atxi20250930

atxi20250930_10q.htm

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2025

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

For the transition period from to

Commission File Number 001-38114

AVENUE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware	47-4113275
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154

(Address of principal executive offices and zip code)

(781) 652‑4500

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Exchange Act: None

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

Title of Class	Trading Symbol(s)
Common Stock	ATXI (OTC Markets Group, Inc.)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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 definition 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 ☒

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.

Class of Common Stock		Outstanding Shares as of November 12, 2025
Common Stock, $0.0001 par value		3,183,558

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AVENUE THERAPEUTICS, INC.

Form 10‑Q

For the Quarter Ended September 30, 2025

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		Page No.
PART I. FINANCIAL INFORMATION

Item 1.	Unaudited Condensed Consolidated Financial Statements	1

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	10

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	15

Item 4.	Controls and Procedures	15

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	16

Item 1A.	Risk Factors	16

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	16

Item 3.	Defaults Upon Senior Securities	16

Item 4.	Mine Safety Disclosures	16

Item 5.	Other Information	16

Item 6.	Exhibits	17

SIGNATURES		18

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AVENUE THERAPEUTICS, INC.

Unaudited Condensed Consolidated Balance Sheets

($ in thousands, except share and per share amounts)

	*September 30,*			*December 31,*
	*2025*			*2024*

ASSETS
Current assets:
Cash and cash equivalents	$	3,709		$	2,594
Prepaid expenses and other current assets		16			78
Total assets	$	3,725		$	2,672

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable and accrued expenses	$	879		$	654
Accounts payable and accrued expenses - related party		541			146
Warrant liability		2			16
Total current liabilities		1,422			816

Total liabilities		1,422			816

Commitments and contingencies (Note 6)

Stockholders’ equity
Preferred stock ($0.0001 par value), 2,000,000 shares authorized
Class A Preferred Stock, 250,000 shares issued and outstanding as of September 30, 2025 and December 31, 2024		—			—
Common stock ($0.0001 par value), 200,000,000 shares authorized
Common shares, 3,183,558 and 2,108,670 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		—			—
Additional paid-in capital		108,337			105,377
Accumulated deficit		(104,780	)		(102,580	)
Total stockholders’ equity attributed to the Company		3,557			2,797

Non-controlling interests		(1,254	)		(941	)
Total stockholders’ equity		2,303			1,856
Total liabilities and stockholders’ equity	$	3,725		$	2,672

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

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AVENUE THERAPEUTICS, INC.

Unaudited Condensed Consolidated Statements of Operations

($ in thousands, except share and per share amounts)

	*For the Three Months Ended September 30,*						*For the Nine Months Ended September 30,*
	*2025*			*2024*			*2025*			*2024*
Revenue
Other revenue	$	—		$	—		$	1,404		$	—

Operating expenses:
Research and development		177			2,327			780			6,080
General and administrative		547			829			2,955			3,607
Total operating expenses		724			3,156			3,735			9,687
Loss from operations		(724	)		(3,156	)		(2,331	)		(9,687	)

Other income (expense):
Interest income		34			51			96			152
Loss on settlement of common stock warrant liabilities		—			—			—			(759	)
Change in fair value of warrant liabilities		(2	)		18			14			157
Total other income (expense)		32			69			110			(450	)
Net loss	$	(692	)	$	(3,087	)	$	(2,221	)	$	(10,137	)

Net loss attributable to non-controlling interests		(9	)		(11	)		(21	)		(29	)
Net loss attributable to Avenue	$	(683	)	$	(3,076	)	$	(2,200	)	$	(10,108	)

Net loss attributable to common stockholders	$	(683	)	$	(3,076	)	$	(2,200	)	$	(18,918	)

Net loss per common share attributable to common stockholders, basic and diluted	$	(0.21	)	$	(1.92	)	$	(0.71	)	$	(17.27	)

Weighted average number of common shares outstanding, basic and diluted		3,183,558			1,600,189			3,113,464			1,095,180

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

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AVENUE THERAPEUTICS, INC.

Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity

($ in thousands, except share amounts)

*Three months ended September 30, 2025*

	*Class A Preferred*								*Additional*					*Non-*			*Total*
	*Shares*				*Common Shares*				*Paid-in*		*Accumulated*			*Controlling*			*Stockholders’*
	*Shares*		*Amount*		*Shares*		*Amount*		*Capital*		*Deficit*			*Interests*			*Equity*
Balance at June 30, 2025		250,000	$	—		3,183,558	$	—	$	108,155	$	(104,097	)	$	(1,226	)	$	2,832
Share based compensation		—		—		—		—		163		—			—			163
Non-controlling interest in subsidiaries		—		—		—		—		19		—			(19	)		—
Net loss attributable to non-controlling interest		—		—		—		—		—		—			(9	)		(9	)
Net loss attributable to common stockholders		—		—		—		—		—		(683	)		—			(683	)
Balance at September 30, 2025		250,000	$	—		3,183,558	$	—	$	108,337	$	(104,780	)	$	(1,254	)	$	2,303

*Nine Months Ended September 30, 2025*

	*Class A Preferred*								*Additional*						*Non-*			*Total*
	*Shares*				*Common Shares*				*Paid-in*			*Accumulated*			*Controlling*			*Stockholders’*
	*Shares*		*Amount*		*Shares*		*Amount*		*Capital*			*Deficit*			*Interests*			*Equity*
Balance at December 31, 2024		250,000	$	—		2,108,670	$	—	$	105,377		$	(102,580	)	$	(941	)	$	1,856
Share based compensation		—		—		239		—		523			—			—			523
Issuance of common stock to Fortress		—		—		135,659		—		55			—			—			55
Issuance of common stock, net of offering costs under open market sales agreement (ATM)		—		—		938,990		—		2,094			—			—			2,094
Shares receivable from AnnJi		—		—		—		—		(4	)		—			—			(4	)
Non-controlling interest in subsidiaries		—		—		—		—		292			—			(292	)		—
Net loss attributable to non-controlling interest		—		—		—		—		—			—			(21	)		(21	)
Net loss attributable to common stockholders		—		—		—		—		—			(2,200	)		—			(2,200	)
Balance at September 30, 2025		250,000	$	—		3,183,558	$	—	$	108,337		$	(104,780	)	$	(1,254	)	$	2,303

*Three months ended September 30, 2024*

	*Class A Preferred*								*Additional*					*Non-*			*Total*
	*Shares*				*Common Shares*				*Paid-in*		*Accumulated*			*Controlling*			*Stockholders’*
	*Shares*		*Amount*		*Shares*		*Amount*		*Capital*		*Deficit*			*Interests*			*Equity*
Balance at June 30, 2024		250,000	$	—		1,189,724	$	—	$	102,724	$	(97,960	)	$	(937	)	$	3,827
Share based compensation		—		—		—		—		331		—			—			331
Common shares issuable - Founders Agreement		—		—		4,023		—		14		—			—			14
Exercise of warrants		—		—		253,500		—		—		—			—			—
Issuance of common stock, net of offering costs under open market sales agreement (ATM)		—		—		160,934		—		567		—			—			567
Non-controlling interest in subsidiaries		—		—		—		—		10		—			(10	)		—
Net loss attributable to non-controlling interest		—		—		—		—		—		—			(11	)		(11	)
Net loss attributable to common stockholders		—		—		—		—		—		(3,076	)		—			(3,076	)
Balance at September 30, 2024		250,000	$	—		1,608,181	$	—	$	103,646	$	(101,036	)	$	(958	)	$	1,652

*Nine Months Ended September 30, 2024*

	*Class A Preferred*								*Additional*						*Non-*			*Total*
	*Shares*				*Common Shares*				*Paid-in*			*Accumulated*			*Controlling*			*Stockholders’*
	*Shares*		*Amount*		*Shares*		*Amount*		*Capital*			*Deficit*			*Interests*			*Equity*
Balance at December 31, 2023		250,000	$	—		341,324	$	3	$	92,507		$	(90,928	)	$	(928	)	$	654
Share based compensation		—		—		283		—		714			—			—			714
Common shares issuable - Founders Agreement		—		—		4,023		—		(357	)		—			—			(357	)
Issuance of common stock to Fortress		—		—		53,586		—		543			—			—			543
Loss on settlement of common stock warrant liabilities		—		—		—		—		1,159			—			—			1,159
Exercise of warrants		—		—		876,806		1		9,420			—			—			9,421
Warrant inducement offering costs		—		—		—		—		(1,207	)		—			—

SEC Form 10-Q filed by Avenue Therapeutics Inc.