OnKure Therapeutics (OKUR) Company Report

OnKure Therapeutics (OKUR) anticipates 2026 to be a year of significant data and progress for its molecules and platform.
The company plans to report clinical data for OKI-219 in Q1 2026, covering monotherapy, combination therapy, and doublet/triplet results. This release was delayed from late 2025 to allow for more mature data, with patients expected to have greater than four months of follow-up.
A primary focus for OKI-219 development is on triplet studies in ER-positive breast cancer (with ribociclib + fulvestrant) and in the HER2-positive setting, aiming to demonstrate superior tolerability and early efficacy in frontline therapy.
OnKure is also advancing pan-mutant selective molecules with greater than 10x selectivity mutant over wild type, with development candidates expected to be detailed in Q1 2026.

Dec 3, 2025, 5:30 PM

OnKure Provides Clinical Development Update for PI3K Alpha Inhibitors

OKUR

New Projects/Investments

Guidance Update

OnKure is progressing its lead PI3K alpha inhibitor, OKI-219, through clinical trials for breast cancer, including monotherapy, doublet, and triplet regimens.
Key clinical data readouts for OKI-219 monotherapy, doublet, and initial triplet studies (tolerability, combinability, early efficacy) are anticipated in the first quarter of 2026.
The company emphasizes OKI-219's high selectivity and tolerability, which it believes will enable superior combinability with other cancer therapies and provide a competitive advantage.
OnKure also has pan-mutant selective molecules nearing nomination, with preclinical development expected to conclude in 2026, and an early discovery program for an E542K selective drug.
OnKure held $70 million in cash and cash equivalents as of September 30, 2025.

Nov 12, 2025, 9:00 PM

OnKure Therapeutics, Inc. enters into Sales Agreement for "at the market offering"

OKUR

Equity Offering

Capital Raise

OnKure Therapeutics, Inc. entered into a Sales Agreement with Leerink Partners LLC on November 6, 2025, to sell shares of its Class A common stock through an "at the market offering" program.
Leerink Partners LLC will act as the sales agent and will be entitled to compensation of up to 3.0% of the gross proceeds from the sales.
The Company will set the parameters for the sale of shares, including the maximum number or dollar amount, and has no obligation to sell any shares, retaining the ability to suspend sales at any time.
The offering will be conducted pursuant to a Registration Statement on Form S-3 to be filed with the Securities and Exchange Commission on November 6, 2025.

Nov 6, 2025, 9:23 PM

OnKure Therapeutics Reports Q3 2025 Financial Results and Business Update

OKUR

Earnings

Guidance Update

New Projects/Investments

OnKure Therapeutics reported a net loss of $14.7 million for Q3 2025, compared to $11.6 million in Q3 2024. The company held approximately $70.3 million in cash and cash equivalents as of September 30, 2025, which is expected to fund operations into the fourth quarter of 2026.
The company initiated dosing in triplet expansion arms of the PIKture-01 trial for OKI-219 and expects to report initial clinical data from several arms in the first quarter of 2026.
Significant progress was made in the next-generation PI3Ka pan-mutant inhibitor program, with an announcement planned for the first quarter of 2026. Additionally, OnKure plans an expansion into vascular malformations, with further information to be provided in 2026.

Nov 6, 2025, 9:06 PM

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