0001193125-26-104147
SEC filingOnKure Therapeutics, Inc. (OKUR), a clinical-stage biopharmaceutical company, reported a net loss of $59.5M for FY 2025 ended December 31, 2025, up 13% from $52.7M in FY 2024, driven by higher operating expenses of $63.0M versus $54.4M prior year. No revenue was generated as the company advances its lead candidate OKI-219 in Phase 1 PIKture-01 trial for PI3Kα H1047R-mutated breast cancer, with data expected in 2026. Research and development expenses rose 10% to $48.3M from $43.8M, reflecting increased personnel costs and clinical activities. General and administrative expenses increased 39% to $14.7M from $10.6M, due to higher share-based compensation and public company costs post-Merger. Balance sheet shows total assets of $62.1M, including $59.0M cash, down from $114.9M prior year. Stockholders' equity stands at $56.2M. Operating cash use was $51.8M, with cash runway into Q4 2026. Going concern doubt persists due to capital needs for clinical advancement. Strategic focus remains on mutant-selective PI3Kα inhibitors, with pan-mutant candidate announcement planned Q1 2026.
OnKure Therapeutics reported FY2025 net loss of $59.5M, a 13% increase from $52.7M in FY2024, with loss per share improving to -$4 from -$15.28 due to higher share count post-Merger (13.5M weighted average shares). Total operating expenses rose 16% to $63.0M from $54.4M, driven by R&D up 10% to $48.3M and G&A up 39% to $14.7M. No revenue generated as pre-commercial biotech. Other income of $3.4M (mainly interest) partially offset losses, up from $1.7M. Cash burn remained steady at ~$52M operating cash use. Balance sheet reflects $62.1M total assets, $56.2M equity, with $59.0M cash supporting operations into Q4 2026.
No revenue reported in FY2025 or FY2024, consistent with clinical-stage focus on OKI-219 Phase 1 trial and preclinical programs. Company operates single segment: clinical research. No geographic breakdown disclosed.
Not applicable due to zero revenue. Operating loss was -$63.0M, fully matching expenses. Loss from operations worsened 16% YoY. Share-based compensation surged to $11.6M from prior year, comprising ~18% of op ex, reflecting post-Merger equity grants. No gross margins as pre-revenue.
Net cash used in operations $51.8M, similar to $51.1M prior year. Investing activities minor outflow $46K (equipment); financing $163K (ESPP). Cash decreased $51.7M to $59.0M from $110.8M. Total assets $62.1M (down 46% YoY), liabilities $5.9M stable. Equity $56.2M after $59.5M loss. No debt post-convertible notes conversion in Merger. Runway into Q4 2026; going concern doubt noted due to funding needs.
Management expects continued losses with higher R&D/G&A in 2026 for PIKture-01 data readout (monotherapy, combos) and pan-mutant candidate Q1 2026. ATM offering up to $16M available but unused. Risks include clinical delays, capital raise uncertainty, competition in PI3Kα inhibitors. Strategic priorities: advance OKI-219 in breast cancer, expand pipeline to vascular malformations.