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Here are 1-3 brief analogies for OnKure Therapeutics:

1. Like a clinical-stage Bristol Myers Squibb focused on discovering new cancer drugs.

2. An emerging Merck concentrating solely on developing groundbreaking cancer treatments.

3. A nascent Genentech dedicated to pioneering innovative oncology therapies.

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• OK-101: An investigational small molecule inhibitor targeting ERK1/2 in the MAPK pathway, currently in Phase 1 clinical trials for various advanced solid tumors.
• OK-201: An investigational small molecule inhibitor of Class I histone deacetylases (HDACs), currently in Phase 1 clinical trials for various advanced solid tumors.

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OnKure Therapeutics (symbol: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision oncology therapeutics. As a clinical-stage company, OnKure Therapeutics is primarily engaged in research and development and is still in the process of developing its drug candidates through clinical trials.

Consequently, OnKure Therapeutics does not currently have any commercialized products on the market, nor does it have major customers (either other companies or individuals) purchasing its products. Its operations are currently funded through equity financing, grants, and potential collaboration or licensing agreements, rather than commercial sales.

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Nicholas A. Saccomano, Ph.D. President & Chief Executive Officer

Nicholas A. Saccomano brings nearly 35 years of experience leading pharmaceutical research and development across multiple therapeutic areas. Before joining OnKure, he was the Chief Science Officer and Site Head at Pfizer's Boulder facility, where he led a team of 170 research scientists focusing on small molecule drug programs. At Pfizer, he oversaw the discovery and progression of central nervous system drugs such as ziprasidone (Geodon®), donepezil (Aricept®), and varenicline (Chantix®). Prior to Pfizer, Dr. Saccomano served as Chief Science Officer at Array BioPharma Inc., where he was instrumental in creating and advancing ten clinical-stage compounds, leading to seven drug approvals. He also held the position of Chief Technology Officer at SomaLogic Inc., managing scientific and technical teams focused on the company's proteomic platform.

Jason Leverone, CPA Chief Financial Officer

Jason Leverone has over 25 years of strategic finance and operational experience, with more than 19 years in the life sciences sector. Before his role at OnKure, he served as Chief Financial Officer and Secretary of miRagen Therapeutics, Inc., a publicly traded biotechnology company that merged with Viridian Therapeutics, Inc. in 2020. During his tenure at miRagen, he played key roles in the company's public offering, strategic license transactions, and mergers and acquisitions. Previously, he was Senior Director of Finance and Controller for Replidyne, Inc., another publicly traded biotechnology company acquired in 2009. Mr. Leverone also served as Corporate Controller for CreekPath Systems, Inc., a private international software development company. He began his professional career in public accounting at Ernst and Young LLP and Arthur Andersen LLP and is a Certified Public Accountant.

Samuel Agresta, M.D. Chief Medical Officer

Dylan Hartley, Ph.D. Chief Scientific Officer

Rogan Nunn, J.D. General Counsel and Secretary

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The key risks to OnKure Therapeutics (symbol: OKUR) primarily stem from the inherent challenges of being a clinical-stage biopharmaceutical company operating in a highly competitive sector:

1. Clinical and Regulatory Risks: As a clinical-stage company, OnKure's success is profoundly dependent on favorable outcomes from its clinical trials and subsequent regulatory approvals for its product candidates. Any delays, failures, or the emergence of significant adverse events during clinical trials could severely impact the company's prospects and its ability to bring products to market. The unpredictability of clinical trial results and regulatory processes represents a foundational risk for the business.
2. Financial Dependence and Inability to Achieve Profitability: OnKure Therapeutics is not yet profitable and consistently incurs significant net losses, relying heavily on external funding to support its extensive research and development operations. The company's high cash burn rate relative to its market capitalization indicates an elevated risk of financial distress if it faces difficulties securing additional capital, which could be exacerbated by economic downturns or investor sentiment.
3. Intense Competition and Market Dependence: OnKure operates within a highly competitive oncology market, contending with both established pharmaceutical giants and numerous emerging biotechnology firms. The company's reliance on a limited number of product candidates, particularly its lead candidate OKI-219, increases its vulnerability to competitive pressures and market fluctuations, as competing therapies or alternative approaches could diminish the potential market share or viability of OnKure's offerings.

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1. Clinical Development and Potential Commercialization of OKI-219: OnKure's lead product candidate, OKI-219, is a selective PI3KαH1047R inhibitor currently undergoing a Phase 1a/1b clinical trial for solid tumors, including breast cancer. The company anticipates releasing initial data from expansion arms in both HR+ metastatic and HER2+ breast cancer in the first quarter of 2026. Successful progression through clinical trials and eventual regulatory approval and launch of OKI-219 would be a primary driver of revenue.
2. Advancement of Next-Generation PI3Kα Pan-Mutant Inhibitors: OnKure is actively developing a pipeline of next-generation PI3Kα pan-mutant inhibitors. These candidates are designed for high selectivity against multiple common PI3Kα mutations (including H1047X, E542K, and E545K) and are aimed at enabling combination therapies due to a favorable safety and tolerability profile. OnKure plans to announce further details on these programs and a development candidate in 2026, which represents a strategic expansion of its product offerings.
3. Expansion into New Therapeutic Areas, Specifically Vascular Malformations: The company is exploring the potential of its PI3Kα inhibitors to treat vascular malformations, as PI3Kα mutations are recognized as common drivers for certain subtypes of these conditions. OnKure expects to provide additional information on its vascular malformations program in 2026, indicating a strategic move to address new, underserved patient populations beyond oncology.

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Share Issuance

• On October 4, 2024, OnKure Therapeutics, Inc. (formerly Reneo Pharmaceuticals, Inc.) completed a merger with OnKure, Inc. and a concurrent $65 million private placement. Prior OnKure, Inc. stockholders owned approximately 53.6%, prior Reneo stockholders owned approximately 25.1%, and private placement investors owned approximately 21.3% of the combined company's outstanding stock following these transactions.
• At the closing of the merger on October 4, 2024, there were approximately 13.3 million shares of common stock outstanding.
• As of June 30, 2025, OnKure Therapeutics had 12,843,434 shares of Class A common stock and 686,527 shares of Class B common stock outstanding.

Inbound Investments

• Concurrent with the merger closing on October 4, 2024, OnKure Therapeutics completed a $65 million private placement with a group of new and existing institutional investors, including Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital (a Citadel company), and Vestal Point Capital.

Capital Expenditures

• Annual capital expenditures were approximately -$1.13 million in December 2022, -$0.25 million in December 2023, and -$0.05 million in December 2024.
• For the trailing twelve months ending June 2025, capital expenditures were approximately -$0.06 million.
• In the three months ending June 2025, capital expenditures were approximately -$0.01 million.