Trevi Therapeutics (TRVI) Q3 2025: $115M Raise Extends Runway, Phase 3 Cough Trials Set for 2026

2025-11-13 | By EarningsIQ Research

Trevi Therapeutics enters 2026 with a $195M cash cushion and clear regulatory momentum, positioning its chronic cough programs for pivotal trials across multiple fibrotic lung diseases. This quarter’s operational focus centered on regulatory engagement, Phase 1 de-risking, and protocol finalization for Phase 3, with management emphasizing broad trial inclusion and strong physician demand. Investors now face a multi-year clinical execution window, with the next inflection tied to Phase 3 starts and regulatory feedback.

Summary

• Cash Infusion Extends Flexibility: $115M capital raise supports multiple late-stage trials and operational runway into 2028.
• Regulatory De-risking Advances: Clean Phase 1 safety and drug-drug interaction data clear path for Phase 3 IPF chronic cough program.
• Payer and Physician Engagement Grows: Strong KOL and investigator interest signals clinical demand ahead of pivotal trial launches.

Performance Analysis

Trevi reported a net loss of $11.8M for Q3 2025, narrowing from $13.2M YoY as R&D expenses declined to $10.1M due to the transition from active enrollment to preparatory work for new studies. G&A expenses rose to $3.8M, reflecting increased professional fees and readiness for SOX 404B compliance, a regulatory requirement for internal controls. The company’s cash and investments reached $195M, a direct result of the $115M raise in June, providing a multi-year operational buffer.

Operationally, Trevi completed two key Phase 1 studies: a drug-drug interaction (DDI) study with standard antifibrotics, showing no PK concerns, and a respiratory safety study with no signals of respiratory depression. These results will feed directly into the Phase 3 program design and regulatory filings. The company is now finalizing Phase 3 protocols for IPF chronic cough and preparing to expand into non-IPF interstitial lung disease (ILD) and refractory chronic cough (RCC), broadening addressable markets.

• R&D Spend Shift: Lower R&D outlays reflect trial completions; focus has moved to protocol development and site selection for upcoming global studies.
• Cash Runway Secured: $195M in cash and investments supports planned Phase 3 and Phase 2b/3 trials through 2028, reducing near-term financing risk.
• G&A Scaling: Higher G&A costs tied to public company compliance and anticipated commercial infrastructure buildout.

With no revenue and a clinical-stage profile, Trevi’s financials remain tied to trial cadence and regulatory milestones. The company’s ability to manage costs while accelerating late-stage programs will be critical as it approaches pivotal readouts.

Executive Commentary

Strategic Positioning

1. Multi-Indication Clinical Expansion

Trevi is targeting three chronic cough indications—IPF, non-IPF ILD, and RCC—using a single platform therapy, nalbuphine ER. The company’s strategy is to leverage overlapping physician networks (pulmonologists) and shared clinical infrastructure to maximize operational efficiency and market reach. Non-IPF ILD alone represents an estimated 228,000 patients, with 50-60% suffering from uncontrolled cough, more than doubling the target population of IPF chronic cough.

2. Regulatory Alignment and De-risking

Recent completion of FDA-requested Phase 1 safety and DDI studies removes key regulatory hurdles for Phase 3 initiation. The company is preparing its end-of-Phase 2 meeting package for FDA submission in Q4, seeking clarity on pivotal trial design, endpoints, and NDA-enabling work. Management emphasized the importance of gaining alignment on inclusion/exclusion criteria and safety database size to avoid protocol delays.

3. Physician and Payer Engagement

Strong investigator and physician demand was evident at recent medical meetings (CHEST, ERS), with clinicians eager to enroll patients in new trials. Management noted that the lack of FDA-approved therapies for chronic cough creates a high unmet need, with payers and prescribers showing early interest in the product profile. Commercial planning is underway, including market segmentation and field force sizing, with ongoing research to inform payer strategy.

4. Broadened Inclusion Criteria

Trevi intends to keep Phase 3 trial eligibility as broad as possible to reflect real-world patient populations, minimizing exclusions except for those that would confound cough measurement or safety. This approach is designed to support robust, generalizable data and facilitate future market adoption.

Key Considerations

The quarter’s narrative was defined by operational execution, regulatory de-risking, and groundwork for commercial readiness. Trevi’s leadership is focused on maintaining trial momentum while managing capital and regulatory complexity.

Key Considerations:

• Phase 3 Readiness: Protocols and sites are being finalized, with first patient-in targeted for the first half of 2026, contingent on FDA feedback.
• Orphan Drug Application: Management will pursue orphan status for IPF cough post-end-of-Phase 2, though impact is uncertain due to broad cough prevalence.
• Drug-Drug Interaction Studies: Additional DDI studies with CYP2C9 inhibitors are anticipated, reflecting the drug’s metabolic pathway and regulatory requirements.
• Commercial Buildout: Early investments in field force planning and payer research aim to accelerate launch readiness once pivotal data are available.

Risks

Trevi faces execution risk around multi-trial launches, regulatory alignment on pivotal endpoints, and potential protocol amendments that could delay timelines. The chronic cough landscape is evolving, with new therapies and shifting standards of care possibly impacting future trial enrollment and positioning. As a single-asset company, any safety or efficacy setback in nalbuphine ER would materially affect prospects.

Forward Outlook

For Q4 and into 2026, Trevi guided to:

• Request and conduct end-of-Phase 2 FDA meeting for IPF chronic cough, with feedback expected early next year.
• Initiate Phase 3 IPF chronic cough and Phase 2b/3 non-IPF ILD and RCC trials in the first half of 2026, pending regulatory alignment.

For full-year 2025, management reiterated:

• Cash runway into 2028, supporting all planned clinical programs through critical milestones.

Management flagged that timing of trial starts and regulatory clarity are the main gating factors for the next value inflection.

• End-of-Phase 2 FDA feedback will determine trial design and launch schedule.
• Additional Phase 1 studies may be required for NDA submission, per FDA guidance.

Takeaways

Trevi’s Q3 update signals operational discipline and regulatory progress, but the investment case remains tied to clinical execution and pivotal trial outcomes.

• Clinical Momentum: Positive data and regulatory de-risking have set the stage for multi-indication Phase 3 execution in 2026.
• Financial Flexibility: The $195M cash position removes near-term financing risk and enables focus on trial delivery and commercial planning.
• Upcoming Catalysts: Investors should watch for FDA feedback on trial design, orphan drug designation updates, and first patient-in for pivotal studies as the next major milestones.

Conclusion

Trevi exits Q3 with strong operational footing and a clear path to Phase 3 trial launches in chronic cough. While execution risk remains, the company’s cash position and regulatory progress offer a foundation for value creation as pivotal data approach.

Industry Read-Through

Trevi’s experience highlights the growing regulatory and commercial focus on symptomatic relief in fibrotic lung diseases, an area where few approved therapies exist. The company’s broad trial inclusion strategy and early engagement with payers and investigators may set a precedent for other rare disease and specialty pharma players. Successful navigation of FDA expectations around DDI, safety, and real-world eligibility could inform trial design and commercialization strategies across the chronic cough and pulmonary fibrosis landscape. Investors in similar clinical-stage biotechs should monitor evolving endpoints, regulatory feedback, and the competitive dynamic as new therapies approach late-stage development.

TRVI Healthcare Biotechnology Rare Disease Chronic Cough Clinical Trials Regulatory Orphan Drug