OnKure Therapeutics Inc. reported its third quarter 2025 financial results and provided a business update. The company announced that the first patients have been dosed in the triplet expansion arms of the PIKture-01 trial, which is evaluating OKI-219 in combination with fulvestrant and ribociclib, as well as in combination with trastuzumab and tucatinib, in patients with metastatic breast cancer. Clinical data from the single agent and fulvestrant combination arms of the PIKture-01 trial are maturing, with initial results from these and the triplet expansion arms expected in the first quarter of 2026. Significant progress was reported in OnKure's next-generation PI3Ka pan-mutant inhibitor program, with multiple candidates identified and an announcement planned for the first quarter of 2026. The company also noted an expansion into vascular malformations, with additional information to be provided in 2026. OKI-219 is OnKure's lead product candidate, described as a highly selective PI3kaH1047 mutant specific inhibitor, and is being evaluated in phase 1 clinical trials for patients with HR+ and HER2+ metastatic breast cancer.