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    KPTI
    Earnings call· Jun 2026(Q2 FY26)

    Karyopharm Therapeutics Q2 FY26 earnings call KPTI

    Aug 13, 2026 Source

    Executive summary

    Karyopharm Q2 FY26 — Myelofibrosis sNDA Submission on Track, Financial Headwinds Addressed

    Karyopharm is sharpening its focus on hematology, advancing selinexor's sNDA for myelofibrosis and growing its multiple myeloma business, XPOVIO. The company is actively addressing a near-term liquidity challenge and debt covenant issue while leveraging its established commercial platform for a potential myelofibrosis launch in early 2027. This strategic pivot follows the disappointing results of the XPORT-EC-042 study in endometrial cancer.

    Highlights

    4

    • Selinexor sNDA submission for myelofibrosis is on track for August 2026, with constructive FDA interactions.

    • The SENTRY study demonstrated statistically significant, rapid, deep, and sustained spleen responses, with an overall survival hazard ratio of 0.43.

    • XPOVIO U.S. net product revenue was $30.8 million in Q2 FY26, up from $29.7 million in Q2 FY25, showing resilience despite competition.

    • Selinexor plus ruxolitinib has the potential to generate up to approximately $1 billion in peak annual revenue in the U.S. alone for myelofibrosis.

    Concerns

    4

    • The Phase 3 XPORT-EC-042 study in endometrial cancer did not achieve statistical significance for its primary endpoint, leading to reduced investment in the program.

    • Total revenue for Q2 FY26 was $33.4 million, down from $37.9 million in the prior year, partly due to reduced reimbursement of development-related expenses.

    • Net loss was $67 million for the quarter, compared to $37.3 million in the prior year period.

    • The company expects to fall below its $10 million minimum liquidity covenant if a $15.8 million principal payment due September 10, 2026, is made without additional financing or a waiver.

    Guidance & targets

    5
    CategoryTargetConfidence
    Full-year 2026 Total Revenue
    $130 million to $150 million
    high materiality
    High
    Full-year 2026 U.S. XPOVIO Net Product Revenue
    $115 million to $130 million
    high materiality
    High
    Full-year 2026 Combined R&D and SG&A Expenses
    $230 million to $245 million
    high materiality
    High
    Selinexor Myelofibrosis Launch
    early as the first quarter of 2027
    high materiality
    Medium
    SENTRY-2 60mg Cohort Top-line Data
    second half of this year
    medium materiality
    High

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    XPOVIO U.S. Net Product Revenue
    Strong commercial execution despite an increasingly competitive treatment landscape, reflecting the resilience of the multiple myeloma franchise.
    Underlying demand: relatively consistent with Q2 FY25Gross to net rate: 26.6%
    		$30.8 millionup from $29.7 million——

    Operational metrics

    10
    Total Revenue
    $33.4 millioncompared to $37.9 million in the prior year period
    Q2 FY26

    Total revenue impacted by reduced reimbursement of development-related expenses.

    R&D Expenses
    $29 milliondown 12% year over year
    Q2 FY26

    Reflects continued prioritization and disciplined investment.

    SG&A Expenses
    $25.9 milliondown 9% respectively year over year
    Q2 FY26

    Reflects continued prioritization and disciplined investment.

    Net Loss
    $67 millioncompared to $37.3 million in the prior year period
    Q2 FY26

    Includes non-cash mark-to-market adjustments.

    Loss from Operations (Adjusted)
    approximately an 8% reductionreduction
    Q2 FY26

    Underlying operating performance improved due to stable net product revenue and expense discipline.

    Cash, Cash Equivalents, Restricted Cash, and Investments
    $65.4 million
    Q2 FY26

    Company's liquidity position at the end of the quarter.

    Liquidity Runway
    into September 2026
    FY26

    Expected funding period based on current operating plan and existing liquidity.

    Senior Secured Term Loan Facility Principal Payment
    $15.8 million
    Q3 FY26

    Payment due that could trigger a liquidity covenant breach.

    Minimum Liquidity Covenant
    $10 million
    Q3 FY26

    If cash falls below this amount, it constitutes an event of default under the term loan.

    Third Quarter Expenses
    modestly higherthan the second quarter
    Q3 FY26

    Due to unique transition period and costs associated with strategic shifts.

    Industry KPIs

    7
    MetricValueDetails
    Launch access metricspotential inclusion in the treatment guidelines in Compendia
    Pipeline read out calendarSENTRY-2 60mg cohort top-line data
    Product franchise net sales$30.8 millionUSD
    Regulatory approvals filingssNDA submission
    Peak long term sales guidanceapproximately $1 billionUSD
    Clinical trial efficacy safety dataSVR35 rates nearly double with combination%
    Collaboration milestone royalty revenueconsisting entirely of royalties

    Risks & headwinds

    3
    XPORT-EC-042 study failure in endometrial cancerQ2 FY26 results

    did not achieve statistical significance for its primary endpoint

    Mitigation: Deliberate decision to sharpen focus on hematology (myelofibrosis and multiple myeloma) and meaningfully reduce planned investment in endometrial cancer.

    Liquidity covenant breachNear-term (September 2026)

    $15.8 million principal payment due September 10, 2026, could cause cash to fall below $10 million minimum liquidity covenant

    Mitigation: Actively evaluating a range of financing opportunities and strategic alternatives; direct dialogue with lenders.

    Increased third-quarter expensesQ3 FY26

    modestly higher than the second quarter

    Mitigation: Acknowledged as a unique transition period, with cost structure expected to decline over time, particularly in 2027.

    What to watch in Q3 FY26

    5

    Selinexor sNDA Submission for Myelofibrosis

    August 2026
    CurrentOn track for August 2026
    TargetSubmitted

    Why it matters

    This is a critical regulatory milestone for the company's lead pipeline asset and future growth.

    We remain on track to submit our sNDA in August as we complete the final elements of our submission in collaboration with the FDA.

    Q&A highlights

    5

    What remains to be done for the sNDA, and how much is already complete, especially given selinexor's existing approval?

    The vast majority of the sNDA is complete. The remaining work involves finalizing alignment with the FDA on the confirmatory data piece, specifically using maturing overall survival (OS) data from the ongoing SENTRY trial. The SENTRY study was designed to follow patients for OS, and this data will serve as the confirmatory data set for accelerated approval.

    “1 of the key pieces that we are just aligning and finalizing with the FDA is just around the confirmatory data piece, right? So I think as we all appreciate under accelerated approval, we are provided an approval, a label, but we do need to provide clinical benefit at some point in the future. And so right now our discussions really have been focused on using the mature overall survival observed from SENTRY.”

    asked by Edward Tenthoff · answered by Reshma Rangwala

    2 min read6 chapters

    Detailed Narrative

    01

    Myelofibrosis sNDA Progress and Regulatory Pathway

    Karyopharm is on track to submit its sNDA for selinexor in myelofibrosis in August 2026, following constructive interactions with the FDA. The submission will be based on week 24 SVR35 results, which the FDA indicated appears to qualify as a reasonably likely surrogate endpoint for overall survival. The company plans to use maturing overall survival data from the ongoing SENTRY trial as confirmatory data for accelerated approval, with the study designed to follow patients for OS.

    02

    SENTRY Study Data and Scientific Rationale

    The SENTRY study demonstrated statistically significant, rapid, deep, and sustained spleen responses, with a promising overall survival hazard ratio of 0.43. The benefit was consistent across pre-specified patient subgroups, including those on suboptimal ruxolitinib doses, where SVR35 rates were as high as 50% compared to 0% with ruxolitinib alone. The biological rationale for combining XPO1 and JAK inhibition is compelling, targeting complementary pathways to improve outcomes beyond symptom control.

    03

    XPORT-EC-042 Study Results and Strategic Re-focus

    The Phase 3 XPORT-EC-042 study in endometrial cancer did not achieve statistical significance for its primary endpoint. Following these results, Karyopharm made a deliberate decision to sharpen its focus on hematology, specifically myelofibrosis and multiple myeloma, where selinexor has the greatest potential to improve patients' lives and create long-term shareholder value. Investment in the endometrial cancer program will be meaningfully reduced, with greater financial benefit expected in 2027.

    04

    Commercial Strategy for Myelofibrosis

    Karyopharm is well-positioned to commercialize selinexor in myelofibrosis by leveraging its established hematology platform built through XPOVIO. This includes existing medical and scientific affairs teams, commercial coverage in community and academic hematology, key account capabilities, and market access expertise. The myelofibrosis market structure, with approximately 70% of patients treated in the community setting, aligns well with the company's existing footprint, allowing for efficient resource deployment.

    05

    XPOVIO Performance in Multiple Myeloma

    XPOVIO U.S. net product revenue was $30.8 million in Q2 FY26, demonstrating strong commercial execution and resilience despite an increasingly competitive treatment landscape. The community setting, representing approximately 60% of the U.S. business, continues to value XPOVIO as a differentiated oral therapy. XPOVIO also holds a unique position in the evolving treatment landscape for T-cell engaging therapies, providing flexibility before and after CAR-T therapy.

    06

    Financial Position and Capital Allocation

    The company ended Q2 FY26 with $65.4 million in cash, cash equivalents, restricted cash, and investments. Based on the current operating plan, existing liquidity is expected to fund operations into September 2026. A $15.8 million principal payment is due on September 10, 2026, under the Senior Secured Term Loan Facility, which could lead to a liquidity covenant breach if not addressed through additional financing or a waiver. The company is actively evaluating financing opportunities and strategic alternatives.

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