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    KURA
    Earnings call· Jun 2026(Q2 FY26)

    Kura Oncology Q2 FY26 earnings call KURA

    Aug 12, 2026 Source

    Executive summary

    Kura Oncology Q2 FY26 — KOMZIFTI Achieves Market Leadership in New Patient Starts

    Kura Oncology reported a strong second quarter, with KOMZIFTI rapidly establishing commercial leadership in new patient starts for relapsed/refractory NPM1-mutant AML, driven by its differentiated profile and effective commercial execution. The company continues to advance ziftomenib's clinical development towards broader AML indications, including frontline and FLT3 combinations, while darlifarnib is emerging as a promising precision oncology platform in solid tumors. Kura maintains a disciplined capital allocation strategy to support these two independent growth franchises.

    Highlights

    5

    • KOMZIFTI generated $9.1 million in net product revenue in its second full quarter on the market.

    • KOMZIFTI captured a majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market.

    • KOMET-007 long-term frontline data showed ziftomenib combines cleanly with standard therapy, deepening responses and supporting durable outcomes, with 12-month overall survival of 94% in newly diagnosed NPM1-mutant and/or KMT2A rearranged AML.

    • Darlifarnib plus cabozantinib demonstrated a 44% objective response rate and 94% disease control rate in cabozantinib-exposed renal cell carcinoma, significantly exceeding historical rates.

    • The company maintains a strong cash position of $519 million, expected to fund the ziftomenib AML program through KOMET-017 Phase III results in 2028.

    Concerns

    2

    • Collaboration revenue decreased to $11.8 million in Q2 FY26 from $15.3 million in Q2 FY25.

    • Net loss for the quarter increased to $68.3 million compared to $66.1 million in the prior year period.

    Guidance & targets

    7
    CategoryTargetConfidence
    Collaboration revenue
    $45M-$55M
    medium materiality
    High
    Collaboration revenue
    $90M-$110M
    medium materiality
    High
    Collaboration revenue
    $90M-$110M
    medium materiality
    High
    KOMET-017 top line Phase III results
    2028
    high materiality
    High
    Darlifarnib + cabo (FIT-001) enrollment completion
    1H 2027
    medium materiality
    High
    Darlifarnib + cabo (FIT-001) initial data
    2H 2027
    medium materiality
    High
    Darlifarnib + daraxonasib platform study initiation
    1H 2027
    medium materiality
    High

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    Menin Inhibitor Franchise (KOMZIFTI)
    KOMZIFTI, in its second full quarter on the market, exceeded expectations by generating $9.1 million in net product revenue and capturing a majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market. This performance is driven by strong physician adoption of its differentiated profile and effective commercial execution, with significant growth in new patient starts and total prescriptions quarter-over-quarter.
    Net product revenue: $9.1MNew patient starts: 115Total prescriptions: 250New patient starts growth QoQ: 35%Total prescriptions growth QoQ: 60%Combination use (physician-initiated): 40%Covered lives: >95%Preferred status covered lives: 16M
    		$9.1M———

    Operational metrics

    5
    Research and development expenses
    $61.9Mvs $62.8M in Q2 FY25
    Q2 FY26

    Slight decrease in R&D expenses year-over-year.

    Selling, general and administrative expenses
    $31.8Mvs $25.2M in Q2 FY25
    Q2 FY26

    Increase in SG&A expenses year-over-year, likely due to commercial launch activities.

    Noncash share-based compensation expense
    $8.2Mvs $6.9M in Q2 FY25
    Q2 FY26

    Included in net loss calculation.

    Cash, cash equivalents and short-term investments
    $519Mvs $667.2M as of 2025-12-31
    as of 2026-06-30

    Strong cash position to fund operations and clinical programs.

    Anticipated payments from Kyowa Kirin
    $180M
    future

    Expected to contribute to funding the ziftomenib AML program through KOMET-017 Phase III results in 2028.

    Industry KPIs

    7
    MetricValueDetails
    Launch access metrics>95% covered lives, 16M preferred lives%
    Pipeline read out calendarMultiple clinical updates
    Peak long term sales guidance$7B TAM, $3B projected peak salesUSD
    Therapeutic drug market shareMajority share%
    Prescription volume new starts115 new patient starts, 250 total prescriptionsunits
    Clinical trial efficacy safety data87% ORR, 70% CRc, 94% 12-month OS%
    Collaboration milestone royalty revenue$11.8MUSD

    Deals & partnerships

    1
    Kyowa KirinCollaboration agreement for ziftomenib

    Kura Oncology is the senior party in the collaboration, booking all U.S. sales, controlling global development, and U.S. commercial activities for ziftomenib.

    Risks & headwinds

    1
    Competitive market share claimsCurrent quarter

    Competitor (Syndax) claims 60% or 2/3 of NPM1 business, while Kura claims majority share of new patient starts in relapsed/refractory NPM1-mutant AML.

    Mitigation: Kura clarifies its claim is specific to NPM1-mutant AML, where its new patient starts grew 35% QoQ, while competitor's NPM1-specific starts declined 25% QoQ. Kura focuses on product differentiation and commercial execution to maintain leadership.

    What to watch in Q3 FY26

    5

    Ziftomenib + gilteritinib (FLT3 combo) data

    Later this year (2H 2026)
    CurrentPreliminary clinical data expected
    TargetPreliminary clinical data release

    Why it matters

    This data will demonstrate ziftomenib's potential in combination with FLT3 inhibitors, addressing a significant co-mutated AML population and expanding its market opportunity.

    Looking ahead, we expect multiple clinical updates in the second half of the year across monotherapy, combination therapy and multiple treatment settings.

    Q&A highlights

    5

    How much of the sequential increase in new patient starts reflects overall menin class penetration versus share gains? And what is the relationship between starts, refills, and revenue, including inventory/gross-to-net effects?

    The growth reflects both taking share from competitors and growing the market. Repeat prescriptions (TRx growth of 60% QoQ) are increasing, and there were no significant inventory or stocking one-time events. The focus is on capturing every new patient.

    “I think what that shows is we're both taking share from competitors, but also having the opportunity to grow the market.”

    asked by Jason Zemansky · answered by Brian Powl

    2 min read5 chapters

    Detailed Narrative

    01

    KOMZIFTI Commercial Performance and Market Leadership

    KOMZIFTI generated $9.1 million in net product revenue in its second full quarter, driven by approximately 115 new patient starts and over 250 total prescriptions. The product achieved a majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market, demonstrating strong physician adoption and commercial execution. Repeat prescribing increased, and adoption expanded across both academic and community treatment centers, with physician-initiated combination use representing approximately 40% of new patient starts.

    02

    Ziftomenib Clinical Development Progress

    New clinical data for ziftomenib reinforced its potential as a foundational AML therapy. Peer-reviewed results from KOMET-007 (ziftomenib + venetoclax + azacitidine) showed an 87% ORR and 70% CRc rate in venetoclax-naive patients. Long-term results from KOMET-007 (ziftomenib + 7+3) in newly diagnosed AML patients demonstrated a 96% ORR and 94% 12-month overall survival, with a median follow-up of 17.6 months. The pivotal KOMET-017 trial continues to accrue globally, with top-line results expected in 2028.

    03

    Darlifarnib as a Differentiated Combination Platform

    Darlifarnib is emerging as a second strategic asset, showing promising data in renal cell carcinoma (RCC) and KRAS G12C mutated solid tumors. In cabozantinib-exposed RCC, darlifarnib plus cabo achieved a 44% ORR and 94% DCR. In cabozantinib-naive patients, ORRs ranged from 33% to 50% with a median PFS of 13 months. The combination with adagrasib in KRAS G12C cancers resulted in tumor shrinkage in 77% of patients, approximately doubling the response rate of monotherapy adagrasib. A platform study for darlifarnib plus daraxonasib in KRAS-mutant pancreatic cancer is planned for 1H 2027.

    04

    Financial Position and Capital Allocation

    Kura Oncology ended Q2 FY26 with $519 million in cash, cash equivalents, and short-term investments. This, combined with anticipated payments from the Kyowa Kirin partnership, is expected to fund the ziftomenib AML program through the KOMET-017 Phase III results in 2028. The company maintains a disciplined approach to capital deployment, focusing on commercial execution, pipeline expansion, and strategic investments to maximize shareholder value.

    05

    Future Clinical Milestones and Strategic Vision

    Multiple clinical updates are expected in the second half of the year for ziftomenib, including preliminary FLT3 combination data (gilteritinib and quizartinib), long-term ven/aza data, and an exploratory analysis in non-NPM1, non-KMT2A menin-dependent AML subtypes. The company aims to establish ziftomenib as a foundational therapy across AML and darlifarnib as a broad precision combination platform, leveraging its financial strength and clinical execution to drive long-term value creation.

    AI-generated summary of the company’s earnings call. Not investment advice.