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 March 31, 2022

☐ 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.)

1140 Avenue of the Americas, Floor 9 New York, NY 10036

(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 May 7, 2022
Common Stock, $0.0001 par value		22,134,784


		Page No.
PART I. FINANCIAL INFORMATION

Item 1.	Unaudited Interim Condensed Financial Statements

	Condensed Balance Sheets as of March 31, 2022 (unaudited) and December 31, 2021	3

	Unaudited Condensed Statements of Operations for the three months ended March 31, 2022 and 2021	4

	Unaudited Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2022 and 2021	5

	Unaudited Condensed Statements of Cash Flows for the three months ended March 31, 2022 and 2021	6

	Notes to Unaudited Interim Condensed Financial Statements	7

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

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	14

Item 4.	Controls and Procedures	14

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	45

Item 3.	Defaults Upon Senior Securities	45

Item 4.	Mine Safety Disclosures	46

Item 5.	Other Information	46

Item 6.	Exhibits	46

Signatures		47


	March 31,		December 31,
	2022		2021
	(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents	$	1,833	$	3,763
Other receivables - related party		—		90
Prepaid expenses and other current assets		123		107
Total Assets	$	1,956	$	3,960

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable and accrued expenses	$	746	$	451
Accounts payable and accrued expenses - related party		51		58
Total current liabilities		797		509

Total Liabilities		797		509

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 March 31, 2022 and December 31, 2021		—		—
Common Stock ($0.0001 par value), 50,000,000 shares authorized
Common shares, 22,134,784 and 21,089,658 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively		2		2
Additional paid-in capital		81,017		80,448
Accumulated deficit		(79,860)		(76,999)
Total Stockholders’ Equity		1,159		3,451
Total Liabilities and Stockholders’ Equity	$	1,956	$	3,960


	For the Three Months Ended
	March 31,		March 31,
	2022		2021
Operating expenses:
Research and development	$	1,808	$	258
General and administrative		1,055		743
Loss from operations		(2,863)		(1,001)

Interest income		(2)		(3)
Net Loss	$	(2,861)	$	(998)

Net loss per common share outstanding, basic and diluted	$	(0.14)	$	(0.06)

Weighted average number of common shares outstanding, basic and diluted		20,957,181		16,556,320


Three months ended March 31, 2022

	Class A Preferred						Additional				Total
	Shares			Common Shares			paid-in		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		capital		deficit		equity
Balance at December 31, 2021	250,000	$	—	21,089,658	$	2	$	80,448	$	(76,999)	$	3,451
Share based compensation	—		—	1,045,126		—		569		—		569
Net loss	—		—	—		—		—		(2,861)		(2,861)
Balance at March 31, 2022	250,000	$	—	22,134,784	$	2	$	81,017	$	(79,860)	$	1,159


Three months ended March 31, 2021

	Class A Preferred						Additional				Total
	Shares			Common Shares			paid-in		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		capital		deficit		equity
Balance at December 31, 2020	250,000	$	—	16,747,803	$	2	$	75,625	$	(73,268)	$	2,359
Share based compensation	—		—	—		—		114		—		114
Cashless exercise of warrants	—		—	265		—		—		—		—
Net loss	—		—	—		—		—		(998)		(998)
Balance at March 31, 2021	250,000	$	—	16,748,068	$	2	$	75,739	$	(74,266)	$	1,475


	For the Three Months Ended
	March 31, 2022		March 31, 2021
Cash flows from operating activities:
Net loss	$	(2,861)	$	(998)
Adjustments to reconcile net loss to net cash used in operating activities:
Share based compensation		569		114
Changes in operating assets and liabilities:
Other receivables - related party		90		—
Prepaid expenses and other current assets		(16)		(6)
Accounts payable and accrued expenses		295		(468)
Accounts payable and accrued expenses - related party		(7)		51
Net cash and cash equivalents used in operating activities		(1,930)		(1,307)

Net change in cash and cash equivalents		(1,930)		(1,307)
Cash and cash equivalents, beginning of period		3,763		3,132
Cash and cash equivalents, end of period	$	1,833	$	1,825


	As of March 31,		As of December 31,
	2022		2021
Accounts payable	$	493	$	304
Accrued employee compensation		45		24
Accrued contracted services and other		208		123
Accounts payable and accrued expenses	$	746	$	451


		Weighted
	Number of Units	Average Grant
	and Awards	Date Fair Value
Unvested balance at December 31, 2021	1,416,356	$	3.75
Forfeited	(10,000)	$	0.93
Vested	(1,085,126)	$	2.52
Unvested balance at March 31, 2022	321,230	$	2.21


	For The Three Months Ended				Change
	March 31,
($ in thousands)	2022		2021		$		%
Operating expenses:
Research and development	$	1,808	$	258	$	1,550	601	%
General and administrative		1,055		743		312	42	%
Loss from operations		(2,863)		(1,001)		(1,862)	186	%

Interest income		(2)		(3)		(1)	(33)	%
Net Loss	$	(2,861)	$	(998)	$	(1,863)	187	%

SEC Form 10-Q filed by Avenue Therapeutics Inc.