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Trevi Therapeutics (TRVI) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

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

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

Risks & headwinds

Competitive program termination in RCC Recent

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 trials Ongoing

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

Non-IPF-ILD program alignment with FDA

H2 FY26
Current Meeting request submitted
Target FDA 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

Find out whether TRVI delivers this. Inve re-checks your case every morning.

Q&A highlights

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 read 6 chapters

Detailed narrative

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.

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.

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.

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.