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OnKure Therapeutics, Inc. (OKUR)·Q4 2024 Earnings Summary

Executive Summary

  • Pre-revenue clinical-stage quarter with cash and operating runway strengthened; cash and cash equivalents ended at $110.8M, supporting operations through multiple PIKture‑01 readouts into Q4 2026 .
  • OpEx stepped up on clinical and company build-out: R&D $14.4M (+63% YoY) and G&A $4.3M (+~3.2x YoY); net loss of $17.4M (EPS $(1.37)) vs $9.5M prior year as programs and public company costs scaled .
  • Clinical execution update: Part A monotherapy enrollment nearly complete up to 1,500 mg BID with no dose-limiting toxicities; Part B fulvestrant combination advancing with initial combination data expected 2H’25 .
  • Pipeline expansion catalyst: pan‑mutant PI3Kα development candidate expected Q2’25; additional OKI‑219 single‑agent and initial combination data from PIKture‑01 expected 2H’25, key stock-moving milestones .

What Went Well and What Went Wrong

What Went Well

  • “We expect to report additional OKI‑219 data from PIKture‑01, announce our pan‑mutant inhibitor program, and declare plans to initiate additional clinical trials” — CEO Nicholas Saccomano, Ph.D., underscoring pipeline momentum and clinical visibility .
  • Safety/tolerability in early OKI‑219 data encouraging: No hyperglycemia, stomatitis, or rash; only grade 1 TRAEs; no dose interruptions, delays, reductions, or discontinuations reported in Part A as of the October 28, 2024 cutoff .
  • Cash strengthened post-merger/PIPE; YE cash and equivalents of $110.8M and runway into Q4 2026, de-risking near-term funding needs through multiple readouts .

What Went Wrong

  • Operating loss widened as R&D and G&A rose materially with trial activity and public company costs: net loss $17.4M vs $9.5M YoY; EPS $(1.37) vs $(30.14) reflecting capital structure changes .
  • Q4 OpEx increased sharply QoQ, reflecting program scale-up: total OpEx $18.7M vs $4.7M in Q3’24 (pre‑merger Reneo footprint), creating higher cash burn entering 2025 .
  • Consensus estimates unavailable via S&P Global this quarter; lack of Street anchors limits beat/miss framing and may dampen immediate estimate-revision catalysts (S&P Global data unavailable due to request limits).

Financial Results

MetricQ4 2023Q3 2024Q4 2024
Cash and Cash Equivalents ($USD Millions)$29.876 $60.689 $110.761
Total Operating Expenses ($USD Millions)$9.892 $4.664 $18.699
Research & Development ($USD Millions)$8.825 $0.904 $14.361
General & Administrative ($USD Millions)$1.067 $3.760 $4.338
Other Income ($USD Millions)$0.437 $0.972 $1.257
Net Loss ($USD Millions)$(9.455) $(3.692) $(17.442)
Diluted EPS ($USD)$(30.14) $(1.10) $(1.37)

Segment breakdown: Not applicable (no revenue segments reported; company remains pre-revenue) .

KPIs

KPIQ4 2023Q3 2024Q4 2024
Part A Monotherapy DLTsN/AN/ANone observed through 1200 mg BID; enrolling final cohort to 1500 mg BID
Safety/Tolerability (Early Data)N/AN/ANo hyperglycemia, stomatitis, rash; only grade 1 TRAEs; no dose interruptions/delays/reductions/discontinuations
PK Coverage (900 mg BID)N/AN/ASteady-state exposure with near-continuous in vivo EC80 pAKT inhibition
Part B Fulvestrant Combo ProgressN/AInitiated 4Q’24 Enrolled through 900 mg BID; no DLTs observed through 600 mg BID
Cash RunwayN/AN/ASufficient through Q4 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
OKI‑219 PIKture‑01 Part A additional single‑agent data (incl. mature data, PK)2H 2025Early clinical data anticipated in Q4 2024 Additional PK and mature single‑agent update in 2H 2025 Maintained cadence; next major update scheduled
OKI‑219 + Fulvestrant initial combination data (Part B)2H 2025Part B dosing initiated in Q4 2024 Initial combination data in 2H 2025 New specific timing window set
Pan‑mutant PI3Kα development candidate announcementQ2 2025Not previously datedDevelopment candidate announcement in Q2 2025 New program milestone
Cash RunwayThrough Q4 2026Not previously disclosedCash sufficient through Q4 2026 New disclosure; extended runway
Additional clinical trials (plans)2025Not specifiedPlans to initiate additional clinical trials (timing to be declared) New directional guidance

Earnings Call Themes & Trends

(Transcript not available; themes derived from filings and press release)

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
R&D execution (OKI‑219)Anticipated early clinical data in Q4’24; post-merger transition Part A monotherapy nearly complete to 1500 mg BID, encouraging safety/PK; Part B advancing Strengthening execution
Safety/tolerability focusN/ANo hyperglycemia/stomatitis/rash; only grade 1 TRAEs; no dose interruptions Positive safety narrative
Pipeline expansionN/APan‑mutant program targeted for Q2’25 announcement; helical domain program targeted for 2026 Broadening pipeline
Financing & runwayCash ~$76.7M pre‑PIPE, sufficiency 12+ months YE cash $110.8M; runway through Q4’26 Improved liquidity
Regulatory/clinical designEmphasis on Project OPTIMUS dose exploration Dose‑finding and PAD selection underway in Parts B/C per design Aligned with FDA paradigms

Management Commentary

  • “I am extremely pleased with the progress we made last year… we are committed to developing product candidates that address the needs of patients who suffer from diseases implicated by PI3Ka…” — Nicholas Saccomano, Ph.D., President & CEO .
  • “This year, we expect to report additional OKI‑219 data from PIKture‑01, announce our pan‑mutant inhibitor program, and declare plans to initiate additional clinical trials.” — Dr. Saccomano .

Q&A Highlights

  • No Q4 2024 earnings call transcript available in the document catalog for OKUR; therefore, Q&A content and any guidance clarifications are not accessible for this period [ListDocuments returned none].

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable due to request limits; as a result, beat/miss analysis versus Street cannot be provided this quarter. Values would normally be retrieved from S&P Global; however, the data were unavailable at the time of analysis (Values retrieved from S&P Global).

Key Takeaways for Investors

  • Liquidity extended: $110.8M cash and runway through Q4 2026 reduces near‑term financing risk and supports multiple clinical data catalysts .
  • Early OKI‑219 data de‑risking safety: absence of key PI3KαWT‑related toxicities (hyperglycemia, stomatitis, rash) and only grade 1 TRAEs supports selectivity thesis and combination potential .
  • Clinical cadence: Expect additional single‑agent and initial fulvestrant combination readouts in 2H’25; pan‑mutant development candidate in Q2’25 — these are the primary stock catalysts in 2025 .
  • OpEx inflection reflects scale‑up; watch quarterly burn versus runway and timing of Part B/C dose optimization and expansion cohorts .
  • Pre‑revenue risk profile persists; execution on dose optimization (Project OPTIMUS) and combination efficacy signals will be critical to medium‑term thesis .
  • Competitive landscape remains active in PI3K/AKT pathway; differentiation hinges on mutant selectivity and tolerability enabling robust combination regimens .
  • Near‑term trading catalysts: Q2’25 pan‑mutant announcement; any interim clinical updates; and governance/financing developments given extended runway .

Notes:

  • Company remains pre‑revenue: “We have never generated any revenue from commercial product sales” .
  • Merger with Reneo and $65M financing closed Oct 4, 2024; Nasdaq trading commenced Oct 7, 2024 under “OKUR,” which helped underpin YE cash .
  • Forward‑looking statements in filings highlight customary development and regulatory risks .