Astria Therapeutics(US:ATXS)2022-11-09 16:00Clinical Development - STAR-0215 is in clinical development for hereditary angioedema (HAE) and aims to provide long-acting treatment with dosing every three months or longer [81]. - The Phase 1a clinical trial for STAR-0215 enrolled 24 healthy subjects, with doses of 100mg, 300mg, and 600mg administered subcutaneously [82]. - The company anticipates significant increases in research and development expenses in the upcoming quarters related to STAR-0215 [93]. - Future funding requirements will depend on various factors, including the progress and costs of clinical trials for STAR-0215 and other product candidates [124]. Financial Performance - The company reported net losses of $38.6 million for the nine months ended September 30, 2022, compared to $209.9 million for the same period in 2021 [87]. - Net loss for the three months ended September 30, 2022, was $12.0 million, compared to a net loss of $7.9 million for the same period in 2021, reflecting an increase of $4.1 million [102]. - As of September 30, 2022, the company had an accumulated deficit of $494.4 million [87]. - Other income, net increased by $595,000 to $642,000 for the nine months ended September 30, 2022, primarily due to higher yields on interest-earning assets [111]. Research and Development Expenses - Research and development expenses for STAR-0215 were $14.6 million for the nine months ended September 30, 2022, compared to $4.4 million for the same period in 2021, reflecting a significant increase [92]. - Total research and development expenses for the company were $24.7 million for the nine months ended September 30, 2022, up from $9.9 million in the prior year [92]. - Research and development expenses increased by $3.9 million to $7.7 million for the three months ended September 30, 2022, representing a 103% increase compared to the same period in 2021 [104]. - For the nine months ended September 30, 2022, research and development expenses increased by $14.8 million to $24.7 million, a 150% increase from $9.9 million in the same period in 2021 [108]. Cash and Funding - The company had $116.6 million in cash, cash equivalents, and short-term investments as of September 30, 2022 [87]. - As of September 30, 2022, the company had cash, cash equivalents, and short-term investments totaling $116.6 million, expected to support operations into mid-2024 [112]. - The company reported cash, cash equivalents, and short-term investments totaling $116.6 million as of September 30, 2022, with an additional $12.7 million raised under the Jefferies ATM Program expected to support operations into mid-2024 [123]. - The company expects to require substantial additional funding to complete the development and commercialization of STAR-0215 and support ongoing operations [87]. Operational Challenges - The company anticipates fluctuations in results of operations due to factors such as research and development progress and regulatory submission outcomes [101]. - The company may be required to delay or reduce product development efforts if additional funds are not secured in a timely manner [128]. - The company does not have any committed external sources of funds and may need to raise capital through equity offerings, debt financings, or collaborations [126]. - If additional capital is raised through equity or convertible debt, stockholders' ownership interests may be diluted [127]. - Debt financing, if available, could impose periodic payment obligations and restrictive covenants that may limit the company's operational flexibility [127]. - Collaborations or licensing arrangements may require the company to relinquish valuable rights to technologies or future revenue streams [128].