Astria Therapeutics, Inc. (NASDAQ:ATXS) is a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for allergic and immunological diseases. The company's lead product candidate is STAR-0215, a potential best-in-class monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema (HAE), a rare, debilitating, and potentially life-threatening disease. Astria's second product candidate is STAR-0310, a monoclonal antibody OX40 antagonist that is in preclinical development for the treatment of atopic dermatitis (AD), an immune disorder associated with loss of skin barrier function and itching.

Business Overview

Astria Therapeutics was incorporated in the State of Delaware on June 26, 2008. The company's focus is to develop first-choice therapies that improve the health and outcomes of patients with allergic and immunological diseases. Astria's lead product candidate, STAR-0215, is currently in clinical development and has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of HAE.

In February 2023, Astria advanced STAR-0215 to a Phase 1b/2 trial called ALPHA-STAR, a global, multi-center, open-label, single and multiple dose proof-of-concept clinical trial in people with HAE. The trial is evaluating the safety, tolerability, HAE attack rate, pharmacokinetics, pharmacodynamics, and quality of life in patients three and six months after subcutaneous STAR-0215 administration.

Astria reported initial proof-of-concept data from the ALPHA-STAR trial in March 2024. The data showed significant reductions in monthly attack rate, moderate and severe attacks, and acute rescue medication use across the different dosing cohorts. STAR-0215 was also generally well-tolerated, with no serious treatment-emergent adverse events and no discontinuations. Based on these results, Astria plans to advance STAR-0215 into a Phase 3 pivotal trial program, with the goal of developing a best-in-class monoclonal antibody inhibitor of plasma kallikrein able to provide long-acting, effective attack prevention for HAE.

Astria's second product candidate, STAR-0310, is a monoclonal antibody OX40 antagonist that is in preclinical development for the treatment of atopic dermatitis (AD). The company believes that OX40 inhibition has the potential to treat AD and other diseases, and that STAR-0310, with its engineered YTE half-life extension technology, could address the need for a safe, effective, and infrequently administered AD treatment.

In 2024, Astria plans to share preclinical profile results for STAR-0310 and submit an investigational new drug (IND) application to the FDA for the product candidate by year-end. If the IND clears, the company anticipates initiating a Phase 1a clinical trial of STAR-0310 in healthy subjects in the first quarter of 2025 and reporting initial results from the trial in the third quarter of 2025.

Financials

Astria Therapeutics' business is almost entirely dependent on the success of its two lead product candidates, STAR-0215 and STAR-0310. The company has not generated any product revenues to date and has financed its operations primarily through public offerings and private placements of its equity securities.

For the fiscal year ended December 31, 2023, Astria reported a net loss of $72.9 million, with no revenue generated. The company's annual operating cash flow was -$68.4 million, and its annual free cash flow was -$68.5 million.

In the first quarter of 2024, Astria reported a net loss of $19.9 million, with no revenue generated. The company's quarterly operating cash flow was -$19.1 million, and its quarterly free cash flow was -$19.1 million.

As of March 31, 2024, Astria had $369.9 million in cash, cash equivalents, and short-term investments, which the company expects will enable it to fund its operating expenses and capital expenditure requirements into mid-2027, including all STAR-0215 program activities through the completion of a planned Phase 3 pivotal trial, as well as advancing the STAR-0310 program through submission of an IND and early proof-of-concept results from a Phase 1a trial.

Liquidity

Astria has raised a total of $823.3 million through equity financings, including private placements of preferred stock before the company became public, a private placement of preferred stock in February 2021, and registered offerings of its common stock, including at-the-market offering programs.

In October 2023, the company closed an underwritten offering that raised $59.5 million in net proceeds. In February 2024, Astria closed another underwritten offering that raised $117.2 million in net proceeds. The company also has an at-the-market offering program in place that allows it to issue and sell up to $150.0 million of shares of common stock.

As of March 31, 2024, Astria had $369.9 million in cash, cash equivalents, and short-term investments, which the company believes will be sufficient to fund its operations into mid-2027. However, advancing the development of STAR-0215, STAR-0310, or any future product candidates will require significant additional capital, and Astria's existing resources will not be sufficient to enable the company to fund the completion of development of any of its product candidates.

Accordingly, Astria will need to obtain substantial additional funding to complete the development and commercialization of STAR-0215, STAR-0310, or any future product candidates, support its continuing operations, future clinical trials, and the expansion of its pipeline. The company may seek to raise capital through equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements, but there can be no assurance that Astria will be able to obtain additional funding on terms acceptable to the company, on a timely basis, or at all.

Risks and Challenges

Astria Therapeutics faces several risks and challenges in its pursuit of developing and commercializing novel therapies for allergic and immunological diseases. The company's business is almost entirely dependent on the success of its two lead product candidates, STAR-0215 and STAR-0310, which are still in clinical and preclinical development, respectively. There is no guarantee that these product candidates will successfully complete clinical trials, obtain regulatory approval, or achieve commercial success, even if approved.

Additionally, Astria will need to raise significant additional capital to fund the continued development and potential commercialization of its product candidates. The company's ability to obtain such funding is subject to various risks, including market conditions, interest rate fluctuations, and the overall economic environment. If Astria is unable to secure the necessary funding, it may be forced to modify its business strategies, reduce or terminate its operations, or seek bankruptcy protection.

The biopharmaceutical industry is also highly competitive, and Astria's product candidates, if approved, will face competition from other approved therapies and potentially from future entrants to the market. The company's ability to successfully compete will depend on factors such as product efficacy, safety, pricing, and the availability of reimbursement from government and private payers.

Furthermore, Astria's operations and the development of its product candidates are subject to extensive regulation by the FDA and other regulatory authorities. Any failure to comply with applicable regulations or obtain necessary regulatory approvals could significantly delay or impair the company's ability to commercialize its product candidates.

Outlook

Astria Therapeutics is a promising biopharmaceutical company with a focus on developing novel therapies for allergic and immunological diseases. The company's lead product candidate, STAR-0215, has shown encouraging results in its Phase 1b/2 ALPHA-STAR trial, and Astria plans to advance the program into a Phase 3 pivotal trial program. The company's second product candidate, STAR-0310, is in preclinical development for the treatment of atopic dermatitis and has the potential to address an unmet need in this therapeutic area.

While Astria faces significant risks and challenges, including the need to raise substantial additional capital to fund its operations and product development, the company's strong cash position and the promising data for its lead product candidate suggest that it is well-positioned to continue advancing its pipeline and potentially bringing much-needed therapies to patients with allergic and immunological diseases.

Conclusion

Investors should closely monitor Astria's progress as the company works to achieve key milestones, such as the initiation of the STAR-0215 Phase 3 program and the advancement of STAR-0310 into the clinic. The company's ability to successfully navigate the regulatory landscape and secure the necessary funding will be critical to its long-term success.