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 PI3Kα  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, Colo., Nov. 06, 2025 (GLOBE NEWSWIRE) -- 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.

GlobeNewsWire • Nov 6, 2025

OnKure Therapeutics to Participate in Upcoming Investor Conferences

BOULDER, Colo., Nov. 04, 2025 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines, today announced that Nichoals Saccomano, Ph.D., President and Chief Executive Officer, will present and be available for one-on-one investor meetings at the following investor conferences:

GlobeNewsWire • Nov 4, 2025

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

-- PIKture-01, a phase 1 clinical trial assessing OKI-219 in patients with advanced solid tumors, including breast cancer, is on track for single agent and fulvestrant combination data in Q4 2025 -- Initiated a new expansion arm of PIKture-01 to evaluate OKI-219 in combination with fulvestrant and ribociclib in HR+ metastatic breast cancer -- Initiated a new expansion arm of PIKture-01 to evaluate OKI-219 in combination with trastuzumab and tucatinib in HER2+ metastatic breast cancer -- Cash position of $83.4M expected to provide cash runway into Q4 2026 BOULDER, Colo., Aug. 12, 2025 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines in oncology, today reported financial results for the second quarter ended June 30, 2025 and provided a business update.

GlobeNewsWire • Aug 12, 2025

OnKure Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights

-- Continued progress in the PIKture-01 trial; on track to report additional data in the second half of 2025, including mature single agent and initial combination data

GlobeNewsWire • May 6, 2025

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

GlobeNewsWire • Mar 10, 2025

OnKure Therapeutics to Present at Upcoming Leerink and Stifel Investor Conferences

BOULDER, Colo., March 04, 2025 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, today announced that Nicholas Saccomano, Ph.D.

GlobeNewsWire • Mar 4, 2025

OnKure Announces Encouraging Preliminary Safety, Tolerability, and Pharmacokinetic (PK) Data from its First-In-Human PIKture-01 Trial of OKI-219

-- OKI-219 is well-tolerated across all doses, and no dose interruptions, delays, reductions, or discontinuations were reported

GlobeNewsWire • Dec 10, 2024

OnKure Announces New Date for Upcoming Investor Call

Investor call to review preliminary data from the PIKture-01 trial is now planned for Tuesday, December 10th, at 7 a.m. CT Investor call to review preliminary data from the PIKture-01 trial is now planned for Tuesday, December 10th, at 7 a.m. CT

GlobeNewsWire • Nov 25, 2024

OnKure to Present Clinical and Preclinical Data for OKI-219 at the 2024 San Antonio Breast Cancer Symposium

OnKure to host a conference call to review key data presented at SABCS and provide a general corporate update on Friday, December 13, 2024 at 8:00 a.m. ET

GlobeNewsWire • Nov 1, 2024

OnKure: Looking To Alter PI3K Inhibitor Targeting In Breast Cancer And Beyond

Initial OnKure Therapeutics, Inc. data from the phase 1 PIKture-01 study, using OKI-219 for the treatment of patients with PI3Ka-H1047R breast cancer and solid tumors, is expected in Q4 of 2024. OKI-219 has 80X fold improved selectivity PI3K-a targeting versus wild-type PI3K-a, potentially allowing for higher dosing and reducing unwanted off-target effects. The merger with Reneo Pharmaceuticals and $65 million private placement boosts OnKure's cash to $139 million, funding operations into Q4 2026.

Seeking Alpha • Oct 24, 2024