ADDED
As of March 11, 2026, the registrant had 13,673,565 shares of Class A common stock, $0.0001 par value per share outstanding.
Our management has concluded that substantial doubt exists as to our ability to continue as a going concern.
Using a structure-based drug design platform, we are committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to achieve optimal efficacy and tolerability by selectively targeting specific mutations shown to be key drivers of cancer and other diseases.
By selectively sparing the wild-type enzyme and preferentially targeting the mutated form of the protein, which is oncogenic and drives disease processes in both cancer and vascular overgrowth syndromes, we aim to discover and develop drugs with improved safety and efficacy by sparing toxicity that arises from non-selective inhibition of the non-mutated (or wild-type) version of the protein.
We designed our current product candidates utilizing disciplined medicinal chemistry, x-ray crystallography and computational chemistry to inhibit specified mutated versions of phosphoinositide 3-kinase alpha ( PI3K ), a key disease creating gene.
We aim to render OKI-219 as a preferred backbone therapy to which other medicines are added in the context of PI3K H1047R -driven disease.
OKI-219 is currently being investigated in a first-in-human Phase 1 open-label multi-arm clinical trial evaluating OKI-219 in patients with solid tumors, including breast cancer harboring a PI3K H1047R mutation ( PIKture-01 ).
In the first arm, OKI-219 is being investigated as a monotherapy in patients with solid tumors, including breast cancer, harboring a PI3K a H1047R mutation.
Data reported from this arm supported the initiation of the first combination arm investigating OKI-219 as part of a doublet therapy in combination with fulvestrant in patients with HR+/HER2- breast cancer harboring a PI3K H1047R mutation ( Part B) .
In the second half of 2025, we expanded PIKture-01 to investigate OKI-219 as part of triplet regimens in two breast cancer subtypes, HR+HER2- (HR+) and HER2+.
REMOVED
As of March 7, 2025, the registrant had 12,749,299 shares of Class A common stock, $0.0001 par value per share, and 686,527 shares of Class B common stock, $0.0001 par value per share, outstanding.
Form 10-K Summary 150 2 Explanatory Note On October 4, 2024 (the "Closing Date"), the Delaware corporation formerly known as Reneo Pharmaceuticals, Inc.
("Reneo") completed its previously announced merger transaction pursuant to the terms of the Agreement and Plan of Merger, dated as of May 10, 2024 (the "Merger Agreement"), by and among Reneo, Radiate Merger Sub I, Inc., a Delaware corporation and a direct, wholly-owned subsidiary of Reneo ("Merger Sub I"), Radiate Merger Sub II, LLC, a Delaware limited liability company and a direct, wholly-owned subsidiary of Reneo ("Merger Sub II"), and OnKure, Inc., a Delaware corporation ("Legacy OnKure").
Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo s issued common stock at a ratio of 1:10 (the "Reverse Stock Split"), (ii) Reneo changed its name to OnKure Therapeutics, Inc.
, (iii) Reneo reclassified all of its common stock as Class A Common Stock or Class B Common Stock, and (iv) Merger Sub I merged with and into Legacy OnKure (the "Merger"), with Legacy OnKure as the surviving company in the Merger and, after giving effect to such Merger, Legacy OnKure became a wholly-owned subsidiary of OnKure Therapeutics, Inc.
Pursuant to the terms of the Merger Agreement, OnKure determined that the Merger would qualify for the intended tax treatment even if only the merger with Merger Sub I was consummated, and therefore the parties determined not to consummate the second merger with Merger Sub II contemplated by the Merger Agreement.
The financial statements included in this Annual Report on Form 10-K include historical financial information of OnKure Therapeutics, Inc., including as of and for the year ended December 31, 2024, unless otherwise indicated or as the context otherwise requires.
In addition, except where otherwise indicated, the information in this Annual Report on Form 10-K as of and for the periods prior to the effective time of the Merger gives effect to the Merger.
Unless the context otherwise requires, OnKure, we, us, our, and the Company refer to the Combined Company.
All references herein to the Board refer to the board of directors of OnKure Therapeutics, Inc.