Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — H.C. Wainwright Global Investment Conference 2023
26 slides from Adial Pharmaceuticals's conference presentation, Sep 11, 2023
Slide 1: Medicines for Addiction – H.C. Wainwright Global Investment Conference
December 2021 CONFIDENTIAL Medicines f or A ddi c tion H.C. Wainwright Global Investment Conference September 11, 2023 CONFIDENTIAL
Slide 2: Forward-looking statements
This presentation includes statements that are, or may be deemed, ‘‘forward - looking statements.’’ In some cases, these forward - l ooking statements can be identified by the use of forward - looking terminology, including the terms “believes,” “might,” estimates,” “approximately,” “expects,” “anti
Slide 3: Vision: clinical-stage company treating addictions
Adial is a clinical - stage biopharmaceutical company focused on the treatment and prevention of addictions and other unmet medical needs. V ision 3 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION
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. 4 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION In the U.S. alone, an estimated 35 MILLION people SUFFER FROM AUD , resulting in significant health, social and financial costs • Leading cause of death ages 15 – 49 • 31% of driv
Slide 5: Significant Segment of Market Not Being Addressed in U.S.
Significant Segment of Market Not Being Addressed in U.S. 5 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Due to limitations of existing therapies, over 95% of people with AUD do not receive medical treatment • The vast majority of patients that have AUD remain undiagnosed and untreated , cre
Slide 6: AUD Represents an Unmet Medical Need in Europe
AUD Represents an Unmet Medical N eed in Europe 6 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION In Europe, approximately 55 MILLION HAVE AUD • Highest proportion drinkers and highest intake of alcohol in the world • 14.7% of the world’s population yet accounts for 25% of world alcohol consump
Slide 7: Current Market Solutions are Failing
Current Market Solutions are Failing 7 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20230322 Abstinence is often the only goal, and current therapies require abstinence prior to initiating therapy • Causes a mismatch between problem and solution • Abstinence requires dramatic changes and oft
Slide 8: Patients are Not Satisfied with Current Options
Patients want to live their current life but with control and dignity; they do not want a life make - over Patients are Not Satisfied with Current Options 8 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION They Want Their Life Improved • Stick to their drinking plan • Not fight with friends and
Slide 9: Novel Mechanism of Action for Treating AUD
AD04 is believed to interfere with the dopamine reward system and lead to reduced alcohol intake Sources: Barnes, NM and Sharp, T, 1999; Dawes, MA et al., 2005b; Johnson, BA et al., 1993; Johnson, BA and Cowen, PJ, 1993; Lovinger , DM, 1991, 1999a; Swift, RM et al., 1996; Tomkins, DM et al., 1995 No
Slide 10: AD04 / Ondansetron
AD04 / Ondansetron 10 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION AD04 is an u ltra - 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 m
Slide 11: AD04 benefits and precision medicine approach
Designed to reduce craving in order to effectively curb alcohol intake Brings 20+ year record of acute clinical use with positive safety and tolerability profile Maximal patient compliance, ease of use & increased effect Ends need for abstinence, a major hurdle in starting & continuing pharmacologic
Slide 12: Genetic Test Expected to Drive Market Uptake
Genetic Test Expected to Drive Market Uptake 12 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION The g enetic test is expected to increase prescription fill rate and compliance • Physician conversation with patient • First step of a test vs. a drug • Patient buy - in to treatment after positive
Slide 13: AD04 addresses key unmet medical needs in AUD market
AD04 addresses key unmet medical needs in AUD market *AD04 is not yet approved for marketing and product characteristics shown as those expected based on currently available data and current plans. In all cases, the characteristics shown are fully qualified based on future data and regulatory approv
Slide 14: Strong IP Protection Through at Least 2031
• 3 patent families under prosecution • Licensed patents issued in >40 countries, including U.S., Europe & Eurasia • Includes obesity, drug addiction, smoking, anxiety and related disorders • Use of ultra - low dose ondansetron (0.33 mg/tab.) pursuant to AD04’s proposed label • Use of ondansetron to
Slide 15: ONWARD Phase 3 Study Conducted in Europe
ONWARD Phase 3 Study Conducted in Europe 15 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION • Randomized, double - blind, placebo - c ontrolled , parallel - group multicenter study • Patients were screened for the appropriate genotypes via an inexpensive, standard blood test to determine eligib
Slide 16: Specific Patient Sub-Groups Responded Well in ONWARD (EU Endpoint)
Specific Patient Sub - Groups Responded Well in ONWARD 16 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Post Hoc Data Analysis Based on European Endpoint E uropean Endpoint PHDD (E . U . Endpoint) (4) P - value at Months 5&6 Total Placebo Arm Treatment Arm DDD Category Genotype 0.024 (0.011 i
Slide 17: Specific Patient Sub-Groups Responded Well Based on U.S. Endpoint
Specific Patient Sub - Groups Responded Well Based on U.S. Endpoint 17 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Post Hoc Data Analysis Based on U.S. Endpoint Post Hoc Analysis of U.S. Endpoint Responder Analysis (U.S. Endpoint) (3) P - Value at Months 5&6 Total Placebo Arm Treatment Arm
Slide 18: Summary – Clinical development strategy
Summary – Clinical development strategy CONFIDENTIAL | 18 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 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 hea
Slide 19: Partner Status
Partner Status • Advancing discussions with potential strategic partners that could fund: • Phase 3 clinical program • Commercialization of AD04 assuming a successful regulatory outcome • Primary Targets - companies with commercial capabilities or pipeline development capabilities in: Alcohol Therap
Slide 20: Revised Corporate Strategy
Revised Corporate Strategy CONFIDENTIAL | 20 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20230606 Target genotypes identified; regulatory discussions advancing; attractive U.S. commercial opportunity now the primary focus Clear path forward that incorporates outcomes from previous trials,
Slide 21: Target Market – Total Potential Annual Gross Revenue
Target Market – Total Potential Annual Gross Revenue 21 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION A small percentage of the potential market would make AD04 a commercial success 1. Note: Assumes 20 % of patients genetically positive and treated; $ 600 per month pricing AD04 Target Market
Slide 22: Next steps
Next steps CONFIDENTIAL | 22 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20230606 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 $
Slide 23: Management Team
Management Team 23 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Experienced personnel in key positions Joseph Truluck , MBA C hief F inancial O fficer Bankole A. Johnson, D.Sc., M.D. C hief Medical Officer Cary J. Claiborne Chief Executive Officer John R. Martin, J.D. Chief Legal Officer Sch
Slide 24: Board of Directors
Board of Directors 24 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Blend of leadership, finance, and life science experience Tony Goodman Managing Director/Founder, Keswick Group Cary J. Claiborne Chief Executive Officer, Adial Kevin Schuyler Chairman of the Board Senior Managing Director, C
Slide 25: Building an Addiction Focused Pharmaceutical Company
Building an Addiction Focused Pharmaceutical Company 25 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 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 •
Slide 26: Contact
C o n t a c t : GENERAL INQUIRES : info@adialpharma.com INVESTOR RELATIONS : Crescendo Communications, LLC 405 Lexington Ave 9th Floor, Suite 9034 New York, NY 10174 T: 212 - 671 - 1021 ADIL@crescendo - ir.com F ind U s @ A dial P harma adialpharma.com MEDIA RELATIONS : Russo Partners , LLC 215 Park
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