CHARLOTTESVILLE, Va., May 18, 2021 (GLOBE NEWSWIRE) —

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW)

(“Adial”), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer, and Dr. Bankole Johnson, Chief Medical Officer, have been featured on multiple news broadcasts nationwide regarding the ‘Second Pandemic of Addiction’ arising from the COVID-19 pandemic.

Recent interviews:

• On May 17, 2021,
  
  Mr. Stilley appeared on KCTV, NBC
  
  , a Meredith Corporation company, where he discussed topics related to the Second Pandemic of Addiction.
  • The dramatic increase in alcohol abuse that has occurred during the COVID-19 pandemic has created the Second Pandemic of Addiction, which is expected to result in greater fatalities and last years longer than the COVID-19 pandemic itself.
  • There is a significant unmet need for new treatments, medicines and resources to meet this new crisis.
  • One such option for combatting this emerging crisis is Adial’s Phase 3 drug candidate, AD04, which is a genetically targeted medicine to treat Alcohol Use disorder.

• On May 17, 2021,
  
  Dr. Bankole Johnson appeared on CBSN, cbsnews.com, and Yahoo! News
  
  , where he discussed how alcohol’s effects are disproportionately affecting women during the Second Pandemic.
  • The NASW Foundation reported that women are seeing a 41% increase in abusive drinking over the last year.
  • A nationwide survey from the American Psychological Association shows nearly 1 in 4 women have increased abusive drinking during the pandemic. That rate nearly doubled for women with children between 5 and 7.
  • The NASW also reported that up to 150,000 more people could die due to increased drinking during the pandemic.

• On May 14, 2021,
  
  Mr. Stilley appeared on WJLA ABC 7, Washington DC
  
  , where he discussed how alcohol abuse was a growing problem before COVID-19 but accelerated during the lockdowns so that it is now worse and becoming the Second Pandemic.
  • Online sales of alcohol skyrocketed 234% in April 2020 compared to the year before according to Nielsen IQ research.
  • Adial’s landmark ONWARD™ Phase 3 pivotal clinical trial includes 290 participants in 7 countries.
  • In Adial’s
    
    Phase 2 clinical trial of AD04
    
    , patients drank almost 50% less often and almost 60% less when they drank.

Links to the above segments are also available on the

media section of Adial Pharmaceuticals’ web site

. Dr. Johnson is also a regular contributor to BNC.com.

For more information, please go to

www.adialpharma.com

or follow the Company on Twitter

@AdialPharm

, or the CEO

@BillStilley

.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity, and the Company develops adenosine analogs for the treatment of pain and other disorders. Additional information is available at

www.adialpharma.com

.

About the Landmark ONWARD™ Pivotal Phase 3 Clinical Trial

The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.

Forward-looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding


the Second Pandemic of Addiction that occurred during the COVID-19 pandemic resulting in greater fatalities and lasting years longer than the COVID-19 pandemic itself and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, the duration and scope of the Second Pandemic of Addiction, our ability to enroll patients within the timelines anticipated and complete clinical trials on time and achieve desired results and benefits as expected, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:


Crescendo Communications, LLC

David Waldman / Natalya Rudman

Tel: 212-671-1021

Email:

[email protected]