OnKure Therapeutics Overview - OnKure is developing mutant-selective PI3Kα inhibitors, targeting the majority of PI3Kα-mutated cancers while preserving wild-type PI3Kα [6, 9, 11] - The company's cash and investments are expected to provide funding through multiple clinical milestones and runway into Q4 2026 [6, 55] - OKI-219 is a PI3KαH1047R mutant selective inhibitor being evaluated in a Phase 1 trial as a monotherapy and in combination with fulvestrant in breast cancer [6] OKI-219 Clinical Development - OKI-219 is in Phase 1 clinical trials (PIKture-01) with data update expected in 2H 2025 [6, 9] - PIKture-01 trial includes Part A (monotherapy) and Part B (Fulvestrant Combination) [39, 51] - Initial combination data with fulvestrant expected in 2H 2025 [52] - As of March 31, 2025, OnKure had approximately $96.7 million in cash and investments [55] PI3Kα and Market Opportunity - PI3Kα is the most frequently mutated oncogene [6, 10] - PI3KαH1047R is present in approximately 15% of breast cancers and 4% of all human cancers [15] - OKI-219 exhibits approximately 80X selectivity for PI3KαH1047R vs PI3KαWT [17, 27]
OnKure Therapeutics (OKUR) Earnings Call Presentation