Trevi Q2 2026 Earnings: Higher Trial Spending Widens the Net Loss

Trevi Therapeutics (Nasdaq: TRVI) reported a Q2 2026 net loss of $17.8 million, compared with $12.3 million a year earlier, while basic and diluted net loss per share widened to $0.11 from $0.09. The larger loss reflected higher spending on multiple Haduvio clinical programs, while an April stock offering helped lift cash, cash equivalents and marketable securities to $318.9 million.

Core financial results

The quarter ended June 30, 2026, was marked by a higher clinical development cost base. R&D expense increased by approximately 61%, mainly because of spending on the Phase 3 OCEAN-1 and OCEAN-2 trials, the Phase 2b LAKE trial and Phase 1 NDA-supportive studies. Higher stock-based compensation and personnel costs also contributed, partially offset by lower spending on the completed Phase 2b CORAL trial.

G&A expense also increased, driven primarily by stock-based compensation and personnel costs. Higher interest income from larger invested balances provided a partial offset, but total operating expenses still rose by approximately 49%.

Clinical pipeline progress

IPF-related chronic cough

Trevi initiated the Phase 3 OCEAN-1 trial during the second quarter. This 52-week fixed-dose study is the first of two parallel Phase 3 trials evaluating Haduvio in patients with idiopathic pulmonary fibrosis-related chronic cough, with topline results expected in the first half of 2028.

The company plans to start the 12-week Phase 3 OCEAN-2 trial in the third quarter of 2026. Topline results from OCEAN-2 are expected in the second half of 2027, making it the earlier of the two planned Phase 3 readouts.

Refractory chronic cough

Trevi also initiated the Phase 2b LAKE trial during Q2. The protocol calls for a sample-size re-estimation after 50% of participants complete treatment, which the company expects in the fourth quarter of 2026. Trevi plans to disclose the outcome of that analysis, while topline trial results are expected in the second half of 2027.

Non-IPF ILD-related chronic cough

The company submitted a meeting request to the FDA to discuss its proposed development plan for chronic cough associated with non-IPF interstitial lung disease. The objective is to align with the agency on the regulatory strategy and registration requirements before advancing the program.

April financing cushions higher trial spending

Trevi completed an underwritten common stock offering in April that generated approximately $162.3 million in net proceeds. At June 30, cash and cash equivalents were $54.3 million and marketable securities were $264.6 million, for a combined balance of $318.9 million. That compares with approximately $188.3 million at December 31, 2025.

Working capital increased to $317.0 million from $181.9 million at year-end. Trevi expects its current resources to extend its cash runway into 2030 and fund the IPF-related chronic cough program through potential FDA approval. The company also expects the balance to cover the non-IPF ILD program through Phase 3 and the ongoing Phase 2b LAKE trial.

The runway estimate has important boundaries: it excludes commercial launch expenses for Haduvio and a Phase 3 trial in refractory chronic cough. Weighted-average shares used to calculate Q2 loss per share also increased to 156.6 million from 130.4 million a year earlier, an increase of approximately 20%.

Investor risks to monitor

• Clinical execution and enrollment: Trevi is now running multiple trials, and its key readouts extend from the second half of 2027 into the first half of 2028. Enrollment or operational delays could affect these timelines.
• Regulatory and clinical uncertainty: Haduvio remains investigational, and its safety and efficacy have not been evaluated by a regulatory authority. The non-IPF ILD program also depends on alignment with the FDA regarding its development and registration plan.
• Rising development costs: R&D expense increased substantially as OCEAN-1 and LAKE began and preparations continued for OCEAN-2 and supporting studies. Spending across several programs makes trial costs and cash-runway assumptions increasingly important.
• Funding scope: The projected runway into 2030 does not cover commercial launch spending or a Phase 3 RCC trial, so it does not represent funding for every potential development and commercialization requirement.

Summary

Trevi’s Q2 2026 results reflected the transition into a more expensive phase of Haduvio development, with two trials launched and another Phase 3 study approaching initiation. The April financing provides substantial support for the current clinical plan, but investors will need to track enrollment, the LAKE sample-size review, the planned OCEAN-2 launch and FDA feedback on the non-IPF ILD program.