TRVI

• Clinical Trial Execution & Milestones:
  • Initiated two new clinical trials in Q2 2026: the OCEAN-1 Phase III 52-week trial for idiopathic pulmonary fibrosis (IPF)-related chronic cough, and the LAKE Phase IIb trial for refractory chronic cough (RCC).
  • The second Phase III trial for IPF-related chronic cough, OCEAN-2, is planned to initiate in Q3 2026. The company is currently activating over 200 global trial sites across all ongoing programs, and early enrollment is on track with pre-set plans.
  • The company plans to disclose 50% enrollment milestones for initiated trials when achieved, and provide quarterly updates after that point.
  • A sample size re-estimation (SSRE) for the LAKE RCC trial is scheduled to read out in Q4 2026, after 50% of patients complete the trial, to confirm powering assumptions and adjust sample size if needed.
• Non-IPF ILD Chronic Cough Program:
  • The company recently submitted a meeting request to the FDA to discuss development plans for this indication, and expects a response on meeting approval in the same month as the call. The program shares significant operational synergies with the existing IPF trial network, allowing for fast execution once FDA alignment is secured.
• Data & Medical Community Recognition:
  • All six of the company's submissions to the 2026 American Thoracic Society (ATS) conference were accepted for presentation or poster display, including new data showing Nalbufine ER reduces breathlessness and cough bouts across all baseline cough severity levels in IPF-related chronic cough and RCC.
  • The company's Phase IIb CORAL trial publication for IPF-related chronic cough was highlighted as a key year-in-review development in ILD research at the ATS conference.
• Commercial Preparation:
  • The company launched an unbranded digital awareness campaign for chronic cough targeting pulmonologists in Q2 2026, which has reached over 17,000 unique pulmonologists to date with high engagement.
• Strategic Positioning:
  • Following the recent termination of a competitor's RCC program, Trevi is the only company actively developing therapies across all three of its targeted chronic cough indications (IPF-related, non-IPF ILD-related, RCC), creating a first-in-class opportunity in a large unmet need market.

• Cash runway guidance remains unchanged from the prior quarter: the company's current $319 million cash position is expected to extend into 2030. This funding is sufficient to support development of the IPF-related chronic cough program through potential FDA approval, complete Phase III development for non-IPF ILD-related chronic cough, complete the ongoing LAKE Phase IIb RCC trial, and fund all planned pre-commercial activities.
• The cash runway guidance does not include funding for a commercial launch or a Phase III clinical trial in RCC.
• Key expected milestones in H2 2026 include: FDA alignment on the non-IPF ILD chronic cough program, reaching 50% enrollment in the LAKE Phase IIb RCC trial, and readout of the LAKE trial SSRE in Q4 2026.

Trevi Therapeutics is a clinical-stage biotech company focused on developing Nalbufine ER (Heduvia) for chronic cough indications, and does not report revenue from commercial product sales as of Q2 2026. The only financial performance reported is the company's ending cash, cash equivalents, and marketable securities position of $319 million as of the end of Q2 2026. No product segment revenue or contribution percentages are provided in the transcript.

• Forward-looking statements (including all trial and milestone plans, funding projections, and expectations of regulatory approval) are inherently uncertain, and actual results may differ materially from expectations due to factors disclosed in the company's SEC filings.
• There is uncertainty around the outcome of the SSRE analysis for the LAKE trial: while the protocol allows for a maximum 50% increase in sample size if needed to reach 80% conditional power, a required sample size increase could extend trial timelines.
• Final trial design, development pathway, and regulatory approval for the non-IPF ILD chronic cough program remain dependent on FDA feedback, which has not yet been received.
• Commercial access and pricing for RCC may be constrained by payer limitations if the company pursues a broad population label, creating commercial risk even if clinical trials are successful.
• Clinical efficacy results for non-IPF ILD chronic cough and RCC are still pending, and there is no guarantee that observed efficacy in earlier phase IPF trials will translate to other chronic cough indications.

Q: What is the company's strategy for the non-IPF ILD chronic cough FDA meeting and trial protocol, and how has the competitor exit from RCC changed market outlook, pricing, or the LAKE trial SSRE? / A: The FDA meeting is for alignment on trial design and the NDA pathway; the protocol will closely match the OCEAN IPF trials, only differing in patient population inclusion criteria. The competitor exit has not changed the RCC strategy, which still targets 1 million U.S. treatment-resistant patients under a specialty commercial and pricing model. The SSRE remains powered on Trevi's own clinical data, and the competitor's results have no impact on the trial design or assumptions.

Q: Is SSRE planned for the OCEAN trials, and what is the commercial optionality for RCC after the competitor exit? / A: SSRE is only conducted for the LAKE Phase IIb RCC trial; the OCEAN Phase III trials are already well-powered based on CORAL study effect size, with no planned intermediate assessment. Commercially, the company retains optionality: if a low 27mg or lower once-daily dose is confirmed, it could launch a second brand to access the broader RCC population, while it will currently stick to targeting high-unmet-need refractory patients seen by specialty pulmonologists to preserve pricing and avoid cannibalizing IPF/ILD revenue.

Q: What scenarios can follow the LAKE SSRE, what is the impact of a sample size increase on timeline, and what secondary endpoints are prioritized for the OCEAN trials? / A: The unblinded external statistician will adjust sample size if the trial does not reach 80% conditional power at the 50% completion mark; a futility assessment is also included. The protocol allows a maximum 50% sample size increase, which is viewed as a routine statistical adjustment not expected to meaningfully alter timelines. For OCEAN, key secondary endpoints are patient-reported outcomes, primarily cough severity NRS score and breathlessness, as well as 50% cough reduction rate. These endpoints are pre-specified and agreed with the FDA, and can be included in labeling if statistically significant.

Q: Will you hold OCEAN-2 top-line results until OCEAN-1 reads out, and has the competitor exit changed strategic partnership discussions? / A: The company will not hold results, and will release OCEAN-2 top-line data when it is available as a public small company. Results from the 12-week OCEAN-2 trial are expected to translate well to the 52-week OCEAN-1 trial, as no waning of effect was seen in longer-term prior studies of Nalbufine ER. No updated comment can be provided on partnership discussions this early after the competitor program termination.