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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): November 2, 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, Ste 495

Charlottesville, VA 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 (§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 ☒

 

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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On November 2, 2021, Cary J. Claiborne joined the board of directors (the “Board”) of Adial Pharmaceuticals, Inc. (the “Company”) to serve as a Class I member of the Board. The appointment expands the size of the Board to seven members. Mr. Claiborne’s term will expire at the Company’s 2022 Annual Meeting of Stockholders and until such time as his successor is duly elected and qualified, whichever is later, or until his re-election or earlier resignation or removal.

 

There are no family relationships between Mr. Claiborne and any of the Company’s directors or executive officers, nor does Mr. Claiborne have any direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K. Other than as described below, there were no arrangements or understandings by which Mr. Claiborne was named as a member of the Board.

 

In connection with his appointment, Mr. Claiborne was awarded an option to purchase 60,000 shares of the Company’s common stock at an exercise price of $3.15 per share, vesting pro rata on a monthly basis over a thirty-six month period, and exercisable for a period of ten years from the date of grant. In accordance with the Company’s policy as currently in effect, Mr. Claiborne will receive a cash retainer for his service on the Board and for service on each committee of which he is a member.

 

Mr. Claiborne previously served as CFO and board member of Indivior PLC, a publicly traded specialty pharmaceutical company developing medicines to treat addiction and serious mental illnesses, from November 2014 until February 2018, when he left Indivior and focused his efforts on Prosperity Capital Management, LLC, a Private Investment and Advisory firm, which he founded in 2001 and where he is currently the CEO. Among his accomplishments, Mr. Claiborne led Indivior’s spin off from its then parent company, Reckitt Benckiser to become an independent, publicly listed company. While at Indivior, he established and oversaw corporate reporting, internal audit, tax, treasury, external audit and information technology.

 

Prior to joining Indivior, Mr. Claiborne served as the CFO of Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, which was later sold to Mallinckrodt. Before joining Sucampo, Mr. Claiborne served as CFO and Corporate Secretary of Osiris Therapeutics, Inc. and oversaw corporate finance during the company’s initial public offering. Other previous positions include executive officer or finance roles in a number of companies including, without limitation New Generation Biofuels, Inc. (Nasdaq: NGBF), where he served as CFO and then CEO, Constellation Energy, The Home Depot, MCI, and GE Capital, and GE, where he worked for 15 years. Cary was also a member of the board of directors of MedicAlert Foundation from 2013-2016, where he served as the Chairman of their Audit & Finance Committees.

 

Mr. Claiborne graduated from Rutgers University with a B.A. in Business Administration and from Villanova University with an M.B.A. and was a National Association of Corporate Directors (NACD) Governance Fellow.

 

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Item 8.01. Other Events.

 

On November 3, 2021, the Company issued a press release announcing the appointment of Mr. Claiborne as a Class I member of the Board. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01   Financial Statements and Exhibits.

 

(d) Exhibits.

 

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

 

Exhibit

Number

  Exhibit Description
     
99.1   Press Release issued by Adial Pharmaceuticals, Inc., dated November 3, 2021
Exhibit 104   Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

 

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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: November 3, 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 Appoints Renowned Pharmaceutical Executive Cary J. Claiborne to Board of Directors

 

Charlottesville, VA – November 3, 2021 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the appointment of Cary J. Claiborne to the Board of Directors, increasing the number of board members to seven.

 

Mr. Claiborne previously served as CFO and board member of Indivior PLC, a publicly traded specialty pharmaceutical company developing medicines to treat addiction and serious mental illnesses. Among his accomplishments, Mr. Claiborne led the company’s spin off from its then parent company, Reckitt Benckiser, to become an independent, listed company. While at Indivior, he established and oversaw corporate reporting, internal audit, tax, treasury, external audit and information technology.

 

Prior to joining Indivior, Mr. Claiborne served as the CFO of Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, which was later sold to Mallinckrodt. Before joining Sucampo, Mr. Claiborne served as CFO and Corporate Secretary of Osiris Therapeutics, Inc., and oversaw corporate finance during the company's initial public offering. He graduated from Rutgers University with a B.A. in Business Administration and from Villanova University with an M.B.A., and was a National Association of Corporate Directors (NACD) Governance Fellow.

 

William Stilley, Adial’s Chief Executive Officer, stated, “We are honored to welcome Cary to the board of directors and believe he will be an important addition at this exciting time in our development, as we move closer to completion of our ONWARD Phase 3 trial of AD04 for the treatment of alcohol use disorder. Moreover, we believe his experience will be invaluable as we begin preparations for the commercial launch of AD04, assuming our trial is successful. We also look forward to his contributions as we seek to advance our Purnovate adenosine platform toward clinical trials, and potentially establish partnership opportunities. Given Cary’s impressive track record in finance and governance, we believe his appointment is a further illustration of our commitment to the highest levels of corporate governance.”

 

About Adial Pharmaceuticals, Inc.

 

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders. 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 Purnovate, Inc.

 

Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, is a pharmaceutical development and chemistry company focused on inventing and developing selective, potent, stable, and soluble adenosine analogs to treat diseases and disorders such as pain, cocaine addiction, inflammation, infectious disease, cancer, asthma, and diabetes. Additional information is available at www.purnovate.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 Mr. Claiborne’s expected contribution to the Adial Board of Directors and Adial, advancing our Purnovate adenosine platform toward clinical trials and potential partnership opportunities and the potential of AD04 to treat other addictive disorders such as Alcohol Use Disorder, 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, Mr. Claiborne’s ability to provide value to Adial as expected, 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 our 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