# EDGAR Filing Document

**Accession Number:** 0001637715
**File Stem:** 0001193125-25-269468
**Filing Date:** 2025-11
**Character Count:** 21414
**Document Hash:** 07bd1a52aa87f94b6ad582d1a6a08906
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-269468.hdr.sgml**: 20251106

**ACCESSION NUMBER**: 0001193125-25-269468

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251106

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251106

**DATE AS OF CHANGE**: 20251106

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** OnKure Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001637715
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 472309515
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40315
- **FILM NUMBER:** 251458198

**BUSINESS ADDRESS:**
- **STREET 1:** 6707 WINCHESTER CIRCLE, SUITE 400
- **CITY:** BOULDER
- **STATE:** CO
- **ZIP:** 80301
- **BUSINESS PHONE:** (720) 307-2892

**MAIL ADDRESS:**
- **STREET 1:** 6707 WINCHESTER CIRCLE, SUITE 400
- **CITY:** BOULDER
- **STATE:** CO
- **ZIP:** 80301

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Reneo Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20150325

?xml version='1.0' encoding='ASCII'? 8-K

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

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## FORM 8-K

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**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 06, 2025<br>

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OnKure Therapeutics, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-40315 | 47-2309515 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>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<br>

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

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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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Class A Common Stock, par value $0.0001 per share | OKUR | The Nasdaq Stock Market LLC |

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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. ☐

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## Item 2.02 Results of Operations and Financial Condition.
On November 6, 2025, OnKure Therapeutics, Inc. issued a press release reporting financial results for the quarter ended September 30, 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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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [<u>Press Release titled "OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update" dated November 6, 2025</u>](okur-ex99_1.htm). |
| 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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **ONKURE THERAPEUTICS, INC.** |
| Date: | November 6, 2025 | By:  | /s/ Jason Leverone |
|  |  |  | Name: Jason Leverone<br>Title: Chief Financial Officer |

---

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## Exhibit 99.1

![img123771468_0.jpg](img123771468_0.jpg)Exhibit 99.1

**OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update** 

*-- First patients dosed in triplet expansion arms of the PIKture-01 trial evaluating OKI-219 in combination with fulvestrant and ribociclib, and in combination with trastuzumab and tucatinib in patients with metastatic breast cancer*

*-- Clinical data from OKI-219 PIKture-01 single agent and fulvestrant combination arms are maturing and is now expected to be reported together with initial data from the triplet expansion arms in the first quarter of 2026* 

*-- Significant progress in next generation PI3Ka pan-mutant inhibitor program; multiple candidates identified - announcement planned for the first quarter of 2026* 

*-- Expansion into Vascular Malformations - additional information to be provided in 2026*

BOULDER, CO, November 6, 2025 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the third quarter ended September 30, 2025 and provided a business update.

"We have made steady progress advancing our lead clinical development program, OKI-219, and are committed to leading the advancement of selective PI3Kα inhibitors for the treatment of patients with breast cancer and rare diseases. Based on its selectivity and safety profile, the differentiated value of OKI-219 is best demonstrated in early lines of therapy. This fact is at the heart of our clinical strategy. It is important to note that the single agent and fulvestrant dose ranging combination arms of our PIKture-01 trial have supported the expanded development of OKI-219 with the recent initiation of two triplet arms of the trial, including an evaluation of OKI-219 in combination with fulvestrant and ribociclib. We are at an exciting time in our company's history, and we look forward to sharing clinical data from several arms of our ongoing PIKture-01 trial of OKI-219 in the first quarter of 2026," said Nick Saccomano, Ph.D., President and Chief Executive Officer of OnKure.

"While the team has been hard at work advancing the development of OKI-219, we have also continued to fuel the future growth of OnKure, with important advancements in our next-generation PI3Ka pan-mutant inhibitor program and the beginnings of an expansion program in vascular malformations. We look forward to offering additional details on these programs as our activities ramp up over the next several months."

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![img123771468_1.jpg](img123771468_1.jpg)

**<u>Program Highlights</u>**

**OKI-219**

*OnKure's lead product candidate, OKI-219, is a highly selective PI3ka*<sup>H1047</sup> *mutant specific inhibitor. OKI-219 is being evaluated in the PIKture-01 phase 1 clinical trial for the treatment of patients with HR+ and HER2+ metastatic breast cancer.*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In August 2025, the Company announced that it had completed and closed enrollment in the monotherapy and fulvestrant combination dose escalation arms of the PIKture-01 trial. As of October 14, 2025, a total of 71 patients have been dosed across both arms: 37 in monotherapy and 34 in combination with fulvestrant. The last patient in the monotherapy arm was dosed in September 2025 and the last patient in the fulvestrant combination arm was dosed in July 2025. The Company expects to announce initial data from these two arms of the trial in the first quarter of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In September 2025, the first patient was dosed in a triplet expansion arm of PIKture-01 evaluating OKI-219 in combination with fulvestrant and ribociclib in patients with PI3Kα<sup>H1047R</sup> mutated, HR+ metastatic breast cancer. The 600 and 900 mg BID cohorts are enrolled. Initial data is expected in the first quarter of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In October 2025, the first patient was dosed in a triplet expansion arm of PIKture-01 evaluating OKI-219 in combination with trastuzumab and tucatinib in patients with PI3Kα<sup>H1047R</sup> mutated, HER2+ breast cancer. Initial data is expected in the first quarter of 2026.

**Next-Generation PI3Ka**<sup>PAN</sup> **Mutant Selective Program**

*OnKure has identified a series of next-generation PI3Ka pan-mutant inhibitors. OnKure believes that to be truly "pan-mutant," a candidate should be highly selective against each of the most common PI3Ka mutations (PI3Kα*<sup>H1047X</sup>*, PI3Kα*<sup>E542K</sup>*, and PI3Kα*<sup>E545K</sup>*), with a favorable safety and tolerability profile that enables combinability with other agents.*

&nbsp;&nbsp;&nbsp;&nbsp;•The Company is evaluating a series of PI3Kα pan-mutant inhibitor development candidates shown preclinically to have an overall selectivity profile, combinability, and pharmaceutical attributes that the Company believes will produce best-in-class pan-mutant PI3Ka inhibitors.

&nbsp;&nbsp;&nbsp;&nbsp;•The Company plans to announce additional details in the first quarter of 2026.

**Vascular Malformations Expansion**

*PI3Kα mutations are the most common driver mutations for specific sub-types of vascular malformations. These mutations in the PI3KCA gene lead to overactivation of the pathway, which controls cell growth, proliferation, and survival.* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•OnKure believes its portfolio of PI3ka inhibitors have great potential to serve patients in this large, underserved population. The Company plans to announce additional information on its vascular malformations program in 2026.

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![img123771468_1.jpg](img123771468_1.jpg)

**<u>Financial Results</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Cash and cash equivalents** were approximately $70.3 million as of September 30, 2025. The Company believes its current cash and cash equivalents will be sufficient to fund its planned clinical activities and corporate operations into the fourth quarter of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Research and development (R&D) expenses** were $11.9 million for the third quarter of 2025, compared with $10.1 million for the third quarter of 2024. The increase in R&D expenses was primarily due to increased personnel-related costs, including share-based compensation charges.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**General and Administrative (G&A) expenses** were $3.6 million for the third quarter of 2025, compared with $1.4 million for the third quarter of 2024. The increase in G&A expenses was primarily due to increased personnel-related costs, including share-based compensation charges, and increases in director compensation, consulting, filing fees, franchise taxes, and other professional service fees.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Net loss and net loss per share** for the third quarter of 2025 were $14.7 million and $1.09 per share, compared with $11.6 million and $36.55 per share for the third quarter of 2024.

**<u>About OnKure Therapeutics</u>**

OnKure Therapeutics, Inc. (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 diseases that are underserved by available therapies. Using a structure-based drug design platform, 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 PI3Kα<sup>H1047R</sup> inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic or pathologically activated PI3Kα and has multiple programs designed to enable best-in-class targeting of this key disease creating gene.

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

**<u>Cautionary Note Regarding Forward-Looking Statements</u>**

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 current and potential future product candidates and programs, including OKI-219 and the pan-mutant program; OnKure's ability to advance additional programs; OnKure's ability to advance and expected timing of additional programs in vascular malformations; expected milestones and timing of such milestones, including additional data for OKI-219 from the PIKture-01 trial and an anticipated development candidate announcement; and statements regarding OnKure's cash runway. In some cases, you can identify forward-looking statements by terminology such as "estimate", "intend", "expect", "may", "plan", "potentially", "will" or the negative of these terms or other similar expressions.

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![img123771468_1.jpg](img123771468_1.jpg)

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, timing of regulatory reviews and approvals, 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 Quarterly Report on Form 10-Q filed with the SEC on November 6, 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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![img123771468_1.jpg](img123771468_1.jpg)

**ONKURE THERAPEUTICS, INC.**

**Condensed Consolidated Balance Sheets**

**(in thousands, unaudited)**

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| | | |
|:---|:---|:---|
|  | **September 30,<br>2025** | **December 31,<br>2024** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $70331 | $110761 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 1195 | 2242 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 71526 | 113003 |
| Property and equipment, net | 720 | 1025 |
| Operating lease, right-of-use asset | 485 | 770 |
| Other assets | 104 | 109 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $72835 | $114907 |
| **Liabilities and Stockholders' Equity**  |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable, accrued expenses, and other liabilities | $5680 | $9994 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities, current portion | 567 | 536 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 6247 | 10530 |
| Long-term liabilities | 160 | 549 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 6407 | 11079 |
| Stockholders' equity | 66428 | 103828 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $72835 | $114907 |

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![img123771468_2.jpg](img123771468_2.jpg)

**ONKURE THERAPEUTICS, INC.**

**Condensed Consolidated Statements of Operations and Comprehensive Loss**

**(in thousands, except share and per share amounts, unaudited)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | &nbsp;&nbsp;**Three Months Ended** | &nbsp;&nbsp;**Three Months Ended** | &nbsp;&nbsp;**Nine Months Ended** | &nbsp;&nbsp;**Nine Months Ended** |
|  | &nbsp;&nbsp;**September 30,** | &nbsp;&nbsp;**September 30,** | &nbsp;&nbsp;**September 30,** | &nbsp;&nbsp;**September 30,** |
|  | &nbsp;&nbsp;**2025** | &nbsp;&nbsp;**2024** | &nbsp;&nbsp;**2025** | &nbsp;&nbsp;**2024** |
| &nbsp;&nbsp;**Operating expenses:** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Research and development | &nbsp;&nbsp;$11915  | &nbsp;&nbsp; $10116  | &nbsp;&nbsp;$37540  | &nbsp;&nbsp;$29434  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;General and administrative | &nbsp;&nbsp; 3586  | &nbsp;&nbsp;1396  | &nbsp;&nbsp;11285  | &nbsp;&nbsp;6253  |
| &nbsp;&nbsp;Total operating expenses | &nbsp;&nbsp;15501  | &nbsp;&nbsp;11512  | &nbsp;&nbsp;48825  | &nbsp;&nbsp;35687  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Loss from operations** | &nbsp;&nbsp; (15501) | &nbsp;&nbsp; (11512) | &nbsp;&nbsp; (48825) | &nbsp;&nbsp;(35687) |
| &nbsp;&nbsp;Total other income and (expense), net | &nbsp;&nbsp;802  | &nbsp;&nbsp;(44) | &nbsp;&nbsp;2811  | &nbsp;&nbsp;456  |
| &nbsp;&nbsp;**Net loss and comprehensive loss** | &nbsp;&nbsp;$(14699) | &nbsp;&nbsp;$(11556) | &nbsp;&nbsp;$(46014) | &nbsp;&nbsp;$(35231) |
| &nbsp;&nbsp;Net loss per share, basic and diluted | &nbsp;&nbsp;$(1.09) | &nbsp;&nbsp; $(36.55) | &nbsp;&nbsp;$(3.41) | &nbsp;&nbsp;$(111.77) |
| &nbsp;&nbsp;Weighted average shares outstanding, |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;basic and diluted | &nbsp;&nbsp;13530892  | &nbsp;&nbsp;316142  | &nbsp;&nbsp;13488493  | &nbsp;&nbsp;315215  |

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