Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Jefferies Healthcare Conference 2023
28 slides from Adial Pharmaceuticals's conference presentation, Jun 9, 2023
Slide 1: Medicines for Addiction – Jefferies Healthcare Conference
December 2021 CONFIDENTIAL Medicines f or A ddi c tion June 9, 2023 CONFIDENTIAL Jefferies Healthcare Conference
Slide 2: 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,” “approximately,” “expects,” “antic
Slide 3: Adial is a clinical-stage biopharmaceutical company focused on 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 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 driving fatalities due to alcohol use • Contributes to ov
Slide 5: Significant Segment of Market Not Being Addressed in U.S.
Significant Segment of Market Not Being Addressed in U.S. • 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 market with limited competition &
Slide 6: AUD Represents Unmet Medical Need in Europe
AUD Represents U nmet Medical Need in Europe 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 consumption • Almost 1M deaths annually • Alcohol responsible for
Slide 7: Abstinence is often the only goal; current therapies require it
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 often serious work and social consequences Patients face extreme solutions • Req uire significant lifest
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 They Do Not Want • Side effects • Painful injections • Public humiliation by admission of problem • Numerous visits to a doctor or other therapie
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 Nov
Slide 10: AD04/Ondansetron Well-Characterized, Widely Used
AD04 is an u ltra - low dose (0.33 mg/tab.) formulation of ondansetron • Ondanstron 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 doses given acutely (fro
Slide 11: Designed to reduce craving to curb alcohol intake
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 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 test • Potential of increased compliance resulting in ma
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 • 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 eligibility for treatment with AD04 • Primary End Point: PH
Slide 16: Specific Patient Sub-Groups Responded Well in ONWARD European Endpoint
Specific Patient Sub - Groups Responded Well in ONWARD 16 E uropean Endpoint Genotype DDD Category Treatment Arm Placebo Arm Total PHDD (E . U . Endpoint) (4) P - value at Months 5&6 AG ( rs1150226) <10 43 37 80 0.024 (0.011 in Mo 6) LL/TT ( rs47955441/rs1042173) <10 39 39 78 0.608 (0.552 in Mo 6) A
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 Post Hoc Analysis of U.S. Endpoint Genotype DDD Category Treatment Arm (2) Placebo Arm Total Responder Analysis (U.S. Endpoint) (3) P - Value at Months 5&6 AG+ <10 37 30 67 0.02 1 0 LL+/TT+ <10 29 29 58 0. 619 AC+ <10 25 25 50 0.
Slide 18: Clear Path Forward in U.S. Based on Post Hoc Analysis of ONWARD
Clear Path Forward in U.S. Based on Post Hoc Analysis of ONWARD 18 • Incorporate outcomes from the ONWARD trial • Refined design to focus on specific genotypes • Incorporate feedback from Type C meeting with FDA Planned Phase 3 trial(s) AG+ patient population represents an estimated 14% of the AUD p
Slide 19: Europe Update
Europe Update 19 Advancing discussions with five European country - level regulatory authorities • Sweden March 2023 • Germany April 2023 • United Kingdom W ritten feedback in Q 2 23 • Finland Confirmation date pending • France Confirmation date pending • Country - level approach provides more regul
Slide 20: Summary – Clinical development strategy
Summary – Clinical development strategy 20 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Rapidly advancing AD04 clinical program based on promising data and feedback from regulatory agencies ONWARD Phase 3 clinical trial data showed that AD 04 achieved a statistically significant mean reducti
Slide 21: Partner Status
Partner Status 21 • 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 The
Slide 22: A small percentage of the potential market would make AD04 a commercial success
A small percentage of the potential market would make AD04 a commercial success 1 AD04 Target Market Patients with AUD & with AD04 Target Genetics Low Hanging Fruit Patients seeking treatment for AUD & with AD04 Target Genetics Color Key: Assuming only 20 % of patients are treatable with AD04, based
Slide 23: Revised Corporate Strategy
Revised Corporate Strategy 23 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Target genotypes identified; regulatory discussions advancing; attractive U.S. commercial opportunity now the primary focus Clear path forward that incorporates outcomes from previous trials, regulatory feedback and i
Slide 24: Next steps
Next steps 24 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Finalize plans to achieve potential commercial launch by end of 2026 Finalize Clinical Development Plan Final decision on conducting one or two Trials Finalize Costs (current estimate $ 8 - $ 12 million per trial) Timeline completion
Slide 25: Management Team
Management Team 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 25 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Experienced personnel in key positions John R. Martin, J.D. Chief Legal Officer Sch
Slide 26: Board of Directors
Board of Directors 26 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Great 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 Direc
Slide 27: Building an Addiction Focused Pharmaceutical Company
Building an Addiction Focused Pharmaceutical Company 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 • Lo
Slide 28: Contact
C o n t a c t : GENERAL INQUIRES info@adialpharma.com INVESTOR RELATIONS Crescendo Communications, LLC Chrysler Building 405 Lexington Ave, 9th Fl New York, NY 10174 T: 212 - 671 - 1021 ADIL@crescendo - ir.com find us @adialpharma adialpharma.com MEDIA RELATIONS Russo Partners , LLC 215 Park Ave Sou
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