RAS program expenses of $0.8 million, a decrease in wages of $0.4 million, a decrease in stock-based compensation of $0.1 million and a decrease in legal expenses of $0.1 million, offset by an increase of $0.7 million in expenses under the Marizyme co-development agreement.

 

Other Expense (Income), Net

 

Gain on Change in Fair Value of Warrant Liabilities

 

During the nine months ended September 30, 2024 and 2023, we experienced a gain of approximately $0.4 million, and a gain of approximately $1.4 million, respectively, on change in fair value of warrant liabilities, primarily due to changes in our stock price and expiration of warrants during the current 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.

 

Loss on Change in Fair Value of Derivative Liabilities

 

During the nine months ended September 30, 2024, we experienced a loss of approximately $0.3 million on change in fair value of derivative liabilities, compared to $0 for the nine months ended September 30, 2023. The fair value of derivative liabilities declined during the current period due to changes in our stock price and a reduction in the remaining term of the underlying instruments. Derivative liabilities in the prior period had no fair value.

 

Interest Expense

 

Interest expense during the nine months ended September 30, 2024 was approximately $0.8 million, compared to interest expense of approximately $1.3 million during the nine months ended September 30, 2023, The decrease was primarily due to reduced accretion of discount on convertible debt during the current period.

 

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.

 

(Gain) Loss on Voluntary Conversion of Convertible Debt Into Common Stock

 

During the nine months ended September 30, 2024, we issued 58,378 shares of common stock with a fair value of approximately $674,000, upon partial voluntary conversion of the 2022 Alpha Debenture at a weighted average share price of $13.00. Upon redemption in shares, we recognized a gain on voluntary conversion of convertible debt into common stock of approximately $85,000.

 

During the nine months ended September 30, 2024, we issued 7,842 shares of common stock with a fair value of approximately $61,000, upon Alpha’s partial voluntary conversion of the 2024 Alpha Debenture at a weighted average share price of $6.50. Upon conversion to shares, we recognized a loss on voluntary conversion of convertible debt into common stock of approximately $29,000.

 

During the nine months ended September 30, 2023, we recognized a $1.1 million loss due to a voluntary conversion by Alpha Capital of approximately $1.1 million of convertible debt into 16,834 shares of common stock.

 

Loss on Monthly Redemptions of Convertible Debt into Common Stock

 

During the nine months ended September 30, 2024, we issued 45,496 shares of common stock with a fair value of approximately $903,000, in lieu of cash for monthly redemptions of $660,000 principal and approximately $34,000 accrued interest redeemed, pursuant to the terms of the 2022 Alpha Debenture at a weighted average share price of $14.51. Upon redemption in shares, we recognized a loss on monthly redemptions of convertible debt into common stock of approximately $209,000.

 

 

Gain on Settlements of Accounts Payable

 

During the three months ended September 30, 2024, we settled $395,000 of our outstanding accounts payable for a gain of $348,000. No such events in 2023.

 

Loss on Fixed Asset Disposal

 

Loss on fixed asset disposal during the nine months ended September 30, 2024 was $0, compared to approximately $22,000 due to a write off of equipment during the nine months ended September 30, 2023.

 

Other Income, Net

 

Other income, net was immaterial during the nine months ended September 30, 2024 and 2023.

 

Discontinued Operations

 

There was a loss from discontinued operations of $0.1 million during the nine months ended September 30, 2024, compared to a loss from discontinued operations of approximately $0.7 million during the nine months ended September 30, 2023. The $0.1 million loss from discontinued operations during the nine months ended September 30, 2024 was generated from the early settlement of an escrow account from the sale of Qualigen, Inc. The $0.7 million loss from discontinued operations during the nine months ended September 30, 2023 consisted of approximately $0.2 million from our former Qualigen, Inc. subsidiary and approximately $0.5 million from NanoSynex.

 

In addition, the Company recorded a loss of approximately $0.6 million on disposal of discontinued operations during the nine months ended September 30, 2023, and $0 during the nine months ended September 30, 2024. This loss consisted of approximately $4.5 million from deconsolidation of NanoSynex, offset by a gain of approximately $3.9 million from the sale of our former Qualigen, Inc. subsidiary (See Note 5 - Discontinued Operations).

 

Liquidity and Capital Resources

 

As of September 30, 2024, we had approximately $338,000 in cash and an accumulated deficit of $122.2 million. For the nine months ended September 30, 2024 and year ended December 31, 2023, we used cash of $4.0 million and $11 million, respectively, in operations.

 

We currently expect our cash balances to fund operations into the fourth quarter of 2024. We expect to continue to have net losses and negative cash flow from operations, which will challenge our liquidity. 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. There is no assurance that we will ever achieve profitable operations, or, if achieved, could be sustained on a continuing basis.

 

Historically, our principal sources of cash have, in addition to previous revenue from product sales and license revenues from the FastPack product of line of Qualigen, Inc. (which we divested in July 2023), included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt. There can be no assurance that further financing can be obtained on favorable terms, or at all. If we are unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, and we could be unable to continue operations.

 

During the nine months ended September 30, 2024 we raised approximately $1.5 million less expenses, in convertible debt. In February 2024 we issued to Alpha Capital Anstalt (“Alpha”) an 8% Convertible Debenture (the “2024 Alpha Debenture”) with a principal amount of $550,000; in connection with this issuance, we also issued to Alpha a 5-year common stock purchase warrant to purchase (at $13.00 per share) 18,001 shares of our common stock. 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 36,001 additional warrants). In April 2024, Alpha assigned this option to Yi Hua Chen (“Chen”) and Chen exercised the option in full; in exchange for $1,000,000 (less expenses) we issued to Chen an 8% Convertible Debenture with a principal amount of $1,100,000; in connection with this issuance, we also issued to Chen a 5-year common stock purchase warrant to purchase 0 per share) 36,001 shares of our common stock with an exercise price of $6.50 as of September 30, 2024.

 

 

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. In addition, any future financing (depending on the terms and conditions) may be subject to the approval of Alpha and Chen under the terms of the Debentures and/or trigger certain adjustments to the Debentures or warrants held by Alpha and Chen.

 

In June 2024, by way of a negotiated early release of escrow, we received $350,000 from the $450,000 escrow account established in connection with our July 2023 sale of Qualigen, Inc. The escrow account had originally been subject to release in January 2025. In exchange for the early release, $100,000 from the escrow account was paid to Chembio Diagnostics, Inc., the buyer of Qualigen, Inc.

 

The Company and an institutional investor entered into a Securities Purchase Agreement dated July 5, 2024 (the “Agreement”), providing for the Company to issue to the investor at par an unsecured, nonconvertible $2,000,000 18% senior note (the “Senior Note”) with a scheduled maturity date of July 8, 2025. The Senior Note includes a requirement for partial prepayments from a percentage of any future Company financings. Otherwise, principal and interest on the Senior Note is not payable until maturity. On July 12, 2024, the investor funded the $2,000,000 loan to the Company and the Company issued the Senior Note to the investor.

 

Delisting of our common stock from Nasdaq would have a serious negative effect on any future financing efforts. A hearing before a Nasdaq Hearing Panel was held on July 16, 2024. On August 2, 2024, the Company received the Panel decision which granted the Company an extension until November 19, 2024 to regain compliance with the Bid Price Rule and the Equity Rule. If the Company is unable to regain compliance with the listing standards of Nasdaq by November 19, 2024, the Company’s securities may be delisted from The Nasdaq Stock Market.

 

The accompanying financial statements have been prepared assuming that we will continue as a going concern. The financial statements do not include any adjustments that would be necessary should we 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.

 

Our current liabilities at September 30, 2024 include approximately $1.6 million of accounts payable, $1.9 million of convertible debt and derivative liabilities, $0.6 million of accrued expenses and other current liabilities, $0.3 million in warrant liabilities.

 

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).

 

NanoSynex Funding Agreement

 

As a condition to our acquisition of a majority voting equity interest in NanoSynex from Alpha and NanoSynex, we entered into a Master Agreement for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”), on May 26, 2022, pursuant to which we agreed to fund NanoSynex up to an aggregate of approximately $10.4 million, subject to NanoSynex’s achievement of certain performance milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement.

 

On July 20, 2023, we entered into the NanoSynex Amendment, which amended the Funding Agreement, pursuant to which the Company agreed to, among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held by the Company, resulting in our ownership in NanoSynex being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex. In addition, we agreed to cancel approximately $3.0 million of promissory notes which NanoSynex had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment obligations to us with respect to such notes. The surrender of shares reducing our interest in NanoSynex from approximately 52.8% to approximately 49.97% occurred on July 20, 2023. Accordingly, NanoSynex was deconsolidated from our financial statements as of July 20, 2023, and is reported as Discontinued Operations in this Quarterly Report.

 

The NanoSynex Amendment superseded any payment obligations contemplated by the original Funding Agreement and amended our obligations to provide funding to NanoSynex, except we agreed to provide future funding as follows: (i) $560,000 on or before November 30, 2023, and (ii) $670,000 on or before March 31, 2024, in each case issued in the form of a promissory note to the Company with a face value in the amount of such funding. However, on November 22, 2023, in full settlement of any additional funding obligations to NanoSynex, we forfeited certain of our shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex from approximately 49.97% to 39.90%. Our investment in NanoSynex will be accounted as an equity method investment prospectively from the July 20, 2023 deconsolidation date.

 

 

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, Inc., a Nevada corporation (“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”). 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,
		2024				2023
Net cash (used in) provided by:
Operating activities		$	(4,057,980	)		$	(4,632,677	)
Investing activities			(900,000	)			3,980,541
Financing activities			4,944,329				(440,000	)
Effect of exchange rate on cash			—				—
Net decrease in cash and restricted cash		$	(13,651	)		$	(1,092,136	)

 

Net Cash Used in Operating Activities

 

During the nine months ended September 30, 2024, operating activities used $4.0 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 $0.4 million loss on issuance of convertible debt, $0.1 million in stock-based compensation expense, $0.4 million in accretion of discount on convertible debt, $0.2 million loss on monthly redemptions of convertible debt into common stock, a $0.3 million loss on change in fair value of derivative liabilities, and a $0.6 million decrease in prepaid expenses and other assets 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 gain on change in fair value of warrant liabilities, a $0.1 million gain on voluntary conversion of convertible debt into common stock and a $0.6 million decrease in accounts payable.

 

During the nine months ended September 30, 2023, operating activities used $4.6 million of cash, primarily resulting from a loss from continuing operations of $10.0 million. Cash flows from operating activities for the nine months ended September 30, 2023 were positively impacted by adjustments for a $1.1 million non cash loss on voluntary conversion of convertible debt, accretion of discount of $1.2 million on convertible debt, $1.0 million in stock-based compensation expense, a $1.0 million increase in accounts payable, a $0.4 million increase in accrued expenses and other current liabilities, and cash provided by discontinued operations of $2.6 million. Cash flows from operating activities for the nine months ended September 30, 2023 were negatively impacted by adjustments for a $1.4 million decrease in fair value of warrant liabilities and a $0.6 million increase in prepaid expenses and other assets.

 

 

Net Cash Provided by (Used in) Investing Activities

 

During the nine months ended September 30, 2024, net cash provided by investing activities resulting from advances to Marizyme of $1.3 million and the disposal of discontinued operations was $0.4 million, due to the early release of escrow from the sale of Qualigen, Inc.

 

During the nine months ended September 30, 2023, net cash provided by investing activities was approximately $4.0 million from discontinued operations, due to $4.7 million in proceeds received from the sale of Qualigen, Inc., offset by $0.5 million advanced to NanoSynex, and $0.2 million in purchases of property and equipment prior to deconsolidation.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities for the nine months ended September 30, 2024 was $4.9 million, of which $3.0 million was resulting from the proceeds from issuance of common shares and prefunded warrants in public offering, $1.5 million was due to issuances of convertible debt, and $0.4 million was due to warrant exercises.

 

Net cash used in financing activities for the nine months ended September 30, 2023 was approximately $0.4 million, due to monthly redemption payments on convertible notes payable.

 

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

 

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024, the end of the period covered by this Quarterly Report.

 

Based on this evaluation, our principal executive officer and principal financial officer have concluded that, due to the material weakness described below, our disclosure controls and procedures as of September 30, 2024 were not effective to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act’), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. We believe that a disclosure controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the disclosure controls system are met, and no evaluation of disclosure controls can provide absolute assurance that all disclosure control issues, if any, within a company have been detected.

 

Changes in Internal Control over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act. Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with U.S. GAAP. As of December 31, 2023, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework, or 2013 Framework. In connection with the audit of our financial statements as of and for the year ended December 31, 2023, we identified material weaknesses related to a lack of sufficient number of personnel within our accounting function to adequately segregate duties, and we have not designed and implemented effective Information Technology General Controls (“ITGC”) related to access controls to financial accounting systems. We lack the resources to employ additional personnel to help mitigate these material weaknesses and we foresee that these material weaknesses will not be remediated until we receive additional funding to support our accounting department. We cannot assure you that these or other measures will fully remediate the material weakness in a timely manner.

 

There was no change in our internal control over financial reporting in the third quarter of 2024.

 

Notwithstanding the identified material weakness, our management believes that the condensed consolidated financial statements included in this Quarterly Report fairly represent in all material respects our financial condition, results of operations and cash flows at and for the periods presented in accordance with U.S. GAAP. Nonetheless, we also believe that an internal control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the internal control system are met, and no evaluation of internal control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company are detected.

 

 

PART II - OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

We are not currently involved in any legal matters. 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.

 

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 2023 Annual Report 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. Except as described below, there have been no material changes to the Company’s risk factors since the 2023 Annual Report.

 

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

 

Unregistered Sales of Equity Securities

 

During the nine months ended September 30, 2024, we issued to Alpha Capital Anstalt 64,312 shares of unregistered common stock for monthly redemptions and voluntary conversions of $807,901 principal and $24,532 accrued interest redeemed, pursuant to the terms of the 2022 Debenture at a weighted average share price of $12.94.

 

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

 

None

 

 

ITEM 6. EXHIBITS

 

				Incorporated by Reference
Exhibit No.		Description		Form		File No.		Exhibit		Filing Date
2.1		Contingent Value Rights Agreement, dated May 22, 2020, among the Company, John Beck in the capacity of CVR Holders’ Representative and Andrew J. Ritter in his capacity as a consultant to the Company.		8-K		001-37428		2.4		5/29/2020
3.1		Amended and Restated Certificate of Incorporation		8-K		001-37428		3.1		7/1/2015
3.2		Certificate of Amendment to the Amended and Restated Certificate of Incorporation		8-K		001-37428		3.1		9/15/2017
3.3		Certificate of Amendment to the Amended and Restated Certificate of Incorporation		8-K		001-37428		3.1		3/22/2018
3.4		Certificate of Amendment to the Amended and Restated Certificate of Incorporation		8-K		001-37428		3.1		11/1/2024
3.5		Certificate of Designation of Preferences, Rights and Limitations of Series Alpha Preferred Stock of the Company, filed with the Delaware Secretary of State on May 20, 2020		8-K		001-37428		3.1		5/29/2020
3.6		Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [reverse stock split]		8-K		001-37428		3.2		5/29/2020
3.7		Certificate of Merger, filed with the Delaware Secretary of State on May 22, 2020		8-K		001-37428		3.3		5/29/2020
3.8		Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [name change]		8-K		001-37428		3.4		5/29/2020
3.9		Amended and Restated Bylaws of the Company, through August 10, 2021		10-Q		001-37428		3.1		8/13/2021
3.10		Certificate of Amendment to the Amended and Restated Certificate of Incorporation, as amended		8-K		001-37428		3.1		11/22/2022
4.1		Warrant, issued by the Company in favor of Alpha Capital Anstalt, dated May 22, 2020		8-K		001-37428		10.13		5/29/2020
4.2		Form of Warrant, issued by the Company in favor of GreenBlock Capital LLC and its designees, dated May 22, 2020 [post-Merger]		8-K		001-37428		10.10		5/29/2020
4.3		Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated July 10, 2020		8-K		001-37428		10.2		7/10/2020
4.4		Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated August 4, 2020		8-K		001-37428		10.3		8/4/2020
4.5		“Two-Year” Common Stock Purchase Warrant for 1,348,314 shares in favor of Alpha Capital Anstalt, dated December 18, 2020		8-K		001-37428		10.3		12/18/2020

 

 

4.6		“Deferred” Common Stock Purchase Warrant for 842,696 shares in favor of Alpha Capital Anstalt, dated December 18, 2020		8-K		001-37428		10.4		12/18/2020
4.7		Form of liability classified Warrant to Purchase Common Stock		10-K		001-37428		4.13		3/31/2021
4.8		Form of “service provider” compensatory equity classified Warrant		10-K		001-37428		4.14		3/31/2021
4.9		Description of Common Stock		10-K/A		001-37428		4.9		7/7/2023
4.10		Amended and Restated Common Stock Purchase Warrant to GreenBlock Capital LLC, dated April 25, 2022		10-Q		001-37428		4.15		5/13/2022
4.11		Amended and Restated Common Stock Purchase Warrant to Christopher Nelson, dated April 25, 2022		10-Q		001-37428		4.16		5/13/2022
4.12		Common Stock Purchase Warrant for 2,500,000 shares in favor of Alpha Capital Anstalt, dated December 22, 2022		8-K		001-37428		4.1		12/22/2022
4.13		Common Stock Purchase Warrant for 900,016 shares in favor of Alpha Capital Anstalt, dated February 27, 2024		8-K		001-37428		10.3		2/27/2024
4.14		Form of Pre-Funded Warrant		8-K		001-37428		4.1		9/9/2024
4.15		Form of Placement Agent Warrant		8-K		001-37428		4.2		9/9/2024
10.1		Securities Purchase Agreement dated July 5, 2024		8-K		001-37428		10.1		7/11/2024
10.2		Securities Purchase Agreement dated July 5, 2024. (Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed July 11, 2024.)		8-K		001-37428		10.1		7/15/2024
10.3		Senior Note dated June 8, 2024.		8-K		001-37428		10.2		7/15/2024
10.4		Promissory Note, dated July 12, 2024, issued by Qualigen Therapeutics, Inc. to Marizyme, Inc.		8-K		001-37428		10.1		7/18/2024
10.5		Placement Agent Agreement		8-K		001-37428		10.1		9/9/2024
31.1*		Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*		Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

101.INS#		Inline XBRL Instance Document.
101.SCH#		Inline XBRL Taxonomy Extension Schema Document.
101.CAL#		Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#		Inline XBRL Taxonomy Extension Definition Linkbase Document.
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104		Cover page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed or furnished herewith.

+ Indicates management contract or compensatory plan or arrangement.

# XBRL (Extensible Business Reporting Language) information is furnished and not filed herewith, is not a part of a registration statement or Prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.

 

 

 

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, 2024	QUALIGEN THERAPEUTICS, INC.
	By:	/s/ Kevin A. Richardson
	Name:	Kevin A. Richardson
	Title:	Interim Chief Executive Officer and Chief Financial Officer

 

 

 

 

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Kevin A. Richardson II, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Qualigen Therapeutics, Inc., a Delaware corporation;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

	a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b)	Designed such control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes with generally accepted accounting principles;
	c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

	a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

November 14, 2024	By:	/s/ Kevin A. Richardson II
	Name:	Kevin A. Richardson II
	Title:	Interim Chief Executive Officer and Interim Chief Financial Officer

 

 

 

Exhibit 32.1

 

CERTIFICATIONS PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Each of the undersigned, Michael S. Poirier, Chief Executive Officer of Qualigen Therapeutics, Inc., a Delaware corporation (the “Company”), and Christopher L. Lotz, Chief Financial Officer of the Company, do hereby certify, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, that, to his knowledge (1) the quarterly report on Form 10-Q of the Company for the three months ended September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

November 14, 2024

 

	By:	/s/ Kevin A. Richardson II
	Name:	Kevin A. Richardson II
	Title:	Interim Chief Executive Officer and Chief Financial Officer

 

These certifications accompanying and being “furnished” with this Report, shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Report, irrespective of any general incorporation language contained in such filing.

 

 

v3.24.3

Cover - $ / shares	9 Months Ended
	Sep. 30, 2024	Nov. 12, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Current Fiscal Year End Date	--12-31
Entity File Number	001-37428
Entity Registrant Name	Qualigen Therapeutics, Inc.
Entity Central Index Key	0001460702
Entity Tax Identification Number	26-3474527
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	5857 Owens Avenue, Suite 300
Entity Address, City or Town	Carlsbad
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92008
City Area Code	(760)
Local Phone Number	452-8111
Title of 12(b) Security	Common Stock, par value $.001 per share
Trading Symbol	QLGN
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		736,431
Entity Listing, Par Value Per Share	$ 0.001

v3.24.3

Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Current assets
Cash and cash equivalents	$ 388,152	$ 401,803
Prepaid expenses and other current assets	626,760	764,964
Short-term note receivable - Marizyme	1,298,082
Total current assets	2,312,994	1,166,767
Other assets		866,481
Total Assets	2,312,994	2,033,248
Current liabilities
Accounts payable	1,638,447	2,222,983
Accrued expenses and other current liabilities	570,148	560,006
Warrant liabilities	274,042	54,600
Total current liabilities	4,453,845	4,136,805
Commitments and Contingencies (Note 10)
Qualigen Therapeutics, Inc. stockholders’ equity (deficit):
Common stock, $0.001 par value; 225,000,000 shares authorized; 548,284 and 107,243 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	65,314	43,262
Additional paid-in capital	119,999,588	114,655,565
Accumulated deficit	(122,205,753)	(116,802,384)
Total Stockholders’ Deficit	(2,140,851)	(2,103,557)
Total Liabilities & Stockholders’ Deficit	2,312,994	2,033,248
Nonrelated Party [Member]
Current liabilities
Convertible debt	1,090,002
Derivative liabilities	368,288
Related Party [Member]
Current liabilities
Convertible debt	344,229	1,299,216
Derivative liabilities	$ 168,689

v3.24.3

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	225,000,000	225,000,000
Common stock, shares issued	548,284	107,243
Common stock, shares outstanding	548,284	107,243

v3.24.3

Condensed Consolidated Statements of Operations and Other Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
EXPENSES
General and administrative	$ 1,145,152	$ 1,336,765	$ 3,186,575	$ 5,132,834
Research and development	123,429	1,441,598	1,242,101	3,898,061
Total expenses	1,268,581	2,778,363	4,428,676	9,030,895
LOSS FROM OPERATIONS	(1,268,581)	(2,778,363)	(4,428,676)	(9,030,895)
OTHER EXPENSE (INCOME), NET
(Gain) loss on change in fair value of warrant liabilities	(1,231)	101,112	(361,137)	(1,377,855)
Loss on change in fair value of derivative liabilities	495,693		321,080
Interest expense	408,359	367,257	808,477	1,288,908
Interest income	(48,082)		(48,082)
Loss on issuance of convertible debt			358,279
(Gain) loss on voluntary conversion of convertible debt into common stock	27,790		(56,010)	1,077,287
Loss on monthly redemptions of convertible debt into common stock			208,852
Gain on settlements of accounts payable	(348,305)		(348,305)
Loss on fixed asset disposal		21,747		21,747
Other income, net	(6,547)	(33,454)	(9,262)	(33,534)
Total other expense (income), net	527,677	456,662	873,892	976,553
LOSS BEFORE PROVISION FOR INCOME TAXES	(1,796,258)	(3,235,025)	(5,302,568)	(10,007,448)
(BENEFIT) PROVISION FOR INCOME TAXES	(2,198)		800
NET LOSS FROM CONTINUING OPERATIONS	(1,794,060)	(3,235,025)	(5,303,368)	(10,007,448)
DISCONTINUED OPERATIONS
Income (loss) from discontinued operations, net of tax		159,507		(683,008)
Loss on disposal of discontinued operations, net of tax		(619,545)	(100,000)	(619,545)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		(460,038)	(100,000)	(1,302,553)
NET LOSS	(1,794,060)	(3,695,063)	(5,403,368)	(11,310,001)
Net loss attributable to non-controlling interest from discontinued operations		(38,526)		(343,038)
Net loss available to Qualigen Therapeutics, Inc.	(1,794,060)	(3,656,537)	(5,403,368)	(10,966,963)
Deemed dividend arising from warrant down-round provision	(27,587)		(87,604)
Net loss attributable to Qualigen Therapeutics, Inc	$ (1,821,647)	$ (3,656,537)	$ (5,490,972)	$ (10,966,963)
Net loss per common share, basic - continuing operations	$ (4.70)	$ (32.01)	$ (24.48)	$ (99.64)
Net loss per common share, diluted - continuing operations	(4.70)	(32.01)	(24.48)	(99.64)
Net loss per common share, basic - discontinued operations
Net loss per common share, diluted - discontinued operations		(4.17)	(0.45)	(9.55)
Total net loss per common share, diluted	$ (4.70)	$ (36.18)	$ (24.93)	$ (109.19)
Weighted-average number of shares outstanding, diluted	387,878	101,049	220,221	100,434
Other comprehensive loss, net of tax
Net loss	$ (1,794,060)	$ (3,695,063)	$ (5,403,368)	$ (11,310,001)
Foreign currency translation adjustment from discontinued operations				(50,721)
Other comprehensive loss	(1,794,060)	(3,695,063)	(5,403,368)	(11,360,722)
Comprehensive loss attributable to noncontrolling interest from discontinued operations		(38,526)		(343,038)
Comprehensive loss attributable to Qualigen Therapeutics, Inc.	$ (1,794,060)	$ (3,656,537)	$ (5,403,368)	$ (11,017,684)

v3.24.3

Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	AOCI Attributable to Parent [Member]	Retained Earnings [Member]	Parent [Member]	Noncontrolling Interest [Member]	Total
Beginning balance, value at Dec. 31, 2022	$ 42,110	$ 110,528,050	$ 50,721	$ (103,385,172)	$ 7,235,709	$ 1,530,881	$ 8,766,590
Balance, shares at Dec. 31, 2022	84,215
Stock-based compensation		247,657			247,657	4,569	252,226
Net loss				(3,846,221)	(3,846,221)	(261,028)	(4,107,249)
Voluntary conversion of convertible debt into common stock	$ 842	1,111,740			1,112,582		1,112,582
Voluntary conversion of convertible debt into common stock, shares	16,835
Foreign currency translation adjustment			119,723		119,723	56,497	176,220
Balance at Mar. 31, 2023	$ 42,952	111,887,447	170,444	(107,231,393)	4,869,450	1,330,919	6,200,369
Balance, shares at Mar. 31, 2023	101,049
Beginning balance, value at Dec. 31, 2022	$ 42,110	110,528,050	50,721	(103,385,172)	7,235,709	1,530,881	8,766,590
Balance, shares at Dec. 31, 2022	84,215
Net loss							(11,310,001)
Balance at Sep. 30, 2023	$ 42,952	112,668,631		(114,352,135)	(1,640,552)		(1,640,552)
Balance, shares at Sep. 30, 2023	101,049
Beginning balance, value at Mar. 31, 2023	$ 42,952	111,887,447	170,444	(107,231,393)	4,869,450	1,330,919	6,200,369
Balance, shares at Mar. 31, 2023	101,049
Stock-based compensation		667,383			667,383	4,728	672,111
Net loss				(3,464,205)	(3,464,205)	(43,484)	(3,507,689)
Foreign currency translation adjustment			(38,553)		(38,553)	(18,194)	(56,747)
Balance at Jun. 30, 2023	$ 42,952	112,554,830	131,891	(110,695,598)	2,034,075	1,273,969	3,308,044
Balance, shares at Jun. 30, 2023	101,049
Stock-based compensation		113,801			113,801		113,801
Net loss				(3,656,537)	(3,656,537)	(38,526)	(3,695,063)
Deconsolidation of discontinued operations			(131,891)		(131,891)	(1,235,443)	(1,367,334)
Balance at Sep. 30, 2023	$ 42,952	112,668,631		(114,352,135)	(1,640,552)		(1,640,552)
Balance, shares at Sep. 30, 2023	101,049
Beginning balance, value at Dec. 31, 2023	$ 43,262	114,655,565		(116,802,384)			(2,103,557)
Balance, shares at Dec. 31, 2023	107,243
Monthly redemptions of convertible debt into common stock	$ 1,138	545,094					546,232
Monthly redemptions of convertible debt into common stock, shares	22,771
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 Mar. 31, 2024	$ 44,400	115,269,047		(118,835,135)			(3,521,688)
Balance, shares at Mar. 31, 2024	130,013
Beginning balance, value at Dec. 31, 2023	$ 43,262	114,655,565		(116,802,384)			(2,103,557)
Balance, shares at Dec. 31, 2023	107,243
Net loss							(5,403,368)
Balance at Sep. 30, 2024	$ 65,314	119,999,588		(122,205,753)			(2,140,851)
Balance, shares at Sep. 30, 2024	548,284
Beginning balance, value at Mar. 31, 2024	$ 44,400	115,269,047		(118,835,135)			(3,521,688)
Balance, shares at Mar. 31, 2024	130,013
Monthly redemptions of convertible debt into common stock	$ 1,137	355,959					357,096
Monthly redemptions of convertible debt into common stock, shares	22,726
Stock-based compensation		33,086					33,086
Net loss				(1,576,558)			(1,576,558)
Voluntary conversion of convertible debt into common stock	$ 1,400	278,801					280,201
Voluntary conversion of convertible debt into common stock, shares	28,000
Stock issued upon partial exercise of warrants	$ 577	149,423					150,000
Stock issued upon partial exercise of warrants, shares	11,538
Balance at Jun. 30, 2024	$ 47,514	116,086,316		(120,411,693)			(4,277,863)
Balance, shares at Jun. 30, 2024	192,278
Fair value of warrant modification for professional services		2,299					2,299
Stock-based compensation		27,208					27,208
Net loss				(1,794,060)			(1,794,060)
Voluntary conversion of convertible debt into common stock	$ 1,911	452,972					454,883
Voluntary conversion of convertible debt into common stock, shares	38,222
Stock issued upon partial exercise of warrants	$ 1,023	264,958					265,981
Stock issued upon partial exercise of warrants, shares	20,460
Issuance of common stock and prefunded warrants in public offering	$ 14,724	3,038,624					3,053,348
Issuance of common stock and prefunded warrants in public offering, shares	294,481
Restricted share settlements issued to former Board members	$ 142	142,209					142,351
Restricted share settlements issued to former Board members, shares	2,843
Fair value of warrants reclassified from equity to liabilities		(14,998)					(14,998)
Balance at Sep. 30, 2024	$ 65,314	$ 119,999,588		$ (122,205,753)			$ (2,140,851)
Balance, shares at Sep. 30, 2024	548,284

v3.24.3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES
NET LOSS	$ (5,403,368)	$ (11,310,001)
Loss from discontinued operations, net of tax	(100,000)	(1,302,553)
Loss from continuing operations	(5,303,368)	(10,007,448)
Adjustments to reconcile loss from continuing operations to net cash used in operating activities:
Stock-based compensation	118,945	1,028,841
Change in fair value of warrant liabilities	(361,137)	(1,377,855)
Change in fair value of derivative liabilities	321,080
Accrued interest on short-term note receivable - Marizyme	(48,082)
(Gain) loss on voluntary conversion of convertible debt	(56,010)	1,077,287
Loss on monthly redemptions of convertible debt into common stock	208,852
Accretion of discount on convertible debt	514,028	1,247,198
Loss on issuance of convertible debt	358,279
Loss on disposal of fixed assets		21,747
Fair value of warrant modification for professional services	12,036
Changes in operating assets and liabilities:
Prepaid expenses and other assets	554,685	(640,105)
Accounts payable	(584,537)	952,269
Accrued expenses and other current liabilities	207,249	443,330
Net cash used in operating activities - continuing operations	(4,057,980)	(7,254,736)
Net cash used in operating activities - discontinued operations		2,622,059
Net cash used in operating activities	(4,057,980)	(4,632,677)
CASH FLOWS FROM INVESTING ACTIVITIES:
Issuance of short-term note receivable - Marizyme	(1,250,000)
Net cash provided by investing activities - discontinued operations	350,000	3,980,541
Net cash provided by (used in) investing activities	(900,000)	3,980,541
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from the issuance of convertible notes payable	1,475,000	(440,000)
Proceeds from issuance of common shares and prefunded warrants in public offering	3,053,348
Net proceeds from issuance of short term debt	2,000,000
Proceeds from warrant exercises	415,981
Payments on short term debt	(2,000,000)
Net cash provided by (used in) financing activities - continuing operations	4,944,329	(440,000)
Net cash provided by (used in) financing activities - discontinued operations
Net cash provided by (used in) financing activities	4,944,329	(440,000)
Net change in cash and cash equivalents	(13,651)	(1,092,136)
Cash and cash equivalents from continuing operations- beginning of period	401,803	3,165,985
Cash and cash equivalents from continuing operations - end of period	388,152	2,073,849
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Interest	61,020
Taxes	7,864	4,900
NONCASH FINANCING AND INVESTING ACTIVITIES:
Monthly redemptions of convertible debt into common stock	903,329
Voluntary conversion of convertible debt into common stock	735,083	1,112,582
Deemed dividend arising from warrant down-round provision	87,604
Exchange of derivative liability for warrant and convertible debt	675,625
Net transfers to equipment held for lease from inventory		$ 83,271

v3.24.3

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES	9 Months Ended
	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES	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).   On May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha Capital Anstalt (“Alpha”), a related party, in exchange for 7,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase 6,629 reverse split adjusted shares of the Company’s common stock at an exercise price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, with NanoSynex (the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex, and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted in the Company acquiring a 52.8% interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex (see Note 5 -Discontinued Operations).   Reverse Stock Split   On October 28, 2024, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended (the “Amendment”) with the Secretary of State of Delaware to effect a 1-for-50 Reverse Stock Split of the Company’s common stock, which became effective on November 5, 2024. The Amendment did not reduce the number of authorized shares of common stock, which remains at 225,000,000, and did not change the par value of the common stock, which remains at $0.0001 per share. As a result of the Reverse Stock Split, every fifty shares of the common stock were combined into one issued and outstanding share of common stock and no fractional shares were issued. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof.   All share and per share information shown herein has been retroactively adjusted to reflect the effect of the Reverse Stock Split Amendment for all periods presented.   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, 2023, which contains the audited financial statements and notes thereto. The financial information as of December 31, 2023 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The interim results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 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 such, assets and liabilities for NanoSynex were 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. See Note 5 – Discontinued Operations for further information.     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.   See Note 5 - Discontinued Operations for further information.   Equity Method Investments   Following deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods. See Note 5 – Discontinued Operations for further information.   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 warrant liabilities, convertible debentures, derivative liabilities, and stock-based compensation. Actual results could materially vary from the estimates that were used.   Cash and Cash Equivalents   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. In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect the Company’s business and financial position.   Impairment of Long-Lived Assets   The Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between the net book value of the assets and their estimated fair values. During the nine months ended September 30, 2024 and 2023, no such impairment losses have been recorded.   Segment Reporting   Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker 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).     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 7-Warrant Liabilities and Note 8- 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, accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.   Comprehensive Loss   Comprehensive loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements of stockholders’ equity (deficit) for all periods presented.   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.   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.   Foreign Currency Translation   The functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).   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   During the year ended 2023 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.   Impact of COVID-19 Pandemic   The COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned subsidiary, to Chembio (see Note 5 - Discontinued Operations).     Accounting Standards   In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The update, among other things, requires disclosure of certain significant segment expenses. We will adopt the updated accounting guidance in our Annual Report on Form 10-K for the year ending December 31, 2024. We do not expect the adoption of the new accounting guidance will have a material impact to our consolidated financial statements.   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.   We do 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.

v3.24.3

LIQUIDITY AND GOING CONCERN	9 Months Ended
	Sep. 30, 2024
Liquidity And Going Concern
LIQUIDITY AND GOING CONCERN	NOTE 2 — LIQUIDITY AND GOING CONCERN   As of September 30, 2024, we had approximately $388,000 in cash and an accumulated deficit of $122.2 million. For the nine months ended September 30, 2024 and year ended December 31, 2023, we used cash of $4.0 million and $11 million, respectively, in operations.   The Company’s cash balances as of the date that these financial statements were issued, without additional financing, are expected to fund operations through the fourth quarter of 2024. The Company expects to continue to have net losses and negative cash flow from operations, which will challenge its liquidity. 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.   Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt. Between February 2024 and April 2024 the Company raised $1.5 million from the sale of Convertible Debentures (see Note 8 - Convertible Debt - Related Party). In July 2024 the Company raised an additional $2.0 million from the sale of a nonconvertible 18% Senior Note, which was subsequently repaid in September 2024. In September 2024, the Company raised additional net proceeds of approximately $3.1 million from the sale of common stock and prefunded warrants in a public offering. There can be no assurance that further financing can be obtained on favorable terms, or at all. If the Company is unable to obtain funding, the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect the Company’s business prospects.   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.

v3.24.3

PREPAID EXPENSES AND OTHER CURRENT ASSETS	9 Months Ended
	Sep. 30, 2024
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
PREPAID EXPENSES AND OTHER CURRENT ASSETS	NOTE 3 — PREPAID EXPENSES AND OTHER CURRENT ASSETS   Prepaid expenses and other current assets consisted of the following at September 30, 2024 and December 31, 2023:  SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS     September 30,     December 31,       2024     2023   Prepaid insurance   $ 313,703     $ 566,011   Other prepaid expenses     63,057       25,053   Prepaid consulting     250,000       —   Prepaid research and development expenses     —       173,900   Prepaid expenses and other current assets   $ 626,760     $ 764,964

v3.24.3

SHORT-TERM NOTE RECEIVABLE - MARIZYME	9 Months Ended
	Sep. 30, 2024
Receivables [Abstract]
SHORT-TERM NOTE RECEIVABLE - MARIZYME	NOTE 4 — SHORT-TERM NOTE RECEIVABLE - MARIZYME   Other current assets consisted of the following at September 30, 2024 and December 31, 2023:  SCHEDULE OF SHORT-TERM NOTE RECEIVABLE     September 30,     December 31,       2024     2023   Short-term note receivable - Marizyme   $ 1,298,082     $ —   Total   $ 1,298,082     $ —     On July 15, 2024, the Company advanced to Marizyme, Inc., $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”). 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.   Under ASC 326-20, known as the current expected credit loss ("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 conclusion was that if the Company were to demand repayment of the loan mentioned above, management expects that the Company would be able to recover substantially all of its investment in a presumed liquidation of Marizyme’s assets, as the Company has seniority in any future bankruptcy or insolvency proceeding. As such, management estimates the expected credit losses on the Marizyme Note to be zero as of September 30, 2024.   The Company is also party to a Co-Development Agreement with Marizyme (see Note 11 - Research and License Agreements).

v3.24.3

DISCONTINUED OPERATIONS	9 Months Ended
	Sep. 30, 2024
Discontinued Operations and Disposal Groups [Abstract]
DISCONTINUED OPERATIONS	NOTE 5 — DISCONTINUED OPERATIONS   The summary of gain (loss) from discontinued operations, net of tax, for the three and nine months ended September 30, 2024 are as follows: SCHEDULE OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS      Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total             Three Months Ended September 30, 2024                 Nine Months Ended September 30, 2024                 Three Months Ended September 30, 2023                 Nine Months Ended September 30, 2023             Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total   Loss on disposal of discontinued operations, net of tax   $      —     $      —     $      —     $ —     $          —     $ —     $ 90,778     $ 68,729     $ 159,507     $ (171,701 )   $ (511,307 )   $ (683,008 ) Income (loss) from discontinued operations, net of tax     —       —       —       (100,000 )     —       (100,000 )     3,859,465       (4,479,010 )     (619,545 )      3,859,465       (4,479,010 )     (619,545 ) GAIN (LOSS) FROM DISCONTINUED OPERATIONS   $ —     $ —     $ —     $ (100,000 )   $ —     $ (100,000 )   $ 3,950,243     $ (4,410,281 )   $ (460,038 )    $ 3,687,764     $ (4,990,317 )   $ (1,302,553 )   Sale of Qualigen Inc.   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 ending September 30, 2024. There was no other activity related to Qualigen, Inc. during the three and nine months ended September 30, 2024.   There were no assets and liabilities remaining related to Qualigen, Inc. as of September 30, 2024 or December 31, 2023.     The Company reclassified the following statement of operations items to discontinued operations for the three and nine months ended September 30, 2023:  SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS     For the Three Months Ended September 30,     For the Nine Months September 30,       2023     2023   REVENUES                 Net product sales   $ 426,920     $ 3,661,121   Total revenues     426,920       3,661,121                     EXPENSES                 Cost of product sales     269,747       2,551,114   General and administrative     26,346       610,559   Research and development     2,612       206,819   Sales and marketing     37,288       405,626   Total expenses     335,993       3,774,118                     OTHER EXPENSE (INCOME), NET                 Loss on disposal of equipment held for lease     —       63,302   Other expense (income), net     149       (4,898 ) Loss on fixed asset disposal     —       300   Total other expense (income), net     149       58,704                     INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.     90,778       (171,701 )                   Gain on sale of Qualigen, Inc.     3,859,465       3,859,465                     INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.   $ 3,950,243     $ 3,687,764     Amendment and Settlement Agreement with NanoSynex Ltd.   On July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, reducing its ownership from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex, and deconsolidation of the subsidiary. On November 22, 2023, the Company further agreed to eliminate the Company’s obligations to lend additional funds to NanoSynex by surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced the Company’s ownership in NanoSynex voting equity from approximately 49.97% to 39.90%.   On the date of deconsolidation, the Company recognized its retained investment at fair value, which during the preparation of these financial statements was determined to be de minimis based on various economic, industry, and other factors. As a result, the Company has discontinued recognition of its proportionate share of equity method losses following the date of initial recognition. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods.   There were no assets and liabilities recognized related to NanoSynex as of September 30, 2024 or December 31, 2023.     There was no activity related to NanoSynex during the three and nine months ended September 30, 2024. The Company reclassified the following statement of operations items to discontinued operations for the three and nine months ended September 30, 2023:  SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS     For the Three Months Ended September 30,     For the Nine Months September 30,       2023     2023   EXPENSES                 Research and development   $ 81,640     $ 869,064   Total expenses     81,640       869,064                     Loss on disposal of discontinued operations     4,479,010       4,479,010                     (BENEFIT) PROVISION FOR INCOME TAXES     (150,369 )     (357,757 )                   LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.     (4,410,281 )     (4,990,317 )                   Loss attributable to noncontrolling interest     (1,276,969 )     (1,578,481 )                   NET LOSS ATTRIBUTABLE TO STOCKHOLDERS   $ (3,133,312 )   $ (3,411,836 )

v3.24.3

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	9 Months Ended
	Sep. 30, 2024
Payables and Accruals [Abstract]
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	NOTE 6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES   Accrued expenses and other current liabilities consisted of the following at September 30, 2024 and December 31, 2023:  SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES     September 30,     December 31,       2024     2023   Board compensation   $ 97,597     $ 129,499   Interest (Convertible debt)     68,318       10,004   License fees     4,907       32,975   Payroll     3,173       1,215   Professional fees     163,270       121,775   Research and development     61,515       104,402   Vacation     164,095       151,286   Other     7,273       8,850   Accrued expenses and other current liabilities   $ 570,148     $ 560,006

v3.24.3

WARRANT LIABILITIES	9 Months Ended
	Sep. 30, 2024
Warrant Liabilities
WARRANT LIABILITIES	NOTE 7 — WARRANT LIABILITIES   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. The Series C Warrants were determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, based on the inclusion of a leveraged ratchet provision for subsequent dilutive issuances. As of December 31, 2022 there were 26,995 Series C Warrants outstanding with an exercise price of $66.00 per share.   On December 22, 2022, in conjunction with the issuance of the 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 “Alpha Warrant”). The exercise price of the Alpha Warrant was $82.50 (equal to 125% of the conversion price of the Debenture on the closing date). The Alpha 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 Alpha Warrant. The fair value of this Alpha Warrant was included in Warrant liabilities-related party on the Company’s consolidated balance sheet as of December 31, 2022. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to a Securities Purchase Agreement, with Alpha. This Amendment eliminated certain adjustment provisions of the Warrant. The Company determined the event resulted in equity classification for the Warrant and, accordingly, the Company remeasured the warrant liabilities to fair value, and reclassified to noncompensatory equity classified warrants (see Note 12 - Stockholders Equity).   On November 24, 2023, 21,952 Series C Warrants expired, and on December 5, 2023 the remaining Series C Warrants were repriced from an exercise price of $66.00 per share to an exercise price of $36.50 per share, with 4,074 additional ratchet Series C Warrants issued, resulting in 9,113 of these Series C Warrants outstanding and exercisable as of December 31, 2023.     On February 27, 2024, these Series C Warrants were repriced again as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture, 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 of these Series C Warrants outstanding and exercisable, and on June 26, 2024 these remaining 25,586 Series C Warrants expired.   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 8 – Convertible Debt), we issued a liability classified warrant to Chen purchase 36,001 shares of our common stock, exercisable until February 27, 2029. 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 warrant remains outstanding and exercisable and was liability classified as of September 30, 2024 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. The fair value of the warrant was $565,582 on the issuance date and $257,492 at September 30, 2024. During the three and nine months ended September 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of $2,784 and $308,090 for this warrant.   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 12 - Stockholders’ Equity).   The following table summarizes the activity in liability classified warrants for the nine months ended September 30, 2024:  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, 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   Expired     (25,586 )   $ 13.00     $ 13.00 - $13.00       —   Forfeited     —       —       —       —   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 summarizes the activity in liability classified warrants for the nine months ended September 30, 2023:       Common Stock Warrants       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding –December 31, 2022     76,992     $ 76.72     $ 66.00 - $82.50       3.9   Granted     —       —       —       —   Exercised     —       —       —       —   Expired     —       —       —       —   Forfeited     —       —       —       —   Total outstanding – September 30, 2023     76,992     $ 76.72     $ 66.00 - $82.50       3.16   Exercisable     76,992     $ 76.72     $ 66.00 - $82.50       3.16       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, 2024:  SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES      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     —       —       —       —   Reclassified from equity     —       —       14,997       14,997   Gain on change in fair value of warrant liabilities     —       —       (361,137 )     (361,137 ) Balance as of September 30, 2024   $ —     $ —     $ 274,042     $ 274,042     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. There were no transfers of financial assets or liabilities between category levels for the three and nine months ended September 30, 2023.   The value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo simulation. 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, 2024 and 2023:  SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES      September 30, 2024     September 30, 2023       Actual     Weighted Average     Range     Weighted Average   Risk-free interest rate     3.61% — 3.61 %     3.61 %     4.523% — 5.401 %     4.83 % Expected volatility (peer group)     119.5% — 119.5 %     119.5 %     57.9% — 134.5 %     108.41 % Term of warrants (years)     4.41 — 4.41       4.41       0.14 — 4.73       3.16   Expected dividend yield     0.00 %     0.00 %     0.00 %     0.00 %

v3.24.3

CONVERTIBLE DEBT	9 Months Ended
	Sep. 30, 2024
Debt Disclosure [Abstract]
CONVERTIBLE DEBT	NOTE 8 — CONVERTIBLE DEBT   2022 Convertible Debenture (Related party)   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 $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, 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 and 12, 2023, we issued 16,832 shares of common stock upon Alpha’s partial voluntary conversion of the 2022 Debenture at a conversion price of $66.00 per share for a total of $1,111,078 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.   During the three and nine months ending September 30, 2023, we issued 0 and 16,832 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 $0 and $66.00 per share, respectively, and a weighted average fair value of $0 and $66.09 per share, respectively.   Commencing June 1, 2023 (the “Initial Monthly Redemption Date”) and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a “Monthly Redemption Date”), we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022 Debenture (the “Monthly Redemption Amount”). The Monthly Redemption Amount must be paid in cash; provided that after the first two monthly redemptions, we may elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i) the then 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 that is immediately before the applicable Monthly Redemption Date, subject to the Equity Conditions (as defined in the 2022 Debenture) having been satisfied or waived.   The 2022 Debenture accrued interest at the rate of 8% per annum, which did not begin accruing until December 1, 2023, and was payable on a monthly or quarterly basis. Interest may be paid in cash or shares of our common stock or a combination thereof at our option; provided that interest may only be paid in shares if the Equity Conditions have been satisfied or waived.   In December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, we entered into a registration rights agreement with Alpha (the “Registration Rights Agreement”), pursuant to which we 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 Registration Rights Agreement requires that the Company file, within 30 days after signing, a resale registration statement and use commercially reasonable efforts to cause the resale registration statement to be declared effective by the SEC on or before the 60th calendar day following the date of signing of the Registration Rights Agreement (or 120 days if such registration statement is subject to full review by the SEC). We 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, we 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, we 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.   The proceeds from the 2022 Debenture were allocated to the initial fair value of the 2022 Warrant, with the residual balance allocated to the initial carrying value of the 2022 Debenture. The Company has not elected the fair value option for the 2022 Debenture. The 2022 Debenture was recognized as proceeds received after allocating the proceeds to the 2022 Warrant, and then allocating remaining proceeds to a suite of bifurcated embedded derivative features (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. The suite of derivative features was measured and determined to have no fair value.   The original issue discount of $0.3 million, the initial fair value of the 2022 Warrant of $2.8 million, the initial fair value of the suite of bifurcated embedded derivative features of $0, and the fees and costs paid to Alpha and other third parties of $0.1 million comprised the debt discount upon issuance. The debt discount is amortized to interest expense over the expected term of the 2022 Debenture using the effective interest method, in accordance with ASC 835-30. The debt host instrument of the 2022 Debenture will subsequently be measured at amortized cost using the effective interest method to accrete interest over its term to bring the 2022 Debenture’s initial carrying value to the principal balance at maturity.     On December 5, 2023, the Company and Alpha executed Amendment No. 1 with regard to Securities Purchase Agreement (the “SPA Amendment”), pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the 2022 Debenture from $66.00 per share to $36.50 per share and reduce the exercise price of the 2022 Warrant from $82.50 per share to $36.50 per share, in each case subject to certain adjustments. In addition, the SPA Amendment revised certain provisions of the 2022 Warrant to (i) limit the circumstances which would trigger a potential adjustment to the exercise price of the 2022 Warrant and (ii) clarify the treatment of the 2022 Warrant upon a Fundamental Transaction. The purpose of these revisions was to remove the terms that caused the 2022 Warrant to be liability-classified under U.S. GAAP. The Company performed an assessment and concluded that all remaining adjustment features in the revised language meet the FASB’s definition of a down-round feature. In addition, the 2022 Warrant was determined to meet all of the additional requirements for equity classification. Accordingly, as of December 5, 2023, the Company remeasured the 2022 Warrant to its fair value immediately prior to the modification and recognized the change in fair value in earnings. The incremental fair value impact from the 2022 Warrant modification of $0.09 million was included in the Company’s evaluation of the 2022 Debenture modification under ASC 470, discussed further below. The Company then reclassified the 2022 Warrant liability to equity at its post-modification fair value of $1.6 million.   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 and will be amortized to interest expense over the expected term of the Debenture using the effective interest method, in accordance with ASC 835-30.   During the three and nine months ended September 30, 2024, the Company recognized a gain of approximately $1,000, and a loss of approximately $124,000 respectively, upon debenture share redemptions, and recorded interest expense of approximately $28,000 and $162,000 (of which approximately $28,000 and $120,000 was attributable to discount accretion, respectively) for the three and nine months ended September 30, 2024 respectively, in other expenses in the condensed consolidated statements of operations related to the 2022 Debenture. As of September 30, 2024 and December 31, 2023, the fair value of the suite of bifurcated embedded derivative features related to the 2022 Debenture was $0.   During the three and nine months ended September 30, 2023, the Company recorded interest of approximately $368,000 and$1.3 million, respectively (of which approximately $350,000 and $1.2 million was attributable to discount amortization, respectively) in other expenses in the condensed consolidated statements of operations. As of September 30, 2023, the fair value of the Alpha Warrant was approximately $2.2 million, and the fair value of the suite of bifurcated embedded derivative features was $0.   On July 3, 2024 and July 5, 2024 Alpha voluntarily converted the remainder of the 2022 Debenture.   2024 Convertible Debenture (Related party)   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 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. Except in respect of an Exempt Issuance, the 2024 Alpha Debenture contains a “ratchet” antidilution provision, with a $5.82 per share floor. 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 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 noncompensatory equity classified 5-year common stock purchase warrant to purchase (at $13.00 per share) 18,001 shares of our common stock (see Note 12 - Stockholders Equity (Deficit)).   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 36,001 additional warrants).   On September 9, 2024 we issued 7,842 shares of common stock upon Alpha’s partial voluntary conversion of the 2024 Alpha Debenture at a conversion price of $6.50 per share for a total of $50,979 principal.   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 interest expense of approximately $165,000 and $403,000, respectively (of which approximately $154,000 and $376,000, respectively was attributable to discount accretion), and loss (gain) on change in derivative liabilities of approximately $151,000 and ($14,000), respectively in other expenses in the condensed consolidated statements of operations. As of September 30, 2024, the fair value of the suite of bifurcated embedded derivative features related to the 2024 Alpha Debenture was approximately $169,000.     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 $36.50 per share to $6.50 per share (see Note 7 - Warrant Liabilities and Note 12 - Stockholders Equity (Deficit).     2024 Convertible Debenture   In April 2024, Alpha assigned its option to Chen and Chen exercised the option in full, in exchange for $1,000,000, less expenses, we issued to Chen an 8% Convertible Debenture (the “2024 Chen Debenture”) with a principal amount of $1,100,000. The 2024 Chen Debenture matures no later than December 31, 2024 and was convertible, at any time, and from time to time, at Chen’s option, into shares of common stock of the Company, at $30.56 per share, subject to adjustment as described in the 2024 Chen Debenture. Except in respect of an Exempt Issuance, the 2024 Chen Debenture contains a “ratchet” antidilution provision, with a $5.82 per share floor. Upon the closing of the public offering on September 6, 2024 per the terms of the antidilution provision, the conversion price of the 2024 Chen Debenture was reduced from $30.56 to $6.50 per share. The 2024 Chen 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 Chen a 5-year liability classified common stock purchase warrant to purchase 36,001 shares of our common stock at $6.50 per share with an initial fair value of $565,582 (see Note 7 - Warrant Liabilities).   During the three and nine months ending September 30, 2024 in connection with the 2024 Chen Debenture, the Company recorded initial derivative liabilities with a fair value of $33,243, and recorded interest expense of approximately $32,000 and $60,000, respectively (of which approximately $10,000 and $18,000, respectively was attributable to discount accretion), and loss on change in derivative liabilities of approximately $345,000 and $335,000, respectively in other expenses in other expenses in the condensed consolidated statements of operations. As of September 30, 2024, the fair value of the suite of bifurcated embedded derivative features related to the 2024 Alpha Debenture was approximately $368,000. The fair value of the warrant issued in connection with the 2024 Chen Debenture was approximately $257,000 at September 30, 2024, and during the three and nine months ended September 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of approximately $2,784 and $308,090 for this warrant.   Convertible debt is comprised of the following as of September 30, 2024 and December 31, 2023:  SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT      September 30, 2024     December 31, 2023   Convertible debt   $ 1,100,000     $        —   Discount on convertible debt     (9,998 )     —   Total convertible debt   $ 1,090,002     $ —         September 30, 2024     December 31, 2023   Convertible debt - related party     499,021       1,418,922   Convertible debt     499,021       1,418,922   Discount on convertible debt - related party     (154,792 )     (119,706 ) Discount on convertible debt     (154,792 )     (119,706 ) Total convertible debt - related party   $ 344,229     $ 1,299,216   Total convertible debt   $ 344,229     $ 1,299,216     As of September 30, 2024, there were no events of default or violation of any covenants under our financing obligations.   The following table presents the Company’s fair value hierarchy for its derivative liabilities arising from the issuance of convertible debt measured at fair value on a recurring basis as of September 30, 2024:    SCHEDULE OF DERIVATIVE LIABILITIES Derivative Liabilities Arising From Issuance of Convertible Debt     Quoted Market Prices for Identical Assets (Level 1)       Significant Other Observable Inputs (Level 2)       Significant Unobservable Inputs (Level 3)       Total   Balance as of December 31, 2023   $ —     $ —     $ —     $ —   Granted     —       —       215,897       215,897   Loss on change in fair value of derivative liabilities     —       —       321,080       321,080   Balance as of September 30, 2024   $ —     $ —     $ 536,977     $ 536,977     The following are the weighted average and the range of assumptions used in estimating the fair value of derivative liabilities arising from the issuance of convertible debt as of September 30, 2024:   SCHEDULE OF RANGE OF ASSUMPTIONS USED IN ESTIMATING THE FAIR VALUE OF DERIVATIVE LIABILITIES     September 30, 2024       Actual     Weighted Average   Risk-free interest rate     4.79% — 4.79 %     4.79 % Expected volatility (peer group)     139.5% — 139.5 %     139.5 % Remaining term (years)     0.25 — 0.25       0.25   Expected dividend yield     0.00 %     0.00 %

v3.24.3

EARNINGS (LOSS) PER SHARE	9 Months Ended
	Sep. 30, 2024
Earnings Per Share [Abstract]
EARNINGS (LOSS) PER SHARE	NOTE 9 — EARNINGS (LOSS) PER SHARE   Basic loss per share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding. 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 stock options and warrants. The Company has included pre-funded warrants in its computation of basic net loss per share based on the nominal exercise price.   The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2024 and 2023 because their effect would be anti-dilutive:  SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE      As of September 30,       2024     2023   Shares of common stock subject to outstanding options     6,740       8,324   Shares of common stock subject to outstanding warrants     90,023       81,199   Shares of common stock subject to outstanding convertible debt     246,003       —   Total common stock equivalents     342,766       89,523

v3.24.3

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 10 — COMMITMENTS AND CONTINGENCIES   Litigation and Other Legal Proceedings   From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of September 30, 2024, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the results of the Company’s operations.

v3.24.3

RESEARCH AND LICENSE AGREEMENTS	9 Months Ended
	Sep. 30, 2024
Research And License Agreements
RESEARCH AND LICENSE AGREEMENTS	NOTE 11 — 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 of 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, 2024 and 2023, there were license costs of $0 and $12,000, and for the nine months ended September 30, 2024 and 2023, there were license costs of approximately $2,000 and $28,000, respectively, related to this agreement which are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.   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.   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.     Sponsored research expenses related to these agreements for the three months ended September 30, 2024 and 2023 were $0 and $101,000, and for the nine months ended September 30, 2024 and 2023 were $0 and $657,000. License costs were approximately $22,000 and $18,000 related to these agreements for the three months ended September 30, 2024 and 2023, respectively, and approximately $76,000 and $47,000 related to these agreements for the nine months ended September 30, 2024 and 2023, 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.   Sponsored research expenses related to these agreements for the three months ended September 30, 2024 and 2023 were both $0, and for the nine months ended September 30, 2024 and 2023 were both $0, and are recorded in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs related to these agreements for the three months ended September 30, 2024 and 2023 were both $0, and for the nine months ended September 30, 2024 and 2023 were approximately $1,000 and $22,000, respectively, and are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss.   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, on July 15, 2024, the Company advanced $1,250,000 to Marizyme, against which Marizyme had previously delivered a demand promissory note to the Company (see Note 4 - Short Term Note Receivable - Marizyme).

v3.24.3

STOCKHOLDERS’ EQUITY	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
STOCKHOLDERS’ EQUITY	NOTE 12 — STOCKHOLDERS’ EQUITY   As of September 30, 2024 and December 31, 2023, 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, 2024, the Company has reserved 590,597 shares of authorized but unissued common stock for possible future issuance. At September 30, 2024, shares were reserved in connection with the following:  SCHEDULE OF RESERVED SHARES            Exercise of issued and future grants of stock options     15,114   Conversion of convertible debt     246,004   Exercise of stock warrants     329,479   Total     590,597     Preferred Stock   At September 30, 2024 and December 31, 2023, there were no shares of preferred stock outstanding.   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, 2024 and December 31, 2023, there were 6,739 and 7,978 outstanding stock options, respectively, under the 2020 Plan and on such dates there were 8,375 and 7,136 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, 2024, 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, 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 was approximately $119,000 and $1.0 million of compensation cost related to outstanding stock options for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, there was approximately $19,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 0.58 years.     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.   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:  SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE      2024     2023     2024     2023       For the Three Months Ended September 30,     For the Nine Months Ended September 30,       2024     2023     2024     2023   General and administrative   $ 27,208     $ 73,384     $ 94,264     $ 881,365   Research and development     —       40,417       24,680       140,674   Total   $ 27,208     $ 113,801     $ 118,944     $ 1,022,039     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 7- Warrant Liabilities.   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 and comprehensive loss. On September 6, 2024 as a result of a down-round provision triggered by shares sold in the public offering, these 1,353 warrants were repriced again from $13.50 per share exercise price to $6.50 per share exercise price. The increase in fair value of $2,299 for the modification of these warrants was charged to general and administrative expenses in the Company’s condensed consolidated statements of operations and comprehensive loss.     No compensatory warrants were issued during the three and nine months ended September 30, 2024 and September 30, 2023.   The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2024:  SCHEDULE OF COMPENSATORY WARRANT ACTIVITY      Common Stock       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding – December 31, 2023     2,381     $ 534.44      $ 36.50—$1,270.25       1.25   Granted     —       —        —       —   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     —       —        —       —     The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2023:       Common Stock     Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding – December 31, 2022     3,581     $ 455.88     $ 66.00 — $1,270.25       1.73   Exercised     —       —       —       —   Expired     (1,200 )   $ 300.00     $ 300.00 — $300.00       —   Forfeited     —       —       —       —   Total outstanding – September 30, 2023     2,381     $ 534.44     $ 66.00 — $1,270.25       1.50   Exercisable     2,381     $ 534.44     $ 66.00 — $1,270.25       1.50   Non-Exercisable     —       —       —       —     There was approximately $2,000 and $12,000 in compensation cost related to outstanding equity classified compensatory warrants for the three and nine months ended September 30, 2024 respectively, and $0 for both the three and nine months ended September 30, 2023. As of September 30, 2024 and September 30, 2023, there was no unrecognized compensation cost related to nonvested warrants.   Noncompensatory Equity Classified Warrants   On May 22, 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha (a related party) for the purchase of common stock. 141 of these warrants remain outstanding and exercisable as of September 30, 2024 and may be exercised in whole or in part, at any time before May 22, 2025. 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.     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 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 in the condensed consolidated statements of changes in stockholders’ equity.   On September 6, 2024, upon the closing of a public offering, the Company issued pre-funded warrants to purchase 239,456 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. No pre-funded warrants were exercised during the three or nine months ending September 30, 2024.   On September 6, 2024, upon the closing of a public offering, 16,019 warrants were issued to the placement agent. These warrants are not exercisable until March 5, 2025 and expire on September 6, 2029.   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).   The following table summarizes the non compensatory equity classified warrant activity for the nine months ended September 30, 2024:  SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY      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       The following table summarizes the non compensatory equity classified warrant activity for the nine months ended September 30, 2023:       Common Stock       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding – December 31, 2022     10,941     $ 987.97     $ 66.00 — $1,000.00       0.33   Granted     —       —       —       —   Exercised     —       —       —       —   Expired     (9,114 )   $ 1,000.00     $ 1,000.00 — $1,000.00       —   Forfeited     —       —       —       —   Total outstanding – September 30, 2023     1,827     $ 927.91     $ 66.00—$1,000.00       0.33   Exercisable     1,827     $ 927.91     $ 66.00—$1,000.00       0.33   Non-Exercisable     —       —       —       —

v3.24.3

RELATED PARTY TRANSACTIONS	9 Months Ended
	Sep. 30, 2024
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	NOTE 13 — RELATED PARTY TRANSACTIONS   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 nine months ended September 30, 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 nine months ended September 30, 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. As of September 30, 2024 this Debenture had a remaining principal balance of $499,021, and was convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company, at a price equal to $6.50 per share, subject to adjustment as described in the Debenture and other terms and conditions described in the Debenture.   See Note 8 – 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. As of September 30, 2024, 141 of these warrants remain outstanding and exercisable, and may be exercised in whole or in part, at any time before May 22, 2025. During the three and nine months ended September 30, 2024 and September 30, 2023, there were no exercises of this warrant.   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. As of September 30, 2024, the exercise price of this warrant was $6.50. 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 three and nine months ended September 30, 2024, Alpha partially exercised this warrant to purchase 20,460 and 31,998 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 $416,000. During the three and nine months ended September 30, 2023, there were no exercises of this warrant.   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. This warrant may be exercised by Alpha, in whole or in part, at any time before February 27, 2029, subject to certain terms and conditions described in the warrant. During the three and nine months ended September 30, 2024, there were no exercises of this warrant.   As of September 30, 2024, the exercise price of all of the above warrants issued to Alpha was $6.50.   The above warrants are included in equity on the Company’s condensed consolidated balance sheets (see Note 12 – Stockholders’ Equity (Deficit)), except for 2,314 shares of the warrant issued on February 27, 2024, which was reclassified to liabilities as of September 30, 2024, until shareholder approval is obtained for the company to issue the shares (see Note 7 - Warrant Liabilities).

v3.24.3

SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2024
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 14 — SUBSEQUENT EVENTS   Annual Shareholder Meeting   On October 9, 2024, the nominating committee of the Board of Directors (the “Board”) nominated Braeden Lichti as a board member. At the Annual Shareholder Meeting on October 27, 2024, Mr. Lichti along with all other board member nominees was elected to serve as a director until the Company’s annual meeting of stockholders in 2025, or until such person’s successor is duly elected and qualified or until such person’s earlier resignation, death, or removal. All other proposals in the Company’s proxy were also approved.   Reverse Stock Split   On October 28, 2024, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended with the Secretary of State of the State of Delaware to effect a 1-for-50 reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding Common Stock, effective November 5, 2024 at 12:01 a.m., Eastern Time (the “Effective Time”). The Reverse Stock Split was approved by the Company’s stockholders at the Company’s reconvened annual meeting of stockholders held on October 25, 2024, at a ratio of not less than 1-for-10 and not greater than 1-for-50, with the exact ratio, if approved and effected at all, to be set within that range at the discretion of the board of directors. On October 25, 2024, the Board of Directors approved a ratio of 1-for-50 for the Reverse Stock Split. The Amendment provides that at the Effective Time, every 50 shares of the Company’s issued and outstanding Common Stock immediately prior to the Effective Time, will automatically be reclassified, without any action on the part of the holder thereof, into one share of Common Stock. No fractional shares will be issued as a result of the Reverse Stock Split. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof. Equiniti Trust Company is acting as exchange agent for the Reverse Stock Split and will send instructions to stockholders of record who hold stock certificates regarding the exchange of certificates for Common Stock, should they wish to do so. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take any action to effect the exchange of their shares. Commencing on November 5, 2024, trading of the Company’s Common Stock will continue on the Nasdaq Capital Stock Market on a reverse stock split-adjusted basis. The new CUSIP number for the Company’s Common Stock following the Reverse Stock Split is 74754R301.   New Chairperson of the Audit Committee and Independent Member of the Board   On October 8, 2024, the Board of Directors (the “Board”) appointed Braeden Lichti as an independent member of the Board, effective immediately. On October 8, 2024, the Board appointed Robert Lim as the chairperson of the Audit Committee, effective immediately.

v3.24.3

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Policies)	9 Months Ended
	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization	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).   On May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha Capital Anstalt (“Alpha”), a related party, in exchange for 7,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase 6,629 reverse split adjusted shares of the Company’s common stock at an exercise price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, with NanoSynex (the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex, and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted in the Company acquiring a 52.8% interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex (see Note 5 -Discontinued Operations).
Reverse Stock Split	Reverse Stock Split   On October 28, 2024, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended (the “Amendment”) with the Secretary of State of Delaware to effect a 1-for-50 Reverse Stock Split of the Company’s common stock, which became effective on November 5, 2024. The Amendment did not reduce the number of authorized shares of common stock, which remains at 225,000,000, and did not change the par value of the common stock, which remains at $0.0001 per share. As a result of the Reverse Stock Split, every fifty shares of the common stock were combined into one issued and outstanding share of common stock and no fractional shares were issued. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof.   All share and per share information shown herein has been retroactively adjusted to reflect the effect of the Reverse Stock Split Amendment for all periods presented.
Basis of Presentation	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, 2023, which contains the audited financial statements and notes thereto. The financial information as of December 31, 2023 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The interim results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future periods.
Principles of Consolidation	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 such, assets and liabilities for NanoSynex were 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. See Note 5 – Discontinued Operations for further information.
Discontinued Operations	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.   See Note 5 - Discontinued Operations for further information.
Equity Method Investments	Equity Method Investments   Following deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods. See Note 5 – Discontinued Operations for further information.
Accounting Estimates	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 warrant liabilities, convertible debentures, derivative liabilities, and stock-based compensation. Actual results could materially vary from the estimates that were used.
Cash and Cash Equivalents	Cash and Cash Equivalents   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. In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect the Company’s business and financial position.
Impairment of Long-Lived Assets	Impairment of Long-Lived Assets   The Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between the net book value of the assets and their estimated fair values. During the nine months ended September 30, 2024 and 2023, no such impairment losses have been recorded.
Segment Reporting	Segment Reporting   Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker 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).
Research and Development	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	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	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 7-Warrant Liabilities and Note 8- Convertible Debt).
Fair Value Measurements	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	Fair Value of Financial Instruments   Cash, accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.
Comprehensive Loss	Comprehensive Loss   Comprehensive loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements of stockholders’ equity (deficit) for all periods presented.
Stock-Based Compensation	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	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.   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.
Foreign Currency Translation	Foreign Currency Translation   The functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).
Global Economic Conditions	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   During the year ended 2023 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.
Impact of COVID-19 Pandemic	Impact of COVID-19 Pandemic   The COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned subsidiary, to Chembio (see Note 5 - Discontinued Operations).
Accounting Standards	Accounting Standards   In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The update, among other things, requires disclosure of certain significant segment expenses. We will adopt the updated accounting guidance in our Annual Report on Form 10-K for the year ending December 31, 2024. We do not expect the adoption of the new accounting guidance will have a material impact to our consolidated financial statements.   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.   We do 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.

v3.24.3

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)	9 Months Ended
	Sep. 30, 2024
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS	Prepaid expenses and other current assets consisted of the following at September 30, 2024 and December 31, 2023:  SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS     September 30,     December 31,       2024     2023   Prepaid insurance   $ 313,703     $ 566,011   Other prepaid expenses     63,057       25,053   Prepaid consulting     250,000       —   Prepaid research and development expenses     —       173,900   Prepaid expenses and other current assets   $ 626,760     $ 764,964

v3.24.3

SHORT-TERM NOTE RECEIVABLE - MARIZYME (Tables)	9 Months Ended
	Sep. 30, 2024
Receivables [Abstract]
SCHEDULE OF SHORT-TERM NOTE RECEIVABLE	SCHEDULE OF SHORT-TERM NOTE RECEIVABLE     September 30,     December 31,       2024     2023   Short-term note receivable - Marizyme   $ 1,298,082     $ —   Total   $ 1,298,082     $ —

v3.24.3

DISCONTINUED OPERATIONS (Tables)	9 Months Ended
	Sep. 30, 2024
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS	The summary of gain (loss) from discontinued operations, net of tax, for the three and nine months ended September 30, 2024 are as follows: SCHEDULE OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS      Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total             Three Months Ended September 30, 2024                 Nine Months Ended September 30, 2024                 Three Months Ended September 30, 2023                 Nine Months Ended September 30, 2023             Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total     Qualigen, Inc.     NanoSynex     Total   Loss on disposal of discontinued operations, net of tax   $      —     $      —     $      —     $ —     $          —     $ —     $ 90,778     $ 68,729     $ 159,507     $ (171,701 )   $ (511,307 )   $ (683,008 ) Income (loss) from discontinued operations, net of tax     —       —       —       (100,000 )     —       (100,000 )     3,859,465       (4,479,010 )     (619,545 )      3,859,465       (4,479,010 )     (619,545 ) GAIN (LOSS) FROM DISCONTINUED OPERATIONS   $ —     $ —     $ —     $ (100,000 )   $ —     $ (100,000 )   $ 3,950,243     $ (4,410,281 )   $ (460,038 )    $ 3,687,764     $ (4,990,317 )   $ (1,302,553 )
NanoSynex [Member]
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS	SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS     For the Three Months Ended September 30,     For the Nine Months September 30,       2023     2023   EXPENSES                 Research and development   $ 81,640     $ 869,064   Total expenses     81,640       869,064                     Loss on disposal of discontinued operations     4,479,010       4,479,010                     (BENEFIT) PROVISION FOR INCOME TAXES     (150,369 )     (357,757 )                   LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.     (4,410,281 )     (4,990,317 )                   Loss attributable to noncontrolling interest     (1,276,969 )     (1,578,481 )                   NET LOSS ATTRIBUTABLE TO STOCKHOLDERS   $ (3,133,312 )   $ (3,411,836 )
Parent [Member]
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS	The Company reclassified the following statement of operations items to discontinued operations for the three and nine months ended September 30, 2023:  SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS     For the Three Months Ended September 30,     For the Nine Months September 30,       2023     2023   REVENUES                 Net product sales   $ 426,920     $ 3,661,121   Total revenues     426,920       3,661,121                     EXPENSES                 Cost of product sales     269,747       2,551,114   General and administrative     26,346       610,559   Research and development     2,612       206,819   Sales and marketing     37,288       405,626   Total expenses     335,993       3,774,118                     OTHER EXPENSE (INCOME), NET                 Loss on disposal of equipment held for lease     —       63,302   Other expense (income), net     149       (4,898 ) Loss on fixed asset disposal     —       300   Total other expense (income), net     149       58,704                     INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.     90,778       (171,701 )                   Gain on sale of Qualigen, Inc.     3,859,465       3,859,465                     INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.   $ 3,950,243     $ 3,687,764

v3.24.3

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2024
Payables and Accruals [Abstract]
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	Accrued expenses and other current liabilities consisted of the following at September 30, 2024 and December 31, 2023:  SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES     September 30,     December 31,       2024     2023   Board compensation   $ 97,597     $ 129,499   Interest (Convertible debt)     68,318       10,004   License fees     4,907       32,975   Payroll     3,173       1,215   Professional fees     163,270       121,775   Research and development     61,515       104,402   Vacation     164,095       151,286   Other     7,273       8,850   Accrued expenses and other current liabilities   $ 570,148     $ 560,006

v3.24.3

WARRANT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2024
Warrant Liabilities
SCHEDULE OF WARRANTS ACTIVITY	The following table summarizes the activity in liability classified warrants for the nine months ended September 30, 2024:  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, 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   Expired     (25,586 )   $ 13.00     $ 13.00 - $13.00       —   Forfeited     —       —       —       —   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 summarizes the activity in liability classified warrants for the nine months ended September 30, 2023:       Common Stock Warrants       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding –December 31, 2022     76,992     $ 76.72     $ 66.00 - $82.50       3.9   Granted     —       —       —       —   Exercised     —       —       —       —   Expired     —       —       —       —   Forfeited     —       —       —       —   Total outstanding – September 30, 2023     76,992     $ 76.72     $ 66.00 - $82.50       3.16   Exercisable     76,992     $ 76.72     $ 66.00 - $82.50       3.16
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES	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, 2024:  SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES      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     —       —       —       —   Reclassified from equity     —       —       14,997       14,997   Gain on change in fair value of warrant liabilities     —       —       (361,137 )     (361,137 ) Balance as of September 30, 2024   $ —     $ —     $ 274,042     $ 274,042
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES	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, 2024 and 2023:  SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES      September 30, 2024     September 30, 2023       Actual     Weighted Average     Range     Weighted Average   Risk-free interest rate     3.61% — 3.61 %     3.61 %     4.523% — 5.401 %     4.83 % Expected volatility (peer group)     119.5% — 119.5 %     119.5 %     57.9% — 134.5 %     108.41 % Term of warrants (years)     4.41 — 4.41       4.41       0.14 — 4.73       3.16   Expected dividend yield     0.00 %     0.00 %     0.00 %     0.00 %

v3.24.3

CONVERTIBLE DEBT (Tables)	9 Months Ended
	Sep. 30, 2024
Debt Disclosure [Abstract]
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT	Convertible debt is comprised of the following as of September 30, 2024 and December 31, 2023:  SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT      September 30, 2024     December 31, 2023   Convertible debt   $ 1,100,000     $        —   Discount on convertible debt     (9,998 )     —   Total convertible debt   $ 1,090,002     $ —         September 30, 2024     December 31, 2023   Convertible debt - related party     499,021       1,418,922   Convertible debt     499,021       1,418,922   Discount on convertible debt - related party     (154,792 )     (119,706 ) Discount on convertible debt     (154,792 )     (119,706 ) Total convertible debt - related party   $ 344,229     $ 1,299,216   Total convertible debt   $ 344,229     $ 1,299,216
SCHEDULE OF DERIVATIVE LIABILITIES	The following table presents the Company’s fair value hierarchy for its derivative liabilities arising from the issuance of convertible debt measured at fair value on a recurring basis as of September 30, 2024:    SCHEDULE OF DERIVATIVE LIABILITIES Derivative Liabilities Arising From Issuance of Convertible Debt     Quoted Market Prices for Identical Assets (Level 1)       Significant Other Observable Inputs (Level 2)       Significant Unobservable Inputs (Level 3)       Total   Balance as of December 31, 2023   $ —     $ —     $ —     $ —   Granted     —       —       215,897       215,897   Loss on change in fair value of derivative liabilities     —       —       321,080       321,080   Balance as of September 30, 2024   $ —     $ —     $ 536,977     $ 536,977
SCHEDULE OF RANGE OF ASSUMPTIONS USED IN ESTIMATING THE FAIR VALUE OF DERIVATIVE LIABILITIES	SCHEDULE OF RANGE OF ASSUMPTIONS USED IN ESTIMATING THE FAIR VALUE OF DERIVATIVE LIABILITIES     September 30, 2024       Actual     Weighted Average   Risk-free interest rate     4.79% — 4.79 %     4.79 % Expected volatility (peer group)     139.5% — 139.5 %     139.5 % Remaining term (years)     0.25 — 0.25       0.25   Expected dividend yield     0.00 %     0.00 %

v3.24.3

EARNINGS (LOSS) PER SHARE (Tables)	9 Months Ended
	Sep. 30, 2024
Earnings Per Share [Abstract]
SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE	The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2024 and 2023 because their effect would be anti-dilutive:  SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE      As of September 30,       2024     2023   Shares of common stock subject to outstanding options     6,740       8,324   Shares of common stock subject to outstanding warrants     90,023       81,199   Shares of common stock subject to outstanding convertible debt     246,003       —   Total common stock equivalents     342,766       89,523

v3.24.3

STOCKHOLDERS’ EQUITY (Tables)	9 Months Ended
	Sep. 30, 2024
Accumulated Other Comprehensive Income (Loss) [Line Items]
SCHEDULE OF RESERVED SHARES	SCHEDULE OF RESERVED SHARES            Exercise of issued and future grants of stock options     15,114   Conversion of convertible debt     246,004   Exercise of stock warrants     329,479   Total     590,597
SCHEDULE OF STOCK OPTION ACTIVITY	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:  SCHEDULE OF STOCK OPTION ACTIVITY       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining 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
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE	The Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations as follows:  SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE      2024     2023     2024     2023       For the Three Months Ended September 30,     For the Nine Months Ended September 30,       2024     2023     2024     2023   General and administrative   $ 27,208     $ 73,384     $ 94,264     $ 881,365   Research and development     —       40,417       24,680       140,674   Total   $ 27,208     $ 113,801     $ 118,944     $ 1,022,039
Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY	The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2024:  SCHEDULE OF COMPENSATORY WARRANT ACTIVITY      Common Stock       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding – December 31, 2023     2,381     $ 534.44      $ 36.50—$1,270.25       1.25   Granted     —       —        —       —   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     —       —        —       —     The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2023:       Common Stock     Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding – December 31, 2022     3,581     $ 455.88     $ 66.00 — $1,270.25       1.73   Exercised     —       —       —       —   Expired     (1,200 )   $ 300.00     $ 300.00 — $300.00       —   Forfeited     —       —       —       —   Total outstanding – September 30, 2023     2,381     $ 534.44     $ 66.00 — $1,270.25       1.50   Exercisable     2,381     $ 534.44     $ 66.00 — $1,270.25       1.50   Non-Exercisable     —       —       —       —
Non Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY	The following table summarizes the non compensatory equity classified warrant activity for the nine months ended September 30, 2024:  SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY      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       The following table summarizes the non compensatory equity classified warrant activity for the nine months ended September 30, 2023:       Common Stock       Shares     Weighted– Average Exercise Price     Range of Exercise Price     Weighted– Average Remaining Life (Years)   Total outstanding – December 31, 2022     10,941     $ 987.97     $ 66.00 — $1,000.00       0.33   Granted     —       —       —       —   Exercised     —       —       —       —   Expired     (9,114 )   $ 1,000.00     $ 1,000.00 — $1,000.00       —   Forfeited     —       —       —       —   Total outstanding – September 30, 2023     1,827     $ 927.91     $ 66.00—$1,000.00       0.33   Exercisable     1,827     $ 927.91     $ 66.00—$1,000.00       0.33   Non-Exercisable     —       —       —       —

v3.24.3

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Details Narrative) - USD ($)					9 Months Ended
	Oct. 28, 2024	Oct. 09, 2024	Jul. 20, 2023	May 26, 2022	Sep. 30, 2024	Sep. 30, 2023	Sep. 06, 2024	Sep. 05, 2024	Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Warrants exercise price					$ 6.50		$ 6.50	$ 13.00
Common stock, shares authorized					225,000,000				225,000,000
Common stock, par value					$ 0.001				$ 0.001
Impairment losses on construction-in-progress					$ 0	$ 0
Subsequent Event [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Reverse stock split	1-for-50	Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended with the Secretary of State of the State of Delaware to effect a 1-for-50 reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding Common Stock, effective November 5, 2024 at 12:01 a.m., Eastern Time (the “Effective Time”). The Reverse Stock Split was approved by the Company’s stockholders at the Company’s reconvened annual meeting of stockholders held on October 25, 2024, at a ratio of not less than 1-for-10 and not greater than 1-for-50, with the exact ratio, if approved and effected at all, to be set within that range at the discretion of the board of directors. On October 25, 2024, the Board of Directors approved a ratio of 1-for-50 for the Reverse Stock Split. The Amendment provides that at the Effective Time, every 50 shares of the Company’s issued and outstanding Common Stock immediately prior to the Effective Time, will automatically be reclassified, without any action on the part of the holder thereof, into one share of Common Stock. No fractional shares will be issued as a result of the Reverse Stock Split. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof. Equiniti Trust Company is acting as exchange agent for the Reverse Stock Split and will send instructions to stockholders of record who hold stock certificates regarding the exchange of certificates for Common Stock, should they wish to do so. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take any action to effect the exchange of their shares. Commencing on November 5, 2024, trading of the Company’s Common Stock will continue on the Nasdaq Capital Stock Market on a reverse stock split-adjusted basis. The new CUSIP number for the Company’s Common Stock following the Reverse Stock Split is 74754R301.
Common stock, shares authorized	225,000,000
Common stock, par value	$ 0.0001
Pre-funded Warrant [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Warrants to purchase common stock				6,629
Warrants exercise price				$ 0.001
Series B Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stock issued during period shares acquisitions				381,786
Series B Preferred Stock [Member] | Amendment and Settlement Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares surrender			281,000
NanoSynex Ltd [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stock issued during period shares acquisitions				7,000
Voting interests acquired				52.80%
NanoSynex Ltd [Member] | Series A-1 Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stock issued during period shares acquisitions				2,232,861
NanoSynex Ltd [Member] | Series B Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stock issued during period, value, acquisitions				$ 600,000

v3.24.3

LIQUIDITY AND GOING CONCERN (Details Narrative) - USD ($)	1 Months Ended		3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Jul. 31, 2024	Apr. 30, 2024	Sep. 30, 2024	Dec. 31, 2023
Cash	$ 388,000			$ 388,000
Retained earnings accumulated deficit	122,205,753			122,205,753	$ 116,802,384
Restricted cash equivalents				$ 4,000,000.0	$ 11,000,000
Proceeds from issuance of debt		$ 2,000,000.0	$ 1,500,000
Common Stock [Member]
Proceeds from sale of common stock	$ 3,100,000

v3.24.3

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid insurance	$ 313,703	$ 566,011
Other prepaid expenses	63,057	25,053
Prepaid consulting	250,000
Prepaid research and development expenses		173,900
Prepaid expenses and other current assets	$ 626,760	$ 764,964

v3.24.3

SCHEDULE OF SHORT-TERM NOTE RECEIVABLE (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Receivables [Abstract]
Short-term note receivable - Marizyme	$ 1,298,082
Total	$ 1,298,082

v3.24.3

SHORT-TERM NOTE RECEIVABLE - MARIZYME (Details Narrative)	Jul. 15, 2024 USD ($)
Accounts, Notes, Loans and Financing Receivable [Line Items]
Principal amount	$ 1,250,000
Notes Receivable [Member]
Accounts, Notes, Loans and Financing Receivable [Line Items]
Principal amount	$ 1,250,000
Interest rate	18.00%

v3.24.3

SCHEDULE OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Loss on disposal of discontinued operations, net of tax		$ 159,507		$ (683,008)
Income (loss) from discontinued operations, net of tax		(619,545)	(100,000)	(619,545)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		(460,038)	(100,000)	(1,302,553)
Parent Company [Member]
Loss on disposal of discontinued operations, net of tax		90,778		(171,701)
Income (loss) from discontinued operations, net of tax		3,859,465	(100,000)	3,859,465
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		3,950,243	(100,000)	3,687,764
NanoSynex [Member]
Loss on disposal of discontinued operations, net of tax		68,729		(511,307)
Income (loss) from discontinued operations, net of tax		(4,479,010)		(4,479,010)
GAIN (LOSS) FROM DISCONTINUED OPERATIONS		$ (4,410,281)		$ (4,990,317)

v3.24.3

SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
(BENEFIT) PROVISION FOR INCOME TAXES		$ 619,545	$ 100,000	$ 619,545
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.		159,507		(683,008)
Loss attributable to noncontrolling interest		(38,526)		(343,038)
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS		(460,038)	(100,000)	(1,302,553)
NanoSynex [Member]
Research and development		81,640		869,064
Total expenses		81,640		869,064
Loss on disposal of discontinued operations		4,479,010		4,479,010
(BENEFIT) PROVISION FOR INCOME TAXES		(150,369)		(357,757)
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.		(4,410,281)		(4,990,317)
Loss attributable to noncontrolling interest		(1,276,969)		(1,578,481)
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS		(3,133,312)		(3,411,836)
Parent Company [Member]
Net product sales		426,920		3,661,121
Total revenues		426,920		3,661,121
Cost of product sales		269,747		2,551,114
General and administrative		26,346		610,559
Research and development		2,612		206,819
Sales and marketing		37,288		405,626
Total expenses		335,993		3,774,118
Loss on disposal of equipment held for lease				63,302
Other expense (income), net		149		(4,898)
Loss on fixed asset disposal				300
Total other expense (income), net		149		58,704
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.		90,778		(171,701)
Gain on sale of Qualigen, Inc.		3,859,465		3,859,465
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.		3,950,243		3,687,764
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.		90,778		(171,701)
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS		$ 3,950,243	$ (100,000)	$ 3,687,764

v3.24.3

DISCONTINUED OPERATIONS (Details Narrative) - USD ($)			3 Months Ended		9 Months Ended		12 Months Ended
	Jun. 04, 2024	Jul. 20, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	May 26, 2022
Escrow deposits related to property sales	$ 350,000
Loss on disposal of discontinued operations				$ 619,545	$ 100,000	$ 619,545
NanoSynex Ltd [Member]
Business acquisition, percentage of voting interests acquired								52.80%
NanoSynex Ltd [Member] | Maximum [Member]
Business acquisition, percentage of voting interests acquired		49.97%
NanoSynex Ltd [Member] | Maximum [Member] | Series B Preferred Stock [Member]
Business acquisition, percentage of voting interests acquired		52.80%
NanoSynex Ltd [Member] | Minimum [Member]
Business acquisition, percentage of voting interests acquired		39.90%
NanoSynex Ltd [Member] | Minimum [Member] | Series B Preferred Stock [Member]
Business acquisition, percentage of voting interests acquired		49.97%
Until January 20, 2025 [Member]
Escrow deposit		$ 450,000
Chembio diagnostics [Member]
Cash consideration		$ 5,400,000					$ 4,900,000

v3.24.3

SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Board compensation	$ 97,597	$ 129,499
Interest (Convertible debt)	68,318	10,004
License fees	4,907	32,975
Payroll	3,173	1,215
Professional fees	163,270	121,775
Research and development	61,515	104,402
Vacation	164,095	151,286
Other	7,273	8,850
Accrued expenses and other current liabilities	$ 570,148	$ 560,006

v3.24.3

SCHEDULE OF WARRANTS ACTIVITY (Details) - $ / shares	3 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Number of Shares, Warrants Granted	0	0
Series C Warrants [Member] | Common Stock Warrants [Member]
Number of Shares, Warrants Outstanding Beginning		9,113	76,992	76,992
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning		$ 36.50	$ 76.72	$ 76.72
Weighted-Average Remaining Life (Years) Outstanding		4 years 4 months 28 days	3 years 1 month 28 days	5 months 26 days	3 years 10 months 24 days
Number of Shares, Warrants Granted		52,474
Weighted Average Exercise Price Per Share Warrants Granted		$ 10.96
Weighted-Average Remaining Life (Years) Outstanding, Granted		4 years 4 months 28 days
Number of Shares, Warrants Exercised
Weighted Average Exercise Price Per Share Warrants Exercised
Number of Shares, Warrants Outstanding Beginning		2,314
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning		$ 6.50
Weighted-Average Remaining Life (Years) Outstanding, Equity		4 years 4 months 28 days
Number of Shares, Warrants Expired		(25,586)
Weighted Average Exercise Price Per Share Warrants Expired		$ 13.00
Number of Shares, Warrants Forfeited
Weighted Average Exercise Price Per Share Warrants Forfeited
Number of Shares, Warrants Outstanding Ending	38,315	38,315	76,992	9,113	76,992
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 6.50	$ 6.50	$ 76.72	$ 36.50	$ 76.72
Number of Shares, Warrants Exercisable	38,315	38,315	76,992
Weighted Average Exercise Price Per Share Exercisable	$ 6.50	$ 6.50	$ 76.72
Weighted-Average Remaining Life (Years) Exercisable		4 years 4 months 28 days	3 years 1 month 28 days
Series C Warrants [Member] | Common Stock Warrants [Member] | Minimum [Member]
Range of Exercise Price, Beginning		$ 36.50	$ 66.00	66.00
Range of Exercise Price, Granted		6.50
Range of Exercise Price Reclassified Equity		6.50
Expired		13.00
Range of Exercise Price, Ending	6.50	6.50	66.00	36.50	66.00
Range of Exercise Price, Exercisable	6.50	6.50	66.00
Series C Warrants [Member] | Common Stock Warrants [Member] | Maximum [Member]
Range of Exercise Price, Beginning		36.50	82.50	82.50
Range of Exercise Price, Granted		13.00
Range of Exercise Price Reclassified Equity		6.50
Expired		13.00
Range of Exercise Price, Ending	6.50	6.50	82.50	$ 36.50	$ 82.50
Range of Exercise Price, Exercisable	$ 6.50	$ 6.50	$ 82.50

v3.24.3

SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES (Details) - USD ($)		1 Months Ended	9 Months Ended
	Apr. 12, 2024	Apr. 30, 2024	Sep. 30, 2024
Platform Operator, Crypto Asset [Line Items]
Fair value for warrant liabilities			$ 54,600
Common Stock Warrant liabilities, Granted	$ 565,582	$ 565,582	565,582
Common Stock Warrant liabilities, Exercises
Common Stock Warrant liabilities, Reclassified from equity			14,997
Gain on change in fair value of warrant liabilities			(361,137)
Fair value for warrant liabilities			274,042
Fair Value, Inputs, Level 1 [Member]
Platform Operator, Crypto Asset [Line Items]
Fair value for warrant liabilities
Common Stock Warrant liabilities, Granted
Common Stock Warrant liabilities, Exercises
Common Stock Warrant liabilities, Reclassified from equity
Gain on change in fair value of warrant liabilities
Fair value for warrant liabilities
Fair Value, Inputs, Level 2 [Member]
Platform Operator, Crypto Asset [Line Items]
Fair value for warrant liabilities
Common Stock Warrant liabilities, Granted
Common Stock Warrant liabilities, Exercises
Common Stock Warrant liabilities, Reclassified from equity
Gain on change in fair value of warrant liabilities
Fair value for warrant liabilities
Fair Value, Inputs, Level 3 [Member]
Platform Operator, Crypto Asset [Line Items]
Fair value for warrant liabilities			54,600
Common Stock Warrant liabilities, Granted			565,582
Common Stock Warrant liabilities, Exercises
Common Stock Warrant liabilities, Reclassified from equity			14,997
Gain on change in fair value of warrant liabilities			(361,137)
Fair value for warrant liabilities			$ 274,042

v3.24.3

SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES (Details)	Sep. 30, 2024	Sep. 30, 2023
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	3.61	4.523
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	3.61	5.401
Measurement Input, Risk Free Interest Rate [Member] | Weighted Average [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	3.61	4.83
Measurement Input, Price Volatility [Member] | Minimum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	119.5	57.9
Measurement Input, Price Volatility [Member] | Maximum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	119.5	134.5
Measurement Input, Price Volatility [Member] | Weighted Average [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	119.5	108.41
Measurement Input, Expected Term [Member] | Minimum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, term	4 years 4 months 28 days	1 month 20 days
Measurement Input, Expected Term [Member] | Maximum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, term	4 years 4 months 28 days	4 years 8 months 23 days
Measurement Input, Expected Term [Member] | Weighted Average [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, term	4 years 4 months 28 days	3 years 1 month 28 days
Measurement Input, Expected Dividend Rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	0.00	0.00
Measurement Input, Expected Dividend Rate [Member] | Weighted Average [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value assumptions, measurement input, percentages	0.00	0.00

v3.24.3

WARRANT LIABILITIES (Details Narrative) - USD ($)				1 Months Ended	3 Months Ended	9 Months Ended
	Apr. 12, 2024	Dec. 05, 2023	Nov. 24, 2023	Apr. 30, 2024	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 06, 2024	Sep. 05, 2024	Jul. 15, 2024	Jun. 26, 2024	Feb. 27, 2024	Feb. 26, 2024	Dec. 31, 2023	Dec. 04, 2023	Dec. 31, 2022	Dec. 22, 2022	Dec. 21, 2022
Warrants exercise price					$ 6.50	$ 6.50		$ 6.50	$ 13.00
Debt principal amount										$ 1,250,000
Fair value of warrants on grant date	$ 565,582			$ 565,582		$ 565,582
Warrant liabilities					$ 257,492	257,492
Gain on change in fair value of warrant liabilities					$ 2,784	308,090
Fair value of warrants						$ (361,137)	$ (1,377,855)
Alpha Capital [Member]
Warrants shares					2,314	2,314
Warrants exercise price					$ 6.50	$ 6.50						$ 13.00	$ 36.50				$ 36.50	$ 82.50
Common shares					2,314	2,314
Fair value of warrants						$ 14,997
Alpha Capital [Member] | Securities Purchase Agreement [Member]
Warrants exercise price		$ 36.50													$ 82.50
Fair value of warrants		$ 90,000.00
Alpha Capital [Member] | Securities Purchase Agreement [Member] | 2024 Debenture [Member]
Interest rate	8.00%
Debt principal amount	$ 1,100,000
Series C Warrants [Member] | Alpha Capital [Member]
Warrants exercise price																	$ 82.50
Warrant to purchase shares																	50,000
Conversion price percentage																	125.00%
Series C Warrants [Member]
Warrants shares																26,995
Warrants exercise price																$ 66.00
Warrants expired			21,952
Series C Warrants [Member] | Securities Purchase Agreement [Member]
Warrants exercise price		$ 36.50										$ 13.00	$ 36.50		$ 66.00
Series C Warrants [Member] | Alpha Capital [Member] | Securities Purchase Agreement [Member]
Warrant to purchase shares		4,074										16,473
Warrants outstanding												25,586		9,113
Warrants exercisable											25,586	25,586		9,113
Number of shares expired											25,586
Common Stock [Member] | Alpha Capital [Member] | Securities Purchase Agreement [Member]
Warrant to purchase shares	36,001
Common Stock [Member] | Alpha Capital [Member] | Securities Purchase Agreement [Member] | Minimum [Member]
Warrants exercise price								13.00
Common Stock [Member] | Alpha Capital [Member] | Securities Purchase Agreement [Member] | Maximum [Member]
Warrants exercise price								$ 6.50

v3.24.3

SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Nonrelated Party [Member]
Short-Term Debt [Line Items]
Total convertible debt	$ 1,090,002
Related Party [Member]
Short-Term Debt [Line Items]
Total convertible debt	344,229	1,299,216
2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member]
Short-Term Debt [Line Items]
Convertible debt	1,100,000
2024 Senior Convertible Debenture [Member] | Related Party [Member]
Short-Term Debt [Line Items]
Convertible debt	499,021	1,418,922
2024 Discount On Convertible Debenture [Member] | Nonrelated Party [Member]
Short-Term Debt [Line Items]
Discount on convertible debt	(9,998)
2024 Discount On Convertible Debenture [Member] | Related Party [Member]
Short-Term Debt [Line Items]
Discount on convertible debt	$ (154,792)	$ (119,706)

v3.24.3

SCHEDULE OF DERIVATIVE LIABILITIES (Details) - Derivative Financial Instruments, Liabilities [Member]	9 Months Ended
	Sep. 30, 2024 USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance, Beginning
Granted	215,897
Loss on change in fair value of derivative liabilities	321,080
Balance, Ending	536,977
Fair Value, Inputs, Level 1 [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance, Beginning
Granted
Loss on change in fair value of derivative liabilities
Balance, Ending
Fair Value, Inputs, Level 2 [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance, Beginning
Granted
Loss on change in fair value of derivative liabilities
Balance, Ending
Fair Value, Inputs, Level 3 [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance, Beginning
Granted	215,897
Loss on change in fair value of derivative liabilities	321,080
Balance, Ending	$ 536,977

v3.24.3

SCHEDULE OF RANGE OF ASSUMPTIONS USED IN ESTIMATING THE FAIR VALUE OF DERIVATIVE LIABILITIES (Details)	Sep. 30, 2024
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	4.79
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	4.79
Measurement Input, Risk Free Interest Rate [Member] | Weighted Average [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	4.79
Measurement Input, Price Volatility [Member] | Minimum [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	139.5
Measurement Input, Price Volatility [Member] | Maximum [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	139.5
Measurement Input, Price Volatility [Member] | Weighted Average [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	139.5
Measurement Input, Expected Term [Member] | Minimum [Member]
Debt Instrument [Line Items]
Remaining term (years)	3 months
Measurement Input, Expected Term [Member] | Maximum [Member]
Debt Instrument [Line Items]
Remaining term (years)	3 months
Measurement Input, Expected Term [Member] | Weighted Average [Member]
Debt Instrument [Line Items]
Remaining term (years)	3 months
Measurement Input, Expected Dividend Rate [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	0.00
Measurement Input, Expected Dividend Rate [Member] | Weighted Average [Member]
Debt Instrument [Line Items]
Derivative liability, measurement input	0.00

v3.24.3

CONVERTIBLE DEBT (Details Narrative) - USD ($)								1 Months Ended			3 Months Ended		9 Months Ended
	Sep. 09, 2024	Apr. 12, 2024	Feb. 27, 2024	Dec. 05, 2023	Jul. 13, 2023	Jan. 12, 2023	Dec. 22, 2022	Apr. 30, 2024	Dec. 31, 2023	Oct. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 06, 2024	Sep. 05, 2024	Jul. 15, 2024	Feb. 26, 2024	Dec. 04, 2023	Dec. 21, 2022
Short-Term Debt [Line Items]
Principal amount																	$ 1,250,000
Fair value of warrant liability													$ (361,137)	$ (1,377,855)
Warrant exercise price											$ 6.50		$ 6.50		$ 6.50	$ 13.00
Gain loss on extinguishment											$ 1,000		$ 124,000
Interest expense											28,000	$ 368,000	162,000	1,300,000
Accretion expense											28,000		120,000
Bifurcated embedded derivative									$ 0		0	2,200,000	0	2,200,000
Accretion expense												350,000		1,200,000
Derivative gain loss											$ (495,693)		(321,080)
Initial fair value		$ 565,582						$ 565,582					565,582
Common Stock [Member]
Short-Term Debt [Line Items]
Number of shares issued											294,481
2022 Senior Convertible Debenture [Member]
Short-Term Debt [Line Items]
Redeemable debt							$ 110,000
Conversion rate							85.00%
Interest rate							8.00%
2024 Chen Convertible Debenture [Member]
Short-Term Debt [Line Items]
Accretion expense											$ 10,000		18,000
Derivative gain loss											345,000		335,000
Warrants fair value											$ 257,000		257,000
2024 Chen Convertible Debenture [Member] | Nonrelated Party [Member]
Short-Term Debt [Line Items]
Interest expense													60,000
Alpha Capital [Member]
Short-Term Debt [Line Items]
Fair value of warrant liability													$ 14,997
Warrant exercise price			$ 13.00				$ 36.50				$ 6.50		$ 6.50					$ 36.50		$ 82.50
Alpha Capital [Member] | Related Party [Member] | Minimum [Member]
Short-Term Debt [Line Items]
Warrant exercise price											$ 6.50		$ 6.50
Alpha Capital [Member] | Securities Purchase Agreement [Member]
Short-Term Debt [Line Items]
Conversion price per share				$ 36.50															$ 66.00
Fair value of warrant liability				$ 90,000.00
Warrant exercise price				$ 36.50															$ 82.50
Warrant liability to equity				$ 1,600,000
Debt instrument fair value				1,400,000
Gain loss on extinguishment				$ 600,000
Alpha Capital [Member] | Common Stock [Member] | Securities Purchase Agreement [Member]
Short-Term Debt [Line Items]
Purchase of warrants for shares		36,001
Alpha Capital [Member] | Common Stock [Member] | Securities Purchase Agreement [Member] | Maximum [Member]
Short-Term Debt [Line Items]
Warrant exercise price															6.50
Alpha Capital [Member] | Common Stock [Member] | Securities Purchase Agreement [Member] | Minimum [Member]
Short-Term Debt [Line Items]
Warrant exercise price															13.00
Alpha Capital [Member] | 2024 Convertible Debenture [Member] | Securities Purchase Agreement [Member] | Related Party [Member]
Short-Term Debt [Line Items]
Conversion price per share	$ 6.50
Shares of common stock conversion	7,842
Principal amount	$ 50,979
Warrant exercise price			$ 13.00
Purchase of warrants for shares			18,001
Alpha Capital [Member] | 2024 Convertible Debenture [Member] | Securities Purchase Agreement [Member] | Related Party [Member] | Maximum [Member]
Short-Term Debt [Line Items]
Stock Issued During Period, Shares, Period Increase (Decrease)			36,001
Alpha Capital [Member] | 2024 Chen Convertible Debenture [Member] | Securities Purchase Agreement [Member]
Short-Term Debt [Line Items]
Warrant exercise price								$ 6.50
Purchase of warrants for shares								36,001
Alpha Capital [Member] | 2022 Senior Convertible Debenture [Member]
Short-Term Debt [Line Items]
Senior convertible debenture rate							8.00%
Principal amount							$ 3,300,000
Purchase price							$ 3,000,000
Maturity date							Dec. 22, 2025
Conversion price per share						$ 66.00	$ 66.00
Issued and outstanding shares percentage					20.00%
Shares of common stock conversion						16,832					30,378	0	103,865	16,832
Principal amount						$ 1,111,078
Number of shares issued									6,193	6,193
Weighted average conversion price per share											$ 13.00	$ 0	$ 13.66	$ 66.00
Alpha Capital [Member] | 2022 Senior Convertible Debenture [Member] | Common Stock [Member]
Short-Term Debt [Line Items]
Weighted average fair value									$ 35.52	$ 35.52
Weighted average fair value price per share											$ 12.97	$ 0	$ 15.19	$ 66.09
Alpha Capital [Member] | 2024 Convertible Debenture [Member] | Related Party [Member]
Short-Term Debt [Line Items]
Interest rate			8.00%
Gain loss on extinguishment											$ 858,279		$ 858,279
Interest expense											165,000		403,000
Bifurcated embedded derivative											169,000		169,000
Accretion expense											154,000		376,000
Debt term			5 years
Derivative gain loss											$ 151,000		$ 14,000
Alpha Capital [Member] | 2024 Convertible Debenture [Member] | Related Party [Member] | Maximum [Member]
Short-Term Debt [Line Items]
Warrant exercise price											$ 36.50		$ 36.50
Alpha Capital [Member] | 2024 Convertible Debenture [Member] | Securities Purchase Agreement [Member] | Related Party [Member]
Short-Term Debt [Line Items]
Conversion price per share			$ 5.82												6.50	30.56
Principal amount			$ 550,000
Interest rate			8.00%
Cash purchase price payment			$ 500,000
Share price per share			$ 30.56
Alpha Capital [Member] | 2024 Convertible Debenture [Member] | Securities Purchase Agreement [Member] | Related Party [Member] | Maximum [Member]
Short-Term Debt [Line Items]
Principal amount			$ 1,100,000
Alpha Capital [Member] | 2024 Chen Convertible Debenture [Member]
Short-Term Debt [Line Items]
Interest rate								8.00%
Interest expense											$ 32,000
Bifurcated embedded derivative											368,000		$ 368,000
Debt term								5 years
Derivative, Fair Value, Net											33,243		33,243
Derivative fair value of warrants											2,784		308,090
Alpha Capital [Member] | 2024 Chen Convertible Debenture [Member] | Securities Purchase Agreement [Member]
Short-Term Debt [Line Items]
Conversion price per share								$ 5.82							$ 6.50	$ 30.56
Share price per share								$ 30.56
Alpha Capital [Member] | 2024 Chen Convertible Debenture [Member] | Securities Purchase Agreement [Member] | Maximum [Member]
Short-Term Debt [Line Items]
Principal amount								$ 1,100,000
Debt Conversion, Converted Instrument, Amount								$ 1,000,000
Alpha Capital Other Third Parties [Member]
Short-Term Debt [Line Items]
Debt discount													300,000
Fair value of warrant liability													2,800,000
Fair value of embedded derivative features											$ 0		0
Fees and costs paid													$ 100,000

v3.24.3

SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE (Details) - shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total common stock equivalents	342,766	89,523
Share-Based Payment Arrangement, Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total common stock equivalents	6,740	8,324
Warrant [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total common stock equivalents	90,023	81,199
Convertible Debt [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total common stock equivalents	246,003

v3.24.3

RESEARCH AND LICENSE AGREEMENTS (Details Narrative) - USD ($)			1 Months Ended				3 Months Ended			9 Months Ended		47 Months Ended
	Apr. 12, 2024	Apr. 11, 2024	Jul. 31, 2024	Jan. 31, 2022	Jul. 31, 2020	Mar. 31, 2019	Sep. 30, 2024	Apr. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Apr. 30, 2022	Jul. 15, 2024
Research and development expense							$ 123,429		$ 1,441,598	$ 1,242,101	$ 3,898,061
Proceeds from convertible debt			$ 2,000,000.0					$ 1,500,000
Principal amount													$ 1,250,000
License Agreement [Member]
Reimbursement of patent				$ 160,000
License cost							0		12,000	2,000	28,000
Sponsored Research and License Agreement [Member]
License cost							0		0	1,000	22,000
Research and development expense							0		0	0
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member]
Reimbursement of research expenses						$ 693,000				2,900,000
Agreement term payment, description					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.
Marketing approval expenses					$ 300,000
Revenue					500,000,000							$ 500,000,000
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | Minimum [Member]
Upfront license fee					20,000
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | Maximum [Member]
Upfront license fee					100,000
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member]
Reimbursement of research expenses												$ 805,000
Agreement term payment, description												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.
Marketing approval expenses												$ 500,000
Proceeds from convertible debt												50,000
Patent costs												200,000
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Licensed Product Sales [Member]
Cumulative sales					5,000,000							5,000,000
Regulatory marketing approval, expenses												500,000
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Minimum [Member]
Milestone payment					50,000							100,000
Shortfall payments												10,000
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Maximum [Member]
Milestone payment					5,000,000							5,000,000
Shortfall payments												50,000
Sponsored Research Agreements And License [Member]
License cost							22,000		18,000	76,000	47,000
Research and development expense							$ 0		$ 101,000	$ 0	$ 657,000
Co Development Agreement [Member]
Funding payment		$ 1,750,000
Exclusivity fee		$ 200,000
Payment for funding	$ 500,000
Agreements under research and development	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.
Net sales	$ 500,000
Upfront Payment [Member] | License Agreement [Member]
Reimbursement of patent				$ 150,000
Phase 1 Clinical Trial [Member] | License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member]
Milestone payment					50,000							100,000
Phase 2 Clinical Trial [Member] | License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member]
Milestone payment					100,000							200,000
Phase 3 Clinical Trial [Member] | License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member]
Milestone payment					$ 150,000							$ 350,000

v3.24.3

SCHEDULE OF RESERVED SHARES (Details)	Sep. 30, 2024 shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	590,597
Share-Based Payment Arrangement, Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	15,114
Convertible Debt [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	246,004
Warrant [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	329,479

v3.24.3

SCHEDULE OF STOCK OPTION ACTIVITY (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending	6 months 29 days
Employees and Non-employee Service Provider [Member]
Number of shares, options outstanding, beginning	7,978
Range of Exercise price, Options Outstanding	$ 1,760.26
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending	6 years 2 months 19 days	7 years 21 days
Number of shares, options granted
Weighted average exercise price, options granted
Number of shares, options expired
Weighted average exercise price, options expired
Number of shares, options forfeited	(1,239)
Weighted average exercise price, options forfeited	$ 743.77
Number of Shares, Options Outstanding at Ending	6,739	7,978
Range of Exercise price, Options Outstanding	$ 1,947.06	$ 1,760.26
Number of shares, options exercisable (vested)	6,153
Range of exercise price, options exercisable (vested)	$ 2,103.52
Weighted- Average Remaining Contractual Life (in Years), Options Exercisable (vested)	6 years 29 days
Number of shares, options non-exercisable (non-vested)	586
Weighted average exercise price, options non-exercisable (non-vested)	$ 305.69
Weighted- Average Remaining Contractual Life (in Years), Options Non-exercisable (non-vested)	7 years 8 months 15 days
Employees and Non-employee Service Provider [Member] | Minimum [Member]
Range of Exercise price, Options Outstanding	$ 256.80
Range of Exercise price, Options Forfeited	256.80
Range of Exercise price, Options Outstanding	256.80	256.80
Range of exercise price, options exercisable (vested)	256.80
Range of exercise price, options non-exercisable (non-vested)	256.80
Employees and Non-employee Service Provider [Member] | Maximum [Member]
Range of Exercise price, Options Outstanding	2,565.00
Range of Exercise price, Options Forfeited	2,565.00
Range of Exercise price, Options Outstanding	2,565.00	$ 2,565.00
Range of exercise price, options exercisable (vested)	2,565.00
Range of exercise price, options non-exercisable (non-vested)	$ 620.00

v3.24.3

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Total	$ 27,208	$ 118,944	$ 113,801	$ 1,022,039
General and Administrative Expense [Member]
Total	27,208	94,264	73,384	881,365
Research and Development Expense [Member]
Total		$ 24,680	$ 40,417	$ 140,674

v3.24.3

SCHEDULE OF COMPENSATORY WARRANT ACTIVITY (Details) - $ / shares	3 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of shares, warrants granted	0	0
Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of Shares, Warrants Outstanding Beginning		2,381	3,581	3,581
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning		$ 534.44	$ 455.88	$ 455.88
Weighted Average Remaining Life (Years) - outstanding		4 years 6 months	1 year 6 months	1 year 3 months	1 year 8 months 23 days
Number of shares, warrants granted
Weighted average exercise price per share warrants granted
Number of Shares, Warrants Exercised
Weighted average exercise price per share warrants exercised
Number of Shares, Warrants Expired		(520)	(1,200)
Weighted average exercise price per share warrants expired		$ 1,033.15	$ 300.00
Number of Shares, Warrants Forfeited
Weighted average exercise price per share warrants forfeited
Number of Shares, Warrants Outstanding Ending	1,861	1,861	2,381	2,381	3,581
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 351.88	$ 351.88	$ 534.44	$ 534.44	$ 455.88
Number of Shares, Warrants Exercisable	1,861	1,861	2,381
Weighted Average Exercise Price Per Share Exercisable	$ 351.88	$ 351.88	$ 534.44
Weighted Average Remaining Life (Years) Exercisable		8 months 19 days	1 year 6 months
Number of shares, warrants non-exercisable
Weighted Average Exercise Price Per Share Non-Exercisable
Range of Exercise Price, Non-Exercisable
Compensatory Warrant Activity [Member] | Minimum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Range of exercise price - beginning		36.50	66.00	66.00
Range of exercise price, granted
Range of exercise price, expired		1,033.15	300.00
Range of exercise price - ending	6.50	6.50	66.00	36.50	66.00
Range of exercise price, exercisable	6.50	6.50	66.00
Range of Exercise Price, Non-Exercisable
Compensatory Warrant Activity [Member] | Maximum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Range of exercise price - beginning		1,270.25	1,270.25	1,270.25
Range of exercise price, expired		1,033.15	300.00
Range of exercise price - ending	1,270.25	1,270.25	1,270.25	$ 1,270.25	$ 1,270.25
Range of exercise price, exercisable	$ 1,270.25	$ 1,270.25	$ 1,270.25

v3.24.3

SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY (Details) - $ / shares	3 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of shares, warrants granted	0	0
Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of Shares, Warrants Outstanding Beginning		2,381	3,581	3,581
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning		$ 534.44	$ 455.88	$ 455.88
Weighted average remaining life (Years) exercisable		4 years 6 months	1 year 6 months	1 year 3 months	1 year 8 months 23 days
Number of shares, warrants granted
Weighted Average Exercise Price, warrants granted
Number of Shares, Warrants Exercised
Weighted Average Exercise Price, warrants exercised
Number of Shares, Warrants Expired		(520)	(1,200)
Weighted Average Exercise Price, warrants expired		$ 1,033.15	$ 300.00
Number of Shares, Warrants Forfeited
Weighted Average Exercise Price, warrants forfeited
Number of Shares, Warrants Outstanding Ending	1,861	1,861	2,381	2,381	3,581
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 351.88	$ 351.88	$ 534.44	$ 534.44	$ 455.88
Number of Shares, Warrants Exercisable	1,861	1,861	2,381
Weighted Average Exercise Price, exercisable	$ 351.88	$ 351.88	$ 534.44
Range of exercise price, Non-exercisable
Weighted Average Remaining Life (Years) Non-Exercisable		4 years 11 months 8 days
Weighted average remaining life (Years) exercisable		8 months 19 days	1 year 6 months
Minimum [Member] | Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Range of exercise price - beginning		$ 36.50	$ 66.00	66.00
Range of exercise price - ending	6.50	6.50	66.00	36.50	66.00
Range of exercise price, exercisable	6.50	6.50	66.00
Range of exercise price, Non-exercisable
Maximum [Member] | Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Range of exercise price - beginning		1,270.25	1,270.25	1,270.25
Range of exercise price - ending	1,270.25	1,270.25	1,270.25	$ 1,270.25	$ 1,270.25
Range of exercise price, exercisable	1,270.25	$ 1,270.25	$ 1,270.25
Non Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of Shares, Warrants Outstanding Beginning		50,141	10,941	10,941
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning		$ 36.50	$ 987.97	$ 987.97
Weighted average remaining life (Years) exercisable				4 years 5 months 19 days	3 months 29 days
Number of shares, warrants granted		70,021
Weighted Average Exercise Price, warrants granted		$ 6.81
Weighted average remaining life (Years) exercisable granted		4 years 6 months 14 days
Number of shares, warrants outstanding prefunded investor warrants issued		239,456
Weighted average exercise price, warrants prefunded investor warrants issued		$ 0.05
Number of Shares, Warrants Exercised		(31,998)
Weighted Average Exercise Price, warrants exercised		$ 13.00
Number of shares, warrants outstanding reclassified to liabilities		(2,314)
Weighted average exercise price, warrants reclassified to liabilities		$ 6.50
Weighted average remaining life (Years) exercisable reclassified to liabilities		4 years 4 months 28 days
Number of Shares, Warrants Expired			(9,114)
Weighted Average Exercise Price, warrants expired			$ 1,000.00
Range of exercise price, expired
Number of Shares, Warrants Forfeited
Weighted Average Exercise Price, warrants forfeited
Number of Shares, Warrants Outstanding Ending	325,306	325,306	1,827	50,141	10,941
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 6.50	$ 6.50	$ 927.91	$ 36.50	$ 987.97
Number of Shares, Warrants Exercisable	309,287	309,287	1,827
Weighted Average Exercise Price, exercisable	$ 6.50	$ 6.50	$ 927.91
Number of Shares, Warrants Exercisable	16,019	16,019
Weighted Average Exercise Price, exercisable	$ 7.80	$ 7.80
Weighted average remaining life (Years) exercisable			3 months 29 days
Non Compensatory Warrant Activity [Member] | Minimum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Range of exercise price - beginning		36.50	$ 66.00	66.00
Range of exercise price, granted	6.50	6.50
Range of exercise price, granted prefunded prefunded investor warrants issued	0.05	0.05
Range of Exercise Price, Exercised	13.00	13.00
Range of exercise price, reclassified to liabilities	6.50	6.50
Range of exercise price, expired			1,000.00
Range of exercise price, forfeited
Range of exercise price - ending	0.00	0.00	66.00	36.50	66.00
Range of exercise price, exercisable	0.00	0.00	66.00
Range of exercise price, Non-exercisable	7.80	7.80
Non Compensatory Warrant Activity [Member] | Maximum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Range of exercise price - beginning		36.50	1,000.00	1,000.00
Range of exercise price, granted	7.80	7.80
Range of exercise price, granted prefunded prefunded investor warrants issued	0.05	0.05
Range of Exercise Price, Exercised	13.00	13.00
Range of exercise price, reclassified to liabilities	6.50	6.50
Range of exercise price, expired			1,000.00
Range of exercise price - ending	6.50	6.50	1,000.00	$ 36.50	$ 1,000.00
Range of exercise price, exercisable	$ 6.50	$ 6.50	$ 1,000.00

v3.24.3

STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)			3 Months Ended		9 Months Ended
	Sep. 06, 2024	Feb. 27, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 05, 2024	Feb. 26, 2024	Dec. 31, 2023	Dec. 22, 2022	Dec. 21, 2022
Accumulated Other Comprehensive Income (Loss) [Line Items]
Shares reserved for future issuance			590,597		590,597
Preferred stock, shares outstanding			0		0				0
Compensation cost					$ 118,945	$ 1,028,841
Unrecognized compensation cost			$ 19,000		$ 19,000
Cost is expected to be recognized over a weighted average period					6 months 29 days
Warrant exercise price	$ 6.50		$ 6.50		$ 6.50		$ 13.00
Fair value of warrants					$ (361,137)	(1,377,855)
Number of warrants issued			0		0
Compensation cost			$ 27,208	$ 118,944	$ 113,801	1,022,039
Deemed dividend	$ 27,587
Alpha Capital [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Warrant exercise price		$ 13.00	$ 6.50		$ 6.50			$ 36.50		$ 36.50	$ 82.50
Fair value of warrants					$ 14,997
Warrants shares			2,314		2,314
Deemed dividend		$ 60,017
Warrant [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of warrants	1,353	1,353
Warrant exercise price	$ 6.50	$ 13.50					$ 13.50	$ 36.50
Fair value of warrants	$ 2,299	$ 9,737
Number of warrants issued	16,019
Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of warrants issued
Compensation cost			$ 2,000	$ 0	$ 12,000	$ 0
Warrants exercisable			1,861	2,381	1,861	2,381
Pre Funded Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of warrants	239,456
Warrant exercise price	$ 0.05
Share price	$ 6.45
Warrants exercised			$ 0		$ 0
Share-Based Payment Arrangement, Option [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Shares reserved for future issuance			15,114		15,114
Compensation cost					$ 119,000	$ 1,000,000.0
Share-Based Payment Arrangement, Option [Member] | 2020 Stock Incentive Plan [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Shares reserved for future issuance			8,375		8,375				7,136
Options outstanding			6,739		6,739				7,978
Noncompensatory Equity Classified Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Warrant exercise price		$ 13.00
Warrants shares			141		141
Warrants exercisable			141		141
Warrant to purchase shares of common stock		18,001
Noncompensatory Equity Classified Warrants [Member] | Alpha Capital [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of warrants										50,000
Warrant exercise price			$ 6.50		$ 6.50					$ 82.50

v3.24.3

RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)			3 Months Ended		9 Months Ended
	Feb. 27, 2024	Dec. 22, 2022	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 06, 2024	Sep. 05, 2024	Feb. 26, 2024	Dec. 31, 2023	Dec. 21, 2022
Exercise price of warrants			$ 6.50		$ 6.50		$ 6.50	$ 13.00
Noncompensatory Equity Classified Warrants [Member]
Warrants outstanding			141		141
Warrants exercisable			141		141
Exercise price of warrants	$ 13.00
Warrant to purchase shares of common stock	18,001
Warrant [Member]
Number of warrant exercised			0	0	0	0
Warrant to purchase shares	1,353						1,353
Exercise price of warrants	$ 13.50						$ 6.50	$ 13.50	$ 36.50
Alpha Capital [Member]
Warrants outstanding			2,314		2,314
Exercise price of warrants	$ 13.00	$ 36.50	$ 6.50		$ 6.50				$ 36.50		$ 82.50
Warrant to purchase shares			20,460	0	31,998	0
Cumulative proceeds from issuance of warrants					$ 416,000
Alpha Capital [Member] | Noncompensatory Equity Classified Warrants [Member]
Weighted average exercise price			$ 13.00		$ 13.00
Warrant to purchase shares		50,000
Exercise price of warrants		$ 82.50	6.50		$ 6.50
Alpha Capital [Member] | Senior Convertible Debenture [Member]
Senior convertible debenture rate		8.00%
Principal amount		$ 3,300,000								$ 1,418,922
Purchase Price		$ 3,000,000
Debt conversion shares issued					103,876
Weighted average exercise price			$ 13.66		$ 13.66
Alpha Capital [Member] | Convertible Debenture [Member]
Senior convertible debenture rate	8.00%
Principal amount	$ 550,000		$ 50,979		$ 50,979
Purchase Price	$ 500,000
Weighted average exercise price			$ 6.50		$ 6.50
Alpha Capital [Member] | Convertible Debenture [Member] | Common Stock [Member]
Principal amount			$ 499,021		$ 499,021
Debt conversion shares issued					7,846
Weighted average exercise price			$ 6.50		$ 6.50

v3.24.3

SUBSEQUENT EVENTS (Details Narrative)	Oct. 28, 2024	Oct. 09, 2024
Subsequent Event [Member]
Subsequent Event [Line Items]
Description of reverse stock split	1-for-50	Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended with the Secretary of State of the State of Delaware to effect a 1-for-50 reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding Common Stock, effective November 5, 2024 at 12:01 a.m., Eastern Time (the “Effective Time”). The Reverse Stock Split was approved by the Company’s stockholders at the Company’s reconvened annual meeting of stockholders held on October 25, 2024, at a ratio of not less than 1-for-10 and not greater than 1-for-50, with the exact ratio, if approved and effected at all, to be set within that range at the discretion of the board of directors. On October 25, 2024, the Board of Directors approved a ratio of 1-for-50 for the Reverse Stock Split. The Amendment provides that at the Effective Time, every 50 shares of the Company’s issued and outstanding Common Stock immediately prior to the Effective Time, will automatically be reclassified, without any action on the part of the holder thereof, into one share of Common Stock. No fractional shares will be issued as a result of the Reverse Stock Split. Stockholders who otherwise would be entitled to receive a fractional share in connection with the Reverse Stock Split will receive a cash payment in lieu thereof. Equiniti Trust Company is acting as exchange agent for the Reverse Stock Split and will send instructions to stockholders of record who hold stock certificates regarding the exchange of certificates for Common Stock, should they wish to do so. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take any action to effect the exchange of their shares. Commencing on November 5, 2024, trading of the Company’s Common Stock will continue on the Nasdaq Capital Stock Market on a reverse stock split-adjusted basis. The new CUSIP number for the Company’s Common Stock following the Reverse Stock Split is 74754R301.

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