Astria Therapeutics(ATXS) - 2023 Q3 - Quarterly Report

Financial Performance - Total current assets decreased from $227,690 thousand as of December 31, 2022, to $191,466 thousand as of September 30, 2023, a decline of approximately 15.9%[17] - The net loss for the three months ended September 30, 2023, was $17,727 thousand, compared to a net loss of $11,997 thousand for the same period in 2022, reflecting a 47.2% increase in losses[22] - The net loss for the nine months ended September 30, 2023, was $41.481 million, compared to a net loss of $38.571 million for the same period in 2022[31] - The company reported a total comprehensive loss of $17,727 thousand for the three months ended September 30, 2023, compared to a comprehensive loss of $12,026 thousand for the same period in 2022[22] - The company reported net cash used in operating activities of $38.207 million for the nine months ended September 30, 2023, compared to $32.869 million for the same period in 2022[31] Cash and Liquidity - Cash and cash equivalents increased significantly from $20,525 thousand to $119,806 thousand, representing a growth of 482.5%[17] - As of September 30, 2023, cash and cash equivalents totaled $119.8 million, a significant increase from $46.0 million on September 30, 2022, representing a growth of 159%[48] - As of September 30, 2023, the company had $188.8 million in available cash, cash equivalents, and short-term investments, estimated to sustain operations for at least twelve months[36] - The company raised an additional $64.0 million in gross proceeds from the October 2023 Financing, enhancing its liquidity position[122] Operating Expenses - Total operating expenses for the three months ended September 30, 2023, were $20,236 thousand, up 63.2% from $12,386 thousand for the same period in 2022[20] - Research and development expenses rose to $13,338 thousand for the three months ended September 30, 2023, compared to $7,698 thousand in the prior year, an increase of 73.5%[20] - General and administrative expenses rose by 47% to $6.9 million for the three months ended September 30, 2023, up from $4.7 million in the prior year[116] - Total operating expenses for the nine months ended September 30, 2023, were $48.8 million, a 25% increase from $39.2 million in the same period of 2022[118] Equity and Liabilities - Total liabilities decreased slightly from $9,417 thousand as of December 31, 2022, to $9,382 thousand as of September 30, 2023[17] - Stockholders' equity decreased from $221,216 thousand as of December 31, 2022, to $184,479 thousand as of September 30, 2023, a decline of approximately 16.6%[17] - The company had an accumulated deficit of $549.1 million as of September 30, 2023[36] Research and Development - The company’s lead product candidate, STAR-0215, is in clinical development for the treatment of hereditary angioedema[34] - STAR-0215 received FDA Fast Track designation in July 2023, indicating its potential as a first-choice preventative treatment for hereditary angioedema[86] - The company plans to submit an IND for STAR-0310 by the end of 2024 and initiate a Phase 1a clinical trial in Q1 2025[96] - Research and development expenses for STAR-0215 were $18.3 million for the nine months ended September 30, 2023, compared to $14.6 million for the same period in 2022[106] Future Outlook and Risks - The company anticipates continuing to incur significant operating losses for the next several years as it develops its product candidates[37] - Future funding requirements will depend on the progress and costs of clinical trials for STAR-0215 and STAR-0310, as well as the ability to establish collaborations and licensing arrangements[140] - The company acknowledges the uncertainty in generating substantial product revenues and may need to rely on additional financing to achieve business objectives[141] - The company’s future commercialization efforts may be delayed or limited if additional funds are not raised when needed[143]