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OnKure Advances PI3Kalpha Inhibitor Development, Plans IND Submission in 2027
"Following our strategic transformation earlier this year, we continue to advance our next-generation PI3Kalpha pan-mutant selective inhibitor pipeline, which we believe represents the most compelling opportunity to deliver differentiated therapies across PI3Kalpha-driven diseases," said Nicholas Saccomano, President and Chief Executive Officer of OnKure. "Both OKI-355 and OKI-345 continue to advance through IND-enabling activities and remain on track for planned IND submissions in the first half of 2027. We believe the combination of our chemistry platform and deep understanding of PI3Kalpha biology positions us to develop differentiated therapies with the potential to meaningfully improve outcomes for patients. Our recent Key Opinion Leader event reinforced the scientific rationale underpinning our strategy and highlighted the significant opportunity for next-generation PI3Kalpha pan-mutant selective inhibitors to overcome the limitations of current therapies across multiple disease settings."
OnKure Focuses on PI3Kalpha New Drug Development
"During the first quarter, we sharpened our strategic focus on advancing our next generation PI3Kalpha pan-mutant selective inhibitor programs, which we believe represent the most compelling opportunity to deliver differentiated therapies across PI3Kalpha-driven diseases," said Nicholas Saccomano, President and Chief Executive Officer of OnKure. "Building on insights gained from our earlier clinical and translational work, we have advanced two highly selective pan-mutant development candidates that were purpose designed to achieve robust target coverage while avoiding class limiting toxicities. As we move forward with OKI-355 in vascular anomalies and OKI-345 in breast cancer, our focus is on translating the strengths of our chemistry platform and deep understanding of PI3Kalpha biology into programs with the potential to deliver meaningful, differentiated, and durable benefit to patients."
OnKure Therapeutics Files to Sell 36.14M Shares of Class A Common
OnKure Therapeutics files to sell 36.14M shares of Class A common for holders
OnKure Therapeutics Completes $150M Private Placement
OnKure Therapeutics announced 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 $150M. OnKure intends to use the net proceeds from the private placement to fund the preclinical and clinical development of its next-generation PI3Ka pan-mutant-selective inhibitor candidates in breast cancer and vascular anomalies, as well as for working capital and general corporate purposes. 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 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, subject to satisfactory closing conditions. With the net proceeds from the private placement, OnKure expects to extend its cash runway into 2029. 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.
OnKure CEO Announces Progress on OKI-219 Trial
"We are pleased with the continued progress across our PI3Kalpha-focused pipeline, including the steady execution of the PIKture-01 trial of OKI-219. We look forward to sharing updated data from this trial later this month," said Nicholas Saccomano, president and CEO of OnKure. "We are also excited to announce our next-generation pan-mutant inhibitor development candidate for HR+ metastatic breast cancer this month and provide additional information on our program in vascular malformations later this year. Overall, we believe our progress to date underscores the power of our mutation-selective approach to PI3Kalpha inhibition and reinforces the momentum we are building as we work to deliver scientifically differentiated therapies to patients."
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