OnKure Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $163.3 million as of September 30, 2026, up from $59.1 million as of December 31, 2025, providing a cash runway into 2029.
• Research and development (R&D) expenses were $15.1 million for the third quarter of 2026, an increase from $11.9 million in the third quarter of 2025, driven by higher outsourced preclinical R&D, manufacturing, and consulting costs.
• General and administrative (G&A) expenses were $4.3 million for the third quarter of 2026, compared to $3.6 million in the third quarter of 2025, driven by increases in personnel and consulting costs.
• Net loss was $17.8 million, or $0.36 per share, for the third quarter of 2026, compared to a net loss of $14.7 million, or $1.09 per share, for the third quarter of 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $51.9 million, compared to $48.8 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $48.3 million, or $1.27 per share, compared to $46.0 million, or $3.41 per share, for the nine months ended September 30, 2025.
• Interest income was $1.5 million for the third quarter of 2026, compared to $0.8 million in the third quarter of 2025.

Guidance and Future Outlook:

• OnKure plans to submit Investigational New Drug (IND) applications for OKI-355 (vascular anomalies) and OKI-345 (breast cancer) in the first half of 2027.
• The company is executing IND-enabling activities for these next-generation PI3Kα pan-mutant-selective candidates.
• Management expects the current cash position to provide runway into 2029.

Business Segments and Product Lines:

• Vascular Anomalies: OKI-355 is a next-generation PI3Kα pan-mutant-selective inhibitor designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα to potentially enable a wider therapeutic index and avoid class-limiting toxicities. It targets high and sustained coverage across all hotspot PI3Kα mutations.
• PANORAMA Registry: The company initiated PANORAMA, a large-scale, multiregional, longitudinal observational registry designed to characterize the natural disease course, treatment patterns, and associations between genetic variants and clinical characteristics in people living with vascular anomalies. Genotyping will be offered to all participants.
• Breast Cancer: OKI-345 is a next-generation PI3Kα pan-mutant-selective inhibitor candidate designed for use as a monotherapy or in combination regimens, aiming for deep and durable responses across hotspot PI3Kα mutations.

Market and Competitive Landscape:

• The company identifies people living with vascular anomalies as an underserved community with a need for new therapies.
• Mutations in the PIK3CA gene are cited as drivers for a range of vascular malformations, providing a rationale for OKI-355.
• OnKure aims to become a leader in targeting PI3Kα with multiple programs designed to enable best-in-class targeting.
• The company faces substantial competition in discovering, developing, or commercializing products.

Risks and Challenges:

• Forward-looking statements involve risks including the ability to raise additional capital, potential delays in IND submissions, and the risk that actual cash usage may differ from assumptions.
• Risks include the potential that data from the PANORAMA registry may not yield useful insights or inform development programs.
• Challenges include the ability to initiate, enroll, and conduct clinical trials, obtain regulatory approval, and commercialize product candidates.
• Other risks include adverse events, toxicities, limited resources, reliance on third-party manufacturers and research organizations, and intellectual property protection.

Management Commentary and Tone:

• Nicholas Saccomano, Ph.D., President and CEO, stated that both lead programs remain on track for IND submissions in the first half of 2027 and emphasized the advancement of next-generation PI3Kα pan-mutant-selective inhibitors.
• Samuel Agresta, M.D., Chief Medical Officer, highlighted the opportunity to shape the future of treatment for vascular anomalies and expressed excitement regarding the PANORAMA registry to generate insights for future research and treatment strategies.

Other Key Points:

• OnKure Therapeutics is a clinical-stage biopharmaceutical company focused on precision medicines targeting vascular anomalies and cancers using a structure and computational chemistry-driven drug design platform.
• The company reported a significant increase in cash reserves from $59.1 million at the end of 2025 to $163.3 million at the end of Q3 2026.
• The press release includes a detailed Cautionary Note regarding forward-looking statements and references to risk factors in SEC filings.