OnKure reports Q2 2026 results, keeps IND filings for two PI3Kα drugs on track for 1H 2027

OnKure Therapeutics reported financial results for the quarter ended June 30, 2026, and gave an update on its two lead pipeline candidates on August 4, 2026.

The company said it is executing IND-enabling activities for next-generation PI3Ka pan-mutant selective candidates OKI-345 in breast cancer and OKI-355 in vascular anomalies, with IND submissions planned for 1H 2027.¹ Chief Executive Officer Nicholas Saccomano said 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 2027.¹

On the vascular anomalies program, OnKure said it continues to advance OKI-355, a candidate selected in March 2026 to lead its development pipeline in that indication¹, and that it plans to submit an IND application to the FDA for OKI-355 in the first half of 2027.¹ The company also said earlier in the year it started a discovery research program to expand its vascular anomalies pipeline beyond targeting PI3Ka.¹

For breast cancer, OnKure said it continues to advance OKI-345, a next-generation PI3Ka pan-mutant-selective inhibitor candidate selected in March 2026¹, with a planned IND submission to the FDA in the first half of 2027.¹

The company also said it hosted a virtual Key Opinion Leader event titled "Selectivity Matters and Pan-Mutant Allosteric Inhibition Delivers," featuring Benjamin F. Cravatt of Scripps Research and Robert Abraham, Chief Scientific Officer of Engine Biosciences¹, and participated as an exhibitor and sponsor at the ISSVA World Congress 2026 in Philadelphia, held in May.¹

On cash, OnKure reported cash, cash equivalents, and marketable securities of $176.4 million as of June 30, 2026, which it said is expected to provide cash runway into 2029.¹