OnKure Therapeutics Reports $52.7 Million Net Loss for 2024 Following Merger

OnKure Therapeutics, Inc. (formerly Reneo Pharmaceuticals, Inc.) completed its merger with OnKure, Inc. on October 4, 2024. The merger included a 1:10 reverse stock split, a name change to OnKure Therapeutics, Inc., and the reclassification of common stock into Class A and Class B shares. The second merger with Radiate Merger Sub II, LLC, was not consummated. The company's financial statements reflect the combined entity's performance, giving effect to the merger for periods prior to its effective time.

For the year ended December 31, 2024, OnKure reported a net loss of $52.7 million, compared to a net loss of $35.3 million in 2023. Operating expenses increased by $17.4 million, primarily driven by a $11.7 million rise in research and development expenses and a $5.8 million increase in general and administrative expenses. The increase in research and development costs stemmed from higher clinical trial and manufacturing expenses, and increased personnel costs due to higher headcount and share-based compensation. General and administrative expenses rose due to increased personnel, professional service, and insurance costs.

The company's lead product candidate, OKI-219, is currently in a Phase 1a/1b clinical trial (PIKture-01). Preliminary safety and pharmacokinetic data from the trial, as of October 28, 2024, showed OKI-219 to be well-tolerated, with only grade 1 treatment-related adverse events reported. Enrollment in Part A (monotherapy) and Part B (combination with fulvestrant) of the trial is nearing completion. Additional data, including initial combination data with fulvestrant, is expected in the second half of 2025. OnKure also plans to announce a pan-mutant development candidate in the second quarter of 2025 and a development candidate targeting helical domain mutations in 2026.

As of December 31, 2024, OnKure had an accumulated deficit of $154.7 million and cash and cash equivalents of $110.8 million. The company anticipates needing substantial additional funding to complete the development of its product candidates and fund operations. Funding may be sought through equity and debt financings, collaborations, or licensing arrangements. The company's cash runway extends into the fourth quarter of 2026. OnKure has 46 employees as of March 7, 2025, with 35 engaged in research and development. The company leases its facilities and does not own any real property. OnKure anticipates that its cash resources will be sufficient to fund its planned operations for at least the next 12 months.