Trevi Therapeutics, Inc. (TRVI) - 10-K Summary
Business Context and Reporting Period
Company: Trevi Therapeutics, Inc.
Reporting Period: Fiscal Year Ended December 31, 2025
Business Model: Clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio (oral nalbuphine ER), an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC).
Key Milestone: In June 2025, the company announced positive topline results from its Phase 2b CORAL trial for IPF-related chronic cough. In March 2025, positive topline data was announced from the Phase 2a RIVER trial for RCC.
Key Financial Metrics
| Metric (in thousands) | 2025 | 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(42,759) | $(47,911) |
| Operating Expenses | $(49,328) | $(51,524) |
| Research & Development | $(33,478) | $(39,377) |
| General & Administrative | $(15,850) | $(12,147) |
| Interest Income, Net | $6,536 | $3,602 |
| Cash, Cash Equivalents & Marketable Securities | $188,300 | $107,600 |
| Accumulated Deficit | $(329,804) | $(287,045) |
Note: The company has not generated any product revenue to date. Interest income increased significantly in 2025 due to higher invested cash balances.
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $5.2 million (10.8%) compared to 2024, primarily driven by a $5.9 million decrease in R&D expenses.
- R&D Expenses: Decreased from $39.4 million to $33.5 million. This reduction was due to decreased clinical development costs for the HAP study, Phase 2a RIVER trial, and Phase 2b CORAL trial, which were actively enrolling in the prior year. This was partially offset by increased personnel and stock-based compensation costs.
- G&A Expenses: Increased by $3.7 million (30.5%) to $15.9 million, driven by higher professional fees (SOX 404(b) compliance), personnel costs, and severance.
- Liquidity Position: Cash and marketable securities increased by approximately $80.7 million, bolstered by a $115.1 million gross proceeds from the June 2025 public offering and a $50.0 million registered direct offering in December 2024.
- Capital Structure: Shares outstanding increased from 93.6 million (Dec 31, 2024) to 128.3 million (Dec 31, 2025) due to equity offerings and warrant exercises.
Guidance, Outlook, and Risks
Outlook and Clinical Pipeline:
- IPF Program: Following positive Phase 2b results, the company plans to initiate two pivotal Phase 3 trials in 2026 (first in Q2, second in H2). The FDA has aligned on the plan for these trials.
- Non-IPF ILD Program: Plans to initiate an adaptive design Phase 2b trial in H2 2026.
- RCC Program: Plans to initiate a Phase 2b trial in Q2 2026 following positive Phase 2a data.
- Regulatory: The company intends to pursue FDA approval under the Section 505(b)(2) pathway.
Liquidity and Funding:
- Management believes existing cash, cash equivalents, and marketable securities ($188.3 million) are sufficient to fund operations into 2028.
- Substantial additional funding will be required to complete development through regulatory approval and commercialization.
Key Risks and Contingencies:
- Single Product Dependence: The company is entirely dependent on the success of Haduvio; failure in clinical trials or regulatory approval would be catastrophic.
- Capital Requirements: Failure to raise additional capital on acceptable terms could force delays or abandonment of development programs.
- Regulatory Uncertainty: Risks associated with the Section 505(b)(2) pathway, potential classification as a controlled substance (DEA scheduling), and opioid class label warnings.
- Third-Party Reliance: Reliance on a single supplier (Par Health) for the active pharmaceutical ingredient (nalbuphine hydrochloride) and third-party CROs for clinical trials.
- Intellectual Property: Dependence on an exclusive license from Keenova Therapeutics plc; failure to comply with license terms could result in loss of rights.
Investor Verification Checklist
- Cash Runway: Verify the specific burn rate and confirm the "into 2028" funding estimate against the current cash balance of $188.3 million.
- Phase 3 Trial Design: Review the specific protocols for the two planned Phase 3 IPF trials (300 patients/52 weeks and 130 patients/12 weeks) and confirm FDA alignment details.
- Supply Chain Security: Assess the risks associated with the single-source supplier for nalbuphine hydrochloride and the status of any alternate source qualification.
- Warrant Dilution: Analyze the impact of outstanding pre-funded warrants (approx. 17.2 million shares) and common stock warrants (approx. 1.9 million shares) on future dilution.
- Regulatory Pathway: Confirm the company's strategy regarding the Section 505(b)(2) NDA submission and potential DEA scheduling of the oral formulation.