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): March 10, 2025

 

 

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 2.02 Results of Operations and Financial Condition.

On March 10, 2025, OnKure Therapeutics, Inc. issued a press release reporting financial results for the quarter and year ended December 31, 2024.

The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) of this report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release titled "OnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights" dated March 10, 2025.
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:	March 10, 2025	By:	/s/ Jason Leverone
			Name: Jason Leverone Title: Chief Financial Officer

 

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OnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

-- PIKture-01 trial update including additional PK data, mature single agent and initial combination data expected in the second half of 2025; reported encouraging preliminary data in December 2024

-- Expansion of PI3Ka franchise to include a pan-mutant selective program; development candidate expected to be announced in Q2 2025

-- $111M in cash and cash equivalents expected to be sufficient to fund operations through multiple PIKture-01 clinical readouts and anticipated milestones into Q4 2026

BOULDER, CO, March 10, 2025 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines in oncology, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business highlights.

“I am extremely pleased with the progress we made last year. With three PI3Ka inhibitor programs, including one in clinical development and a second development candidate expected next quarter, we are committed to developing product candidates that address the needs of patients who suffer from diseases implicated by PI3Ka, which is a key mediator in cancer growth signaling,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure.

“The extensive expertise of our research and development team in discovering development candidates with favorable drug properties is our strength, and the entire OnKure team is contributing to the execution of our strategy. This year, we expect to report additional OKI-219 data from PIKture-01, announce our pan-mutant inhibitor program, and declare plans to initiate additional clinical trials,” concluded Dr. Saccomano.

Recent Business Highlights and Upcoming Anticipated Milestones

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Fourth Quarter 2024 Financial Results

Cash and cash equivalents were approximately $110.8 million as of December 31, 2024.

Research and development (R&D) expenses were $14.4 million for the fourth quarter of 2024, compared to $8.8 million for the fourth quarter of 2023. The increase of $5.6 million was primarily driven by an increase of $3.4 million in clinical trial and manufacturing related expenses in addition to $2.1 million of higher personnel-related costs, including share-based compensation charges.

General and Administrative (G&A) expenses were $4.3 million for the fourth quarter of 2024, compared to $1.1 million for the fourth quarter of 2023. The increase of $3.2 million was primarily driven by an increase in personnel-related costs of $2.0 million and an increase in consulting and professional service expenses of $1.2 million including, audit, tax, insurance, board of director compensation and other consulting expenses.

Net loss and net loss per share for the fourth quarter of 2024 were $17.4 million or $1.37 per share, compared to $9.5 million, or $30.14 per share, for the fourth quarter of 2023.

About OnKure Therapeutics

OnKure Therapeutics (Nasdaq: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure-based drug design platform,

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OnKure is building a pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing OKI-219, a selective PI3KαH1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic PI3Kα and has multiple programs designed to enable best-in-class targeting of this key oncogene.

For more information about OnKure, visit us at www.onkure.com and follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, OnKure’s product candidates and programs, including OKI-219; the pan-mutant program; OnKure’s ability to advance additional programs; the expected milestones and timing of such milestones, including additional data for OKI-219 from the PIKture-01 trial, anticipated development candidate announcements and OnKure’s discovery stage programs; and statements regarding OnKure’s financial position, including its liquidity, cash runway and the sufficiency of its cash resources. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially” “will” or the negative of these terms or other similar expressions.

We based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things, OnKure’s limited operating history; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the risk that actual uses of cash and cash equivalents differ from the assumptions underlying our expected cash runway; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, OnKure’s product candidates; the outcome of preclinical testing and early clinical trials for OnKure’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; OnKure’s limited resources; the risk of adverse events, toxicities or other undesirable side effects; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; the decision to develop or seek strategic collaborations to develop OnKure’s current or future product candidates in combination with other therapies and the cost of combination therapies; OnKure’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the substantial competition OnKure faces in discovering, developing, or commercializing products; OnKure’s ability to protect its intellectual property and proprietary technologies; developments relating to OnKure’s competitors and its industry, including competing product candidates and therapies; reliance on third parties, contract manufacturers, and contract research organizations; legislative, regulatory, political and economic developments and general market conditions; and those risks described in the section entitled “Risk Factors” in documents that OnKure

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files from time to time with the Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10-K filed with the SEC on March 10, 2025 and any subsequent filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release.

Contact:

Dan Ferry

LifeSci Advisors

daniel@lifesciadvisors.com

 

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ONKURE THERAPEUTICS, INC.

Consolidated Condensed Balance Sheets

(In thousands, unaudited)

 

		December 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	110,761			$	29,876
Prepaid expenses and other current assets			2,242				3,890
Total current assets			113,003				33,766
Property and equipment, net			1,025				1,432
Operating lease, right-of-use asset			770				478
Other assets			109				58
Total assets		$	114,907			$	35,734
Liabilities, Convertible Preferred Stock, and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable, accrued expenses, and other liabilities		$	9,994			$	7,077
Operating lease liabilities, current portion			536				208
Total current liabilities			10,530				7,285
Long-term operating lease liabilities			549				466
Total liabilities			11,079				7,751
Convertible preferred stock			—				129,825
Stockholders’ equity (deficit)			103,828				(101,842)
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)		$	114,907			$	35,734

 

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ONKURE THERAPEUTICS, INC.

Consolidated Condensed Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data, unaudited)

 

	Three Months Ended				Years Ended
	December 31,				December 31,
	2024		2023		2024		2023
Operating expenses:
Research and development	$ 14,361		$ 8,825		$ 43,795		$ 32,115
General and administrative	4,338		1,067		10,591		4,819
Total operating expenses	18,699		9,892		54,386		36,934
Loss from operations	(18,699)		(9,892)		(54,386)		(36,934)
Total other income and (expense), net	1,257		437		1,713		1,623
Net loss and comprehensive loss	$ (17,442)		$ (9,455)		$ (52,673)		$ (35,311)
Net loss per share attributable to common stockholders:
Basic and diluted	$ (1.37)		$ (30.14)		$ (15.28)		$ (124.41)
Weighted average shares outstanding:
Basic and diluted	12,774,553		313,652		3,447,071		283,817

 

 

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v3.25.0.1

Document And Entity Information	Mar. 10, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 10, 2025
Entity Registrant Name	OnKure Therapeutics, Inc.
Entity Central Index Key	0001637715
Entity Emerging Growth Company	true
Entity File Number	001-40315
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-2309515
Entity Address, Address Line One	6707 Winchester Circle, #400
Entity Address, City or Town	Boulder
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80301
City Area Code	720
Local Phone Number	307-2892
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Class A Common Stock, par value $0.0001 per share
Trading Symbol	OKUR
Security Exchange Name	NASDAQ

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