What OnKure Therapeutics does

OnKure Therapeutics is a clinical-stage biopharmaceutical company headquartered in Boulder, Colorado, that designs and develops precision small molecule medicines targeting validated oncogenic drivers, with a primary focus on mutant-selective inhibitors of PI3Kα. The company is publicly traded on Nasdaq under the ticker OKUR and was formed in October 2024 through the merger of privately held OnKure, Inc. with Reneo Pharmaceuticals, accompanied by a $65 million PIPE financing. Its pipeline is anchored by OKI-219, a brain-penetrant PI3Kα H1047R mutant-selective inhibitor in Phase 1 (PIKture-01) for metastatic breast cancer and other mutant-selected solid tumors, and two next-generation pan-mutant-selective PI3Kα inhibitors—OKI-345 (breast cancer) and OKI-355 (vascular anomalies)—which are in IND-enabling studies with INDs planned for the first half of 2027. Earlier-stage assets include OKI-179 (Bocodepsin), an oral class I-selective HDAC inhibitor evaluated in Phase 1/1b studies in RAS-pathway-mutated solid tumors and NRAS-mutated melanoma, and OKI-1546, a selective oral CDK12 inhibitor in preclinical development.

The company's discovery engine is built on structure-based drug design combined with a computational drug discovery platform led by SVP James Blake, Ph.D., leveraging structure- and ligand-based design, physical property optimization, virtual screening, and library design. The scientific leadership carries a deep Array BioPharma and Pfizer Boulder pedigree, with the CEO, CSO, CFO, General Counsel, and multiple SVPs having previously worked together at those organizations. OnKure's core technical differentiation is mutant selectivity: first-generation PI3Kα inhibitors are only 1–5x selective for mutant versus wild-type PI3Kα and carry on-target toxicity (hyperglycemia, rash, stomatitis, diarrhea), whereas OKI-219 is engineered for high H1047R selectivity and OKI-345/OKI-355 are designed to address the H1047R, E542K, and E545K mutations that together account for PI3Kα mutations in up to 38% of breast cancer cases.

The business model is pre-commercial and pre-revenue. OnKure funds its R&D through equity financings—including venture rounds (Form D offering of ~$56M in March 2022; $54M Series C in May 2023) and post-IPO private placements ($65M PIPE at the Reneo merger; oversubscribed $150M PIPE in March 2026 led by Access Biotechnology)—with no marketed products, no pricing model, and no disclosed customer relationships. Future revenue is expected to derive from commercialization of PI3Kα inhibitors in oncology and vascular anomalies, supplemented by potential licensing royalties and milestone payments; near-term economics are driven by capital raises, not commercial sales. The company maintains a small organization (11–50 employees per firmographics, with no explicit headcount disclosed), is GDPR-compliant in its data handling, and is governed by a Delaware-incorporated parent entity with corporate operations in Boulder.

Name

OnKure Therapeutics

Legal name

OnKure, Inc.

Website

https://onkuretherapeutics.com

Company type

Public

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

OnKure Therapeutics is a clinical-stage biopharmaceutical company designing mutant-selective PI3Kα small molecule precision oncology drugs, with lead candidate OKI-219 in Phase 1 trials for breast cancer and next-generation pan-mutant PI3Kα inhibitors in IND-enabling studies.

Ownership category

akta.pro rank

Product category

Precision Oncology Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Oncology & Hematology Pharmaceuticals (HLAIAAAC)

Keywords

• Precision oncology therapeutics
• PI3K alpha inhibitors
• Small molecule drug discovery
• Cancer kinase inhibitors
• Clinical-stage biopharmaceuticals

Headquarters

HQ city

Boulder

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pre-revenue / clinical-stage: OnKure Therapeutics is a clinical-stage biopharmaceutical company with no commercial product revenue. As of March 2026 the company reported approximately $60 million in cash on hand and is funded by equity financings (Series C, PIPE, private placement). Future revenue is expected to come from commercialization of PI3Kα inhibitor drug candidates (OKI-219, OKI-345, OKI-355) in breast cancer and vascular anomalies, with potential for licensing royalties, milestone payments, and ultimately drug sales / managed-market reimbursement once approved.

Go-to-market motion1 record

Core offering

OnKure Therapeutics is a clinical-stage biopharmaceutical company that discovers and develops precision small-molecule medicines targeting validated cancer drivers, anchored on a structure-based drug design and computational chemistry platform. Its pipeline is built around mutant-selective PI3Kα inhibitors — lead candidate OKI-219 (PI3Kα H1047R mutant-selective, Phase 1) and next-generation pan-mutant candidates OKI-345 (breast cancer) and OKI-355 (vascular anomalies) — supplemented by an oral class I-selective HDAC inhibitor (OKI-179/Bocodepsin) and a selective CDK12 inhibitor (OKI-1546).

Product overview

OnKure Therapeutics is a clinical-stage biopharmaceutical company that operates a single integrated drug discovery and development platform focused on precision oncology (and related vascular anomaly) medicines. Its offering is built on a structure-based drug design platform used to generate a portfolio of small molecule candidates that selectively target biologically validated oncogenic drivers — primarily mutant PI3Kα — and is complemented by expertise in kinase inhibition, cell cycle biology, signal transduction, epigenetics, and pathway destabilization. The platform produces individual pipeline assets including the lead clinical-stage PI3Kα H1047R mutant-selective inhibitor OKI-219 (in Phase 1 for solid tumors including metastatic breast cancer) and two next-generation PI3Kα pan-mutant-selective inhibitors — OKI-345 (breast cancer) and OKI-355 (vascular anomalies), both advancing through IND-enabling studies toward 1H 2027 IND filings — together with earlier-stage programs such as the oral class I-selective HDAC inhibitor OKI-179 (Bocodepsin) and the CDK12 inhibitor OKI-1546. Together these named candidates constitute OnKure's precision-medicine pipeline, anchored by the strategic emphasis on becoming a leader in targeting oncogenic PI3Kα.

Differentiator

Problem solved

Functional benefit

Products and services

• OKI-219 Lead clinical-stage precision oncology candidate: a brain-penetrant PI3Kα H1047R mutant-selective inhibitor being evaluated in the Phase 1 PIKture-01 trial for mutant-selected solid tumors including metastatic breast cancer. Designed to selectively target the H1047R mutation that drives breast cancer tumorigenesis and resistance to HER2-targeted therapies, with significantly higher mutant vs wild-type selectivity than first-generation PI3Kα inhibitors (which are only 1-5X selective).
• OKI-345 Next-generation PI3Kα pan-mutant-selective inhibitor in IND-enabling studies for the initial indication of breast cancer. Designed to address the H1047R, E542K, and E545K mutations that together account for PI3Kα mutations in up to 38% of breast cancer cases, building on the OKI-219 selectivity profile but with broader mutation coverage.
• OKI-355 Next-generation PI3Kα pan-mutant-selective inhibitor in IND-enabling studies for the initial indication of vascular anomalies, extending the pan-mutant-selective PI3Kα franchise beyond oncology into vascular disease.
• OKI-179 (Bocodepsin) Class I-selective, orally bioavailable depsipeptide histone deacetylase (HDAC) inhibitor with a romidepsin-like profile, evaluated alone and in combination with binimetinib in RAS-pathway-mutated solid tumors and NRAS-mutated melanoma. Preclinical work also explored overcoming doxorubicin resistance in triple-negative breast cancer.
• OKI-1546 Selective, orally bioavailable inhibitor of CDK12 shown to cause tumor regression in multiple preclinical cancer models. Presented at AACR 2023 as part of OnKure's earlier-stage precision oncology portfolio.

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Broad incumbents

• Schrödinger, Inc. Computational drug discovery platform company serving both internal pipeline development and pharma partnerships. Comparable to OnKure's structure-based drug design platform and emphasis on computational chemistry led by SVP James Blake (a Schrödinger-platform-era Array BioPharma alumnus).
• Agios Pharmaceuticals: Commercial-stage precision medicine company with FDA-approved oncology drugs Tibsovo and Idhifa (both led through approval by OnKure's current CMO Samuel Agresta). Comparable in precision oncology focus, kinase/epigenetic target expertise, and historical role as a developer of mutant-selective cancer therapies.
• Mirati Therapeutics (BMS): Precision oncology company (acquired by Bristol-Myers Squibb in 2024 for ~$4.8B) that developed Krazati (adagrasib, KRAS G12C) and advanced PI3Kα programs. Highly relevant given Mirati's PI3Kα mutant-selective efforts and its role as a benchmark for M&A in precision oncology targeting validated drivers.

Direct peers

• Foghorn Therapeutics: Clinical-stage precision oncology company targeting chromatin regulatory systems and oncogenic drivers, with similar headcount scale and public-market profile. OnKure's prior CMO Samuel Agresta joined from Foghorn, indicating direct talent and strategic overlap in the precision oncology space.
• Relay Therapeutics: Clinical-stage precision oncology company using a motion-based drug design platform to target validated oncogenic drivers, including mutant-selective PI3Kα programs (e.g., RLY-2608). Direct competitor to OnKure's pan-mutant PI3Kα strategy with a similar technical approach to selectivity and a public Nasdaq listing.
• Revolution Medicines: Clinical-stage precision oncology company developing mutant-selective inhibitors of RAS(ON) and other oncogenic drivers. Comparable in approach (structure-based design of mutant-selective small molecules) and in public-market positioning, with a similar clinical-stage profile and pipeline depth.
• Repare Therapeutics: Clinical-stage precision oncology company leveraging synthetic lethality and computational discovery to develop targeted cancer therapies. Comparable in platform-driven approach, public Nasdaq listing, and pipeline-stage development.
• Kymera Therapeutics: Clinical-stage precision medicine company developing targeted protein degraders against validated disease drivers. Comparable in structure-based design approach, public Nasdaq listing, and pipeline-stage profile in the precision oncology space.

Others

• Blueprint Medicines (Roche): Precision therapy company (acquired by Roche in 2025) that developed Ayvakit and Gavreto for genomically defined cancers. Comparable in structure-based design of kinase inhibitors against validated oncogenic drivers, with a successful track record in bringing mutant-selective oncology drugs to market.

Emerging players

• Infinity Pharmaceuticals: Clinical-stage oncology company that developed duvelisib (Copiktra), a PI3K delta/gamma inhibitor. Comparable historical overlap in PI3K class drug development and ties to OnKure's CMO Agresta (who was Infinity's CMO). Relevant for understanding PI3K class development and regulatory dynamics.

Market position

Strengths5 records

Weaknesses4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/OnKureTx
• LinkedInlinkedin.com/company/onkure-inc.

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries2 records

Funding overview

Funding rounds10 records

Investors23 records

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M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about OnKure Therapeutics