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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): May 8, 2023

 

Adial Pharmaceuticals, Inc.

(Exact name of registrant as specified in charter)

 

Delaware   001-38323   82-3074668
(State or other jurisdiction
 of incorporation)
  (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)

 

N/A

(Former name or former address, if changed since last report)

 

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 (see General Instruction A.2. below):

 

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   The Nasdaq Stock Market LLC
(Nasdaq Capital Market)
         
Warrants   ADILW   The Nasdaq Stock Market LLC
(Nasdaq Capital Market)

 

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 1.01. Material Definitive Agreement.

 

On May 8, 2023, Adovate, LLC (formerly known as Adenomed, LLC) (collectively, “Adovate”) gave irrevocable notice of its exercise of the option (the “Option”) to acquire all of the assets and business of Purnovate, Inc. (“Purnovate”) under that certain Option Agreement for the Acquisition of Purnovate, Inc. by Adenomed, LLC, dated as of January 27, 2023 (the “Option Agreement”). In connection with exercise of the Option, Adial Pharmaceuticals, Inc. (the “Company”) received from Adovate a non-refundable option exercise fee and upfront payment of $450,000 and entered into an option exercise agreement with Adovate (the “Option Exercise Agreement”) providing that the exercise of the Option will be effective as of May 16, 2023 and that any Purnovate expenses incurred on or subsequent to May 16, 2023 will be the sole responsibility of Adovate.

 

Pursuant to the Option Agreement, the Company will be reimbursed by Adovate for any Purnovate expenditures incurred and paid commencing December 1, 2022 through and including May 15, 2023, to be paid within thirty (30) days of execution of the final acquisition agreement, and will hold a security interest in the assets of Adovate until the expense reimbursement is paid in full and the equity in Adovate described below is issued to Company.

 

The Option Agreement sets forth the terms of the final acquisition agreement to be negotiated in good faith by the parties after exercise of the Option which include: (i) the issuance by Adovate to the Company of 19.99% of the equity of Adovate within thirty (30) days of execution of the final acquisition agreement (such 19.99% to be subject to anti-dilution protection until Adovate has raised $4,000,000); (ii) the assumption by Adovate of the obligations of Company under that certain Equity Purchase Agreement by and among Company, Purnovate, the members of Purnovate, and Robert D. Thompson as the member’s representative, dated December 7, 2020 and amended January 25, 2021; (iii) the assumption by Adovate of the obligations of the Company under that certain Employment Agreement, dated July 31, 2018, as amended, by and between Company and William Stilley; (iv) low, single digit royalty payments on net sales; (v) cash payments of up to approximately $11 million in development and approval milestones for each compound after payments to the prior members of Purnovate pursuant to the PNV EPA; and (vi) cash payments of up to an aggregate of $50,000,000 upon the achievement of certain commercial milestones.

 

The foregoing summaries of the Option Agreement and Option Exercise Agreement do not purport to be complete and are subject to and are qualified in their entirety by reference to the full text of such documents attached as Exhibits 2.1 and 2.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.

 

Item 7.01 Regulation FD Disclosure

 

On May 10, 2023, the Company issued a press release announcing the exercise of the Option. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information presented in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise be subject to the liabilities of that section, nor is it incorporated by reference into any filing of the Company, under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

1

 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description

2.1

  Option Agreement for the Acquisition of Purnovate, Inc. by Adenomed, LLC, dated as of January 27, 2023 (incorporated by reference Exhibit 2.1 to the Current Report on Form 8-K as filed by the Registrant with the Securities and Exchange Commission on February 1, 2023 (File No. 001-38323)
2.2   Option Exercise Agreement, dated May 8, 2023, by and between Adovate LLC and Adial Pharmaceuticals, Inc.
99.1   Press Release issued by Adial Pharmaceuticals, Inc.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* * *

 

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: May 10, 2023 ADIAL PHARMACEUTICALS, INC.
   
  By: /s/ Cary J. Claiborne
  Name: Cary J. Claiborne
  Title: President and Chief Executive Officer

 

 

3

 

 

Exhibit 2.2

 

   

1180 Seminole Tr., Suite 495

Charlottesville, VA 22901

+1 (434) 202-2525

www.adenomed.com

 

 

May 8, 2023

 

Cary Claiborne

Chief Executive Officer

Adial Pharmaceuticals, Inc.

1180 Seminole Tr., Ste. 495

Charlottesville, VA 22901

 

RE: Notice of Option Exercise

 

Dear Mr. Claiborne,

 

Reference is made to that certain Option Agreement to acquire the business of Purnovate, Inc. (“Option Agreement”), effective as of January 27, 2023, by and between Purnovate, Inc., a Delaware corporation (“Purnovate”), a wholly owned subsidiary of Adial Pharmaceuticals, Inc., a Delaware corporation (“Adial”), (Purnovate and Adial are together the “Seller”) on the one hand, and Adovate, LLC (formerly Adenomed, LLC), a Virginia limited liability company (“Buyer”) on the other hand. Capitalized terms not otherwise defined herein have the meaning defined in the Option Agreement.

 

Buyer hereby provides Notice per Section 3.03 of the Option Agreement of its irrevocable exercise of the Option. A check in the non-refundable amount of $450,000, which includes the $150,000 Exercise Price and the $300,000 Up-front Payment, is enclosed with this letter.

 

By this letter, Seller and Buyer agree that the Option Exercise shall be deemed to be effective as of May 16, 2023 and the Reimbursement of Expenses shall include the dates that run through and including May 15, 2023. Buyer acknowledges and agrees that Seller may publicly disclose its receipt of Notice from Buyer prior to the Option Exercise becoming effective.

 

All of us at Adovate look forward to working with you and the rest of the Seller’s team to smoothly transition the Assets and business of Purnovate for the benefit of each of our companies and the Adial shareholders.

 

With warmest regards,  
   
/s/ William B. Stilley  
William B. Stilley  
CEO  

 

  Agreed:
   
Enclosure /s/ Cary Claiborne
  Cary Claiborne
  CEO, Adial Pharmaceuticals, Inc.

 

 

 

Exhibit 99.1

 

 

Adial Pharmaceuticals Receives Notice of Exercise from

Adovate for the Acquisition of Purnovate’s Assets and Business

 

Adial to receive potential development and commercial milestone payments of up to $83 million

on the first three compounds plus 19.9% equity stake and ongoing royalties

 

Charlottesville, VA – May 10, 2023 – 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 Adovate, LLC (formerly known as Adenomed, LLC) (“Adovate”), has provided irrevocable notice of exercise of its previously announced option to acquire the assets and business of Purnovate, Inc., a wholly owned subsidiary of the Company, under the terms previously agreed. Adovate was recently formed by William Stilley, co-founder and former CEO of Adial, for the sole purpose of acquiring, funding and advancing Purnovate’s business. The option exercise is effective May 16, 2023.

 

With the notice, Adial received a non-refundable option exercise fee and upfront payment of $450,000, and, after a final acquisition agreement is signed, will receive expense reimbursement of approximately $0.9 million for Purnovate expenditures incurred and paid by Adial after December 1, 2022 through and including May 15, 2023. Any Purnovate expenses incurred on and subsequent to May 16, 2023, will become the responsibility of Adovate. In addition, the Company is entitled to receive up to approximately $11 million in development and approval milestones for each compound (up to $33 million in total development and approval milestones for the first three compounds alone), as well as a total of $50 million in additional commercial milestones, for a total consideration of up to $83 million with potential milestone payments on additional compounds. Additionally, the Company will receive a single digit royalty and receive a 19.9% equity stake in Adovate.

 

Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We believe this is another significant milestone for Adial as it demonstrates our commitment to maximizing the value of our assets, as well as advancing our assets in the most cost-efficient way possible. By executing this agreement with Adovate, we will effectively reduce our cash burn rate, receive upfront non-dilutive capital, and maintain meaningful equity and downstream economics. In addition, this will enable us to focus exclusively on advancing AD04 which remains our top priority through potential regulatory approvals and prioritize our resources accordingly. Given recent positive developments as it relates to AD04, we believe it is an ideal time for us to sell the Purnovate assets and business in order to maximize the value of both AD04 and Purnovate for our shareholders.”

 

Mr. Stilley commented, “I’m proud to support Adial through this partnership and look forward to advancing Purnovate’s drug candidates to meaningful developmental milestones as we build Adovate around Purnovate’s drug development platform. These next-generation compounds have already demonstrated preclinical efficacy and are well-positioned for clinical translation, further validating our belief in their potential to address important unmet medical needs. I believe that by allocating distinct and separate resources to the Purnovate assets, we can accelerate development to important inflection points and maximize the value of these assets for both Adovate and the Adial shareholders. Moving forward my primary focus will be on Adovate and I am departing from my active management role with Adial. I will, however, continue to lend my support, and look forward to ongoing collaboration as both a significant Adial shareholder and member of the board.”

 

Using the Purnovate adenosine drug development platform, Adovate intends to focus on inventing and developing best-in-class adenosine receptor agonists and antagonists. The adenosine receptors have been associated with a broad range of disease classes, including pain, oncology, addiction, pulmonary, inflammation and others. Historically, the majority of adenosine compounds have been limited to a nonclinical setting due in part to inadequate solubility profiles that limit their distribution to the target tissue (bioavailability). The Purnovate technology is designed to address this limitation by delivering substantially improved biodistribution. These next-generation compounds have already demonstrated preclinical efficacy and are being advanced towards clinical studies.

 

The transaction was independently evaluated and unanimously approved, first by the Adial Audit Committee of the Board of Directors, and then by its full Board of Directors, with Mr. Stilley, a current board member, abstaining from the vote.

 

 

 

 

About Adial Pharmaceuticals, Inc.

 

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Companys lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Companys ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Companys proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. The Company’s Purnovate subsidiary has been also developing adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adial.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 Company’s proposed sale of Purnovate to Adovate, LLC (formerly known as Adenomed, LLC), entering into a final acquisition agreement for the transaction pursuant to which the Company will receive $450,000 upon the exercise of the option and then be reimbursed for any Purnovate expenditures incurred and paid after December 1, 2022, the Company receiving up to approximately $11 million in development and approval milestones for each compound and a total of $50 million in additional commercial milestones, for a total consideration of up to $83 million on the first three compounds, receiving potential milestone payments on additional compounds, a single-digit royalty and a 19.9% equity stake in Adovate, maximizing the value of the Company’s assets, advancing the Company’s assets in the most cost-efficient way possible, reducing the Company’s cash burn rate and maintaining meaningful equity and downstream economics, focusing exclusively on advancing AD04 through potential regulatory approvals and prioritizing the Company’s resources accordingly, being an ideal time for the Company to sell the Purnovate assets and business in order to maximize the value of both AD04 and Purnovate for its shareholders, advancing Purnovate’s drug candidates to meaningful developmental milestones as Adovate is built around Purnovate’s drug development platform, the potential of Purnovate’s compounds to address important unmet medical needs, accelerating development to important inflection points by allocating distinct and separate resources to the Purnovate assets, , 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 complete the sale of the assets and business of Purnovate to Adovate as planned and receive up to $83 million in development/commercial milestones and other compensation, our ability to reduce our current burn rate and extend our cash runway, our ability to implement our strategic plan for AD04 and continue discussions with potential pharmaceutical partners, Adovate’s ability to advance Purnovate’s drug candidates to meaningful developmental milestones, our ability to 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, 2022, 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 / Alexandra Schilt
Tel: 212-671-1021
Email: adil@crescendo-ir.com