UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 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: 001-37467

Astria Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		26-3687168
(State or Other Jurisdiction of Incorporation or Organization)		(IRS Employer Identification No.)

75 State Street Suite 1400
Boston, Massachusetts		02109
(Address of Principal Executive Offices)		(Zip Code)

(617) 349-1971

(Registrant’s Telephone Number, Including Area Code)

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value per share		ATXS		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 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 April 30, 2024, there were 54,913,061 shares of the registrant’s common stock, par value $0.001 per share, outstanding.

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		Page
PART I. FINANCIAL INFORMATION		5
Item 1.	Financial Statements (unaudited)	5
	Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023	5
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2024 and 2023	6
	Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2024 and 2023	7
	Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity for the three months ended March 31, 2024 and 2023	8
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023	10
	Notes to Condensed Consolidated Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 4.	Controls and Procedures	28
PART II. OTHER INFORMATION		29
Item 1A.	Risk Factors	29
Item 5.	Other Information	29
Item 6.	Exhibits	30

SIGNATURES		31

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance, strategy, future financial condition and clinical and preclinical development programs. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, clinical and preclinical development programs, regulatory filings and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

●

our expectations regarding the potential significance of the results from the Phase 1a clinical trial of STAR-0215;

●

our expectations regarding the potential significance of the initial results from the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215, including our expectation that the results from such trial could allow us to move directly into a Phase 3 pivotal trial of STAR-0215 as a potential treatment for hereditary angioedema, or HAE, immediately followed by a second Phase 3 trial to support label expansion to dosing every six months;

●

our expectations regarding the timing of reporting additional data from the ALPHA-STAR trial and reporting initial safety and efficacy data from the ALPHA-SOLAR long-term open-label trial of STAR-0215;

●

our expectations about the design and anticipated timing of a Phase 3 pivotal trial for STAR-0215 as a potential treatment for HAE and a second Phase 3 trial to support label expansion to dosing every six months;

●

our expectations about the unmet medical need for HAE, the potential differentiating attributes of STAR-0215 as a potential treatment for HAE, along with the potential market impact of such differentiation, the potential of STAR-0215 to be a best-in-class monoclonal antibody inhibitor of plasma kallikrein able to provide long-acting, effective attack prevention for HAE, and our vision for STAR-0215 to become the first-choice preventative treatment for HAE with administration every three or six months with the goal of normalizing the lives of people living with HAE;

●

the nature and anticipated growth of the global HAE market and HAE therapies;

●

our plans to optimize the formulation of STAR-0215 and corresponding work to develop a drug-device combination for STAR-0215 for potential use in late-stage clinical trials and commercially, if approved;

●

our expectations that we have scaled the manufacturing process for STAR-0215 in a manner to generate sufficient material for our planned STAR-0215 nonclinical and clinical studies;

●

the potential therapeutic benefits and potential attributes of STAR-0310, a preclinical stage product candidate which we licensed in October 2023, and our plans to develop STAR-0310 as a treatment for atopic dermatitis, or AD;

●

our expectations regarding the timing of regulatory submissions for STAR-0310;

●

our expectations about the design and anticipated timing of planned clinical trials of STAR-0310;

●

our expectations regarding the timing and nature of anticipated data for planned clinical trials of STAR-0310;

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●

the potential commercial opportunity for STAR-0310 in AD and the likelihood that it can effectively compete in AD, assuming it is approved;

●

the estimated size and anticipated growth of the AD market and the need for treatments for AD;

●

the potential to pursue the development of STAR-0310 in additional indications;

●

our goals and visions for the STAR-0310 program;

●

our expectations regarding our ability to expand our pipeline;

●

the potential benefits of any future acquisition, in-license, collaboration or preclinical development activities;

●

our manufacturing plans, capabilities and strategy;

●

our intellectual property position and strategy;

●

our estimates regarding our cash runway, expenses, future revenue, capital requirements and needs for additional financing, including additional financing to fund our long-term operations;

●

developments relating to our competitors and our industry; and

●

the impact of government laws and regulations.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, particularly in the sections entitled “Summary of the Material Risks Associated with Our Business” and “Risk Factors”, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or enter into.

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PART I- FINANCIAL INFORMATION

Item 1. Financial Statements

Astria Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)


	March 31,		December 31,
	2024		2023
Assets
Current assets:
Cash and cash equivalents	$	172,012	$	175,530
Short-term investments		197,895		71,000
Prepaid expenses and other current assets		4,614		4,412
Total current assets		374,521		250,942
Right-of-use asset		210		363
Other assets		4,076		3,361
Total assets	$	378,807	$	254,666
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	862	$	1,513
Accrued expenses		10,042		9,708
Current portion of operating lease liabilities		168		329
Total current liabilities		11,072		11,550
Total liabilities		11,072		11,550
Commitments (Note 6)
Stockholders’ equity:
Preferred stock, $0.001 par value per share, 4,908,620 shares authorized and no shares issued and outstanding		—		—
Series X redeemable convertible preferred stock, $0.001 par value per share, 91,380 shares authorized; 31,107 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively		95,324		95,324
Common stock, $0.001 par value per share, 150,000,000 shares authorized; 54,903,061 and 41,034,797 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		55		41
Additional paid-in capital		872,832		728,285
Accumulated other comprehensive loss		(14)		—
Accumulated deficit		(600,462)		(580,534)
Total stockholders’ equity		367,735		243,116
Total liabilities and stockholders’ equity	$	378,807	$	254,666

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

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Astria Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)


	Three Months Ended March 31,
	2024		2023
Operating expenses:
Research and development	$	15,726	$	8,033
General and administrative		8,424		5,460
Total operating expenses		24,150		13,493
Loss from operations		(24,150)		(13,493)
Other income (expense):
Interest and investment income		4,241		2,321
Other expense, net		(19)		(16)
Total other income, net		4,222		2,305
Net loss		(19,928)		(11,188)
Net loss per share attributable to common shareholders - basic and diluted	$	(0.38)	$	(0.40)
Weighted-average common shares outstanding used in net loss per share - basic and diluted		52,294,765		27,944,458

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

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Astria Therapeutics, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)


	Three Months Ended March 31,
	2024		2023
Net loss	$	(19,928)	$	(11,188)
Other comprehensive (loss) gain:
Unrealized (loss) gain on short-term investments, net of tax of $0		(14)		75
Total other comprehensive (loss) gain:		(14)		75
Comprehensive loss	$	(19,942)	$	(11,113)

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

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Astria Therapeutics, Inc.

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity

(In thousands, except shares)

(Unaudited)


	Series X	Series X
	redeemable	redeemable									Accumulated
	convertible	convertible					Additional				other			Total
	preferred stock,	preferred stock,		Common stock,	Common stock,		paid-in		Accumulated		comprehensive			stockholders’
	shares	value		shares	par value		capital		deficit		loss			equity
Balance at December 31, 2023	31,107	$	95,324	41,034,797	$	41	$	728,285	$	(580,534)	$	—	$	243,116
Issuance of common stock pursuant to an underwriting agreement, net of underwriter’s discount and issuance costs	—		—	10,340,000		10		117,162		—		—		117,172
Issuance of common stock for at-the-market offerings, net of issuance costs	—		—	2,945,806		3		19,999		—		—		20,002
Issuance of common stock upon exercise of options and warrants	—		—	582,458		1		4,632		—		—		4,633
Stock-based compensation expense	—		—	—		—		2,754		—		—		2,754
Unrealized loss on short-term investments	—		—	—		—		—		—		(14)		(14)
Net loss	—		—	—		—		—		(19,928)		—		(19,928)
Balance at March 31, 2024	31,107	$	95,324	54,903,061	$	55	$	872,832	$	(600,462)	$	(14)	$	367,735

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

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Astria Therapeutics, Inc.

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity

(In thousands, except shares)

(Unaudited)

SEC Form 10-Q filed by Astria Therapeutics Inc.