Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (August 2022)
28 slides from Adial Pharmaceuticals's investor presentation, August 2022
Slide 1: Medicines for Addiction
Medicines for Addiction August 2022 CONFIDENTIAL ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20211019A CONFIDENTIAL | 1
Slide 2: Forward Looking Statements
Forward Looking Statements 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,” estimates,” “approximatel
Slide 3: Vision
Vision To build the world’s leading addiction focused pharmaceutical company ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20211019A CONFIDENTIAL | 3
Slide 4: Adial Pharmaceuticals: An Addiction Focused Pharmaceutical Company
Investment Opportunity—Treating Addiction Adial Pharmaceuticals An Addiction Focused Pharmaceutical Company • AD04: Phase 3 Drug Candidate For Alcohol Use Disorder • Adenosine analog for the treatment of pain (non-opioid) • Adenosine platform for other disease targets ADIAL PHARMACEUTICALS INC. | ME
Slide 5: AD04 for Alcohol Use Disorder (AUD)
Investment Opportunity—Treating Addiction AD04 for Alcohol Use Disorder (AUD) AUD is a potentially multi-billion dollar market with limited competition & unmet need (accounts for ~5.3% of deaths worldwide and ~5.1% of disease worldwide) • The Lancet reports that alcohol is the number one cause of de
Slide 6: Medicines for the Treatment of Addiction
Investment Opportunity—Treating Addiction Adial Pharmaceuticals Medicines for the Treatment of Addiction AD04: For Alcohol Use Disorder (AUD) • Currently in Phase 3; successful Phase 2b trial (283 patients) • Reformulated drug with low-cost manufacturing: reduced regulatory risk & expedited path to
Slide 7: AUD is a Major Public Health Problem in the United States
AUD is a Major Public Health Problem in the United States Failure to help people with AUD is a major health, social and financial problem: • Leading cause of death ages 15–49 • 31% of driving fatalities due to alcohol use 35M • Contributes to over 200 different diseases people suffer from AUD • More
Slide 8: Significant Segment of Market not being Addressed in U.S. Market
Significant Segment of Market not ~ 2.7M being Addressed in U.S. Market Patients seeking treatment for AUD The vast majority of patients that have AUD remain undiagnosed and untreated, creating a large market opportunity for a 35M product that can address patient needs Patients with AUD Due to limit
Slide 9: Excessive Alcohol Consumption is a Major Public Health Problem in Europe
Excessive Alcohol Consumption is a Major Public Health Problem in Europe High level of prevalence and consequences: • Highest proportion drinkers and highest 55M intake or alcohol in the world people suffer from AUD • 14.7% of the world’s population yet accounts for 25% of world alcohol consumption
Slide 10: Current Market Solutions are Failing
Current Market Solutions are Failing Major characteristics of current therapeutic approaches are significant barriers to patient adoption Abstinence Barrier Efficacy Barrier Abstinence is often the only goal, and current therapies Data show that current therapeutic solutions are ineffective require
Slide 11: What Patients Want and Do Not Want
What Patients Want and Do Not Want Adial’s market research indicates that patients are not satisfied with current options They Want Their Life Improved • Stick to their drinking plan They Do Not Want • Not fight with friends and family • Side effects • Not embarrass themselves • Painful injections •
Slide 12: AD04 is Designed to Meet the Market Need and Allow Management of Heavy Drinking
AD04 is Designed to Meet the Market Need and Allow Management of Heavy Drinking New Method of Action (MOA) for treating AUD Reduction of heavy drinking target indication Designed to reduce craving in order to Ends need for abstinence, a major hurdle in effectively curb alcohol intake starting & cont
Slide 13: Genetic Test Expected to Drive Market Uptake
Genetic Test Expected to Drive Market Uptake Precision Medicine Enables: • Physician conversation with patient • First step of a test vs. a drug • Patient buy-in to treatment after positive test • Potential of increased compliance resulting in maximal effect Genetic test is expected to increase pres
Slide 14: AD04 Expected Unique Profile Compared to Currently Approved Products
AD04 Expected Unique Profile Compared to Currently Approved Products Key expected unique selling points drive AD04 differentiation - Expected to meet patient needs ADO4* Selincro** Vivitrol Campral Revia Antabuse Novel Mechanism of Action Oral Dosing Designed to reduce Heavy Drinking No Abstinence R
Slide 15: Novel Mechanism of Action for Treating AUD
Novel Mechanism of Action for Treating AUD Studies suggest that blockade of serotonin-3 receptors will influence the dopamine reward system activated by alcohol, decreasing dopamine release and attenuating craving for alcohol Reduced Serotonin-3 Receptor Signaling Reduced Release of Decreased Dopami
Slide 16: AD04 for Alcohol Use Disorder — Ondansetron
AD04 for Alcohol Use Disorder — Ondansetron Ultra-low dose (0.33 mg/tab.) formulation of ondansetron, which is widely used for nausea and vomiting at much higher doses (brand name: Zofran) • Ondansetron is well-characterized and has been on the market since 1991 with a good safety profile at high do
Slide 17: Intellectual Property Protection through at least 2032
Intellectual Property Protection through at least 2032 Patents expected to prohibit competitors from bringing ondansetron to market for AUD at any dose and also at the AD04 dose Multiple licensed patents to protect AD04 While ondansetron’s chemical composition is currently off-patent, Adial has an I
Slide 18: AD04 Primary & Secondary Endpoints Achieved
AD04 Primary & Secondary Endpoints Achieved Phase 2b Results Drinks Per Drinking Day Percentage of Days 283 Patients in Study Abstinent p = 0.004 p = 0.035 Primary endpoint of 6 50 Percentage of Days Abstinent severity of drinking Drinks Per Drinking Day measured in drinks 40 per drinking day 4 30 S
Slide 19: AD04 Clinically Meaningful Endpoint
AD04 Clinically Meaningful Endpoint Phase 2b Results 283 Patients in Study Percentage of Heavy Reduction in Percentage of Drinking Days (PHDD) Heavy Drinking Days in Target p = 0.045 Genotypes 50 0 Percentage Heavy Drinking Days Percent Heavy Drinking Days Change from Baseline in 40 -10 Approval exp
Slide 20: AD04 Phase 3 Trial Design
AD04 Phase 3 Trial Design Incoming Patients Non-Responder Two 24-week trials projected at 294 Genetic Screening Genotypes Excluded patients each are expected to be required for approval in Europe. To achieve significance against the U.S. Responder Genotypes endpoint, 580 patients are expected to Ran
Slide 21: AD04 Clinical Development Strategy
AD04 Run the Phase 3 clinical trials in Clinical Development Strategy series, continuing with success Clinical Development Plan Est. Completion 1st Phase 3 Trial in Scandinavia & Eastern Europe Stage 1 Trial targeting EMA endpoint of reduction of heavy Data in 2022 drinking (294 patients) 2nd Phase
Slide 22: AD04 Commercialization Strategy
AD04 Commercialization Strategy Launch commercially with niche sales forces, expanding with success Commercialization Plan Launch Targeting Psychiatrists & High Prescribers • Specialty sales force Stage 1 • Core markets and countries • Focusing on the top 10k targets in the U.S. • Focusing on the to
Slide 23: Target Market – Total Potential Annual Revenue
Target Market – Total Potential Annual Revenue U.S. MARKET $2.8B Patients seeking treatment for AUD Color Key: Assuming only 33% of AD04 Target Market patients are treatable with Patients with AUD & with AD04 Target AD04, based on the genetic Genetics test, the total potential annual revenue for AD0
Slide 24: Chemistry, Manufacturing, & Controls (CMC)
Chemistry, Manufacturing, & Controls (CMC) CMC is developed to commercial scale Active Pharmaceutical Ingredient Drug Product Tablets • Compressed tablets already manufactured at Commercial supply contract in place registration scale • Vendor is well-respected • Clinical Trial Material for 1st Phase
Slide 25: Management Team
Management Team Experienced personnel in key positions William B. Stilley, Bankole A. Johnson, Joseph Truluck MBA Jack Reich, Ph.D Mark H. Peikin, J.D. Cary J. Claiborne D.Sc., M.D. CFO Head of Regulatory Chief Strategy Officer MBA Purnovate Chief Chief Executive Officer CMO Previously, VP, Ops & Fi
Slide 26: Board of Directors
Board of Directors Kevin Schuyler J. Kermit Anderson James W. Newman, Jr. Vice Chairman & Lead CFO and VP, Cumberland Life science entrepreneur, investor Independent Director Development Company; formerly and board member; Chairman & with AMVEST President, Medical Predictive Senior Managing Director
Slide 27: Building an Addiction Focused Pharmaceutical Company
Building an Addiction Focused Pharmaceutical Company Lead product for AUD • Large market with unmet need • Late stage oral drug (Phase 3) • Companion diagnostic designed to identify responders • Seeking 505(B)(2) path to regulatory approval • Low cost manufacturing • Licensed patent protection throu
Slide 28: Contact
Contact: adialpharma.com GENERAL INQUIRES info@adialpharma.com INVESTOR RELATIONS Crescendo Communications, LLC 5 Penn Plaza Suite 1953 New York, NY 10001 find us @adialpharma T: 212-671-1021 ADIL@crescendo-ir.com
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