OnKure Therapeutics (Nasdaq: OKUR) details 2025 results and PI3Kα trial plans
Rhea-AI Filing Summary
OnKure Therapeutics, Inc. reported fourth quarter and full-year 2025 results alongside updates on its PI3Kα‑focused oncology pipeline. Cash and cash equivalents were $59.1 million as of December 31, 2025, compared with $110.8 million a year earlier, reflecting continued investment in clinical development.
For Q4 2025, research and development expenses were $10.7 million and general and administrative expenses were $3.4 million, both below Q4 2024 levels. Net loss for the quarter was $13.5 million, or $0.99 per share, versus $17.4 million, or $1.37 per share, in Q4 2024.
Full-year 2025 net loss was $59.5 million, or $4.40 per share. Operationally, the company highlighted progress for lead candidate OKI‑219 in the PIKture‑01 phase 1 study, including completed enrollment in early trial parts and ongoing triplet combination arms, with multiple data readouts and a next‑generation PI3Kα pan‑mutant candidate announcement expected in 2026.
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Insights
OnKure trims Q4 operating spend, advances PI3Kα pipeline, but cash balance declines.
OnKure Therapeutics remains a clinical-stage story with no revenue, so cash and trial progress are central. Cash and cash equivalents were $59.1 million as of December 31, 2025, down from $110.8 million a year earlier, while 2025 net loss totaled $59.5 million.
Fourth quarter 2025 operating expenses fell year over year: R&D declined to $10.7 million and G&A to $3.4 million, helping reduce the quarterly net loss to $13.5 million from $17.4 million. This suggests some cost discipline even as development work continues.
Pipeline progress is notable but still early. The PIKture‑01 phase 1 study of OKI‑219 has completed enrollment in monotherapy and fulvestrant-combination arms and is enrolling triplet combinations. Initial and updated data are planned in March 2026, alongside a next‑generation PI3Kα pan‑mutant candidate announcement. Actual impact will depend on the quality of these upcoming data.
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
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Securities registered pursuant to Section 12(b) of the Act:
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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.
Item 2.02 Results of Operations and Financial Condition.
On March 12, 2026, OnKure Therapeutics, Inc. issued a press release reporting financial results for the quarter and year ended December 31, 2025.
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.
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Description |
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99.1 |
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Press Release titled "OnKure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results" dated March 12, 2026. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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.
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ONKURE THERAPEUTICS, INC. |
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March 12, 2026 |
By: |
/s/ Jason Leverone |
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Name: Jason Leverone |
EXHIBIT 99.1
OnKure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
-- Data from the ongoing PIKture-01 trial is expected to be announced in March 2026; continued enrollment in breast cancer triplet combinations
-- Next-generation PI3Kapan-mutant inhibitor development candidate for HR+ metastatic breast cancer is expected to be announced in March 2026
-- Approximately $59M in cash and cash equivalents at the end of Q4 2025
BOULDER, CO, March 12, 2026 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent business highlights.
“We are pleased with the continued progress across our PI3Kα‑focused pipeline, including the steady execution of the PIKture‑01 trial of OKI-219. We look forward to sharing updated data from this trial later this month,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “We are also excited to announce our next‑generation pan‑mutant inhibitor development candidate for HR+ metastatic breast cancer this month and provide additional information on our program in vascular malformations later this year. Overall, we believe our progress to date underscores the power of our mutation‑selective approach to PI3Kα inhibition and reinforces the momentum we are building as we work to deliver scientifically differentiated therapies to patients.”
OKI-219 Program Highlights
OnKure’s lead product candidate, OKI-219, is a highly selective PI3KαH1047 mutant specific inhibitor. OKI-219 is being evaluated in the PIKture-01 phase 1a/1b clinical trial for the treatment of patients with HR+ and HER2+ metastatic breast cancer.
Next-Generation PI3KaPAN Mutant Selective Program
OnKure expects to announce its next-generation PI3Ka pan-mutant inhibitor candidate for HR+ metastatic breast cancer in March 2026.
Additionally, PI3Kα mutations represent the most common driver alterations in key subtypes of vascular malformations, where activating PIK3CA variants lead to dysregulated signaling that promotes abnormal cell growth, proliferation, and survival. OnKure believes its differentiated portfolio of PI3Kα inhibitors has significant potential to address a large and underserved patient population. The Company expects to provide additional details on its PI3Kα pan‑mutant program in 2026. This progression reflects the Company’s strategic expansion into indications driven by PI3Kα biology.
Financial Results
Cash and cash equivalents were approximately $59.1 million as of December 31, 2025.
Research and development (R&D) expenses were $10.7 million for the fourth quarter of 2025, compared to $14.4 million for the fourth quarter of 2024. The decrease of $3.6 million was primarily driven by a decrease in consulting, outsourced R&D, clinical trial, and manufacturing related expenses in addition to lower personnel-related costs.
General and Administrative (G&A) expenses were $3.4 million for the fourth quarter of 2025, compared to $4.3 million for the fourth quarter of 2024. The decrease of $0.9 million was primarily driven by a decrease in personnel-related costs and consulting and professional service expenses including audit, tax, insurance, board of director compensation, and other consulting expenses.
Net loss and net loss per share for the fourth quarter of 2025 were $13.5 million, or $0.99 per share, compared to $17.4 million, or $1.37 per share, for the fourth quarter of 2024.
About PIKture-01 Study
PIKture-01 is a global, multi-center, dose-escalation, first-in-human phase 1a/1b study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs. Phase 1a (Part A) of the study is investigating escalating doses of OKI-219 monotherapy, and Phase 1b is currently investigating OKI-219 (at a tolerated dose determined in Part A) in combination with fulvestrant (Part B), trastuzumab and tucatinib (Part C), and ribociclib and fulvestrant (Part E). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met. Additional information about PIKture-01 may be found at www.ClinicalTrials.gov, using Identifier: NCT06239467.
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 and other diseases that are underserved by available therapies. Using a structure-based drug design platform, OnKure is building a pipeline of small molecule drugs designed to achieve optimal efficacy and tolerability by selectively targeting specific mutations shown to be key drivers of cancer and other diseases. OnKure is currently developing OKI-219, a highly 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 and 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, the anticipated development candidate announcement and details on the pan-mutant program; statements regarding OnKure’s financial position, including its liquidity, cash runway and the sufficiency of its cash resources; and statements by OnKure’s President and Chief Executive Officer. 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 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 12, 2026 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
ONKURE THERAPEUTICS, INC.
Consolidated Condensed Balance Sheets
(In thousands, unaudited)
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December 31, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
59,050 |
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$ |
110,761 |
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Prepaid expenses and other current assets |
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1,789 |
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2,242 |
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Total current assets |
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60,839 |
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113,003 |
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Property and equipment, net |
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618 |
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1,025 |
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Operating lease, right-of-use asset |
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387 |
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770 |
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Other assets |
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273 |
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109 |
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Total assets |
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$ |
62,117 |
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$ |
114,907 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable, accrued expenses, and other liabilities |
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$ |
5,372 |
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$ |
9,994 |
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Operating lease liabilities, current portion |
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549 |
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536 |
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Total current liabilities |
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5,921 |
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10,530 |
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Long-term liabilities |
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12 |
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549 |
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Total liabilities |
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5,933 |
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11,079 |
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Stockholders’ equity |
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56,184 |
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103,828 |
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Total liabilities and stockholders’ equity |
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$ |
62,117 |
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$ |
114,907 |
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ONKURE THERAPEUTICS, INC.
Consolidated Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data, unaudited)
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Three Months Ended |
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Years Ended |
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December 31, |
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December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
Operating expenses: |
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Research and development |
$ 10,720 |
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$ 14,361 |
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$ 48,260 |
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$ 43,795 |
General and administrative |
3,405 |
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4,338 |
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14,690 |
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10,591 |
Total operating expenses |
14,125 |
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18,699 |
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62,950 |
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54,386 |
Loss from operations |
(14,125) |
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(18,699) |
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(62,950) |
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(54,386) |
Total other income and (expense), net |
622 |
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1,257 |
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3,433 |
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1,713 |
Net loss and comprehensive loss |
$ (13,503) |
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$ (17,442) |
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$ (59,517) |
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$ (52,673) |
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Net loss per share attributable to common stockholders: |
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Basic and diluted |
$ (0.99) |
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$ (1.37) |
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$ (4.40) |
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$ (15.28) |
Weighted average shares outstanding: |
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Basic and diluted |
13,597,287 |
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12,774,553 |
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13,515,915 |
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3,447,071 |
FAQ
What were OnKure Therapeutics (OKUR) key financial results for Q4 2025?
OnKure reported a Q4 2025 net loss of $13.5 million, or $0.99 per share. Research and development expenses were $10.7 million and general and administrative expenses were $3.4 million, both lower than Q4 2024, reflecting reduced operating spending while clinical development continues.
How much cash did OnKure Therapeutics (OKUR) have at the end of 2025?
OnKure ended December 31, 2025 with cash and cash equivalents of $59.1 million. This compares with $110.8 million at year-end 2024, indicating substantial cash usage during 2025 to fund research, clinical trials, and general operations.
What was OnKure Therapeutics (OKUR) full-year 2025 net loss and loss per share?
For full-year 2025, OnKure reported a net loss of $59.5 million, or $4.40 per share. This compares with a 2024 net loss of $52.7 million, or $15.28 per share, highlighting ongoing investment typical of clinical-stage biopharmaceutical companies.
What progress did OnKure Therapeutics (OKUR) report for its OKI-219 PIKture-01 trial?
OnKure completed enrollment in the monotherapy and fulvestrant combination arms of the PIKture‑01 phase 1a/1b trial, dosing 71 patients. Triplet expansion arms in HR+ and HER2+ metastatic breast cancer are enrolling, with updated safety, tolerability, and activity data expected beginning in March 2026.
What upcoming milestones did OnKure Therapeutics (OKUR) highlight for 2026?
OnKure expects to share updated data from multiple parts of the PIKture‑01 OKI‑219 study and announce a next‑generation PI3Kα pan‑mutant inhibitor candidate for HR+ metastatic breast cancer in March 2026, with further details on the pan‑mutant program later in 2026.
How did OnKure Therapeutics (OKUR) operating expenses change in Q4 2025 versus Q4 2024?
In Q4 2025, research and development expenses were $10.7 million compared with $14.4 million in Q4 2024, and general and administrative expenses were $3.4 million versus $4.3 million. The company attributed these decreases mainly to lower consulting, clinical, manufacturing, and personnel-related costs.
Filing Exhibits & Attachments
2 documentsPress Releases
