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]

Updated interim data remain consistent, showing 10.3-month median PFS overall and 11.0-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer Data continue to support planned initiation of pivotal study in mid-2025 Next-generation triplet combinations with atirmociclib (CDK4-selective) & ribociclib ongoing CAMBRIDGE, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery pro ...

Core Insights - OnKure Therapeutics, Inc. reported a net loss of $17.4 million for Q4 2024, with cash and cash equivalents of approximately $110.8 million expected to fund operations through multiple clinical readouts into Q4 2026 [1][5][10]. Financial Performance - Research and development (R&D) expenses for Q4 2024 were $14.4 million, an increase from $8.8 million in Q4 2023, primarily due to higher clinical trial and manufacturing costs [8]. - General and Administrative (G&A) expenses rose to $4.3 million in Q4 2024 from $1.1 million in Q4 2023, driven by increased personnel-related costs and consulting expenses [9]. - The net loss per share for Q4 2024 was $1.37, compared to $30.14 per share in Q4 2023 [10]. Business Highlights - OnKure is advancing three PI3Ka inhibitor programs, with one in clinical development and another expected to be announced in Q2 2025 [2]. - The PIKture-01 trial has shown encouraging preliminary safety and tolerability data for the OKI-219 monotherapy, with no dose-limiting toxicities observed [7]. - The company initiated patient dosing in Part B of the PIKture-01 trial, evaluating OKI-219 in combination with fulvestrant for metastatic breast cancer [6][7]. - A merger with Reneo Pharmaceuticals closed on October 4, 2024, along with a $65 million financing, leading to a name change and new ticker symbol "OKUR" [6]. Upcoming Milestones - Additional data from the PIKture-01 trial is expected in the second half of 2025, along with the announcement of a pan-mutant selective program [6][3]. - OnKure aims to demonstrate approximately 10-fold selectivity of its pan-mutant inhibitor against common mutations over wild type [6].

Core Viewpoint - OnKure Therapeutics, Inc. is focused on developing novel precision medicines in oncology, with a particular emphasis on targeting biologically validated drivers of cancers that are underserved by existing therapies [1]. Company Overview - OnKure Therapeutics, Inc. is a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker OKUR [1]. - The company utilizes a structure- and computational chemistry-driven drug design platform to create a pipeline of tumor-agnostic candidates aimed at achieving optimal efficacy and tolerability [1]. - The lead program, OKI-219, is a selective PI3Kα inhibitor, and OnKure aims to become a leader in targeting oncogenic PI3Kα with multiple programs designed for best-in-class targeting of this key oncogene [1]. Upcoming Events - Nicholas Saccomano, Ph.D., President and CEO of OnKure, will present at the Leerink Partners Global Healthcare Conference on March 11, 2025, at 4:20 p.m. ET, with a live audio webcast available [3]. - OnKure will also participate in a fireside chat at the Stifel Targeted Oncology Forum, which will be held virtually on April 8-9, 2025 [3].