Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (January 2025)
20 slides from Adial Pharmaceuticals's investor presentation, January 2025
Slide 1: Medicines for Addiction
Medicines for Addiction Investor Presentation January 2025 December 2021 CONFIDENTIAL
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 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 20250108 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 Excessive Alcohol Use: • Leading risk factor for death ages 15–49 (Globally) 30M people suffer • 31% of driving fatalities due to alcohol use from AUD • C
Slide 5: Significant Segment of Market Not Being Addressed in U.S.
Significant Segment of Market Not Being Addressed in U.S. ~2.6M 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: Current Market Solutions are Failing
Current Market Solutions are Failing 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 abstinence prior to initi
Slide 7: 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 8: AD04 is Designed to Meet the Market Need
AD04 is Designed to Meet the Market Need Management of Heavy Drinking New Mechanism Action: Treatment of Alcohol Use Disorder (AUD) AD04 Effectively Curbs Alcohol Intake by Reducing Craving AD04 is a Near Micro-Dose (0.33 mg/tablet) Formulation of Ondansetron. Ondansetron (brand name: Zofran), widel
Slide 9: AD04 is Designed to Meet the Market Need
AD04 is Designed to Meet the Market Need Management of Heavy Drinking A new approach for patients who desire to Reduction of Heavy Drinking Target Indication control drinking but cannot or will not Ends need for abstinence, a major hurdle in undertake existing treatment options. starting & continuin
Slide 10: AD04/Ondansetron
AD04/Ondansetron Well-Characterized, Widely Used Limited Threat of Off-Label Use • Lack of Efficacy – Efficacy not seen at Zofran doses in clinical testing for AUD • Safety Concerns – Warning for cardiovascular side effects at higher doses Phase 2b Trial of AD04 in AUD Completed • Trial met primary
Slide 11: 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 effective therapeutic The genetic test is expected to in
Slide 12: AD04 Expected Unique Profile Compared to Currently Approved Products
AD04 Expected Unique Profile Compared to Currently Approved Products Key anticipated 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 A
Slide 13: 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 14: 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 15: Pharmacokinetics Study for AD04
Pharmacokinetics Study for AD04 Objective defined by the FDA to design a precise and informed Phase 3 Trial • Adial recently completed a Pharmacokinetics Study, a key component to progress AD04’s clinical development as advised by the FDA. • Topline Results indicate that AD04 displays proportional d
Slide 16: Significant Progress Made in 2024
Significant Progress Made in 2024 Laying the Groundwork to Advance AD04 to Phase 3 August 13: Adial February 13: Patent approval collaborates with expands estate for the April 22: Patent approval Boudicca Dx to combination of genetic for combination of select companion diagnostic to identify patient
Slide 17: Next Steps
Next Steps Finalize plans to achieve potential commercial launch by 2027 • Complete Pharmacokinetics Study to Optimize Elements of Phase 3 Studies • Finalize Clinical Development Plan • Final decision on conducting one or two Trials • Finalize Trial design and Costs (current estimate $8 - $12 millio
Slide 18: $40 Billion Target Market – Total Addressable Market (TAM) Potential
Target Market – Total Addressable Market (TAM) Potential U.S. 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 reven
Slide 19: 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 20: 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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