Trevi Therapeutics, Inc. · NASDAQ:TRVI
Trevi Therapeutics — Investor Presentation (August 2026)
33 slides from Trevi Therapeutics's investor presentation, August 2026
Slide 1: Corporate Presentation
Controlling cough where it countsTM Corporate Presentation August 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: Our Pipeline: Advancing Haduvio Across Three Chronic Cough Indications
Our Pipeline: Advancing Haduvio (nalbuphine ER) Across Three Chronic Cough Indications Preclinical Phase 1 Phase 2 Phase 3 Filing Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic cough Non-IPF Interstitial Lung Chronic Disease (Non-IPF ILD)-Related Cough Chronic Cough Refractory Chronic Cough (RC
Slide 4: Best-in-Class and First-in-Class Potential for Haduvio Across Difficult to Treat Chronic Cough Conditions
Best-in-Class and First-in-Class Potential for Haduvio Across Difficult to Treat Chronic Cough Conditions Significant unmet need* Differentiated central and peripheral mechanism Positive results across cough counts and PROs in chronic cough trials in IPF and RCC Potential for specialty pricing and s
Slide 5: 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 6: Opioid Class Differences and Abuse Liability Are Explained by Receptor-Level Interactions
Opioid Class Differences and Abuse Liability Are Explained by Receptor-Level Interactions – Nalbuphine was Designed to be Unique Differences in opioid receptor interactions across medication classes drive variation in therapeutic and safety outcomes • Nalbuphine is in a unique opioid class called “m
Slide 7: IPF-Related Chronic Cough and non-IPF ILD-Related Chronic Cough
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough and non-IPF Interstitial Lung Disease (non-IPF ILD)-Related Chronic Cough
Slide 8: 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, • No FDA-approved therapies for IPF-related or and Lung Transplant by LCQ Score (Cough QoL) non-IPF ILD-related chronic cough Severity Over Time for ILD Patients fro
Slide 9: 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 KAMA Peripheral Mechanisms Have Failed in pirfenidone Genentech Other IPF-Related Chronic Cough thalidomide Haduvio Trevi Therapeutics Celgene RVT-1601 Respivant Anti-Fibrotics H
Slide 10: Phase 2b Clinical Trial Design in Patients with IPF-Related Chronic Cough
Phase 2b Clinical Trial Design in Patients with IPF-Related Chronic Cough (N=165) Primary Efficacy Endpoint Blinded Double-Blind Titration Period# Fixed Dose Period • Relative change from Baseline in 24- (2 weeks) (4 weeks) hour cough frequency versus Randomization placebo at Week 6 (using objective
Slide 11: Baseline Characteristics of 165 Randomized Patients
Baseline Characteristics of 165 Randomized Patients Race Age Duration of Cough 1.8% Mean (SD): 70.1 (7.3) years Mean (SD): 1.8% 1.2% 4.2 (6.6) years 40 50 60 70 80 0 5 10 Years Years Asian Black/African-American Lung Function Parameters White 95.2% Sex Not Reported Mean (SD) FEV1 liters: 2.6 (0.9) C
Slide 12: 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 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 LCQ Change from Baseline at Week 6 4.00 + + LCQ Total Score (change
Slide 14: Summary of Common (≥ 5%) 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 15: IPF-Related Chronic Cough: OCEAN Phase 3 Program Trial Framework
IPF-Related Chronic Cough: OCEAN Phase 3 Program Trial Framework Safety Follow-Up Screening Period Titration Period Fixed-Dose Period Period Weeks 3 – 54 Weeks 1 - 2 3 Weeks 24wk Primary Endpoint (PE) 2:1 Randomization NAL ER 27 mg n = 204 QD BID NAL ER 54 mg BID No Treatment Placebo n = 102 QD
Slide 16: IPF-Related Chronic Cough: OCEAN Phase 3 Clinical Program Overview
IPF-Related Chronic Cough: OCEAN Phase 3 Clinical Program Overview 2026 2027 2028 2Q 3Q 4Q 1H 2H 1H 2H 52-weeks fixed dosing Phase 3a, N=306 PE TLD 12-weeks fixed dosing Phase 3b, N=201 TLD Multinational Trial Primary Efficacy Endpoint OCEAN-1 Key Secondary Endpoints • Δ from Baseline in the CS-NRS*
Slide 17: Leading with IPF Specialty Indication with a High Unmet Need and Favorable Commercial Dynamics
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 90+ ILD Care Centers in the US Tessalon Perles 38% Covered by 50-75 Reps PPIs 36% Codeine 15% ~140,000 Neuromodulators (e.g.
Slide 18: Non-IPF ILD-Related Chronic Cough Represents a Large, Untreated, and Underserved Population
Non-IPF ILD-Related Chronic Cough Represents a Large, Untreated, and Underserved Population Expansion Into Non-IPF ILD More Than Doubles the Addressable Patient Population Estimated 2026 US ILD Prevalence Patients with Non-IPF ILD-related chronic 140k 228k cough are similar to patients with IPF-rela
Slide 19: Refractory Chronic Cough (RCC)
Refractory Chronic Cough (RCC)
Slide 20: 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 No FDA-approved therapies 61% have anxiety and/or depression 34% reduction in work activities 30% reduction in non-work activities Impaired physical and psychological health ~2 in 3 women with chronic cough exper
Slide 21: Haduvio's Central and Peripheral Mechanism Has Best-in-Class and First-in-Class Potential in RCC
Haduvio’s Central and Peripheral Mechanism Has Best-in-Class and First-in-Class Potential in RCC NK1 Na Channel Blocker NTX-1175 orvepitant Nocion NeRRe Haduvio’s Differentiation in RCC KAMA RVT-1601 Roivant Other • Central and peripheral mechanism Haduvio • Achieved a deep, broad, and rapid effect
Slide 22: Physicians Recognize the High Unmet Need, QoL, and Importance of Treating in Refractory Chronic Cough
Physicians Recognize the High Unmet Need, QoL, and Importance of Treating in Refractory Chronic Cough Similarities Between Chronic Cough in IPF, non-IPF ILD, and RCC Very High 10 9 8 7 Rating (1-10) 6 5 4 3 2 1 Unmet Need Impact on QoL Importance of Treating IPF non-IPF ILD RCC 22 Indegene Market Re
Slide 23: Specialty-Focused Commercial Model Efficiently Targets Treatment-Resistant RCC Patients
Specialty-Focused Commercial Model Efficiently Targets Treatment-Resistant RCC Patients US RCC Opportunity RCC Commercial Model RCC Prescribing Drivers Plan to target pulmonologists and allergists would provide significant ~12M 1 Efficacy Patients with chronic cough (5% of US pop) overlap with ILD c
Slide 24: RIVER Phase 2a Clinical Trial in RCC
RIVER Phase 2a Clinical Trial in RCC (N=66) 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
Slide 25: Baseline Characteristics of 66 Randomized Patients
Baseline Characteristics of 66 Randomized Patients Cough Severity (VAS, mm) Duration of Cough Cough-associated Medical Mean (SD): Conditions Mean (SD): 72.2 (13.3) 12.6 (10.4) years 21.2% Asthma 42.4% Cough Frequency None Mean (SD): 34.7 (29.2) 1 (coughs/hour) 21.2% >800 coughs/day UACS 0 10 20 30 B
Slide 26: 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 27: Patient-Reported Cough-Related Quality of Life
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 RIVER NAL ER LCQ Total Score LCQ Total Score Placebo Adjusted Change NAL ER comparison to caml
Slide 28: Summary of Treatment-Emergent Adverse Events by Preferred Term
Summary of Treatment-Emergent Adverse Events by Preferred Term Treatment-Emergent Placebo NAL ER Total (N = 66) Adverse Events at ≥10% N=59 N=63 Frequency n (%) n (%) Discontinued Treatment, n (%) 15 (22.7%) Constipation 4 (6.8) 18 (28.6) Adverse Event 10 (15.2%) Somnolence 0 (0) 16 (25.4) Withdrawa
Slide 29: Refractory Chronic Cough: Phase 2b Trial Framework
Refractory Chronic Cough: Phase 2b Trial Framework A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended- Release Tablets for the Treatment of Patients with Refractory Chronic Cough Screening Period Safety Follow-Up Titration Per
Slide 30: Refractory Chronic Cough: LAKE Phase 2b Trial Overview
Refractory Chronic Cough: LAKE Phase 2b Trial Overview 2026 SSRE 2027 2028 2Q 3Q 4Q 1H 2H 1H 2H SSRE 4-weeks fixed dosing Phase 2b, N=100 TLD Primary Endpoint PRO Secondary Endpoints Assumptions: Relative change from Baseline in objective 24- Assessed changes from Baseline, measured at week 6 and ot
Slide 31: Haduvio Represents a Potential $6B+ Peak Sales Opportunity Across Chronic Cough Indications
Haduvio Represents a Potential $6B+ Peak Sales Opportunity Across Chronic Cough Indications Treatment Resistant IPF Non-IPF ILD Total RCC (TR-RCC) Est. U.S. 2026 Patients 140K 228K 650K – 1M Eligible Patients 80 – 105K 115 – 135K 650K – 1M 850K – 1.2M Share Assumptions 25 – 35% 20 – 30% 3 – 10% Key
Slide 32: Robust IP Portfolio Potentially Extends Protection Into 2040s
Robust IP Portfolio Potentially Extends Protection Into 2040s Worldwide IP Filed • Foundational Method of Use Protection • Broad claims defend against ANDA and 505(b)(2) competition • Chronic Cough in IPF • Issued U.S. patent (expires 2039) • Granted European patent (expires 2039) • Pipeline Indicat
Slide 33: Expected Key Clinical Milestones and Data Readouts
Expected Key Clinical Milestones and Data Readouts Timing for all dates is depicted as 2026 2027 2028 middle of the corresponding half 1H 2H 1H 2H 1H Ph3 IPF-Related Chronic Cough Ph3 Non-IPF ILD- Related Chronic Ph2b Cough Refractory Ph2b Chronic Cough SSRE Trial Initiation Topline Data Cash, Cash
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