Trevi Therapeutics Earnings Call Transcripts
Fiscal Year 2026
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A differentiated therapy for chronic cough is advancing through pivotal trials in IPF and RCC, with strong efficacy and safety data, a large addressable market, and a robust financial position to support development through 2030. Key data readouts are expected in 2027–2028.
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The event outlined a focused strategy to lead in chronic cough with Haduvio, advancing pivotal trials in IPF, non-IPF ILD, and RCC, supported by strong financials and patent protection. Large, underserved markets and rapid physician adoption are expected, with peak sales potential of $6B across indications.
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Clinical programs for IPF, non-IPF ILD, and RCC chronic cough are advancing, with strong cash reserves and extended runway into 2030. New patents strengthen IP, and key trial readouts are expected in late 2026 and 2027.
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Strong Phase II results in chronic cough have set the stage for two pivotal Phase III trials, with FDA alignment on endpoints and timelines targeting NDA filing in about two and a half years. Expansion into non-IPF ILD and RCC, differentiated mechanism, and robust financial runway position the program for significant commercial impact.
Fiscal Year 2025
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Major growth in 2025 was driven by positive clinical data and a clear FDA path for pivotal trials in chronic cough. With $188M in cash, the company is positioned to fund key trials into 2028 and expand into larger markets with high unmet need.
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Positive clinical data and a $115M capital raise have extended cash runway into 2028, supporting multiple late-stage trials in chronic cough indications. Q3 net loss narrowed to $11.8M, with strong investigator interest and regulatory alignment underway.
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A single-asset company is advancing a mixed agonist-antagonist opioid drug for chronic cough in IPF, non-IPF ILDs, and RCC, with strong phase 2 data and a specialty-focused commercial strategy. Patent protection extends to 2039, and over $200 million in cash supports trials through 2028. FDA engagement and AI-driven operations are key priorities.
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The company is advancing STAT3 inhibitors for IPF and oncology, with a pivotal IPF data readout expected in Q4 and HCC data in H1 2026. Interim trial results show promising lung function stabilization, and a next-generation prodrug is in development for improved delivery.
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Strong CORAL and RIVER trial results enabled a $115M capital raise, boosting cash to $204M and funding late-stage trials into 2029. Haduvio showed significant efficacy and quality of life improvements in IPF cough, with Phase III and additional studies planned pending FDA alignment.
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The phase 2b CORAL trial showed that NAL ER (Haduvio) significantly reduced chronic cough in IPF patients, with rapid, dose-dependent effects and a favorable safety profile. Patient-reported outcomes and expert commentary highlight the therapy's potential to address a major unmet need.
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Strong Q1 momentum with positive River trial results and Coral trial enrollment completed. Net loss narrowed year-over-year, and cash runway extends into Q4 2026. Awaiting Coral trial data this quarter to guide next development steps and regulatory strategy.
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Positive clinical results in both IPF and RCC cough support a central mechanism of action, with rapid onset and strong efficacy. The company is well-funded through 2026, planning pivotal trials and market expansion, and holds robust IP protection.
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The phase II-A RIVER trial showed Haduvio significantly reduced cough frequency in refractory chronic cough patients, with robust efficacy across all dose levels and a favorable safety profile. Patient-reported outcomes supported objective results, and the drug's unique mechanism addresses a high unmet need in a large market.
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Upcoming clinical data for IPF and RCC are expected in the first half of the year, with Haduvio showing strong efficacy and a unique central mechanism. The company is well-funded, has robust patent protection, and is planning parallel pivotal studies with differentiated pricing strategies for each indication.
Fiscal Year 2024
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Three positive clinical readouts in 2024 advanced Haduvio as a first-in-class therapy for IPF and RCC chronic cough, with robust trial execution and strong financial positioning. Phase II-B CORAL data is expected in Q2 2025, and cash runway extends into 2026.
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Top-line results from the HAP study show nalbuphine has significantly lower abuse potential than a Schedule IV comparator, with no clear dose-response for abuse-related endpoints. Decades of real-world use and study data support maintaining its unscheduled status, with further regulatory discussions and clinical milestones ahead.
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The presentation highlighted strong clinical progress in chronic cough and IPF, with promising efficacy data and multiple upcoming milestones. Both programs have significant market potential, and strategic interest is high as the company advances toward pivotal trials.
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Clinical programs for chronic cough and IPF advanced with key data readouts expected in late 2024 and early 2025. Q3 net loss widened to $13.2M on higher R&D spend, with cash runway into 2H 2026. HAP study and pivotal trial milestones are critical upcoming catalysts.
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Strong phase II data in IPF cough showed a 75% reduction in cough frequency, with ongoing phase II-B and RCC studies expected to yield key data by early 2025. The drug's unique mechanism targets both central and peripheral pathways, and a solid cash position supports continued development.
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Q2 2024 saw increased R&D and net loss as clinical trials in IPF and RCC advanced, with key data readouts expected in Q4 2024 and H1 2025. Cash runway extends into 2026, supported by a recent share issuance.