Full Press Release Details
Astria Therapeutics Reports Fourth Quarter
and Full Year 2024 Financial Results and Provides a Corporate Update
-- ALPHA-ORBIT Pivotal Phase 3 Trial Evaluating
Every 3- and Every 6-Month Administration of Navenibart (STAR-0215) in Hereditary Angioedema is Underway --
-- Initial Efficacy and Safety Data from Navenibart
ALPHA-SOLAR Long-Term Extension Trial Expected Mid-2025 --
-- Phase 1a Trial of STAR-0310, a Potential
Best-in-Class Monoclonal Antibody OX40 Antagonist, Ongoing with Initial Results Anticipated in Q3 2025 --
BOSTON, Mass., March 11, 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 fourth quarter and full year ended December 31, 2024,
and provided a corporate update.
"2025 promises to be an exciting year for
Astria, and we are building on the momentum from a successful 2024 with the initiation of two important clinical trials," said
Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. "With the ALPHA-ORBIT Phase 3 trial of navenibart, we are
enabling the potential for HAE patients to break free from the gravity of their disease and supporting low treatment burden by including
both every 3-month and every 6-month regimens in a single trial. We believe that navenibart has the potential to be the market-leading
therapy for HAE, and we look forward to building on our track record of strong execution throughout the trial. We also initiated a clinical
trial evaluating STAR-0310 in healthy subjects and expect these results will demonstrate STAR-0310's differentiated profile in
the third quarter this year."
Navenibart (STAR-0215)
Fourth Quarter and Full Year 2024 Financial
Cash Position: As of December 31,
2024, Astria had cash, cash equivalents and short-term investments of $328.1 million, compared to $246.5 million as of December 31,
2023. The Company expects that its cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient
to fund its operations into mid-2027, 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 for potential dosing of navenibart, and (ii) for STAR-0310, the completion of the ongoing Phase 1a clinical
trial of healthy subjects and any related anticipated milestone payments. Net cash used in operating activities for the three months
ended December 31, 2024, was $17.4 million, compared to $30.2 million for the three months ended December 31, 2023. Net cash
used in operating activities for the full year 2024 was $81.2 million, compared to $68.4 million for the full year 2023.
R&D Expenses: Research and development
expenses were $20.2 million for the three months ended December 31, 2024, compared to $11.7 million for the three months ended December 31,
2023, and $77.1 million for the full year 2024, compared to $42.1 million for the full year 2023. The increase in research and development
expenses was attributed to an increase in external expenses for the navenibart ALPHA-STAR and ALPHA-SOLAR clinical trials and start-up
activities to support the ALPHA-ORBIT Phase 3 trial in addition to external research, manufacturing, and IND-enabling activities for
the STAR-0310 program.
G&A Expenses: General and administrative
expenses were $9.4 million for the three months ended December 31, 2024, compared to $7.3 million for the three months ended December 31,
2023, and $34.5 million for the full year 2024, compared to $25.7 million for the full year 2023. The increase in general and administrative
expenses was attributable to stock-based compensation and company growth to support the advancement of our programs.
Operating Loss: Loss from operations was
$29.6 million for the three months ended December 31, 2024, compared to $34.2 million for the three months ended December 31,
2023, and $111.6 million for the full year 2024, compared to $83.0 million for the full year 2023.
Net Loss: Net loss was $25.6 million for
the three months ended December 31, 2024, compared to a net loss of $31.4 million for the three months ended December 31, 2023,
and $94.3 million for the full year 2024, compared to $72.9 million for the full year 2023.
Net Loss Per Share Basic and Diluted: Net
loss per share basic and diluted was $0.44 for the three months ended December 31, 2024, compared to $0.86 per share for the three
months ended December 31, 2023, and $1.68 per share for the full year 2024, compared to $2.42 per share for the full year 2023.
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; the expected timing of release of initial safety and efficacy data from the ALPHA-SOLAR 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 potential for STAR-0310 to have the best-in-class monoclonal antibody OX40 antagonist and be the best
overall OX40 therapy and 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 demonstrate STAR-0310's differentiated profile; the potential to develop STAR-0310 in additional indications; our goals and
vision for STAR-0310; 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
the 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