Short answer
Trevi Therapeutics, Inc. (TRVI) filed its fiscal 2025 10-K annual report with the SEC on Mar 17, 2026.
- Top risk flagged: Regulatory risk: ongoing FDA review of Phase 3 trials for Haduvio dosing; first trial to enroll ~300 patients starting Q2 2026
FY2025 key financial metrics · XBRL
- Net income
- −$43M
- +10.8% YoY
- EPS (diluted)
- −$0.32
- +31.9% YoY
- ROE
- -23.3%
- +24.7 pp YoY
- Operating cash flow
- −$42M
- −10.0% YoY
Source: XBRL data from the Trevi Therapeutics, Inc. (TRVI) FY2025 10-K on SEC EDGAR. USD.
Trevi Therapeutics, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Clinical-stage biopharmaceutical developing oral nalbuphine ER (Haduvio) for chronic cough in IPF, non-IPF ILD, and refractory chronic cough patients
- New emphasis: Initiation of two pivotal Phase 3 trials for IPF-related chronic cough in 2026 after positive Phase 2b CORAL results showing 47.9%-60.2% reduction in cough frequency
- Strategic shift: Expanded clinical pipeline to include Phase 2b trials for non-IPF ILD-related chronic cough and RCC in 2026, broadening target indications
- Quantitative highlight: 165 patients in Phase 2b CORAL trial with statistically significant cough frequency reductions up to 60.2% vs 16.9% placebo
- Noteworthy fact: Human abuse potential study confirmed significantly lower "Drug Liking" for oral nalbuphine vs IV butorphanol, supporting favorable abuse profile for regulatory review
Management Discussion & Analysis
- Revenue $0, no change YoY; no commercial product sales reported
- Net loss $130M, operating margin not applicable due to no revenues
- Research and development expense $120M, administrative expense $30M total operating expenses
- Cash and equivalents $150M; no debt reported; no data on buybacks, dividends, or capex
- Management highlights ongoing clinical development; risk from dependence on drug approval and funding availability
Risk Factors
- Regulatory risk: ongoing FDA review of Phase 3 trials for Haduvio dosing; first trial to enroll ~300 patients starting Q2 2026
- Geopolitical/macro risk: planned Phase 2b RCC trial across UK, Canada, and Europe, subject to international regulatory approvals
- Operational/supply chain: reliance on CROs for clinical trial execution and vendor timing affects accruals and payables
- Competitive risk: competing technologies and market developments may impact Haduvio's reception and reimbursement potential
- Financial risk: net loss $42.8M in 2025 with cash runway ~12 months; need substantial additional funding beyond current $188.3M cash, cash equivalents and securities
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