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]