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Kura Oncology, Inc. (KURA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 results were mixed: collaboration revenue rose sequentially to $20.8M, but came in below S&P Global consensus; diluted EPS of $(0.85) also missed consensus as operating expenses stepped up with Phase 3 acceleration and pre-commercial spend . Consensus values marked with an asterisk are from S&P Global.
  • Strategic execution accelerated: first patients dosed in both intensive and non‑intensive KOMET‑017 Phase 3 frontline AML trials (Sep/Oct), with two $30M milestones received in Oct/Nov and two ASH 2025 oral presentations accepted; NDA for ziftomenib remains under FDA Priority Review with 11/30/2025 PDUFA date .
  • Balance sheet remains strong: $549.7M quarter-end cash and $609.7M pro forma including Oct/Nov milestones; management reiterates cash runway into 2027 and indicates resources, with anticipated collaboration funding, should support ziftomenib through topline KOMET‑017 results .
  • Key near-term catalysts: PDUFA on 11/30/2025; ASH 2025 oral data on ven/aza combinations; continued KOMET‑017 enrollment; potential estimate revisions to reflect timing of milestone recognition .

What Went Well and What Went Wrong

What Went Well

  • Frontline Phase 3 momentum: “KOMET‑017 comprises two global, randomized, double‑blind, placebo‑controlled trials” across intensive and non‑intensive regimens; first patients dosed in both trials in Sep/Oct, unlocking two $30M milestones and broadening reach to >50% of AML settings .
  • Differentiation narrative gaining traction: Management emphasized a favorable safety profile versus competitors (no black box for QTc/Torsades), positioning ziftomenib for “best‑in‑class potential” and combinability; call commentary highlighted safety tradeoffs as a key prescriber decision factor .
  • Balance sheet strength and visibility: $549.7M cash at 9/30/25 and $609.7M pro forma including Oct/Nov milestones; runway into 2027 and expected collaboration funding to carry through topline KOMET‑017 results .

What Went Wrong

  • Miss vs consensus: Collaboration revenue of $20.8M and EPS of $(0.85) underperformed S&P Global consensus for Q3 2025; street models likely need to refine milestone timing assumptions (estimates marked with asterisk are from S&P Global) .
  • OpEx intensity: R&D rose to $67.9M and G&A to $32.8M (both up y/y), reflecting Phase 3 scale‑up and pre‑commercial activities, elevating quarterly net loss to $(74.1)M .
  • Continued losses: Despite collaboration revenue, total operating expenses of $100.7M drove an operating shortfall that outweighed other income; net loss per share widened to $(0.85) from $(0.75) in Q2 .

Financial Results

P&L vs prior periods and S&P Global consensus (Q3 2025)

MetricQ3 2024Q2 2025Q3 2025 ActualQ3 2025 Consensus*
Collaboration Revenue ($USD Millions)$0.0 $15.3 $20.8 $46.3*
R&D Expense ($USD Millions)$41.7 $62.8 $67.9 n/a
G&A Expense ($USD Millions)$18.2 $25.2 $32.8 n/a
Net Loss ($USD Millions)$(54.4) $(66.1) $(74.1) n/a
Diluted EPS ($)$(0.63) $(0.75) $(0.85) $(0.68)*

Notes:

  • No product revenue; collaboration revenue driven by Kyowa Kirin agreement .
  • Consensus values marked with an asterisk are from S&P Global.

Balance Sheet and Liquidity

Metric ($USD Millions)Q1 2025 (3/31)Q2 2025 (6/30)Q3 2025 (9/30)
Cash, Cash Equivalents & Short‑Term Investments$658.2 $630.7 $549.7
Pro Forma Cash (incl. earned milestones)$703.2 $630.7 $609.7
Working Capital$634.4 $552.9 $499.4
Stockholders’ Equity$364.4 $305.5 $242.5

KPIs and Operating Drivers

KPIQ1 2025Q2 2025Q3 2025
PDUFA Date (ziftomenib, R/R NPM1‑m AML)NDA submitted; awaiting acceptance Priority Review; PDUFA 11/30/2025 Priority Review; PDUFA 11/30/2025 reaffirmed
KOMET‑017 Frontline Phase 3Planned 2H25 start On track for 2H25 start First patients dosed (IC & NIC)
ASH 2025 Presentations (ven/aza combos)Planned H2 2025 Planned H2 2025 Two orals accepted
Cash Runway (Mgmt)Into 2027 Into 2027 Into 2027 (unchanged)

Segment breakdown: Not applicable (no commercial product revenue) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent UpdateChange
Ziftomenib PDUFABy 11/30/2025Priority Review; PDUFA 11/30/2025 (Q2 update) Priority Review; PDUFA 11/30/2025 reaffirmed (Q3) Maintained
KOMET‑017 Phase 3 (IC & NIC)2H 2025On track to initiate 2H 2025 First patients dosed in Sep/Oct Achieved/Advanced
ASH 2025 (ven/aza data)Dec 2025Preliminary data planned H2 2025 Two oral presentations accepted Upgraded (secured orals)
Cash RunwayMulti‑yearFund ops into 2027 Fund ops into 2027 (unchanged) Maintained
Milestone ReceiptsNear‑termUp to $375M (Q1) Two $30M milestones received Oct/Nov; $105M received YTD; up to $315M more near‑term Achieved partial; remaining potential reiterated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025 and Q2 2025)Current Period (Q3 2025)Trend
Regulatory (NDA)Q1: NDA submitted ; Q2: Priority Review; PDUFA 11/30/25; interactions “collaborative” Interactions remain “open and constructive”; on track for 11/30 PDUFA Steady; confidence maintained
Frontline Phase 3 strategyQ1/Q2: Two Phase 3s planned 2H25 to cover intensive & non‑intensive First patients dosed; emphasis on broad coverage (~50% AML) and dual primary endpoints Accelerating
Safety differentiation vs competitorQ2: Low QTc concern highlighted CEO/CMO underscore competitor’s QTc/Torsades black box; positioning ziftomenib on benefit‑risk Strengthening differentiation narrative
Commercial readinessQ2: Sales team onboarded; payer PAI underway “Launch‑ready” with KK “1K” field teams trained; one‑SKU simplicity Execution ready
FTI platformQ2: Three ESMO abstracts, expansion cohorts planned ESMO data: manageable safety and ORR (RCC and HNSCC combos) Building optionality

Management Commentary

  • “With the initiation of the pivotal KOMET‑017 Phase 3 trials, we are executing a robust, focused development strategy to unlock ziftomenib’s best‑in‑class potential across the continuum of unmet need in AML.”
  • “Communication with FDA continues to be open and constructive, and we remain focused on achieving a successful review outcome [for ziftomenib]” with PDUFA on November 30, 2025 .
  • On safety differentiation: “If you have two agents… but one of which has a one in a hundred or more chance of sudden cardiac death, what are you going to choose?... we’re going to have a differentiated and favorable benefit‑risk profile” .
  • On commercial readiness: “Our teams are launch‑ready and confident in our execution plan… our two field teams… completed their training and pre‑certification” .

Q&A Highlights

  • Safety/label dynamics: Detailed discussion of competitor black box for QTc/Torsades and how safety profile could drive prescriber choice, especially in frontline where duration is longer .
  • Launch strategy/second‑mover: Management argued differentiation plus execution (one SKU, distribution readiness, experienced field force, payer groundwork) will overcome any first‑mover advantage .
  • ASH orals: Expect more evaluable patients, deeper MRD analyses, subgroup cuts (FLT3, IDH), and longer follow‑up beyond June 2025 abstract cutoffs .
  • NCCN listing: Plans to submit COMET‑001 data “within days of approval” for NCCN inclusion; cannot submit pre‑approval .
  • FDA cadence: No disruption noted despite broader FDA changes; still on track for 11/30 PDUFA .

Estimates Context

  • Q3 2025 actuals vs S&P Global consensus: Revenue $20.8M vs $46.3M*; Diluted EPS $(0.85) vs $(0.68)* — both indicate a miss (actuals from 8‑K/press release, estimates from S&P Global) . Values with asterisk are retrieved from S&P Global.
  • Implications: Street models may need to adjust for milestone timing given first‑patient dosing achievements triggered $60M in Oct/Nov, post quarter‑end .

Key Takeaways for Investors

  • Regulatory overhang: 11/30/2025 PDUFA is the primary near‑term stock catalyst; management commentary suggests constructive FDA engagement .
  • Frontline expansion: KOMET‑017 first‑patient dosing in both IC and NIC settings validates operational execution and broadens TAM; Phase 3s designed with dual primary endpoints enabling accelerated/full approval paths .
  • Competitive positioning: Safety/tolerability and combinability remain central to the “best‑in‑class” case versus menin peers; ASH data could reinforce differentiation .
  • Financial runway: ~$550M cash at quarter‑end and ~$610M pro forma support launch prep and Phase 3 execution into 2027; collaboration milestones provide added flexibility .
  • Model reset risk: Q3 underperformed consensus on revenue/EPS; watch for estimate shifts around milestone recognition and pre‑commercial/Phase 3 OpEx ramp .
  • Trading setup: PDUFA outcome, ASH orals, and ongoing site activation/enrollment updates are likely to drive near‑term sentiment and flows .
  • Medium‑term thesis: If approved in R/R NPM1‑m and with positive combination data, ziftomenib could become a backbone across AML settings; FTI program offers additional optionality in solid tumors .

Citations:

  • Q3 2025 8‑K and Exhibit 99.1 press release:
  • Q3 2025 standalone press release:
  • Q3 2025 earnings call transcript:
  • Q2 2025 8‑K/financials:
  • Q2 2025 earnings call:
  • Q1 2025 8‑K/financials:
  • Milestone/payment press releases:

Notes:

  • Consensus/estimate values marked with an asterisk (*) are retrieved from S&P Global.