TRVI

Trevi Therapeutics, Inc. (TRVI) - Q2 2026 Filing Summary

Business Context and Reporting Period

This Quarterly Report on Form 10-Q covers the period ended June 30, 2026. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). The company has no product revenue and operates as a single reportable segment.

Key Financial Metrics

Material Changes vs. Prior Period

• Increased Operating Expenses: Total operating expenses for the six months ended June 30, 2026, increased by $10.2 million (41%) compared to the same period in 2025. This was driven primarily by a $7.9 million increase in Research and Development (R&D) expenses due to the initiation of Phase 3 trials (OCEAN-1 and OCEAN-2) and the Phase 2b LAKE trial.
• Capital Raise: In April 2026, the company completed an underwritten public offering (April 2026 Offering), issuing 13.34 million shares (including full exercise of the underwriters' option) for net proceeds of approximately $162.3 million.
• Share Count: Outstanding common shares increased from 128.3 million at December 31, 2025, to 142.4 million at June 30, 2026, due to the April 2026 offering and stock option exercises.
• Investing Activities: Net cash used in investing activities increased significantly to $95.1 million (YTD 2026) from $12.6 million (YTD 2025), reflecting heavy purchases of marketable securities ($162.0 million) to deploy the new capital raised.

Outlook, Guidance, and Risks

• Clinical Pipeline Progress:
  • IPF Program: Phase 3 OCEAN-1 trial initiated in Q2 2026; Phase 3 OCEAN-2 planned for initiation in Q3 2026. Topline results expected in H1 2028 (OCEAN-1) and H2 2027 (OCEAN-2).
  • RCC Program: Phase 2b LAKE trial initiated in Q2 2026. Sample size re-estimation expected in Q4 2026; topline results expected in H2 2027.
  • Non-IPF ILD Program: Adaptive Phase 2b trial planned for initiation in H2 2026.
• Liquidity Outlook: Management believes existing cash, cash equivalents, and marketable securities ($318.9 million) will fund operations and capital expenditures into 2030, covering the IPF Phase 3 program through potential FDA approval. However, additional funding will be required for commercialization and to complete development for non-IPF ILD and RCC indications.
• Risks:
  • Substantial additional funding is required; failure to raise capital could delay or discontinue development.
  • Competition from other chronic cough therapies (e.g., P2X3 antagonists).
  • Regulatory risks regarding the approval of Haduvio.
  • Transition from "smaller reporting company" status expected in Q1 2027, which may increase disclosure costs.
• Subsequent Event: In July 2026, the company purchased an active pharmaceutical ingredient for approximately $2.4 million from Par Health (related party transaction).

Investor Verification Checklist

• Cash Runway: Verify the specific burn rate assumptions used to project funding sufficiency into 2030, particularly regarding the exclusion of commercialization costs.
• Trial Enrollment: Monitor enrollment rates for the Phase 3 OCEAN-1 and OCEAN-2 trials, as delays could materially impact the timeline for topline data.
• Capital Needs: Assess the likelihood and timing of future equity dilution required to fund the non-IPF ILD and RCC Phase 3 programs.
• Related Party Transactions: Review the terms of the July 2026 purchase of active pharmaceutical ingredient from Par Health.
• Regulatory Alignment: Confirm the status of the FDA End-of-Phase 2 meeting outcomes and any additional data requirements for the NDA submission.