Astria Therapeutics Inc 2024年度报告

Dear Stockholders, At Astria, our goal is to transform science that works into therapies that patients want. In the pastyear, we have made substantial progress, and believe we are in a strong position to become a leading allergyand immunology company. Our lead product candidate is navenibart, formerly called STAR-0215, amonoclonal antibody inhibitor of plasma kallikrein in Phase 3 clinical development for the treatment ofhereditary angioedema (HAE). We believe navenibart could become the market-leading HAE therapy. Wehave also made significant progress this year on our second program, STAR-0310, a potential best-in-classmonoclonal antibody OX40 antagonist that we are developing for the treatment of atopic dermatitis(AD) and potentially additional indications. We believe that we can significantly benefit patients’ lives withthese programs, and we are looking forward to advancing these programs in 2025. We believe that navenibart has the potential to transform the way that people live with HAE and arethrilled with the enthusiasm for the program that we are seeing from patients and physicians. With the datathat we have generated to-date, we believe that navenibart can provide rapid and sustained protection againstHAE attacks, with administration only 2 or 4 times per year. In December 2024, we shared final resultsfrom the target enrollment patients in our Phase 1b/2 ALPHA-STAR clinical trial that supported this visionand enabled us to progress to our Phase 3 ALPHA-ORBIT clinical trial, which initiated early this year.The ALPHA-ORBIT trial is underway and enrolling patients, and we are executing with efficiency with thegoal of bringing navenibart to patients as quickly as possible. Importantly, we are in a position to deliveron this key value proposition and expect that we have funding beyond Phase 3 topline data, which we expectin early 2027. We also anticipate initial safety and efficacy data for every 3-month and every 6-monthadministration from the ALPHA-SOLAR long-term open-label trial in mid-2025. Over the course of 2024, we progressed STAR-0310 into Phase 1a development for the treatment ofAD. STAR-0310 was designed to capitalize on the learnings of other OX40 receptor and OX40 ligandprograms, with the goal of developing the best-overall OX40 therapy. The FDA granted clearance for theInvestigational New Drug application for STAR-0310 in December 2024, and we initiated a Phase 1a trial inhealthy subjects in January 2025. We anticipate initial results from the Phase 1a trial in the third quarter of2025 to be informative on differentiation about the potential for STAR-0310. We believe STAR-0310 has thepotential to address the need for a safe, effective and infrequently administered AD treatment. We are grateful for your support and your belief in Astria’s mission. In 2025, we are focused on effectivelydelivering on our programs, with the ultimate goal of bringing life-changing therapies to people living withallergic and immunologic diseases. We are in a strong position to execute on these goals, and we look forwardto sharing updates on our exciting progress throughout the year. Sincerely,Jill C. Milne, Ph.D.Chief Executive OfficerApril 28, 2025 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.☐Yes☒No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.☐Yes☒No 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 suchreports), 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 Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act: Non-accelerated filer☒☒ 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by theregistered public accounting firm that pr