Trevi Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $21.5 million for the quarter ended September 30, 2026, compared to a net loss of $11.8 million in the same period in 2025.
• Research and development (R&D) expenses increased to $19.1 million in Q3 2026 from $10.1 million in Q3 2025, driven by clinical development costs for Phase 3 OCEAN-1, Phase 2b LAKE, and Phase 3 OCEAN-2 trials, as well as increased stock-based compensation and personnel expenses.
• General and administrative (G&A) expenses rose to $5.4 million in Q3 2026 from $3.8 million in Q3 2025, primarily due to higher stock-based compensation and personnel costs.
• Other income, net increased to $3.0 million in Q3 2026 from $2.1 million in Q3 2025, attributed to higher interest income from increased invested cash equivalents and marketable securities.
• Ended the quarter with $299.4 million in cash, cash equivalents, and marketable securities, up from $188.3 million (sum of $18.9 million cash and $169.3 million marketable securities) as of December 31, 2025.
• Working capital increased to $297.9 million as of September 30, 2026, compared to $181.9 million as of December 31, 2025.
• Total assets were $310.8 million as of September 30, 2026, compared to $193.4 million as of December 31, 2025.
• Stockholders' equity was $302.8 million as of September 30, 2026, compared to $183.2 million as of December 31, 2025.
• Net loss per share (basic and diluted) was $(0.13) for the three months ended September 30, 2026, compared to $(0.08) in the same period in 2025.

Guidance and Future Outlook:

• Management expects current cash resources to provide a runway into 2030, funding the development of Haduvio for IPF-related chronic cough through potential FDA approval.
• Cash resources are expected to fund clinical development through Phase 2 for non-IPF ILD-related chronic cough and the ongoing Phase 2b LAKE trial for refractory chronic cough.
• Topline results for the Phase 3 OCEAN-2 trial (IPF-related chronic cough) are expected in the second half of 2027.
• Topline results for the Phase 3 OCEAN-1 trial (IPF-related chronic cough) are expected in the first half of 2028.
• The Phase 2 dose-ranging trial for non-IPF ILD-related chronic cough is expected to initiate in the first quarter of 2027, with topline results expected in the first half of 2028.
• The outcome of the sample size re-estimation (SSRE) analysis for the Phase 2b LAKE trial (refractory chronic cough) is expected early in the first quarter of 2027.
• Topline results for the full Phase 2b LAKE trial are expected in the second half of 2027.

Business Segments and Product Lines:

• IPF-Related Chronic Cough: Both Phase 3 OCEAN trials are actively recruiting patients globally. The 12-week fixed-dose OCEAN-2 trial was initiated in Q3 2026. The 52-week fixed-dose OCEAN-1 trial was initiated in Q2 2026.
• Non-IPF ILD-Related Chronic Cough: Trevi held a positive FDA meeting in October 2026, achieving alignment on the development path and Phase 2 dose-ranging trial design. The trial will evaluate 54 mg BID and 27 mg BID doses of nalbuphine ER versus placebo in approximately 120 patients, with the primary endpoint being relative change in 24-hour cough frequency at 12 weeks.
• Refractory Chronic Cough (RCC): The Phase 2b LAKE trial was initiated in Q2 2026, with enrollment progressing. The trial includes a sample size re-estimation analysis once 50% of patients complete treatment.
• Patent Protection: Received a Notice of Allowance from the USPTO for a patent application covering nalbuphine ER dosing in hepatically impaired patients with non-IPF ILD-related chronic cough, expected to expire in 2041 and listable on the Orange Book.
• Product Mechanism: Haduvio (oral nalbuphine ER) acts as a dual-acting kappa opioid receptor agonist and mu opioid receptor antagonist (KAMA), hypothesized to reduce cough hypersensitivity by modulating central neural pathways and peripheral airway nerves.

Market and Competitive Landscape:

• Chronic cough in IPF and non-IPF ILD patients represents a high unmet need with no FDA-approved therapies; approximately 140,000 U.S. patients have IPF (two-thirds with uncontrolled cough) and 228,000 U.S. patients have non-IPF ILD (50-60% with uncontrolled cough).
• Refractory chronic cough affects approximately 2-3 million U.S. patients and is defined as a persistent cough lasting over 8 weeks despite treatment for underlying conditions.
• Chronic cough is associated with significant morbidity, including up to 1,500 coughs per day, increased respiratory hospitalizations, higher risk of lung transplant, and potential decline in quality of life.

Risks and Challenges:

• Forward-looking statements highlight risks including uncertainties in estimating cash runway, future expenses, and the ability to fund future operations and clinical trials.
• Risks include uncertainties regarding the success, cost, and timing of product candidate development and clinical trials, including the initiation of trials and generation of data.
• There is a risk that positive data from a clinical trial may not predict results of later trials in the same or different indications.
• Uncertainties exist regarding regulatory authorities' views on trial data and next steps for FDA approval in the U.S. and foreign countries.
• Risks related to the execution of the company's strategy and the potential for actual results to differ materially from forward-looking statements are noted.

Management Commentary and Tone:

• President and CEO Jennifer Good described the period as an "important time of clinical execution" with active global site openings and patient enrollment across all three trials.
• Management expressed confidence in aligning with the FDA on the non-IPF ILD program and believes the dual central and peripheral mechanism of Haduvio is important for treating these patients.
• Management highlighted that chronic cough remains a significant unmet need and that the associated hospitalizations and transplant risks result in higher costs for patients where no FDA-approved therapies currently exist.

Other Key Points:

• Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio for IPF-related chronic cough, non-IPF ILD-related chronic cough, and refractory chronic cough.
• Parenteral nalbuphine has been approved and marketed for pain indications for decades in the U.S. and Europe and is not currently scheduled by the U.S. Drug Enforcement Administration.
• The FDA has conditionally accepted "Haduvio" as the trade name for nalbuphine ER; safety and efficacy have not yet been evaluated by any regulatory authority.
• The company plans to host a conference call and webcast at 4:30 p.m. ET on the release date to discuss results and business highlights.
• Nine months ended September 30, 2026, R&D expenses were $44.2 million compared to $27.3 million in the same period in 2025.
• Nine months ended September 30, 2026, G&A expenses were $15.8 million compared to $11.8 million in the same period in 2025.
• Nine months ended September 30, 2026, net loss was $52.4 million compared to $34.4 million in the same period in 2025.