OKUR

Business Context and Reporting Period

This Form 10-Q covers the quarterly period ended September 30, 2024, for Onkure Therapeutics, Inc. (formerly Reneo Pharmaceuticals, Inc.). The financial statements presented reflect the historical operations of Reneo Pharmaceuticals, Inc. prior to a merger completed on October 4, 2024. On that date, Reneo merged with Legacy OnKure, Inc., changed its name to Onkure Therapeutics, Inc., and effected a 1:10 reverse stock split. The combined company is a clinical-stage biopharmaceutical firm focused on precision medicines, with its lead candidate, OKI-219, currently in Phase 1 trials. Reneo's historical operations, including the development of mavodelpar, were suspended prior to the merger.

Key Financial Metrics

Note: All figures in millions unless otherwise noted. The company has no revenue and operates at a loss.

Material Changes vs. Prior Period

• Significant Expense Reduction: Total operating expenses decreased by approximately 77% year-over-year for the nine months ended September 30, 2024. This was driven by a 84% reduction in R&D expenses and a 26% reduction in G&A expenses.
• Operational Suspension: The reduction in expenses is primarily attributed to the suspension of development activities for the product candidate mavodelpar and cash preservation measures, including workforce reductions in late 2023 and early 2024.
• Investment Portfolio Shift: Short-term investments decreased from $75.3 million at year-end 2023 to $16.0 million at September 30, 2024, as the company utilized these funds to support operations.
• Liabilities: Current liabilities dropped significantly from $18.2 million to $3.2 million, largely due to the payment of accrued expenses and the reduction of accounts payable.

Guidance, Outlook, and Risks

• Merger and Capital Raise: Following the October 4, 2024 merger, the company completed a concurrent private placement (PIPE) raising approximately $65.0 million. Management believes the combined cash resources are sufficient to fund operations for at least the next 12 months.
• Strategic Focus: The company has pivoted entirely to the Legacy OnKure business plan, focusing on the development of OKI-219, a selective PI3Kα inhibitor. Early clinical data for OKI-219 is anticipated in the fourth quarter of 2024.
• Legal Proceedings: Two shareholder complaints were filed in New York Supreme Court challenging the merger and financial projections. The company intends to vigorously defend against these claims.
• Risk Factors: The company faces standard biotech risks including the need for substantial additional capital, dependence on the success of OKI-219, regulatory approval uncertainties, and potential dilution from future financing. As a result of the merger, the company is subject to SEC reporting requirements for shell company business combinations, including restrictions on using Form S-3 for one year.

Investor Verification Checklist

• Merger Integration: Verify the successful integration of Legacy OnKure's operations and the transition of the corporate name and ticker symbol (OKUR).
• Cash Runway: Confirm the post-merger cash position including the $65 million PIPE proceeds and the projected burn rate for the OKI-219 clinical trials.
• Legal Status: Monitor the status of the shareholder lawsuits filed in September 2024 regarding the merger fairness and financial projections.
• Clinical Milestones: Track the release of early clinical data for OKI-219 expected in Q4 2024.
• SEC Filing Status: Note the restrictions on capital raising (ineligible for Form S-3) for one year following the merger due to shell company rules.