Kura Oncology, Inc. (KURA)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 results reflected modest collaboration revenue and increased operating spend as Kura advances toward ziftomenib commercialization: collaboration revenue $15.3M, net loss $66.1M, cash and investments $630.7M as of June 30, 2025 .
• FDA accepted the NDA for ziftomenib with Priority Review; PDUFA target action date is November 30, 2025, and U.S. sales force hiring/onboarding is complete, positioning for launch upon potential approval .
• Street expectations were materially higher: Q2 revenue ($15.3M) and EPS (-$0.75) missed consensus ($64.9M and -$0.37) as collaboration revenue proved lower than modeled; management did not provide quarterly revenue guidance, focusing instead on regulatory and clinical milestones . Values retrieved from S&P Global.
• Near‑term catalysts: the PDUFA decision (11/30/25), initiation of two Phase 3 frontline trials (KOMET‑017‑IC/NIC) in 2H 2025, and multiple FTI program data sets at ESMO October 2025; Kura cites up to $375M in additional near‑term milestone potential under the Kyowa Kirin collaboration .

What Went Well and What Went Wrong

What Went Well

• NDA acceptance with Priority Review and defined PDUFA date, with management describing constructive FDA interactions on-track with priority timelines: “We were pleased to announce FDA accepted our NDA… granting priority review with a PDUFA target action date of 11/30/2025” and “interactions have all been collaborative… in alignment with the timeline for a priority review” .
• Commercial readiness: “Hiring and onboarding of U.S. field sales team are now complete,” with pre‑approval information exchanges and distribution/access planning underway .
• Strong clinical narrative supporting launch and expansion: KOMET‑001 achieved CR/CRh of 23% in R/R NPM1‑m AML; favorable safety, combinability, and once‑daily dosing positioned as potential “best‑in‑class” profile; Phase 3 frontline trials on track for 2H 2025 start with dual primary endpoints enabling potential accelerated approval .

What Went Wrong

• Financial results missed Street expectations: Q2 revenue $15.3M vs consensus $64.9M and EPS -$0.75 vs -$0.37; prior quarter also missed, highlighting variability in collaboration revenue recognition timing. Values retrieved from S&P Global.
• Operating spend rose as programs scale toward Phase 3 and commercialization: R&D $62.8M vs $39.7M YoY; G&A $25.2M vs $16.7M YoY; net loss widened to $66.1M vs $50.8M YoY .
• Competitive questions intensifying around menin class dynamics and potential first‑mover advantages; management emphasized differentiation and rapid Phase 3 execution, while analysts probed NCCN guideline timing and competitive positioning .

Financial Results

P&L trend (oldest → newest)

Q2 2025 vs Prior Year (YoY)

Results vs S&P Global Consensus (oldest → newest)

Values retrieved from S&P Global.*

Revenue breakdown

KPIs and Balance Sheet

Note: Gross margin and operating margin not meaningful at this stage given absence of product sales.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “FDA’s acceptance of our NDA for ziftomenib represents another important step… With preparations underway for commercialization… and a strong pipeline… we believe Kura is well‑positioned to deliver meaningful benefit to patients and long‑term value to stakeholders.” – Troy Wilson, CEO .
• “We were pleased to announce FDA accepted our NDA… granting priority review with a PDUFA target action date of 11/30/2025… we’re focused on achieving a successful review outcome.” – Troy Wilson .
• “FDA alignment on the use of MRD negative CR and CR as dual primary endpoints for accelerated approval in both trials could substantially shorten development timelines… [KOMET‑017] is now in study startup and on track for initiation in the second half of this year.” – Mollie Leoni, CMO .
• “Our sales team… has deep experience in hematology oncology… [We are] implementing a focused distribution network… to ensure a rapid launch… upon FDA approval.” – Brian Powl, CCO .

Q&A Highlights

• Regulatory interactions: Management reiterated constructive, routine discussions with FDA during Priority Review; no change in quantity/quality of interactions; Ph3 design was agreed months prior and is now operationalizing .
• Competitive dynamics/NCCN guidelines: Team acknowledged first‑mover considerations but emphasized ziftomenib’s efficacy, safety, compatibility, and convenience; expects to submit promptly to NCCN upon approval, with listing specifics (drug vs class) uncertain .
• Launch ramp/bolus: Management does not expect a large bolus given R/R NPM1‑m AML demographics and limited warehousing; focus is on immediate access, payer coverage, and communicating differentiation .
• Ph3 start/enrollment confidence: Single‑protocol design (IC and NIC) viewed as site‑friendly; strong site enthusiasm expected to drive robust enrollment toward 2028 top‑line .
• FTI program path: RCC expansion cohorts designed to differentiate beyond cabo monotherapy; additional KRAS combinations likely to be shared next year .

Estimates Context

• Consensus vs actuals:

  • Q2 2025: Revenue $64.95M* vs $15.29M actual; EPS $(0.37)* vs $(0.75) actual – significant misses.
  • Q1 2025: Revenue $39.08M* vs $14.11M; EPS $(0.60)* vs $(0.66) – misses.
  • Q4 2024: Revenue $57.96M* vs $53.88M; EPS $(0.64)* vs $(0.22) – revenue slight miss, EPS beat.
    Values retrieved from S&P Global.*

• Implications: Street models may need to recalibrate collaboration revenue timing and cadence given variability quarter‑to‑quarter while Kura remains pre‑commercial; near‑term estimate revisions likely to focus on opex run‑rate, runway, and probability‑weighted launch scenarios (post‑PDUFA). Values retrieved from S&P Global.*

Key Takeaways for Investors

• The central near‑term catalyst is the 11/30/25 PDUFA for ziftomenib; commercial infrastructure is in place to execute rapidly upon potential approval .
• Two registrational frontline trials are moving to initiation in 2H 2025 with dual primary endpoints that could enable accelerated approval, broadening the addressable AML opportunity if successful .
• Q2 financials missed consensus on revenue/EPS; expect variability in collaboration revenue until product launch; liquidity remains strong with cash into 2027 and potential for up to $375M in near‑term milestones . Values retrieved from S&P Global.*
• Competitive questions in the menin class persist; management is positioning ziftomenib as potential best‑in‑class based on efficacy, safety, compatibility, and convenience, and expects to move quickly on guidelines post‑approval .
• Additional 2H 2025 catalysts from the FTI program (three ESMO abstracts) and updates on combinations (e.g., venetoclax/azacitidine) can broaden medium‑term optionality beyond AML .
• For trading, PDUFA and Ph3 “first patient in” updates are likely stock drivers; estimate revisions may focus on non‑dilutive milestone timing and cash runway sustainability .

Values retrieved from S&P Global.*