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OnKure Therapeutics

OKUR Lead: Preclinical 2 Biotech Distilled articles ↓ 17 filings & releases ↓ Cash $151M (Sep 30, 2026) ↓ 2 verdicts ↓
Oncology Small Molecule

Market cap $116M 40.5M shares (10-Q, Nov 2, 2026) × $2.87 close Nov 6, 2026

Most recent annual filing: 2026-03-12

Catalyst timeline

10 trackedQuarter catalyst calendar →
  1. OKI-219 readoutBy year-end 2026: PIKture-01 "mature data"OKI-219 readout, By year-end 2026: PIKture-01 "mature data", major
  2. Zovegalisib Relay Ph3 readoutBy year-end 2026 (competitor)Zovegalisib Relay Ph3 readout, By year-end 2026 (competitor), material
  3. OnKure corporate updateNov 2026OnKure corporate update, Nov 2026, routine
  4. OKI-345 / OKI-355 IND filing1H 2027OKI-345 / OKI-355 IND filing, 1H 2027, material
  5. OnKure equity plan corporate updateJan 1, 2027OnKure equity plan corporate update, Jan 1, 2027, routine
  6. Zovegalisib Relay Ph3 startEarly 2027 (competitor): zovegalisib first-line Phase 3 startZovegalisib Relay Ph3 start, Early 2027 (competitor): zovegalisib first-line Phase 3 start, routine
  7. SNV4818 Novartis Ph1 readout~Apr 2027SNV4818 Novartis Ph1 readout, ~Apr 2027, notable
  8. OKI-345 / OKI-355 interim~2028OKI-345 / OKI-355 interim, ~2028, major
  9. OnKure corporate updateFeb 2028OnKure corporate update, Feb 2028, routine
  10. Zovegalisib Relay readout~Apr 2028Zovegalisib Relay readout, ~Apr 2028, notable

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (2 active programs)

Technology platforms

PI3K Platform

Structure-based small molecule drug design platform utilizing disciplined medicinal chemistry, x-ray crystallography and computational chemistry to discover mutation-selective inhibitors of PI3Kα; focused on oncology (breast cancer) and vascular malformations

Targets: PI3Kα H1047R, PI3Kα E545K, PI3Kα E542K

Structure-Based Drug Design Platform

Small molecule design platform using structure-based approaches to selectively target specific oncogenic mutations; focus area: PI3Kα-driven cancers and vascular malformations

Targets: PI3Kα

Structure- and Computational Chemistry-Driven Drug Design Platform

Structure- and computational chemistry-driven drug design platform used to discover and develop small molecule drugs selectively targeting specific mutations driving cancer and vascular anomalies, including mutant PI3Kα programs.

Targets: PI3Kα

Discontinued (1)

Capital (as filed)

Cash
$151M cash and cash equivalents · Sep 30, 2026 (10-Q)
Short-term investments
$11.9M Sep 30, 2026
Operating cash flow
−$13.1M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$163M cash, runway into 2029 per the update of Nov 4, 2026 — the company's own words as read there, not the filed figure

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (2)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (2 calls)

Every verdict Biotech Distilled has published on OnKure Therapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-10-23 Watch OnKure Therapeutics (OKUR) - Scientific Deep Dive for OKI-345, OKI-355 and Pipeline Products OnKure trades below cash with two preclinical PI3Kα programs and no published efficacy from its only clinical molecule, warranting a watch stance until PIKture-01 data, ATM discipline, and first-in-human glucose/liver data are confirmed.
  2. 2026-11-05 Watch UPDATE: OnKure Therapeutics (OKUR) - The Q3 Checkpoint: Two Boxes Ticked, One Still Empty Q3 10-Q confirms no ATM sales and cash on plan, but PIKture-01 data remain absent and manufacturing is single-sourced in China, so the watch stance is maintained pending year-end data.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Filings & releases (17)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Nov 4, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

17 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)