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    TRVI
    Earnings call· Jun 2026(Q2 FY26)

    Trevi Therapeutics Q2 FY26 earnings call TRVI

    Aug 6, 2026 Source

    Executive summary

    Trevi Therapeutics Q2 FY26 — Clinical Milestones Achieved, Strong Cash Runway

    Trevi Therapeutics achieved significant clinical milestones in Q2 FY26, initiating two key trials for chronic cough indications and maintaining a strong financial position with cash runway into 2030. The company is focused on executing its development plan for nalbuphine ER, aiming to be a first-in-class therapy in areas of high unmet need, particularly following a competitor's program termination in refractory chronic cough.

    Highlights

    5

    • Initiated OCEAN-1 Phase III and LAKE Phase IIb trials in Q2 FY26, on track with plans.

    • Cash, cash equivalents, and marketable securities of approximately $319 million at Q2 FY26 end.

    • Cash runway extends into 2030, funding development through potential FDA approval for IPF-related chronic cough and Phase III for non-IPF-ILD-related chronic cough.

    • Six submissions selected for presentations or posters at ATS 2026, highlighting data on breathlessness reduction and robust response across cough counts.

    • Unbranded digital campaign reached over 17,000 unique pulmonologists, showing high engagement.

    Concerns

    2

    • Competitive program termination in RCC

    • Uncertainty of placebo effect in clinical trials

    Guidance & targets

    5
    CategoryTargetConfidence
    Non-IPF-ILD-related chronic cough program alignment
    Alignment on program
    medium materiality
    High
    LAKE Phase IIb trial enrollment
    50% enrollment
    medium materiality
    High
    LAKE trial Sample Size Reestimation (SSRE) readout
    Readout
    high materiality
    High
    OCEAN-2 Phase III trial initiation
    Initiation
    medium materiality
    High
    Cash runway
    Into 2030
    high materiality
    High

    Operational metrics

    8
    Cash, cash equivalents and marketable securities
    $319M
    Q2 FY26

    Company ended the second quarter with approximately $319 million in cash, cash equivalents and marketable securities.

    Pulmonologists reached by unbranded campaign
    17,000
    Q2 FY26

    Through digital efforts, the unbranded campaign reached more than 17,000 unique pulmonologists.

    Clinical trial sites
    200+
    Q2 FY26

    The team is focused on bringing up global sites for each of these trials, which total more than 200 sites.

    Patent applications filed
    3
    last few months

    The company has filed 3 more patent applications in just the last few months.

    Conditional power for LAKE trial SSRE
    80%
    SSRE

    The company is looking for conditional power of 80% at the time of the SSRE for the LAKE program.

    Maximum sample size increase for LAKE trial SSRE
    50%
    SSRE

    The protocol allows for up to a 50% increase in sample size for the LAKE trial if needed after the SSRE.

    US ILD care centers
    90
    current

    There are 90 ILD care centers in the United States, which allows for a focused commercial approach.

    RCC patient population (US)
    1M
    current

    The treatment-resistant proportion of RCC patients represents a sizable market opportunity of about 1 million patients in the U.S.

    Industry KPIs

    3
    MetricValueDetails
    Pipeline clinical milestones3 active clinical trials
    Regulatory approvals filingsFDA meeting request submitted
    Clinical trial efficacy safety dataATS 2026 presentations

    Risks & headwinds

    2
    Competitive program termination in RCCRecent

    GSK's competitive RCC program terminated

    Mitigation: Company's RCC approach remains unchanged, targeting treatment-resistant patients; trial powered by own strong data; potential to be alone in all three cough indications.

    Uncertainty of placebo effect in clinical trialsOngoing

    Not clear line of sight to placebo at this point

    Mitigation: Inclusion of SSRE in LAKE trial protocol to protect the overall program and adjust sample size if needed.

    What to watch in Q3 FY26

    4

    Non-IPF-ILD program alignment with FDA

    H2 FY26
    CurrentMeeting request submitted
    TargetFDA meeting granted and alignment achieved

    Why it matters

    Successful alignment with the FDA is crucial for advancing the development of nalbuphine ER for this new indication, expanding the potential market.

    As we look forward to the rest of this year, you should expect the following key milestones from us: one, alignment on our non-IPF-ILD-related chronic cough program during the second half of this year

    Q&A highlights

    6

    What questions do you expect from the FDA regarding the non-IPF-ILD chronic cough program, and what are the options for trial protocol relative to IPF chronic cough?

    The FDA meeting will be an alignment meeting, building on the solid IPF program. The protocol will closely follow the OCEAN program, with differences primarily in patient population inclusion/exclusion criteria. The goal is alignment on the approach and pathway to an NDA filing for this indication.

    “So really, it's going to be on alignment on the inclusion/exclusion criteria now looking at the non-IPF population, and we'll look at other very specific but not very different parameters for the protocol in relationship to what we already did for IPF.”

    asked by Roanna Clarissa Ruiz · answered by James Cassella

    2 min read6 chapters

    Detailed Narrative

    01

    Clinical Trial Progress and Enrollment

    Trevi Therapeutics initiated both the OCEAN-1 Phase III 52-week trial for IPF-related chronic cough and the LAKE Phase IIb trial for refractory chronic cough (RCC) during Q2 FY26. The company also plans to initiate the OCEAN-2 Phase III 12-week trial for IPF-related chronic cough in Q3 FY26. Global site activation is underway for these trials, totaling over 200 sites, with early enrollment on track. A milestone disclosure will occur once approximately 50% enrollment is reached in any trial.

    02

    Non-IPF-ILD Chronic Cough Program

    The company submitted a meeting request to the FDA to discuss its non-IPF-ILD-related chronic cough program, expecting a response this month. If granted, a full protocol and briefing document will be submitted for discussion on the next trial and development plan. Management notes significant synergies with IPF studies, as these patient populations are seen in the same care centers by the same pulmonologists, allowing for efficient trial setup.

    03

    LAKE Trial SSRE and RCC Market Landscape

    The Sample Size Reestimation (SSRE) for the LAKE trial in RCC is expected to read out in Q4 FY26. This SSRE is designed to confirm powering assumptions and adjust the sample size if needed, based on an analysis by an external unblinded statistician. Management emphasized that the recent termination of a competitive RCC program does not impact their trial design, which is powered by their own data and strong effect size observed in previous studies. The company maintains its strategy to target treatment-resistant RCC patients, a sizable market opportunity.

    04

    ATS 2026 Highlights and Awareness Campaign

    At the American Thoracic Society (ATS) 2026 meeting, all six of Trevi's submissions were selected for presentations or posters. These included new data on nalbuphine ER's reduction of breathlessness and cough bouts in IPF and RCC patients, and its robust response across all baseline cough counts. The Phase IIb CORAL trial for IPF-related chronic cough was also highlighted in the Clinical Year in Review session. Additionally, an unbranded digital campaign raising awareness of chronic cough among pulmonologists reached over 17,000 unique pulmonologists, demonstrating strong engagement.

    05

    Financial Position and Cash Runway

    Trevi Therapeutics ended Q2 FY26 with approximately $319 million in cash, cash equivalents, and marketable securities. The company remains on track with its budget and plans, and its cash runway guidance extends into 2030. This funding is expected to cover the development program for IPF-related chronic cough through potential FDA approval, the clinical development program through Phase III for non-IPF-ILD-related chronic cough, and the ongoing Phase IIb LAKE trial for RCC, including pre-commercial activities. It does not include expenses for commercial launch or a Phase III RCC trial.

    06

    Intellectual Property Expansion

    The company is actively expanding its intellectual property portfolio, with several incremental patent applications filed in recent months. While no new issuances have been disclosed since the last quarter, the ongoing effort aims to strengthen the company's position and protect its programs.

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