Financial Data and Key Metrics Changes - The meeting confirmed the election of two class one directors and the ratification of KPMG as the independent registered public accounting firm for the fiscal year ending December 31, 2025 [5][13]. Business Lines Data and Key Metrics Changes - No specific data or metrics related to individual business lines were discussed in the meeting [1]. Market Data and Key Metrics Changes - No specific market data or metrics were provided during the meeting [1]. Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining strong governance by electing qualified directors and ensuring reliable financial oversight through the appointment of KPMG [5][13]. Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting [1]. Other Important Information - The meeting was conducted virtually, and a sufficient number of shares were present to constitute a quorum [3][4]. Summary of Q&A Session - There were no questions or comments from attendees during the Q&A session [7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 80301 (Zip Code) (Registrant's telephone number, including area code): (720) 307-2892 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading symbol | Na ...

Financial Performance - OnKure Therapeutics reported cash and cash equivalents of approximately $96.7 million as of March 31, 2025, expected to fund operations through multiple anticipated milestones into Q4 2026[5][17]. - The net loss for Q1 2025 was $15.9 million, or $1.19 per share, compared to a net loss of $9.5 million, or $30.37 per share, in Q1 2024[8][18]. - Interest income for Q1 2025 was $1.1 million, compared to $0.3 million in Q1 2024, reflecting improved cash management[18]. - Total operating expenses for Q1 2025 were $17.0 million, significantly higher than $9.8 million in Q1 2024, indicating increased investment in R&D and G&A[18]. Research and Development - Research and development (R&D) expenses increased to $13.0 million for Q1 2025, up from $8.6 million in Q1 2024, primarily due to higher personnel-related costs and clinical trial expenses[6]. - The PIKture-01 trial has completed dose escalation in Part A, with only one patient experiencing dose limiting toxicities, and a mature clinical update is expected in the second half of 2025[4][11]. - OnKure is actively enrolling patients in Part B of the PIKture-01 trial, evaluating OKI-219 in combination with fulvestrant, with no dose limiting toxicities observed to date[11]. - The company plans to announce a pan-mutant selective development candidate in Q2 2025, targeting approximately 10-fold selectivity against common PI3Ka mutations[3][11]. - OnKure aims to solidify its leadership in developing PI3K inhibitors with the ongoing PIKture-01 trial and the advancement of its pan-mutant program[2][3]. General and Administrative Expenses - General and Administrative (G&A) expenses rose to $4.0 million in Q1 2025, compared to $1.3 million in Q1 2024, driven by increased personnel-related costs and legal expenses[7].

Core Insights - OnKure Therapeutics is making progress in its PIKture-01 trial, with additional data expected in the second half of 2025, including mature single-agent and initial combination data [1][2] - The company plans to expand its PI3Ka franchise with a pan-mutant selective development candidate announcement anticipated in Q2 2025 [1][3] - As of March 31, 2025, OnKure has approximately $96.7 million in cash and cash equivalents, which is expected to fund operations through multiple anticipated milestones into Q4 2026 [1][4] Business Highlights and Upcoming Milestones - The PIKture-01 trial Part A has completed dose escalation, with only one patient experiencing dose-limiting toxicities at the highest dose level [3] - Preliminary data from Part A showed that OKI-219 was well tolerated across all dose levels, with no significant adverse events reported [3] - In Part B of the PIKture-01 trial, OnKure is actively enrolling patients to evaluate OKI-219 in combination with fulvestrant for treating PI3Kα mutated HR+/HER2- metastatic breast cancer, with initial combination data expected in the second half of 2025 [6] Financial Results - Research and development expenses for Q1 2025 were $13.0 million, an increase from $8.6 million in Q1 2024, primarily due to higher personnel-related costs and clinical trial expenses [5] - General and administrative expenses for Q1 2025 were $4.0 million, up from $1.3 million in Q1 2024, driven by increased personnel-related costs and legal expenses [7] - The net loss for Q1 2025 was $15.9 million, compared to a net loss of $9.5 million in Q1 2024, with a net loss per share of $1.19 [8][16]

Financial Performance - OnKure reported approximately $110.8 million in cash and cash equivalents as of December 31, 2024, an increase from $29.9 million in 2023[5][15]. - The net loss for Q4 2024 was $17.4 million, or $1.37 per share, compared to a net loss of $9.5 million, or $30.14 per share, in Q4 2023[7][16]. - Total operating expenses for the year ended December 31, 2024, were $54.4 million, compared to $36.9 million in 2023, representing a 47.2% increase[16]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $14.4 million, up from $8.8 million in Q4 2023, reflecting a 63.6% increase[5][16]. - OnKure has completed patient enrollment in the Part A monotherapy arm of the PIKture-01 trial, with no dose limiting toxicities observed[4]. - The company initiated patient dosing in Part B of the PIKture-01 trial in Q4 2024, evaluating OKI-219 in combination with fulvestrant[8]. Administrative Expenses - General and Administrative (G&A) expenses rose to $4.3 million in Q4 2024, compared to $1.1 million in Q4 2023, marking a 290.9% increase[6][16]. Future Plans and Updates - OnKure expects to provide a clinical update on the PIKture-01 trial in the second half of 2025, with additional data from the OKI-219 program anticipated[4][3]. - OnKure plans to announce a pan-mutant development candidate in Q2 2025, targeting key mutations with approximately 10-fold selectivity[8]. Mergers and Financing - The merger with Reneo Pharmaceuticals closed on October 4, 2024, along with a $65 million financing[8].

Financial Performance - The company has incurred significant net losses of $52.7 million and $35.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $154.7 million as of December 31, 2024[182]. - The company expects to incur losses for the foreseeable future and might never achieve profitability, with substantial increased operating losses projected for at least the next several years[369]. - The market price of the company's Class A Common Stock has been volatile and is expected to continue to fluctuate significantly[366]. - Market volatility may adversely affect the trading price of the company's Class A Common Stock, especially during economic downturns[368]. Revenue Generation - The company has never generated any revenue from product sales and does not anticipate doing so for many years, if ever[184]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future, with net losses fluctuating significantly from quarter to quarter[183]. Product Development and Regulatory Approval - The company is currently evaluating its product candidate OKI-219 in a Phase 1 clinical trial, which requires demonstrating safety and efficacy before seeking regulatory approvals[194]. - The company has not previously submitted a New Drug Application (NDA) to the FDA or similar regulatory authority for any product candidate, which is necessary for marketing approval[188]. - The regulatory approval processes for the company's product candidates are lengthy and unpredictable, and failure to obtain such approvals would significantly harm the business[202]. - The company is substantially dependent on the success of OKI-219, and any delays or failures in its clinical development could materially harm the business[193]. - The FDA's approval process for product candidates is unpredictable and can take many years, influenced by various factors including trial design and data interpretation[203]. - Regulatory authorities may require additional clinical data or disagree with trial results, potentially delaying or preventing marketing approval[204]. - Delays in patient enrollment for clinical trials can significantly impact the timeline for obtaining regulatory approvals[211]. - The company has not yet submitted for regulatory approval for any product candidates, and there is a risk that none will ever receive approval[203]. - The company plans to provide updated data from ongoing trials in the second half of 2025, with preliminary data indicating potential for further development[218]. Funding and Financial Needs - The company will need substantial additional funding to complete the development of its product candidates, with cash expected to fund operations into the fourth quarter of 2026[189]. - The company may seek to raise additional funds through equity and debt financings or strategic collaborations, but there are no assurances that sufficient funds will be secured[190]. Competition and Market Risks - There is substantial competition in the pharmaceutical industry, with competitors having greater financial resources and established market presence, which may hinder the company's ability to obtain regulatory approvals[232]. - Multiple PI3Kα-pathway targeted agents are either approved or in clinical development, posing competitive threats to OKI-219 and the company's portfolio[233]. Intellectual Property Risks - The company relies on a combination of patents and trade secrets for intellectual property protection, which is critical for the commercialization of product candidates[253]. - The patent application process is expensive and time-consuming, with no guarantee that patents will be issued or enforced effectively[256]. - There is a risk of litigation from third parties claiming infringement of their intellectual property rights, which could delay product development and commercialization[273]. - The company may face significant litigation expenses and resource diversion in defending against intellectual property claims[277]. - The company may struggle to prevent misappropriation of its intellectual property rights, especially in jurisdictions with weaker protections, which could adversely affect its operations[282]. Compliance and Regulatory Challenges - The company is subject to user fees and periodic inspections by the FDA to ensure compliance with Good Manufacturing Practices (cGMPs)[316]. - Non-compliance with regulatory requirements could result in marketing restrictions, product recalls, or withdrawal from the market[317]. - Changes in FDA policies or government regulations could delay or prevent regulatory approval of product candidates[318]. - The company may face ongoing regulatory requirements for product candidates, including safety monitoring and potential costly post-market studies[314]. Operational Risks - The company relies on third parties for clinical trials and studies, and any failure by these parties could delay regulatory approval and commercialization of product candidates[347]. - The company relies on third-party manufacturers for the production of its product candidates, which increases the risk of supply shortages and delays in clinical trials[352]. - The company does not have internal manufacturing capabilities and does not intend to develop such infrastructure, relying entirely on external partners[353]. Management and Personnel - The company is highly dependent on attracting and retaining skilled executives, with significant competition in the biotechnology field[356]. - The company may struggle to attract and retain key personnel due to intense competition in the biotechnology sector[371]. Legal and Compliance Risks - The company may face challenges in protecting its trademarks and trade names, which could adversely affect its ability to build brand recognition and compete effectively in its markets[298]. - The company may face claims regarding the wrongful use of confidential information by employees or contractors, which could result in costly litigation and loss of intellectual property rights[296].

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].