Clinical-stage biopharmaceutical - OnKure Therapeutics - has finalized its merger with Reneo Pharmaceuticals and raised $65 mn through a private investment as the company looks to accelerate the development of their mutant-specific PI3Kα inhibitor portfolio.

PI3Kα is the most frequently mutated oncogene in cancers, with the most common - PI3KαH1047R - found in 15% of breast cancer and 4% of cancers overall. OnKure’s lead product candidate, OKI-219, is an orally bioavailable, highly selective inhibitor of PI3KαH1047R, which the company suggests should significantly improve the activity and safety relative to currently approved PI3Kα inhibitors.

OnKure Therapeutics, Inc. (Nasdaq: OKUR) (“OnKure”), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, today announced the completion of its previously announced merger of OnKure, Inc. and Reneo Pharmaceuticals, Inc. (“Reneo”). The combined company will operate under the name OnKure Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on October 7, 2024 under the ticker symbol "OKUR".

Concurrent with the closing of the merger, the company completed a $65 million private placement with a group of new and existing investors, including Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital (a Citadel company), Vestal Point Capital, and other undisclosed investors. Following the transactions, OnKure is expected to have a cash runway through multiple clinical readouts and into Q4-2026.

“We are ecstatic to finalize this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. Combined with our unique expertise in PI3K-mutated cancers, we aim to fully target and exploit the vulnerabilities of this oncogenic menace for the benefit of patients suffering needlessly,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Our lead program OKI-219, a highly selective inhibitor of PI3KαH1047R, has the potential to provide benefit to breast cancer patients. With the PIKture-01 trial of OKI-219 well underway, we look forward to releasing early clinical data in the fourth quarter of 2024 and initiating planned combination arms of the PIKture-01 trial.”

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