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 22, 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.)

 

1180 Seminole Trail, Suite 495

Charlottesville, Virginia 22901

(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 8.01. Other Events.

 

On September 22, 2020, the Adial Pharmaceuticals, Inc., a Delaware corporation (the “Company”), issued a press release relating to sales of its FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through the iRemedy network and ecommerce platform.

 

The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

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

 

Exhibit
Number

 

Description

   
99.1   Press Release issued by Adial Pharmaceuticals, Inc. on September 22, 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: September 22, 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 and iRemedy Partner to Sell COVID-19 Antibody Test Kits to U.S. Medical Providers and Commence Sales

 

Charlottesville, VA – September 22, 2020 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and The iRemedy Healthcare Companies, Inc. (“iRemedy”), pioneers of the iRemedy medical supply marketplace platform, today announced that the two companies have commenced sales of FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through the iRemedy network and ecommerce platform.

 

As reported previously, Adial has secured rights to distribute COVID-19 antibody tests to designated channel partners and customers. Antibody test kits distributed by Adial are FDA emergency use authorization (EUA) registered, 10-minute, ‘instant’ point-of-care test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in human whole blood, serum or plasma specimens. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette’s coated membrane.

 

Tony Paquin, Co-Founder and Chief Executive Officer of iRemedy, commented, “We are delighted to partner with Adial to advance sales of the FaStep COVID-19 antibody test kits across our network of U.S. healthcare providers and hospitals in order to help address the unmet market need for these differentiated test kits, given the prolonged and devastating impact of COVID-19. We see a significant market potential in these instant and efficient tests that provide results within 10-minutes, with the ability to detect IgG antibodies at a 97.3% accuracy and IgM antibodies at a 99.1% accuracy. With established relationships with over 5,000 healthcare provider clients nationwide, ranging from private medical practices to major hospitals, we believe iRemedy is an exemplary commercial partner for Adial and we look forward to continuing to build our sales and distribution relationship.”

 

“We have experienced first-hand the value of COVID-19 antibody tests, which are being used to enhance patient safety and maximize subject retention during our ongoing landmark ONWARD™ pivotal Phase 3 clinical trial of AD04, for the treatment of Alcohol Use Disorder,” stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals. “Given iRemedy’s healthcare customer base and distinguished Medical Advisory Board, we are confident that iRemedy is an ideal partner for Adial. Along with Tony and the entire iRemedy team, we are aligned in the goal to bring these COVID-19 antibody tests to market in a timely and cost-effective manner. In addition to the partnership, we are especially excited to have already commenced sales of these important tests on iRemedy.com and appreciate the support of iRemedy in helping to make these tests broadly available.”

 

For more information on purchasing FaStep COVID-19 antibody test kits, please contact Keisha Graham at 407-395-4283 or via email at keisha@iremedy.com.

 

 

 

 

About The iRemedy Healthcare Companies

 

With 15 years in healthcare supply, iRemedy is a trusted partner for acquiring medical supplies and Personal Protective Equipment. iRemedy guarantees the access to verified supplies by sourcing directly from established manufacturers and distributors around the world. The industry-leading technology and group purchasing power help enable transparency and competition, driving low pricing for customers. iRemedy is headquartered in Stuart, Florida and has offices in New York, California and Washington, and distribution centers in Florida and Arizona. For more information, please visit www.iremedy.com.

 

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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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

 

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 building sales and distribution of FaStep COVID-19 antibody tests through the iRemedy network and ecommerce platform, the market potential in instant and efficient tests that provide results within 10-minutes, iRemedy’s healthcare customer base and distinguished Medical Advisory Board making iRemedy an ideal partner for Adial, bringing COVID-19 antibody tests to market in a timely and cost-effective manner 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, our ability to build sales and distribution of FaStep COVID-19 antibody tests through the iRemedy network and ecommerce platform, 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:

 

For Adial Pharmaceuticals, Inc. For iRemedy Healthcare Companies, Inc.
Crescendo Communications, LLC Keisha Graham
David Waldman / Natalya Rudman keisha@iremedy.com
Tel: 212-671-1021  
Email: dwaldman@crescendo-ir.com