Trevi Therapeutics (TRVI) investor relations material

Executive summary

• Advanced clinical programs for chronic cough, including OCEAN-1 and LAKE-2b trials initiated in Q2 2026 for IPF-related and refractory chronic cough, with OCEAN-2 set to begin in Q3 2026 and global trial sites expanding to over 200.

• Haduvio (oral nalbuphine ER) is being developed for chronic cough in IPF, non-IPF ILD, and RCC, with positive topline results in Phase 2b CORAL and Phase 2a RIVER trials showing significant reductions in cough frequency and favorable safety profiles.

• Early enrollment underway for initiated trials, with milestone updates planned at 50% enrollment and SSRE for LAKE trial to confirm powering assumptions in Q4 2026.

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

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

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; R&D expenses rose to $15.2 million and G&A expenses to $5.4 million in Q2 2026.

• Cash runway guidance unchanged, extending into 2030, supporting clinical development through key milestones and potential FDA approval.

• Funding covers phase III for IPF and non-IPF ILD chronic cough, ongoing phase II-B LAKE trial for RCC, and pre-commercial activities, but excludes commercial launch and phase III RCC trial costs.

• Raised $162.3 million net proceeds from April 2026 public offering and $115.1 million from June 2025 offering.

Outlook and guidance

• Key milestones expected in H2 2026: FDA alignment on non-IPF ILD program, 50% enrollment in LAKE-2b, and SSRE results for LAKE trial.

• Topline results from Phase 3 OCEAN-1 expected in H1 2028 and from OCEAN-2 and LAKE trials in H2 2027; SSRE for LAKE trial to confirm powering assumptions and adjust sample size if needed.

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