Reneo Pharmaceuticals(RPHM) - 2025 Q1 - Quarterly Report

Part I Condensed Consolidated Financial Statements (Unaudited) The unaudited condensed consolidated financial statements for OnKure Therapeutics, Inc. as of March 31, 2025, reflect a net loss of $15.9 million and a decrease in cash to $96.7 million, driven by higher operating expenses Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2025, shows total assets of $99.9 million, a decrease from $114.9 million, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $96,661 | $110,761 | | Total current assets | $98,172 | $113,003 | | Total assets | $99,882 | $114,907 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $8,785 | $10,530 | | Total liabilities | $9,234 | $11,079 | | Total stockholders' equity | $90,648 | $103,828 | | Total liabilities and stockholders' equity | $99,882 | $114,907 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended March 31, 2025, the company reported a net loss of $15.9 million, an increase from $9.5 million in the prior-year period, driven by higher operating expenses Statement of Operations Summary (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $13,012 | $8,566 | | General and administrative | $3,988 | $1,265 | | Total operating expenses | $17,000 | $9,831 | | Loss from operations | $(17,000) | $(9,831) | | Interest income | $1,075 | $295 | | Net loss and comprehensive loss | $(15,925) | $(9,536) | | Net loss per share (Basic and diluted) | $(1.19) | $(30.37) | Condensed Consolidated Statements of Cash Flows For the first quarter of 2025, net cash used in operating activities increased to $14.0 million, leading to a $14.1 million decrease in cash and cash equivalents, ending at $96.7 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,005) | $(10,629) | | Net cash used in investing activities | $(18) | $(9) | | Net cash (used in) provided by financing activities | $(77) | $10 | | Net decrease in cash and cash equivalents | $(14,100) | $(10,628) | | Cash and cash equivalents, end of period | $96,661 | $19,248 | Notes to Condensed Consolidated Financial Statements The notes detail the company's organization, the October 2024 reverse merger, significant accounting policies, and financial position, including an accumulated deficit of $170.6 million - The company was formed through a reverse merger with Reneo Pharmaceuticals on October 4, 2024, accounted for as a reverse recapitalization[35][36] - As of March 31, 2025, the company had an accumulated deficit of $170.6 million and cash and cash equivalents of $96.7 million, which management believes is sufficient for at least the next 12 months[39][42] - Share-based compensation expense for Q1 2025 was $2.745 million, a significant increase from $107,000 in Q1 2024[94] - The company is involved in legal proceedings related to the merger, with two complaints alleging misrepresentations in the Proxy Statement/Prospectus[97] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's focus as a clinical-stage biopharmaceutical company, highlighting a net loss of $15.9 million for Q1 2025 and increased R&D and G&A expenses - The company's lead product candidate, OKI-219, is a highly selective inhibitor of PI3Kα H1047R, currently in a Phase 1a/1b clinical trial for advanced breast cancer[106] Comparison of Operating Results (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | $ Change | | :--- | :--- | :--- | :--- | | Research and development | $13,012 | $8,566 | $4,446 | | General and administrative | $3,988 | $1,265 | $2,723 | | Net loss | $(15,925) | $(9,536) | $(6,389) | - The $4.4 million increase in R&D expenses in Q1 2025 was primarily due to increased personnel-related costs, clinical trial and manufacturing expenses, and outsourced research[123] - The company believes its existing cash and cash equivalents of $96.7 million will be sufficient to fund planned operations for at least the next 12 months[130] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, OnKure is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, OnKure is exempt from providing quantitative and qualitative disclosures about market risk[147] Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[148] - No changes in internal control over financial reporting occurred during the three months ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[149] Part II Other Information Legal Proceedings The company is involved in legal proceedings stemming from its merger with Reneo Pharmaceuticals, facing two complaints alleging misrepresentations in the Proxy Statement/Prospectus - Two complaints were filed in New York related to the merger, alleging misrepresentations and/or omissions in the Proxy Statement/Prospectus concerning financial projections and advisor conflicts of interest[97] - The company intends to vigorously defend against the complaints and any other similar actions that may be filed[98] Risk Factors This section outlines numerous risks, including the company's early-stage status, dependence on OKI-219, clinical trial uncertainties, reliance on third parties, competition, and the need for additional funding - The company is an early-stage biopharmaceutical firm with significant net losses ($170.6 million accumulated deficit as of March 31, 2025) and no products approved for sale, making its future success uncertain[156][159] - Business success is substantially dependent on the clinical development and commercialization of a single product candidate, OKI-219, where failure or significant delays would materially harm the company[171] - The company relies on third parties for critical functions, including CROs for clinical trials and single-source CMOs for manufacturing, increasing risks related to quality, compliance, and supply chain continuity[332][337] - As a result of the reverse merger with Reneo, a former shell company, OnKure is subject to more stringent SEC reporting requirements, offering limitations, and resale restrictions on its stock[380][382][383] Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None[392] Defaults Upon Senior Securities There were no defaults upon senior securities during the period - None[393] Mine Safety Disclosures This item is not applicable to the company - None[394] Other Information During the last fiscal quarter, no officers or directors adopted or terminated a Rule 10b5-1 trading arrangement - No officers or directors adopted or terminated a Rule 10b5-1 trading arrangement in the last fiscal quarter[395] Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including the Merger Agreement, corporate governance documents, and required certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[398] - The exhibits include the company's Amended and Restated Certificate of Incorporation and Bylaws, as well as Inline XBRL data files[398]