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2023 ANNUAL REPORT
Dear Stockholders,
In the past year at Astria, we have made significant progress towards our goal of becoming a leading allergy and immunology company through the
development of potential first-choice products that could improve the health of patients. Our exciting pipeline of products is based on established
mechanisms with differentiated profiles that we believe will improve patient outcomes and experiences. Our lead product candidate is STAR-0215, a
monoclonal antibody inhibitor of plasma kallikrein, which we are developing as a potential first-choice preventative treatment for hereditary angioedema
(HAE), which is now supported by positive initial proof-of-concept data in patients with HAE. In 2023, we also expanded Astria   s pipeline to include STAR0310, a monoclonal antibody OX40 antagonist that we are developing as a potential best-in-class treatment for atopic dermatitis (AD) and additional
indications. We believe that these programs put us in a strong position to make a positive impact on patients    lives, and we are looking forward to delivering
on that vision in the years to come.
Our goal for STAR-0215 is to normalize the lives of patients with HAE by providing them with a safe, highly effective, and long-acting
preventative therapy, and our recent initial proof-of-concept results in HAE patients (announced in March 2024) give us conviction that we have the potential
market-leading treatment for HAE. Specifically, the initial data showed a 90-96% reduction in monthly attacks, rapid attack prevention, a favorable safety
profile with no reports of injection site pain, and support for the potential to dose STAR-0215 once every three to six months. These data are best in class,
and support progressing to a Phase 3 pivotal trial of STAR-0215, with trial initiation expected in the first quarter of 2025. We are working to bring this
treatment to HAE patients as quickly as possible.
This past year, we also expanded our pipeline with the addition of STAR-0310, a high-affinity OX40 antagonist with YTE half-life extension
technology that we are developing as a long-acting treatment for AD, with the opportunity to expand into additional indications. We are on track to submit
an investigational new drug application (IND) for STAR-0310 by year-end 2024, and we anticipate sharing data on the preclinical profile of the program at
scientific conferences in 2024. Subject to clearance of the IND, we plan to initiate a Phase 1a trial of STAR-0310 in the first quarter of 2025 and expect to
have initial results that could inform on STAR-0310   s profile as a long-acting OX40 inhibitor in the third quarter of 2025. We believe that the ongoing
development of our pipeline programs will enable Astria to make a difference broadly for allergy and immunology patients.
Thank you for your support and strong belief in our mission to bring life-changing therapies to patients with allergic and immunological diseases.
We are proud of all that we accomplished in 2023 and believe we are in a strong position to deliver on our 2024 goals. We look forward to an exciting year
and sharing our success along the way.
Sincerely,
Jill C. Milne, Ph.D.
Chief Executive Officer
April 22, 2024
 • shareholder letter icon 4/22/2024 Letter Continued (Full PDF)
 • stockholder letter icon 4/20/2023 ATXS Stockholder Letter
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ATXS Shareholder/Stockholder Letter Transcript:

2023 ANNUAL REPORT

Dear Stockholders,
In the past year at Astria, we have made significant progress towards our goal of becoming a leading allergy and immunology company through the
development of potential first-choice products that could improve the health of patients. Our exciting pipeline of products is based on established
mechanisms with differentiated profiles that we believe will improve patient outcomes and experiences. Our lead product candidate is STAR-0215, a
monoclonal antibody inhibitor of plasma kallikrein, which we are developing as a potential first-choice preventative treatment for hereditary angioedema
(HAE), which is now supported by positive initial proof-of-concept data in patients with HAE. In 2023, we also expanded Astria   s pipeline to include STAR0310, a monoclonal antibody OX40 antagonist that we are developing as a potential best-in-class treatment for atopic dermatitis (AD) and additional
indications. We believe that these programs put us in a strong position to make a positive impact on patients    lives, and we are looking forward to delivering
on that vision in the years to come.
Our goal for STAR-0215 is to normalize the lives of patients with HAE by providing them with a safe, highly effective, and long-acting
preventative therapy, and our recent initial proof-of-concept results in HAE patients (announced in March 2024) give us conviction that we have the potential
market-leading treatment for HAE. Specifically, the initial data showed a 90-96% reduction in monthly attacks, rapid attack prevention, a favorable safety
profile with no reports of injection site pain, and support for the potential to dose STAR-0215 once every three to six months. These data are best in class,
and support progressing to a Phase 3 pivotal trial of STAR-0215, with trial initiation expected in the first quarter of 2025. We are working to bring this
treatment to HAE patients as quickly as possible.
This past year, we also expanded our pipeline with the addition of STAR-0310, a high-affinity OX40 antagonist with YTE half-life extension
technology that we are developing as a long-acting treatment for AD, with the opportunity to expand into additional indications. We are on track to submit
an investigational new drug application (IND) for STAR-0310 by year-end 2024, and we anticipate sharing data on the preclinical profile of the program at
scientific conferences in 2024. Subject to clearance of the IND, we plan to initiate a Phase 1a trial of STAR-0310 in the first quarter of 2025 and expect to
have initial results that could inform on STAR-0310   s profile as a long-acting OX40 inhibitor in the third quarter of 2025. We believe that the ongoing
development of our pipeline programs will enable Astria to make a difference broadly for allergy and immunology patients.
Thank you for your support and strong belief in our mission to bring life-changing therapies to patients with allergic and immunological diseases.
We are proud of all that we accomplished in 2023 and believe we are in a strong position to deliver on our 2024 goals. We look forward to an exciting year
and sharing our success along the way.
Sincerely,
Jill C. Milne, Ph.D.
Chief Executive Officer
April 22, 2024



shareholder letter icon 4/22/2024 Letter Continued (Full PDF)
 

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