Astria Therapeutics(ATXS) - 2022 Q1 - Quarterly Report

Financial Performance - The company reported net losses of $15.3 million for Q1 2022, compared to $170.1 million for Q1 2021, which included $164.6 million in in-process research and development expenses [91]. - Total operating expenses decreased significantly from $170.1 million in Q1 2021 to $15.4 million in Q1 2022, primarily due to the absence of acquired in-process research and development expenses [111]. - The net loss for the three months ended March 31, 2022, was $15.3 million, a reduction of $154.8 million compared to a net loss of $170.1 million in the same period of 2021 [111]. - Research and development expenses increased by 299% to $10.4 million for the three months ended March 31, 2022, compared to $2.6 million for the same period in 2021 [108]. - General and administrative expenses rose by 74% to $5.0 million for the three months ended March 31, 2022, up from $2.9 million in the prior year [109]. - Net cash used in operating activities was $12.6 million for the three months ended March 31, 2022, compared to $8.7 million for the same period in 2021 [118]. Cash and Funding - As of March 31, 2022, the company had an accumulated deficit of $471.1 million and $112.8 million in cash, cash equivalents, and short-term investments [91]. - Cash, cash equivalents, and short-term investments totaled $112.8 million as of March 31, 2022, sufficient to support operations through 2023 [112]. - The company raised an aggregate of $426.0 million through various financing activities from inception through March 31, 2022 [112]. - The company anticipates needing substantial additional funding to complete the development and commercialization of STAR-0215 and support ongoing operations [91]. - The company expects to incur additional funding needs to support the development and commercialization of STAR-0215 and other future product candidates [113]. - The company anticipates needing additional financing to achieve business objectives, as substantial product revenues are not expected for several years [124]. - Future funding requirements will depend on various factors, including the progress of clinical trials for STAR-0215 and other product candidates [122]. - The company has no committed external source of funds and may need to raise capital through equity offerings or debt financing, which could dilute stockholder ownership [125]. - The company may have to relinquish rights to technologies or revenue streams if it raises funds through collaborations or licensing arrangements [126]. Product Development - The lead product candidate, STAR-0215, is in preclinical development for hereditary angioedema (HAE) and is expected to enter a Phase 1a clinical trial in mid-2022, with initial results anticipated by year-end 2022 [83]. - STAR-0215 has shown to be approximately 10-fold more potent than lanadelumab in inhibiting bradykinin production, with a projected half-life of approximately 34 days compared to lanadelumab's 10 days [84]. - The company plans to initiate a Phase 1b/2 trial in HAE patients in 2023, assuming positive data from the Phase 1a trial [83]. - The acquisition of Quellis Biosciences in January 2021 provided the STAR-0215 program, with gross proceeds of approximately $110.0 million from a private placement in February 2021 [82]. - The global market for HAE therapy is strong and growing, indicating a significant unmet medical need that STAR-0215 aims to address [83]. - The company anticipates significant research and development expenses in future periods related to the development of STAR-0215, with costs expected to be higher than prior year periods [96]. Operational Considerations - The impact of the COVID-19 pandemic on operations and business prospects remains a consideration [123]. - The company has not experienced changes in internal control over financial reporting that materially affect its operations as of March 31, 2022 [133]. - Management's disclosure controls and procedures were deemed effective at the reasonable assurance level as of March 31, 2022 [132]. - Total contractual cash obligations amounted to $2.39 million, with $1.63 million related to operating lease obligations and $0.77 million under vendor agreements contingent on clinical milestones [128].