OnKure Therapeutics, Inc.
OKUR evidence brief
What we can confirm
- BioSniper Score:
- 4.7 / 10
- Market Cap:
- $111.5M
- Lead Asset:
- mavodelpar (Preclinical)
What it means
What to watch
Prepared research question
What matters most for OKUR—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · OKUR
OnKure Therapeutics, Inc. (OKUR) is a clinical-stage biopharmaceutical company focused on developing PI3Kα inhibitors for cancer, with no approved products and ongoing clinical trials.
Key risk: No approved products
BioSniper Score
Based on 4 of 6 signals
Market Cap
$111.5M
Cash Runway
—
Lead Asset
mavodelpar (Preclinical)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 1 clinical trial for OnKure Therapeutics, Inc..
OnKure Therapeutics, Inc. (OKUR) is a clinical-stage biopharmaceutical company focused on developing PI3Kα inhibitors for cancer, with no approved products and ongoing clinical trials.
- Cash and equivalents of $166.5M as of 2026-06-30 [sec].
- Net loss of -$15.3M for the quarter ended 2026-06-30 [sec].
- Shareholders' equity of $172.1M as of 2026-06-30 [sec].
- Phase 1a/1b PIKture-01 trial evaluating OKI-219 in HR+ and HER2+ advanced breast cancer is ongoing [sec · filed 2026-03-30].
- IND applications for next-generation PI3Kα pan-mutant inhibitors OKI-345 and OKI-355 planned for first half of 2027 [sec · filed 2026-03-30].
What works
- Cash position of $166.5M as of 2026-06-30 provides a runway of at least 12 months from that date [sec_mda · as of 2026-08-04].
- The company's PI3Kα pan-mutant candidates are designed for broad combinability with minimal drug-drug interaction potential [sec · filed 2026-03-30].
- Phase 2 dose evaluation for OKI-219 combination triplets is expected to be completed in 2026 [sec_mda · as of 2026-05-05].
What to weigh
- No product candidates approved for sale and no revenue from product sales generated to date [sec_mda · as of 2026-08-04].
- Accumulated significant operating losses, with net losses of $30.5M for the six months ended June 30, 2026 and $59.5M for the year ended December 31, 2025 [sec_mda · as of 2026-08-04].
- The company does not plan to pursue further clinical development of OKI-219 independently, relying on next-generation candidates [sec_mda · as of 2026-05-05].
- Will need additional capital to fund operations, which may be sought from equity or debt financings [sec_mda · as of 2026-08-04].
From the filings
Quoted directly from source documents.
Cash position and financial runway
“Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the date of issuance of our unaudited condensed consolidated financial statements for the quarter ended June 30, 2026.”
SEC MD&A · August 4, 2026
No revenue from product sales
“We do not have any product candidates approved for sale, have not generated any revenue from product sales, and do not expect to generate revenues from the commercial sale of any products for the foreseeable future, if ever.”
SEC MD&A · August 4, 2026
IND submission timeline for next-generation candidates
“The Company plans to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration for each of OKI-345 and OKI-355 in the first half of 2027.”
SEC filings · March 30, 2026
Net losses incurred
“Our net losses were $30.5 million and $59.5 million for the six months ended June 30, 2026 and the year ended December 31, 2025, respectively.”
SEC MD&A · August 4, 2026
Catalyst timeline
- 2024-02-26 · PIKture-01 Phase 1 Start — First-in-human study of OKI-219 as monotherapy and in combination for advanced breast cancer.
Risks & what to watch (4)›
Key risks
- No approved products — No product candidates approved for sale; no revenue from product sales generated [sec_mda · as of 2026-08-04].
- Continued operating losses — Net losses of $30.5M for six months ended June 30, 2026; accumulated deficit not specified [sec_mda · as of 2026-08-04].
- Dependence on next-gen candidates — Company does not plan further independent development of OKI-219; relies on OKI-345/OKI-355 IND in H1 2027 [sec_mda · as of 2026-05-05].
- Need for additional capital — Will need additional capital to fund operations; may seek equity or debt financings [sec_mda · as of 2026-08-04].
What to watch
- Completion of Phase 2 dose evaluation for OKI-219 combination triplets in 2026 [sec_mda · as of 2026-05-05].
- IND submissions for OKI-345 and OKI-355 expected in first half of 2027 [sec · filed 2026-03-30].
- Data from PIKture-01 trial announced in March 2026 [news · published 2026-03-12].
- Next-generation PI3Kα pan-mutant inhibitor development candidate announcement expected in March 2026 [news · published 2026-03-12].
Sources: Catalysts · News · Pipeline · SEC filings · SEC MD&A · Generated October 7, 2026 · How we verify sources →
Run OnKure Therapeutics, Inc. through your own thesis
Use the pipeline, catalyst, financial, FDA, and market facts on this page as inputs to a protocol you control.
Your protocol can:
- Turn available OnKure Therapeutics, Inc. facts into screen rules or deeper checks
- Show cited findings, blockers, and unresolved evidence together
- Save the logic and rerun it as the company evidence changes
Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.04 · 0% dilution
Lead: Preclinical
1 candidate
No upcoming catalysts tracked
0 buys · 2 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
50
Total value held
$112.6M
| Holder | Shares | Value |
|---|---|---|
| ra capital management, l.p. | 3,998,333 | $16.6M |
| acorn capital advisors, llc | 2,839,674 | $11.8M |
| stepstone group lp | 2,660,612 | $11.0M |
| adar1 capital management, llc | 2,434,941 | $10.1M |
| prosight management, lp | 2,154,381 | $8.9M |
| bvf inc/il | 1,978,972 | $8.2M |
| vivo capital, llc | 1,927,710 | $8.0M |
| vestal point capital, lp | 1,839,819 | $7.6M |
| foresite capital management vi llc | 1,445,783 | $6.0M |
| adage capital partners gp, l.l.c. | 1,204,819 | $5.0M |
Showing top 10 of 50 institutional holders of OnKure Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of Apr 30, 2026- % of float
- 0.2%
- Days to cover
- 0.1
- Shares short
- 69,494
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
OKUR short interestGovernance
Frequently asked questions
What is the AI investment thesis for OnKure Therapeutics, Inc.?
OnKure Therapeutics, Inc. (OKUR) is a clinical-stage biopharmaceutical company focused on developing PI3Kα inhibitors for cancer, with no approved products and ongoing clinical trials.
What is OnKure Therapeutics, Inc.'s lead drug candidate?
OnKure Therapeutics, Inc.'s most advanced tracked candidate is mavodelpar (Preclinical) for primary mitochondria myopathy (PMM) due to mitochondrial DNA (mtDNA) defects.
Who is the CEO of OnKure Therapeutics, Inc.?
Dr. Nicholas A. Saccomano Ph.D. is the chief executive officer of OnKure Therapeutics, Inc. (OKUR).
Where is OnKure Therapeutics, Inc. headquartered?
OnKure Therapeutics, Inc. (OKUR) is headquartered in Boulder, CO, United States.
What therapeutic areas does OnKure Therapeutics, Inc. focus on?
OnKure Therapeutics, Inc. develops therapies across Oncology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.