PI3Kα inhibition
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OnKure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-03-12 20:05
Core Insights - OnKure Therapeutics is progressing with its PI3Kα-focused pipeline, particularly the PIKture-01 trial of OKI-219, with updated data expected in March 2026 [2][3] - The company plans to announce a next-generation PI3Kα pan-mutant inhibitor candidate for HR+ metastatic breast cancer in March 2026 [4] - As of December 31, 2025, OnKure reported approximately $59 million in cash and cash equivalents [6] Clinical Development - OKI-219 is being evaluated in the PIKture-01 phase 1a/1b clinical trial for HR+ and HER2+ metastatic breast cancer, with a total of 71 patients dosed across different arms [3][7] - Enrollment in both the monotherapy and fulvestrant combination arms of the PIKture-01 trial has been completed, with 38 patients in monotherapy and 33 in combination with fulvestrant [7] - The company continues to enroll patients in the triplet expansion arm for both HR+ and HER2+ breast cancer, with initial data expected in 2026 [7] Financial Performance - Research and development expenses for Q4 2025 were $10.7 million, down from $14.4 million in Q4 2024, primarily due to reduced consulting and clinical trial costs [8] - General and administrative expenses decreased to $3.4 million in Q4 2025 from $4.3 million in Q4 2024, attributed to lower personnel-related costs [9] - The net loss for Q4 2025 was $13.5 million, or $0.99 per share, compared to a net loss of $17.4 million, or $1.37 per share, in Q4 2024 [10][19]