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Kura Oncology, Inc. (KURA)·Q1 2025 Earnings Summary

Executive Summary

  • Kura submitted its first NDA for ziftomenib in R/R NPM1-mutant AML on March 31, requested Priority Review, and expects FDA’s acceptance decision in Q2 2025; ASCO/EHA podium/encore presentations are scheduled, supporting near‑term visibility on clinical data .
  • Q1 results: collaboration revenue $14.1M, net loss $(57.4)M, EPS $(0.66); pro forma cash $703.2M including a $45M NDA submission milestone earned under the Kyowa Kirin collaboration; runway into 2027 maintained .
  • Versus S&P Global consensus, Q1 revenue and EPS missed as collaboration revenue recognized ($14.1M) lagged Street expectations despite milestone earning; Street had modeled higher collaboration revenue recognition in the quarter (see Estimates Context) .
  • Key catalysts likely to drive stock: FDA acceptance/PDUFA setting with potential Priority Review, ASCO/EHA data (KOMET‑001 monotherapy; KOMET‑007 7+3 combo), and Phase 3 KOMET‑017 trial initiations in 2H25 .

What Went Well and What Went Wrong

  • What Went Well

    • Regulatory execution: “we achieved a significant milestone with the submission of our first NDA for ziftomenib,” with Priority Review requested and no observed FDA disruptions; BTD status supports review resourcing .
    • Clinical momentum: KOMET‑001 monotherapy accepted for ASCO oral; KOMET‑007 7+3 frontline data accepted for EHA oral; robust enrollment across combo studies .
    • Balance sheet strength: Pro forma cash $703.2M including a $45M milestone; management reiterated runway into 2027 and ability (with collaboration funding) to support frontline commercialization .

  • What Went Wrong

    • Miss vs estimates: Q1 collaboration revenue ($14.1M) and EPS (−$0.66) missed S&P consensus as Street expected higher collaboration revenue recognition; net loss widened y/y despite collaboration revenue .
    • OpEx step-up: R&D rose to $56.0M (from $36.3M y/y) and G&A to $22.8M (from $18.2M y/y) as Kura scaled development and pre-commercial efforts .
    • Sequential cash decline: Cash and equivalents fell to $658.2M from $727.4M at year‑end (though pro forma cash including the earned milestone was $703.2M) .

Financial Results

MetricQ1 2024Q4 2024Q1 2025
Collaboration Revenue ($USD Millions)$0.0 $53.9 $14.1
Research & Development ($USD Millions)$36.3 $52.3 $56.0
General & Administrative ($USD Millions)$18.2 $24.1 $22.8
Total Operating Expenses ($USD Millions)$54.5 $76.3 $78.8
Net Loss ($USD Millions)$(49.5) $(19.2) $(57.4)
Diluted EPS ($)$(0.59) $(0.22) $(0.66)

Balance sheet and liquidity

MetricQ4 2024Q1 2025
Cash, Cash Equivalents & Short‑Term Investments ($USD Millions)$727.4 $658.2
Pro Forma Cash incl. $45M Milestone ($USD Millions)—$703.2
Cash RunwayInto 2027 Into 2027

Q1 2025 vs S&P Global consensus

MetricActualConsensus*Surprise
Collaboration Revenue ($USD Millions)$14.108 $39.076*−$24.968 (−63.9%)*
Diluted EPS ($)$(0.66) $(0.600)*$(0.06)*
  • Street context: EPS estimates (8) and revenue estimates (12) were embedded in the consensus for Q1 2025*. Q4 2024 had revenue consensus $58.0M vs actual $53.9M and EPS consensus $(0.64) vs actual $(0.22), reflecting volatility in collaboration revenue recognition across periods*.
  • Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious Guidance (Q4 2024)Current Update (Q1 2025)Change
NDA for ziftomenib (R/R NPM1‑m AML)Submission/ReviewSubmit in Q2 2025 Submitted Mar 31, 2025; Priority Review requested; acceptance decision expected Q2 2025 Achieved/advanced
KOMET‑017 (Phase 3 IC & NIC frontline)Initiation2H 2025 Study start‑up underway; on track to initiate 2H 2025 Maintained
KOMET‑001 (monotherapy pivotal)Data visibilityTopline in Q2 2025 Accepted for ASCO oral presentation in Q2 2025 Scheduled
KOMET‑007 (7+3 frontline)Data visibilityPresent preliminary data in Q2 2025 EHA oral June 12; updated dataset to be presented Scheduled
KOMET‑007 (ven/aza frontline)Data visibility2H 2025 2H 2025 medical meeting Maintained
Cash runwayMulti‑yearInto 2027 Into 2027 Maintained

Earnings Call Themes & Trends

TopicQ3 2024 (two quarters ago)Q4 2024 (prior quarter)Q1 2025 (current)Trend
Regulatory path (NDA/Priority Review)Preparing pivotal topline early 2025; BTD status emphasized Alignment with FDA/EMA on KOMET‑017; NDA planned for Q2 2025 NDA submitted; Priority Review requested; expecting acceptance decision Q2; no FDA disruption Accelerating/derisked
Frontline Phase 3 design & endpointsMRD negativity discussed as potential surrogate; survival endpoints base case Dual primary endpoints (MRD‑neg CR and EFS/OS) aligned with FDA/EMA Dual primary endpoints reiterated; timing on initiations intact Clarity improving
Combination strategy (7+3, ven/aza)ASH abstracts showed robust safety/combinability; dose escalation to 600mg Expansion cohorts open; strong duration on therapy in frontline EHA oral (7+3) in June; ven/aza data 2H25; focus on safety first for triplet Execution steady
GIST expansionPreclinical synergy with imatinib; IND cleared POC trial expected 1H25 First patients dosed in KOMET‑015 (ziftomenib+imatinib) Transition to clinic
FTI program (KO‑2806)Initiated combinations (cabo; adagrasib) First clinical data 2H25 Data 2H25; plan expansion cohorts in RCC 2H25 Milestones approaching
Competitive dynamicsEmphasis on tolerability/combinability Differentiation via safety, once‑daily dosing Expect competitive R/R market; may not be second to market; focus on “fighting for every patient” Competitive readiness

Management Commentary

  • “We achieved a significant milestone with the submission of our first NDA for ziftomenib… and are strategically advancing our pre‑commercial activities to prepare for potential approval” — Troy Wilson, CEO .
  • “KOMET‑001… achieved its primary CR/CRh endpoint… data will be shared in an oral presentation at ASCO” — Mollie Leoni, CMO .
  • “As adjusted for the $45 million milestone… Kura had on a pro forma basis, $703.2 million in cash… sufficient to fund… into 2027” — Thomas Doyle, SVP Finance .
  • “We requested priority review… we expect to receive notification… in the second quarter… at this point, it’s business as usual [with FDA]” — Troy Wilson .
  • “In frontline 7+3, we’re seeing high response rates… durability and MRD will be key; bone marrow MRD negativity around ~40% is a useful anchor for better‑performing subgroups” — Mollie Leoni .

Q&A Highlights

  • Priority Review/ODAC: Company “feels good” about review dynamics; not anticipating an ODAC given palliative setting and safety profile .
  • Combo data expectations: For frontline ven/aza triplet, safety is the first priority; preliminary efficacy, time on treatment, and combinability readouts expected 2H25 .
  • Market positioning: Management argues it’s “not obvious we’ll be second to market” and is planning a resource‑intensive launch with Kyowa Kirin to compete for every R/R patient .
  • Phase 3 gating steps: Study start‑up ongoing globally; target initiation in 2H25; strong investigator interest and site feedback .
  • Off‑label competitor use: Company expects some experimentation but aims to win via risk‑benefit communication; emphasis on safety/tolerability and combinability .

Estimates Context

  • Q1 2025 vs S&P Global consensus: Revenue $14.108M vs $39.076M consensus (miss), EPS $(0.66) vs $(0.600) consensus (miss). 8 EPS estimates and 12 revenue estimates informed consensus*. The shortfall ties to lower recognized collaboration revenue despite earning a $45M milestone upon NDA submission; collaboration revenue recognized for Q1 was $14.1M while pro forma cash reflects the milestone .
  • Q4 2024 context: Revenue $53.9M vs $58.0M consensus (slight miss), EPS $(0.22) vs $(0.64) (beat), highlighting volatility in collaboration accounting across periods .
  • Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Regulatory momentum is strong: NDA filed; Priority Review requested; acceptance/PDUFA setting in Q2 is the next catalyst .
  • Near‑term clinical visibility: ASCO (KOMET‑001 monotherapy) and EHA (KOMET‑007 7+3) in Q2, with ven/aza triplet data in 2H25 .
  • Frontline path clarified: Dual primary endpoints (MRD‑neg CR and survival) aligned with FDA/EMA; Phase 3 initiation targeted for 2H25 .
  • Funding derisks execution: Pro forma cash $703M and up to $375M in anticipated near‑term milestones support launch prep and Phase 3 execution into 2027 .
  • Q1 miss likely driven by conservative collaboration revenue recognition; watch for cadence of milestone recognition vs Street modeling in coming quarters .
  • GIST expansion now clinical (KOMET‑015 first patients dosed), adding optionality beyond AML .
  • Focus areas for diligence: FDA acceptance/PDUFA timing, ASCO/EHA data quality (CR/CRh, durability, MRD), triplet tolerability signals, and clarity on Phase 3 start‑up pace .

Footnote: *Values retrieved from S&P Global.