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OnKure Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Business Update
Globenewswire· 2025-08-12 20:05
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]
OnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
Globenewswire· 2025-03-10 20:05
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].
OnKure Therapeutics to Present at Upcoming Leerink and Stifel Investor Conferences
Globenewswire· 2025-03-04 13:00
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].