Financial Performance - For the nine months ended September 30, 2025, the net loss was $46.0 million, compared to a net loss of $35.2 million for the same period in 2024, representing an increase of $10.8 million[115][130]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[115]. - The company incurred a loss from operations of $15.5 million for the three months ended September 30, 2025, compared to a loss of $11.5 million for the same period in 2024, an increase of $3.99 million[126]. - The company has not generated any revenue from product sales and expects to continue incurring significant operating losses and negative cash flows as it advances clinical development[137]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $11.9 million, an increase of approximately $1.8 million from $10.1 million in the same period in 2024[127]. - General and administrative expenses for the three months ended September 30, 2025, were $3.6 million, up from $1.4 million in the same period in 2024, reflecting an increase of approximately $2.2 million[128]. - Total operating expenses for the nine months ended September 30, 2025, were $48.8 million, compared to $35.7 million for the same period in 2024, an increase of $13.1 million[130]. - Research and development expenses increased to $37.5 million for the nine months ended September 30, 2025, up from $29.4 million in the same period of 2024, representing an increase of approximately 27.5%[131]. - General and administrative expenses rose to $11.3 million for the nine months ended September 30, 2025, compared to $6.3 million in 2024, marking an increase of approximately 79.4%[133]. - Cash used in operating activities was $40.3 million for the nine months ended September 30, 2025, compared to $27.8 million in 2024, indicating an increase of approximately 45%[147]. - The net decrease in cash and cash equivalents was $40.4 million for the nine months ended September 30, 2025, compared to a decrease of $21.9 million in 2024, representing an increase of approximately 84.5%[146]. Cash and Financing - Cash and cash equivalents as of September 30, 2025, were $70.3 million, sufficient to fund planned operations for at least the next 12 months[116]. - The company completed a private placement of 2,839,005 shares at approximately $22.895 per share for an aggregate of approximately $65.0 million[113]. - Interest income for the three months ended September 30, 2025, was $804,000, compared to $174,000 for the same period in 2024, an increase of $630,000[126][129]. - Cash used in financing activities was $77 thousand for the nine months ended September 30, 2025, compared to $5.9 million provided in 2024, indicating a significant decrease in financing activity[151]. - The company will require additional capital to fund operations and may seek to obtain it through equity or debt financings, collaborations, or licensing arrangements[138]. Future Outlook - The company is currently conducting a first-in-human Phase 1a/1b clinical trial for its lead product candidate, OKI-219[110]. - The company anticipates that research and development expenses will be higher in 2025 compared to 2024 due to ongoing clinical and preclinical program advancements[132]. - General and administrative expenses are expected to increase in 2025 as the company operates as a public entity for the full year[134].
OnKure Therapeutics, Inc.(OKUR) - 2025 Q3 - Quarterly Report