Core Insights - OnKure Therapeutics 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] Business Highlights - The company is advancing three PI3Ka inhibitor programs, with one in clinical development and another expected to be announced in Q2 2025 [2][6] - OnKure plans to report additional data from the OKI-219 program and initiate new clinical trials in 2025 [3][6] Financial Performance - R&D expenses for Q4 2024 were $14.4 million, up from $8.8 million in Q4 2023, primarily due to increased clinical trial and personnel-related costs [8] - General and Administrative expenses rose to $4.3 million in Q4 2024 from $1.1 million in Q4 2023, driven by higher personnel and consulting costs [9] - The net loss per share for Q4 2024 was $1.37, compared to $30.14 per share in Q4 2023 [10][18] Clinical Trials Update - The PIKture-01 trial's Part A monotherapy showed encouraging preliminary safety and tolerability data, with no significant adverse events reported [7][6] - Patient dosing for Part B of the PIKture-01 trial has begun, evaluating OKI-219 in combination with fulvestrant for specific breast cancer mutations [7][6] Strategic Developments - OnKure completed a merger with Reneo Pharmaceuticals on October 4, 2024, and raised $65 million in financing, subsequently changing its name and ticker symbol [6]

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].

Core Viewpoint - OnKure Therapeutics is preparing to present preliminary data from its first-in-human clinical trial of OKI-219 at the 2024 San Antonio Breast Cancer Symposium, with a focus on its potential as a precision medicine in oncology [1][5]. Group 1: Company Announcements - OnKure will hold an investor call on December 10, 2024, to review preliminary data from the PIKture-01 study of OKI-219, rescheduled from December 13, 2024 [2]. - The full text of all regular abstracts from the SABCS has been published, and OnKure plans to include additional data in its poster presentations [3]. - The company is developing OKI-219 as a selective PI3KαH1047R inhibitor, targeting advanced solid tumors and advanced breast cancer [5][6]. Group 2: Poster Presentation Details - The poster titled "Preliminary results from PIKture-01, a First-in-Human Study of OKI-219" will be presented on December 12, 2024, from 12:30 PM to 2:00 PM CST [4]. - Another poster titled "OKI-219 enhances activity of SOC therapies in double and triple combinations" will also be presented on December 12, 2024, from 5:30 PM to 7:00 PM CST [4]. Group 3: Company Background - OnKure is focused on developing precision medicines that target biologically validated drivers of cancers, utilizing a structure-based drug design platform [6]. - The company aims to become a leader in targeting oncogenic PI3Kα, with multiple programs designed for optimal efficacy and tolerability [6].

Financial Performance - Reneo's total operating expenses for the three months ended September 30, 2024, were $4.664 million, a decrease of $16.224 million compared to $20.888 million in the same period of 2023[71] - Reneo reported a net loss of $3.692 million for the three months ended September 30, 2024, compared to a net loss of $19.196 million in the same period of 2023, reflecting an improvement of $15.504 million[71] - For the nine months ended September 30, 2024, total operating expenses were $20.591 million, down $37.456 million from $58.047 million in the same period of 2023[75] - Reneo's net loss for the nine months ended September 30, 2024 was $17.5 million, adjusted for non-cash items[85] Research and Development - Research and development expenses decreased by $12.718 million to $904,000 for the three months ended September 30, 2024, primarily due to the suspension of development activities for mavodelpar[72] - Research and development expenses for the nine months ended September 30, 2024, were $6.436 million, a decrease of $32.573 million compared to $39.009 million in the same period of 2023[76] - Early clinical data for the lead product candidate, OKI-219, is expected in the fourth quarter of 2024[64] - Future funding requirements will depend on the costs and outcomes of research and development activities, including clinical trials for product candidates[82] - The company is subject to risks inherent in the development of new biopharmaceutical products, which may lead to unforeseen expenses and delays[81] Cash Flow and Capital Needs - As of September 30, 2024, Reneo had approximately $76.7 million in cash, cash equivalents, and short-term investments[79] - Net cash used in operating activities for the nine months ended September 30, 2024 was $30.1 million, a decrease from $43.9 million in the same period of 2023[84] - Net cash provided by investing activities for the nine months ended September 30, 2024 was $61.2 million, compared to a net cash used of $29.3 million in 2023[86] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $0.1 million, significantly lower than $65.0 million in 2023[87] - Reneo's cash flow for the nine months ended September 30, 2024 showed a net increase of $33.1 million, contrasting with a decrease of $8.2 million in 2023[84] - The company anticipates needing additional capital to fund operations, which may be sought through equity or debt financings, collaborations, or licensing arrangements[80] - Reneo's ability to secure additional capital is contingent upon the success of its product candidates and may involve dilution of existing stockholders' interests[81] - The company may need to raise additional capital through equity or debt financing, which could impose restrictions on its operations[81] Operational Focus - Following the Merger, Legacy OnKure's operations will be the focus, with expectations of significant expenses and operating losses as clinical development advances[79] - The company has never generated revenue from product sales and does not expect to do so until regulatory approval is obtained[81]