OnKure Closes Merger with Reneo Pharmaceuticals and $65 Million Private Placement

OnKure Therapeutics, Inc. has announced the successful merger with Reneo Pharmaceuticals, Inc., forming a newly combined entity that will focus on developing precision medicines for oncology. Following the merger, the company will retain the name OnKure Therapeutics, Inc. and will commence trading on the Nasdaq Global Market under the ticker symbol "OKUR" starting October 7, 2024.

The completion of the merger was accompanied by a $65 million private placement involving both new and existing investors. This influx of capital is expected to extend OnKure's financial runway through multiple clinical milestones and into the fourth quarter of 2026. The investors in this private placement include notable names such as Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital, Vestal Point Capital, and other undisclosed participants.

Dr. Nicholas Saccomano, President and CEO of OnKure, expressed enthusiasm about the merger, citing the potential for accelerated development of their PI3Kα inhibitor portfolio. The company’s lead program, OKI-219, is a highly selective inhibitor of the PI3KαH1047R mutation, which is primarily associated with breast cancer. Initial clinical data from the ongoing PIKture-01 trial for OKI-219 is anticipated in the fourth quarter of 2024, with plans to introduce combination arms in the study.

As part of the merger, Reneo undertook a 1-for-10 reverse stock split. Upon the final exchange ratios, the combined company now has roughly 13.3 million shares of common stock outstanding. Former Reneo stockholders hold approximately 31.8% of the new entity, while previous OnKure stockholders own about 68.2%. After the $65 million private placement, the ownership distribution shifted to 53.6% for prior OnKure stockholders, 25.1% for prior Reneo stockholders, and 21.3% for the new private placement investors.

Financial and legal advisors played a crucial role in the merger and subsequent private placement. Leerink Partners served as Reneo’s exclusive financial advisor, with legal counsel provided by Jones Day and Cooley LLP. Placement agents for the private placement included Leerink Partners, Evercore ISI, and LifeSci Capital, with legal support from Covington & Burling LLP. Oppenheimer & Co. and Wilson Sonsini Goodrich & Rosati, P.C. served as OnKure’s capital markets and legal advisors, respectively.

The leadership of the new OnKure is headlined by Dr. Nicholas A. Saccomano as President and CEO, with 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 is a blend of members from both original companies, including Dr. Saccomano, Isaac Manke, Ph.D., R. Michael Carruthers, Andrew Philips, Ph.D., Michael Grey, Edward T. Mathers, and Valerie M. Jansen, Ph.D.

OnKure’s therapeutic focus lies in PI3Kα mutations, particularly the PI3KαH1047R mutation, which is prevalent in approximately 15% of breast cancers and 4% of cancers overall. Current PI3Kα inhibitors suffer from significant on-target toxicity due to a lack of selectivity for the mutant form of the enzyme. OnKure aims to address this challenge with their portfolio of highly selective inhibitors, including their lead candidate OKI-219, which demonstrates around 80-fold selectivity for the mutated enzyme compared to its wild-type counterpart. This specificity is expected to enhance both the efficacy and safety profile of the treatment.

OnKure is committed to becoming a leader in precision oncology, leveraging their structure-based drug design platform to develop therapies that target the fundamental drivers of cancer. Their pipeline, highlighted by OKI-219, aims to offer new treatment options for patients with PI3Kα mutations, striving for superior outcomes and minimized side effects compared to existing therapies.