Trevi Therapeutics (TRVI) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Strategic positioning and clinical progress

• Focused on cough indications: IPF cough, ILD cough, and refractory chronic cough, leveraging a central mechanism with strong efficacy data and minimal competition after peripheral-only mechanisms failed.

• Advanced to phase IIb and phase III trials with clear regulatory alignment and robust study designs, including OCEAN-1 (52-week, 300 patients) and OCEAN-2 (12-week, 200 patients) for IPF cough.

• Implemented learnings from prior industry failures, focusing on patient selection and placebo management to optimize trial outcomes.

• Upcoming milestones include an FDA meeting for ILD, RCC sample size re-estimation by year-end, and major data readouts in the second half of 2027.

• Well-capitalized with $319 million in cash, supporting all planned milestones and internal launch preparations.

Commercial strategy and market opportunity

• Pricing strategy differentiates between rare disease (IPF/ILD, $75,000–$125,000/year) and broader RCC market ($15,000–$20,000/year), with payer-tested step edits for treatment-resistant populations.

• Targeting pulmonologists with a scalable sales force (50–100 reps for IPF/ILD, plus 25 for RCC), enabling a biotech-scale launch.

• Commercial opportunity could reach $2 billion annually with 20,000 patients at $100,000 each, driven by high unmet need and lack of alternatives.

• Strategic interest from potential partners is expected to increase post-phase III data, with management preferring to maximize value through clinical de-risking.

• Ex-U.S. strategy is to retain global rights for now, focusing on the robust U.S. pricing environment and considering partnerships for future international launches.

Clinical trial design and differentiation

• LAKE trial for RCC uses a parallel-arm design with multiple low-dose arms, aiming to clarify optimal dosing and effect size, with built-in sample size re-estimation.

• Powering assumptions are conservative, with flexibility to increase sample size if needed, and timelines could extend by 3–6 months if upsized.

• Efficacy data show a large proportion of patients achieving significant cough reduction, with responder analyses indicating robust and rapid effects.

• Product profile and pricing are relatively insensitive to small changes in effect size, given the lack of alternatives and high patient need.

• Expansion into non-IPF ILD and other respiratory indications is under consideration, with ongoing IP filings and exploration of additional opportunities such as bronchiectasis and lung cancer.