RPHM Reneo Pharmaceuticals Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 07, 2024

 

 

OnKure Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-40315	47-2309515
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
6707 Winchester Circle, #400
Boulder, Colorado				80301
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 720 307-2892

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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

Title of each class		Trading Symbol(s)		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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

 

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Item 4.01 Changes in Registrant’s Certifying Accountant.

	(a)	Dismissal of Independent Registered Public Accounting Firm

On November 7, 2024, Ernst & Young LLP ("EY") was dismissed as the independent registered public accounting firm of OnKure Therapeutics, Inc. (formerly Reneo Pharmaceuticals, Inc.) (the "Company"). The decision to dismiss EY was approved by the Audit Committee of the Board of Directors (the “Audit Committee”).

The reports of EY on the consolidated financial statements of the Company for the fiscal years ended December 31, 2023 and 2022 did not contain an adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles, except that the 2022 audit report contained an explanatory paragraph regarding the Company’s ability to continue as a going concern.

During the Company’s two most recent fiscal years and the subsequent interim period through November 7, 2024, there were (i) no disagreements (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions thereto) with EY on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreement, if not resolved to the satisfaction of EY, would have caused it to make reference to the subject matter of the disagreement in connection with its report and (ii) no reportable events (as described in Item 304(a)(1)(v) of Regulation S-K).

The Company provided EY with a copy of the disclosures made in this Item 4.01 and requested EY to furnish the Company with a letter addressed to the SEC stating whether it agrees with the statements made by the Company and, if not, stating the respects in which it does not agree. A copy of EY’s letter to the SEC dated November 7, 2024 regarding these statements is filed as Exhibit 16.1 to this Current Report on Form 8-K.

	(b)	Appointment of New Independent Registered Public Accounting Firm

KPMG LLP (“KPMG”) served as the independent registered public accounting firm of Legacy OnKure prior to the consummation of the Merger. On November 7, 2024, the Audit Committee engaged KPMG as the independent registered public accounting firm of the Company.

During Legacy OnKure’s two most recent fiscal years and the subsequent period from January 1, 2024 to September 30, 2024, neither Legacy OnKure nor anyone on its behalf consulted KPMG regarding: (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on Legacy OnKure’s financial statements, and neither a written report nor oral advice was provided to Legacy OnKure that KPMG concluded was an important factor considered by Legacy OnKure in reaching a decision as to any accounting, auditing or financial reporting issue; or (ii) any matter that was the subject of a disagreement (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions thereto) or a reportable event (as described in Item 304(a)(1)(v) of Regulation S-K).

Item 8.01 Other Events.

On October 4, 2024 (the “Closing Date”), Reneo Pharmaceuticals, Inc., a Delaware Corporation and our predecessor ("Reneo") consummated the previously announced merger (the "Merger") 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").

 

On November 7, 2024, the Company filed its quarterly report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”). The Form 10-Q includes the unaudited interim financial statements of Reneo as of and for the period ended September 30, 2024 because the Merger was consummated after the period covered by the Form 10-Q. Accordingly, the Company is filing this Current Report on Form 8-K to include the (i) unaudited interim financial statements of Legacy OnKure as of and for the period ended September 30, 2024 and the notes related thereto (the “Legacy OnKure Interim Financial Statements”), (ii) management’s discussion and analysis of financial condition and results of operations of Legacy OnKure as of September 30, 2024 and for the nine months ended September 30, 2024 and 2023 (the “MD&A”), and (iii) unaudited pro forma condensed combined financial information of Reneo and Legacy OnKure as of September 30, 2024, for the nine months ended September 30, 2024 and for the year ended December 31, 2023 (the “Pro Forma Financials”). The Legacy OnKure Interim Financial Statements, MD&A, and Pro Forma Financials are attached hereto as Exhibits 99.1, 99.2 and 99.3, respectively, and incorporated by reference herein by reference.

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Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
15.1		Letter regarding Unaudited Interim Financial Information.
16.1		Letter from Ernst & Young, LLP dated November 7, 2024.
99.1		Unaudited interim financial statements of OnKure, Inc. as of and for the period ended September 30, 2024.
99.2		Management’s Discussion and Analysis of Financial Condition and Results of Operations of OnKure, Inc. for the three and nine months ended September 30, 2024.
99.3		Unaudited pro forma condensed combined financial information of Reneo Pharmaceuticals, Inc. and OnKure, Inc. as of September 30, 2024, for the nine months ended September 30, 2024 and for the year ended December 31, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			ONKURE THERAPEUTICS, INC.
Date:	November 7, 2024	By:	/s/ Jason Leverone
			Name: Jason Leverone Title: Chief Financial Officer

 

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November 7, 2024

 

OnKure, Inc.
Boulder, CO

Re: Form 8-K dated November 7, 2024

With respect to the subject current report, we acknowledge our awareness of the use therein of our report dated November 7, 2024 related to our review of interim financial information.

Pursuant to Rule 436 under the Securities Act of 1933 (the Act), such report is not considered part of a registration statement prepared or certified by an independent registered public accounting firm, or a report prepared or certified by an independent registered public accounting firm within the meaning of Sections 7 and 11 of the Act.

/s/ KPMG LLP

Denver, Colorado

 

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November 7, 2024

 

Securities and Exchange Commission

100 F Street, N.E.

Washington, DC 20549

 

Commissioners:

 

We have read Item 4.01 of Form 8-K dated November 7, 2024, of OnKure Therapeutics, Inc. (formerly Reneo Pharmaceuticals, Inc.) and are in agreement with the statements contained in the second through fourth paragraphs as reported under Item 4.01(a) therein. We have no basis to agree or disagree with other statements of the registrant contained therein.

 

/s/ Ernst & Young LLP

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INDEX TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

 

UNAUDITED CONDENSED FINANCIAL STATEMENTS:		Page
Independent Auditors' Review Report		2
Unaudited Balance Sheets as of September 30, 2024 and December 31, 2023		3
Unaudited Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023		4
Unaudited Statements of Changes in Convertible Preferred Stock and Stockholders’ Deficit for the Three and Nine Months Ended September 30, 2024 and 2023		5
Unaudited Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023		6
Notes to Unaudited Financial Statements		7

 

 

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Independent Auditors’ Review Report

Board of Directors and Stockholders
OnKure, Inc.:

Results of Review of Condensed Interim Financial Information

We have reviewed the financial statements of OnKure, Inc. (the Company), which comprise the balance sheetas of September 30, 2024, and the related statements of operations and comprehensive loss, changes in convertible preferred stock and stockholders’ deficit, and cash flows for the three- and nine-month periods ended September 30, 2024 and 2023, and the related notes (collectively referred to as the interim financial information).

Based on our reviews, we are not aware of any material modifications that should be made to the accompanying condensed interim financial information for it to be in accordance with U.S. generally accepted accounting principles.

Basis for Review Results

We conducted our reviews in accordance with auditing standards generally accepted in the United States of America (GAAS) applicable to reviews of interim financial information and in accordance with the auditing standards of the Public Company Accounting Oversight Board (United States) (PCAOB). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. A review of interim financial information is substantially less in scope than an audit conducted in accordance with GAAS and in accordance with the auditing standards of the PCAOB, the objective of which is an expression of an opinion regarding the financial information as a whole, and accordingly, we do not express such an opinion. We are required to be independent of the Company and to meet our other ethical responsibilities in accordance with the relevant ethical requirements relating to our reviews. We believe that the results of the review procedures provide a reasonable basis for our conclusion.

Responsibilities of Management for the Condensed Interim Financial Information

Management is responsible for the preparation and fair presentation of the interim financial information in accordance with U.S. generally accepted accounting principles and for the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of interim financial information that is free from material misstatement, whether due to fraud or error.

Report on Condensed Balance Sheet as of December 31, 2023

We have previously audited, in accordance with GAAS and in accordance with the auditing standards of the PCAOB, the balance sheet as of December 31, 2023, and the related statements of operations and comprehensive loss, changes in convertible preferred stock and stockholders’ deficit, and cash flows for the year then ended (not presented herein); and we expressed an unmodified audit opinion on those audited financial statements in our report dated May 13, 2024. In our opinion, the accompanying balance sheet of the Company as of December 31, 2023 is consistent, in all material respects, with the audited financial statements from which it has been derived.

/s/ KPMG LLP

Denver, Colorado
November 7, 2024

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ONKURE, INC.

BALANCE SHEETS

(in thousands, except share and per share data)

	September 30,				December 31,
	2024				2023
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	7,959			$	29,876
Prepaid expenses and other current assets		3,998				3,890
Total current assets		11,957				33,766
Property and equipment, net		1,126				1,432
Operating lease right-of-use asset		367				478
Other assets		58				58
Total assets	$	13,508			$	35,734
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable	$	8,191			$	3,417
Accrued expenses		3,920				3,660
Operating lease liabilities, current portion		220				208
Convertible notes payable, net of debt issuance costs		5,986				—
Other current liabilities		116				—
Total current liabilities		18,433				7,285
Operating lease liabilities, net of current portion		300				466
Total liabilities		18,733				7,751
Commitments and contingencies
Convertible preferred stock, Series C, $0.0001 par value;   51,141,064 shares authorized; 47,243,806 shares issued or   outstanding at September 30, 2024 and December 31, 2023;   liquidation preference of $195,823 as of September 30, 2024 and   December 31, 2023, respectively		129,825				129,825
Stockholders’ deficit:
Common stock, Class A, $0.0001 par value; 78,000,000 and   40,000,000 shares authorized; 13,401,523 and 13,296,584 shares issued and   outstanding at September 30, 2024 and December 31, 2023,   respectively		1				1
Common stock, Class B, $0.0001 par value; 9,589,983 shares   authorized; no shares issued and outstanding at September 30, 2024   and December 31, 2023		—				—
Additional paid-in capital		2,231				208
Accumulated deficit		(137,282	)			(102,051	)
Total stockholders’ deficit		(135,050	)			(101,842	)
Total liabilities, convertible preferred stock, and stockholders’ deficit	$	13,508			$	35,734

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

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ONKURE, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

	Three Months Ended								Nine Months Ended
	September 30,								September 30,
	2024				2023				2024				2023
	(in thousands, except share and per share amounts)
Operating expenses:
Research and development	$	10,116			$	8,253			$	29,434			$	23,290
General and administrative		1,396				1,403				6,253				3,752
Total operating expenses		11,512				9,656				35,687				27,042
Loss from operations		(11,512	)			(9,656	)			(35,687	)			(27,042	)
Other income and (expense):
Interest income		174				668				699				1,192
Interest and other expense		(218	)			(6	)			(243	)			(6	)
Total other income and (expense)		(44	)			662				456				1,186
Net loss and comprehensive loss	$	(11,556	)		$	(8,994	)		$	(35,231	)		$	(25,856	)
Net loss per share attributable to common stockholders:
Basic and diluted	$	(0.86	)		$	(0.68	)		$	(2.64	)		$	(2.22	)
Weighted average shares outstanding:
Basic and diluted		13,398,233				13,257,550				13,359,203				11,622,314

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

 

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ONKURE, INC

STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

(in thousands, except share information)

(Unaudited)

																			Additional								Total
			Convertible Preferred Stock								Common stock								Paid-In				Accumulated				Stockholders'
			Shares				Amount				Shares				Amount				Capital				Deficit				Deficit
Balance, December 31, 2023				47,243,806				$129,825				13,296,584			$	1			$	208			$	(102,051	)		$	(101,842	)
Issuance of Class A Common Stock for cash upon the exercise of stock options				—				—				42,476				—				10				—				10
Share-based compensation expense				—				—				—				—				107				—				107
Net loss				—				—				—				—				—				(9,536	)			(9,536	)
Balance, March 31, 2024				47,243,806				129,825				13,339,060				1				325				(111,587	)			(111,261	)
Issuance of Class A Common Stock for cash upon the exercise of stock options				—				—				47,898				—				10				—				10
Share-based compensation				—				—				—				—				1,813				—				1,813
Net loss				—				—				—				—				—				(14,139	)			(14,139	)
Balance, June 30, 2024				47,243,806				129,825				13,386,958				1				2,148				(125,726	)			(123,577	)
Issuance of Class A Common Stock for cash upon the exercise of stock options				—				—				14,565				—				6				—				6
Share-based compensation				—				—				—				—				77				—				77
Net loss				—				—				—				—				—				(11,556	)			(11,556	)
Balance, September 30, 2024				47,243,806			$	129,825				13,401,523			$	1			$	2,231			$	(137,282	)		$	(135,050	)

 

											Additional				Total
			Convertible Preferred Stock				Common stock				Paid-In		Accumulated		Stockholders'
			Shares		Amount		Shares		Amount		Capital		Deficit		Deficit
Balance, December 31, 2022			25,822,452		64,389		7,745,744		$1		$2,655		$(57,074)		$(54,418)
Issuance of Series C Preferred Stock under   a stock purchase agreement, net of   issuance costs of $0.7 million			19,463,456		53,068		—		—		—		—		—
Issuance of Class A Common Stock and   Series C Preferred Stock in exchange for   Series A, A-1, and Series B Preferred   Stock under a stock purchase agreement			1,957,898		12,376		5,402,428		—		(2,711)		(9,666)		(12,377)
Issuance of Class A Common Stock for   cash upon the exercise of stock options			—		—		96,666		—		41		—		41
Share-based compensation expense			—		—		—		—		15		—		15
Net loss			—		—		—		—		—		(8,679)		(8,679)
Balance, March 31, 2023			47,243,806		129,833		13,244,838		1		—		(75,419)		(75,418)
Issuance costs of Series C Preferred Stock			—		(8)		—		—		—		—		—
Issuance of Class A Common Stock for   cash upon the exercise of stock options			—		—		10,833		—		5		—		5
Share-based compensation			—		—		—		—		17		—		17
Net loss			—		—		—		—		—		(8,183)		(8,183)
Balance, June 30, 2023			47,243,806		129,825		13,255,671		1		22		(83,602)		(83,579)
Issuance of Class A Common Stock for   cash upon the exercise of stock options			—		—		17,286		—		65		—		65
Share-based compensation			—		—		—		—		8		—		8
Net loss			—		—		—		—		—		(8,994)		(8,994)
Balance, September 30, 2023			47,243,806		$129,825		13,272,957		$1		$95		$(92,596)		$(92,500)

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

 

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ONKURE, INC.

STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

	Nine Months Ended
	September 30,
	2024				2023
	(in thousands)
Cash flows from operating activities:
Net loss	$	(35,231	)		$	(25,856	)
Adjustments to reconcile net loss to net cash used    in operating activities:
Share-based compensation expense		1,997				97
Depreciation and amortization		343				304
Amortization of right-of-use asset - operating		111				131
Amortization of debt issuance costs		128				—
Change in operating assets and liabilities:
Prepaid and other assets		(108	)			(2,199	)
Accounts payable, accrued and other liabilities		5,151				154
Lease liabilities		(154	)			(157	)
Net cash used in operating activities		(27,763	)			(27,526	)
Cash flows from investing activities:
Purchases of property and equipment		(37	)			(213	)
Net cash used in investing activities		(37	)			(213	)
Cash flows from financing activities:
Proceeds from the sale of Series C Preferred Stock		—				53,783
Payment of issuance costs associated with the issuance of Series C   Preferred Stock		—				(724	)
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		25				56
Net cash provided by financing activities		5,883				53,115
Net increase (decrease) in cash and cash equivalents		(21,917	)			25,376
Cash and cash equivalents, beginning of year		29,876				11,543
Cash and cash equivalents, end of period	$	7,959			$	36,919
Supplemental cash flow information:
Interest paid	$	—			$	—
Supplemental disclosure of noncash financing transactions:
Issuance of Series C Preferred Stock on conversion of prior   Preferred Stock	$	—			$	23,313

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

 

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ONKURE, INC.

NOTES TO FINANCIAL STATEMENTS

(Unaudited)

(1) DESCRIPTION OF BUSINESS

OnKure, Inc., a Delaware corporation (Legacy 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, Legacy OnKure is 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.

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 Legacy OnKure. See Note 12 for further discussion.

Liquidity and Capital Resources

The Company had recurring losses from operations, an accumulated deficit of $137.3 million and cash and cash equivalents of $8.0 million as of September 30, 2024. 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.

As of December 31, 2023, the Company had determined that substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of the issuance of those financial statements did exist. However, following the completion of the Merger, as described in more detail in Note 12, management believes the Combined Company’s (as defined in Note 12) cash, cash equivalents and short-term investments will be sufficient to fund the Combined Company’s current operating plan for at least the next 12 months from the date of issuance of these unaudited condensed financial statements and as such substantial doubt is alleviated as of September 30, 2024.

The Company’s ability to secure capital is dependent upon 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 may be unable to realize value from the Company’s assets or discharge 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.

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.

Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on the Company’s financial condition and its ability to discover and develop its product candidates. Changing circumstances may cause the Company to consume capital significantly faster or slower than currently anticipated. If the Company is unable to acquire additional capital or resources, it will be required to modify its operational plans. 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 financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.

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(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The Company has prepared the accompanying unaudited financial statements in accordance with U.S. generally accepted accounting principles (GAAP). The Company recommends that these unaudited financial statements be read in conjunction with the audited financial statements and the notes thereto included in the Company’s audited financial statements for the year ended December 31, 2023.

In the opinion of management, all adjustments, including normal recurring adjustments, considered necessary for a fair presentation of the financial statements, have been included in the accompanying unaudited financial statements. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

Summary of Significant Accounting Policies

The significant accounting policies used in the preparation of these financial statements for the period ended September 30, 2024 are consistent with those discussed in Note 3 to the financial statements in the Legacy OnKure’s audited financial statements for the year ended December 31, 2023 and 2022 included in the proxy statement/prospectus (the Proxy Statement/Prospectus) filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the Securities Act), with the SEC on August 26, 2024.

Use of Estimates

The preparation of the financial statements in accordance with U.S. 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 external research and development expenses, and the fair value of stock options and restricted stock awards and units.

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 Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) Topic 820, Fair Value Measurements and Disclosures (ASC 820), establishes a hierarchy of inputs used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are those 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. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of financial instruments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:

Level 1 —Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2 —Valuations are based on quoted prices for similar assets or liabilities in active markets, or quoted prices in markets that are not active for which significant inputs are observable, either directly or indirectly. The Company had no Level 2 valuations for the periods ended September 30, 2024, or year ended December 31, 2023, respectively.

Level 3 —Valuations are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. Inputs reflect management’s best estimate of what market participants would use in valuing the asset or liability at the measurement date. The Company had no Level 3 valuations for the periods ended September 30, 2024, or year ended December 31, 2023, respectively.

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

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New Accounting Pronouncements

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to update reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. This update is effective beginning with the Company’s 2024 fiscal year annual reporting period, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its financial statements.

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, 2025 for emerging growth companies, with early adoption permitted. The Company is currently evaluating the impact of this pronouncement.

There were various accounting standards and interpretations issued recently, none of which are expected to have a material impact on the Company’s financial position, operations or cash flows. The Company is an emerging growth company, and as an emerging growth company, can adopt a new or revised standard at the time private companies adopt a new or revised standard.

(3) LEASES

The Company leases office and lab facilities in Boulder, Colorado under non-cancellable operating leases with rights to extend. 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, 2024 (Unaudited)				December 31, 2023
Operating lease right-of-use assets		$	367			$	478
Current operating lease liabilities			220				208
Noncurrent operating lease liabilities			300				466
Total lease liabilities		$	520			$	674

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

	Three Months Ended September 30,								Nine Months Ended September 30,
	2024				2023				2024				2023
Operating lease cost	$	44			$	45			$	131			$	130
Variable lease expense		47				47				140				130
Short-term lease expense		—				—				—				—

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

		As of September 30,
		2024				2023
Weighted-average remaining lease term - operating leases (years)		2.25				3.25
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		$	154			$	157

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The aggregate maturities of the Company’s operating lease liabilities were as follows as of September 30, 2024 (in thousands):

Remaining in 2024	$	59
2025		240
2026		247
Total future minimum lease payments		546
Less: imputed interest		(26	)
Less: Current portion		(220	)
Operating lease liability, net of current portion	$	300

(4) SHARE-BASED COMPENSATION

The Company had share-based compensation plans which are described below:

2011 Equity Incentive Plan

In October 2011, the Company established an equity incentive plan (the 2011 Plan). The 2011 Plan provides for the grant of stock options and restricted stock awards (RSA) to employees, non-employee directors, advisors, and consultants. The aggregate number of shares of common stock that may be issued under the 2011 Plan will not exceed 1,266,000 shares. Shares are no longer available for issuance under the 2011 Plan, which was subsequently terminated in March 2023.

2021 Equity Incentive Plan

In February 2021, the Company established an equity incentive plan (the 2021 Plan). The 2021 Plan provides for the grant of stock options and RSA to employees, non-employee directors, advisors, and consultants. The aggregate number of shares of common stock that may be issued under the 2021 Plan will not exceed 9,838,497 shares. Upon the closing of the Merger, all shares available for issuance under the 2021 Plan were cancelled. See Note 12 for discussion of the new equity plans adopted as part of the Merger.

2023 RSU Equity Incentive Plan

In September 2023, the Company established an equity incentive plan (the 2023 Plan). The 2023 Plan provides for the grant of restricted stock units (RSU) to employees, directors, and consultants. The aggregate number of shares of common stock that may be issued under the 2023 Plan will not exceed 2,000,000 shares. Upon the closing of the Merger, all shares available for issuance under the 2023 Plan were cancelled. See Note 12 for discussion of the new equity plans adopted as part of the Merger.

Stock Options

Options granted under the Company’s equity incentive plans have an exercise price equal to or in excess of the market value of the common stock at the date of grant and expire no more than 10 years from the date of grant. Generally, options vest 25% on the first anniversary of the vesting commencement date and 75% ratably in equal monthly installments over the remaining 36 months. Stock options granted to non-employees generally vest quarterly over two to three years.

As of September 30, 2024, there were 698,688 options available for issuance under the 2021 Plan, of which the Company is restricted from granting stock awards for 361,600 shares of its common stock under certain conditions.

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A summary of common stock option activity 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, 2023			7,197,551			$	0.40				8.88			$	16
Granted			854,795				0.33
Exercised			(104,939	)			0.24
Expired			(20,324	)			0.54
Forfeited			(11,414	)			0.42
Options outstanding - September 30, 2024			7,915,669			$	0.39				7.19			$	2
Options exercisable - September 30, 2024			4,658,957			$	0.41				6.13			$	2
Options vested and expected to vest -       September 30, 2024			7,726,169			$	0.39				7.15			$	2

As of September 30, 2024, the Company had unrecognized compensation cost for unvested stock options of $332,000, expected to be recognized over a weighted-average period of approximately 2.4 years.

From time to time, the Company grants performance-based stock options. As of September 30, 2024, the Company had granted 358,089 performance-based shares. The Company recognized $0 and $30,000 in performance-based compensation expense for the three and nine months ended September 30, 2024, respectively. No performance-based shares were outstanding as of September 30, 2024. No performance-based shares were granted and no performance-based expense was recognized for the three and nine months ended September 30, 2023. These performance-based stock options are not included in the table above.

Restricted Stock Awards and Restricted Stock Units

RSA typically vests 25% on the first anniversary of the issuance date and incrementally vest monthly for the three-year period thereafter. In the event of termination of services, all unvested shares are forfeited, and the Company has the option to purchase all outstanding vested shares at their fair market value.

RSU vests based on a service-based requirement and a liquidity event plus service requirement.

As of September 30, 2024, there were 527,040 restricted stock units available for issuance under the 2023 Plan. Upon the close of the Merger, all shares available for issuance under the 2023 Plan were cancelled. See Note 12 for discussion of the new equity plans adopted as part of the merger.

A summary of restricted stock awards and restricted stock units activity are as follows:

		Number of Shares				Weighted Average Grant Date Fair Value
Unvested balance as of December 31, 2023			1,481,122			$	2.76
Granted			—				—
Vested (RSA)			(4,407	)			0.12
Forfeited			(3,755	)			2.76
RSUs outstanding - September 30, 2024			1,472,960			$	2.76
Unvested balance as of September 30, 2024			950,841			$	2.76
Vested outstanding (RSU) as of      September 30, 2024			522,119			$	2.76

As of September 30, 2024, the Company had unrecognized compensation cost for unvested RSU awards of $2.5 million, expected to be recognized over a weighted-average period of approximately 2.5 years.

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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,
	2024				2023				2024				2023
Research and development	$	31			$	26			$	1,586			$	53
General and administrative		46				38				411				44
Total	$	77			$	64			$	1,997			$	97

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.

(5) NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS 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 exercise of all outstanding stock options and restricted stock units were excluded from the diluted net loss per share calculation for the three and nine months ended September 30, 2024 and 2023 because such shares are anti-dilutive.

Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:

	September 30,
	2024				2023
Outstanding stock options		8,273,758				2,991,710
Unvested restricted stock units		1,472,960				8,813
		9,746,718				3,000,523

(6) PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following (in thousands):

		September 30, 2024 (Unaudited)				December 31, 2023
Prepaid clinical trials		$	933			$	3,192
Deferred transaction costs			2,255				—
Prepaid insurance			140				68
Prepaid other			670				630
Total prepaid expenses		$	3,998			$	3,890

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(7) PROPERTY AND EQUIPMENT, NET

The following summarizes the components of property and equipment (in thousands):

		September 30, 2024 (Unaudited)				December 31, 2023
Lab equipment		$	705			$	706
Leasehold improvements			1,090				1,090
Computer hardware and software			176				141
Furniture and fixtures			160				160
Property and equipment, gross			2,131				2,097
Less: Accumulated depreciation and amortization			(1,005	)			(665	)
Property and equipment, net		$	1,126			$	1,432

Depreciation expense for the three and nine months ended September 30, 2024 was $114,000 and $343,000, respectively. Depreciation expense for the three and nine months ended September 30, 2023 was $107,000 and $304,000, respectively.

(8) ACCRUED EXPENSES

Accrued expenses consisted of the following (in thousands):

		September 30, 2024 (Unaudited)				December 31, 2023
Accrued contract manufacturing costs		$	750			$	1,627
Accrued compensation			2,086				1,663
Accrued legal			543				—
Accrued other			541				370
Total accrued expenses		$	3,920			$	3,660

(9) COMMITMENTS AND CONTINGENCIES

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 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, 2024.

(10) MERGER AND FINANCING

In May 2024, the Company entered into a definitive merger agreement with Reneo to combine the Company with Reneo in an all-stock transaction. The Combined Company will focus on advancing Legacy OnKure’s pipeline candidates. Upon completion of the Merger on October 4, 2024, the Combined Company operates under the name OnKure Therapeutics, Inc., and began trading on the Nasdaq Global Market (Nasdaq) under the ticker symbol “OKUR” effective October 7, 2024. See Note 12 for further discussion.

In connection with the transaction, Reneo has entered into a subscription agreement for a $65 million private investment in public equity (PIPE) financing which closed concurrently with the closing of the Merger, with a group of institutional investors.

Pre-Merger Reneo stockholders own approximately 32% of the Combined Company, and pre-Merger Company stockholders own approximately 68% of the Combined Company, upon the closing of the Merger, exclusive of the PIPE financing. The expected

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relative ownership percentages of pre-Merger Company stockholders and pre-Merger Reneo stockholders of the combined company are calculated using the treasury stock method, as described in the Merger Agreement, on a fully diluted basis prior to giving effect to the concurrent PIPE financing and excluding any shares reserved for future grants.

(11) CONVERTIBLE PROMISSORY NOTES

In June 2024, the Company entered into convertible promissory note agreements with certain of its existing investors for up to $12.0 million. At Closing, the Company received total proceeds of $6.0 million and may draw up to an additional $6.0 million in the event the Merger with Reneo had not closed by September 30, 2024, but no additional draw was made. The notes bear interest rates from 6% to 8% per annum. All unpaid principal and accrued interest are due in December 2025, unless earlier converted. In October 2024, the unpaid notes automatically converted into shares issued in the PIPE financing at the price per share paid by investors in the PIPE financing. See Note 12 for further discussion. No principal or interest was due until maturity. The Company incurred $0 and $142,000 of debt issuance costs related to the convertible promissory notes during the three and nine months ended September 30, 2024, respectively. Debt issuance costs are amortized as a component of interest expense over the term of the related debt using the straight-line method, which approximates the interest method. The Company recognized $127,000 and $128,000 in interest expense related to the amortization of the debt issuance costs for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company had accrued interest of $116,000 related to the convertible promissory notes, which is included in Other current liabilities on the balance sheet.

(12) SUBSEQUENT EVENTS

Agreement and Plan of Merger and PIPE Financing

On May 10, 2024, the Company entered into the Merger Agreement, pursuant to which Legacy OnKure merged with and into Radiate Merger Sub I (the Merger) on October 4, 2024 (the Closing), Reneo changed its name to “OnKure Therapeutics, Inc.”, with Legacy OnKure continuing after the Merger as the surviving company and a wholly-owned subsidiary of OnKure Therapeutics, Inc. (together, the Combined Company). At the Closing, each outstanding share of Legacy OnKure capital stock was converted into the right to receive shares of Reneo Class A Common Stock or Class B Common Stock, as set forth in the Merger Agreement. Upon closing of the Merger, the Combined Company has continued to be listed on Nasdaq.

Under the exchange ratio formulas in the Merger Agreement, immediately following the Closing, (i) (a) 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 the Common Exchange Ratio, which was reclassified as Class A Common Stock in connection with the Merger, and (b) 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 the Preferred Exchange Ratio; provided that a holder of Legacy OnKure preferred stock chose 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, (ii) each then-outstanding option to purchase shares of Legacy OnKure common stock was assumed by the Combined Company and converted into an option to purchase Class A Common Stock based on the Common Exchange Ratio, subject to adjustments set forth in the Merger Agreement, and (iii) each then-outstanding RSU of Legacy OnKure corresponding to shares of Legacy OnKure preferred stock was assumed by the Combined Company and converted into RSUs of the Combined Company covering 213,254 shares of Class A Common Stock based on the Preferred Exchange Ratio, subject to adjustments set forth in the Merger Agreement. Each share of Reneo common stock, each option to purchase shares of Reneo common stock and each RSU award covering shares of Reneo common stock that was issued and outstanding as of immediately prior to the Closing remained issued and outstanding in accordance with its terms and such shares, options and RSUs, subject to the Reverse Stock Split, were reclassified as Class A Common Stock but were otherwise unaffected by the Merger; provided that, to the extent not previously vested, all such options and RSUs held by Reneo’s directors and executive officers vested at Closing.

Concurrently with the execution of the Merger Agreement, Reneo entered into the Subscription Agreement with the PIPE Investors, pursuant to which the PIPE Investors subscribed for and purchased 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.

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 Combined 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

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3,343,525 shares of Class A Common Stock. Immediately after the Merger, there were approximately 12,652,811 shares of Class A Common Stock outstanding, 686,527 shares of Class B Common Stock outstanding, and 905,204 shares of Class A Common Stock subject to outstanding options and RSUs under the Combined Company’s equity incentive plans.

In addition, the Combined Company adopted the 2024 Equity Incentive Plan (the 2024 Plan) and 2024 Employee Stock Purchase Plan (the 2024 ESPP Plan). Under the 2024 Plan a total of 2,480,000 shares of Class A Common Stock were initially reserved for issuance. In addition, shares reserved for issuance under the 2024 Plan will include shares of Class A Common Stock equity awards granted under the Reneo 2021 Plan and any shares of Class A Common Stock equity awards that were assumed in the Merger. Under the 2024 ESPP Plan, an aggregate of 137,500 shares of Class A Common Stock are currently reserved and available for issuance. On October 4, 2024, the Combined Company granted to certain officers, directors, employees, consultants, and advisors, options to purchase an aggregate of 1,733,150 shares of Class A Common Stock with an exercise price of $18.20 per share under the 2024 Plan.

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

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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 (i) unaudited consolidated interim financial statements as of and for the periods ended September 30, 2024 and 2023 and related notes thereto, filed as Exhibit 99.1 to this Current Report on Form 8-K, and (ii) 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, 2023 and 2022 included in the proxy statement/prospectus (the Proxy Statement/Prospectus) filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the Securities Act), with the SEC on August 26, 2024. Unless otherwise indicated, all references 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” refers to the Company prior to the completion of the Merger.

Forward-Looking Statements

In addition to historical financial information, this discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated 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 of the Quarterly Report on Form 10-Q for the period ended September 30, 2024, filed with the SEC on November 7, 2024. Defined terms included below have the same meaning as terms defined and included elsewhere in the Current Report on Form 8-K of which this exhibit forms a part, including Exhibit 99.1 thereto, unless defined 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 Current Report on Form 8-K, 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

OnKure Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines designed to 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. Our lead product candidate, OKI-219, is a highly selective inhibitor of 3 kinase alpha (PI3Kα), a key mediator in cancer growth signaling, harboring the H1047R mutation (PI3KαH1047R) that has a much smaller impact on non-mutated (or wild-type) PI3Kα (PI3KαWT). OKI-219 is currently in a first-in-human Phase 1 monotherapy dose-escalation trial in H1074R-mutated advanced solid tumors including breast cancer. Early clinical data are anticipated in the fourth quarter of 2024. In addition to OKI-219, we are also pursuing programs designed to selectively target the other specific mutations of PI3Kα.

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 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, and (iv) 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 became a wholly-owned subsidiary of OnKure Therapeutics, Inc. Pursuant to the terms of the Merger Agreement, we 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.

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Concurrently with the closing of the Merger, Reneo completed a private placement with certain investors (the PIPE Investors) to purchase 2,839,005 shares of Class A 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 PIPE Investments). In connection with the Concurrent PIPE Investments, Reneo entered into a registration rights agreement with the PIPE 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 Class A Common Stock issued pursuant to the Concurrent PIPE Investments. Immediately after the effective time of the Merger, following the consummation of the Concurrent PIPE Investments, Legacy OnKure stockholders owned approximately 53.6%, pre-Merger Reneo stockholders owned approximately 25.1%, and the PIPE Investors owned approximately 21.3% of our outstanding common stock.

As of the open of trading on October 7, 2024, our Class A Common Stock began trading on the Nasdaq Global Market (Nasdaq) under the symbol “OKUR.”

Components of Legacy OnKure's Results of Operations

Basis of Presentation

The following discussion highlights Legacy OnKure’s results of operations and the principal factors that have affected its financial condition as well as its liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the balance sheets and statements of operations and comprehensive loss presented herein. The following discussion and analysis are based on Legacy OnKure’s audited financial statements and related notes and unaudited interim financial statements and related notes contained in this Current Report on Form 8-K, which have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). You should read the discussion and analysis together with such audited financial statements and the related notes thereto and unaudited interim financial statements and related notes thereto.

Components of Results of Operations

Revenue

To date, Legacy OnKure has not generated any revenue and it does not expect to generate any revenue from the sale of products or from other sources in the foreseeable future.

Operating Expenses

Research and Development

Research and development expenses account for a significant portion of Legacy OnKure’s operating expenses and consist primarily of expenses incurred in connection with the discovery and development of its product candidates.

Research and development expenses consist of costs incurred for the research and development of Legacy OnKure’s programs and product candidates, which include:

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Legacy OnKure makes 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 Legacy OnKure receives or takes ownership of the goods or when the services are performed. At any one time, Legacy OnKure is 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, Legacy OnKure does not track its 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 Legacy OnKure initiates new clinical trials, its 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, Legacy OnKure expects that its research and development expenses will increase substantially over the next several years as Legacy OnKure advances product candidates through preclinical studies into and through clinical trials, continues to discover and develop additional product candidates, undertakes activities to expand, maintain, protect and enforce its intellectual property portfolio, and hires 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. Legacy OnKure anticipates that it 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 its 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. Legacy OnKure will need to raise additional capital and may seek strategic alliances in the future to advance its 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 Legacy OnKure’s 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. Legacy OnKure recognizes general and administrative expenses in the periods in which they are incurred.

Legacy OnKure expects that its general and administrative expenses will increase over the next several years as it hires additional personnel to support the growth of its 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 Legacy OnKure’s cash equivalents in interest-bearing money market accounts.

Interest Expense

Interest expense consists of interest expense generated from Legacy OnKure’s convertible notes payable.

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Legacy OnKure Results of Operations

Comparison of the Three Months Ended September 30, 2024 and 2023

The following table summarizes Legacy OnKure’s results of operations for the periods indicated:

 

	Three Months Ended
	September 30,
	2024				2023				$ Change
	(in thousands)
Operating expenses:
Research and development	$	10,116			$	8,253			$	1,863
General and administrative		1,396				1,403				(7	)
Total operating expenses		11,512				9,656				1,856
Loss from operations		(11,512	)			(9,656	)			(1,856	)
Other income and (expense):
Interest income		174				668				(494	)
Interest and other expense		(218	)			(6	)			(212	)
Total other income and (expense)		(44	)			662				(706	)
Net loss and comprehensive loss	$	(11,556	)		$	(8,994	)		$	(2,562	)

Research and Development Expenses

Research and development expenses were $10.1 million for the three months ended September 30, 2024 compared to $8.3 million for the three months ended September 30, 2023, an increase of $1.9 million. This increase was primarily due to an increase in research and development costs, consisting of a $1.0 million increase in clinical trial and manufacturing expenses, $0.3 million increase in outsourced research, and a $0.6 million increase in personnel-related costs due to an increase in headcount, severance, and share-based compensation charges.

General and Administrative Expenses

General and administrative expenses were $1.4 million for the three months ended September 30, 2024 and for the three months ended September 30, 2023. During 2024, personnel-related and consulting costs increased by $0.1 million and audit fees increased by $0.1 million. These increases were offset by a decrease in legal service costs of $0.2 million.

Other Income (Expense)

Other income (expense) was $44 thousand of net expense for the three months ended September 30, 2024 compared to $0.7 million of net income for the three months ended September 30, 2023. The change was primarily due to a decrease in interest income due to a decrease in cash and cash equivalents available to invest during the quarter ended September 30, 2024 and increased interest expense related to convertible notes payable issued in 2024.

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Comparison of the Nine Months Ended September 30, 2024 and 2023

The following table summarizes Legacy OnKure’s results of operations for the periods indicated:

 

	Nine Months Ended
	September 30,
	2024				2023				$ Change
	(in thousands)
Operating expenses:
Research and development	$	29,434			$	23,290			$	6,144
General and administrative		6,253				3,752				2,501
Total operating expenses		35,687				27,042				8,645
Loss from operations		(35,687	)			(27,042	)			(8,645	)
Other income and (expense):
Interest income		699				1,192				(493	)
Interest and other expense		(243	)			(6	)			(237	)
Total other income and (expense)		456				1,186				(730	)
Net loss and comprehensive loss	$	(35,231	)		$	(25,856	)		$	(9,375	)

 

Research and Development Expenses

Research and development expenses were $29.4 million for the nine months ended September 30, 2024 compared to $23.3 million for the nine months ended September 30, 2023, an increase of $6.1 million. This increase was primarily due to an increase in research and development costs, consisting of a $2.9 million increase in clinical trial and manufacturing expenses and a $4.1 million increase in personnel-related costs due to an increase in headcount, severance, and share-based compensation charges. These increases were partially offset by a decrease of $1.0 million in outsourced research.

General and Administrative Expenses

General and administrative expenses were $6.3 million for the nine months ended September 30, 2024 compared to $3.8 million for the nine months ended September 30, 2023, an increase of $2.5 million. The increase was primarily due to an increase in personnel-related and consulting costs of $0.8 million and an increase in legal service costs of $1.6 million.

Other Income (Expense)

Other income (expense) was $0.5 million net income for the nine months ended September 30, 2024 compared to $1.2 million net income for the nine months ended September 30, 2023, a decrease of $0.7 million. The decrease was primarily due to a decrease an increase in cash and cash equivalents available during 2024 and an increase in interest expense related to the convertible notes payable issued in 2024.

 

 

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Liquidity and Capital Resources

Since inception, Legacy OnKure has not generated any revenue from product sales and has incurred significant operating losses and negative cash flows from its operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing our product candidates to support commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company following the Closing. As a result, we will need additional capital to fund our operations, which we may seek to obtain from equity or debt financings, collaborations, licensing arrangements or other sources.

Legacy OnKure has funded its operations primarily through private placements of its common stock, preferred stock and convertible debt. As of September 30, 2024, Legacy OnKure had cash, cash equivalents and short-term investments of approximately $8.0 million. After giving effect to the Merger and the PIPE Financing in October 2024, we believe the resulting cash resources are sufficient to fund our planned operations for at least the next 12 months from the date of issuance of these unaudited condensed financial statements.

Funding Requirements

Our primary uses of cash to date have been to fund our research and development activities, including with respect to our PI3Kα and other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these activities.

We have never generated any revenue from product sales and do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval for our product candidates, and management does not know when, or if, that will occur. Until we can generate significant revenue from product sales, if ever, we will continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future. We are subject to all the risks inherent in the development of new biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business.

In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize product candidates, if approved, we will require substantial additional capital. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales or other sources, we expect to seek to raise any necessary additional capital through equity financings, debt financings or other capital sources, which could include income from collaborations, partnerships, licensing or other strategic arrangements with third parties. To the extent that we raise additional capital through equity financings or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our own common stock, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise capital through collaborations, partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all.

Our ability to secure capital is dependent upon a number of factors, including our success in developing our product candidates. The failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to delay, reduce or curtail our research, product development or future commercialization efforts. We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot provide assurance that we will ever generate positive cash flow from operating activities.

Our future funding requirements will depend on many factors, including:

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A change in the outcome of any of these or other factors with respect to the development of OKI-219 or any of our future product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional capital to meet the capital requirements associated with such operating plans.

Cash Flows

The following table summarizes Legacy OnKure’s cash flows for the periods indicated, in thousands:

 

	Nine Months Ended September 30,
	2024				2023
	(in thousands)
Net cash used in:
Operating activities	$	(27,763	)		$	(27,526	)
Investing activities		(37	)			(213	)
Financing activities		5,883				53,115
Net (decrease) increase in cash and cash equivalents	$	(21,917	)		$	25,376

Cash Flows from Operating Activities

Net cash used in operating activities during the nine months ended September 30, 2024 was $27.8 million. This consisted primarily of a net loss of $35.2 million, a net decrease in Legacy OnKure’s operating assets and liabilities of $4.9 million, and by an increase in non-cash charges for share-based compensation and depreciation and amortization of $2.6 million.

Net cash used in operating activities during the nine months ended September 30, 2023 was $27.5 million. This consisted primarily of a net loss of $25.9 million, a net decrease in Legacy OnKure’s operating assets and liabilities of $2.2 million, partially offset by a increase in non-cash charges for share-based compensation, depreciation and amortization of $0.5 million.

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Cash Flows from Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2024 was $37 thousand and related to purchase of property and equipment.

Net cash used in investing activities for the nine months ended September 30, 2023 was $213 thousand and related to the purchase of property and equipment.

 

Cash Flows from Financing Activities

Net cash provided by financing activities was $5.9 million during the nine months ended September 30, 2024 and related primarily to proceeds from the issuance of convertible notes payable.

Net cash provided by financing activities was $ 53.1 million during the nine months ended September 30, 2023. This consisted primarily of proceeds of $53.8 million resulting from the sale of shares of Legacy OnKure Preferred Stock, partially offset by $0.7 million of issuance costs.

Material Cash Requirements

The discussion below summarizes Legacy OnKure’s significant contractual obligations and commitments as of September 30, 2024.

Leases. See Note 3 of Notes to Legacy OnKure Condensed Financial Statements included in Exhibit 99.1 to this Current Report on Form 8-K for information regarding its leases, including the future operating lease minimum payments.

Critical Accounting Policies and Estimates

Legacy OnKure’s management’s discussion and analysis of its financial condition and results of operations are based on its consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these consolidated financial statements requires Legacy OnKure to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Legacy OnKure bases its estimates on historical experience, known trends and events, and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Legacy OnKure’s critical accounting policies are described in its audited financial statements and the related notes for the years ended December 31, 2023 and 2022 included in the Proxy Statement/Prospectus filed pursuant to Rule 424(b) under the Securities Act, with the SEC on August 26, 2024, and the notes to the consolidated financial statements in Exhibit 99.1 to this Current Report on Form 8-K. During the nine months ended September 30, 2024, there were no material changes to Legacy OnKure’s critical accounting policies from those discussed in its audited financial statements and the related notes for the years ended December 31, 2023 and 2022 included in the Proxy Statement/Prospectus filed pursuant to Rule 424(b) under the Securities Act, with the SEC on August 26, 2024.

Recent Accounting Pronouncements

See Note 2 of Notes to Legacy OnKure Financial Statements included in Exhibit 99.1 to this Current Report on Form 8-K for a description of recent accounting pronouncements applicable to our consolidated financial statements.

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UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

Defined terms included below have the same meaning as terms defined and included elsewhere in the Current Report on Form 8-K of which this exhibit forms a part, including Exhibit 99.1 and 99.2 thereto, unless defined below.

On May 10, 2024, Reneo entered into the Merger Agreement with Merger Sub I, Merger Sub II and Legacy OnKure, pursuant to which, on the Closing Date, (i) Reneo changed its name to “OnKure Therapeutics, Inc.” and (ii) Merger Sub I merged with and into Legacy OnKure in the Merger, with Legacy OnKure surviving the Merger as a wholly owned subsidiary of OnKure Therapeutics, Inc. On October 4, 2024, the Merger was consummated and the Combined Company’s shares began trading on Nasdaq on October 7, 2024 under the ticker symbol “OKUR”.

On October 4, 2024, in connection with the closing of transactions contemplated by the Merger Agreement, Reneo effected the Reverse Stock Split, whereby each ten shares of Reneo’s common stock was combined into one share of Reneo’s Class A Common Stock.

On October 4, 2024:

Concurrently with the closing of the Merger, Reneo completed a private placement with certain investors (the “PIPE Investors”) to purchase 2,839,005 shares of Class A Common Stock at a price per share of $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 PIPE Investments”). In connection with the Concurrent PIPE Investments, Reneo entered into a registration rights agreement with the PIPE 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 Class A Common Stock issued pursuant to the Concurrent PIPE Investments. Such registration statement was declared effective on October 30, 2024.

Immediately after the Effective Time, following the consummation of the Concurrent PIPE Investments, Legacy OnKure stockholders owned approximately 53.6%, pre-Merger Reneo stockholders owned approximately 25.1%, and the PIPE Investors owned approximately 21.3% of the Combined Company’s outstanding common stock.

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In addition, a majority of options to purchase Reneo common stock issued pursuant to a Reneo equity plan or otherwise ("Reneo Options") and restricted stock units corresponding to shares of Reneo common stock issued pursuant to a Reneo equity plan or otherwise ("Reneo RSUs") outstanding as of immediately prior to the Effective Time were accelerated in full as of immediately prior to the Effective Time and remain outstanding following the Merger. These Reneo Options and Reneo RSUs generally will be subject to the same terms and conditions as were applicable to such Reneo Options and Reneo RSUs as of immediately prior to the Effective Time, except that as of the Effective Time, such Reneo Options and Reneo RSUs cover shares of Class A Common Stock instead of Reneo common stock. However, Reneo Options held by directors and executive officers have extended periods of exercisability and Reneo RSUs held by directors and executive officers are subject to a lock-up for 90 days after the Closing.

The unaudited pro forma condensed combined financial statements include adjustments to reflect the amendment and/or termination of multiple operating leases as required by the Merger Agreement, as well as the abandonment and/or disposal of tenant improvements, furniture and equipment (see Notes to the unaudited pro forma condensed combined financial statements). The unaudited pro forma condensed combined financial information gives effect to the Merger, which has been accounted for as a reverse recapitalization under GAAP. Legacy OnKure is considered to be the accounting acquirer for financial reporting purposes because on the Closing Date, the pre-combination assets of Reneo were primarily cash, cash equivalents, short-term investments, and other non-operating assets. In addition, this determination is based on the expectation that, immediately following the Merger: (i) Legacy OnKure stockholders will own a substantial majority of the voting rights of the Combined Company; (ii) Legacy OnKure will designate a majority (six of eight) of the initial members of the board of directors of the Combined Company; and (iii) Legacy OnKure’s management team will continue as the management team of the Combined Company. The Combined Company was renamed “OnKure Therapeutics, Inc.” and is headquartered in Boulder, Colorado. Accordingly, the Merger is treated for accounting purposes as the equivalent of Legacy OnKure issuing stock to acquire the net assets of Reneo. As a result of Legacy OnKure being treated as the accounting acquirer, Legacy OnKure’s assets and liabilities was recorded at their pre-combination carrying amounts and Reneo’s assets and liabilities was measured and recognized at their fair values as of the Effective Time. At completion of the Merger, the historical financial statements of Legacy OnKure became the historical consolidated financial statements of the Combined Company.

The unaudited pro forma condensed combined balance sheet data assumes that the Merger took place on September 30, 2024 and combines the historical balance sheets of Reneo and Legacy OnKure as of such date. The unaudited pro forma condensed combined statements of operations and comprehensive loss for the nine-month period ended September 30, 2024 and for the year ended December 31, 2023 assume that the Merger took place as of January 1, 2023 and combines the historical results of Reneo and Legacy OnKure for the periods then ended. The unaudited proforma condensed combined financial information was prepared pursuant to the rules and regulations of Rule 8-05 and Article 11 of SEC Regulation S-X.

The unaudited pro forma condensed combined financial statements have been derived from and should be read in connection with:

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The unaudited pro forma condensed combined financial information is provided for illustrative purposes only, does not necessarily reflect what the actual consolidated results of operations and financial position would have been had the Merger occurred on the dates assumed and may not be useful in predicting the future consolidated results of operations or financial position of the Combined Company.

The unaudited pro forma condensed combined financial information is based on the assumptions and adjustments that are described in the accompanying notes. Accordingly, the pro forma adjustments are preliminary, subject to further revision as additional information becomes available and additional analyses are performed and have been made solely for the purpose of providing unaudited pro forma condensed combined financial information. Differences between these preliminary accounting conclusions and estimates and the final accounting conclusions and amounts may occur as a result of, among other reasons, (i) changes in initial assumptions in the determination of the accounting acquirer and related accounting, (ii) changes in the amount of cash used in Reneo’s operations, and (iii) other changes in Reneo’s assets and liabilities, which are expected to be completed after the Closing, and these differences could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the Combined Company’s future results of operations and financial position.

The unaudited pro forma condensed combined financial information does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies. The unaudited pro forma condensed combined financial information, including the notes thereto, should be read in conjunction with the separate historical financial statements of Reneo and Legacy OnKure, and their respective management’s discussion and analysis of financial condition and results of operations included elsewhere in this prospectus.

The accounting policies of Reneo may materially vary from those of Legacy OnKure. During preparation of the unaudited pro forma condensed combined financial information, management has performed a preliminary analysis and is not aware of any material differences, and accordingly, this unaudited pro forma condensed combined financial information assumes no material differences in accounting policies. Following the Merger, management is conducting a final review of Reneo’s accounting policies in order to determine if differences in accounting policies require adjustment or reclassification of Reneo’s results of operations or reclassification of assets or liabilities to conform to Legacy OnKure’s accounting policies and classifications. As a result of this review, management may identify differences that, when conformed, could have a material impact on these unaudited pro forma condensed combined financial statements.

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Unaudited Pro Forma Condensed Combined Balance Sheets

As of September 30, 2024 (In thousands)

Historical

Legacy OnKure

Reneo

Transaction Accounting Adjustments

Note 4

Pro Forma Combined Total