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): August 6, 2020

 

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, Virginia 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 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

 

Emerging growth company   ☒

 

If an emerging growth company, indicate by check mark 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 August 6, 2020, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it had entered into a Distribution Agreement (the “Agreement”) with Brik, LLC (“Brik”), an independent sales and marketing firm, to act as a third-party agent to the Company for the sale and distribution of Rapid Result COVID-19 antibody test kits (“Tests”), which test for the antibodies indicating potential previous exposure and possible resistance to COVID-19. Under the Agreement, Brik will sell and distribute Tests under a profit-sharing arrangement with the Company.

 

A copy of the press release is attached 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.

 

Item 8.01. Other Events.

 

On August 6, 2020, the Company issued a press release announcing that it had entered into a Distribution Agreement with Brik, an independent sales and marketing firm, to act as a third-party agent to the Company for the sales and distribution of Tests. Under the Agreement, Brik will sell and distribute Tests under a profit-sharing arrangement with the Company.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

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

 

Exhibit No.   Description
99.1 Press Release issued by Adial Pharmaceuticals, Inc. dated August 6, 2020.

 

1

 

 

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:  August 6, 2020 ADIAL PHARMACEUTICALS, INC.
     
  By: /s/ William B. Stilley, III
  Name: William B. Stilley
  Title: President and Chief Executive Officer

 

 

2

 

Exhibit 99.1


 

Adial Pharmaceuticals Announces Third-Party Sales and Distribution
Agreement with Brik for Rapid Result COVID-19 Antibody Test Kits

 

Charlottesville, VA – August 6, 2020 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial”), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has entered into an agreement with Brik LLC (“Brik”), an independent sales and marketing firm, to act as a third-party agent to Adial for the sale and distribution of Rapid Result COVID-19 antibody test kits. As reported on June 8, 2020, Adial and BioLab Sciences, Inc. entered into a distribution agreement, whereby Adial has the exclusive rights to sell and distribute the Rapid Result COVID-19 antibody tests to designated channel partners and customers.

 

Gérard Brikkenaar Van Dijk, Principal and co-founder of Brik, commented, “We are delighted to partner with Adial to advance the sales, marketing and distribution of the Rapid Result COVID-19 antibody test kits. These FDA emergency use authorization (EUA) registered tests provide results within 10-minutes, with the ability to detect both lgG and lgM antibodies specific to SARS-CoV-2. Importantly, these tests are able to detect IgG antibodies at a 98.6% accuracy and IgM antibodies at a 92.9% accuracy. We see significant market potential for this differentiated test kit, given the prolonged and devastating impact of COVID-19. We look forward to leveraging our global network of suppliers and end-users to help bring the product to market in a timely and cost-effective manner.”

 

William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, “This distribution partnership is important, as Brik has a proven track record and established relationships that we believe will help us better attack the market given the urgent need. Moreover, this agreement also allows us to focus internal resources on advancing the ongoing ONWARD™ Phase 3 pivotal clinical trial of our lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, which is now well underway across Europe. We are already incorporating the use of these Rapid Result COVID-19 antibody test kits in our ONWARD™ trial, which was our original goal. We believe these tests have proven beneficial in enhancing patient safety during the current pandemic and that offering them to study subjects will increase trial subject retention rates.”

 

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. www.adialpharma.com

 

 

About Brik, LLC

 

Focused on quality and upscale markets, both consumer and industrial, Brik, LLC helps clients connect and converse, and establish new operations and markets. Co-founded by Gerard Brikkenaar van Dijk and Keith Rosenfeld in 2002, Brik LLC brings together American and global investors, purchasers and suppliers. Our experience spans numerous industries, including: medical; online transaction security; pharmaceuticals; consumer electronics; multinational data centers; food production/retailing; and education.

 

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 significant market potential for this differentiated test kit, given the prolonged and devastating impact of COVID-19 and Brik leveraging its global network of suppliers and end-users to help bring the product to market in a timely and cost-effective manner, Brik’s track record and established relationships helping us better attack the market given the urgent need, these tests having proven beneficial in enhancing patient safety during the current pandemic and that offering them to study subjects will increase trial subject retention rates 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, Brik’s ability to leverage its relationships, including its global network of suppliers and end-users to help bring the product to market in a timely and cost-effective manner, our ability to increase trial subject retention rates by offering study subject the tests,, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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: dwaldman@crescendo-ir.com