UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40315 ONKURE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-2309515 (State or other juris ...

-- Cash position of $83.4M expected to provide cash runway into Q4 2026 BOULDER, CO, August 12, 2025 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines in oncology, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. "We are encouraged by the continued progress in the development of our lead asset, OKI-219, as we have completed the enrollment of the single agent and th ...

Part I [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(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](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) 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](index=35&type=chunk)[36](index=36&type=chunk) - 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](index=39&type=chunk)[42](index=42&type=chunk) - Share-based compensation expense for Q1 2025 was **$2.745 million**, a significant increase from **$107,000** in Q1 2024[94](index=94&type=chunk) - The company is involved in legal proceedings related to the merger, with two complaints alleging misrepresentations in the Proxy Statement/Prospectus[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=106&type=chunk) 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](index=123&type=chunk) - 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](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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](index=147&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=148&type=chunk) - 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](index=149&type=chunk) Part II Other Information [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=97&type=chunk) - The company intends to vigorously defend against the complaints and any other similar actions that may be filed[98](index=98&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) 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](index=156&type=chunk)[159](index=159&type=chunk) - 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](index=171&type=chunk) - 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](index=332&type=chunk)[337](index=337&type=chunk) - 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](index=380&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[392](index=392&type=chunk) [Defaults Upon Senior Securities](index=83&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[393](index=393&type=chunk) [Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[394](index=394&type=chunk) [Other Information](index=84&type=section&id=Item%205.%20Other%20Information) 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](index=395&type=chunk) [Exhibits](index=85&type=section&id=Item%206.%20Exhibits) 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](index=398&type=chunk) - The exhibits include the company's Amended and Restated Certificate of Incorporation and Bylaws, as well as Inline XBRL data files[398](index=398&type=chunk)

Exhibit 99.1 OnKure Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights -- Continued progress in the PIKture-01 trial; on track to report additional data in the second half of 2025, including mature single agent and initial combination data -- Expansion of the Company's PI3Ka franchise with the planned announcement of a pan-mutant selective development candidate in Q2 2025 -- $96.7M in cash and cash equivalents expected to be sufficient to fund operations through multiple antic ...

Financial Performance - OnKure reported approximately $110.8 million in cash and cash equivalents as of December 31, 2024, an increase from $29.9 million in 2023[5][15]. - The net loss for Q4 2024 was $17.4 million, or $1.37 per share, compared to a net loss of $9.5 million, or $30.14 per share, in Q4 2023[7][16]. - OnKure's total operating expenses for the year ended December 31, 2024, were $54.4 million, compared to $36.9 million in 2023, representing a 47.2% increase[16]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $14.4 million, up from $8.8 million in Q4 2023, reflecting a 63.6% increase[5][16]. - OnKure initiated patient dosing in Part B of the PIKture-01 trial in Q4 2024, evaluating OKI-219 in combination with fulvestrant for specific breast cancer mutations[8]. - The company plans to announce a pan-mutant development candidate in Q2 2025, targeting key PI3Kα mutations[8]. - OnKure expects to provide a clinical update on the PIKture-01 trial in the second half of 2025, with additional data from the OKI-219 program anticipated[4][3]. Administrative Expenses - General and Administrative (G&A) expenses rose to $4.3 million in Q4 2024, compared to $1.1 million in Q4 2023, marking a 290.9% increase[6][16]. Corporate Developments - The merger with Reneo Pharmaceuticals closed on October 4, 2024, along with a $65 million financing, leading to the company's rebranding as OnKure Therapeutics, Inc.[8]. - The company aims to advance multiple PI3Ka inhibitor programs, with a commitment to addressing patient needs in oncology[2][3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-40315 ONKURE THERAPEUTICS, INC. | (Exact name of registrant as specified in its charter) | | | --- | --- | | Delaware | 47-2309515 | ...

[Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) This section presents the unaudited consolidated financial statements and management's discussion for Reneo Pharmaceuticals, Inc. [Item 1. Reneo Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Reneo%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents OnKure Therapeutics' unaudited consolidated financial statements, covering balance sheets, operations, equity, cash flows, and related notes. [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) This section details the Company's financial position, including assets, liabilities, and equity, as of September 30, 2024 Financial Position (in thousands) | Metric | Sep 30, 2024 | Dec 31, 2023 | Change (2024 vs 2023) | | :--------------------------- | :----------- | :----------- | :-------------------- | | Cash and cash equivalents | $60,689 | $27,632 | +$33,057 | | Short-term investments | $15,979 | $75,331 | -$59,352 | | Total current assets | $76,999 | $106,622 | -$29,623 | | Total assets | $77,645 | $107,436 | -$29,791 | | Total current liabilities | $3,248 | $18,177 | -$14,929 | | Total liabilities | $3,627 | $18,826 | -$15,199 | | Total stockholders' equity | $74,018 | $88,610 | -$14,592 | | Accumulated deficit | $(235,953) | $(218,474) | -$17,479 | [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section presents the Company's operating results, including expenses and net loss, for the periods ended September 30, 2024 Operating Results (in thousands) | Metric | 3 Months Sep 30, 2024 | 3 Months Sep 30, 2023 | Change (YoY) | 9 Months Sep 30, 2024 | 9 Months Sep 30, 2023 | Change (YoY) | | :------------------------------------------ | :-------------------- | :-------------------- | :----------- | :-------------------- | :-------------------- | :----------- | | Research and development | $904 | $13,622 | -$12,718 | $6,436 | $39,009 | -$32,573 | | General and administrative | $3,760 | $7,266 | -$3,506 | $14,155 | $19,038 | -$4,883 | | Total operating expenses | $4,664 | $20,888 | -$16,224 | $20,591 | $58,047 | -$37,456 | | Loss from operations | $(4,664) | $(20,888) | +$16,224 | $(20,591) | $(58,047) | +$37,456 | | Other income | $972 | $1,692 | -$720 | $3,112 | $4,213 | -$1,101 | | Net loss | $(3,692) | $(19,196) | +$15,504 | $(17,479) | $(53,834) | +$36,355 | | Net loss per share, basic and diluted | $(1.10) | $(5.68) | +$4.58 | $(5.23) | $(18.11) | +$12.88 | [Consolidated Statements of Changes in Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This section outlines changes in stockholders' equity, including additional paid-in capital and accumulated deficit, across reporting periods Stockholders' Equity Changes (in thousands) | Metric | Dec 31, 2023 | Mar 31, 2024 | Jun 30, 2024 | Sep 30, 2024 | | :--------------------------- | :----------- | :----------- | :----------- | :----------- | | Additional Paid-In Capital | $307,076 | $308,154 | $309,143 | $309,969 | | Accumulated Deficit | $(218,474) | $(226,900) | $(232,261) | $(235,953) | | Total Stockholders' Equity | $88,610 | $81,242 | $76,869 | $74,018 | - Key activities impacting equity for the nine months ended September 30, 2024, include **$2.893 million** in stock-based compensation and a net loss of **$(17.479) million**[14](index=14&type=chunk)[55](index=55&type=chunk) [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the Company's cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (in thousands) | Activity | 9 Months Sep 30, 2024 | 9 Months Sep 30, 2023 | Change (YoY) | | :------------------------------------------ | :-------------------- | :-------------------- | :----------- | | Net cash used in operating activities | $(30,102) | $(43,929) | +$13,827 | | Net cash provided by (used in) investing activities | $61,248 | $(29,254) | +$90,502 | | Net cash provided by financing activities | $1,911 | $64,993 | -$63,082 | | Net increase (decrease) in cash and cash equivalents | $33,057 | $(8,190) | +$41,247 | | Cash and cash equivalents, end of period | $60,689 | $11,737 | +$48,952 | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the Company's accounting policies, significant transactions, and other financial disclosures [1. Organization and Business](index=10&type=section&id=1.%20Organization%20and%20Business) This note describes the Company's corporate structure, recent merger, and strategic focus as a clinical-stage biopharmaceutical entity - Reneo Pharmaceuticals, Inc. completed a merger with OnKure, Inc. on October 4, 2024, becoming OnKure Therapeutics, Inc. and effecting a **1:10 reverse stock split**[3](index=3&type=chunk)[22](index=22&type=chunk) - A concurrent private placement raised approximately **$65.0 million** through the sale of **2,839,005 shares** of Class A Common Stock[22](index=22&type=chunk) - Post-Merger, Legacy OnKure stockholders own **~53.6%**, pre-Merger Reneo stockholders **~25.1%**, and PIPE Investors **~21.3%** of the Combined Company's outstanding common stock[22](index=22&type=chunk) - OnKure Therapeutics, Inc. is now a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with lead product candidate OKI-219 in a Phase 1 trial, anticipating early clinical data in Q4 2024[22](index=22&type=chunk) [Liquidity](index=11&type=section&id=Liquidity) This note discusses the Company's cash position, historical losses, and management's assessment of future funding sufficiency - Reneo has incurred significant losses and negative cash flows from operations since its inception in 2014[25](index=25&type=chunk) - As of September 30, 2024, Reneo had **$76.7 million** in cash, cash equivalents, and short-term investments[25](index=25&type=chunk) - Management believes the Company's cash resources, post-Merger, will be sufficient to fund its operating plan for at least the next 12 months[25](index=25&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the consolidated financial statements - The unaudited consolidated financial statements are prepared in accordance with GAAP, with certain information condensed or omitted[26](index=26&type=chunk) - All share and per share amounts are retroactively adjusted for the Reverse Stock Split, excluding authorized shares and par value[26](index=26&type=chunk) - No recently issued accounting standards or interpretations are expected to have a material impact on Reneo's financial position, operations, or cash flows[28](index=28&type=chunk) [3. Net Loss Per Share](index=11&type=section&id=3.%20Net%20Loss%20Per%20Share) This note explains the calculation of basic and diluted net loss per share and identifies anti-dilutive securities - Basic loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding[29](index=29&type=chunk) - Diluted net loss per share excludes anti-dilutive common stock equivalents, such as stock options and unvested restricted stock units, from the calculation[30](index=30&type=chunk) Anti-Dilutive Securities (as of Sep 30, 2024) | Category | Amount | | :--------------------------- | :----- | | Common stock options outstanding | 467,129 | | Unvested restricted stock units | 29,658 | | **Total** | **496,787** | [4. Fair Value Measurements](index=12&type=section&id=4.%20Fair%20Value%20Measurements) This note details the fair value hierarchy and measurement of financial assets and liabilities - Reneo categorizes financial assets and liabilities measured at fair value into a three-tier hierarchy: Level 1 (quoted prices in active markets), Level 2 (significant other observable inputs), and Level 3 (significant unobservable inputs)[32](index=32&type=chunk) Assets Measured at Fair Value (Sep 30, 2024, in thousands) | Asset | Level 1 | Level 2 | Level 3 | Total | | :------------------------- | :------ | :------ | :------ | :------- | | Money market investments | $57,629 | — | — | $57,629 | | U.S. treasury securities | — | $15,979 | — | $15,979 | | **Total Assets** | **$57,629** | **$15,979** | **—** | **$73,608** | - The Performance Award liability, measured using Level 3 inputs, was reduced from **$7 thousand** at January 1, 2024, to **$0** at September 30, 2024, as its conditions were not probable of being achieved[32](index=32&type=chunk)[35](index=35&type=chunk) [5. Marketable Debt Securities](index=13&type=section&id=5.%20Marketable%20Debt%20Securities) This note describes the Company's available-for-sale debt securities and their fair market value - Reneo's debt securities are classified as current assets available-for-sale and are carried at fair value[36](index=36&type=chunk) Available-for-Sale Securities (Sep 30, 2024, in thousands) | Metric | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | | :--------------------- | :------------- | :--------------------- | :---------------------- | :---------------- | | U.S. treasury securities | $15,976 | $2 | — | $15,978 | | **Total** | **$15,976** | **$2** | **—** | **$15,978** | - Unrealized losses in the investment portfolio were considered temporary as of September 30, 2024, with no realized gains or losses for the three and nine months ended September 30, 2024 and 2023[38](index=38&type=chunk) [6. Accrued Expenses](index=14&type=section&id=6.%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, including clinical, manufacturing, and compensation costs Accrued Expenses (in thousands) | Accrued Expense | Sep 30, 2024 | Dec 31, 2023 | Change (2024 vs 2023) | | :-------------------------------- | :----------- | :----------- | :-------------------- | | Accrued clinical and regulatory | — | $3,661 | -$3,661 | | Accrued contract manufacturing cost | — | $1,100 | -$1,100 | | Accrued compensation | $361 | $3,948 | -$3,587 | | Accrued other | $364 | $420 | -$56 | | **Total accrued expenses** | **$725** | **$9,129** | **-$8,404** | [7. Leases](index=14&type=section&id=7.%20Leases) This note details the Company's operating lease commitments and related financial information - Reneo leases office space in Irvine, California (expires November 2026) and previously in Sandwich, United Kingdom, which was terminated early in January 2024[40](index=40&type=chunk) Operating Lease Information (as of Sep 30, 2024) | Metric | Value | | :------------------------------------------------------------------------------------------ | :---- | | Weighted incremental borrowing rate | 5% | | Weighted average remaining lease term (in years) | 2.1 | | Cash paid for amounts included in the measurement of lease liabilities (in thousands) | $291 | | Lease expense (in thousands) | $214 | Maturities of Lease Liabilities (in thousands) | Fiscal Year | Amount (Sep 30, 2024) | | :------------------------- | :-------------------- | | 2024 (remaining three months) | $98 | | 2025 | $371 | | 2026 | $285 | | **Total lease payments** | **$754** | | Less: Imputed interest | $(89) | | **Present value of lease liabilities** | **$665** | [8. Stock-Based Compensation](index=15&type=section&id=8.%20Stock-Based%20Compensation) This note outlines the Company's stock-based compensation plans, reserved shares, and related expenses Shares Reserved for Future Issuance (as of Sep 30, 2024) | Category | Shares Reserved | | :-------------------------------------------------------------------------- | :-------------- | | Common stock options outstanding | 467,129 | | Unvested restricted stock units | 29,658 | | Available for future grants under the 2021 Equity Incentive Plan | 442,366 | | Available for future grants under the 2021 Employee Stock Purchase Plan | 78,009 | | **Total shares of common stock reserved** | **1,017,162** | - Upon the close of the Merger, all shares available for issuance under the 2021 Plan and 2021 ESPP were cancelled, and new equity plans (2024 Plan and 2024 ESPP Plan) were adopted[45](index=45&type=chunk)[58](index=58&type=chunk) Stock-Based Compensation Expense (in thousands) | Expense Category | 3 Months Sep 30, 2024 | 3 Months Sep 30, 2023 | 9 Months Sep 30, 2024 | 9 Months Sep 30, 2023 | | :------------------------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | Research and development | $245 | $537 | $742 | $1,504 | | General and administrative | $581 | $892 | $2,151 | $2,289 | | **Total** | **$826** | **$1,429** | **$2,893** | **$3,793** | [9. License Agreement](index=18&type=section&id=9.%20License%20Agreement) This note describes the Company's license agreement with vTv Therapeutics and its recent termination - Reneo entered into a License Agreement with vTv Therapeutics in December 2017 for PPARδ agonists, including mavodelpar, but has suspended all development activity related to mavodelpar[56](index=56&type=chunk) - On October 30, 2023, Reneo repurchased **576,443 shares** of its common stock from vTv Therapeutics for approximately **$4.4 million**[56](index=56&type=chunk) - The Company provided notice on October 22, 2024, to terminate the vTv License Agreement, effective 90 days from the notice date[56](index=56&type=chunk) [10. Subsequent Events](index=18&type=section&id=10.%20Subsequent%20Events) This note discloses significant events occurring after the balance sheet date, including the merger and new equity plans - On October 4, 2024, Reneo completed its merger, changed its name to OnKure Therapeutics, Inc., and reclassified its common stock as Class A Common Stock[57](index=57&type=chunk) - Post-Merger, approximately **12,652,811 shares** of Class A Common Stock and **686,527 shares** of Class B Common Stock were outstanding[58](index=58&type=chunk) - The Company adopted the 2024 Equity Incentive Plan (**2,480,000 shares** reserved) and 2024 Employee Stock Purchase Plan (**137,500 shares** reserved)[58](index=58&type=chunk) - Class A Common Stock began trading on the Nasdaq Global Market under the symbol "OKUR" on October 7, 2024[58](index=58&type=chunk) - The Company paid approximately **$4.3 million** in severance and retention bonuses and recognized **$3.0 million** in stock-based compensation due to vesting acceleration post-Merger[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses OnKure Therapeutics' financial condition and results, focusing on the merger's impact, cessation of Reneo's business, and new biopharmaceutical focus [Forward-Looking Statements](index=20&type=section&id=Forward-Looking%20Statements) This section cautions that the discussion contains forward-looking statements subject to substantial risks and uncertainties - This discussion contains forward-looking statements based on current expectations, involving substantial risks and uncertainties[61](index=61&type=chunk) - Actual results could differ materially from those anticipated, and investors are cautioned not to unduly rely on these statements[61](index=61&type=chunk) - Various factors, including those in the "Risk Factors" section, could cause actual results to differ[61](index=61&type=chunk) [Merger](index=20&type=section&id=Merger) This section details the consummation of the merger, name change, reverse stock split, and concurrent private placement - Reneo consummated its merger with Legacy OnKure on October 4, 2024, changing its name to OnKure Therapeutics, Inc., effecting a reverse stock split, and reclassifying common stock to Class A[62](index=62&type=chunk) - A concurrent private placement raised approximately **$65.0 million** through the sale of **2,839,005 shares** of Class A Common Stock[62](index=62&type=chunk) - Post-Merger, Legacy OnKure stockholders own **~53.6%**, pre-Merger Reneo stockholders **~25.1%**, and PIPE Investors **~21.3%** of the Combined Company's outstanding common stock[63](index=63&type=chunk) - The Class A Common Stock began trading on the Nasdaq Global Market under the symbol "OKUR" on October 7, 2024[63](index=63&type=chunk) [Post-Merger Business](index=21&type=section&id=Post-Merger%20Business) This section describes the Company's new focus as a clinical-stage biopharmaceutical entity and its lead product candidate - Reneo's historic business operations ceased following the Merger, and the Company's go-forward operations are now those of Legacy OnKure[64](index=64&type=chunk) - The Company is a clinical-stage biopharmaceutical company focused on discovering and developing precision medicines for cancer[64](index=64&type=chunk) - Its lead product candidate, OKI-219, a highly selective PI3Kα inhibitor, is currently in a first-in-human Phase 1 trial, with early clinical data anticipated in Q4 2024[64](index=64&type=chunk) [License Agreement](index=21&type=section&id=License%20Agreement) This section discusses the termination of Reneo's vTv License Agreement related to mavodelpar development - Reneo's vTv License Agreement, related to mavodelpar, was terminated on October 22, 2024, following the suspension of all mavodelpar development activities[65](index=65&type=chunk) - Reneo had previously repurchased **576,443 shares** of its common stock from vTv Therapeutics for approximately **$4.4 million** on October 30, 2023[65](index=65&type=chunk) [Components of Reneo's Results of Operations](index=22&type=section&id=Components%20of%20Reneo's%20Results%20of%20Operations) This section explains the primary drivers of Reneo's research and development, general and administrative expenses, and other income - Research and Development expenses primarily related to preclinical and clinical development of mavodelpar, including personnel, CROs, manufacturing, and regulatory activities[67](index=67&type=chunk) - General and Administrative expenses consisted mainly of costs related to the Merger, personnel, professional fees (accounting, legal, commercial development), insurance, and corporate facility costs[68](index=68&type=chunk) - Other income was derived from interest income on Reneo's cash, cash equivalents, and short-term investments[69](index=69&type=chunk) [Reneo's Results of Operations](index=23&type=section&id=Reneo's%20Results%20of%20Operations) This section analyzes Reneo's operating results, including expenses and net loss, for the periods ended September 30, 2024 [Comparison of Three Months Ended September 30, 2024 and 2023](index=23&type=section&id=Comparison%20of%20Three%20Months%20Ended%20September%2030%2C%202024%20and%202023) This section compares Reneo's operating results for the three months ended September 30, 2024, and 2023 Operating Results (in thousands) | Metric | 3 Months Sep 30, 2024 | 3 Months Sep 30, 2023 | Change (YoY) | | :--------------------------- | :-------------------- | :-------------------- | :----------- | | Research and development | $904 | $13,622 | $(12,718) | | General and administrative | $3,760 | $7,266 | $(3,506) | | Total operating expenses | $4,664 | $20,888 | $(16,224) | | Loss from operations | $(4,664) | $(20,888) | $16,224 | | Other income | $972 | $1,692 | $(720) | | Net loss | $(3,692) | $(19,196) | $15,504 | - The decrease in R&D expenses was primarily due to the suspension of mavodelpar development activities and workforce reductions[72](index=72&type=chunk) - The decrease in G&A expenses was mainly due to reduced commercial development and consulting costs, and lower facility and personnel-related costs from workforce reductions[73](index=73&type=chunk) [Comparison of Nine Months Ended September 30, 2024 and 2023](index=24&type=section&id=Comparison%20of%20Nine%20Months%20Ended%20September%2030%2C%202024%20and%202023) This section compares Reneo's operating results for the nine months ended September 30, 2024, and 2023 Operating Results (in thousands) | Metric | 9 Months Sep 30, 2024 | 9 Months Sep 30, 2023 | Change (YoY) | | :--------------------------- | :-------------------- | :-------------------- | :----------- | | Research and development | $6,436 | $39,009 | $(32,573) | | General and administrative | $14,155 | $19,038 | $(4,883) | | Total operating expenses | $20,591 | $58,047 | $(37,456) | | Loss from operations | $(20,591) | $(58,047) | $37,456 | | Other income | $3,112 | $4,213 | $(1,101) | | Net loss | $(17,479) | $(53,834) | $36,355 | - The **$32.6 million** decrease in R&D expenses was primarily due to the suspension of mavodelpar development and workforce reductions[76](index=76&type=chunk) - The **$4.9 million** decrease in G&A expenses was driven by reduced commercial development/consulting costs and facility/personnel costs, partially offset by a **$2.1 million** increase in legal and advisory fees related to the Merger[77](index=77&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses Reneo's historical losses, current cash position, and future capital requirements for operations - Reneo has incurred significant losses and negative cash flows since inception, financing operations primarily through equity sales[79](index=79&type=chunk) - As of September 30, 2024, the Company had **$76.7 million** in cash, cash equivalents, and short-term investments[79](index=79&type=chunk) - Post-Merger, the Company expects to incur significant expenses for clinical development and will require additional capital, but believes current resources are sufficient for at least the next 12 months[79](index=79&type=chunk)[80](index=80&type=chunk) - Future funding requirements depend on the scope, timing, and costs of R&D, clinical trials, regulatory review, commercialization, manufacturing, intellectual property, and public company operations[81](index=81&type=chunk)[82](index=82&type=chunk) [Reneo's Cash Flows](index=26&type=section&id=Reneo's%20Cash%20Flows) This section analyzes Reneo's cash flows from operating, investing, and financing activities for the nine months ended September 30, 2024 Cash Flow Summary (in thousands) | Activity | 9 Months Sep 30, 2024 | 9 Months Sep 30, 2023 | Change (YoY) | | :------------------------------------------ | :-------------------- | :-------------------- | :----------- | | Net cash used in operating activities | $(30,102) | $(43,929) | +$13,827 | | Net cash provided by (used in) investing activities | $61,248 | $(29,254) | +$90,502 | | Net cash provided by financing activities | $1,911 | $64,993 | -$63,082 | | Net increase (decrease) in cash and cash equivalents | $33,057 | $(8,190) | +$41,247 | - Net cash used in operating activities decreased to **$30.1 million** in 2024, primarily due to a lower net loss and changes in operating assets and liabilities[85](index=85&type=chunk) - Net cash provided by investing activities significantly increased to **$61.2 million** in 2024, mainly from maturities of available-for-sale short-term investments[86](index=86&type=chunk) - Net cash provided by financing activities decreased to **$1.9 million** in 2024, primarily from private placement deposits, compared to **$65.0 million** in 2023 from public and private offerings[87](index=87&type=chunk) [Reneo's Material Cash Requirements](index=27&type=section&id=Reneo's%20Material%20Cash%20Requirements) This section outlines the Company's significant future cash obligations, including lease payments and potential license agreement payments - Material cash requirements include future operating lease minimum payments (detailed in Note 7) and potential milestone/royalty payments under the vTv License Agreement, which was terminated in October 2024 (detailed in Note 9)[88](index=88&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights the key accounting policies and estimates that require significant management judgment - Reneo's financial statements rely on estimates and judgments, but no material changes to critical accounting policies occurred during the nine months ended September 30, 2024, compared to the 2023 Annual Report on Form 10-K[89](index=89&type=chunk) [Recent Accounting Pronouncements](index=27&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to disclosures regarding recently issued accounting standards and their expected impact - Refer to Note 2 of the Consolidated Financial Statements for a description of recent accounting pronouncements applicable to Reneo's consolidated financial statements[90](index=90&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not required for smaller reporting companies, and therefore no disclosures about market risk are provided - This item is not required for smaller reporting companies[91](index=91&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the Company's disclosure controls and procedures as of September 30, 2024, and states that there were no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms management's conclusion on the effectiveness of the Company's disclosure controls and procedures - Management concluded that the Company's disclosure controls and procedures were effective as of September 30, 2024[92](index=92&type=chunk) - These controls provide reasonable assurance that required information is recorded, processed, summarized, and reported within specified time periods[92](index=92&type=chunk) [Changes in Internal Control over Financial Reporting](index=28&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in the Company's internal control over financial reporting during the quarter - There were no changes in internal control over financial reporting during the three months ended September 30, 2024, that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[93](index=93&type=chunk) [Part II. Other Information](index=29&type=section&id=Part%20II.%20Other%20Information) This section covers legal proceedings, risk factors, equity sales, and other miscellaneous disclosures [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) This section details legal proceedings related to the merger, including complaints alleging misrepresentation, which the Company intends to defend [Merger Proceedings](index=29&type=section&id=Merger%20Proceedings) This section describes the legal complaints filed concerning alleged misrepresentations in the merger's Proxy Statement/Prospectus - Two complaints were filed in New York (Thomas v. Reneo Pharmaceuticals, Inc., et al., and Kent v. Reneo Pharmaceuticals, Inc., et al.) on September 5-6, 2024, related to the Merger[95](index=95&type=chunk) - Allegations include misrepresentation and/or omission of material information in the Proxy Statement/Prospectus concerning financial projections, the fairness opinion, and potential conflicts of interest[95](index=95&type=chunk) - The Company and individual defendants intend to vigorously defend against these complaints[95](index=95&type=chunk) [Other Proceedings](index=29&type=section&id=Other%20Proceedings) This section confirms the absence of other material adverse legal proceedings affecting the Company - The Company is not currently a party to or aware of any other legal proceedings that are expected to have a material adverse effect on its business, financial condition, or results of operations[96](index=96&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks for OnKure Therapeutics, covering its early development, financial needs, product commercialization, intellectual property, and stock ownership [Summary of Risk Factors](index=29&type=section&id=Summary%20of%20Risk%20Factors) This section provides an overview of the Company's key risks, including its early development stage, financial needs, and product development challenges - The Company is in early development, has no approved products, and has incurred significant net losses, requiring substantial additional funding[98](index=98&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - Success is highly dependent on OKI-219, facing risks in clinical development, regulatory approval, and commercialization, including intense competition and market acceptance challenges[99](index=99&type=chunk)[107](index=107&type=chunk)[127](index=127&type=chunk)[129](index=129&type=chunk) - Intellectual property protection is critical but uncertain, with risks of infringement claims and challenges to patent validity[99](index=99&type=chunk)[137](index=137&type=chunk)[148](index=148&type=chunk) - Reliance on third parties for clinical trials and manufacturing, ongoing regulatory obligations, and the volatile market price of Class A Common Stock are also significant risks[99](index=99&type=chunk)[172](index=172&type=chunk)[186](index=186&type=chunk)[197](index=197&type=chunk) [Risks Related to Our Operating History, Financial Position and Need for Additional Capital](index=31&type=section&id=Risks%20Related%20to%20Our%20Operating%20History%2C%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section details risks associated with the Company's historical losses, lack of revenue, and ongoing need for substantial additional funding - The Company is an early-stage biopharmaceutical company with no products approved for commercial sale and has never generated revenue[101](index=101&type=chunk)[103](index=103&type=chunk) - It has incurred significant net losses since inception (Legacy OnKure: **$35.3 million** in 2023, **$29.5 million** in 2022) and expects to continue incurring losses for the foreseeable future[102](index=102&type=chunk) - Substantial additional funding will be required to complete product development, with current cash expected to fund operations into Q4 2026[105](index=105&type=chunk) - Raising additional capital through equity could lead to significant stockholder dilution, while debt financing may involve restrictive covenants[105](index=105&type=chunk) [Risks Related to Our Development and Commercialization of Our Product Candidates](index=34&type=section&id=Risks%20Related%20to%20Our%20Development%20and%20Commercialization%20of%20Our%20Product%20Candidates) This section outlines risks concerning clinical trial success, regulatory approval, market acceptance, and competition for product candidates - The Company is substantially dependent on OKI-219, currently in a Phase 1 clinical trial, and its ability to obtain regulatory approval and commercialize it[107](index=107&type=chunk) - Clinical trials may fail to demonstrate safety and efficacy, leading to additional costs, delays, or inability to complete development[109](index=109&type=chunk) - The regulatory approval processes are lengthy, time-consuming, and unpredictable, with no guarantee of approval or broad indication[111](index=111&type=chunk) - Difficulties in patient enrollment or retention in clinical trials could delay or prevent necessary regulatory approvals[115](index=115&type=chunk) - The Company faces substantial competition from companies with greater resources and established market presence, potentially leading to competitors developing products more successfully or earlier[127](index=127&type=chunk) - Even if approved, product candidates may fail to achieve market acceptance among physicians, patients, and third-party payors due to various factors including efficacy, price, and side effects[129](index=129&type=chunk) [Risks Related to Our Intellectual Property](index=46&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses risks in obtaining, maintaining, and defending intellectual property rights, including patent challenges and infringement claims - The Company relies on patents, trademarks, and trade secrets, but faces risks in obtaining and maintaining sufficient patent protection, as patents may be challenged, invalidated, or have inadequate terms[137](index=137&type=chunk)[138](index=138&type=chunk)[142](index=142&type=chunk) - There is a significant risk of becoming involved in third-party claims of intellectual property infringement, which could delay development, lead to substantial damages, or require costly licenses[148](index=148&type=chunk) - Changes in U.S. or foreign patent laws and the inability to protect intellectual property rights globally could diminish the value of patents and impair the business[154](index=154&type=chunk)[156](index=156&type=chunk) - Failure to protect the confidentiality of trade secrets or claims that employees used confidential information of former employers could harm the Company's competitive position[157](index=157&type=chunk)[159](index=159&type=chunk) - Future collaboration or license agreements may not be successful, or non-compliance could lead to termination and loss of critical intellectual property rights[166](index=166&type=chunk)[168](index=168&type=chunk) [Risks Related to Our Regulatory Approval and Other Legal Compliance Matters](index=61&type=section&id=Risks%20Related%20to%20Our%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) This section covers risks related to ongoing regulatory obligations, healthcare legislation, and compliance with anti-kickback and privacy laws - Even with regulatory approval, the Company will be subject to ongoing, costly regulatory obligations and oversight, with potential for significant penalties for non-compliance[172](index=172&type=chunk)[174](index=174&type=chunk) - Disruptions at regulatory agencies (e.g., FDA, SEC) due to funding shortages or global health concerns could hinder product development and approval timelines[175](index=175&type=chunk)[177](index=177&type=chunk) - Healthcare legislative measures, such as the Inflation Reduction Act of 2022, and state-level regulations aimed at reducing healthcare costs, could adversely affect pricing and revenue prospects[178](index=178&type=chunk)[179](index=179&type=chunk) - The Company is subject to federal and state anti-kickback, false claims, and privacy laws (HIPAA), with risks of significant civil, criminal, and administrative penalties for violations[180](index=180&type=chunk)[182](index=182&type=chunk) - Misconduct by employees, contractors, or other third parties, as well as compliance with environmental, health, and safety laws, pose additional risks[183](index=183&type=chunk) [Risks Related to Our Reliance on Third Parties](index=68&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section highlights risks associated with dependence on third parties for clinical trials, manufacturing, and supply chain management - The Company relies heavily on third parties, including independent clinical investigators and CROs, to conduct preclinical studies and clinical trials, increasing risks of delays, non-compliance, and compromised data[186](index=186&type=chunk) - Reliance on single-source third-party manufacturers for drug substance and drug product increases the risk of supply disruptions, cost increases, and failure to comply with cGMP regulations[188](index=188&type=chunk)[189](index=189&type=chunk) - Manufacturing drugs is complex, and difficulties in production by third-party manufacturers could delay or prevent the adequate supply of product candidates for clinical trials or commercialization[190](index=190&type=chunk) [Risks Related to Our Business Operations](index=70&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations) This section discusses risks concerning talent retention, future acquisitions, and vulnerabilities in computer systems and data security - The Company's success is highly dependent on its ability to attract and retain highly skilled executive officers and employees, facing intense competition for talent[191](index=191&type=chunk)[193](index=193&type=chunk) - Future acquisitions, in-licensing, or strategic partnerships may increase capital requirements, dilute stockholders, incur debt, and divert management attention[194](index=194&type=chunk) - The Company's computer systems and those of its contractors are vulnerable to damage from cyberattacks, natural disasters, and other system failures, potentially disrupting operations and compromising data[195](index=195&type=chunk)[196](index=196&type=chunk) [Risks Related to Ownership of Our Class A Common Stock](index=72&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Class%20A%20Common%20Stock) This section addresses risks related to stock price volatility, SEC reporting requirements, potential dilution, and concentrated ownership - The market price of the Company's Class A Common Stock is expected to be volatile due to various factors, including clinical trial results, regulatory actions, competition, and general market conditions[197](index=197&type=chunk)[198](index=198&type=chunk) - The Company is subject to stringent SEC requirements applicable to reporting shell company business combinations, which will increase costs, limit capital raising, and restrict resale of securities[215](index=215&type=chunk)[216](index=216&type=chunk) - Future sales of shares by existing stockholders, particularly after lock-up agreements expire, could cause the Class A Common Stock price to decline[217](index=217&type=chunk) - Concentrated ownership by executive officers, directors, and principal stockholders (approximately **49.8%**) gives them significant influence over matters submitted to stockholders for approval[218](index=218&type=chunk) - The Company's ability to use net operating loss carryforwards and other tax attributes may be limited due to ownership changes, including those resulting from the Merger, under Sections 382 and 383 of the Code[222](index=222&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no unregistered equity sales and details the use of proceeds from Reneo's 2021 IPO, with most funds utilized [Unregistered Sales of Equity Securities](index=82&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) This section confirms that there were no unregistered sales of equity securities during the reporting period - There were no unregistered sales of equity securities[227](index=227&type=chunk) [Use of Proceeds](index=82&type=section&id=Use%20of%20Proceeds) This section details the allocation and remaining balance of net proceeds from the Company's initial public offering - Reneo completed its IPO in April 2021, generating **$84.6 million** in net proceeds from the sale of **6,250,000 shares** at **$15.00 per share**[228](index=228&type=chunk) - As of September 30, 2024, approximately **$83.5 million** of the net IPO proceeds have been used[229](index=229&type=chunk) - The remaining net proceeds are invested in highly liquid money market funds and short-term investments to fund operations[229](index=229&type=chunk) [Item 3. Defaults Upon Senior Securities](index=82&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities - There were no defaults upon senior securities[230](index=230&type=chunk) [Item 4. Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that no mine safety disclosures are applicable to the Company - No mine safety disclosures are applicable[230](index=230&type=chunk) [Item 5. Other Information](index=82&type=section&id=Item%205.%20Other%20Information) This section indicates that no other information is reported - No other information is reported in this section[230](index=230&type=chunk) [Item 6. Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including merger agreements and executive officer certifications - Key exhibits include the Agreement and Plan of Merger (2.1), Amended and Restated Certificate of Incorporation (3.1), Amended and Restated Bylaws (3.2), and Certifications of Principal Executive and Financial Officers (31.1, 31.2, 32.1)[233](index=233&type=chunk) [Signatures](index=84&type=section&id=Signatures) The report is officially signed by the President, CEO, and CFO of Reneo Pharmaceuticals, Inc. on November 7, 2024 - The report was signed by Nicholas A. Saccomano, Ph.D., President and Chief Executive Officer, and Jason Leverone, Chief Financial Officer[235](index=235&type=chunk) - The signing date for the report was November 7, 2024[235](index=235&type=chunk)

Core Points - Reneo Pharmaceuticals and OnKure, Inc. are merging, with the combined company to be named OnKure Therapeutics, Inc. and trading under the ticker "OKUR" on Nasdaq [2] - The merger is expected to close on or around October 4, 2024, and will focus on advancing OnKure's pipeline targeting oncogenic mutations in PI3Kα [2] - Reneo will implement a 1-for-10 reverse stock split prior to the merger, affecting the common stock of the combined company [3][4] Company Overview - Reneo Pharmaceuticals specializes in therapies for rare genetic mitochondrial diseases [9] - OnKure, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines targeting cancer drivers, with its lead program OKI-219 currently in Phase 1 clinical trials [8]

About Monteverde & Associates PC NEW YORK, June 21, 2024 (GLOBE NEWSWIRE) -- Monteverde & Associates PC (the "M&A Class Action Firm"), has recovered money for shareholders and is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and is investigating Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), relating to its proposed merger with OnKure, Inc. Under the terms of the agreement, Reneo stockholders are expe ...

```markdown PART I — FINANCIAL INFORMATION This section presents the unaudited consolidated financial statements and related disclosures for the company [Item 1. Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(Unaudited)) Net loss reduced due to decreased R&D after mavodelpar suspension, maintaining stable liquidity Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :-------------------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $20,375 | $27,632 | $(7,257) | | Short-term investments | $62,460 | $75,331 | $(12,871) | | Total current assets | $83,927 | $106,622 | $(22,695) | | Total assets | $84,639 | $107,436 | $(22,797) | | Total current liabilities | $2,814 | $18,177 | $(15,363) | | Total liabilities | $3,397 | $18,826 | $(15,429) | | Total stockholders' equity | $81,242 | $88,610 | $(7,368) | | Accumulated deficit | $(226,900) | $(218,474) | $(8,426) | Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | :----- | | Research and development expenses | $4,942 | $10,991 | $(6,049) | | General and administrative expenses | $4,622 | $5,132 | $(510) | | Total operating expenses | $9,564 | $16,123 | $(6,559) | | Loss from operations | $(9,564) | $(16,123) | $6,559 | | Other income | $1,138 | $1,016 | $122 | | Net loss | $(8,426) | $(15,107) | $6,681 | | Comprehensive loss | $(8,446) | $(15,052) | $6,606 | | Net loss per share, basic and diluted | $(0.25) | $(0.60) | $0.35 | | Weighted-average shares outstanding | 33,420,808 | 25,036,410 | 8,384,398 | Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Net cash used in operating activities | $(21,014) | $(9,048) | $(11,966) | | Net cash provided by investing activities | $13,757 | $18,507 | $(4,750) | | Net cash provided by financing activities | $0 | $1,009 | $(1,009) | | Net (decrease) increase in cash and cash equivalents | $(7,257) | $10,468 | $(17,725) | | Cash and cash equivalents, end of period | $20,375 | $30,395 | $(10,020) | - The Company has **suspended all development activities** for its only product candidate, mavodelpar, after its pivotal STRIDE study failed to meet primary or secondary efficacy endpoints on December 14, 2023, leading to **workforce reductions** and **approximately $4.1 million in severance and benefit expenses**[24](index=24&type=chunk)[122](index=122&type=chunk) - As of March 31, 2024, the Company had **$82.8 million in cash, cash equivalents, and short-term investments**, which management believes will be **sufficient to fund operations for at least one year**[26](index=26&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) Accrued Expenses (in thousands) | Category | March 31, 2024 | December 31, 2023 | Change | | :-------------------------- | :------------- | :---------------- | :----- | | Accrued clinical and regulatory | $190 | $3,661 | $(3,471) | | Accrued contract manufacturing cost | $1 | $1,100 | $(1,099) | | Accrued compensation | $1,170 | $3,948 | $(2,778) | | Total accrued expenses | $1,807 | $9,129 | $(7,322) | - The Company exercised an **early termination option** for its Sandwich, United Kingdom office lease in January 2024[46](index=46&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $253 | $473 | $(220) | | General and administrative | $825 | $684 | $141 | | Total | $1,078 | $1,157 | $(79) | - The Company **repurchased all 576,443 shares** of its common stock previously issued to vTv Therapeutics under the vTv License Agreement for **approximately $4.4 million** in October 2023, and **No milestone payments were achieved or recorded** for the three months ended March 31, 2024 and 2023[68](index=68&type=chunk)[69](index=69&type=chunk) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time [Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss over specific reporting periods [Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This statement outlines the changes in the company's equity accounts, including common stock and accumulated deficit, over time [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This statement categorizes cash inflows and outflows from operating, investing, and financing activities for specific periods [Notes to Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(Unaudited)) These notes provide additional detailed information and explanations essential for understanding the company's financial statements [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Strategic shift after mavodelpar failure led to reduced R&D expenses and workforce, with sufficient liquidity for 12 months - Reneo Pharmaceuticals, Inc. has **suspended all development activities** for its only product candidate, mavodelpar, following the **failure of its pivotal STRIDE study** in December 2023[74](index=74&type=chunk) - The Board of Directors initiated a formal process in January 2024 to **evaluate potential strategic alternatives**, including **merger, sale, or other business combinations**, to maximize stockholder value, with **dissolution and liquidation** potentially pursued if no strategic alternative is consummated[75](index=75&type=chunk)[120](index=120&type=chunk) Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $4,942 | $10,991 | $(6,049) | | General and administrative | $4,622 | $5,132 | $(510) | | Total operating expenses | $9,564 | $16,123 | $(6,559) | - **Research and development expenses decreased by $6.0 million**, primarily due to the **suspension of mavodelpar development** and **workforce reductions**[88](index=88&type=chunk) - **General and administrative expenses decreased by $0.5 million**, mainly due to **workforce reductions**[89](index=89&type=chunk) - **Other income increased by $0.1 million**, driven by higher interest rates in 2024[90](index=90&type=chunk) - As of March 31, 2024, the company had an **accumulated deficit of $226.9 million** and a **net loss of $8.4 million** for the quarter[93](index=93&type=chunk) - The company **terminated its at-the-market equity offering sales agreement** (2023 ATM Facility) with Leerink Partners LLC on April 8, 2024, under which **no shares were sold**[92](index=92&type=chunk) - **Material cash requirements** include future operating lease payments, a **special performance award for the CEO (up to $7.5 million)**, and **potential milestone/royalty payments** under the vTv License Agreement, in addition to **costs for evaluating strategic alternatives**[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) [Overview](index=18&type=section&id=Overview) This section provides a high-level introduction to the company's financial condition and operational results, emphasizing recent strategic shifts [History of Mavodelpar Clinical Trials Overview](index=19&type=section&id=History%20of%20Mavodelpar%20Clinical%20Trials%20Overview) This section summarizes the development and clinical trial history of the company's lead product candidate, mavodelpar [License Agreement](index=19&type=section&id=License%20Agreement) This section details the terms and financial implications of the company's licensing agreements, particularly concerning its product candidates [Components of Our Results of Operations](index=20&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section explains the key revenue and expense categories that constitute the company's financial performance [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the company's financial performance, comparing current and prior period operating results [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations and its sources of funding [Cash Flows](index=23&type=section&id=Cash%20Flows) This section analyzes the sources and uses of cash across operating, investing, and financing activities [Material Cash Requirements](index=23&type=section&id=Material%20Cash%20Requirements) This section outlines the company's significant future contractual obligations and other cash commitments [Critical Accounting Policies and Estimates](index=24&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section describes the accounting policies and estimates that require significant judgment and can materially impact financial reporting [Recent Accounting Pronouncements](index=24&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses the impact of recently issued accounting standards on the company's financial statements [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Reneo Pharmaceuticals, Inc. is not required to provide market risk disclosures [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control over financial reporting - **Disclosure controls and procedures were effective as of March 31, 2024**[107](index=107&type=chunk) - **No material changes in internal control over financial reporting occurred during the three months ended March 31, 2024**[109](index=109&type=chunk) [Evaluation of Disclosure Controls and Procedures](index=24&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section provides an overview of Evaluation of Disclosure Controls and Procedures [Changes in Internal Control over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section provides an overview of Changes in Internal Control over Financial Reporting PART II — OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, and equity disclosures [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, but acknowledges potential future litigation - The company is **not currently a party to any material legal proceedings**[112](index=112&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Significant ongoing net losses, strategic alternative uncertainties, and employee retention challenges pose substantial risks to the company - The company has **incurred significant net losses** since its inception in 2014, with an **accumulated deficit of $226.9 million** as of March 31, 2024, and **expects to continue incurring losses**[117](index=117&type=chunk)[118](index=118&type=chunk) - There is **no assurance** that the evaluation of strategic alternatives will result in a definitive transaction or enhance stockholder value, and a **dissolution and liquidation could lead to a total loss of investment**[119](index=119&type=chunk)[121](index=121&type=chunk) - The company's recent **workforce reductions** (December 2023 and February 2024) may lead to a **loss of key employees**, **impacting the ability to pursue strategic alternatives**[123](index=123&type=chunk) - Future development of any product candidates would require **substantial additional capital**, which may not be available on acceptable terms, potentially forcing **delays or elimination of programs**[124](index=124&type=chunk)[126](index=126&type=chunk) - The regulatory approval process is **lengthy, expensive, and uncertain**, with **no guarantee of success**, and any approved products may face **challenges in market acceptance and reimbursement**[136](index=136&type=chunk)[160](index=160&type=chunk) - The company relies on third parties for clinical trials and manufacturing, and their **failure to meet contractual duties or regulatory requirements could delay or prevent product development**[211](index=211&type=chunk)[218](index=218&type=chunk) - Obtaining and maintaining intellectual property protection is **critical but uncertain**, with **risks of patent invalidation, infringement claims, and challenges in global enforcement**[222](index=222&type=chunk)[233](index=233&type=chunk)[286](index=286&type=chunk) - The company's **common stock price is highly volatile**, influenced by clinical trial results, regulatory decisions, and general market factors, and could **decline due to substantial sales or future dilution**[328](index=328&type=chunk)[344](index=344&type=chunk)[347](index=347&type=chunk) - The company is subject to various U.S. and foreign laws, including anti-corruption, data privacy, and cybersecurity regulations, with non-compliance potentially leading to **significant penalties and business disruptions**[187](index=187&type=chunk)[357](index=357&type=chunk)[359](index=359&type=chunk) [Risks Related to Our Business and Industry](index=26&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This section details the specific challenges and uncertainties inherent in the company's operations and the pharmaceutical industry [Risks Related to Our Reliance on Third Parties](index=47&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section highlights the potential risks arising from the company's dependence on external partners for key functions like manufacturing and clinical trials [Risks Related to Our Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses the challenges and uncertainties associated with protecting and enforcing the company's intellectual property rights [Risks Related to Ownership of Our Common Stock](index=72&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) This section outlines the factors that could negatively impact the value and liquidity of the company's common stock for investors [General Risk Factors](index=80&type=section&id=General%20Risk%20Factors) This section covers broad, overarching risks that could affect the company's overall business, financial condition, and future prospects [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred; IPO proceeds primarily funded operations, with remaining funds in liquid assets - **No unregistered sales of equity securities occurred during the period**[375](index=375&type=chunk) - The company **completed its IPO in April 2021, generating net proceeds of $84.6 million**. As of March 31, 2024, **approximately $66.6 million of these proceeds have been used to fund operations**, with the remaining invested in **highly liquid money market funds and short-term investments**[376](index=376&type=chunk)[377](index=377&type=chunk) [Unregistered Sales of Equity Securities](index=83&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) This section discloses any sales of equity securities that were not registered under the Securities Act of 1933 [Use of Proceeds](index=83&type=section&id=Use%20of%20Proceeds) This section details how the net proceeds from the company's public offerings, such as its IPO, have been utilized [Item 3. Defaults Upon Senior Securities](index=82&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reneo Pharmaceuticals, Inc. reported no defaults upon senior securities - **There were no defaults upon senior securities**[378](index=378&type=chunk) [Item 4. Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Reneo Pharmaceuticals, Inc. reported no mine safety disclosures - **There were no mine safety disclosures**[378](index=378&type=chunk) [Item 5. Other Information](index=82&type=section&id=Item%205.%20Other%20Information) Reneo Pharmaceuticals, Inc. reported no other information required to be disclosed under this item - **No other information was reported**[379](index=379&type=chunk) [Item 6. Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and data files - The report includes **certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1) and Inline XBRL Instance Document (Exhibit 101.INS)**[382](index=382&type=chunk) [Signatures](index=84&type=section&id=Signatures) The report is duly signed by the President and CEO, and SVP of Finance and Administration, as of May 7, 2024 - The report was **signed by Gregory J. Flesher, President and Chief Executive Officer, and Jennifer P. Lam, Senior Vice President, Finance and Administration, on May 7, 2024**[386](index=386&type=chunk) ```