OnKure Therapeutics reports Q3 2026 financial results

Item 2.02 Results of Operations and Financial Condition.

On November 4, 2026, OnKure Therapeutics, Inc. issued a press release reporting financial results for the quarter ended September 30, 2026¹.

The press release is attached hereto as Exhibit 99.1² 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 Third Quarter 2026 Financial Results and Provides Business Highlights" dated November 4, 2026 .

104

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.

ONKURE THERAPEUTICS, INC.

Date:

November 4, 2026

By:

/s/ Jason Leverone

Name: Jason Leverone

Title: Chief Financial Officer

OnKure Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Highlights

-- Announces PANORAMA, an OnKure-sponsored, large-scale, multiregional registry designed to characterize the natural disease course and treatment patterns of people living with vascular anomalies

-- Executing IND-enabling activities for next-generation PI3Kα pan-mutant-selective candidates OKI-345 in breast cancer and OKI-355 in vascular anomalies, with IND submissions planned for 1H 2027

BOULDER, CO, November 4, 2026 -- 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, 2026, and provided recent business highlights.

"We continue to advance the development of next-generation PI3Kα pan-mutant-selective inhibitors through our pipeline, including OKI-355 in vascular anomalies and OKI-345 in breast cancer. Both of our lead programs remain on track for IND submissions in the first half of 2027," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure.

"People living with vascular anomalies remain underserved, and we believe OnKure has an opportunity to help shape the future of treatment for this community. Mutations in the PIK3CA gene drive a range of vascular malformations, providing a compelling rationale for our development of OKI-355, which is designed to provide broad coverage across these mutations. We are excited to build on that work with the introduction of PANORAMA, a large-scale observational registry designed to generate insights that may inform future research and treatment strategies. Together, these efforts reflect our commitment to addressing both the need for new therapies and the gaps in disease knowledge that can guide their development," said Samuel Agresta, M.D., Chief Medical Officer of OnKure.

Vascular Anomalies

OnKure continues to advance its development of OKI-355, a next-generation PI3Kα pan-mutant-selective inhibitor candidate announced in March 2026 to lead its development pipeline in vascular anomalies. OKI-355 is designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in vascular anomalies. OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI - 355 in the first half of 2027³.

Expanding its commitment to the vascular anomalies community, the Company is also initiating PANORAMA, a large-scale, multiregional, longitudinal observational registry of people living with vascular anomalies⁴. The registry will support retrospective and prospective analyses to characterize the natural disease course, treatment patterns, and associations between genetic variants and clinical characteristics. Genotyping will be offered to all participants and may support clinical diagnosis in regions where access to genetic testing is limited.

Breast Cancer

In breast cancer, OnKure continues to advance its development of OKI-345, a next-generation PI3Kα pan-mutant-selective inhibitor candidate selected in March 2026. OKI-345 is designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination regimens. OnKure plans to submit an IND application to the FDA for OKI - 345 in the first half of 2027.

Financial Results

Cash position: As of September 30, 2026, the Company reported cash, cash equivalents, and marketable securities of $163.3 million⁵, which is expected to provide cash runway into 2029.

Research and development (R&D) expenses: R&D expenses were $15.1 million for the third quarter of 2026, compared to $11.9 million for the third quarter of 2025. The increase was primarily driven by an increase in outsourced preclinical R&D expenses, manufacturing costs and consulting expenses.

General and Administrative (G&A) expenses: G&A expenses were $4.3 million for the third quarter of 2026, compared to $3.6 million for the third quarter of 2025. The increase was primarily driven by increases in personnel-related and consulting costs.

Net loss and net loss per share were $17.8 million, or $0.36 per share, for the third quarter of 2026⁶, compared to $14.7 million, or $1.09 per share, for the third quarter of 2025.

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 vascular anomalies and cancers that are underserved by available therapies. Using a structure and computational chemistry-driven drug design platform, OnKure is committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of vasc