Astria Therapeutics Reports First Quarter 2025 Financial Results and Provides a Corporate Update

-- ALPHA-ORBIT Pivotal Phase 3 Trial Evaluating Every 3- and Every 6-Month Administration of Navenibart (STAR-0215) in Hereditary Angioedema is Enrolling Patients --

-- Upcoming Navenibart and STAR-0310 Data: ALPHA-SOLAR Long-Term Extension Trial Results Expected Mid-2025 and Phase 1a STAR-0310 Healthy Subject Results Expected in Q3 2025 --

BOSTON--(BUSINESS WIRE)--May 13, 2025-- 

Astria Therapeutics, Inc. $(ATXS)$, a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today reported financial results for the first quarter ended March 31, 2025, and provided a corporate update.

"As a late-stage clinical company, we are focused on delivering on navenibart, a therapy with a trusted mechanism and modality, best-in-class profile, and the potential to change the way that people live with HAE," said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. "Our goal is to ensure that navenibart reaches its full potential as the market-leading HAE therapy. We are thrilled with patient and physician enthusiasm for the program as we enroll patients in our trial. With STAR-0310, we anticipate early proof-of-concept results from the Phase 1a trial in Q3, which we expect to be informative on differentiation regarding efficacy, safety, and low treatment burden and next steps."

Navenibart (STAR-0215)

   -- The ALPHA-ORBIT pivotal Phase 3 trial of navenibart in people with 
      hereditary angioedema $(HAE)$ is enrolling patients, with top-line results 
      expected in early 2027. The ALPHA-ORBIT trial is a global, randomized, 
      double-blind, placebo-controlled Phase 3 clinical trial to evaluate the 
      efficacy and safety of navenibart over 6 months and includes both every 
      3-month (Q3M) and every 6-month (Q6M) treatment arms. The primary 
      endpoint is time-normalized monthly HAE attacks at 6 months, and a key 
      secondary endpoint includes the proportion of participants who are 
      attack-free at 6 months. After 6 months, patients may be eligible to 
      enter a long-term trial called ORBIT-EXPANSE, in which all patients will 
      be treated with navenibart and which will include a patient-centered 
      flexible dosing period and assess the long-term safety and tolerability 
      as well as efficacy of navenibart. The navenibart Phase 3 program 
      consists of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term 
      trial, which are designed to support registration globally. 
 
   -- Positive final top-line results from target enrollment in the Phase 1b/2 
      ALPHA-STAR trial of navenibart, announced in December 2024, showed rapid 
      onset of robust and durable efficacy, favorable safety and tolerability, 
      and pharmacokinetics and pharmacodynamics consistent with sustained 
      plasma kallikrein inhibition for both Q3M and Q6M administration. Final 
      results included reduction in mean monthly attack rate of 90-95% and up 
      to a 67% attack-free rate over 6 months. 
 
   -- All of the 16 target enrollment patients from ALPHA-STAR have entered the 
      ALPHA-SOLAR long-term open-label trial. Initial safety and efficacy data 
      from ALPHA-SOLAR, with long-term Q3M and Q6M administration, are expected 
      mid-2025. 
 
   -- Physician market research (n=50) reinforced the potential for navenibart 
      to be the market-leading therapy for HAE. Physicians anticipated that 
      offering both Q3M and Q6M options would gain 53% of their patient share 
      for those initiating preventative therapy for the first time based on the 
      existing treatment landscape, and 46% for those switching from currently 
      available injectable and oral therapies. 

STAR-0310

   -- Astria is developing STAR-0310, an investigational high-potency and 
      long-acting monoclonal antibody OX40 antagonist that incorporates YTE 
      technology, for the treatment of atopic dermatitis (AD) and potentially 
      other indications. STAR-0310 was intentionally designed to capitalize on 
      the learnings of OX40 receptor and OX40 ligand programs with the goal of 
      having the best overall OX40 therapy. 
 
   -- The Company initiated a Phase 1a clinical trial of STAR-0310 in healthy 
      subjects in January 2025. The Phase 1a trial is intended to assess the 
      safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 
      in healthy adult participants, with early proof-of-concept (POC) results 
      expected in the third quarter of 2025. 
 
   -- Preclinical data supporting the differentiated profile of STAR-0310 was 
      presented at AAAAI in March 2025. STAR-0310 demonstrated an extended 
      half-life in cynomolgus monkeys and STAR-0310 preserved T-cells. 
      STAR-0310 significantly reduced antibody-dependent cellular cytotoxicity 
      (ADCC) on activated T-cells and regulatory T-cells when compared to other 
      anti-OX40 monoclonal antibodies. Reduction in ADCC activity has the 
      potential to support a more favorable safety profile and wider 
      therapeutic window for STAR-0310, which the Company believes could drive 
      greater efficacy. 

Corporate Updates

   -- Astria recently published its Corporate Responsibility Report. To learn 
      more about Astria's Corporate Responsibility initiatives, please view the 
      full report at this link: 
      https://astriatx.com/about-us/corporate-responsibility/. 
 
   -- The Company will be attending the following upcoming investor conferences 
      in June: 
 
          -- Jefferies Global Healthcare Conference: June 3-5, 2025, New York, 
             New York 
 
          -- Oppenheimer Innovators in I&I Summit: June 25, 2025, New York, New 
             York 

First Quarter 2025 Financial Results

Cash Position: As of March 31, 2025, Astria had cash, cash equivalents and short-term investments of $295.1 million, compared to $328.1 million as of December 31, 2024. The Company expects that its cash, cash equivalents and short-term investments as of March 31, 2025 will be sufficient to fund its operations into mid-2027, including (i) for navenibart, support for all program activities through completion of our ALPHA-ORBIT Phase 3 trial, including activities related to the planned ORBIT-EXPANSE long-term trial and Phase 3 development and testing of drug device combinations for potential dosing of navenibart, and (ii) for STAR-0310, the completion of the ongoing Phase 1a clinical trial of healthy subjects. Net cash used in operating activities for the three months ended March 31, 2025 was $34.0 million, compared to $19.1 million for the three months ended March 31, 2024.

R&D Expenses: Research and development expenses were $27.8 million for the three months ended March 31, 2025, compared to $15.7 million for the three months ended March 31, 2024. The increase in research and development expenses was attributed to an increase in external expenses related to the ALPHA-ORBIT and STAR-0310 Phase 1a clinical trials during the three months ended March 31, 2025.

G&A Expenses: General and administrative expenses were $9.2 million for the three months ended March 31, 2025, compared to $8.4 million for the three months ended March 31, 2024. The increase in general and administrative expenses was attributable to stock-based compensation and company growth to support the advancement of our programs.

Operating Loss: Loss from operations was $37.0 million for the three months ended March 31, 2025, compared to $24.2 million for the three months ended March 31, 2024.

Net Loss: Net loss was $33.7 million for the three months ended March 31, 2025, compared to a net loss of $19.9 million for the three months ended March 31, 2024.

Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was $0.58 for the three months ended March 31, 2025, compared to a net loss basic and diluted of $0.38 per share for the three months ended March 31, 2024.

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 immunologic diseases. Our lead program, navenibart (STAR-0215), is an investigational monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is an investigational monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on 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: the expected timing of receipt of topline results from the navenibart ALPHA-ORBIT Phase 3 trial; the goals and objectives of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, including that they are designed to support registration of Q3M and Q6M navenibart administration; the expected timing of release of initial safety and efficacy data from the ALPHA-SOLAR trial; our goal of developing two dosing options for navenibart; the potential for navenibart in the HAE market, including the potential to be the market leading treatment in HAE, the potential therapeutic and other benefits of navenibart as a treatment for HAE, and our vision and goals for the program; the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the nature and timing of receipt of early proof-of-concept results from such trial, including our expectation that such results will inform on STAR-0310's differentiated profile; the potential to develop STAR-0310 in additional indications; our goals and vision for STAR-0310; anticipated cash runway; and the

(MORE TO FOLLOW) Dow Jones Newswires

May 13, 2025 16:10 ET (20:10 GMT)