Reneo Pharmaceuticals, Inc.

-- OnKure is focused on advancing a pipeline of candidates targeting oncogenic mutations in phosphoinositide 3-kinase alpha (PI3Kα), initially in breast cancer -- On track to announce early clinical data for its lead program, OKI-219, in Q4-2024 -- Post-transaction cash, cash equivalents, and short-term investments of approximately $139 million expected to provide funding through multiple clinical readouts and runway into Q4-2026 -- Shares to trade on Nasdaq under the new ticker symbol “OKUR” commencing on October 7, 2024 Oct. 04, 2024 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR) (“OnKure”), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, today announced the completion of its previously announced merger of OnKure, Inc. and Reneo Pharmaceuticals, Inc. (“Reneo”). The combined company will operate under the name OnKure Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on October 7, 2024 under the ticker symbol "OKUR". Concurrent with the closing of the merger, the company completed a $65 million private placement with a group of new and existing investors, including Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital (a Citadel company), Vestal Point Capital, and other undisclosed investors. Following the transactions, OnKure is expected to have a cash runway through multiple clinical readouts and into Q4-2026. “We are ecstatic to finalize this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. Combined with our unique expertise in PI3K-mutated cancers, we aim to fully target and exploit the vulnerabilities of this oncogenic menace for the benefit of patients suffering needlessly,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Our lead program OKI-219, a highly selective inhibitor of PI3KαH1047R, has the potential to provide benefit to breast cancer patients. With the PIKture-01 trial of OKI-219 well underway, we look forward to releasing early clinical data in the fourth quarter of 2024 and initiating planned combination arms of the PIKture-01 trial.” In connection with the closing of the merger, Reneo effected a 1-for-10 reverse stock split of its common stock. Following the reverse stock split and based on the final exchange ratios of 0.0236 shares of Reneo common stock for each share of OnKure common stock and 0.1448 shares of Reneo common stock for each share of OnKure preferred stock, at the closing of the merger there were approximately 13.3 million shares of common stock outstanding, with prior Reneo stockholders owning approximately 31.8% and prior OnKure, Inc. stockholders holding approximately 68.2% of the combined company's outstanding common stock before the concurrent financing. Following the consummation of the private placement of $65.0 million of newly issued common stock, prior OnKure, Inc. stockholders own approximately 53.6%, prior Reneo stockholders own approximately 25.1%, and the private placement investors own approximately 21.3% of the combined company’s outstanding stock. Leerink Partners served as exclusive financial advisor for Reneo. Jones Day and Cooley LLP served as legal counsel for Reneo for the transactions. Leerink Partners, Evercore ISI and LifeSci Capital served as the placement agents for the private placement financing. Covington & Burling LLP served as legal counsel to the placement agents in connection with the private placement financing. Oppenheimer & Co. served as capital markets advisor to OnKure, Inc., and Wilson Sonsini Goodrich & Rosati, P.C. served as legal counsel to OnKure, Inc. The combined company will be led by Nicholas A. Saccomano, Ph.D. as President and Chief Executive Officer of OnKure. In addition to Dr. Saccomano, the OnKure leadership team includes Samuel Agresta, M.D., as Chief Medical Officer, Dylan Hartley, Ph.D., as Chief Scientific Officer, and Jason Leverone, as Chief Financial Officer. The Board of Directors of OnKure will be composed of Dr. Saccomano, Isaac Manke, Ph.D., R. Michael Carruthers, Andrew Philips, Ph.D., who join from OnKure, Inc.’s Board of Directors, Michael Grey and Edward T. Mathers, who continue from Reneo’s Board of Directors, and Valerie M. Jansen, who joined the Board at the closing of the merger. PI3Kα is the most frequently mutated oncogene in cancers, and PI3KαH1047R is the most common mutation in this gene, being found in 15% of breast cancer and 4% of cancers overall. While novel drugs targeting PI3Kα have been approved for treatment, the lack of mutant selectivity of these therapeutics drives considerable on-target toxicity by inhibiting the normal version of this protein in various tissues. OnKure is discovering and developing a portfolio of highly mutant-selective PI3Kα inhibitors with the goal of improving efficacy and safety with molecules that fully inhibit the mutant oncogene while sparing the wild-type enzyme in normal tissues. OnKure’s lead product candidate, OKI-219, is an orally bioavailable, highly selective inhibitor of PI3KαH1047R with approximately 80-fold selectivity for the mutated form of the enzyme compared to wild-type. OnKure believes that the wild-type-sparing properties of OKI-219 should significantly improve the activity and safety relative to currently approved PI3Kα inhibitors. Currently, OKI-219 is being evaluated in a Phase 1 clinical trial in solid tumor patients with PI3KαH1047R mutations, including breast cancer. OnKure is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure-based drug design platform, OnKure is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing OKI-219, a selective PI3KαH1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic PI3Kα and has multiple programs designed to enable best-in-class targeting of this key oncogene. 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Plus, news about ViiV’s long-acting PrEP and a newly announced merger: Galapagos investor gets board seat: After building up a stake in the struggling Belgian drugmaker, EcoR1 Capital founder Oleg Nodelman has been named to the board. In August, EcoR1 said it planned to discuss Galapagos’ “performance, business, operations, strategic opportunities and governance, including board composition.” Nodelman replaces Dan Baker, who was chair of the company’s science and development committee. — Kyle LaHucik OnKure completes Reneo merger, secures $65M private placement: Thanks to the merger and private placemen t, the company, which will continue to be called OnKure Therapeutics, will have a cash runway into the fourth quarter of 2026. OnKure’s lead drug, dubbed OKI-219, is a PI3Kα inhibitor currently in a Phase 1 trial in solid tumor patients, including breast cancer. — Katherine Lewin ViiV Healthcare expands long-acting HIV PrEP supply to low- and middle-income countries: The company announced Monday that it would make at least two million doses of long-acting cabotegravir, marketed as Apretude, available in 2025 and 2026, tripling the 2024 supply. By the end of this year, ViiV will have supplied its HIV drug to 14 countries. — Katherine Lewin Virios Therapeutics and Wex Pharmaceuticals announce merger: The new name of the combined companies will be Dogwood Therapeutics, with a focus on developing three drugs: Halneuron, which is in a Phase 2b trial for chemotherapy-induced neuropathic pain; a second asset that is ready for Phase 3 development in fibromyalgia; and a third drug in Phase 2 to treat long covid. — Katherine Lewin

OKI-219 is in Phase I trials for solid tumours. Credit: Nemes Laszlo/Shutterstock. OnKure has announced the successful completion of its merger with Reneo Pharmaceuticals, with the combined entity set to operate under the OnKure Therapeutics name. The shares will commence trading on the Nasdaq Global Market under the “OKUR” ticker symbol. The companies first reached an agreement to combine in an all-stock deal in May 2024. OnKure has also finalised a $65m private placement backed by both new and existing investors. This strategic financial move will extend the company’s cash runway through multiple clinical readouts until the fourth quarter of 2026. See Also: Boehringer kickstarts two Phase III trials as MASH therapy wins breakthrough status The leadership of the merged company will include Nicholas Saccomano as president and CEO, Samuel Agresta as chief medical officer, Dylan Hartley as chief scientific officer and Jason Leverone as chief financial officer. The board of directors will feature a mix of members from both OnKure and Reneo, along with Valerie Jansen, who joined at the merger’s closure. Saccomano stated: “We are ecstatic to finalise this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. “Combined with our unique expertise in PI3K-mutated cancers, we aim to fully target and exploit the vulnerabilities of this oncogenic menace for the benefit of patients suffering needlessly.” OnKure is engaged in the development of a suite of mutant-selective PI3Kα inhibitors, aiming to enhance treatment efficacy and safety. Its lead product candidate, OKI-219, demonstrates significant selectivity for the mutant oncogene, potentially offering improved outcomes for patients with PI3Kα H1047R mutations. OKI-219 is currently under a Phase I clinical trial, targeting solid tumours including breast cancer. The merger unites OnKure’s expertise in precision oncology with Reneo’s resources, focusing on advancing treatments for oncogenic mutations in PI3Kα. OKI-219 is a pivotal part of the combined company’s pipeline, now progressing through clinical trials.