Core Insights - OnKure Therapeutics has initiated triplet expansion arms in the PIKture-01 trial for its lead product candidate, OKI-219, targeting metastatic breast cancer [1][2] - Initial clinical data from the single agent and combination arms of the trial is expected to be reported in the first quarter of 2026 [1][5] - The company is advancing its next-generation PI3Kα pan-mutant inhibitor program and plans to provide further details in 2026 [1][3] Company Developments - OKI-219 is being evaluated in the PIKture-01 phase 1 clinical trial for HR+ and HER2+ metastatic breast cancer, with a focus on its selectivity and safety profile [3][4] - The triplet arms of the trial include combinations of OKI-219 with fulvestrant and ribociclib, as well as trastuzumab and tucatinib, with initial data expected in early 2026 [5][6] - OnKure is also expanding into vascular malformations, leveraging its PI3Kα inhibitors to address this underserved population, with more information to be shared in 2026 [6] Financial Performance - As of September 30, 2025, OnKure reported cash and cash equivalents of approximately $70.3 million, sufficient to fund operations into the fourth quarter of 2026 [12] - Research and development expenses for Q3 2025 were $11.9 million, an increase from $10.1 million in Q3 2024, primarily due to higher personnel-related costs [12][17] - The net loss for Q3 2025 was $14.7 million, compared to a net loss of $11.6 million in Q3 2024, with a net loss per share of $1.09 [12][17]
OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update