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, 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) | | | | Delawar ...

EXHIBIT 99.1 OnKure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results -- Data from the ongoing PIKture-01 trial is expected to be announced in March 2026; continued enrollment in breast cancer triplet combinations -- Approximately $59M in cash and cash equivalents at the end of Q4 2025 BOULDER, CO, March 12, 2026 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for ...

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 September 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 ...

Exhibit 99.1 OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update -- First patients dosed in triplet expansion arms of the PIKture-01 trial evaluating OKI-219 in combination with fulvestrant and ribociclib, and in combination with trastuzumab and tucatinib in patients with metastatic breast cancer -- Clinical data from OKI-219 PIKture-01 single agent and fulvestrant combination arms are maturing and is now expected to be reported together with initial data from the ...

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 | ...