Reneo Pharmaceuticals and OnKure Plan Merger

Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM) and OnKure, Inc., a private clinical-stage biopharmaceutical firm, have signed a definitive merger agreement. This all-stock transaction will combine the two companies, focusing on advancing OnKure's precision oncology drug portfolio. The merger will result in a Nasdaq-listed entity under the name OnKure Therapeutics, Inc., trading under the ticker symbol “OKUR”.

The merger anticipates that the new entity, OnKure Therapeutics, Inc., will have about $120 million in cash resources at closing, expected to fund multiple clinical milestones through the fourth quarter of 2026. The merger also includes a $65 million private investment in public equity (PIPE) financing involving several institutional investors. These transactions are subject to various conditions, including stockholder approval from both companies and effectiveness of a registration statement filed with the U.S. Securities and Exchange Commission. The combined company must also maintain at least $55 million in net cash at closing, excluding the PIPE financing proceeds.

OnKure's lead program, OKI-219, is currently in a Phase 1 clinical trial targeting solid tumors. Initiated in February 2024, this first-in-human clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OKI-219 both as a monotherapy and in combination with other therapies for advanced breast cancer. OKI-219 is designed to selectively inhibit the PI3KαH1047R mutation, which is prevalent in 15% of breast cancers and 4% of cancers overall. This selectivity aims to reduce toxicity by sparing the normal, non-mutated form of the enzyme.

Mike Grey, Executive Chairman of Reneo Pharmaceuticals, and Nicholas Saccomano, President and CEO of OnKure, both expressed optimism about the merger. Grey emphasized the potential for OKI-219 to benefit breast cancer patients, while Saccomano highlighted the strategic timing of the merger, aligning with the initiation of the PIKture-01 trial.

Reneo stockholders are expected to own approximately 31% of the combined company, while OnKure stockholders will own around 69%, subject to adjustments based on Reneo’s net cash at closing. The merger has been unanimously approved by the boards of both companies and is expected to close in 2024, pending customary closing conditions and stockholder approvals.

Post-merger, the combined company will be headquartered in Boulder, Colorado, with Nicholas Saccomano leading as CEO. The board of directors will consist of eight members, six from OnKure and two from Reneo. Legal and financial advisors for the transaction include Leerink Partners, Jones Day, Cooley LLP, and others.

Reneo Pharmaceuticals focuses on developing therapies for rare genetic mitochondrial diseases, while OnKure specializes in precision oncology medicines targeting biologically validated cancer drivers. OnKure's pipeline, including OKI-219, aims to provide best-in-class treatments with optimal efficacy and tolerability.

The completion of this merger is expected to enhance the combined company’s ability to advance its oncology drug candidates, driving innovation and potentially improving treatment options for patients suffering from various cancers.