Trevi Therapeutics, Inc. (TRVI) Q2 2025 Earnings Call Transcript

Trevi Therapeutics reported a Q2 2025 net loss of $12.3 million, underpinned by a robust cash position of $204 million, providing runway into 2029 following a $115 million capital raise. This financial stability supports the advancement of Haduvio, notably after positive CORAL trial data for chronic cough in IPF met its primary endpoint and demonstrated statistically significant quality of life improvements, with the 54mg BID dose identified as pivotal for future development. Trevi plans to initiate Phase III trials for IPF cough and a Phase IIb study for refractory chronic cough in H1 2026, alongside a new study for non-IPF interstitial lung diseases, which significantly expands the market opportunity. Key near-term milestones include completing Phase I safety and drug-drug interaction studies, with an End of Phase II FDA meeting expected in Q4 2025 to finalize Phase III designs.

Analysis

Trevi Therapeutics has reached a significant inflection point, underpinned by positive Phase IIb CORAL trial data for Haduvio in treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The drug met its primary endpoint and demonstrated statistically and clinically significant improvements in quality of life, with the Leicester Cough Questionnaire (LCQ) score increasing by 3.7 points at the 54mg dose, well above the 1.3-point threshold for clinical meaningfulness. This data has solidified the 54mg BID dose as a likely anchor for the Phase III program. Financially, the company is in a robust position following a $115 million capital raise, which extended its cash runway to 2029 with a balance of $204 million. This capital is sufficient to fund its multi-trial late-stage development plan, including two Phase III trials in IPF, a trial in non-IPF interstitial lung diseases (ILD) that more than doubles the addressable market, and a Phase IIb study in refractory chronic cough (RCC). Key upcoming catalysts include an End-of-Phase II meeting with the FDA in Q4 2025 to finalize the Phase III design, with trial initiations planned for the first half of 2026. The completion of prerequisite Phase I studies on drug-drug interactions and respiratory safety is on track to support these regulatory discussions, further de-risking the path forward.

Key Decisions for Investors

• Investors should monitor the outcome of the End-of-Phase II meeting with the FDA scheduled for Q4 2025, as a clear alignment on the Phase III trial design for Haduvio in IPF will be a major de-risking milestone.
• The company's cash position of $204 million, providing a runway into 2029, significantly mitigates near-term financing risk and allows for the full execution of its late-stage clinical plans.
• Consider the strategic expansion into non-IPF interstitial lung diseases, a move that the company estimates more than doubles its market opportunity and leverages existing clinical and commercial synergies with the IPF program.
• The identification of the 54mg BID dose as a 'sweet spot' with a strong efficacy and quality-of-life profile from the CORAL trial provides increased confidence in the potential for a successful Phase III outcome.