BOULDER, Colo. — August 4, 2026 — Leads & Copy — OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights, including advancements in its next-generation PI3Kα pan-mutant selective candidate programs OKI-345 for breast cancer and OKI-355 for vascular anomalies.
The company is executing IND-enabling activities for both candidates, with Investigational New Drug (IND) submissions planned for the first half of 2027. OnKure reported $176 million in cash, cash equivalents, and marketable securities as of June 30, 2026, a figure expected to fund operations into 2029.
“Following our strategic transformation earlier this year, we continue to advance our next-generation PI3Kα pan-mutant selective inhibitor pipeline, which we believe represents the most compelling opportunity to deliver differentiated therapies across PI3Kα-driven diseases,” said Nicholas Saccomano, Ph.D., 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 PI3Kα 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 PI3Kα pan-mutant selective inhibitors to overcome the limitations of current therapies across multiple disease settings.”
In vascular anomalies, OnKure is advancing OKI-355, a candidate designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα. This approach aims to provide a wider therapeutic index and avoid class-limiting toxicities, with high and sustained target coverage for potential deep and durable responses. The company also initiated a discovery research program earlier this year to expand its vascular anomalies pipeline beyond targeting PI3Kα.
For breast cancer, OKI-345 is being developed with a similar design to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα. OnKure anticipates submitting an IND application to the U.S. Food and Drug Administration (FDA) for OKI-345 in the first half of 2027.
OnKure recently hosted a virtual Key Opinion Leader event featuring Benjamin F. Cravatt, Ph.D., of Scripps Research, and Robert Abraham, Ph.D., Chief Scientific Officer of Engine Biosciences. The event focused on the scientific rationale for next-generation PI3Kα pan-mutant selective inhibitors, including the importance of PI3Kα selectivity and the potential to address limitations of current therapies, as well as the company’s structure-based drug design approach.
The company also participated as an exhibitor and sponsor at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia in May, engaging with leading clinicians and researchers in the field.
Financial results for the second quarter ended June 30, 2026, show cash, cash equivalents, and marketable securities totaling $176.4 million. Research and development expenses were $12.6 million for the quarter, consistent with the prior year’s second quarter. General and administrative expenses increased to $4.3 million from $3.7 million in the second quarter of 2025, primarily due to personnel and consulting costs. The net loss for the second quarter of 2026 was $15.3 million, or $0.31 per share, compared to a net loss of $15.4 million, or $1.14 per share, for the second quarter of 2025.
OnKure Therapeutics is a clinical-stage biopharmaceutical company dedicated to discovering and developing precision medicines for underserved vascular anomalies and cancers. Utilizing a structure and computational chemistry-driven drug design platform, the company aims to build a pipeline of small molecule drugs targeting specific mutations, with a focus on becoming a leader in PI3Kα inhibition.
Source: OnKure Therapeutics, Inc.
