Press Release

-- On Track to File IND Application for STAR-0215 Mid-Year --

-- Initial Phase 1a Clinical Results Anticipated by Year End 2022 --

BOSTON--(BUSINESS WIRE)--Mar. 10, 2022-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.

“We are excited to advance STAR-0215 to the clinic this year with the planned initiation of our Phase 1a study,” said Jill C. Milne, Ph.D., Chief Executive Officer of Astria. “STAR-0215 was created with a clear vision aimed at reducing treatment burden for HAE patients with dosing once every three months or longer. Our goals for the Phase 1a trial are to evaluate safety and tolerability, demonstrate inhibition of plasma kallikrein activity, and establish the prolonged half-life of STAR-0215. We expect initial results from this trial by the end of this year.”

STAR-0215 for the Treatment of HAE

• Lead program STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for HAE with dosing once every three months or longer. The goal for STAR-0215 is to provide the most patient-friendly preventative treatment option for people living with HAE.
• HAE is a rare genetic disorder characterized by severe, recurrent, unpredictable, painful, and sometimes life-threatening swelling in the face, limbs, abdomen, and airway. Targeted plasma kallikrein inhibition can prevent HAE attacks by suppressing the pathway that generates bradykinin and causes excessive swelling.
• Astria is on track to file an Investigational New Drug application for STAR-0215 in the middle of this year and plans to initiate a Phase 1a clinical trial shortly thereafter with initial results anticipated by year end. The Phase 1a clinical trial is planned to be conducted in healthy volunteers and evaluate several single ascending dose cohorts with subcutaneous administration. The goals of this initial proof of concept trial are to demonstrate safety and tolerability, establish prolonged half-life of STAR-0215, and to demonstrate inhibition of plasma kallikrein activity. We plan to initiate a Phase 1b/2 trial in patients with HAE in 2023.
• Astria presented new preclinical data demonstrating how STAR-0215 binds to plasma kallikrein at the American Academy of Allergy, Asthma, and Immunology Annual Scientific Meeting in February.

Fourth Quarter and Full Year 2021 Financial Results

Cash Position: As of December 31, 2021, Astria had cash, cash equivalents and short-term investments of $125.5 million, compared to $131.8 million as of September 30, 2021. The Company expects that it has sufficient cash to fund its current operating plan through 2023. Net cash used in operating activities for the three months ended December 31, 2021, was $6.3 million, compared to $8.1 million for the three months ended December 31, 2020. Net cash used in operating activities for the full year 2021 was $30.2 million, compared to $32.5 million for the full year 2020.

R&D Expenses: Research and development expenses were $5.7 million for both the three months ended December 31, 2021 and 2020, and $15.6 million for the full year 2021, compared to $25.6 million for the full year 2020.

G&A Expenses: General and administrative expenses were $3.8 million for the three months ended December 31, 2021, compared to $3.2 million for the three months ended December 31, 2020, and $14.8 million for the full year 2021, compared to $11.8 million for the full year 2020.

Operating Loss: Loss from operations was $9.5 million for the three months ended December 31, 2021, compared to $9.0 million for the three months ended December 31, 2020, and $195.0 million for the full year 2021, compared to $37.4 million for the full year 2020. The year-over-year increase in net loss was largely attributable to the $164.6 million in acquired in-process R&D expense associated with acquiring Quellis Biosciences.

Net Loss: Net loss was $9.5 million for the three months ended December 31, 2021, compared to a net loss of $9.0 million for the three months ended December 31, 2020, and $194.9 million, or $21.84 per share, for the full year 2021, compared to $37.3 million, or $12.20 per share, for the full year 2020.

Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was $0.73 for the three months ended December 31, 2021, compared to a net loss basic and diluted of $2.77 per share for the three months ended December 31, 2020.

About Astria Therapeutics:

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in preclinical development for the treatment of hereditary angioedema. Learn more about our company on our website, www.astriatx.com, or follow us on Twitter and 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 Company’s projected cash runway; expectations regarding the timing for the filing of an IND for STAR-0215; commencement of a Phase 1 clinical trial for STAR-0215 and planned design of such trial, the timing of the initial results from such trial and that the results from such trial could demonstrate inhibition of plasma kallikrein activity and establish the prolonged half-life of STAR-0215; the planned initiation of a Phase 1b/2 clinical trial of STAR-0215; the potential attributes and differentiated profile of STAR-0215 as a treatment for HAE, and the potential commercial opportunity for STAR-0215 in HAE; the need for effective treatments for HAE; and the Company’s broader goal to meet the unmet needs of patients with rare and niche allergic and immunological diseases. 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,” or “would” 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 the Company’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 Company’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 risks and uncertainties: related to changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including the COVID-19 pandemic; 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 pre-clinical studies may not be replicated in clinical studies, the Company’s ability to enroll patients in our clinical trials, and the risk that any of the Company’s clinical trials may not commence, continue or be completed on time, or at all; decisions made by, or feedback received from, the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and other review bodies with respect to STAR-0215 and any future product candidates; the Company’s ability to manufacture sufficient quantities of drug substance and drug product on a cost-effective and timely basis; the Company’s ability to obtain, maintain and enforce intellectual property rights for STAR-0215 and any other future product candidates; competition with respect to STAR-0215 in HAE or with respect to any other future product candidates; the anticipated position of STAR-0215 in HAE based on its pre-clinical profile; the Company’s ability to manage its cash usage and the possibility of unexpected cash expenditures; the Company’s ability to obtain necessary financing to conduct its planned activities and to manage unplanned cash requirements; general economic and market conditions; as well as the risks and uncertainties set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. The Company may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on the Company’s forward-looking statements. Neither the Company, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

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Astria:
Investor relations:
Andrea Matthews
investors@astriatx.com

Media:
Elizabeth Higgins
media@astriatx.com

Source: Astria Therapeutics, Inc.