Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (November 2024)
19 slides from Adial Pharmaceuticals's investor presentation, November 2024
Slide 1: Medicines for Addiction Investor Presentation
Medicines for Addiction Investor Presentation November 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 20241024 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. ~2.3M 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 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 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 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 9: 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 10: 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 11: 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 12: 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 13: 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 14: 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 15: 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 16: Next Steps
Next Steps Finalize plans to achieve potential commercial launch by 2027 • Complete pharmacokinetics study to optimize elements needed for Phase 3 studies • Finalize Clinical Development Plan • Final decision on conducting one or two Trials • Finalize Trial design and Costs (current estimate $8 - $1
Slide 17: Target Market – Total Addressable Market (TAM) Potential
Target Market – Total Addressable Market (TAM) Potential 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 18: 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 19: 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
Adial Pharmaceuticals — Investor Presentation (November 2024) on 6ix