Astria Therapeutics(ATXS) - 2023 Q1 - Quarterly Report

Clinical Development - STAR-0215 is in clinical development for hereditary angioedema (HAE) and aims to be a best-in-class treatment with potential administration every three or six months[56] - The Phase 1a clinical trial for STAR-0215 showed it was well-tolerated across all dose levels, with an estimated half-life of up to 117 days and sustained target engagement for at least three months[56] - The company initiated a Phase 1b/2 trial called ALPHA-STAR in February 2023, evaluating safety and quality of life in HAE patients[56] - Initial results from the Phase 1a trial are expected in the fourth quarter of 2023, with final results also anticipated in the same timeframe[56] Financial Performance - Research and development expenses decreased by 22% to $8.0 million for the three months ended March 31, 2023, down from $10.4 million in the same period in 2022[64] - The company reported an accumulated deficit of $518.8 million as of March 31, 2023, with losses from operations of $13.5 million for the three months ended March 31, 2023[59] - General and administrative expenses increased by 9% to $5.5 million for the three months ended March 31, 2023, compared to $5.0 million in the same period in 2022[64] - Total operating expenses decreased by $1.885 million to $13.493 million for the three months ended March 31, 2023, compared to $15.378 million in the same period of 2022[66] - Net loss narrowed by $4.135 million to $11.188 million for the three months ended March 31, 2023, compared to a net loss of $15.323 million in the same period of 2022[66] - Other income increased significantly to $2.305 million for the three months ended March 31, 2023, from $55 thousand in the same period of 2022, primarily due to higher yields on interest-earning assets[67] Cash and Funding - Cash, cash equivalents, and short-term investments totaled $213.3 million as of March 31, 2023, expected to fund operations through the first half of 2025[59] - The company raised an aggregate of $579.3 million through equity financings since inception, including a public offering that closed on December 19, 2022, generating net proceeds of $107.6 million[70] - Net cash used in operating activities was $13.253 million for the three months ended March 31, 2023, compared to $12.559 million in the same period of 2022[74] - Net cash provided by investing activities was $194.992 million for the three months ended March 31, 2023, primarily from maturities of short-term investments[74] - The company anticipates needing substantial additional funding to complete the development and commercialization of STAR-0215 and other product candidates[69] - The company has no committed external sources of funds and may need to seek additional financing sooner than planned due to various risks and uncertainties[69] Corporate Governance - The 2022 Inducement Stock Incentive Plan has been amended and incorporated by reference in the current report[10.1] - The principal executive officer and principal financial officer have certified compliance with the Securities Exchange Act of 1934[31.1][31.2] - The report includes certifications pursuant to the Sarbanes-Oxley Act of 2002[32.1] - Inline XBRL Instance Document is included, with embedded XBRL tags[101.INS] - The report is signed by Noah C. Clauser, Chief Financial Officer, on May 11, 2023[83]