ATXS Astria Therapeutics Inc

-- ALPHA-STAR Phase 1b/2 Trial Initial Proof-of-Concept Results Support Potential for STAR-0215 to Become the Market Leader in HAE with Q3M and Q6M Administration --

-- Preclinical Results for STAR-0310, Potential Best-in-Class OX40 Program for the Treatment of Atopic Dermatitis, to be Shared at Upcoming Society for Investigative Dermatology Conference --

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

“We are thrilled with the ALPHA-STAR initial proof-of-concept results that we shared in March, and believe that STAR-0215 can be a life-changing therapy for people living with HAE,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “The efficacy we have seen to date, along with the favorable safety and tolerability profile with no injection pain observed, support the ability to administer STAR-0215 every three and every six months and give us confidence that we are developing a therapy that has the potential to lead the HAE market. We are progressing to a pivotal Phase 3 trial, expected to initiate in Q1 2025 for our Q3M regimen. Our plans are to develop a Q3M regimen first to take the fastest path to market, and then to rapidly expand the label with Q6M administration to further reduce the treatment burden for people with HAE.”

STAR-0215

• The Company shared positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with hereditary angioedema (HAE) in March 2024. STAR-0215 dosed once or twice over six months reduced monthly attack rates by 90-96% and supports chronic dosing two or four times per year. The trial saw a 92-100% decrease in moderate or severe attacks and a 91-95% reduction in attacks requiring rescue medications with STAR-0215. Additionally, STAR-0215 was very well-tolerated with no serious adverse events and no discontinuations. Initial pharmacodynamic data show strong, durable, and clinically-relevant inhibition of plasma kallikrein through up to six months after one or two doses. Initial pharmacokinetic data are consistent with modeling developed from the Phase 1a data. The Company plans to report additional data from ALPHA-STAR in the second half of 2024.
• Based on the positive results from the ALPHA-STAR trial, Astria plans to advance STAR-0215 to Phase 3 development. To progress STAR-0215 to market as quickly as possible, the Company plans to start the Phase 3 program with Q3M dosing, with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026. The company believes STAR-0215 Q3M dosing will be life-changing for HAE patients, the fastest path to market, and help to establish STAR-0215 as the market leader in HAE. Following the enrollment of the Q3M Phase 3 trial, the Company plans to initiate a Q6M Phase 3 trial to support label expansion with the goal of further solidifying STAR-0215’s leadership position in the HAE market.
• After completion of the ALPHA-STAR trial, patients have the opportunity to continue to receive STAR-0215 every three or six months in the long-term open-label Phase 2 ALPHA-SOLAR trial. Initial safety and efficacy data from ALPHA-SOLAR, including from Q3M and Q6M administration, are expected mid-2025.

STAR-0310

• Astria is developing STAR-0310, a high affinity monoclonal antibody OX40 antagonist that incorporates YTE technology, for the treatment of atopic dermatitis (AD).
• STAR-0310, a preclinical stage program, has the potential to have the best-in-class profile in AD. Astria is on track to submit an Investigational New Drug (IND) application for STAR-0310 by year-end 2024 and plans to initiate a Phase 1a clinical trial in healthy subjects in the first quarter of 2025, with initial results from the trial expected in the third quarter of 2025.
• Astria will present a poster titled, “Preclinical Profile of STAR-0310, a Novel OX40 Antagonistic Monoclonal Antibody” at the Society for Investigative Dermatology (SID) Annual Meeting in Dallas, Texas. The poster will be available during Session One of the Pharmacology and Therapeutic Development Select E-Poster Discussions on May 16, 2024 at 5:00pm CST.

Corporate Updates

• Astria recently published its inaugural Corporate Social Responsibility (CSR) Report. The 2023 report provides a comprehensive update on the Company’s performance and progress across key Environmental, Social, and Governance (ESG) areas of focus. To learn more about Astria’s CSR initiatives, please view the full report at this link: https://ir.astriatx.com/corporate-social-responsibility.
• Astria appointed Sunil Agarwal, M.D., to its Board of Directors. Dr. Agarwal has more than 20 years of biotechnology research, development, and commercialization experience.

First Quarter 2024 Financial Results

Cash Position: As of March 31, 2024, Astria had cash, cash equivalents and short-term investments of $369.9 million, compared to $246.5 million as of December 31, 2023. The Company expects that its cash, cash equivalents and short-term investments as of March 31, 2024 will be sufficient to fund its operations into mid-2027, including all STAR-0215 program activities through the completion of a planned Q3M Phase 3 pivotal trial as well as advancing the STAR-0310 OX40 program through submission of an IND and early proof-of-concept results from a Phase 1a clinical trial. Net cash used in operating activities for the three months ended March 31, 2024 was $19.1 million, compared to $13.3 million for the three months ended March 31, 2023.

R&D Expenses: Research and development expenses were $15.7 million for the three months ended March 31, 2024, compared to $8.0 million for the three months ended March 31, 2023. The increase in research and development expenses was primarily associated with our STAR-0215 program’s advancement in our multi-site international clinical trials in addition to external research and development costs associated with our STAR-0310 program including manufacturing and IND-enabling activities.

G&A Expenses: General and administrative expenses were $8.4 million for the three months ended March 31, 2024, compared to $5.5 million for the three months ended March 31, 2023. The increase in general and administrative expenses was primarily attributable to company growth and supporting activities for the advancement of our programs.

Operating Loss: Loss from operations was $24.2 million for the three months ended March 31, 2024, compared to $13.5 million for the three months ended March 31, 2023.

Net Loss: Net loss was $19.9 million for the three months ended March 31, 2024, compared to a net loss of $11.2 million for the three months ended March 31, 2023.

Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was $0.38 for the three months ended March 31, 2024, compared to a net loss basic and diluted of $0.40 per share for the three months ended March 31, 2023.

About Astria Therapeutics:

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in preclinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on X and Instagram @AstriaTx and on Facebook and LinkedIn.

Forward Looking Statements:

This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: our expectations regarding the potential significance of the initial results from the Phase 1b/2 ALPHA-STAR clinical trial of STAR-0215, and that the results from such trial will allow us to move directly into a Phase 3 trial of STAR-0215 as a potential treatment for hereditary angioedema (HAE); the expected timing of the release of additional data from the ALPHA-STAR trial; the expected timing of initiation and design of the planned Phase 3 trials of STAR-0215; the expected timing of release of the safety and efficacy data from the ALPHA-SOLAR trial; the potential for STAR-0215 in the HAE market, including to be the market leader, and to have the best-in-class profile in HAE, the potential therapeutic benefits of STAR-0215 as a treatment for HAE and our vision and goals for the program; the potential for STAR-0310 to have the best-in-class profile in AD and the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the timing of regulatory filings for STAR-0310; expectations regarding the timing of initiation and planned design of clinical trials for STAR-0310; the expectations regarding the timing and nature of anticipated data for planned trials of STAR-0310; our goals and vision for STAR-0310; anticipated cash runway; and the goal to meet the unmet needs of patients with rare and niche allergic and immunological diseases. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or "vision," and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Astria’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of the Astria’s product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the following risks and uncertainties: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and/or competitive factors; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies may not be replicated in clinical trials, that the preliminary or interim results from clinical trials may not be indicative of the final results, that the results of early stage clinical trials, such as the results from the Phase 1a clinical trial, may not be replicated in later stage clinical trials, including the ALPHA-STAR trial, the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the U.S. Food and Drug Administration and other regulatory authorities on our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including investigational review boards at such sites, and other review bodies with respect to STAR-0215, STAR-0310, and any other future development candidates; our ability to manufacture sufficient quantities of drug substance and drug product for STAR-0215, STAR-0310, and any other future product candidates on a cost-effective and timely basis, and to develop dosages and formulation for STAR-0215, STAR-0310, and any other future product candidates that are patient-friendly and competitive; our ability to develop biomarker and other assays, along with the testing protocols therefore; our ability to obtain, maintain and enforce intellectual property rights for STAR-0215, STAR-0310, and any other future product candidates; our potential dependence on collaboration partners; competition with respect to STAR-0215, STAR-0310, or any of our other future product candidates; the risk that survey results and market research may not be accurate predictors of the commercial landscape for HAE, the ability of STAR-0215 to compete in HAE and the anticipated position and attributes of STAR-0215 in HAE based on clinical data to date, its preclinical profile, pharmacokinetic modeling, market research and other data; risks that any of our clinical trials of STAR-0310 may not commence, continue or be completed on time, or at all; risks that results of preclinical studies of STAR-0310 will not be replicated in clinical trials; risks with respect to the ability of STAR-0310 to compete in AD and the anticipated position and attributes of STAR-0310 in AD based on its preclinical profile; our ability to manage our cash usage and the possibility of unexpected cash expenditures; our ability to obtain necessary financing to conduct our planned activities and to manage unplanned cash requirements; the risks and uncertainties related to our ability to recognize the benefits of any additional acquisitions, licenses or similar transactions; and general economic and market conditions; as well as the risks and uncertainties discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the period ended December 31, 2023 and in other filings that we may make with the Securities and Exchange Commission.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Astria may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on Astria’s forward-looking statements. Neither Astria, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Astria’s views as of any date subsequent to the date hereof.

Astria Therapeutics, Inc. 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

 

Astria Therapeutics, Inc. Selected Consolidated Balance Sheets Data (In thousands) (Unaudited)

March 31, December 31,

2024

 

2023

Assets Cash and cash equivalents

$

172,012

$

175,530

Short-term investments

 

197,895

 

71,000

Right-of-use asset

 

210

 

363

Other current and long-term assets

 

8,690

 

7,773

Total assets

 

378,807

 

254,666

Liabilities and stockholders’ equity Current portion of operating lease liabilities

 

168

 

329

Other current and long-term liabilities

 

10,904

 

11,221

Total liabilities

 

11,072

 

11,550

Total stockholders’ equity

$

367,735

$

243,116

Astria Therapeutics, Inc. Selected Consolidated Statements of Cash Flows Data (In thousands) (Unaudited)

Three Months Ended March 31,

 

2024

 

 

 

2023

 

Net cash used in operating activities

$

(19,094

)

$

(13,253

)

Net cash (used in) provided by investing activities

 

(126,231

)

 

194,992

 

Net cash provided by financing activities

 

141,807

 

 

37

 

Net (decrease) increase in cash, cash equivalents and restricted cash

$

(3,518

)

$

181,776

 

 

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Investor Relations and Media: Elizabeth Higgins investors@astriatx.com