OnKure Therapeutics Inc (NASDAQ: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of precision small molecule drugs targeting mutated forms of PI3Kα, a gene implicated in cancer and vascular overgrowth syndromes. The company generates no product revenue as of its 10-K filed March 12, 2026, operating entirely on capital raised through equity financing. OnKure is headquartered in Boulder, Colorado. The current entity was formed through a merger completed October 4, 2024, in which Reneo Pharmaceuticals, Inc. (incorporated in Delaware in November 2014) acquired Legacy OnKure, Inc. (incorporated in Delaware in March 2011) and changed its name to OnKure Therapeutics, Inc. The company's structure-based drug design platform uses medicinal chemistry, x-ray crystallography, and computational chemistry to develop mutant-selective inhibitors, with lead candidate OKI-219 showing approximately 80-fold selectivity for PI3KαH1047R over wild-type PI3Kα as disclosed in the same filing.

Revenue model

No product revenue. Clinical-stage company funded by equity capital raises. No licensing, royalty, or commercial revenue disclosed in the 10-K filed March 12, 2026.

Products and services

Lead product candidate OKI-219: a mutant-selective PI3Kα inhibitor targeting the PI3KαH1047R mutation, the most common PI3Kα mutation in breast cancer, with approximately 80-fold selectivity over wild-type PI3Kα (per 10-K filed March 12, 2026). Pan-mutant PI3Kα inhibitor program: pipeline candidates in development targeting PI3KαH1047X, PI3KαE542K, and PI3KαE545K mutations with greater than 10-fold selectivity across each mutation. All candidates are pre-commercial as of the filing date.

Customers and end markets

No commercial customers as of the 10-K filed March 12, 2026. Target end market is oncology, specifically patients with PI3Kα-mutated cancers including hormone receptor-positive metastatic breast cancer (HR+ mBC). Secondary end market includes vascular overgrowth syndromes.

Value-chain role

Drug discovery and early clinical development. Contracts with third parties for disposal of hazardous laboratory materials. No manufacturing or commercial distribution operations disclosed in the filing.

Geographic exposure

Principal executive offices located in Boulder, Colorado. Regulatory references include the United States FDA approval pathway and international markets including Europe and Canada, though no commercial operations outside the U.S. are disclosed in the 10-K filed March 12, 2026.

Source: SEC 10-K, filed 2026-03-12

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