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    SMMT
    Earnings call· Jun 2026(Q2 FY26)

    Summit Therapeutics Inc. SMMT

    Jul 23, 2026 Source

    Executive summary

    Summit Therapeutics Q2 FY26 — Positive HARMONi OS Data and HARMONi-3 Progress

    Summit Therapeutics reported Q2 FY26 results highlighted by updated overall survival data for its HARMONi trial, showing consistent benefit across geographies with increased follow-up. The company is advancing its broad ivonescimab clinical development program, including the fully enrolled HARMONi-3 study, and preparing for a potential U.S. FDA approval later this year. Management emphasized the platform potential of ivonescimab across solid tumors and its strong cash position to support ongoing development and commercialization efforts.

    Highlights

    5

    • Updated OS analysis for HARMONi trial showed consistent OS benefit (HR 0.76) in Western patients with increased follow-up (median over 23 months), aligning with Asian patients.

    • HARMONi-3 trial completed enrollment in both squamous and non-squamous cohorts, with PFS analysis for squamous cohort expected in H2 2026.

    • Strong cash position of $690.7 million at Q2 FY26 end, representing a $92 million increase from Q1 FY26.

    • Ivonescimab has read out 4 positive Phase III clinical studies to date, leading to 2 approvals in China and 15 Phase III trials ongoing globally.

    • New collaborations established with GSK and Arcus Biosciences to evaluate ivonescimab in novel combinations, expanding its clinical reach.

    Concerns

    3

    • The FDA noted that a statistically significant overall survival benefit is necessary for marketing authorization in the EGFR-mutated NSCLC setting, which HARMONi did not achieve at primary OS analysis.

    • Total GAAP operating expenses increased to $220.5 million in Q2 FY26 from $195.2 million in Q1 FY26, primarily due to increased R&D expenses.

    • Non-GAAP operating expenses increased to $151.8 million in Q2 FY26 from $122.4 million in Q1 FY26, driven by R&D investments.

    Guidance & targets

    8
    CategoryTargetConfidence
    PFS analysis for HARMONi-3 squamous cohort
    Expected to reach number of events needed
    high materiality
    High
    Early interim OS look for HARMONi-3 squamous cohort
    Corresponding to PFS analysis
    high materiality
    High
    First independent OS look for HARMONi-3 squamous cohort
    Expected to reach number of events for OS
    high materiality
    High
    PFS analysis for HARMONi-3 non-squamous cohort
    Expected to reach number of events needed
    high materiality
    High
    PDUFA date for ivonescimab BLA
    November 14, 2026
    high materiality
    High
    GSK collaboration first patient enrollment
    Expected later this quarter
    medium materiality
    High
    Arcus collaboration initial data generation
    Expected by mid next year
    medium materiality
    High
    ILLUMINE trial start in China
    Intended to start later this year
    low materiality
    Medium

    Operational metrics

    25
    Cash and investments balance
    $690.7MUp $92M from Q1 2026 end
    Q2 2026 end

    Strong cash position at the end of the second quarter.

    Cash raised from ATM facility
    $231M
    Q2 2026

    Primary reason for the increase in cash position.

    Cash used in operating activities
    $140M
    Q2 2026

    Offsetting the cash raised from ATM facility.

    Total GAAP operating expenses
    $220.5Mvs $195.2M for Q1 2026
    Q2 2026

    Increase primarily due to R&D expenses related to clinical trials.

    Non-GAAP operating expenses
    $151.8Mvs $122.4M for Q1 2026
    Q2 2026

    Increase primarily related to R&D expenses, excluding stock-based compensation.

    New ATM facility authorization
    $380M
    Filed today

    To provide additional flexibility for financing.

    Ivonescimab patients dosed in trials
    Over 4,000
    To date

    Across the world in either Summit-sponsored or Akeso-sponsored clinical trials.

    Ivonescimab patients administered commercially
    Over 70,000
    Commercially in China

    Commercial administration of ivonescimab in China.

    Ivonescimab Phase III trials
    15
    To date

    Number of Phase III trials currently ongoing or having read out in multiple tumor types.

    Ivonescimab clinical trials initiated
    52
    To date

    Number of clinical trials initiated evaluating ivonescimab in a variety of solid tumors.

    Ivonescimab clinical trials listed on clinicaltrials.gov
    171
    To date

    Total number of clinical trials, including investigator-initiated and collaborative studies.

    Ivonescimab publications/presentations/posters
    Over 50
    To date

    Number of publications, presentations, and posters featuring ivonescimab.

    Investigator-sponsored trials (ISTs) to support
    Over 65
    Ongoing

    Number of ISTs Summit intends to support in various stages of development.

    Investigator-sponsored trials (ISTs) currently enrolling
    24
    Current

    Number of ISTs currently enrolling patients.

    HARMONi median follow-up time (Western patients)
    Over 23 months
    June 2026 data cutoff

    Median follow-up time for Western patients in the HARMONi study, showing increased time on study.

    HARMONi median follow-up time (Asian patients)
    33 months
    June 2026 data cutoff

    Median follow-up time for Asian patients in the HARMONi study.

    HARMONi OS Hazard Ratio
    0.76
    June 2026 data cutoff

    Observed hazard ratio for overall survival in the HARMONi study, consistent across geographies.

    HARMONi-2 OS Hazard Ratio
    0.78
    At 39% data maturity

    Overall survival hazard ratio reported for the HARMONi-2 study, which evaluated ivonescimab monotherapy against pembro monotherapy.

    HARMONi-6 OS Hazard Ratio
    0.68
    Announced ASCO 2026

    Overall survival hazard ratio for the HARMONi-6 study, comparing ivonescimab with chemo against anti-PD-1 plus chemo.

    HARMONi-6 OS benefit
    34%
    Announced ASCO 2026

    Reduction in the risk of death observed in the HARMONi-6 study over a PD-1 inhibitor.

    HARMONi-6 median follow-up time
    21 months
    OS analysis

    Median follow-up time for the overall survival analysis in the HARMONi-6 study.

    EGFR-mutated NSCLC patient population
    Nearly 100,000
    Annual, US alone

    Represents a significant unmet medical need for the HARMONi-3 target population.

    Ivonescimab total addressable market
    In excess of $100B
    Globally

    Estimated total addressable market for ivonescimab across solid tumors.

    NSCLC immunotherapy market estimate
    Exceed $20B
    Per year by 2028

    Market estimates for immunotherapy in non-small cell lung cancer.

    HARMONi study patient split
    60% Asian, 40% Western
    Study enrollment

    Patient enrollment split in the HARMONi study, typical for EGFR mutation-positive lung cancer.

    Industry KPIs

    4
    MetricValueDetails
    Pipeline read out calendarMultiple
    Regulatory approvals filingsBLA under review
    Clinical trial efficacy safety dataOS HR 0.76
    Cumulative patients uptake since launchOver 70,000patients

    Deals & partnerships

    3
    Revolution MedicinesClinical collaboration to evaluate ivonescimab in combination with 3 novel RAS inhibitors.

    Enrollment began in Q1 2026 across multiple solid tumor settings, including pancreatic, colorectal, and non-small cell lung cancers.

    GSKClinical collaboration to evaluate ivonescimab in combination with their B7-H3 ADC.

    First patient enrollment is expected later in Q3 2026, targeting multiple solid tumor settings such as lung and colorectal cancers.

    Arcus BiosciencesClinical collaboration to evaluate ivonescimab in combination with Arcus HIF-2 alpha inhibitor, casdatifan.

    The combination will be evaluated in first-line metastatic clear cell renal cell carcinoma, with initial data expected by mid-2027.

    Risks & headwinds

    3
    Regulatory requirement for statistically significant OS benefitNear-term (PDUFA November 14, 2026)

    FDA noted a statistically significant overall survival benefit is necessary for marketing authorization.

    Mitigation: Company believes ivonescimab is a potential treatment option with favorable benefit-risk profile, supported by updated HARMONi data showing consistent OS benefit and KOL discussions.

    Increased R&D expensesOngoing

    Total GAAP operating expenses increased to $220.5M in Q2 2026 from $195.2M in Q1 2026; Non-GAAP operating expenses increased to $151.8M in Q2 2026 from $122.4M in Q1 2026.

    Mitigation: Increase primarily due to R&D expenses related to clinical trial expenses for HARMONi-GI3, HARMONi-3, and HARMONi-7, indicating investment in pipeline growth.

    Potential for PDUFA date movement or ODAC panelNear-term (PDUFA November 14, 2026)

    FDA decision on BLA for ivonescimab.

    Mitigation: Company has no expectation of the PDUFA date moving and defers to the agency for any decisions regarding advisory committees, while continuing to prepare for commercial launch.

    What to watch in Q3 FY26

    5

    HARMONi-3 squamous PFS analysis

    H2 2026 (likely middle to back end)
    CurrentEnrollment completed
    TargetPFS analysis results

    Why it matters

    This is a key registrational trial for frontline NSCLC, and PFS results will provide the first look at efficacy in this large patient population.

    We expect to reach the number of events needed to conduct the PFS analysis for the squamous cohort in the second half of this year, which would also come with a corresponding early interim look at overall survival.

    Q&A highlights

    5

    How do the consistent OS results across geographies in HARMONi translate to other larger markets like frontline NSCLC?

    Management emphasized that maturity and follow-up time are critical for ivonescimab. With meaningful follow-up, consistent OS benefit magnitude was observed. They expect to show clinically meaningful results in other frontline studies with appropriate follow-up time, similar to HARMONi-6 (21 months median follow-up) and HARMONi Western patients (23 months).

    “we expect the ability to translate clinically meaningful results in China to clinically meaningful results across the globe with meaningful follow-up time.”

    asked by Yigal Nochomovitz · answered by Dave Gancarz

    2 min read5 chapters

    Detailed Narrative

    01

    Ivonescimab's Clinical Profile and Development

    Ivonescimab, a PD-1/VEGF bispecific antibody, has demonstrated positive data in 4 Phase III clinical studies to date, leading to 2 approvals in China and 15 Phase III trials currently ongoing or having read out. A total of 52 clinical trials have been initiated by Summit and its partner Akeso, with 171 trials listed on clinicaltrials.gov including investigator-initiated studies. Over 4,000 patients have been dosed in Summit-sponsored or Akeso-sponsored clinical trials, and over 70,000 patients have been administered ivonescimab commercially in China.

    02

    Updated HARMONi Overall Survival Analysis

    The global Phase III HARMONi trial, evaluating ivonescimab plus chemotherapy in EGFR-mutated non-small cell lung cancer after TKI therapy, showed an updated overall survival (OS) hazard ratio of 0.76 for both the total population and Western patients. This analysis, with a data cutoff in June 2026, indicated that Western patients increased their time on study, reaching a median follow-up of over 23 months, demonstrating consistency in OS benefit magnitude with Asian patients who had a median follow-up of 33 months. The safety profile remained acceptable and manageable, consistent with previous Phase III results.

    03

    HARMONi-3 Trial Progress and Future Readouts

    The global Phase III HARMONi-3 trial, comparing ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in frontline metastatic non-small cell lung cancer, has completed enrollment in both squamous and non-squamous cohorts. The progression-free survival (PFS) analysis for the squamous cohort is expected in the second half of 2026, accompanied by an early interim look at overall survival. A first independent OS analysis for the squamous cohort is anticipated in the first half of 2027, and the PFS analysis for the non-squamous cohort is also expected in the first half of 2027.

    04

    Strategic Collaborations and Pipeline Expansion

    Summit has established several clinical trial collaborations to evaluate ivonescimab in novel combinations. The collaboration with Revolution Medicines, evaluating ivonescimab with three novel RAS inhibitors across multiple solid tumor settings, began enrolling in Q1 2026. The GSK collaboration, combining ivonescimab with their B7-H3 ADC, is expected to enroll its first patient later in Q3 2026. Additionally, a new collaboration with Arcus Biosciences will evaluate ivonescimab with their HIF-2 alpha inhibitor, casdatifan, in first-line metastatic clear cell renal cell carcinoma, with initial data expected by mid-2027.

    05

    Commercialization Efforts and Market Opportunity

    Summit is actively growing its commercial capabilities in anticipation of a potential U.S. FDA approval and launch of ivonescimab later this year, with a PDUFA date of November 14, 2026. The company views ivonescimab as a potential platform blockbuster drug with a total addressable market exceeding $100 billion globally across solid tumors. The non-small cell lung cancer immunotherapy market alone is projected to exceed $20 billion per year by 2028, highlighting the significant opportunity for ivonescimab.

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