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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)



☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025



☐	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 jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

6707 Winchester Circle, Suite 400 Boulder, Colorado (Address of Principal Executive Offices)	80301 (Zip Code)
(Registrant’s telephone number, including area code): (720) 307-2892

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading symbol	Name of each exchange on which registered
Class A Common Stock, par value $0.0001 per share	OKUR	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.



Large accelerated filer	☐	Accelerated filer	☐
		Smaller reporting company	☒
Non-accelerated filer	☒	Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 5, 2025, the registrant had 12,861,672 shares of Class A common stock, $0.0001 par value per share, and 686,527 shares of Class B common stock, $0.0001 par value per share, outstanding.

Explanatory Note

On October 4, 2024 (the “Closing Date”), the Delaware corporation formerly known as “Reneo Pharmaceuticals, Inc.” (“Reneo”) completed its previously announced merger transaction pursuant to the terms of the Agreement and Plan of Merger, dated as of May 10, 2024 (the “Merger Agreement”), by and among Reneo, Radiate Merger Sub I, Inc., a Delaware corporation and a direct, wholly owned subsidiary of Reneo (“Merger Sub I”), Radiate Merger Sub II, LLC, a Delaware limited liability company and a direct, wholly owned subsidiary of Reneo (“Merger Sub II”), and OnKure, Inc., a Delaware corporation (“Legacy OnKure”).

Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo’s issued common stock at a ratio of 1:10 (the “Reverse Stock Split”), (ii) Reneo changed its name to “OnKure Therapeutics, Inc.”, (iii) Reneo reclassified all of its common stock as Class A Common Stock or Class B Common Stock, and (iv) Merger Sub I merged with and into Legacy OnKure (the “Merger”), with Legacy OnKure as the surviving company in the Merger and, after giving effect to such Merger, Legacy OnKure became a wholly owned subsidiary of OnKure Therapeutics, Inc. (together, the “Combined Company”). Pursuant to the terms of the Merger Agreement, OnKure determined that the Merger would qualify for the intended tax treatment even if only the merger with Merger Sub I was consummated, and therefore the parties determined not to consummate the second merger with Merger Sub II contemplated by the Merger Agreement.

The financial statements included in this Quarterly Report on Form 10-Q include historical financial information of OnKure Therapeutics, Inc., including as of and for the three and nine months ended September 30, 2025, unless otherwise indicated or as the context otherwise requires. In addition, except where otherwise indicated, the information in this Quarterly Report on Form 10-Q as of and for the periods prior to the effective time of the Merger gives effect to the Merger.

Unless the context otherwise requires, “OnKure,” “we,” “us,” “our,” and the “Company” refer to the Combined Company. All references herein to the “Board” refer to the board of directors of OnKure Therapeutics, Inc.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

•

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

•

the beneficial characteristics, and the potential safety, efficacy, and therapeutic effects of OKI-219 and any other product candidates we have or may in the future develop;

•

our future results of operations and financial position;

•

our ability to obtain funding for our operations, including funding necessary to develop and commercialize our current and future product candidates, subject to regulatory approvals;

•

our cash runway and our ability to extend our operating capital;

•

the initiation, timing, progress and results of our preclinical and clinical activities for OKI-219 and any other product candidates we have or may in the future develop, including the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials may become available, research development programs, and the announcement of product candidates;

•

the potential of our technologies and our ability to execute on our corporate strategy;

•

expectations regarding the approval and use of our product candidates in combination with other drugs;

•

our expectations regarding the market opportunities for our product candidates and PI3Kα inhibitors generally;

•

our ability to obtain and adequately protect intellectual property rights for our product candidates;

•

our ability to obtain regulatory approval for our product candidates and any related restrictions, limitations and/or warnings in the label of any approved product candidate;

•

expectations regarding our reliance on third parties for the manufacture of our product candidates for clinical trials;

•

our competitive position and the success of competing therapies that are or may become available;

•

existing regulations and regulatory developments in the United States and other jurisdictions; and

•

our ability to realize some or all of the anticipated benefits of the Merger.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update

or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements such as “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

TABLE OF CONTENTS


		Page

Part I	Financial Information	6

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	6

	Condensed Consolidated Balance Sheets	6

	Condensed Consolidated Statements of Operations and Comprehensive Loss	7

	Condensed Consolidated Statements of Changes in Stockholders’ Equity	8

	Condensed Consolidated Statements of Cash Flows	9

	Notes to Condensed Consolidated Financial Statements	10

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	29

Item 4.	Controls and Procedures	29

Part II	Other Information	31

Item 1.	Legal Proceedings	31

Item 1A.	Risk Factors	32

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	85

Item 3.	Defaults Upon Senior Securities	85

Item 4.	Mine Safety Disclosures	85

Item 5.	Other Information	85

Item 6.	Exhibits	86

Signatures		88

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

ONKURE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(Unaudited)


	September 30,			December 31,
	2025			2024

ASSETS
Current assets:
Cash and cash equivalents	$	70,331		$	110,761
Prepaid expenses and other current assets		1,195			2,242
Total current assets		71,526			113,003
Property and equipment, net		720			1,025
Operating lease right-of-use asset		485			770
Other assets		104			109
Total assets	$	72,835		$	114,907

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,290		$	2,968
Accrued expenses and other current liabilities		4,390			7,026
Operating lease liabilities, current portion		567			536
Total current liabilities		6,247			10,530
Long-term operating lease liabilities		120			549
Other long-term liabilities		40			—
Total liabilities		6,407			11,079
Commitments and contingencies
Stockholders’ equity:
Common stock, Class A, $0.0001 par value; 200,000,000 shares authorized; 12,861,672 and 12,660,590 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		1			1
Common stock, Class B, $0.0001 par value; 10,000,000 shares authorized; 686,527 shares issued and outstanding at both September 30, 2025 and December 31, 2024		—			—
Additional paid-in capital		267,165			258,551
Accumulated deficit		(200,738	)		(154,724	)
Total stockholders’ equity		66,428			103,828
Total liabilities and stockholders’ equity	$	72,835		$	114,907

The accompanying notes are an integral part of these condensed consolidated financial statements.

ONKURE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2025			2024			2025			2024
	(in thousands, except share and per share amounts)
Operating expenses:
Research and development	$	11,915		$	10,116		$	37,540		$	29,434
General and administrative		3,586			1,396			11,285			6,253
Total operating expenses		15,501			11,512			48,825			35,687
Loss from operations		(15,501	)		(11,512	)		(48,825	)		(35,687	)
Other income:
Interest income		804			174			2,813			699
Interest and other expense		(2	)		(218	)		(2	)		(243	)
Total other income (expense)		802			(44	)		2,811			456
Net loss and comprehensive loss	$	(14,699	)	$	(11,556	)	$	(46,014	)	$	(35,231	)

Net loss per share attributable to common stockholders:
Basic and diluted	$	(1.09	)	$	(36.55	)	$	(3.41	)	$	(111.77	)
Weighted average shares outstanding:
Basic and diluted		13,530,892			316,142			13,488,493			315,215

The accompanying notes are an integral part of these condensed consolidated financial statements.

ONKURE THERAPEUTICS, INC

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

(in thousands, except share information)

(Unaudited)



																Additional						Total
	Convertible Preferred Stock						Class A Common stock					Class B Common stock				Paid-In			Accumulated			Stockholders'
	Shares			Amount			Shares			Amount		Shares		Amount		Capital			Deficit			Equity (Deficit)


Balance, December 31, 2023		6,840,620		$	129,825			313,747		$	—		—	$	—	$	209		$	(102,051	)	$	(101,842	)
Issuance of Class A Common Stock for cash upon the exercise of stock options		—			—			1,002			—		—		—		10			—			10
Share-based compensation expense		—			—			—			—		—		—		107			—			107
Net loss		—			—			—			—		—		—		—			(9,536	)		(9,536	)
Balance, March 31, 2024		6,840,620			129,825			314,749			—		—		—		326			(111,587	)		(111,261	)
Issuance of Class A Common Stock for cash upon the exercise of stock options		—			—			1,130			—		—		—		10			—			10
Share-based compensation		—			—			—			—		—		—		1,813			—			1,813
Net loss		—			—			—			—		—		—		—			(14,139	)		(14,139	)
Balance, June 30, 2024		6,840,620			129,825			315,879			—		—		—		2,149			(125,726	)		(123,577	)
Issuance of Class A Common Stock for cash upon the exercise of stock options		—			—			344			—		—		—		6			—			6
Share-based compensation		—			—			—			—		—		—		77			—			77
Net loss		—			—			—			—		—		—		—			(11,556	)		(11,556	)
Balance, September 30, 2024		6,840,620			129,825			316,223			—		—		—		2,232			(137,282	)		(135,050	)
Conversion of Convertible Preferred Stock for Class A and B Common Stock in connection with the Merger		(6,840,620	)		(129,825	)		6,154,093			1		686,527		—		129,824			—			129,825
Issuance of Class A Common Stock in the Concurrent Financing, less issuance costs		—			—			2,571,736			—		—		—		54,428			—			54,428
Issuance of common stock to former stockholders of Reneo Pharmaceuticals, Inc. in the reverse recapitalization		—			—			3,343,604			—		—		—		65,499			—			65,499
Reverse recapitalization transaction costs of OnKure		—			—			—			—		—		—		(2,085	)		—			(2,085	)
Issuance of Class A Common Stock for the conversion of Convertible Promissory Notes		—			—			267,269									6,120						6,120
Issuance of Class A common stock for the settlement of restricted stock units		—			—			7,700			—		—		—		—			—			—
Adjustment for fractional shares in the reverse recapitalization		—			—			(35	)		—		—		—		—			—			—
Share-based compensation		—			—			—			—		—		—		2,533			—			2,533
Net loss		—			—			—			—		—		—		—			(17,442	)		(17,442	)
Balance, December 31, 2024		—		$	—			12,660,590		$	1		686,527	$	—	$	258,551		$	(154,724	)	$	103,828
Vesting of restricted stock units, net		—			—			94,758			—		—		—		—			—			—
Share-based compensation		—			—			—			—		—		—		2,745			—			2,745
Net loss		—			—			—			—		—		—		—			(15,925	)		(15,925	)
Balance, March 31, 2025		—			—			12,755,348			1		686,527		—		261,296			(170,649	)		90,648
Vesting of restricted stock units		—			—			88,086			—		—		—		—			—			—
Share-based compensation		—			—			—			—		—		—		2,908			—			2,908
Net loss		—			—			—			—		—		—		—			(15,390	)		(15,390	)
Balance, June 30, 2025		—			—			12,843,434			1		686,527		—		264,204			(186,039	)		78,166
Vesting of restricted stock units		—			—			18,238			—		—		—		—			—			—
Share-based compensation		—			—			—			—		—		—		2,961			—			2,961
Net loss		—			—			—			—		—		—		—			(14,699	)		(14,699	)
Balance, September 30, 2025		—		$	—			12,861,672		$	1		686,527	$	—	$	267,165		$	(200,738	)	$	66,428

The accompanying notes are an integral part of these condensed consolidated financial statements.

ONKURE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)


	Nine Months Ended
	September 30,
	2025			2024
	(in thousands)
Cash flows from operating activities:
Net loss	$	(46,014	)	$	(35,231	)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation expense		8,614			1,997
Depreciation and amortization		343			343
Amortization of right-of-use asset - operating		285			111
Loss on disposal of property and equipment		2			—
Amortization of debt issuance costs		—			128
Change in operating assets and liabilities:
Prepaid and other assets		1,052			(108	)
Accounts payable, accrued and other liabilities		(4,240	)		5,151
Lease liabilities		(398	)		(154	)
Other long-term liabilities		40			—
Net cash used in operating activities		(40,316	)		(27,763	)
Cash flows from investing activities:
Purchases of property and equipment		(37	)		(37	)
Net cash used in investing activities		(37	)		(37	)
Cash flows from financing activities:
Payment of issuance costs associated with the Concurrent Financing		(37	)		—
Payment of reverse recapitalization transaction costs		(40	)		—
Proceeds from issuance of convertible notes payable		—			6,000
Payment of issuance costs associated with the issuance of convertible notes payable		—			(142	)
Proceeds from the issuance of common stock in connection with equity plans		—			25
Net cash (used in) provided by financing activities		(77	)		5,883
Net decrease in cash and cash equivalents		(40,430	)		(21,917	)
Cash and cash equivalents, beginning of period		110,761			29,876
Cash and cash equivalents, end of period	$	70,331		$	7,959
Supplemental cash flow information:
Interest paid	$	—		$	—
Supplemental disclosure of noncash investing activities:
Purchases of property and equipment in accounts payable	$	3		$	—

The accompanying notes are an integral part of these condensed consolidated financial statements.

ONKURE THERAPEUTICS, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Organization and Business

OnKure Therapeutics, Inc. (“OnKure” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, OnKure is committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer. The Company was formed in 2014 as Reneo Pharmaceuticals, Inc. (“Reneo”) under the laws of the State of Delaware. On October 4, 2024, the Company changed its name to OnKure Therapeutics, Inc.

Merger with Reneo

On October 4, 2024, Radiate Merger Sub I, Inc. (“Merger Sub I”) a wholly-owned subsidiary of Reneo completed its merger with and into OnKure, Inc. (referred to herein as “Legacy OnKure”), with Legacy OnKure continuing as the surviving entity as a wholly-owned subsidiary of Reneo. This transaction is referred to as the “Merger.” Following the Merger, Reneo changed its name to OnKure Therapeutics, Inc. Legacy OnKure remains as a wholly-owned subsidiary of the Company, and, together with the Company, is referred to as the “Combined Company” below. The Merger was effected pursuant to an Agreement and Plan of Merger, dated as of May 10, 2024 (the “Merger Agreement”), by and among Reneo, Radiate Merger Sub I, Inc., a Delaware corporation Radiate Merger Sub II, LLC, a Delaware limited liability company (“Merger Sub II”), and Legacy OnKure. In connection with the Merger Agreement, certain parties entered into a subscription agreement with the Company to purchase shares of Reneo’s common stock for an aggregate purchase price of $65.0 million contingent upon the concurrent consummation of the Merger (the “Concurrent Financing”). On October 4, 2024 (the “Closing Date”), the Merger and the Concurrent Financing closed.

The Merger was accounted for as a reverse recapitalization in accordance with accounting principles generally accepted in the United States of America (“GAAP”). For accounting purposes, Legacy OnKure is considered the accounting acquirer and Reneo is the acquired company based on the terms of the Merger Agreement and other factors, such as relative voting rights and the composition of the Company’s board of directors and senior management. Accordingly, the Merger was treated as the equivalent of Legacy OnKure issuing stock to acquire the net assets of Reneo. As a result of the Merger, the net assets of Reneo were recorded at their acquisition-date fair value in the financial statements of the Combined Company and the reported operating results prior to the Merger are those of Legacy OnKure. Legacy OnKure’s historical financial statements became the historical consolidated financial statements of the Combined Company. All issued and outstanding Legacy OnKure common stock, convertible preferred stock, restricted stock units, and options to purchase common stock prior to the effective date of the Merger have been retroactively adjusted to reflect the exchange ratio for all periods presented.

See Note 3 for further discussion.

Risks and Uncertainties

The board of directors of the Company (the “Board”) discusses with management macroeconomic and geopolitical developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, international conflicts, cybersecurity, tariffs, and sanctions so that the Company can be prepared to react to new developments as they arise. The Board and the management of the Company are carefully monitoring these developments and the resulting economic impact on the Company’s financial condition and results of operations.

Liquidity

The Company had recurring losses from operations, an accumulated deficit of $200.7 million and cash and cash equivalents of $70.3 million as of September 30, 2025. The Company’s ability to fund its ongoing operations is

highly dependent upon raising additional capital through the issuance of equity securities, issuing debt or other financing vehicles.

The Company’s ability to secure capital depends on its success in discovering and developing its drug candidates. The Company cannot provide assurance that additional capital will be available on acceptable terms, if at all. The issuance of additional equity or debt securities will likely result in substantial dilution to the Company’s stockholders. Should additional capital not be available to the Company in the near term, or not be available on acceptable terms, the Company will be required to modify its operational plans and may be unable to realize value from its assets or discharge its liabilities in the normal course of business, which may, among other alternatives, cause the Company to delay, substantially reduce, or discontinue operational activities to conserve cash, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. Changing circumstances, including due to macroeconomic and geopolitical effects outside of the Company’s control, may cause the Company to consume capital significantly faster or slower than currently anticipated. The estimates included herein are based on assumptions that may prove to be wrong, and the Company could exhaust its available financial resources sooner than currently anticipated.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Management believes the Company’s cash and cash equivalents will be sufficient to fund its current operating plan for at least the next 12 months from the date of issuance of these condensed consolidated financial statements.

2. Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The unaudited Condensed Consolidated Financial Statements of the Company have been prepared in accordance with GAAP for interim financial information and with the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, since they are interim statements, they do not include all of the information and notes required by GAAP for complete consolidated financial statements. The Company’s consolidated financial statements reflect the operation of the Company and its wholly owned subsidiary OnKure, Inc. All intercompany balances and transactions among the consolidated entities have been eliminated in consolidation. See Notes 1 and 3 for further discussion.

In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Results of operations and cash flows for the interim periods presented herein are not necessarily indicative of the results that would be achieved during a full year of operations or in future periods. These unaudited Condensed Consolidated Financial Statements and notes thereto should be read in conjunction with the Consolidated Financial Statements and notes thereto included in the Company’s Form 10-K.

Segment Information

The Company operates in one operating segment: clinical research. All equipment and other property and equipment are physically located within the United States. As a result of the adoption of ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, the Company has presented the three and nine months ended September 30, 2024 amounts consistent with the corresponding 2025 period presentation.

Use of Estimates

The preparation of the Company’s consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates. The most significant estimates relate to the accrual of external research and development expenses, and the fair value of stock options and restricted stock units.

Comprehensive Loss

Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company’s comprehensive loss was the same as its reported net loss for all periods presented.

Research and Development Expenses

Research and development (“R&D”) costs are expensed as incurred in performing research and development activities. The costs include employee-related expense, including salaries, severance, benefits, share-based compensation, costs of research and development activities conducted by third parties on the Company’s behalf, costs to have clinical trial materials manufactured, fees for acquiring and maintaining licenses under third-party license agreements, consulting fees, depreciation, and facilities and overhead costs.

Accrued Research and Development Expenses

The Company records research and development expenses in the period in which it receives or takes ownership of the applicable goods or when the applicable services are performed. The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants, and contract research organizations, in connection with conducting research and development activities. The financial terms of these contracts are subject to negotiations, vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company reflects research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its preclinical studies or clinical trials, as measured by the timing of various aspects of the study or related activities. The Company determines accrual estimates through a review of the underlying contracts along with the preparation of financial models considering discussions with research and other key personnel as to the progress of studies, trials, or other services being conducted. During a study or trial, the Company adjusts its rate of expense recognition if actual results differ from its estimates. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as an expense in the period that the related goods are consumed, or services are performed.

Share-Based Compensation

The Company maintains an equity incentive compensation plan under which incentive stock options and nonqualified stock options to purchase common stock, and restricted stock units for common stock, are granted to employees, board of directors, and non-employee consultants. Stock-based compensation cost is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite service or performance period. The fair value of stock options granted to employees is estimated using the Black-Scholes option pricing model.

The Black-Scholes valuation method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend. Options granted have a maximum contractual term of 10 years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the arithmetic average of the original contractual term of the stock option and its weighted-average vesting term. The expected volatility of stock options is based on the historical volatility of several publicly traded companies in similar stages of clinical development. The Company will continue to apply this process until enough historical information regarding the volatility of its stock price becomes available. The risk-free interest rates used are based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the stock options. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future, and therefore has estimated the dividend yield to be zero. (See Note 10).

The Company recognizes stock-based compensation expense for grants under its various equity incentive plans and employee stock purchase plan. The Company accounts for all stock-based awards granted to employees and directors at their fair value and recognizes compensation expense over the award’s vesting period. Determining the amount of stock-based compensation to be recorded requires the Company to develop estimates of fair values of stock options as of the grant date. The Company calculates the grant date fair values of stock options using the Black-Scholes valuation model, which requires the input of subjective assumptions, including but not limited to expected stock price volatility over the term of the awards and the expected term of stock options. The fair value of restricted stock awards granted to employees is based on the quoted closing market price per share on grant date.

Fair Value of Financial Instruments

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values.

The carrying amounts of the Company’s financial assets and liabilities, such as cash, receivables, prepaid and other current assets, accounts payable, and accrued expenses approximate their fair values because of the short maturity of these instruments.

Cash and Cash Equivalents

All highly liquid investments with maturities of 90 days or less, at the time of purchase, are classified as cash equivalents. Cash equivalents are reported at cost, which approximates fair value. The Company’s cash and cash equivalents consist of money held in demand depository accounts and money market funds. The carrying amount of cash and cash equivalents was $70.3 million and $110.8 million as of September 30, 2025 and December 31, 2024, respectively, which approximates fair value and was determined based upon Level 1 inputs. The money market account is valued using quoted market prices with no valuation adjustments applied and is categorized as Level 1.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains accounts in federally insured financial institutions. At times, amounts held in federally insured accounts are above the federally insured limit of $250,000. Management believes the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which these deposits are held and of the money market funds in which these investments are made.

Leasing – Lessee Accounting

The Company determines if an arrangement is a lease at inception. The Company’s operating lease agreements are primarily for office space and research labs.

For operating leases with a term greater than one year, the Company recognizes the right-of-use (“ROU”) assets and lease liabilities related to the lease payments on its balance sheet. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. The ROU assets represent the Company’s right to use the underlying assets for the term of the lease and the lease liabilities represent the Company’s obligation to make lease payments arising for the agreements. ROU assets are initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. The ROU asset is periodically reviewed for impairment unless a triggering event occurs. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Variable lease payments, except for the ones that depend on index or rate, are excluded from the calculation of the ROU assets and lease liabilities and are recognized as variable lease expense in the statements of operations and comprehensive loss in the period in which they are incurred. Sublease inflows are netted against the respective lease outflows.

As the interest rate implicit in the Company’s leases is not readily determinable, the Company uses its estimated incremental borrowing rate in its present value calculations. One of the Company’s lessee agreements include an option to extend the lease, which the Company does not include in its minimum lease term unless it is reasonably certain to exercise such option. Operating leases with a term of less than one year are recognized as a lease expense over the term of the lease, with no asset or liability recognized on the balance sheet.

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. The requirements of the ASU are effective for annual periods beginning after December 15, 2024, with early adoption permitted. This ASU may be applied either prospectively or retrospectively. The Company is currently evaluating the impact of this pronouncement and will apply ASU 2023-09 to its annual tax disclosures for the fiscal year ended December 31, 2025.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires more detailed disclosures, on an annual and interim basis, about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. This ASU may be applied either prospectively or retrospectively. The Company is currently evaluating the impact of this pronouncement.

The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe any accounting pronouncements issued through the date of this report will have a material impact on its financial statements.

3. Merger Agreement and Concurrent Financing

As described in Note 1, Merger Sub I merged with and into Legacy OnKure, with Legacy OnKure surviving as a wholly owned subsidiary of the Company on October 4, 2024.

At the Closing, each then-outstanding share of Legacy OnKure common stock was converted into the right to receive 0.023596 shares of common stock of Reneo based on an exchange ratio (the “Common Exchange Ratio”), which was reclassified as Class A Common Stock in connection with the Merger, and each then-outstanding share of Legacy OnKure preferred stock was converted into the right to receive 0.144794 shares of Class A Common Stock based on an exchange ratio (the “Preferred Exchange Ratio”); provided that one holder of Legacy OnKure preferred stock elected to receive 686,527 shares that it would otherwise have received in the form of Class A Common Stock in an equal number of shares of Class B Common Stock. Upon the closing of the Merger, (i) an aggregate of 6,470,281 shares of Class A Common Stock and 686,527 shares of Class B Common Stock of the Company were issued in exchange for the shares of Legacy OnKure capital stock outstanding as of immediately prior to the Closing and (ii) outstanding shares of Reneo common stock were reclassified into an aggregate of approximately 3,343,604 shares of Class A Common Stock.

In connection with the Merger Agreement, Reneo entered into a subscription agreement with certain investors, pursuant to which the investors subscribed for and purchased, concurrent with the closing of the Merger, an aggregate of 2,839,005 shares of Class A Common Stock at a price of approximately $22.895 per share for aggregate gross proceeds of approximately $65.0 million, including the conversion of previously funded Convertible Promissory Notes principal of $6.0 million and accrued interest thereon of $120 thousand, on October 4, 2024.

At the effective time of the Merger, the authorized shares of Class A Common Stock of the Company were 200,000,000 with par value of $0.0001, and Class B Common Stock of the Company were 10,000,000 with par value of $0.0001.

The Merger was accounted for as a reverse recapitalization in accordance with GAAP, with Legacy OnKure as the accounting acquirer of Reneo. Legacy OnKure was determined to be the accounting acquirer based on the terms of the Merger Agreement and other factors, such as relative voting rights and the composition of the Company’s board of directors and senior management.

As a result, Legacy OnKure’s historical financial statements became the historical consolidated financial statements of the Combined Company for accounting purposes together with a deemed issuance of shares, equivalent to the shares held by the former stockholders Reneo, the legal acquirer, and a recapitalization of the

equity of Legacy OnKure, the accounting acquirer. The final transaction amounts have been recorded as a reduction of proceeds in stockholders’ equity.

At the effective time of the Merger, the net assets of Reneo were recorded at their acquisition-date fair value in the financial statements of the Combined Company, which approximated book value due to the short-term nature. Reneo’s development programs had ceased prior to the Merger and were deemed to be de minimis in value at the transaction date. No goodwill or intangible assets were recognized.

As part of the recapitalization, excluding the Concurrent Financing, the Company acquired the assets and liabilities listed below (in thousands):


	Amount
Cash and cash equivalents	$	57,736
Short-term investments		15,979
Other current assets		690
Other assets		553
Accrued expenses		(9,072	)
Long-term operating lease liability		(387	)
Net assets acquired	$	65,499

4. Segment

The Company is a publicly listed company focused on the development of clinical and pre-clinical product candidates with a single reportable segment: clinical research. Before adopting the ASU, because the Company has one reportable segment, it provided only the entity-wide disclosures required by ASC 280. The accounting policies of the clinical research segment are the same as those described in the summary of significant accounting policies.

The Company has yet to generate revenue and anticipates substantial expenses and operating losses as it advances its product candidates through clinical trials and regulatory processes.

The Chief Operating Decision Maker (“CODM”) assesses financial performance primarily using operating expenses as reported on the statement of operations, supplemented by internal budget and forecast models to guide resource allocation and performance evaluation. Segment assets are reported as total assets on the Company’s consolidated balance sheet, and segment loss is reflected as net loss in the Company’s consolidated statements of operations and comprehensive loss, effectively mirroring the Company’s overall financial position due to its single-segment structure. The Company does not have intra-entity sales or transfers.

The Company’s CODM is the senior executive committee that is comprised of the Chief Executive Officer and the Chief Financial Officer.


	Clinical Research Segment
	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2025			2024			2025			2024

	(in thousands)
Operating expenses:
Direct program expense	$	6,824		$	6,906		$	22,187		$	17,939
Indirect program expense		459			520			1,417			1,562
Workforce salaries and benefits		4,202			3,457			12,952			10,645
Share-based compensation expense		2,961			77			8,614			1,997
General corporate expenses		1,055			552			3,655			3,544
Interest and other expense		2			218			2			243
Segment net loss		15,503			11,730			48,827			35,930
Reconciliation of loss:
Interest income		(804	)		(174	)		(2,813	)		(699	)
Adjustments and reconciling items		(804	)		(174	)		(2,813	)		(699	)
Net loss	$	14,699		$	11,556		$	46,014		$	35,231

5. Leases

The Company’s headquarters are located in Boulder, Colorado, where it leases 14,790 square feet of office and lab facilities under operating leases that expire in December 2026, with rights to extend for a five-year period. In the Merger with Reneo, the Company assumed the lease in Irvine, California, where it leases office space under a lease agreement that expires in November 2026 (the “Irvine lease”). In January 2025, the Company entered into a sublease on the Irvine lease for all of the leased square footage, which expires in November 2026. Payments under the sublease for the three and nine months ended September 30, 2025 were $59 thousand and $172 thousand and were netted against operating lease costs in the Statement of Operations.

Right-of-use assets and lease liabilities for operating leases as included in the Company’s financial statements are as follows (in thousands):


	September 30, 2025		December 31, 2024
Operating lease right-of-use assets	$	485	$	770
Current operating lease liabilities		567		536
Noncurrent operating lease liabilities		120		549
Total lease liabilities	$	687	$	1,085

Lease expense for operating leases, net of sublease receipts, as included in the Company’s financial statements are as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Operating lease cost	$	46	$	44	$	142	$	131
Variable lease expense		44		47		118		140

Lease term, discount rates, and additional information for operating leases are as follows (in thousands):


	As of September 30,
	2025			2024
Weighted-average remaining lease term - operating leases (years)	1.16			2.25
Weighted-average discount rate - operating leases		4.5	%		4.5	%
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	427		$	154

The aggregate maturities of the Company’s operating lease liabilities were as follows as of September 30, 2025 (in thousands):


Remaining in 2025	$	145
2026		560
Total future minimum lease payments		705
Less: imputed interest		(18	)
Less: current portion		(567	)
Operating lease liability, net of current portion	$	120

6. Net Loss Per Share

The Company computes basic loss per share by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share assumes the conversion, exercise, or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock shares to be issued upon if-converted method for the convertible Series C Preferred Stock, exercise of all outstanding stock options and restricted stock units were excluded from the diluted net loss per share calculation for the nine months ended September 30, 2024 because such shares are anti-dilutive. Common stock shares to be issued upon exercise of all outstanding stock options and restricted stock units were excluded from the diluted net loss per share calculation for the nine months ended September 30, 2025 because such shares are anti-dilutive.

Anti-dilutive securities outstanding during the period not included in the diluted net loss per share calculation include the following:


	September 30,
	2025		2024
Outstanding common stock options		2,763,057		195,228
Unvested restricted stock units		51,415		213,276
		2,814,472		408,504

7. Fair Value Measurements

ASC Topic 820, Fair Value Measurement, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing an asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

ASC Topic 820 identifies fair value as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes between the following:

•

Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities.

•

Level 2 – Inputs, other than quoted prices in active markets, which are observable for the asset or liability, either directly or indirectly.

•

Level 3 – Unobservable inputs in which there is little or no market data, which requires the Company to develop its own assumptions.

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company’s financial assets are subject to fair value measurements on a recurring basis.

The Company categorizes its money market funds as Level 1, using the quoted prices in active markets. The fair value of the Company’s investments in certain money market funds is their face value and such instruments are classified as Level 1 and are included in cash and cash equivalents on the consolidated balance sheets.

No assets or liabilities were transferred into or out of their classifications during the nine months ended September 30, 2025 and 2024.

As part of the Merger, the Company acquired, and disposed of shortly thereafter, certain short-term investments in debt securities that were carried at fair value and classified as current assets available-for-sale and represented the investment of funds available for current operations. The Company had no available-for-sale securities as of September 30, 2025 or December 31, 2024.

8. Property and Equipment, Net

Property and equipment, net, consisted of the following (in thousands):


	September 30, 2025			December 31, 2024
Lab equipment	$	675		$	705
Leasehold improvements		1,090			1,090
Computer hardware and software		163			189
Furniture and fixtures		152			160
Property and equipment, gross		2,080			2,144
Less: accumulated depreciation and amortization		(1,360	)		(1,119	)
Property and equipment, net	$	720		$	1,025

Depreciation and amortization expense for the three and nine months ended September 30, 2025 was $108,000 and $343,000, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2024 was $114,000 and $343,000, respectively.

9. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	September 30, 2025		December 31, 2024
Accrued compensation and ESPP contributions	$	2,978	$	3,173
Accrued contract manufacturing costs		72		1,565
Accrued clinical trial costs		123		1,302
Accrued other		1,217		986
Total accrued expenses and other current liabilities	$	4,390	$	7,026

Accrued compensation includes severance costs. For further information see Note 12.

10. Share-Based Compensation

Stock Options

A summary of the Company’s stock option activity and related information is as follows:


	Options Outstanding
	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Options outstanding - December 31, 2024		2,393,824		$	23.54		7.90	$	1
Granted		774,800			4.98
Exercised		—			—
Expired		(405,567	)		42.88
Forfeited		—			—
Options outstanding - September 30, 2025		2,763,057		$	15.50		8.84	$	15
Options exercisable - September 30, 2025		839,941		$	19.94		8.24	$	—

All outstanding options as of September 30, 2025 are expected to vest.

The aggregate intrinsic value is calculated as the difference between the exercise price and the estimated fair value of the Company’s common stock as of September 30, 2025.

The Company granted 8,449 performance-based shares, which are included in the table above, during the year ended December 31, 2023. There was no performance-based compensation expense for the nine months ended September 30, 2025. The Company recognized $0 and $30,000 in performance-based compensation expense for the three and nine months ended September 30, 2024.

The Company estimates stock awards fair value on the date of grant using the Black-Scholes valuation, with the vesting being subject to service requirements. The Company accounts for forfeitures when they occur.

Restricted Stock Units (RSUs)

RSUs vest based on a service requirement and a liquidity event plus service requirement. The following table summarizes RSU activities during the nine months ended September 30, 2025:



	Number of Shares			Weighted Average Grant Date Fair Value
Unvested balance as of December 31, 2024		213,254		$	22.88
Granted		26,724			2.95
Vested and released		(188,563	)		20.06
Forfeited		—			—
RSUs outstanding - September 30, 2025		51,415		$	22.89
Unvested balance as of September 30, 2025		51,415		$	22.89

During the three months ended March 31, 2025, 4,481 shares were used to settle grantee's tax withholding obligations for vesting of restricted stock units.

In addition to the RSUs in the table above, in connection with the Merger, the Company assumed 24,700 RSUs which were fully vested at the time of the Merger. The RSUs were releasable upon set timeframes after completion of the Merger. The 17,000 RSUs that were unreleased as of December 31, 2024 were released in January 2025.

2024 Employee Stock Purchase Plan

In October 2024, the Board adopted the 2024 Employee Stock Purchase Plan (the “2024 ESPP”), which became effective immediately upon completion of the Merger. As of September 30, 2025, no shares have been issued under the 2024 ESPP. The Company recorded $62,000 and $117,000 of share-based compensation expense during the three and nine months ended September 30, 2025 related to the 2024 ESPP, which is reflected in the Share-Based Compensation Expense table below.

Share-Based Compensation Expense

The following table shows the allocation of share-based compensation expense related to the Company’s share-based awards (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Research and development	$	1,431	$	31	$	4,158	$	1,586
General and administrative		1,530		46		4,456		411
Total	$	2,961	$	77	$	8,614	$	1,997

There were no modifications during the nine months ended September 30, 2025. The Company recorded accelerated share-based compensation expenses related to modifications of RSUs under certain separation agreements of $40 thousand and $1.7 million during the three and nine months ended September 30, 2024, respectively, which is reflected in the above table. See Note 12 for further discussion on severance.

11. Income Taxes

In accordance with GAAP, a valuation allowance should be provided if it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Due to the uncertainty of future profitable operations and taxable income, the Company has recorded a full valuation allowance against its net deferred tax assets. The Company believes its tax filing positions and deductions related to tax periods subject to examination will be sustained upon audit and, therefore, has no reserve for uncertain tax positions.

On July 4, 2025, the One Big Beautiful Bill Act was signed into law in the United States, which contains a broad range of tax reform provisions affecting businesses. The Company is evaluating the full effects of the legislation on its estimated annual effective tax rate, but it expects that the legislation will likely not have a material impact on the consolidated financial statements given its full valuation allowance against its net deferred tax assets.

12. Commitments and Contingencies

Legal Proceedings

Merger Proceedings

In connection with the Merger, two complaints were filed in the Supreme Court of the State of New York, County of New York, captioned Thomas v. Reneo Pharmaceuticals, Inc., et al., Index No. 654628/2024 (filed September 5, 2024) and Kent v. Reneo Pharmaceuticals, Inc., et al., Index No. 654642/2024 (filed September 6, 2024) (together, the “Complaints”). The Complaints generally allege that the Proxy Statement/Prospectus filed by Reneo with the SEC misrepresented and/or omitted certain purportedly material information relating to Reneo management’s financial projections for Reneo and OnKure, the data and inputs underlying the financial valuation analyses that support the fairness opinion provided by Leerink Partners, Reneo’s financial advisor, and potential conflicts of interest with Leerink Partners LLC, Evercore Group L.L.C., and LifeSci Capital LLC, which were the

placements agents for the Concurrent Financing that closed concurrently with the Merger. The Complaints assert violations of negligent misrepresentation and concealment in violation of New York common law and negligence in violation of New York common law. The Complaints sought orders enjoining the proposed Merger, or in the event that the Merger was consummated, orders rescinding the Merger or awarding actual and punitive damages, as well as all of the plaintiffs’ fees and expenses in connection with the litigation, including reasonable attorneys’ and experts’ fees and expenses.

We cannot predict the outcome of the Complaints or any other litigation that might be filed arising out of the Merger or the Concurrent Financing. The Company and the individual defendants intend to vigorously defend against the Complaints and any subsequently filed, similar actions. It is possible additional lawsuits may be filed arising out of the Merger or the Concurrent Financing. Absent new or significantly different allegations, the Company will not necessarily disclose such additional filings.

From time-to-time in the future, the Company could be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business, which may have a material adverse effect on the Company’s consolidated results of operations or financial position.

Indemnification

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with its officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs because of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its financial statements as of September 30, 2025.

Severance

A former officer of the Company terminated his employment with the Company on May 24, 2024 and entered into a separation agreement and release on that date. The separation agreement and release provides for payments and benefits including continuing payments of base salary for a period of 14 months following termination of employment, payment for or reimbursement for COBRA premiums for up to 14 months following termination of employment, a full accelerated vesting of his equity awards and extension of the post-termination exercise period applicable to his Options through the earlier of 12 months following termination of service or the applicable option expiration date. As of September 30, 2025 and December 31, 2024, $0 and $326,000, respectively, remained unpaid and was included in accrued compensation. The related RSU shares were released in January 2025. No expense was recorded for these severance benefits for the three or nine months ended September 30, 2025. During the three months ended June 30, 2024, the Company recorded an expense of $622,000 for these severance benefits in research and development expense. See Note 10 for discussion of stock-based compensation recorded for the modifications of equity awards discussed above.

Certain Reneo employees became employees of the Company to assist with the Merger transition through December 31, 2024 at which time they were terminated and received severance benefits in accordance with the Reneo severance agreements. As of September 30, 2025, the December 31, 2024 balance of $154,000 was fully paid. No expense was recorded for these severance benefits for the three or nine months ended September 30, 2025 or 2024.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Legacy OnKure’s audited financial statements and the related notes for the years ended December 31, 2024 and 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings. Unless otherwise indicated, all references in this Quarterly Report on Form 10-Q to “OnKure,” the “Company,” “we,” “our,” “us,” or similar terms refer to OnKure Therapeutics, Inc. and its subsidiaries after completion of the Merger. In addition, references to “Reneo” refer to the Company prior to the completion of the Merger.

Forward-Looking Statements

In addition to historical financial information, this discussion and analysis contains forward-looking statements based upon our current beliefs, estimates, plans, and expectations that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those contained in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” under Part II, Item 1A below. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “project,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” or the negative of these terms or other similar expressions.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

Overview

We are a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, we are committed to improving clinical outcomes for patients by building a robust pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer. By improving selectivity for the oncogenic and mutated form of these cancer-driver proteins, we aim to discover and develop drugs with improved safety and efficacy by sparing toxicity that arises from non-selective inhibition of the non-mutated (or wild-type) version of the protein. We work under the belief that inhibiting target proteins with specific mutations instead of wild-type variants should enable precise patient selection that will, in turn, improve the probability of clinical success. We designed our current product candidates utilizing disciplined medicinal chemistry, x-ray crystallography, and computational chemistry to inhibit specified mutated versions of PI3Kα, a key mediator in cancer growth signaling. Our lead product candidate, OKI-219, is a highly selective inhibitor of PI3KαH1047R that has a much smaller impact on PI3KαWT. We plan to initially focus on the development of OKI-219 in patients with advanced breast cancer of genetic subtypes that are (a) both HR+ and HER2-; and (b) HER2+. We believe we can potentially expand the application of OKI-219 by conducting appropriate clinical trials in earlier lines of treatment within breast cancer, other subtypes of breast cancer, and potentially in other solid tumors. OKI-219 is currently in a first-in-human Phase 1a/1b clinical trial.

Merger

On the Closing Date, Reneo consummated the previously announced Merger pursuant to the terms of the Merger Agreement, by and among Reneo, Merger Sub I, Merger Sub II, and Legacy OnKure.

Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo’s issued common stock at a ratio of 1:10, (ii) Reneo changed its name to “OnKure Therapeutics, Inc.”, (iii) Reneo reclassified all of its common stock as “Class A Common Stock” or “Class B Common Stock”, and (iv) Radiate Merger Sub I merged with and into Legacy OnKure, with Legacy OnKure as the surviving company in the Merger and, after giving effect to such Merger, Legacy OnKure becoming a wholly owned subsidiary of OnKure

Therapeutics, Inc.

Concurrently with the closing of the Merger, Reneo completed a private placement with certain investors (the “Concurrent Investors”) to purchase 2,839,005 shares of Common Stock at a price per share of approximately $22.895 per share for an aggregate purchase price of approximately $65.0 million, including the conversion of outstanding convertible notes and accrued but unpaid interest thereon held by certain Legacy OnKure investors (the “Concurrent Financing”). In connection with the Concurrent Financing, Reneo entered into a registration rights agreement with certain investors, pursuant to which Reneo agreed to use commercially reasonably efforts to prepare and file a registration statement with the SEC within 45 calendar days after the Closing Date, registering the resale of the shares of Common Stock issued pursuant to the Concurrent Financing, which was filed in October 2024. Immediately after the effective time of the Merger, following the consummation of the Concurrent Financing, shares received by Legacy OnKure stockholders represented approximately 53.6%, pre-Merger Reneo shares outstanding represented approximately 25.1%, and the shares purchased in the Concurrent Financing represented approximately 21.3% of our outstanding Common Stock.

As of the open of trading on October 7, 2024, our Common Stock began trading on Nasdaq under the symbol “OKUR.”

Macroeconomic and Geopolitical Considerations

Our business and operations may be negatively affected by macroeconomic, geopolitical, and regulatory developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, international conflicts, cybersecurity, tariffs, sanctions, export controls, government policy positions, and changes in regulatory agencies with oversight of our operations. These developments could affect our supply chain, manufacturing processes, regulatory compliance costs, regulatory approval timelines, and cross-border operations. Further, it is possible that U.S. and non-U.S. government policy changes and related uncertainty about policy changes could increase market volatility and our operating expenses. The extent, severity, and duration of the impacts of these events and conditions on our business cannot be predicted and may not be fully reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy worsens, our business, financial condition, and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events and conditions on our business, financial condition, and operating results, see the section titled “Risk Factors” included in this Quarterly Report.

Financial Overview

Since our inception, our operations have primarily focused on raising capital, establishing and protecting our intellectual property portfolio, organizing and staffing our company, business planning, and conducting preclinical and clinical development of and manufacturing development for our product candidates. We do not have any product candidates approved for sale, have not generated any revenue from product sales, and do not expect to generate revenues from the commercial sale of any products for the foreseeable future, if ever. Since inception, we have incurred significant operating losses. Our net losses were $46.0 million and $52.7 million for the nine months ended September 30, 2025 and the year ended December 31, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $200.7 million and cash and cash equivalents of $70.3 million.

We have funded our operations primarily through private placements of our common stock and preferred stock and issuance of convertible debt. As of September 30, 2025, we believe our cash resources are sufficient to fund our planned operations for at least the next 12 months from the date of issuance of these financial statements.

Components of Our Results of Operations

Operating Expenses

Research and Development Expenses

Research and development expenses primarily relate to expenses incurred in connection with the discovery and development of our product candidates.

Research and development expenses include:

•

employee-related expenses, including salaries, severance, retention, benefits, insurance, and share-based compensation expense;

•

expenses incurred under agreements with CROs, which are investigative sites that conduct our clinical trials, other clinical trial-related vendors, and clinical consultants;

•

the costs of acquiring, developing, and manufacturing and testing clinical and preclinical materials, including costs incurred under agreements with CMOs;

•

costs associated with non-clinical activities and regulatory operations; and

•

facilities, depreciation, market research, and other expenses, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, and laboratory supplies.

We make non-refundable advance payments for goods and services that will be used in future research and development activities. These payments are recorded as expenses in the period in which we receive or take ownership of the goods or when the services are performed. At any one time, we are working on multiple research or drug discovery programs and internal resources. Employees and infrastructure are not directly tied to any one program and are typically deployed across multiple programs; therefore, we do not track our research and development expenses on a program-specific basis.

Conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming. As we initiate new clinical trials, our research and development expenses may increase. Product candidates in later stages of development generally have higher development costs than those in earlier stages. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates, undertake activities to expand, maintain, protect, and enforce our intellectual property portfolio, and hire additional research and development personnel.

Successful development of product candidates is highly uncertain and may not result in approved products. The probability of success for each product candidate may be affected by numerous factors, including clinical data, preclinical data, competition, manufacturability, and commercial viability. Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. We anticipate that we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to our ability to enter strategic alliances with respect to each program or product candidate, the scientific and clinical success of each product candidate, and ongoing assessments as to each product candidate’s commercial potential. We will need to raise additional capital and may seek strategic alliances in the future to advance our various programs.

General and Administrative

General and administrative expenses consist primarily of salaries, bonuses and related benefits, share-based compensation, and severance and retention benefits related to our executive, finance, and administrative functions, professional fees for auditing, tax, consulting, and legal services, as well as insurance, board of director compensation, consulting, and other administrative expenses. We recognize general and administrative expenses in the periods in which they are incurred.

We expect that our general and administrative expenses will increase over the next several years as we hire additional personnel to support the growth of our business. In addition, we will incur significant additional expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.

Other Income

Interest Income

Interest income primarily consists of interest income generated from our cash equivalents in interest-bearing money market accounts.

Interest Expense

Interest expense consists primarily of interest expense generated from our convertible notes payable, which were issued in 2024 and converted at the time of the Merger in 2024.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the periods indicated:


	Three Months Ended
	September 30,
	2025			2024			$ Change
	(in thousands)
Operating expenses:
Research and development	$	11,915		$	10,116		$	1,799
General and administrative		3,586			1,396			2,190
Total operating expenses		15,501			11,512			3,989
Loss from operations		(15,501	)		(11,512	)		(3,989	)
Other income:
Interest income		804			174			630
Interest and other expense		(2	)		(218	)		216
Total other income and (expense)		802			(44	)		846
Net loss and comprehensive loss	$	(14,699	)	$	(11,556	)	$	(3,143	)

Research and Development Expenses

Research and development expenses were $11.9 million for the three months ended September 30, 2025 compared to $10.1 million for the three months ended September 30, 2024. The increase of approximately $1.8 million was primarily due to a $1.9 million increase in personnel-related costs, including $1.3 million of increased share-based compensation charges.

General and Administrative Expenses

General and administrative expenses were $3.6 million for the three months ended September 30, 2025 compared to $1.4 million for the three months ended September 30, 2024. The increase of approximately $2.2 million was primarily due to $1.5 million in increased personnel-related costs, including $1.3 million of increased share-based compensation charges. In addition, director compensation, consulting, filing fees and franchise taxes and other professional service fees, including audit fees and insurance, increased by $0.5 million.

Other Income (Expense)

Other income (expense), net was $0.8 million for the three months ended September 30, 2025 compared to $0.1 million for the three months ended September 30, 2024. The change was primarily due to an increase in interest income due to an increase in cash and cash equivalents available to invest during the quarter ended September 30, 2025 as compared to the quarter ended September 30, 2024.

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the periods indicated:


	Nine Months Ended
	September 30,
	2025

OnKure Therapeutics, Inc. 10-Q