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): June 24, 2021

 

Adial Pharmaceuticals, Inc.

(Exact name of registrant as specified in charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-38323   82-3074668
(Commission File Number)   (IRS Employer Identification No.)

 

1001 Research Park Blvd., Suite 100

Charlottesville, VA 22911

(Address of principal executive offices and zip code)

 

(434) 422-9800

(Registrant’s telephone number including area code)

 

 

(Former Name and Former Address)

 

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:

 

☐ 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   NASDAQ
Warrants   ADILW   NASDAQ

 

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   þ

 

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.

 

On June 24, 2021, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release providing information regarding its application for a Fast Track Designation for its lead product candidate AD04 for the treatment of Alcohol Use Disorder (AUD) in pediatric patients and adult patients with Alcoholic Liver Disease (ALD) with select polymorphisms of the serotonin transporter and receptor genes. The Company reported that on June 23, 2021, it received notice from the FDA that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge the unmet medical needs of adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated that the product shows potential to address an unmet medical need in the situation where other treatments are available. Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration. Based on this feedback, the Company will review the additional requirements and data requested by the FDA for a Fast Track Designation.

 

A copy of the press release is furnished as Exhibit 99.1 to this Report on Form 8-K. The information contained in the press release is being furnished to the Securities and Exchange Commission (the “Commission”) and shall not be deemed incorporated by reference into any of the Registrant’s registration statements or other filings with the Commission.

 

The information in this Item 7.01, and in the press release 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.

  

Item 8.01 – Other Events.

 

On June 24, 2021, the Company issued a press release providing information regarding its application for a Fast Track Designation for its lead product candidate AD04 for the treatment of Alcohol Use Disorder (AUD) in pediatric patients and adult patients with Alcoholic Liver Disease (ALD) with select polymorphisms of the serotonin transporter and receptor genes. The Company reported that on June 23, 2021, it received notice from the FDA that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge the unmet medical needs of adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated that the product shows potential to address an unmet medical need in the situation where other treatments are available. Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration. Based on this feedback, the Company will review the additional requirements and data requested by the FDA for a Fast Track Designation.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibit is furnished with this Current Report on Form 8-K:

  

Exhibit No.   Description
99.1   Press Release issued by Adial Pharmaceuticals, Inc., dated June 24, 2021.

 

 

 

 

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:  June 24, 2021 ADIAL PHARMACEUTICALS, INC.
   
     
  By: /s/ William B. Stilley, III
  Name: William B. Stilley
  Title: President and Chief Executive Officer

 

 

  

Exhibit 99.1

 

Adial Pharmaceuticals Provides Regulatory and Development Update

 

Charlottesville, VA – June 24, 2021 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has received correspondence related to its request for Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) in pediatric patients and adult patients with Alcoholic Liver Disease (ALD) with select polymorphisms of the serotonin transporter and receptor genes. While AD04 is being developed and undergoing a pivotal Phase 3 trial to treat any adult with AUD with the targeted genetics, Adial believes AD04 holds the potential to effectively and safely treat AUD patients that are adolescents or have ALD.

 

The Company is reporting that on June 23, 2021, it received notice from the FDA that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge the unmet medical needs of adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated that the product shows potential to address an unmet medical need in the situation where other treatments are available. Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration. Based on this feedback, Adial will review the additional requirements and data requested by the FDA for a Fast Track Designation.

 

The FDA’s Fast Track is a process designed to facilitate development and expedite the regulatory review of drugs that treat serious conditions and address unmet medical needs with the purpose of getting important drugs to patients earlier. While the FDA judges the seriousness of a condition on a case-by-case basis, the FDA generally considers whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, left untreated, will progress to a more serious state.

 

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.

 

 

 

 

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 overt 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. The Company is also developing adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adialpharma.com.

 

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 ability to meet the requirements for approval of Fast Track Designation in the future, 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, 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 our product candidates in the marketplace and the successful development, marketing or sale of our 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, 2020, 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: adil@crescendo-ir.com