ATXS Shareholder/Stockholder Letter Transcript:
2024 ANNUAL REPORT
Dear Stockholders,
At Astria, our goal is to transform science that works into therapies that patients want. In the past
year, we have made substantial progress, and believe we are in a strong position to become a leading allergy
and immunology company. Our lead product candidate is navenibart, formerly called STAR-0215, a
monoclonal antibody inhibitor of plasma kallikrein in Phase 3 clinical development for the treatment of
hereditary angioedema (HAE). We believe navenibart could become the market-leading HAE therapy. We
have also made significant progress this year on our second program, STAR-0310, a potential best-in-class
monoclonal 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 with
these 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 are
thrilled with the enthusiasm for the program that we are seeing from patients and physicians. With the data
that we have generated to-date, we believe that navenibart can provide rapid and sustained protection against
HAE attacks, with administration only 2 or 4 times per year. In December 2024, we shared final results
from the target enrollment patients in our Phase 1b/2 ALPHA-STAR clinical trial that supported this vision
and 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 the
goal of bringing navenibart to patients as quickly as possible. Importantly, we are in a position to deliver
on this key value proposition and expect that we have funding beyond Phase 3 topline data, which we expect
in early 2027. We also anticipate initial safety and efficacy data for every 3-month and every 6-month
administration 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 of
AD. STAR-0310 was designed to capitalize on the learnings of other OX40 receptor and OX40 ligand
programs, with the goal of developing the best-overall OX40 therapy. The FDA granted clearance for the
Investigational New Drug application for STAR-0310 in December 2024, and we initiated a Phase 1a trial in
healthy subjects in January 2025. We anticipate initial results from the Phase 1a trial in the third quarter of
2025 to be informative on differentiation about the potential for STAR-0310. We believe STAR-0310 has the
potential 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 effectively
delivering on our programs, with the ultimate goal of bringing life-changing therapies to people living with
allergic and immunologic diseases. We are in a strong position to execute on these goals, and we look forward
to sharing updates on our exciting progress throughout the year.
Sincerely,
Jill C. Milne, Ph.D.
Chief Executive Officer
April 28, 2025
4/28/2025 Letter Continued (Full PDF)