Trevi Therapeutics, Inc. · NASDAQ:TRVI
Trevi Therapeutics — Q4 2025 Earnings Presentation
24 slides from Trevi Therapeutics's earnings presentation, Mar 17, 2026
Slide 1: Corporate Presentation
Controlling cough where it countsTM Corporate Presentation March 2026 Nasdaq: TRVI
Slide 2: Forward Looking Statement Disclaimer
Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation regarding matters that are not historical facts are "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1
Slide 3: Best-in-Class Potential for Haduvio Across Difficult to Treat Chronic Cough Conditions
Best-in-Class Potential for Haduvio (nalbuphine ER) Across Difficult to Treat Chronic Cough Conditions Significant unmet need* Differentiated central and peripheral MOA Only investigational therapy with positive results in IPF-related chronic cough and RCC studies Specialty pricing and sales model $
Slide 4: Nalbuphine ER Has a Differentiated Central and Peripheral Mechanism of Action
Nalbuphine ER Has a Differentiated Central and Peripheral Mechanism of Action nalbuphine Nalbuphine is an unscheduled kappa κ-agonist µ-antagonist receptor agonist and mu receptor Brain neuron antagonist (KAMA) that acts on the cough reflex arc centrally and peripherally by Cough targeting opioid re
Slide 5: Patients with IPF and non-IPF ILD Chronic Cough
Patients with Idiopathic Pulmonary Fibrosis (IPF) and non-IPF Interstitial Lung Disease-Related (non-IPF ILD) Chronic Cough
Slide 6: Chronic Cough in ILDs May Cause Damage to the Lungs and Deteriorates Quality of Life
Chronic Cough in ILDs May Cause Damage to the Lungs and Deteriorates Quality of Life Estimates for Respiratory Hospitalization, Death, and Lung Transplant by LCQ Score (Cough QoL) • No FDA approved therapies in the US Severity Over Time from the US Pulmonary Fibrosis Foundation Registry (N=1,447) •
Slide 7: Opportunity to be Best-in-Class and First-in-Class in IPF-Related Chronic Cough
Opportunity to be Best-in-Class and First-in-Class in IPF-Related Chronic Cough NK1 Na Channel Blocker thalidomide Vicore Peripheral Only Mechanisms Have Failed in IPF-Related Chronic Cough KAMA pirfenidone Genentech • P2x3: gefapixant Other Haduvio Trevi Therapeutics • TRPA1: BI 1839100 thalidomide
Slide 8: Phase 2b Clinical Trial Design in Patients with IPF-Related Chronic Cough
Phase 2b Clinical Trial Design in Patients with IPF-Related Chronic Cough Blinded Double-Blind Primary Efficacy Endpoint Titration Period# Fixed-Dose Period (2 weeks) (4 weeks) • Relative change from Baseline in 24- Randomization hour cough frequency versus Screening NAL ER NAL ER 27 mg BID 2-week p
Slide 9: Rapid, Persistent, and Broad Response Observed in CORAL Phase 2b Trial
Rapid, Persistent, and Broad Response Observed in CORAL Phase 2b Trial Significant Reduction in Cough Frequency (Primary Endpoint) Broad Coverage Clinically Meaningful Response Relative Change from Baseline at Week 6 ^ Response Thresholds for 24-Hour Cough Frequency^ 100% 0% Percentage of Responders
Slide 10: Significant Improvement in Patient-Reported Cough-Related Quality of Life
Significant Improvement in Patient-Reported Cough-Related Quality of Life Change from Baseline in LCQ Total Score (higher score indicates better QoL) An improvement of 1.3 units is considered clinically important on a 21-point scale LCQ Change from Baseline at Week 6 4.00 + + LCQ Total Score (change
Slide 11: Summary of Common TEAEs by Dose Received at Onset of AE
Summary of Common (≥ 5%) TEAEs by Dose Received at Onset of AE TEAEs most frequently occurred during the titration period at 27 mg Denominator is total placebo events (placebo) or Total Active events (active doses) Placebo 27 mg BID 54 mg BID 108 mg BID Total Active (m = 63) (m = 208) (m = 94) (m =
Slide 12: Phase 3 Clinical Trial Designs in Patients with IPF-Related Chronic Cough
Phase 3 Clinical Trial Designs in Patients with IPF-Related Chronic Cough Two Phase 3 randomized, double-blind, placebo-controlled, multicenter, global trials Double-Blind Fixed-Dose Period Primary Efficacy NAL ER 54 mg BID Endpoint • Relative change from Blinded Titration Period Placebo BID Baselin
Slide 13: $2-3B Haduvio Opportunity in IPF with High Unmet Need and Favorable Commercial Dynamics
$2-3B Haduvio Opportunity in IPF Leading with a Specialty Indication with a High Unmet Need and Favorable Commercial Dynamics US IPF Opportunity Today IPF Cough Treatment Paradigm4 Expected Commercial Model 80+ ILD Care Centers in the US Tessalon Perles 38% Covered by 50-75 Reps PPIs 36% Codeine 15%
Slide 14: $2-3B Haduvio Expansion Opportunity Into Non-IPF ILD-Related Chronic Cough
$2-3B Haduvio Expansion Opportunity Into Patients with Non-IPF ILD-Related Chronic Cough Estimated 2025 US ILD Prevalence Patients with Non-IPF ILD-related chronic cough are similar to patients with IPF-related 150k 228k chronic cough2,3 Idiopathic Pulmonary Non-IPF Interstitial Lung Fibrosis (IPF)1
Slide 15: Patients with Refractory Chronic Cough (RCC)
Patients with Refractory Chronic Cough (RCC)
Slide 16: Refractory Chronic Cough Carries a High Burden of Disease and Impact on Patients' Lives
Refractory Chronic Cough Carries a High Burden of Disease and Impact on Patients’ Lives Average of 8 years with chronic cough Patient prior to diagnosis 60 year-old male Chronic cough since 1977 (>45 years) 61% have anxiety and/or depression Tried two cough therapies and codeine 34% reduction in wor
Slide 17: A Specialty Commercial Model in the RCC Market
A Specialty Commercial Model in the RCC Market US RCC Opportunity Current Treatment Paradigm RCC Commercial Model Inhalers/Sprays 43% Plan to target pulmonologists and allergists would provide significant 12M Cough suppressants 36% Patients with chronic cough (5% of US pop) overlap with ILD centers
Slide 18: Haduvio's Central and Peripheral Mechanism Has Best-in-Class Potential in RCC
Haduvio’s Central and Peripheral Mechanism Has Best-in-Class Potential in RCC NK1 Na Channel Blocker NTX-1175 Haduvio is well-positioned in a category orvepitant NeRRe Nocion with a high unmet need and no FDA- KAMA approved therapies RVT-1601 Roivant Other • Differentiated central and peripheral Had
Slide 19: RIVER Phase 2a Clinical Trial in RCC
RIVER Phase 2a Clinical Trial in RCC Subgroups (24-hour cough frequency): Treatment Treatment ≥20 coughs/hour Period 1 Period 2 10–19 coughs/hour Randomization NAL ER Placebo Screening (Day 1 – Day 21) 3-week (Day 1 – Day 21) Primary Efficacy Endpoint washout 2-week period / follow- • 24-hour cough
Slide 20: Large, Broad, and Rapid Effect Observed in RIVER Phase 2a Trial in RCC
Large, Broad, and Rapid Effect Observed in RIVER Phase 2a Trial in RCC Significant Reduction in Cough Frequency (Primary Endpoint) Broad Coverage Clinically Meaningful Response Relative Change from Baseline at Day 21 (108 mg BID) Responder Analysis Day 21 (108 mg BID) 0% 87% *** -9% 100% Relative Ch
Slide 21: Significant Improvement in Patient-Reported Cough-Related Quality of Life
Significant Improvement in Patient-Reported Cough-Related Quality of Life Change from Baseline in LCQ Total Score (higher score indicates better QoL) An improvement of 1.3 units is considered clinically important on a 21-point scale NAL ER LCQ Total Score LCQ Total Score Placebo Adjusted Change 21 N
Slide 22: Summary of Treatment-Emergent Adverse Events by Preferred Term
Summary of Treatment-Emergent Adverse Events by Preferred Term Total (N = 66) Treatment-Emergent Placebo NAL ER Discontinued Treatment, n (%) 15 (22.7%) Adverse Events at ≥10% N=59 N=63 Frequency Adverse Event 10 (15.2%) n (%) n (%) Withdrawal by Subject 4 (6.1%) Constipation 4 (6.8) 18 (28.6) Other
Slide 23: Phase 2b Clinical Trial Design in RCC
Phase 2b Clinical Trial Design in RCC (N ~100) Blinded Double-Blind 24-hour cough frequency Titration Period Fixed-Dose Period inclusion criteria: (2 weeks) (4 weeks) ≥10 coughs/hour Randomization Placebo Run-In Screening NAL ER NAL ER 27 mg QD 2-week Primary Efficacy Endpoint (>1 week) follow- • Re
Slide 24: Milestones and Value Creation
Milestones and Value Creation First Half 2026 Second Half 2026 Expected Clinical Development Milestones Expected Clinical Development Milestones ✓ Completed End-of-Phase 2 Meeting with - Initiation of Phase 3b IPF-related chronic the FDA for IPF-related Chronic Cough cough trial Program - Initiation