On August 4, 2026 OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights.

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"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."

Vascular Anomalies

OnKure continues to advance OKI-355, a next-generation PI3Kα pan-mutant-selective inhibitor candidate announced in March 2026 to lead its development pipeline in vascular anomalies. OKI-355 has been 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 in vascular anomalies. OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI-355 in the first half of 2027.

Additionally, earlier this year, OnKure initiated a discovery research program to expand its vascular anomalies pipeline beyond targeting PI3Kα.

Breast Cancer

In breast cancer, OnKure continues to advance OKI-345, a next-generation PI3Kα pan-mutant-selective inhibitor candidate selected in March 2026. OKI-345 has been 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 in breast cancer, both as monotherapy and in combination. OnKure plans to submit an IND application to the FDA for OKI-345 in the first half of 2027.

Scientific Engagement

OnKure recently hosted a virtual Key Opinion Leader event titled "Selectivity Matters and Pan-Mutant Allosteric Inhibition Delivers," featuring Benjamin F. Cravatt, Ph.D., of Scripps Research, and Robert Abraham, Ph.D., Chief Scientific Officer of Engine Biosciences. The discussion explored the scientific rationale supporting next-generation PI3Kα pan-mutant selective inhibitors, including the importance of PI3Kα selectivity, the potential to overcome limitations of current therapies, and the Company’s structure-based drug design approach.

OnKure also participated as an exhibitor and sponsor at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia, held in May.

Financial Results

Cash position: As of June 30, 2026, the Company reported cash, cash equivalents, and marketable securities of $176.4 million, which is expected to provide cash runway into 2029.

Research and development (R&D) expenses: R&D expenses were $12.6 million for both the second quarter of 2026 and the second quarter of 2025. During the second quarter of 2026, an increase in clinical trial and outsourced manufacturing expenses was offset by a decrease in outsourced preclinical R&D expenses.

General and Administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter of 2026, compared to $3.7 million for the second quarter of 2025. The increase of $0.6 million was primarily driven by increases in personnel-related and consulting costs.

Net loss and net loss per share were $15.3 million, or $0.31 per share, for the second quarter of 2026, compared to $15.4 million, or $1.14 per share, for the second quarter of 2025.

(Press release, OnKure Therapeutics, AUG 4, 2026, View Source [SID1234669685])