Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (September 2018)
23 slides from Adial Pharmaceuticals's investor presentation, Sep 24, 2018
Slide 1: Treating Addiction Investor Presentation
Treating Addiction Investor Presentation - September 2018 William Stilley, CEO
Slide 2: Forward-looking statements
2 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,” “ap proximately,” “expects,” “a
Slide 3: Investment Opportunity – Treating Addiction
3 Investment Opportunity – Treating Addiction AD04 for Alcohol Use Disorder (“AUD”) Late stage compound for alcohol use disorder with large potential and niche infrastructure requirement. ▪ AUD is a potentially multi - billion dollar market with limited competition & unmet need (accounts for ~5.9% o
Slide 4: AUD is a Major Public Health Problem in the U.S.
4 Sources: The Lancet Sep. 2018; 35 million based upon the 2012 data provided in Grant, et. al., JAMA Psychiatry , Epidemiology of DSM - 5 AUD, 2015;72(8):757 - 766 adjusted to reflect a compound annual growth rate of 1.13%, which is the growth rate reported by U.S. Census Bureau for the general adu
Slide 5: Significant Segment of Market Not Being Addressed
5 Significant Segment of Market Not Being Addressed U.S. Market 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 Patients With AUD 35 Million ~2.7M ~1.3M Patients seen by a health care pract
Slide 6: Excessive Alcohol Consumption is a Major Public Health Problem in Europe
6 Excessive Alcohol Consumption is a Major Public Health Problem in Europe In Europe, approximately 55 million have AUD. High level of prevalence and consequences: ▪ Has 14.7% of the world’s population yet accounts for 25% of world alcohol consumption . ▪ Eastern Europe has a high rate of AUD with a
Slide 7: Current Market Solutions are Failing
7 Current Market Solutions are Failing Major characteristics of current therapeutic approaches are significant barriers to patient adoption Sources: JAMA Psychiatry, Epidemiology of DSM - 5 AUD, 2015. Dodes , et. al., The Sober Truth: Debunking the Bad Science Behind 12 - Step Programs and the Rehab
Slide 8: What Patients Want, And Do Not Want
8 What Patients Want, And Do Not Want Adial’s market research indicates that 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. ▪ Stick to their drinking plan ▪ Not fight with friends and family
Slide 9: AD04 Is Designed to Meet the Market Need
9 AD04 Is Designed to Meet the Market Need and Allow Management of Heavy Drinking » New Method of Action (MOA) for treating AUD ▪ Designed to reduce craving in order to effectively curb alcohol intake » Good safety profile, high tolerability ▪ Brings 20+ year track record of clinical use with excell
Slide 10: Novel Mechanism of Action for Treating AUD
10 Novel Mechanism of Action for Treating AUD AD04 believed to interfere with the dopamine reward system and lead to reduced alcohol intake. Studies suggest that blockade of serotonin - 3 receptors will influence the dopamine reward system activated by alcohol, decreasing dopamine release and attenu
Slide 11: AD04 for Alcohol Use Disorder (AUD)
11 AD04 for Alcohol Use Disorder (AUD) Expected reduced risk and time to market , low risk of off - label use of Zofran. ▪ Ondansetron is well - characterized and has been on the market since 1991 with an good safety profile at high doses given acutely (from 4 mg oral to 16 mg i.v.) ▪ Patient strati
Slide 12: Intellectual Property – Protection through at least 2032
12 Intellectual Property – Protection through at least 2032 Patents should prohibit competitor from bringing ondansetron to market for AUD at any dose and also at the AD04 dose. ▪ Multiple licensed patents to protect AD04 » 3 patent families under prosecution » Licensed patents issued in >40 countri
Slide 13: AD04 Phase 2b Results: Primary & Secondary Endpoints Achieved
13 0 10 20 30 40 50 60 70 AD04* Placebo AD04 Placebo Percentage of days abstinent Percentage of Days Abstinent p = 0.021 p = 0.035 p = 0.806 Target Genotypes Other Genotypes Primary endpoint of severity of drinking measured in drinks per drinking day, and secondary endpoint of frequency of drinking
Slide 14: AD04 Phase 2b Results – Clinically Meaningful Endpoint
14 AD04 Phase 2b Results – Clinically Meaningful Endpoint Approval expected to be based on a Heavy Drinking Days (HDD)* end point. Trial not powered for the percentage of HDD; still achieved significance. AD04 significantly reduced heavy drinking in patients with the targeted genotypes. * Heavy drin
Slide 15: AD04 Phase 3 Trial Design
15 AD04 Phase 3 Trial Design Two 24 - week trials projected at 294 patients each are expected to be required for approval in Europe. To achieve significance against the U.S. endpoint, 580 patients are expected to be required. U.S. FDA indicated Adial may proceed with this trial design. AD04 Placebo
Slide 16: AD04 – Clinical Development Strategy
16 AD04 – Clinical Development Strategy Run the Phase 3 clinical trials in series, continuing with success AD04 Clinical Development Plan provides for staged investments to optimally reduce risk while progressing toward approval. *Additional funding will be required to achieve data readout. **If 1 s
Slide 17: AD04 – Commercialization Strategy
17 AD04 – Commercialization Strategy Launch commercially with niche sales forces, expanding with success If regulatory approval is obtained, staged investment into commercialization infrastructure allows for optimal commercial risk reduction without limiting upside potential. Commercialization Plan
Slide 18: Target Market – Total Potential Annual Revenue
18 Target Market – Total Potential Annual Revenue U.S. Market Assuming only 33% of patients are treatable with AD04 based on the genetic test, the total potential annual revenue for AD04 in the U.S. alone is significant Note: Assumes 33% of patients genetically positive and treated; $235 per month p
Slide 19: Chemistry, Manufacturing, & Controls (CMC)
19 Chemistry, Manufacturing, & Controls (CMC) CMC is developed to commercial scale. CMC is straightforward and low - cost; drug supply for 1 st Phase 3 trial already produced. ▪ Low cost commercial supply contract in place ▪ Vendor is well - respected and already produces the drug for generic drug p
Slide 20: Management Team
20 William B. Stilley, MBA, CEO. Successful deals and financings (e.g., J&J, Novartis, Santen Pharmaceuticals, Novartis Ventures, ATEL Ventures). Previously, VP Bus Dev & Strategic Projects at Clinical Data (NASDAQ: CLDA) where he transacted licensing/M&A, managed Phase 3 development, and drug manuf
Slide 21: Board of Directors
21 ▪ Bankole A. Johnson, D.Sc., M.D., Chairman – World - leading neuroscientist and pioneer in addictive disorders; at the University of Maryland is the Chairman of Dept. of Psychiatry, Prof. of Neurobiology, Neurology, Medicine, and Pharmacology, and the Director of the Brain Science Research Conso
Slide 22: Summary – Treating Addiction
22 Summary – Treating Addiction AD04 for Alcohol Use Disorder x Large market with unmet need x Late stage oral drug (Phase 3 ready) x Companion diagnostic to identify responders x Efficient path to regulatory approval x Low cost manufacturing x Licensed patent protection through 2032 x Indication ex
Slide 23: Key Statistics
23 Ticker: ADIL Exchange: NASDAQ Share Price (9/19/18): $3.00 Shares Outstanding (9/19/18): 6.6M Market Cap (9/19/18): $19.7M Warrant/Option Shares (wt. avg. ex. Price: $5.79) 5.3M Debt: $350,000 Ownership by Directors, Officers, and Affiliated Entities (% shares out. / fully diluted): 38.68% / 37.3
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