Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — IPO Roadshow (November 2017)
30 slides from Adial Pharmaceuticals's IPO roadshow presentation, Nov 27, 2017
Slide 1: Adial Pharmaceuticals and AD04 for Alcohol Use Disorder
Adial Pharmaceuticals and AD04 for Alcohol Use Disorder Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Number 333 - 220368 ______________, 2017
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,” “approximately,” “exp ects,” “a
Slide 3: Free Writing Prospectus Statement
3 This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement (including a preliminary prospectus) with the SEC for the offering to whic
Slide 4: Offering Summary
4 Issuer Adial Pharmaceuticals, Inc. Shares Offered 1,400,000 Shares (100% Primary) Price Range $9.00 - $11.00 per Share Exchange Listing NASDAQ Capital Market: ADIL Over - Allotment 15% or 210,000 Shares (100% Primary) Use of Proceeds To fund completion of our first Phase 3 clinical trial of AD04 f
Slide 5: Investment Opportunity
5 Investment Opportunity 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% of deaths worldwide an
Slide 6: William B. Stilley, CEO
6 William B. Stilley, CEO. Experienced life science executive and entrepreneur. Prior to joining Adial Pharmaceuticals, he was Vice President, Business Development & Strategic Projects at Clinical Data, Inc. (NASDQ CLDA). At Clinical Data, Mr. Stilley worke d o n licensing and M&A transactions and w
Slide 7: Board of Directors
7 ▪ Bankole A. Johnson, D.Sc., M.D., Chairman – World - leading neuroscientist and pioneer in addictive disorders; Chairman of Department of Psychiatry, University of Maryland ▪ Kevin Schuyler, Vice Chairman & Lead Independent Director – Senior Managing Director, Cornerstone Partners, which manages
Slide 8: Market Opportunity
S, Adial PHARMACEUTICALS Market Opportunity Medicines For Addictions
Slide 9: AUD is a Major Public Health Problem in the U.S.
9 Sources: 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 adult population from 201
Slide 10: Significant Segment of Market Not Being Addressed
10 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 prac
Slide 11: Excessive Alcohol Consumption is a Major Public Health Problem in Europe
11 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
Slide 12: Current Market Solutions are Failing
12 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 Reha
Slide 13: What Patients Want, And Do Not Want
13 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 famil
Slide 14: AD04 Is Designed to Meet the Market Need
14 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 excel
Slide 15: AD04 - In Detail
S, Adial PHARMACEUTICALS AD04 - In Detail Medicines For Addictions
Slide 16: Novel Mechanism of Action for Treating AUD
16 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 17: AD04 for Alcohol Use Disorder (AUD)
17 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 18: Intellectual Property – Protection through at least 2032
18 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 19: AD04 Phase 2b Results
19 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 20: AD04 Phase 2b Results – Clinically Meaningful Endpoint
20 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 21: AD04 Phase 3 Trial Design
21 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 22: AD04 – Clinical Development Strategy
22 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. *If 1 st trial is not accepted by the US FDA, then only the 2 nd Phase
Slide 23: AD04 – Commercialization Strategy
23 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 24: Target Market – Total Potential Annual Revenue
24 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 25: Chemistry, Manufacturing, & Controls (CMC)
25 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 26: Financing
S, Adial PHARMACEUTICALS Financing Medicines For Addictions
Slide 27: Use of Proceeds – $14 Million Offering
27 Use of Proceeds – $14 Million Offering $14M gross proceeds estimated to reach Phase 3 data, and position AD04 for the final pivotal trial to gain approval.* Funds raised expected to achieve data readout for 1 st Phase 3 trial. Phase 3 Clinical Trial , $6.5 Personnel , $2.7 Other R&D , $0.6 Notes
Slide 28: Capitalization Summary
28 Issuer Adial Pharmaceutical, Inc. Shares Outstanding 1 Warrants 2, 3 Options Initial Public Offering Shares 4 Fully Diluted Shares Outstanding After IPO 4,074,856 870,718 (WAEP $7.67 ) 174,282 (Exercise price $5.70) 1,400,000 6,519,856 Principal Shareholders 5 Bankole A. Johnson (21.4%) Becker Sp
Slide 29: Summary
S, Adial PHARMACEUTICALS Summary Medicines For Addictions
Slide 30: Summary AD04 for Alcohol Use Disorder
30 Summary 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 expansion opportunities