Astria Therapeutics(US:ATXS)2022-08-08 16:00Clinical Development - STAR-0215 is in clinical development for hereditary angioedema (HAE) with a potential dosing regimen of once every three months or longer[84]. - The Phase 1a clinical trial for STAR-0215 is evaluating safety and pharmacokinetics with preliminary results anticipated by year-end 2022[85]. - The company plans to initiate a Phase 1b/2 trial in participants with HAE in 2023, assuming positive data from the Phase 1a trial[85]. Financial Performance - The company reported net losses of $26.6 million for the six months ended June 30, 2022, compared to $177.6 million for the same period in 2021[91]. - Net loss for the six months ended June 30, 2022, was $26.6 million, a decrease of $150.9 million from a net loss of $177.5 million for the same period in 2021[113]. - Other income, net increased by $234,000 to $253,000 for the six months ended June 30, 2022, from $19,000 for the same period in 2021, mainly due to higher yields on interest-earning assets[115]. Research and Development Expenses - Research and development expenses for STAR-0215 were $10.1 million for the six months ended June 30, 2022, significantly up from $2.9 million in the same period of 2021[96]. - Total research and development expenses for the six months ended June 30, 2022, were $17.0 million, compared to $6.1 million in the same period of 2021[96]. - Research and development expenses increased by 180% to $17.0 million for the six months ended June 30, 2022, compared to $6.1 million for the same period in 2021[112]. - Research and development expenses for the three months ended June 30, 2022, increased by 90% to $6.6 million from $3.5 million for the same period in 2021[108]. Cash and Investments - The company had $102.5 million in cash, cash equivalents, and short-term investments as of June 30, 2022, expected to support operations through 2023[91]. - Cash, cash equivalents, and short-term investments totaled $102.5 million as of June 30, 2022, expected to support operating expenses through 2023[116]. - As of June 30, 2022, the company had available cash, cash equivalents, and short-term investments of $102.5 million, expected to support operating expenses and capital expenditures through 2023[126]. Operating Expenses - General and administrative expenses rose by 43% to $9.9 million for the six months ended June 30, 2022, from $6.9 million for the same period in 2021[114]. - The total operating expenses for the six months ended June 30, 2022, were $26.8 million, a decrease of $150.7 million compared to $177.6 million for the same period in 2021, primarily due to the absence of acquired in-process research and development expenses[113]. - General and administrative expenses for the three months ended June 30, 2022, increased by 21% to $4.8 million from $4.0 million for the same period in 2021[109]. Funding and Capital Requirements - The company anticipates needing substantial additional funding to complete the development and commercialization of STAR-0215 and future product candidates[117]. - The company raised an aggregate of $426.0 million through various financing activities since inception, with net proceeds of approximately $104.3 million from the February 2021 Financing[116][118]. - The company may need to seek additional funds sooner than planned due to uncertainties in research, development, and commercialization of biotechnology products[127]. - Future funding requirements will depend on various factors, including clinical trial progress and regulatory approval outcomes[127]. - The company does not have any committed external source of funds and may rely on equity offerings, debt financings, and collaborations for financing[129]. - If additional capital is raised through equity or convertible debt, stockholders' ownership interests may be diluted[129]. - The company may have to relinquish valuable rights to technologies or future revenue streams if funds are raised through collaborations or licensing arrangements[130]. Impact of COVID-19 - The impact of the COVID-19 pandemic on operations and business prospects remains a concern for future funding and development efforts[127].