Trevi Therapeutics, Inc. · NASDAQ:TRVI
Trevi Therapeutics — Q2 2025 Earnings Presentation
27 slides from Trevi Therapeutics's earnings presentation, Aug 7, 2025
Slide 1: Corporate Presentation
Controlling cough where it countsTM Corporate Presentation August 2025 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 Across Difficult to Treat Chronic Cough Conditions Significant unmet need* Differentiated central and peripheral MOA Only investigational therapy with positive results in IPF and RCC chronic cough studies Potential for specialty pricing and sales model $5B+ market
Slide 4: Haduvio's Differentiated Central and Peripheral Mechanism of Action
Haduvio’s Differentiated Central and Peripheral Mechanism of Action Haduvio (nalbuphine ER) Importance of Central and Peripheral Activity Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key rol
Slide 5: IPF Chronic Cough
IPF Chronic Cough trev! THERAPEUTICS
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) Severity Over Time from the US Pulmonary Fibrosis • No approved therapies in the US Foundation Registry (N=1,447) • Grow
Slide 7: Opportunity to be Best-in-Class and First-in-Class in IPF Chronic Cough
Opportunity to be Best-in-Class and First-in-Class in IPF Chronic Cough NK1 Na Channel Blocker thalidomide Vicore P2x3s Failed in IPF Chronic Cough KAMA pirfenidone Genentech • Gefapixant (P2x3) Other Haduvio ME-015 Melius – 12% reduction (p=0.8983) Trevi Therapeutics thalidomide U.S. Celgene RVT-16
Slide 8: Phase 2b Clinical Trial Design in IPF Patients with Chronic Cough
Phase 2b Clinical Trial Design in IPF Patients with 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 NAL ER NAL ER 27 mg BID placebo at Week 6 (using o
Slide 9: Patient Demographics
Patient Demographics Total (N = 165)1 Age (years), mean (std) 70.1 (7.29) Male, n (%) 118 (71.5%) Female, n (%) 47 (28.5%) Race, n (%) White 157 (95.2%) Asian 3 (1.8%) Not Reported 3 (1.8%) Black or African American 2 (1.2%) Cough Duration (years), Mean (std) 4.22 (6.60) Mean Dose Group Range of Bas
Slide 10: Objective 24-hour Cough Frequency
Objective 24-hour Cough Frequency Primary Endpoint: Relative Change from Baseline at Week 6 Significant difference in the relative change from Baseline observed across all dose groups Relative Change from Baseline at Week 6 0.0% -10.0% -16.9% Relative Change from Baseline (%) -20.0% (Coughs / Hour)
Slide 11: Rapid, Persistent, and Broad Response with Haduvio
Rapid, Persistent, and Broad Response with Haduvio Majority of patients achieved at least a 50% reduction in objective Rapid and persistent cough reduction observed by Week 2 cough frequency Relative Change from Baseline in 24-Hour Response Thresholds for 24-Hour Cough Cough Frequency^ Frequency 0%
Slide 12: Patient-Reported Outcomes Consistent With Objective Cough Measures
Patient-Reported Outcomes Consistent With Objective Cough Measures “Please indicate the severity of cough you experienced over the E-RS®:IPF Cough Subscale “How often did you cough today?” past 24 hours” Relative Change from Baseline at Week 6 Cough Severity Numerical Rating Scale 0.0% (CS-NRS) at W
Slide 13: 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 Haduvio LCQ Total Score LCQ Change from Baseline at Week 6 5 Higher
Slide 14: Summary of Common Treatment-Emergent Adverse Events
Summary of Common (≥ 5% in Total Active Group) TEAEs by Preferred Term Onset of TEAEs listed by actual dose 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 = 73) (m = 375) Preferred
Slide 15: CORAL Topline Data Conclusions
CORAL Topline Data Conclusions • First parallel-group study that demonstrated significant reduction in cough frequency in patients with IPF • Haduvio was observed to result in statistically significant dose-related reduction in cough frequency • Statistically-significant changes in topline secondary
Slide 16: Haduvio Opportunity Leading with IPF Specialty Indication
$2-3B Haduvio Opportunity Leading with IPF Specialty Indication with a High Unmet Need and Favorable Commercial Dynamics US IPF Opportunity Today IPF Cough Treatment Paradigm4 Expected Commercial Model Tessalon Perles 38% 88 ILD Care Centers in the US Covered by 35-50 Reps PPIs 36% OFEV® nintedanib
Slide 17: Haduvio Expansion Opportunity in Non-IPF ILD Chronic Cough
$2-3B Haduvio Expansion Opportunity in Patients with Non-IPF ILD Chronic Cough Estimated 2025 US ILD Prevalence Non-IPF ILD Patients with Chronic Cough Are Similar to IPF Patients with Chronic 150k 228k Cough2,3 Idiopathic Pulmonary Non-IPF Interstitial Lung Fibrosis (IPF)1 Diseases (Non-IPF ILD)1 -
Slide 18: Refractory Chronic Cough
Refractory Chronic Cough
Slide 19: 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 20: 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 21: 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 has an opportunity to be second- orvepitant NeRRe Nocion to-market in a category with a high unmet KAMA need where many mechanisms have failed RVT-1601 Roivant Other • Differentiated
Slide 22: 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 Haduvio Placebo Screening (Day 1 – Day 21) 3-week (Day 1 – Day 21) Primary Efficacy Endpoint washout 2-week period / follow- • 24-hour cough
Slide 23: 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% -9% 100% 87% *** 80% *** Rel
Slide 24: Patient-Reported Outcomes Consistent With Objective Cough Measures
Patient-Reported Outcomes Consistent With Objective Cough Measures Significant Improvement in Patient Perception of Cough Severity Patient-Reported Cough Frequency in Line With Objective Results Cough Severity Visual Analog Scale (CS-VAS) “Over the past 24 hours, how often did you Severity of Cough
Slide 25: 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 Haduvio LCQ Total Score LCQ Total Score Placebo Adjusted Change Had
Slide 26: Summary of Treatment-Emergent Adverse Events by Preferred Term
Summary of Treatment-Emergent Adverse Events by Preferred Term Total (N = 66) Treatment-Emergent Placebo Haduvio Discontinued Treatment, n (%) 15 (22.7%) Adverse Events at ≥10% N=59 N=63 Frequency n (%) Adverse Event 10 (15.2%) n (%) Withdrawal by Subject 4 (6.1%) Constipation 4 (6.8) 18 (28.6) Othe
Slide 27: Near-Term Opportunity to be a Derisked Ph3 Ready Asset
Near-Term Opportunity to be a Derisked Ph3 Ready Asset Expected upcoming milestones • 2H 2025: Request meeting with FDA on non-IPF Cash and Investments ILD protocol $203.9M in cash, cash equivalents and • 4Q 2025: Request End-of-Phase 2 meeting to marketable securities as of 6/30/25 align on Phase