atxi20240930

atxi20240930_10q.htm

Table of Contents

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

☐ 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:

Title of Class	Trading Symbol(s)	Exchange Name
Common Stock	ATXI	Nasdaq Capital Market

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 11, 2024
Common Stock, $0.0001 par value		1,911,633

Table of Contents

AVENUE THERAPEUTICS, INC.

Form 10‑Q

For the Quarter Ended September 30, 2024

Table of Contents

		Page No.
PART I. FINANCIAL INFORMATION

Item 1.	Unaudited Condensed Consolidated Financial Statements

	Unaudited Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	1

	Unaudited Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023	2

	Unaudited Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2024 and 2023	3

	Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	4

	Notes to Unaudited Condensed Consolidated Financial Statements	5

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

Table of Contents

AVENUE THERAPEUTICS, INC.

Unaudited Condensed Consolidated Balance Sheets

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

	*September 30,*			*December 31,*
	*2024*			*2023*

ASSETS
Current assets:
Cash and cash equivalents	$	2,597		$	1,783
Prepaid expenses and other current assets		28			67
Total assets	$	2,625		$	1,850

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable and accrued expenses	$	427		$	287
Accounts payable and accrued expenses - related party		517			323
Warrant liability		29			586
Total current liabilities		973			1,196

Total liabilities		973			1,196

Commitments and contingencies

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, 2024 and December 31, 2023		—			—
Common stock ($0.0001 par value), 200,000,000 and 75,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively
Common shares, 1,604,158 and 341,324 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively		—			3
Additional paid-in capital		103,646			92,507
Accumulated deficit		(101,036	)		(90,928	)
Total stockholders’ equity attributed to the Company		2,610			1,582

Non-controlling interests		(958	)		(928	)
Total stockholders’ equity		1,652			654
Total liabilities and stockholders’ equity	$	2,625		$	1,850

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

Table of Contents

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,*
	*2024*			*2023*			*2024*			*2023*
Operating expenses:
Research and development	$	2,327		$	907		$	6,080		$	5,149
Research and development – licenses acquired		—			—			—			4,230
General and administrative		829			1,161			3,607			3,042
Loss from operations		(3,156	)		(2,068	)		(9,687	)		(12,421	)

Other income (expense):
Interest income		51			9			152			104
Financing costs – warrant liabilities		—			—			—			(332	)
Loss on settlement of common stock warrant liabilities		—			—			(759	)		—
Change in fair value of warrant liabilities		18			2,572			157			1,544
Total other income (expense)		69			2,581			(450	)		1,316
Net income (loss)	$	(3,087	)	$	513		$	(10,137	)	$	(11,105	)

Net loss attributable to non-controlling interests		(11	)		(13	)		(29

SEC Form 10-Q filed by Avenue Therapeutics Inc.