OnKure Therapeutics Stock Price, News & Analysis

OnKure Therapeutics (Nasdaq: OKUR) announced that President and CEO Nicholas Saccomano, Ph.D. will present and hold one-on-one investor meetings at three investor conferences in November–December 2025.

Scheduled appearances: a fireside chat at the Guggenheim Healthcare Innovation Conference in Boston on Nov 10, 2025 at 4:00 p.m. ET; a corporate presentation at the Stifel Healthcare Conference in New York on Nov 12, 2025 at 4:00 p.m. ET; and a fireside chat at the Evercore Healthcare Conference in Miami on Dec 3, 2025 at 12:30 p.m. ET. Live audio webcasts will be available for each event and replays will be posted on the company website for 30 days after the events.

OnKure Therapeutics (NASDAQ:OKUR) has reported significant progress in its clinical trials for OKI-219, their lead precision medicine for cancer treatment. The company has completed enrollment for both monotherapy and fulvestrant combination arms in the PIKture-01 trial, with 70 total patients enrolled. Two new expansion arms were initiated to evaluate OKI-219 in triple combinations: one with fulvestrant and ribociclib for HR+ breast cancer, and another with trastuzumab and tucatinib for HER2+ breast cancer.

Financially, OnKure reported $83.4 million in cash as of June 30, 2025, providing runway into Q4 2026. Q2 2025 resulted in a net loss of $15.4 million ($1.14 per share), compared to $14.1 million in Q2 2024. R&D expenses increased to $12.6 million, up from $10.8 million year-over-year.

The company plans to announce monotherapy and fulvestrant combination data in Q4 2025, along with nominating a pan-mutant selective PI3Kα inhibitor candidate by year-end.

OnKure Therapeutics (NASDAQ: OKUR) reported Q1 2025 financial results and business updates. The company's PIKture-01 trial for OKI-219, targeting PI3KαH1047R mutations in cancer, showed promising preliminary results with good tolerability across all dose levels. The company has $96.7M in cash, expected to fund operations through Q4 2026. Key financial metrics include R&D expenses of $13.0M (up from $8.6M in Q1 2024) and a net loss of $15.9M. OnKure plans to announce a pan-mutant selective development candidate in Q2 2025 and expects to report mature clinical data from PIKture-01 trial's single-agent arm and initial combination data with fulvestrant in H2 2025.

OnKure Therapeutics (NASDAQ: OKUR) reported its Q4 and full year 2024 financial results, highlighting progress in its PI3Ka inhibitor programs. The company's PIKture-01 trial showed encouraging preliminary data, with OKI-219 demonstrating good tolerability across all dose levels. Cash position stands at $110.8 million, expected to fund operations through Q4 2026.

Key financial metrics for Q4 2024 include:

• R&D expenses increased to $14.4 million (up from $8.8 million in Q4 2023)
• G&A expenses rose to $4.3 million (up from $1.1 million in Q4 2023)
• Net loss of $17.4 million or $1.37 per share

The company expects to announce its pan-mutant development candidate in Q2 2025 and provide additional PIKture-01 trial data, including combination results with fulvestrant, in H2 2025.

OnKure Therapeutics (Nasdaq: OKUR), a clinical-stage biopharmaceutical company specializing in precision oncology medicines, has announced its upcoming participation in two major investor conferences.

The company's President and CEO, Nicholas Saccomano, Ph.D., will participate in:

• A fireside chat at the Leerink Partners Global Healthcare Conference in Miami on March 11, 2025, at 4:20 p.m. ET, with a live audio webcast available online
• A fireside chat at the virtual Stifel Targeted Oncology Forum scheduled for April 8-9, 2025

The Leerink conference presentation will be accessible through a webcast link and the company's website, with replays available for 90 days post-event.

OnKure Therapeutics (NASDAQ: OKUR) announced encouraging preliminary data from its PIKture-01 trial of OKI-219, a mutant-selective PI3KαH1047R inhibitor. The drug showed positive safety and tolerability across all dose levels, with no dose interruptions or reductions required. Of 17 treated patients, the most common treatment-related adverse events were mild Grade 1 effects.

At 900 mg twice daily, OKI-219 demonstrated steady-state exposure levels with near-continuous coverage. Two patients with HR+/HER2- breast cancer showed prolonged stable disease, with one patient maintaining >95% reduction in PIK3CAH1047R ctDNA after seven months of treatment. The company has initiated Part 1b of the trial, evaluating OKI-219 in combination with fulvestrant, with initial data expected in 2H-2025.

OnKure Therapeutics (NASDAQ: OKUR) has rescheduled its investor call to review preliminary data from the PIKture-01 trial of OKI-219 to Tuesday, December 10, 2024, at 7:00 a.m. CT, moved from the previously announced December 13 date. The call will coincide with the publication of posters at the 2024 San Antonio Breast Cancer Symposium (SABCS).

Two posters will be presented at SABCS: one showing preliminary results from the PIKture-01 first-in-human study of OKI-219, and another demonstrating OKI-219's enhanced activity in pre-clinical PI3KαH1047R mutant breast cancer models. The PIKture-01 trial investigates OKI-219 as monotherapy in advanced solid tumors and in combination with endocrine or HER2-Targeted therapy for advanced breast cancer.

OnKure Therapeutics (NASDAQ: OKUR), a clinical-stage biopharmaceutical company specializing in precision oncology medicines, has announced its participation in the Stifel 2024 Healthcare Conference. Nicholas Saccomano, Ph.D., President and CEO, will deliver a corporate presentation on November 18, 2024, at 1:50 p.m. ET in New York.

The presentation will be accessible via live webcast through the 'Events' section of OnKure's website, with a replay available for approximately 90 days following the event.

OnKure Therapeutics (NASDAQ: OKUR) announced the presentation of two abstracts featuring preliminary clinical and preclinical data for OKI-219, their mutant-selective PI3KαH1047R inhibitor, at the 2024 San Antonio Breast Cancer Symposium (SABCS). The presentations will cover results from the PIKture-01 first-in-human study and preclinical data on OKI-219's enhanced activity in breast cancer models. The symposium will be held both virtually and in-person from December 10-13, 2024. OnKure will host a conference call on December 13 to discuss the preliminary data and provide a corporate update.