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 4, 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.)

 

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 3.02. Unregistered Sales of Equity Securities.

 

On August 3, 2021 and August 4, 2021, Adial Pharmaceuticals, Inc. (the “Company”), following the effectiveness of the registration statement on Form S-3 (File No. 333-258048) that the Company filed with the U.S. Securities and Exchange Commission on July 20, 2021 (the “Registration Statement”), closed the second tranche of its private offering of common stock (the “2nd Tranche”) pursuant to those certain Securities Purchase Agreements, dated July 6, 2021 (the “Securities Purchase Agreements”), with each of Bespoke Growth Partners, Inc. (“Bespoke”), a company controlled by Mark Peikin, the Company’s Chief Strategy Officer (non-executive), Keystone Capital Partners, LLC (“Keystone”) and Richard Gilliam (“Gilliam”), pursuant to which: (i) Bespoke purchased 750,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement; (ii) Keystone purchased 450,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement; and (iii) Gilliam purchased 300,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement. The shares of common stock issued in the 2nd Tranche were priced at $3.00 per share of common stock for proceeds to the Company of $4,500,000. No warrants were issued and no brokers fees were incurred.

 

The shares of the Company’s common stock issued under the Securities Purchase Agreements were pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated thereunder. Bespoke, Keystone and Gilliam are accredited investors who have purchased the securities as an investment in the private placement, which did not involve a general solicitation.  This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.

 

The foregoing description of the Securities Purchase Agreements is qualified in their entirety by reference to the form of Securities Purchase Agreement filed hereto as Exhibit 10.1, which is incorporated herein by reference.

  

Item 8.01. Other Events.

 

On August 5, 2021, the Company issued a press release announcing the closing of the second tranche under the Securities Purchase Agreements, a copy of which is furnished 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.

  

Exhibit
Number

 

Description

     
10.1   Form of Securities Purchase Agreement (Incorporated by reference to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 9, 2021 (File No. 001-38323)
     
99.1   Press Release issued by Adial Pharmaceuticals, Inc. on August 5, 2021

 

 

2

 

 

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 5, 2021 ADIAL PHARMACEUTICALS, INC.
     
  By: /s/ William B. Stilley, III
  Name: William B. Stilley
  Title:  President and Chief Executive Officer

 

3

Exhibit 99.1

 

 

 

 

Adial Pharmaceuticals Announces Closing of $5 Million Private Placement Priced at a Premium to Market

 

Financing fully funds ONWARD™ Phase 3 trial until data read-out

 

Charlottesville, VA – August 5, 2021 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it has completed the $5,000,002 private placement of 1,666,668 shares of common stock at a price of $3.00 per share (the “Shares”) on August 4, 2021. The private placement was led by Bespoke Growth Partners, Inc., which invested $2,500,000, and is a company controlled by Mark Peikin, Adial’s Chief Strategy Officer, and also included Richard Gilliam, founder of Cumberland Resources, and Keystone Capital Partners LLC, all of whom were previous investors in the Company. No warrants were issued in this financing, and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as an advisor on the transaction.

 

As previously disclosed, the Company received $500,002 upon the parties’ execution of their respective Securities Purchase Agreements and has now received the balance of $4,500,000 following the U.S. Securities and Exchange Commission declaring the registration statement on Form S-3, registering the resale of the private placement shares, effective on July 29, 2021.

 

In combination with the private placement previously announced on June 3, 2021, this transaction marks the completion of a set of financings totaling $7.1 million.

 

William Stilley, Adial’s Chief Executive Officer, commented, “We are pleased to close this last piece of our $7.1 million in private placements, and we appreciate the support of the participating investors. We believe this latest financing illustrates the tremendous confidence and support of our existing shareholders, as well as our conviction in the positive outlook for the business. This funding is anticipated to provide us more than sufficient capital to complete the ONWARD™ Phase 3 trial of AD04 as a genetically targeted treatment for Alcohol Use Disorder through data read-out. Additionally, it is expected to allow us to achieve key milestones for our pre-clinical adenosine program for non-opiate pain relief.”

 

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.

 

 

 

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 financing illustrating the tremendous confidence and support of our existing shareholders, as well as as our conviction in the positive outlook for the business, the funding providing us more than sufficient capital to complete the ONWARD™ Phase 3 trial of AD04 as a genetically targeted treatment for Alcohol Use Disorder through data read-out, this funding allowing us to achieve key milestones for our pre-clinical adenosine program for non-opiate pain relief 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 maintain the confidence and support of our existing shareholders, as well as as our conviction in the positive outlook for the business, our ability to complete the ONWARD™ Phase 3 trial of AD04 as a genetically targeted treatment for Alcohol Use Disorder through data read-out as planned, our ability to achieve key milestones for our pre-clinical adenosine program for non-opiate pain relief, 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, 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