Astria Therapeutics Reports $94.26 Million Net Loss for 2024, Driven by Increased R&D Expenses

Astria Therapeutics, Inc. reported a net loss of $94.26 million for the year ended December 31, 2024, compared to a net loss of $72.89 million in 2023. This increase in net loss is primarily attributed to a rise in research and development expenses, which increased by 83% to $77.1 million, and a 34% increase in general and administrative expenses to $34.5 million. The increase in research and development expenses reflects the advancement of the STAR-0310 program into manufacturing and IND-enabling activities, and the progression of the navenibart program through international clinical trials. The company also recorded $15.2 million in acquired in-process research and development expense in 2023 related to a licensing agreement, with no such expense in 2024.

The company's cash, cash equivalents, and short-term investments totaled $328.1 million as of December 31, 2024. Astria expects this amount to fund operations into mid-2027, based on its current operating plan which includes the completion of the ALPHA-ORBIT Phase 3 trial for navenibart and the Phase 1a trial for STAR-0310. However, the company acknowledges that additional funding will be required to complete the development and commercialization of its product candidates and to support ongoing operations. The company raised $64 million in gross proceeds from an October 2023 financing and $125 million in gross proceeds from a February 2024 financing. Additionally, $36.2 million in gross proceeds were generated from at-the-market offerings during 2024.

Astria's lead product candidate, navenibart, is in Phase 3 clinical development for hereditary angioedema (HAE). The company initiated a Phase 3 trial (ALPHA-ORBIT) in February 2025 and anticipates top-line results in early 2027. Final results from the ALPHA-STAR Phase 1b/2 trial, completed in December 2024, showed a 90-95% reduction in mean monthly attack rate in HAE patients. An ongoing long-term open-label trial (ALPHA-SOLAR) is assessing the long-term safety and efficacy of navenibart, with initial data expected in mid-2025. Astria is also developing drug-device combinations for easier navenibart administration. The company's second product candidate, STAR-0310, is in Phase 1a clinical development for atopic dermatitis (AD), with early proof-of-concept data expected in the third quarter of 2025. As of December 31, 2024, Astria had 78 full-time employees, 45 of whom were in research and development.

The company highlights significant risks associated with its business, including dependence on the success of its product candidates, the need for substantial additional funding, the lengthy and expensive nature of clinical trials, substantial competition, reliance on third-party manufacturers and contractors, and the inherent uncertainties of the drug development and regulatory approval processes. Astria also notes the potential for highly volatile stock prices and the complexities of intellectual property protection and enforcement. The company's financial statements and supplementary data are included in the filing, along with disclosures regarding controls and procedures, and unresolved staff comments (none reported). The company's outlook is contingent upon successful clinical trial results, regulatory approvals, and securing adequate funding.