TRVI — Trevi Therapeutics, Inc.

Summary of Trevi Therapeutics Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• Trevi ended 2025 with approximately $188 million in cash, cash equivalents, and marketable securities, providing a runway into 2028.
• This cash position supports key clinical milestones, including pivotal trials for chronic cough indications.

2. Strategic Updates and Business Highlights

• Major Growth Inflection: 2025 marked a significant growth period for Trevi, driven by positive data from the CORAL trial (idiopathic pulmonary fibrosis-related chronic cough) and the RIVER trial (refractory chronic cough).
• FDA Engagement: A positive End-of-Phase 2 meeting with the FDA confirmed the development plan for the IPF-related cough program, leading to the initiation of two pivotal Phase III trials.
• Trial Plans: The first Phase III trial for IPF-related chronic cough is set to begin in Q2 2026, with a global design involving 300 patients. A second trial will follow in the second half of the year, enrolling 130 patients.
• Expansion Plans: Trevi plans to submit a protocol for a non-IPF interstitial lung disease (ILD) chronic cough program, aiming to initiate a Phase IIb trial by year-end 2026, potentially doubling the market opportunity.
• Refractory Chronic Cough: A Phase IIb trial for refractory chronic cough is also planned for Q2 2026.

3. Forward Guidance and Outlook

• Trevi is positioned to execute its clinical trials efficiently, with expectations for significant data readouts in 2026.
• The company is focused on becoming a leader in chronic cough treatment, with plans for an Investor and Analyst Day on May 7, 2026, and participation in the American Thoracic Society meeting in May.

4. Bad News, Challenges, or Points of Concern

• Regulatory Risks: The need for a 52-week safety data set for the IPF trial could delay the 24-week primary endpoint readout, potentially impacting market entry.
• Competition: The landscape for IPF treatments is evolving, with competitors like United Therapeutics and BMS potentially launching products that could affect Trevi's market position.
• Funding Needs: While the current cash runway is sufficient, Trevi emphasizes the importance of being appropriately capitalized for future clinical milestones.

5. Notable Q&A Insights

• Phase I Studies: Management clarified that remaining Phase I studies are routine and will not delay the NDA submission.
• Secondary Endpoints: There is a focus on patient-reported outcomes (PROs) related to cough frequency and breathlessness, which will be included in the Phase III trials.
• Placebo Effect: The company is aware of the placebo response from prior studies and is prepared to analyze its impact on trial outcomes.
• Enrollment Expectations: Trevi anticipates a 1-year enrollment period for the Phase III IPF trial, with 80-100 sites primarily in the U.S.
• Drug Scheduling: Management expressed confidence that their drug will remain unscheduled, based on positive discussions with the FDA regarding its abuse potential.

Overall, Trevi Therapeutics is advancing its clinical programs with a solid financial position, although it faces regulatory and competitive challenges as it seeks to establish itself in the chronic cough treatment market.