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OnKure Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Business Update

Core Insights - OnKure Therapeutics is advancing its lead asset, OKI-219, through the PIKture-01 clinical trial, with data expected in Q4 2025 for both monotherapy and combination treatments [1][2][6] - The company has initiated new expansion arms in the PIKture-01 trial to evaluate OKI-219 in combination with fulvestrant and ribociclib for HR+ metastatic breast cancer, as well as with trastuzumab and tucatinib for HER2+ metastatic breast cancer [1][3][6] - OnKure's cash position of approximately $83.4 million is projected to sustain operations into Q4 2026 [1][13] Clinical Development - Enrollment for the single agent and fulvestrant combination arms of the PIKture-01 trial has been completed, with a total of 70 patients dosed: 36 in monotherapy and 34 in combination with fulvestrant [6] - The new triplet combination arms will assess the safety of escalating doses of OKI-219 in conjunction with fulvestrant and ribociclib, and trastuzumab and tucatinib, specifically targeting PI3Kα mutated breast cancer [6][3] Financial Performance - For Q2 2025, OnKure reported R&D expenses of $12.6 million, up from $10.8 million in Q2 2024, primarily due to increased clinical trial and research costs [13][17] - General and Administrative expenses were $3.7 million for Q2 2025, slightly higher than $3.6 million in Q2 2024, attributed to increased personnel-related costs [13][17] - The net loss for Q2 2025 was $15.4 million, or $1.14 per share, compared to a net loss of $14.1 million, or $44.82 per share, in Q2 2024 [13][17] Strategic Outlook - OnKure aims to position OKI-219 as a significant treatment option in the first-line hormone receptor positive setting and is expanding its PI3Kα portfolio with plans to nominate a pan-mutant selective PI3Kα inhibitor by the end of 2025 [3][4]