Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (January 2025)
27 slides from Adial Pharmaceuticals's investor presentation, Jan 13, 2025
Slide 1: a =
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Slide 2: Forward Looking Statements
PHARMACEUTICALS Forward Looking Statements €, Adial This presentation includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “might,” es
Slide 3: AD-04 For the Treatment of Alcohol Use Disorder
é, Adial PHARMACEUTICAL: AD-04 For the Treatment of Alcohol Use Disorder ¢ First Precision Medication in Field After FDA Approval * Novel Indication in AUD * Harm Reduction vs Abstinence * Companion Diagnostic Biomarker * Safety and Tolerability Comparable to Placebo « Phase 3 ready Molecule
Slide 4: Executive Summary of AD-04
Executive Summary of AD-04 7, dial AD-04: small molecule (ondansetron hcl) with established clinical profile - defined by 40+ years of clinical experience PK/PD data supporting twice-daily oral formulation. Near micro doses with a safety and tolerability profile (comparable to placebo) — no hepatic,
Slide 5: Background: Adial, the Science and AD-04 Development
Background: Adial, the Science and AD-04 Development €, Adial PHARMACEUTICALS SSRI’s: 1990's-building on pioneering research of the human serotonin transporter (SERT) and studies revealing SSRIs could impact drinking behavior in some patents, the field witnessed some synergies when combining/complem
Slide 6: Strategic Considerations
Strategic Considerations €, Adial PHARMACEUTICALS Focus has been on understanding the results within the precision medicine frame-work and modifying our assumptions accordingly. Detailed analysis of the all the clinical data, especially the 11-week RCT POC study and ONWARD trial results, market rese
Slide 7: AD-04 A U.S. Phase Ready Molecule
AD-04 A U.S. Phase 3 Ready Molecule €, Adial Precision Med velopment: AD-04 for a new indication: AUD Biomarker Driven Drug Development (Iterative Discovery, Learn and Confirm) + Based on the MOA, the program successively conducted studies designed to determine patient and disease traits, genotypes
Slide 8: AUD: Disease Overview / Burden
AUD: Disease Overview / Burden y—S 7] - AUD is characterized by an impaired ability to stop or control alcohol use despite social, occupational, or health consequences - AUD is considered a brain disorder and can be classified as mild, moderate, or severe (by DSM-VR criteria) - Lasting changes in th
Slide 9: Alcohol is the #1 risk factor for death in the U.S.
Alcohol is the #1 risk factor for death in the U.S. €, Adial (~13.9% of US population over 18 yrs, or 29.5M have AUD) Significant Segment of Market Not Being Addressed in U.S. Current Market Solutions are failing Large market opportunity for a product that can address patient needs 29.5M Patients wi
Slide 10: Clinical Development & Efficacy
Clinical Development & Efficacy €, Adial PHARMACEUTICALS A Phase 1 Pharmacokinetic (PK) bridging study (AD04-103) was completed to satisfy FDA 505(b2) registration requirements 2 Key Adial clinical trials most inform the design of the future planned Phase 3 US FDA registration program: + Adial evalu
Slide 11: AD-04 103: Phase 1 PK Bridging study Completed
@,Adial AD-04 103: Phase 1 PK Bridging study Completed + Adial’s formulation exhibited predictable bioavailability relative to the reference standard, near micro-doses exhibited dose proportionality in pharmacokinetic exposure, and no food effect + Rapidly absorbed following oral administration and
Slide 12: Important Abbreviations and Endpoints in AUD Clinical Trials
Adial PHARMACEUTICALS Important Abbreviations and Endpoints in AUD Clinical Trials ZZ ADI Abbrev. Description/Endpoint Comment/Regulatory Drink + US."standard drink" any beverage containing 0.6 fl oz or 14 grams pure alcohol typically found in (12 oz regular beer, 5 oz wine, 1.5 02 distilled spirits
Slide 13: AD-04 Phase Trial Overview (NCT00000443)
AD-04 Phase 2 Trial Overview (NCT00000443) + Trial design: A randomized, two-center, parallel-group, placebo-controlled study to (1) evaluate the efficacy, safety, and tolerability of AD-04 (ondansetron) as a treatment for alcohol dependent patients, to assess whether early- versus late- onset alcoh
Slide 14: AD-04 Phase Trial (ONWARD) [NCT-04101227]
AD-04 Phase 3 Trial (ONWARD) [NCT-04101227] Trial design: A randomized, double-blind, placebo-controlled, parallel-group multicenter study to evaluate the efficacy, safety, and tolerability of AD-04 (ondansetron) as a treatment in heavy drinking adults with selected polymorphisms in the serotonin tr
Slide 15: Specific Patient Sub-Groups Responded Well Based on U.S. Endpoint
Specific Patient Sub-Groups Responded Well Based on U.S. Endpoint €, Adial FDA Endpoint Responder Analysis, defined as the perc i ie treatment arm versus placebo at months 5 and 6 Key Findings: Post Hoc Data Analysis Based on U.S. Endpoint (Patients in Group 1: Heavy drinker) + AG+ genotype group sh
Slide 16: ONWARD Trial: Signals of Treatment Impact
ONWARD Trial: Signals of Treatment Impact NI lals of Tre =, Adial EU multisite RCT of AD-04 in patients with AUD (total N=328) PRABMRCEITENS PNHDD by Genotype Percent No HDDs in Months 5 and 6 in oT 47% Patients with DDD <10 DDD sd — 2% Treatment response in AG+ subgroup with 2% 24% 23% marked diffe
Slide 17: Analysis of the AG genotype in the Ph study
Analysis of the AG genotype in the Ph 2 study, also showed a marked difference from Placebo in PNHDD Results consistent with the ONWARD trial PHDD, TAC, and PNHDD Results by Genotype, in Subjects <10 DDD PNHDD Responder study PHDD! TAC (post-hoc) Phase % % P Genotype N Mo Differences P value Differe
Slide 18: ONWARD Trial Response Curves by Genotype
ONWARD Trial Response Curves by Genotype in Patients with ©) Adial <10 DDD HDDs by Study Month a HDDs by Study Month ‘AG- M/F, <10 DDD AC- MF, <10DDD 8 a2 8 1409 g 20 AG 7 g 20 1000 consistently § 1000 < 800 separated < 800 “- from placebo _ 400 400 200 200 000 + ono 4 HDDs by Study Month —— HDDs by
Slide 19: AD-04 Evidence Based Summary of Product Attributes
AD-04 Evidence Based Summary of Product Attributes ©, Adial Mechanism of Action + Mechanism validated across a range of invitro and in vivo pre-clinical and human studies. + Adial Phase 1 BA study- demonstrated excellent PK; twice-daily oral formulation, will rely on weight of historical data packag
Slide 20: Patients are Not Satisfied with Current Options
Adial Patients are Not Satisfied with Current Options Adial’s ket research indicates patients are not satisfied with current options They Want Their Life Improved They Do Not Want ° Stick to their drinking plan Side effects ° Not fight with friends and family Painful injections ° Not embarrass thems
Slide 21: AD04 is Designed to Meet the Market Need
AD04 is Designed to Meet the Market Need @ dial m Action: Treatment of Alcohol Use Disorder (AUD) AD04 Designed To Curb Alcohol Intake by Reducing Craving AD04 is a Near Micro-Dose (0.33 mg/tablet) Formulation of Ondansetron. Ondansetron (brand name: Zofran), widely used for nausea since 1991, is we
Slide 22: AD04 is Designed to Meet the Market Need
AD04 is Designed to Meet the Market Need eZ hdial A new approach for patients who desire to control drinking Reduction of Heavy Drinking Target Indication but cannot or will not undertake existing treatment options. . . . Ends need for abstinence, a major hurdle in starting & continuing pharmacologi
Slide 23: Genetic Test Expected to Drive Market Uptake
Genetic Test Expected to Drive Market Uptake &) Adial Precision Medicine Enables: ° Physician conversation with patient First step is a test vs a drug ° Patient more likely to engage treatment after positive genetic test Potential of increased compliance resulting in maximal effect The genetic test
Slide 24: AUD Competitive Set / Indications
Adial PHARMACEUTICALS AUD Competitive Set/ Indications 7) Product (molecule) Brai Indicat REVIA is indicated in the treatment of alcohol dependence and for the blocade of the effects of exogenously administered opioids naltrexone REVIA REVIA has not been shown to provide any therapeutic benefit expe
Slide 25: AD-04 Expected Unique Profile
AD-04 Expected Unique Profile “sj pep Zhdial Compared to Currently Approved Products Key expected unique selling points drive AD-04 differentiation — Expected to meet patient needs EU only AD-04* _—_ Selincro** Vivitrol Campral Revia Antabuse x %* X Y * ¥ vy YY *& Y x & x x Novel Mechanism of Action
Slide 26: Opportunity to Change Treatment in AUD
é, Adial PHARMACEUTICALS Opportunity to Change Treatment in AUD AUD is a complex, multi-faceted disease A person's risk for developing AUD depends in part on how much, how often, and how quickly they consume alcohol. Alcohol mis-use is a risk factor for AUD and includes binge drinking and heavy alco
Slide 27: Leadership
Leadership &) Adial Experienced personnel in key positions Management Team b Cary Claiborne Tony Goodman Brigitte Robertson, MD Vinay Shah John R. Martin, JD Chief Executive Officer, Director Chief Operating Officer, Director Acting Chief Medical Officer Chief Financial Officer Chief Legal Officer B
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