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

Explicit Guidance:

• OCEAN 2 (IPF): 12-week reading expected in the second half of 2027.
• OCEAN 1 (IPF): 24-week efficacy endpoint and 52-week safety data expected in the first half of 2028.
• Non-IPF ILD Phase II: Trial initiation planned for the first quarter of 2027; top-line data anticipated in the first half of 2028.
• RCC (LATE) Trial: Full trial results (including potential Sample Size Re-estimation outcomes) confirmed for the second half of 2027; SSRE analysis expected in early Q1.
• Cash Runway: Current cash position of $299 million (as of Q3 2026) extends to 2030, funding trials through key inflection points (FDA approval for IPF, top-line data for Non-IPF ILD Phase II, and completion of RCC Phase IIb), excluding commercial launch costs.

Business-Segment Outlook:

• IPF Chronic Cough (Lead Program): OCEAN 1 and OCEAN 2 trials are active with global site activations underway; company maintains exclusive position in IPF cough with no active competitors.
• Non-IPF ILD Chronic Cough: Phase II dose-ranging study designed to confirm optimal dosing for future SNDA submission; trial design mirrors IPF program but includes a longer duration to support Phase III readiness.
• Refractory Chronic Cough (RCC): Single remaining asset in space after competitive failures; strategy focuses on severe patient population (cough >1 year, failed therapies) estimated at ~1 million patients; no competitive programs currently active.
• Patent Protection: New dosing patent issued for hepatic-impaired patients and non-IPF ILD extending protection to 2041; method-of-use patents for base indications extend to 2039.

Market and Competitive Outlook:

• Competitive Landscape: No active competitors remain in RCC or targeted chronic cough indications; peripheral-only mechanisms have failed to address cough heterogeneity.
• Mechanism of Action: Company hypothesis validated that central mechanisms are critical for mitigating hypersensitivity, distinguishing Heduvio from failed peripheral-only competitors.
• Pricing Strategy: Monitoring potential for differential pricing between RCC and IPF/ILD indications; assessing whether lower RCC doses require separate branding to avoid cannibalizing IPF/ILD pricing.
• Market Development: Unbranded campaigns targeting 93% of pulmonologists; focus on IPF and ILD markets initially, with RCC market development efforts deferred pending clinical data.

Macro / Industry Outlook:

• Regulatory Alignment: Strong, collaborative relationships with FDA; Non-IPF ILD development plan aligned for a streamlined SNDA (Supplemental New Drug Application) pathway leveraging IPF data.
• Patient Focus: FDA engaged in patient-focused drug development (PFDD) to recognize chronic cough as a significant unmet need; "Voice of the Patient" report expected in 2027.
• Drug Development Trends: Acknowledgment of high placebo effect and patient heterogeneity in chronic cough trials; competitive failures (e.g., GSK, Novan) attributed to trial design and enrichment issues rather than fundamental efficacy of central/peripheral mechanisms.

Strategic Initiatives:

• Clinical Trials:
  • Non-IPF ILD Phase II: Up to 120 patients; will study two doses for 12 weeks; site overlap with North American IPF Phase III sites.
  • RCC Phase IIb (LATE): Sample Size Re-estimation (SSRE) built-in; independent stats team to analyze 50% enrollment data (approx. 50 patients) to confirm powering.
• Trial Adjustments (SSRE):
  • Scenario A: If 80% power confirmed, trial continues with original 100 patients.
  • Scenario B: If conditional power 40–80%, trial upsize proportional to reach 80% power, capped at 152 patients (up to +52).
  • Scenario C: If conditional power <40% (futility), trial enrolls to original 100 patients for completion.
• Filing Strategy: Comprehensive integrated NDA filing for IPF program combining OCEAN 1 and OCEAN 2 data; no intent to file in pieces even if Fast Track designation is granted.
• Commercial Rights: Company intends to retain global commercial rights for all programs rather than licensing out, though co-promotion options remain open.

Risks and Headwinds to Outlook:

• Patient Heterogeneity: Non-IPF ILD population encompasses >100 conditions; variability may impact trial results, though trial design focuses on the common thread of fibrotic lung disease.
• Placebo Effect: High placebo rates in chronic cough trials remain a significant challenge, necessitating the SSRE design to ensure statistical significance.
• Trial Execution: Enrollment speed in RCC trial slightly delayed from December to early Q1 due to holidays; potential need for trial upsize if effect size assumptions are not met.
• Commercial Dynamics: Uncertainty regarding payer acceptance for RCC despite lack of alternatives; potential need to segment RCC market to preserve pricing in IPF/ILD.

Management Tone on the Future:

• Confidence Level: High confidence in clinical execution and alignment with regulatory authorities; management expresses enthusiasm regarding site activation and patient interest.
• Strategic Positioning: Assertive stance on being the sole player in all three cough indications; belief that competitive failures have cleared the path for Heduvio to capture significant market share.
• Financial Outlook: Reiterated confidence in funding sufficiency through critical milestones (2030 runway), emphasizing a "well-capitalized" status to execute without immediate dilution pressure.
• Hedges: Statements include standard forward-looking disclaimers regarding variability in patient populations, regulatory feedback, and potential delays in data readouts.

Miscellaneous:

• Stifel Conference: Company leadership confirmed attendance at the upcoming Stifel Conference.
• FDA Interaction: Recent FDA meeting on ILD described as "positive," "supportive," and "collaborative," resulting in clear alignment on the development plan.
• Dosing Assumptions: Assumption that Non-IPF ILD dosing will mirror IPF results (favoring BID dosing over QD), with 27mg BID considered potentially insufficient based on IPF data.