On March 27, 2026 OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, reported that it has entered into a securities purchase agreement for a private placement with certain institutional and accredited healthcare investors, raising gross proceeds of approximately $150 million.

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OnKure intends to use the net proceeds from the private placement to fund the preclinical and clinical development of its next-generation PI3Kα pan-mutant-selective inhibitor candidates in breast cancer and vascular anomalies, as well as for working capital and general corporate purposes. The private placement is being led by new investor, Access Biotechnology, with participation from other new and existing investors, including BVF Partners LP, RA Capital Management, Trails Edge Capital Partners, Coastlands Capital, StepStone Master G, L.P., Vivo Capital, ADAR1 Capital Management, Foresite Capital, Adage Capital Partners LP, Vestal Point Capital, Acorn Bioventures, Logos Capital and Prosight Capital.

"This transformational financing enables us to advance the development strategy for our next‑generation PI3Kα pan‑mutant selective inhibitor candidates, which represent a defining phase of our mutation‑selective strategy. We appreciate the significant commitment by the participating specialist biotech investors who believe in the potential of our PI3Ka pan-mutant portfolio," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. "We believe the clinical experience generated from the PIKture‑01 trial provided important validation of our approach to selectively targeting PI3Kα while avoiding class‑limiting toxicities predictably seen by insufficiently selective inhibitors. These insights directly informed the design of our pan‑mutant programs, defining the high bar attributes of our molecules. With the additional capital raised through this private placement, we are focused on leveraging our chemistry platform and clinical insights into PI3Kα signaling into differentiated, next-generation candidates for breast cancer and vascular anomalies, with the goal of delivering medicines that offer meaningful improvements in efficacy and tolerability for patients."

Next-Generation PI3Kα Pan-Mutant Programs

The portfolio includes two next-generation PI3Kα pan-mutant programs, OKI-345 in breast cancer and OKI-355 in vascular anomalies. These candidates are designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses, both as monotherapy and in combination regimens. The pan-mutant candidates are designed to have minimal drug-drug interaction potential, supporting broad combinability with current standards of care. Together with a commanding intellectual property estate, OnKure believes it is well positioned to address a significant unmet need across various PI3Kα-driven indications.

PI3Kα mutations represent the most common driver alterations in key subtypes of vascular anomalies, where PIK3CA variants lead to dysregulated signaling that promotes abnormal cell growth, proliferation, and survival. OnKure believes that OKI-355 has significant potential to address this large and underserved patient population as a differentiated systemic chronic therapy.

OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for each of OKI‑345 and OKI‑355 in the first half of 2027.

PIKture‑01 Trial and OKI-219 Update

The PIKture-01 trial is a global, multi-center, dose-escalation, first-in-human phase 1a/1b study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs for the treatment of HR+ and HER2+ advanced breast cancer. As of March 26, 2026, the PIKture-01 trial has completed enrollment in single-agent OKI-219 dose escalation (n=38) and OKI-219 + fulvestrant dose escalation (n=33). Phase 2 dose evaluation in the OKI-219 + tucatinib and trastuzumab triplet and the OKI-219 + ribociclib and fulvestrant triplets will be completed in 2026. Given the progress of the Company’s PI3Kα pan-mutant inhibitors, OnKure is not planning to pursue further clinical development of OKI-219 independently at this time. Mature data from PIKture-01 will be presented by the end of the year.

Additional information about PIKture-01 may be found at www.ClinicalTrials.gov, using Identifier: NCT06239467.

Private Placement and Appointment of Liam Ratcliffe to Board of Directors

Pursuant to the terms of the securities purchase agreement, OnKure has agreed to sell an aggregate of 26,713,636 shares of its Class A common stock ("Common Stock") at a purchase price of $4.15 per share and, in lieu of Common Stock, pre-funded warrants to purchase 9,430,959 shares of Common Stock at a purchase price of $4.1499 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.0001 per share and will be immediately exercisable. The private placement is expected to close on March 31, 2026, subject to satisfactory closing conditions. With the net proceeds from the private placement, OnKure expects to extend its cash runway into 2029.

In conjunction with the financing, Liam Ratcliffe, M.D., Ph.D., Head of Biotechnology, Access Biotechnology will join OnKure’s Board of Directors. Andrew Phillips, Ph.D., OnKure’s Chairman of the Board of Directors, commented, "we are grateful for the commitment of our new and existing investors to the growth of OnKure. We are very pleased to welcome Liam to our Board of Directors. Liam is a well-respected leader who brings a remarkable track record of accomplishment to our Board."

Leerink Partners is acting as lead placement agent for the financing. Evercore ISI, LifeSci Capital, and Oppenheimer & Co. are serving as co-placement agents for the financing.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering. The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state securities laws, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of Common Stock and the Common Stock issuable upon exercise of the pre-funded warrants, in each case sold under the terms of the securities purchase agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, OnKure Therapeutics, MAR 27, 2026, View Source [SID1234663992])