Trevi Therapeutics (TRVI) Q2 2026 earnings summary

Executive summary

• Advanced clinical programs for chronic cough, including OCEAN-1 phase III (IPF-related) and LAKE phase II-B (RCC) trials initiated in Q2 2026, with OCEAN-2 phase III set to begin in Q3 2026 and early enrollment underway.

• Focused on developing Haduvio (oral nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and RCC, with multiple ongoing and planned clinical trials, including two pivotal Phase 3 studies for IPF-related chronic cough and a Phase 2b trial for RCC.

• Achieved positive topline results in Phase 2b CORAL (IPF-related cough) and Phase 2a RIVER (RCC) trials, with significant reductions in cough frequency and favorable safety profiles.

• Submitted FDA meeting request for non-IPF ILD-related chronic cough program, aiming for alignment and rapid trial initiation.

• Positioned as the sole developer in all three cough indications following a competitor's program termination, with strong investigator and KOL enthusiasm for ongoing trials.

Financial highlights

• Ended Q2 2026 with $319 million in cash, cash equivalents, and marketable securities.

• Net loss for Q2 2026 was $17.8 million, compared to $12.3 million in Q2 2025; research and development expenses rose to $15.2 million in Q2 2026, and G&A expenses increased to $5.4 million.

• Cash runway guidance unchanged, extending into 2030, covering all planned clinical development through potential FDA approval for IPF-related chronic cough.

• Funding also supports phase III non-IPF ILD and ongoing phase II-B RCC trials, as well as pre-commercial activities.

• No product revenue generated to date; accumulated deficit reached $360.8 million as of June 30, 2026.

Outlook and guidance

• Key milestones expected in H2 2026: FDA alignment on non-IPF ILD program, 50% enrollment in LAKE trial, and SSRE results for LAKE trial.

• OCEAN-2 readout expected in H2 2027, OCEAN-1 in H1 2028; top-line results will be released as available.

• Existing cash resources expected to fund operations and capital expenditures into 2030, including completion of Phase 3 trials for IPF-related cough and Phase 2b for non-IPF ILD and RCC.

• Additional funding will be required for commercial launch activities and to complete regulatory approval for non-IPF ILD and RCC indications.

• SSRE for LAKE trial to confirm powering assumptions and adjust sample size if needed, with readout in Q4 2026.