Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (April 2023)
30 slides from Adial Pharmaceuticals's investor presentation, April 2023
Slide 1: Medicines for Addiction
Medicines for Addiction April 2023 2021 December CONFIDENTIAL 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 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 35M 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: 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 They Do Not Want • Stick to their drinking plan • Side effects • Not fight with friends and family • Painful injections • Not embarrass themselves •
Slide 9: Investment Opportunity—Treating Addiction
Investment Opportunity—Treating Addiction AD04 for Addiction Use Disorder 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 death
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 • 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 saf
Slide 12: AD04 is Designed to Meet the Market Need
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 The genetic test is expected to increase
Slide 14: AD04 Phase 2b Met Primary and Secondary Endpoints
AD04 Phase 2b Met Primary and Secondary Endpoints AD04 demonstrated a reduced frequency & quantity of drinking in targeted genotypes Drinks Per Drinking Day Percentage of Days p = 0.004 Abstinent 283 Patients in Study p = 0.035 6 50 Primary endpoint of severity of drinking Percentage of Days Abstine
Slide 15: AD04 Phase 3 Trial Design
AD04 Phase 3 Trial Design Completed with 302 patients enrolled U.S. FDA indicated Adial Incoming Patients may proceed with this trial design Primary Endpoints (vs.) Non-responder Genetic Screening genotypes excluded EU: Reduction from baseline: heavy drinking days & average alcohol consumed/day Rand
Slide 16: 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 17: Specific Patient Sub-Groups Responded Well in ONWARD
Specific Patient Sub-Groups Responded Well in ONWARD Post Hoc Data Analysis Based on European Endpoint • Primary End Point: PHDD change from baseline (months 5 & 6) • Patients in Group 1: Heavy drinker (< 10 drinks/drinking day): 63% of trial participants • Heavy drinkers with AG and/or AC genotype
Slide 18: 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 19: 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 Planned Phase 3 trial • Incorporate outcomes from the ONWARD trial • Refined design to focus on specific genotypes • Type C meeting with FDA granted and scheduled for Q2 2023 to discuss our clinical program in the U.S. Phase 2 & Phase 3
Slide 20: Europe Strategy
Europe Strategy Advancing discussions with five European country-level regulatory authorities • Sweden • Country-level approach provides more regulatory shots on March 2023 goal • Germany • To gain a clear understanding from each regulatory April 2023 authority regarding the most expeditious path to
Slide 21: Partner Status
Partner Status Currently in discussions with potential partners • Advancing discussions with potential strategic partners that could fund: • Phase 3 clinical program, if required • Commercialization of AD04 assuming a successful regulatory outcome • Companies with existing relationships with psychia
Slide 22: 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 and also at the AD04 dose Multiple licensed patents to protect AD04 While ondansetron’s chemical composition is currently off-patent, Adial has an IP strategy s
Slide 23: 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 24: Target Market – Total Potential Annual Gross Revenue
Target Market – Total Potential Annual G r o s s 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 $40Billion ann
Slide 25: Chemistry, Manufacturing, & Controls (CMC)
Chemistry, Manufacturing, & Controls (CMC) CMC is developed to commercial scale Active Pharmaceutical Ingredient Drug Product Commercial supply contract in place Tablets • Vendor is well-respected • Compressed tablets already manufactured at registration • Already produces the drug for generic scale
Slide 26: Summary – Clinical development strategy
Summary – Clinical development strategy Rapidly advancing AD04 clinical program based on promising data • ONWARD Phase 3 clinical trial data showed that AD04 achieved a statistically significant mean reduction in heavy drinking days among the pre-specified group of “heavy drinkers.” • Additional ana
Slide 27: Management Team
Management Team Experienced personnel in key positions Cary J. Claiborne William B. Stilley Bankole A. Johnson, D.Sc., M.D. Joseph Truluck, MBA John R. Martin, J.D. Schuyler Vinzant Chief Executive Officer, Chief Executive Officer Chief Medical Officer Chief Financial Officer Chief Legal Officer VP
Slide 28: Board of Directors
Board of Directors Blend of leadership, finance, and life science experience Cary J. Claiborne J. Kermit Anderson James W. Newman, Jr. Chief Executive Officer, Chief Financial Officer & Vice President, Chairman & President, Adial Cumberland Development Company; Medical Predictive Kevin Schuyler Chai
Slide 29: 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 30: Contact
Contact: adialpharma.com GENERAL INQUIRES: info@adialpharma.com INVESTOR RELATIONS: MEDIA RELATIONS: Crescendo Communications, 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@cres
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