Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — IPO Roadshow (September 2017)
29 slides from Adial Pharmaceuticals's IPO roadshow presentation, Sep 28, 2017
Slide 1: Adial Pharmaceuticals and AD04 for Alcohol Use Disorder
Adial Pharmaceuticals and AD04 for Alcohol Use Disorder September 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,
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
Slide 4: Offering Summary
- 4 - Offering Summary AD04 for Alcohol Use Disorder (“AUD”) Issuer Adial Pharmaceuticals, Inc. Shares Offered 1,400,000 Shares (100% Primary) Price Range $9.00 - $11.00 per Share Exchange:Ticker NASDAQ Capital Market : ADIL Over - Allotment 15% or 210,000 Shares (100% Primary) Use of Proceeds To fu
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
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 a
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 mana
Slide 8: Market Opportunity
Z, 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
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
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 over 25% of the total alcohol consumed worldwide. ▪ Eastern Europe has a hig
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
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 the life their current life but with control and dignity; they do not want a life make - over. ▪ Stick to their drinking plan ▪ Not fight with frie
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 e
Slide 15: AD04 - In Detail
Z, adial PHARMACEUTICALS AD04 - In Detail Medicines For Addictions
Slide 16: AD04 for Alcohol Use Disorder
- 16 - AD04 for Alcohol Use Disorder (AUD) Ultra - low dose (0.33 mg/tab.) formulation of ondansetron, widely used for emesis at higher doses (Zofran) Reduced risk and time to market, patient stratification, low risk of off - label use of Zofran. ▪ Ondansetron is well - characterized and has been on
Slide 17: Intellectual Property – Protection through at least 2032
- 17 - 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 cou
Slide 18: AD04 Phase 2b Results: Primary & Secondary Endpoints Achieved
- 18 - 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 drink
Slide 19: AD04 Phase 2b Results – Clinically Meaningful Endpoint
- 19 - 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 d
Slide 20: AD04 Phase 3 Trial Design
- 20 - 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 Plac
Slide 21: AD04 – Clinical Development Strategy
- 21 - AD04 – Clinical Development Strategy Run the Phase 3 clinical trials in series, continuing with success AD04 Clinical Development Plan allows for staged investment for optimal development risk reduction without limiting approval risk for a high unmet need indication *If 1 st trial is not acce
Slide 22: AD04 – Commercialization Strategy
- 22 - 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 P
Slide 23: Target Market – Total Potential Annual Revenue
- 23 - 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 mon
Slide 24: Chemistry, Manufacturing, & Controls (CMC)
- 24 - 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 dru
Slide 25: Financing
PHARMACEUTICALS Z, adial Financing Medicines For Addictions
Slide 26: Use of Proceeds – $14 Million Offering
- 26 - 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 Co
Slide 27: Capitalization Summary
- 27 - Capitalization Summary Issuer Adial Pharmaceutical, Inc. Current Shares Outstanding Warrants outstanding and Issuable 1 Options Shares Issuable at IPO 3 Public Offering Shares Fully Diluted Shares Outstanding After IPO 3.3 million 0.9 million, wt. avg. ex price $7.64 2 0.2 million, wt. avg. e
Slide 28: Summary
PHARMACEUTICALS Z, adial Summary Medicines For Addictions
Slide 29: Summary: AD04 for Alcohol Use Disorder
- 29 - 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 opportuni
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