TREVI THERAPEUTICS, INC. 3Q 2026 FINANCIAL RESULTS - TREVI THERAPEUTICS INC

Financial Performance:

• Ended Q3 2026 with $299 million in cash, cash equivalents, and marketable securities.
• Current cash runway extends into 2030, fully funding clinical trials for lead IPF program through FDA approval, the non-IPF ILD Phase II trial through top-line data, and the ongoing RCC Phase IIb trial through completion.
• Funding covers pre-commercial activities but excludes commercial launch expenses, Phase III costs for RCC or non-IPF ILD, and costs for the DVO launch.
• No specific quarterly revenue or profit figures disclosed, consistent with a clinical-stage biopharmaceutical company.

Guidance and Future Outlook:

• OCEAN 2 (IPF) 12-week reading expected in H2 2027; OCEAN 1 (IPF) efficacy endpoint (52-week safety) expected in H1 2027 (transcript notes "first half of 2020" but context implies 2027).
• Non-IPF ILD Phase II dose-ranging study initiation planned for Q1 2027, with top-line data expected in H1 2028.
• RCC (Refractory Chronic Cough) Phase IIb (LATE) trial sample size re-estimation (SSRE) analysis expected in early Q1 2027; full trial results maintained in H2 2027 even if trial upsizing occurs.
• FDA Patient-Focused Drug Development (PFDD) meeting results to be released in 2027 via a "Voice of the Patient" report.

Business Segments and Product Lines:

• IPF-Related Chronic Cough: OCEAN 1 and OCEAN 2 trials initiated globally; regulatory approvals secured in all trial countries; site activation and enrollment ongoing.
• Non-IPF ILD: FDA alignment achieved for a Phase II dose-ranging study (n=120); trial uses same sites as North American IPF program; studies two doses of Heduvio for 12 weeks.
• Refractory Chronic Cough (RCC): Phase IIb (LATE) trial designed with a built-in Sample Size Re-Estimation (SSRE) to account for variability and placebo effect; focuses on patients with severe chronic cough and no other treatment options.
• Patent Portfolio: Received new patent issued for dosing in hepatic impaired patients and non-IPF ILD, extending protection to 2041; base method-of-use patents extend through 2039.

Market and Competitive Landscape:

• Competitive Landscape: No active competitive programs remain in RCC or other targeted chronic cough indications following recent failures by GSK (camlapixim) and other candidates; Trevi Therapeutics is the only player in all three cough indications.
• Market Opportunity: Non-IPF ILD opportunity is estimated to more than double the IPF market potential; severe RCC market (diagnosed >1 year, failed therapies) estimated at ~1 million patients.
• Market Positioning: Strategy centers on unifying diverse ILD conditions (100+ types) under the common thread of fibrotic lung disease and cough; focusing commercial efforts on pulmonologists (93% of target market reached with unbranded campaigns).

Risks and Challenges:

• Clinical Variability: Chronic cough indications face high heterogeneity of patient populations and significant placebo effects, necessitating the SSRE in the RCC trial.
• Enrollment Timing: Minor timeline shifts noted for the RCC SSRE analysis (moving from late Q4 2026 to early Q1 2027) attributed to holiday enrollment slowdowns rather than trial design failure.
• Regulatory Pathway: While FDA alignment is positive, the non-IPF ILD program will proceed via an SNDA (Supplemental New Drug Application) building on IPF data, requiring careful justification.
• Commercialization: Future success in RCC depends on navigating payer dynamics and defining the specific patient segment (severe, refractory) to maximize value proposition.

Management Commentary and Tone:

• Tone is confident and execution-focused, emphasizing the company's unique position as the sole player in the cough space following competitor failures.
• Management expressed optimism about site activation and patient enthusiasm, citing genuine excitement around a new therapy option for IPF.
• Emphasized that the "SSRE design ensures a non-futile result translates to a clinically meaningful benefit," framing the statistical adjustment as a risk mitigation tool rather than a failure signal.
• Explicitly stated intent to retain global commercial rights and not partner out core assets.

Analyst Questions and Answers:

• FDA Alignment (Non-IPF ILD): FDA agreed the Phase II will mirror the IPF study design (dose-ranging) to support an SNDA; focus is on fibrotic lung disease rather than specific comorbidity subgroups.
• RCC SSRE Mechanics: Analysis will be driven by the 54mg BID arm only; no data on why an upsize is needed will be provided to maintain bias protection; upsize would restore 80% power to a max of 152 patients.
• RCC Market Size & Pricing: Severe RCC target is ~1M patients; pricing strategies will be refined post-trial to avoid cannibalization with IPF/ILD indications if lower doses (e.g., 27mg) are found effective.
• Enrollment Status: OCEAN 1/2 enrollment progressing well; updates on specific enrollment numbers will be provided only upon reaching 50% completion.
• Filing Strategy: Plan for a comprehensive, integrated NDA filing combining OCEAN 1 and 2 data; fast-track status would not significantly alter the timeline as FDA review begins only after all data is submitted.
• Dosing Strategy: Non-IPF ILD trial will use 54mg BID and 27mg BID; 27mg QD was not chosen due to inferior efficacy seen in IPF at that dose.

Other Key Points:

• The company views the RCC space as a severe unmet need where quality of life impact is profound, similar to how Dupixent navigated payer dynamics in other conditions.
• Management noted that the competitive failures in RCC (GSK, Novartis) were attributed to issues like trial upsizing and mid-stream changes, reinforcing Trevi's strategy of adhering to original powering assumptions.
• The company will present at the Stifel Conference in the following week.