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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (date of earliest event reported):
September 11, 2023
Adial Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
| Delaware |
|
001-38323 |
|
82-3074668 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
1180 Seminole Trail, Ste 495
Charlottesville, VA 22901
(Address of principal executive offices and zip
code)
(434) 422-9800
(Registrant’s telephone number including
area code)
N/A
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions (see General
Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Securities |
registered pursuant to Section 12(b) of the Act: |
| Title of each class |
|
Trading Symbols |
|
Name of each exchange on which registered |
| Common Stock |
|
ADIL |
|
The Nasdaq
Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant
is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by checkmark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01. Regulation FD Disclosure.
Adial Pharmaceuticals,
Inc. (the “Company”) will be making several presentations to investors over the next several weeks, including at the H.C.
Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 at the Lotte New York Palace Hotel in New York City.
In connection with the presentations, the Company intends to discuss the investor presentation, which is furnished as Exhibit 99.1 to
this Current Report on Form 8-K.
The information in this
Item 7.01 and in the investor presentation furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section
or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with
the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
The investor presentation
furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities
Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather
than historical.
The Company undertakes
no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time
to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with
the Securities and Exchange Commission, through press releases or through other public disclosures.
Item 9.01 Financial Statements and Exhibits.
The following
exhibits are furnished with this Current Report on Form 8-K:
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: September 11, 2023 |
ADIAL PHARMACEUTICALS, INC. |
| |
|
| |
By: |
/s/ Cary J. Claiborne |
| |
Name: |
Cary J. Claiborne |
| |
Title: |
President and Chief Executive Officer |
2
Exhibit
99.1
December 2021 CONFIDENTIAL Medicines f or A ddi c tion H.C. Wainwright Global Investment Conference September 11, 2023 CONFIDENTIAL
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,” “expects,” “anticipates,” “in tends,” “estimates,” “plans,” “seeks,” “may,” “should,” “could,” “would,” “will”, “future,” “likely,” “goal,” “continue,” “appears,” “suggests,” “ongoing,” or, in each case, their negative o r o ther variations thereon or comparable terminology, although not all forward - looking statements contain these words. Forward looking statements appear in a number of places throughout this presenta tion and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and pla nned discovery and development of drugs targeting alcohol addiction, , the strength and breadth of our intellectual property, our planned clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our ability to partner our product development, the degree of clinical util ity of our products, particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity, prospects, growth and st rategies, the length of time that we will be able to continue to fund our operating expenses and capital expenditures, our expected financing needs and sources of financing, the industry in wh ich we operate and the trends that may affect the industry or us. By their nature, forward - looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines tha n anticipated. Although we believe that we have a reasonable basis for each forward - looking statement contained in this presentation, we caution you that forward - looking statemen ts are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward - looking statements contained in this presentation. In addition, even if our results of operations, financial condition and liquidity, and the de vel opment of the industry in which we operate are consistent with the forward - looking statements contained in this presentation, they may not be predictive of results or developments in future p eriods. Any forward - looking statements that we make in this presentation speak only as of the date of such statement, and we undertake no obligation to update such statements to re fle ct events or circumstances after the date of this presentation, except as required by law. You should read carefully our “Cautionary Note Regarding Forward - Looking Statements” and the factors described in the “Risk Fact ors” sections of our Annual Report on Form 10 - K for the year ended December 31, 2022 and any subsequent reports that have been filed with the Securities and Exchange Commission (th e “SEC”) to better understand the risks and uncertainties inherent in our business. . 2 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Forward Looking Statements
Adial is a clinical - stage biopharmaceutical company focused on the treatment and prevention of addictions and other unmet medical needs. V ision 3 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION
Alcohol Use Disorder is a Major Public Health Problem in the U.S. 4 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION In the U.S. alone, an estimated 35 MILLION people SUFFER FROM AUD , resulting in significant health, social and financial costs • Leading cause of death ages 15 – 49 • 31% of driving fatalities due to alcohol use • Contributes to over 200 different diseases • Costs U.S. economy approximately $250 billion annually • 50% increase in prevalence from 2002 to 2013 Despite these enormous costs, just over 7% seek help, but less than 5% AUD cases are treated by a health care practitioner 3 5M people suffer from AUD 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 adult population from 2012 - 2017. NIAAA Alcohol Facts & Statistics. www.cdc.gov/features/costsofdrinking/index.html accessed Sep. 10. 2017. NIH study finds alcohol use disorder on the increase, June 3, 2015. Failure to help people with AUD is a major health, social and financial problem:
Significant Segment of Market Not Being Addressed in U.S. 5 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Due to limitations of existing therapies, over 95% of people with AUD do not receive medical treatment • 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 market with limited competition & unmet need (accounts for ~5.3% of deaths worldwide and ~5.1% of disease worldwide) • The Lancet reports that alcohol is the number one cause of death in the U.S. & globally among both men and women ages 15 to 49 years Sources: Prevalence of AUD over 12 - months as reported by Grant, et. al., JAMA Psychiatry, Epidemiology of DSM - 5 AUD, 2015;72(8):757 - 766. 3 5M Patients with AUD Sources: NIAAA Alcohol Facts & Statistics. www.cdc.gov/features/costsofdrinking/index.html accessed June 3, 2020. The Lancet Sep. 2018., WHO Fact Sheets www.who.int/news - room/fact - sheets/detail/alcohol ~2.7M patients seeking treatment AUD
AUD Represents an Unmet Medical N eed in Europe 6 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION In Europe, approximately 55 MILLION HAVE AUD • Highest proportion drinkers and highest intake of alcohol in the world • 14.7% of the world’s population yet accounts for 25% of world alcohol consumption • Almost 1M deaths annually • Alcohol responsible for 1 in 4 young adult deaths (ages 20 - 24) Sources: WHO Global status report on alcohol use - https://www.euro.who.int/en/health - topics/disease - prevention/alcohol - use 5 5M people suffer from AUD 5 5M people suffer from AUD High level of prevalence and consequences:
Current Market Solutions are Failing 7 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20230322 Abstinence is often the only goal, and current therapies require abstinence prior to initiating therapy • Causes a mismatch between problem and solution • Abstinence requires dramatic changes and often serious work and social consequences Patients face extreme solutions • Req uire significant lifestyle changes – e.g., Abstinence – e.g., Vivitrol is injectable by physician • Need to avoid friends, family and social events • Social & professional damage for admitting problem Significant side effects of current therapies • Mental — Nausea, dizziness, psychiatric disorders and depressive symptoms • Physical — Vomiting, abdominal pain, arthritis and joint stiffness Data show that current therapeutic solutions are ineffective • 90% of patients do not achieve long - term abstinence • AUD largely goes untreated … fears of stigmatization and beliefs that treatment is ineffective may explain the lack of AUD treatment in the U.S. Abstinence Barrier Side Effect Barrier Efficacy Barrier Ease of Use & Stigmatization Barriers 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 Industry, 2014 Major characteristics of current therapeutic approaches are significant barriers to patient adoption
Patients want to live their current life but with control and dignity; they do not want a life make - over Patients are Not Satisfied with Current Options 8 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION They Want Their Life Improved • Stick to their drinking plan • Not fight with friends and family • Not embarrass themselves • Not feel bad the next day • Not miss work and other events in their life • Avoid other negative consequences (e.g . auto accidents, etc.) • Reduce the monetary costs • Attend events where there is alcohol Adial’s market research indicates that patients are not satisfied with current options They Do Not Want • Side effects • Painful injections • Public humiliation by admission of problem • Numerous visits to a doctor or other therapies • Self help group sessions
AD04 is believed to interfere with the dopamine reward system and lead to reduced alcohol intake Sources: Barnes, NM and Sharp, T, 1999; Dawes, MA et al., 2005b; Johnson, BA et al., 1993; Johnson, BA and Cowen, PJ, 1993; Lovinger , DM, 1991, 1999a; Swift, RM et al., 1996; Tomkins, DM et al., 1995 Novel Mechanism of Action for Treating AUD Studies suggest that blockade of serotonin - 3 receptors will influence the dopamine reward system activated by alcohol, decreasing dopamine release and attenuating alcohol craving s 9 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Reduced Serotonin - 3 Receptor Signaling D e c r e ased Cravings Reduced Release of Dopamine
AD04 / Ondansetron 10 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION AD04 is an u ltra - 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 safety profile at high doses given acutely (from 4 mg oral to 16 mg i.v. ) Limited threat of off - label use of Zofran for AUD • Lack of Efficacy – Efficacy not seen at Zofran doses in clinical testing • Safety Concerns – Warning for cardiovascular side effects at higher doses Phase 2b trial of AD04 in AUD completed • Trial met primary and secondary endpoints ONWARD Phase 3 trial of AD04 in AUD completed • 302 - patient randomized double - blind, placebo - controlled study • Limited side effects observed • Pre - specified patient sub - groups responded extraordinarily well to AD04 Well - Characterized, Widely Used
Designed to reduce craving in order to effectively curb alcohol intake Brings 20+ year record of acute clinical use with positive safety and tolerability profile Maximal patient compliance, ease of use & increased effect Ends need for abstinence, a major hurdle in starting & continuing pharmacologic therapy Takes treatment from detox clinics & group therapy - realizes patients’ desire of reduced drinking Companion genetic biomarker test identifies the patients likely to benefit from AD04 New M echanism Action (MOA) for treating AUD Good safety profile, high tolerability Oral daily dosing (twice - a - day now, once - a - day expected) Reduction of heavy drinking target indication Lowers the stigma of AUD and empowers the patient Genetic Tests for Precision Medicine Designed to address needs of patients who desire to control their drinking but cannot/will not undertak e abstinence or significant side effects 11 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION AD04 is Designed to Meet the Market Need And Allow Management of Heavy Drinking
Genetic Test Expected to Drive Market Uptake 12 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION The g enetic test is expected to increase prescription fill rate and compliance • 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 Precision Medicine Enables:
AD04 addresses key unmet medical needs in AUD market *AD04 is not yet approved for marketing and product characteristics shown as those expected based on currently available data and current plans. In all cases, the characteristics shown are fully qualified based on future data and regulatory approval. ** Taken as needed; all others are on a time regiment of at least daily or are a monthly injection (i.e. Vivitrol). . A DO 4 * EU only S e l in c r o * * V iv i tr o l C a m p ral R e v i a A nta b us e Novel Mechanism of Action Oral Dosing Designed to reduce Heavy Drinking No Abstinence Requirement Genetic Targeting 13 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION AD04 Expected Unique Profile Compared to Currently Approved Products Key expected unique selling points drive AD04 differentiation – Expected to meet patient needs
• 3 patent families under prosecution • Licensed patents issued in >40 countries, including U.S., Europe & Eurasia • Includes obesity, drug addiction, smoking, anxiety and related disorders • Use of ultra - low dose ondansetron (0.33 mg/tab.) pursuant to AD04’s proposed label • Use of ondansetron to treat any of the four genotypes in the panel • Potential competitors should be unable to modify the genetic panel without expensive and long clinical trials While ondansetron’s chemical composition is currently off - patent, Adial has an IP strategy surrounding the following : Multiple licensed patents to protect AD04 Marketing ondansetron under AD04 label expected to violate the patents & there should be no other label for marketing the AD04 dose – Competitors Prohibited Strong IP Protection Through at Least 2031 14 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Patents expected to prohibit competitors from bringing ondansetron to market for AUD at any dose
ONWARD Phase 3 Study Conducted in Europe 15 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION • Randomized, double - blind, placebo - c ontrolled , parallel - group multicenter study • Patients were screened for the appropriate genotypes via an inexpensive, standard blood test to determine eligibility for treatment with AD04 • Primary End Point: PHDD change from baseline (months 5 & 6) • Eligibility Criteria (n=302) Trial design Source: Company filings, presentations. Note: DDD = Drinks per Drinking Day; HDD = Heavy Drinking Day; PHDD = Percentage of Heavy Drinking Days; EtOH = Alcohol. HDD is defined as >= 60g of EtOH for M and >=40g of EtOH for FM; ctrl = controlled. (1) Adial ONWARD Phase 3 Trial results (publication pending). • ≥6 HDDs in 4 weeks prior to Baseline Visit • ≥40g EtOH per day for males or ≥20g EtOH for females 4 weeks prior to Screening Visit • ≤14 consecutive abstinent days • DSM - V Moderate - or Severe - AUD • No withdrawal symptoms • No in n or out - patient treatment w/in 28 days prior to Baseline V i sit Conducted in six countries in Central/Eastern Europe Group 1: Heavy drinker (< 10 drinks/drinking day): ~63% of trial participants Group 2: Very heavy drinker (> 10 drinks/drinking day: ~37% of trial participants 37% 63% Very Heavy Drinker Heavy Drinker
Specific Patient Sub - Groups Responded Well in ONWARD 16 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Post Hoc Data Analysis Based on European Endpoint E uropean Endpoint PHDD (E . U . Endpoint) (4) P - value at Months 5&6 Total Placebo Arm Treatment Arm DDD Category Genotype 0.024 (0.011 in Mo 6) 80 37 43 <10 AG (rs1150226) 0.608 (0.552 in Mo 6) 78 39 39 <10 LL/TT ( rs47955441/rs1042173) 0.031 (0.018 in Mo 6) 61 31 30 <10 AC (rs17614942) 0.251 (0.248 in Mo 6) 37 20 17 <10 GG ( rs1176713) Source: Company filings, presentations. Note: DDD = Drinks per Drinking Day; HDD = Heavy Drinking Day; PHDD = Percentage of Heavy Drinking Days; EtOH = Alcohol. HDD is defined as >= 60g of EtOH for M and >=40g of EtOH for FM; ctrl = controlled. (1) Adial ONWARD Phase 3 Trial results (publication pending). • Primary End Point: PHDD change from baseline (months 5 & 6) • Patients in Group 1: Heavy drinker (< 10 drinks/drinking day): 63% of trial participants • Heavy drinkers with AG and/or AC genotype responded extraordinarily well to AD04 treatment • No significant contraindications, warnings, nor adverse events
Specific Patient Sub - Groups Responded Well Based on U.S. Endpoint 17 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Post Hoc Data Analysis Based on U.S. Endpoint Post Hoc Analysis of U.S. Endpoint Responder Analysis (U.S. Endpoint) (3) P - Value at Months 5&6 Total Placebo Arm Treatment Arm (2) DDD Category Genotype 0.02 1 0 67 30 37 <10 AG+ 0. 619 58 29 29 <10 LL+/TT+ 0. 329 50 25 25 <10 AC+ 0. 116 24 12 12 <10 GG+ 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 point. • AG+ subjects showed statistically significant separation from placebo (p=0.02 1 0 in Months 5 & 6 ) • The percentage of 0 HDD patients in the treatment arm appears to increase linearly during the study period of 6 months • Analysis of data from patients in Group 1: Heavy drinker Source: Company filings, presentations. Note: DDD = Drinks per Drinking Day; HDD = Heavy Drinking Day; PHDD = Percentage of Heavy Drinking Days; EtOH = Alcohol. HDD is defined as >= 60g of EtOH for M and >=40g of EtOH for FM; ctrl = controlled. (1) R esponder analysis is defined as the percentage of patients with 0 HDDs in the treatment arm versus placebo at a specific time point. (2) The U.S. responder analysis excludes individuals who did not have recorded measurements during the assessment period which in turn results in lower sample sizes for some genotypes. (3) Adial analysis of Phase 3 Trial results.
Summary – Clinical development strategy CONFIDENTIAL | 18 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Advancing AD04 based on promising data and favorable regulatory feedback FDA confirmed primary U . S . endpoint based on PNHDD – patients who reduced their alcohol consumption to zero heavy drinking days in the last two months of a six - month study . FDA acknowledged the results from the Phase 2 and Phase 3 post hoc analysis against the US endpoint of PNHDD, which demonstrated statistical significance of responder analysis of specific genotypes, are useful information for planning future studies of AD 04 . Safety data from the ONWARD trial did not raise any concerns . In addition, Adial received favorable feedback from EU regulators . Adial will prioritize FDA to pursue approval in the US, while trials will be designed to satisfy both US and EU submission requirements . While possible to file for registration with one additional trial, current planning assumptions are that Adial will need to conduct two Phase 3 trials with AD 04 . Adial believes conducting two trials in parallel may be the best strategy to minimize risk , optimize timing & costs and improve probability of regulatory authority acceptance and approval in the US and Europe P N HDD = Percentage of No Heavy Drinking Days
Partner Status • Advancing discussions with potential strategic partners that could fund: • Phase 3 clinical program • Commercialization of AD04 assuming a successful regulatory outcome • Primary Targets - companies with commercial capabilities or pipeline development capabilities in: Alcohol Therapeutics, Addiction, Psychiatry, Neurology, and niche Orphan CNS • Secondary Targets - companies focused on DTP (Direct to Patient) and DTC (Direct to Consumer) Health Platforms • Fully integrated capabilities with telemedicine, behavioral health, genetic screening, and product fulfillment • D irect to patients with obesity, anxiety, depression, obesity and other mental health diagnosis. • Tertiary Targets - companies with a commercial focus where excessive alcohol consumption may be the primary cause of downstream health effects such as hypertension, obesity, alcohol induced steatohepatitis, and other comorbidities. • Currently in discussions under CDA with several companies that have expressed interest in both the U.S. and European markets and are currently reviewing data and regulatory feedback received • Partnerships of this quality would allow us to rapidly penetrate the U.S. given the expectation of AD04 being widely accessible, reasonably priced, and reimbursable 19 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Discussions with potential partners progressing
Revised Corporate Strategy CONFIDENTIAL | 20 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20230606 Target genotypes identified; regulatory discussions advancing; attractive U.S. commercial opportunity now the primary focus Clear path forward that incorporates outcomes from previous trials, regulatory feedback and includes a modified design that focuses on heavy drinkers with specific genotypes (AG and potentially GG) Refinement of genetic panel increases the probability of success in future trials by targeting those genotypes that outperformed others in previous studies This approach gives us a high level of confidence that we will be able to meet FDA’s pre - specified primary endpoint and the European endpoint The genotypes are part of the existing genetic panel used to qualify patients for AD 04 , are easily identified and are estimated to exist in about 20 % of the AUD population based on patient screening in our trial . For this specific patient population, AD 04 performs extraordinarily well . Healthcare payer research following the completion of the ONWARD trial suggests that unit pricing for AD 04 could be more than double the previous assumptions for the U . S . The sale of our preclinical subsidiary Purnovate’s assets and business better positions us to execute our outlined strategy and extends our cash runway Overall, Adial is now focused on a refined, well - researched, and commercially attractive plan for AD 04 with a primary focus in the U . S .
Target Market – Total Potential Annual Gross Revenue 21 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION A small percentage of the potential market would make AD04 a commercial success 1. Note: Assumes 20 % of patients genetically positive and treated; $ 600 per month pricing AD04 Target Market Patients with AUD & with AD04 Target Genetics Low Hanging Fruit Patients seeking treatment for AUD & with AD04 Target Genetics Color Key: Assuming only 20 % of patients are treatable with AD04, based on the genetic test, the total potential annual revenue for AD04 in the U.S. alone is $ 40 Billion 1 $ 3.4 B Patients seeking treatment for AUD $ 40 Billion US Market
Next steps CONFIDENTIAL | 22 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 20230606 Finalize plans to achieve potential commercial launch by end of 2026 Finalize Clinical Development Plan Final decision on conducting one or two Trials Finalize Trial design and Costs (current estimate $ 8 - $ 12 million per trial pending final design and scope) Timeline completion Review study protocol and statistical analysis plan with FDA and EMA Finalize Partnering process and funding requirements
Management Team 23 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Experienced personnel in key positions Joseph Truluck , MBA C hief F inancial O fficer Bankole A. Johnson, D.Sc., M.D. C hief Medical Officer Cary J. Claiborne Chief Executive Officer John R. Martin, J.D. Chief Legal Officer Schuyler Vinzant VP Development
Board of Directors 24 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Blend of leadership, finance, and life science experience Tony Goodman Managing Director/Founder, Keswick Group Cary J. Claiborne Chief Executive Officer, Adial Kevin Schuyler Chairman of the Board Senior Managing Director, Cornerstone Partners J. Kermit Anderson Chief Financial Officer & Vice President, Cumberland Development Company; Robin Gilliland Principal, Keller Enterprises James W. Newman, Jr. Chairman & President, Medical Predictive William B. Stilley Chief Executive Officer, Adovate
Building an Addiction Focused Pharmaceutical Company 25 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION 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 through 203 1 Potential indication expansion opportunities for AD04 (opioid use disorder, obesity, others) Experienced and qualified management team
C o n t a c t : GENERAL INQUIRES : info@adialpharma.com INVESTOR RELATIONS : Crescendo Communications, LLC 405 Lexington Ave 9th Floor, Suite 9034 New York, NY 10174 T: 212 - 671 - 1021 ADIL@crescendo - ir.com F ind U s @ A dial P harma adialpharma.com MEDIA RELATIONS : Russo Partners , LLC 215 Park Ave South Suite 1905 New York, NY 1000 3 T: 817 - 371 - 0654 Adial@RussoPR.com
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|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
Adial Pharmaceuticals (NASDAQ:ADIL)
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