Full Press Release Details
Astria Therapeutics Reports Third Quarter 2025
Financial Results and Provides a Corporate Update
-- BioCryst's Acquisition of Astria Expected
to Close in the First
-- Phase 3 ALPHA-ORBIT Trial for Navenibart
is Progressing as Planned with Topline Results Anticipated in Early 2027; First Patient Now Enrolled in the ORBIT-EXPANSE Long-Term Extension
-- Final Phase 1b/2 ALPHA-STAR Results in 29
HAE Patients Reinforces Navenibart's Robust HAE Attack Prevention and Favorable Safety Profile --
-- STAR-0310, an OX40 Antagonist, Demonstrated
a Best-In-Class Profile with Initial Phase 1a Data Presented at the European Academy of Dermatology and Venereology Congress --
November 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 third quarter ended September
30, 2025, and provided a corporate update.
"We believe that the proposed transaction
with BioCryst provides the best opportunity to advance navenibart, enabling people with HAE to potentially live free from the limitations
of their disease," said Jill C. Milne, Ph.D., CEO of Astria Therapeutics. "We also believe the acquisition represents a compelling
outcome for Astria stockholders, providing cash for their shares at closing as well as continued ownership of BioCryst. I'm incredibly
inspired by our talented Astria team, whose commitment and determination have made this achievement possible."
On October 14, 2025,
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) and Astria Therapeutics, Inc. entered into a definitive agreement under which BioCryst will
acquire all outstanding shares of Astria for consideration per share consisting of $8.55 in cash and 0.59 shares of BioCryst common stock.
The transaction was unanimously approved by both the BioCryst and Astria Boards of Directors. Upon closing of the transaction, which is
expected in the first quarter of 2026 and subject to customary closing conditions and approval by Astria stockholders, Jill C.
Milne will join the BioCryst Board of Directors.
Navenibart (STAR-0215)
Third Quarter 2025 Financial Results
As of September 30, 2025, Astria had cash, cash equivalents and short-term investments of $227.7 million, compared to $344.3 million as
of September 30, 2024. Without giving effect to the transactions contemplated by the BioCryst merger agreement and assuming Astria remains
a standalone entity, the Company expects that its cash, cash equivalents and short-term investments as of September 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 September 30, 2025 was $32.3 million, compared to $28.0 million for the three
months ended September 30, 2024.
Revenue: Collaboration revenue was $0.7 million for the three and nine months ended September 30, 2025 from the Kaken license
agreement. As of September 30, 2025, deferred revenue from the Kaken license agreement was $16.5 million, of which $4.5 million is classified
as current and $12.0 million is classified as long-term. Deferred revenue will be recognized as performance obligations identified in
the Kaken license agreement are met.
Research and development expenses were $24.1 million for the three months ended September 30, 2025, compared to $20.5 million for the
three months ended September 30, 2024. The increase in research and development expenses was attributed to an increase in navenibart expenses
related to the support of the Phase 3 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 September 30, 2025.
General and administrative expenses were $10.7 million for the three months ended September 30, 2025, compared to $8.5 million for the
three months ended September 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.
Loss from operations was $34.1 million for the three months ended September 30, 2025, compared to $29.0 million for the three
months ended September 30, 2024.
loss was $31.6 million for the three months ended September 30, 2025, compared to a net loss of $24.5 million for the three months ended
Share Basic and Diluted: Net loss per share basic and diluted was $0.55 for the three months ended September 30, 2025, compared
to a net loss basic and diluted of $0.42 per share for the three months ended September 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:
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 potential significance of the results of the ALPHA-STAR 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 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; the potential significance of the initial results from the STAR-0310 Phase 1a trial; our goals and
vision for STAR-0310; our plans to pursue strategic alternatives 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 and STAR-0310 Phase 1a clinical trials and the results from the ALPHA-STAR trial or ALPHA-SOLAR trial,
may not be replicated in later stage clinical trials, including the ALPHA-ORBIT Phase 3 trial or the ORBIT-EXPANSE long-term extension
trial; 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