Financial Performance - The company reported net losses of $22.7 million and $81.9 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $428.9 million as of September 30, 2025[107]. - Net loss for the three months ended September 30, 2025, was $28.7 million, compared to a net loss of $6.6 million in Q3 2024, representing a 77% increase in loss[123]. - Total operating expenses for the three months ended September 30, 2025, were $6.9 million, down 77% from $29.6 million in the same period of 2024[123]. - Total operating expenses for the nine months ended September 30, 2025, were $23.7 million, a decrease of 72% from $85.3 million in the same period of 2024[129]. - Net cash used in operating activities was $26.3 million for the nine months ended September 30, 2025, compared to $71.2 million in 2024[142][143]. Cash and Investments - Cash, cash equivalents, and investments totaled $25.2 million as of September 30, 2025[107]. - The company anticipates that existing cash, cash equivalents, and investments will be sufficient to fund operations for at least the next 12 months[110]. - As of September 30, 2025, the company had $25.2 million in cash, cash equivalents, and investments, sufficient to fund operations for at least the next 12 months[134][136]. - The company has raised approximately $407.4 million in net cash proceeds since inception, primarily from equity securities[107]. - The company raised aggregate net cash proceeds of $407.4 million since inception, primarily from the issuance of common stock[133]. Research and Development - ATH-1105, the lead drug candidate, is currently in Phase 1 clinical trials for the treatment of amyotrophic lateral sclerosis (ALS) and has shown a favorable safety profile[99][102]. - The LIFT-AD trial for the previous lead drug candidate, fosgonimeton, did not reach statistical significance, leading to a pause in its development[100]. - The company has paused further development of fosgonimeton and shifted focus to the clinical development of ATH-1105[117]. - Research and development expenses decreased by $50.5 million, from $61.3 million in 2024 to $10.8 million in 2025, a reduction of 82%[130]. - Research and development expenses for the nine months ended September 30, 2025, were $10.8 million, down 82% from $61.3 million in the same period of 2024[129]. - The company expects to continue incurring research and development expenses as drug candidates advance into later stages of development[117]. - The current focus is on enhancing the neurotrophic HGF system to treat neurodegenerative diseases[98]. Operating Expenses - Research and development expenses decreased by $15.1 million, from $17.9 million in Q3 2024 to $2.8 million in Q3 2025, a reduction of 84%[123]. - General and administrative expenses decreased by approximately $3.6 million, from $7.6 million in Q3 2024 to $4.0 million in Q3 2025, a decrease of 47%[126]. - General and administrative expenses decreased by approximately $7.0 million, from $19.9 million in 2024 to $12.9 million in 2025[131]. - The company anticipates lower research and development and general administrative expenses in the near term due to a pause in the fosgonimeton program and a focus on ATH-1105[135]. - Total operating expenses for the nine months ended September 30, 2025, were $23.7 million, a decrease of 72% from $85.3 million in the same period of 2024[129]. Strategic Direction - The company is exploring strategic alternatives to maximize stockholder value, including potential acquisitions or partnerships[105]. - The company plans to build a commercial infrastructure to support future sales if drug candidates are successfully developed[106]. - The company is classified as a smaller reporting company and is not required to provide the information requested by Item 305 of Regulation S-K[154]. Other Income - Other income, net, decreased by $0.6 million, from $0.9 million in Q3 2024 to $0.3 million in Q3 2025, a decrease of 70%[127]. - Other income, net, decreased by $2.4 million, from $3.4 million in 2024 to $1.0 million in 2025[132]. Lease Obligations - The company has lease payment obligations of $1.0 million as of September 30, 2025, with $0.5 million due within 12 months[135].
Athira Pharma(ATHA) - 2025 Q3 - Quarterly Report