Reneo Pharmaceuticals, Inc. and OnKure, Inc. have announced an all-stock merger agreement aimed at creating a Nasdaq-listed, clinical-stage biopharmaceutical titan specializing in oncology precision medicines. The combined entity, which would adopt the OnKure Therapeutics name and trade under the ticker symbol OKUR, plans to focus on advancing OnKure’s portfolio, specifically targeting oncogenic mutations in phosphoinositide 3-kinase alpha (PI3K). Their leading program, the OKI-219 currently in Phase 1 clinical trial, shows promise for the treatment of solid tumors, particularly in breast cancer. The merger is engineered to combine the strengths of OnKure’s innovative drug development and Reneo’s established commercialization track record. With both boards unanimously approving the agreement, it’s contingent on stockholder approval, regulatory clearances, Reneo’s net cash minimums, and meeting NASDAQ listing standards. The anticipated cash resources of approximately $120 million at closure should fund clinical milestones and operations into Q4 2026. This further cements the strategic move that has been considered beneficial by Reneo’s board and executive team, providing an exciting development pathway for OKI-219, expected to offer enhanced treatment options. Meanwhile, the management teams of OnKure are poised to lead the new company post-merger, aiming to pioneer in mutant-selective PI3K inhibitor therapies. The advisory teams for the transaction consist of financial guidance from Leerink Partners and legal counsel by Jones Day and Cooley LLP for Reneo, while OnKure has tapped Oppenheimer & Co. for capital markets advice and Wilson Sonsini Goodrich & Rosati, P.C. for legal counsel. The deal is buttressed by a $65 million PIPE financing endeavor, backed by a roster of institutional investors and facilitated by Leerink Partners, Evercore ISI, and LifeSci Capital.

Biopharmaceuticals, Oncology, Clinical-Stage Precision Medicine,United States