Trevi Therapeutics, Inc. (TRVI) FY2025 10-K Annual Report
Trevi Therapeutics, Inc. (TRVI) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 17, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
Trevi Therapeutics, Inc. FY2025 10-K Analysis
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
Trevi Therapeutics, Inc. FY2025 Key Financial MetricsXBRL
Net Income
-$43M
▲ +10.8% YoY
ROE
-23.3%
▲ +2475bp YoY
Total Assets
$193M
▲ +74.4% YoY
EPS (Diluted)
$-0.32
▲ +31.9% YoY
Operating Cash Flow
-$42M
▼ -10.0% YoY
Source: XBRL data from Trevi Therapeutics, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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