Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (February 2024)
23 slides from Adial Pharmaceuticals's investor presentation, February 2024
Slide 1: Medicines for Addiction
Medicines for Addiction Investor Presentation February 2024 December 2021 CONFIDENTIAL
Slide 2: Forward Looking Statements
Forward LookingStatements 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,” “approximately
Slide 3: Vision
Vision Adial is a clinical-stage biopharmaceutical company focused on the treatment and prevention of addictions and other unmet medical needs. ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20240215 3
Slide 4: Alcohol Use Disorder is a Major Public Health Problem in the U.S.
Alcohol Use Disorder is a Major Public Health Problem in the U.S. Failure to help people with AUD is a major health, social and financial problem: • Leading cause of death ages 15–49 30M people suffer • 31% of driving fatalities due to alcohol use • Contributes to over 200 different diseases from AU
Slide 5: Significant Segment of Market Not Being Addressed in U.S.
Significant Segment of Market Not Being Addressed in U.S. ~2.7M patients seeking treatment AUD • The vast majority of patients that have AUD remain undiagnosed and untreated, creating a large market opportunity for a product that can address patient needs • AUD is a potentially multi-billion dollar
Slide 6: AUD Represents an Unmet Medical Need in Europe
AUD Represents an Unmet Medical Need in Europe High level of prevalence and consequences: • Highest proportion drinkers and highest intake of alcohol in the world 55M • 14.7% of the world’s population yet accounts for 25% of world alcohol consumption people suffer from AUD • Almost 1M deaths annuall
Slide 7: 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 8: Patients are Not Satisfied with Current Options
Patients are Not Satisfied with Current Options Adial’s market research indicates that 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
Slide 9: AD04 is Designed to Meet the Market Need
AD04 is Designed to Meet the Market Need And Allow Management of Heavy Drinking New Mechanism 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 10: 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 alcohol cravings Reduced Serotonin-3 Receptor Signaling Reduced Release of Decreased Dopamine
Slide 11: AD04/Ondansetron
AD04/Ondansetron Well-Characterized, Widely Used AD04 is an ultra-low dose (0.33 mg/tab.) formulation of ondansetron • Ondansetron 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 sa
Slide 12: 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 The genetic test is expected to increase
Slide 13: 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 EU only ADO4* Selincro** Vivitrol Campral Revia Antabuse Novel Mechanism of Action Oral Dosing Designed to reduce Heavy Drinking No Abst
Slide 14: Strong IP Protection Through at Least 2031
Strong IP Protection Through at Least 2031 Patents expected to prohibit competitors from bringing ondansetron to market for AUD at any dose Multiple licensed patents to protect AD04 While ondansetron’s chemical composition is currently off-patent, Adial has an IP strategy surrounding the following:
Slide 15: ONWARD Phase 3 Study Conducted in Europe
ONWARD Phase 3 Study Conducted in Europe Trial design • Randomized, double-blind, placebo-controlled, parallel- group multicenter study 37% 63% • Patients were screened for the appropriate genotypes via an inexpensive, standard blood test to determine eligibility for treatment with AD04 • Primary En
Slide 16: Specific Patient Sub-Groups Responded Well Based on U.S. Endpoint
Specific Patient Sub-Groups Responded Well Based on U.S. Endpoint Post Hoc Data Analysis Based on U.S. Endpoint Responder Analysis(1) (AG+ <10DDD) • U.S. Primary End Point: Responder Analysis, defined as the percentage of patients with 0 HDDs in the treatment arm versus placebo at a specific time po
Slide 17: Summary – Clinical development strategy
Summary – Clinical development strategy Advancing AD04 based on promising data and favorable regulatory feedback • FDA confirmed primary U.S. endpoint based on PNHDD – patients who reduced their alcohol consumption to zero heavy drinking days in the last two months of a six-month study. • FDA acknow
Slide 18: Revised Corporate Strategy
Revised Corporate Strategy U.S. Commercial Opportunity Now the Primary Focus • This strategy presents a clear path forward that incorporates outcomes from previous trials, regulatory feedback, and includes a modified design that focuses on heavy drinkers with specific genotypes (AG and potentially G
Slide 19: Target Market – Total Potential Annual Gross Revenue
Target Market – Total Potential Annual Gross Revenue US Market $3.4B Patients seeking treatment for AUD Assuming only 20% of Color Key: patients are treatable with AD04 Target Market Patients with AUD AD04, based on the genetic & with AD04 Target test, the total potential Genetics annual revenue for
Slide 20: Next Steps
Next Steps Finalize plans to achieve potential commercial launch by end of 2026 • Finalize Clinical Development Plan • Final decision on conducting one or two Trials • Finalize Trial design and Costs (current estimate $8 - $12 million per trial pending final design and scope) • Timeline completion •
Slide 21: Executive Leadership
Executive Leadership Experienced personnel in key positions Management Team Bankole A. Johnson, D.Sc., MD Joseph Truluck, MBA John R. Martin, J.D. Schuyler Vinzant Cary J. Claiborne Tony Goodman Chief Executive Officer Chief Operating Officer Chief Medical Officer Chief Financial Officer Chief Legal
Slide 22: 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 23: Contact
Contact: adialpharma.com GENERAL INQUIRES: info@adialpharma.com INVESTOR RELATIONS: MEDIA RELATIONS: CrescendoCommunications,LLC Russo Partners,LLC 405 Lexington Ave 215 Park Ave South 9th Floor, Suite 9034 Suite 1905 New York, NY 10174 New York, NY 10003 T: 212-671-1021 T: 817-371-0654 ADIL@crescen
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