In This Story
OnKure Therapeutics Inc. (OKUR-0.97%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's focus on developing precision medicines targeting cancer drivers. OnKure's lead product candidate, OKI-219, is a selective inhibitor of the PI3KαH1047R mutation, currently in a Phase 1a/1b clinical trial.
The company reported a net loss of $52.7 million for the year, compared to $35.3 million in 2023, with an accumulated deficit of $154.7 million as of December 31, 2024.
OnKure's development pipeline includes a pan-mutant PI3Kα inhibitor targeting common mutations and an allosteric inhibitor for helical domain mutations, with plans to announce a development candidate in 2026.
The filing notes risks associated with OnKure's early-stage development, including dependence on OKI-219, potential delays in clinical trials, and the need for additional funding to continue operations.
OnKure relies on third-party manufacturers for the production of its product candidates and faces competition from other companies developing PI3Kα pathway-targeted therapies.
The company highlights the importance of attracting and retaining skilled personnel, as well as the potential impact of regulatory changes on its operations.
OnKure's intellectual property strategy includes a portfolio of patents and applications covering its PI3K platform, with ongoing efforts to protect its proprietary technologies.
The filing outlines various regulatory and legal risks, including compliance with healthcare laws, data protection regulations, and potential litigation related to intellectual property rights.
OnKure's corporate headquarters are located in Boulder, Colorado, with additional leased space in Irvine, California, which has been subleased following the merger with Reneo Pharmaceuticals, Inc.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the OnKure Therapeutics Inc. annual 10-K report dated March 10, 2025. To report an error, please email earnings@qz.com.