Navenibart

-- Kaken Pharmaceutical, Co., Ltd. Will Pay Astria Therapeutics Up to $32 Million in Upfront and Milestone Payments, Plus Royalties for Japanese Development and Commercialization Rights Related to Navenibart -- -- Updated Cash Runway Supports the Company’s Operating Plan into 2028 -- -- ALPHA-ORBIT, A Pivotal Phase 3 Trial Evaluating Every 3- and Every 6- Month Administration of Navenibart (STAR-0215) in Hereditary Angioedema, is Enrolling Patients with Topline Data Anticipated in Early 2027-- -- STAR-0310, an OX40 inhibitor in Development for Atopic Dermatitis, Expected to Report Initial Phase 1a Healthy Subject Results in Q3 2025 -- BOSTON --(BUSINESS WIRE)--Aug. 12, 2025-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today reported financial results for the second quarter ended June 30, 2025 , and provided a corporate update. “Delivering on navenibart's best-in-class potential is our top priority, and enrollment in the global Phase 3 ALPHA-ORBIT trial is well underway with active sites across the U.S. , U.K. , Canada , Hong Kong , and South Africa” said Jill C. Milne , Ph.D., Chief Executive Officer at Astria Therapeutics . "We are encouraged by the strong enthusiasm from patients and physicians, including at the recent HAEA conference, where we had the opportunity to engage with the HAE community. We were also thrilled to announce a strategic partnership with Kaken. Their expertise supports our ongoing Phase 3 enrollment, contributes to strengthening our financial position, and may ultimately help expand global patient access to navenibart.” Navenibart (STAR-0215) In August, Astria announced that it has exclusively licensed development and commercialization rights in Japan to Kaken Pharmaceutical for navenibart. Under the agreement, Astria will receive an upfront payment of $16 million , with the potential for an additional $16 million in total commercialization and sales milestones. In addition to these payments, Astria is also eligible for tiered royalties with the royalty rate as a percentage of net sales up to 30%, and partial Phase 3 cost reimbursement. 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. ALPHA-ORBIT is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of navenibart over a 6-month treatment period, with dosing arms every 3 months (Q3M) and every 6 months (Q6M). Enrollment is ongoing and top-line results are expected in early 2027. After completing ALPHA-ORBIT, eligible patients may continue into the open-label ORBIT-EXPANSE study, which includes 6 months of additional treatment followed by a patient-centric flexible dosing phase. Positive initial results from the ongoing ALPHA-SOLAR long-term open-label trial of navenibart were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. All 16 ALPHA-STAR target enrollment participants continued into ALPHA-SOLAR and the results are highly consistent with ALPHA-STAR - showing robust overall reduction in monthly attack rates (92% mean and 97% median) and a well-tolerated safety profile. 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. Data presented at the European Academy of Allergy and Clinical Immunology (EAACI) annual congress support STAR-0310 as a potential best-in-class OX40 antagonist, with a unique allosteric inhibition mechanism, enhanced disruption of OX40/OX40L signaling compared to other agents, and pure antagonistic activity without agonism. These findings, along with previously reported low ADCC activity and robust cytokine suppression, highlight STAR-0310’s differentiated profile and its potential to achieve deeper inhibition of T cell responses. Upcoming Corporate Events Cantor Global Healthcare Conference ( September 3-5, 2025 , New York, New York ) Second Quarter 2025 Financial Results Cash Position: As of June 30, 2025 , Astria had cash, cash equivalents and short-term investments of $259.2 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 June 30, 2025 , together with the Kaken upfront payment and expected reimbursement of a portion of the Company’s Phase 3 program costs, will be sufficient to fund its current operating plan into 2028, 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, 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 June 30, 2025 was $36.1 million , compared to $16.8 million for the three months ended June 30, 2024 . R&D Expenses: Research and development expenses were $25.9 million for the three months ended June 30, 2025 , compared to $20.7 million for the three months ended June 30, 2024 . The increase in research and development expenses was attributed to an increase in navenibart expenses related to the support of the ALPHA-ORBIT clinical trial and employee expenses, partially due to increases in stock-based compensation and company growth to support the advancement of our programs, during the three months ended June 30, 2025 . G&A Expenses: General and administrative expenses were $9.9 million for the three months ended June 30, 2025 , compared to $8.1 million for the three months ended June 30, 2024 . The increase in general and administrative expenses was attributable to company growth to support the advancement of our programs, stock-based compensation and other professional services. Operating Loss: Loss from operations was $35.8 million for the three months ended June 30, 2025 , compared to $28.8 million for the three months ended June 30, 2024 . Net Loss: Net loss was $33.1 million for the three months ended June 30, 2025 , compared to a net loss of $24.2 million for the three months ended June 30, 2024 . Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was $0.57 for the three months ended June 30, 2025 , compared to a net loss basic and diluted of $0.43 per share for the three months ended June 30, 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; 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 objectives, goals and potential payments from our agreement with Kaken Pharmaceutical; 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; statements about the Company’s current operating plan and the Company’s anticipated cash runway; and the goal of bringing life changing therapies to patients and families affected by allergic and immunological diseases and to become a leading allergy and immunology company. 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 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, including of navenibart and STAR-0310, 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 navenibart Phase 1a clinical trial and the initial results from the ALPHA-STAR trial, may not be replicated in later stage clinical trials, including additional and final results from the ALPHA-STAR trial or the planned navenibart Phase 3 development program; 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 FDA 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 navenibart, STAR-0310, and any other future development candidates, and devices for such product candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates, and devices for such product candidates, on a cost-effective and timely basis, and to develop dosages and formulation for navenibart, 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 navenibart, STAR-0310, and any other future product candidates; our potential dependence on collaboration partners; competition with respect to navenibart, 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 navenibart to compete in HAE and the anticipated position and attributes of navenibart in HAE based on clinical data to date, its preclinical profile, pharmacokinetic modeling, market research and other data; 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, including the costs associated with commercialization of navenibart if regulatory approval is obtained, 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” sections of our Annual Report on Form 10-K for the period ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 , 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) 2025 2024 2025 2024 $ 25,945 $ 20,709 $ 53,731 $ 36,435 9,875 8,094 19,084 16,518 35,820 28,803 72,815 52,953 (35,820 ) (28,803 ) (72,815 ) (52,953 ) 2,889 4,647 6,235 8,888 (121 ) (16 ) (181 ) (35 ) 2,768 4,631 6,054 8,853 (33,052 ) (24,172 ) (66,761 ) (44,100 ) $ (0.57 ) $ (0.43 ) $ (1.15 ) $ (0.81 ) 58,005,312 56,485,962 58,005,312 54,390,364 Astria Therapeutics, Inc. Selected Consolidated Balance Sheets Data (In thousands) (Unaudited) 2025 2024 $ 76,319 $ 59,820 182,859 268,312 4,546 5,114 18,200 9,117 281,924 342,363 1,399 1,384 3,367 3,969 16,645 17,747 21,411 23,100 $ 260,513 $ 319,263 Astria Therapeutics, Inc. Selected Consolidated Statements of Cash Flows Data (In thousands) (Unaudited) 2025 2024 $ (70,076 ) $ (35,885 ) 86,575 (194,334 ) - 141,901 $ 16,499 $ (88,318 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20250812909332/en/ Astria Contact: Investor Relations and Media: Elizabeth Higgins investors@astriatx.com Source: Astria Therapeutics, Inc.