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):
January 26, 2021
Adial
Pharmaceuticals, Inc.
(Exact name of registrant as specified in
charter)
Delaware
(State or other jurisdiction of incorporation)
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001-38323
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82-3074668
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(Commission File Number)
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(IRS Employer Identification No.)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbols
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Name of each exchange on which registered
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Common Stock
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ADIL
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NASDAQ
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Warrants
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ADILW
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NASDAQ
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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 1.01. Entry into a Material Definitive
Agreement.
On January 26, 2021, Adial Pharmaceuticals,
Inc. (“Adial”) closed the acquisition (the “Acquisition”) contemplated by that certain Equity Purchase
Agreement, dated December 7, 2020, as amended, (the “Purchase Agreement”), by and among Adial, Purnovate, LLC (“Purnovate”),
each of the members of Purnovate (the “Members”) and Robert D. Thompson, as representative of the Members.
About Purnovate
Purnovate is a drug development company with
a platform focused on developing drug candidates for non-opioid pain reduction and other diseases and disorders potentially targeted
with adenosine analogs that are selective, potent, stable, and soluble. Purines are a class of chemical structures that include
adenosine, an important neurotransmitter. Purnovate uses innovative methods and technologies to enhance the drug properties of
purines (“Purines” + “Innovate” = Purnovate). With its proprietary purification and solubilizing platform
technologies it synthesizes and develops adenosine analogs to treat serious diseases and disorders with a focus on pain, cocaine
addiction, infectious disease, inflammation, cancer, asthma, and diabetes. Purnovate’s platform technologies are believed
to also offer opportunities to improve the characteristics of other classes of molecules outside of the adenosine chemistry space
and maybe even outside the purine chemistry space. All drug candidates developed using Purnovate’s platform technologies
are expected to be patently distinct new chemical entities (i.e., patentable compositions of matter). Purnovate operates a chemistry
and analytics laboratory in its 4,175 square feet leased laboratory and office space. Purnovate has been synthesizing new adenosine
analog chemical entities with promising potency, selectivity, stability, and solubility characteristics.
Dr. Thompson D. Thompson, Purnovate’s
Chief Executive Officer who is continuing employment with Purnovate and joining Adial as its Vice President of Chemistry after
the Acquisition, is a distinguished adenosine chemist that has been working in the field for over 35 years. He is an inventor on
over 20 adenosine analog patents covering tens of thousands of novel molecules and has authored dozens of scientific publications.
Purnovate, was formed in 2019 by Dr. Thompson,
William Stilley, Chief Executive Officer of Adial and a Member, Mikel Poulsen, a Member and consultant to Purnovate, and Cameron
Black, a Member
Material Terms of the Acquisition
In exchange for Purnovate, Adial paid the Members
an aggregate of $350,000 (the “Cash Consideration”) and issued to the Members an aggregate of 700,000 shares of Adial
restricted common stock (the “Stock Consideration”), which issuance will be exempt from registration pursuant to Section
4(a)(2) of the Securities Act of 1933, as amended. In addition, Members will receive (i) development milestone payments in an aggregate
amount of up to $2,100,000 for each compound developed, (ii) development milestone payments in an aggregate amount of up to $20,000,000
for each compound commercialized, and (iii) royalties of 3.0% of Net Sales (as such term is defined in the Purchase Agreement).
The Stock Consideration has been placed into escrow to secure certain indemnification and other obligations of Purnovate and the
Members in connection with the Acquisition.
The acquisition was effected by a merger (the
“Merger”) of Purnovate into Purnovate, Inc., a Delaware corporation and wholly owned subsidiary of Adial, which will
survive the Merger. In connection with the Merger, on January 20, 2021, Purnovate converted from a limited liability company to
a corporation and on January 25, 2021, the parties entered into an Amendment to the Purchase Agreement (the “Amendment”)
to provide for the mechanism of closing the Acquisition through a Merger.
The foregoing description of the Purchase Agreement
does not purport to be complete and is subject to, and are qualified in their entirety by reference to the provisions of such Purchase
Agreement which was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on December 10, 2020 and incorporated herein by reference. The foregoing description of the terms of the Amendment is
qualified in its entirety by reference to the provisions of such Amendment, which is attached hereto as Exhibit 10.2, and incorporated
herein by reference.
The representations, warranties and covenants
contained in the Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the
benefit of the parties to the Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly,
the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the
Purchase Agreement, and not to provide investors with any other factual information regarding Adial, Purnovate or either of their
businesses, and should be read in conjunction with the disclosures in Adial’s periodic reports and other filings with the
Securities and Exchange Commission.
Item 2.01. Completion of Acquisition or
Disposition of Assets.
As disclosed in Item 1.01 of this Current Report
on Form 8-K, on January 26, 2021, Adial completed the Acquisition of Purnovate pursuant to the Purchase Agreement. The information
set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference into this Item 2.01 in its entirety.
Pursuant to the Purchase Agreement, in connection
with the Acquisition Mr. Stilley sold approximately a 28.7% interest in Purnovate for 201,109 shares of Adial common stock and
Mr. Newman, through two entities he controls, together sold an aggregate 0.53% interest in Purnovate for 3,731 shares of Adial
common stock, which shares have been placed in escrow as described in Item 1.01 above.
Item 3.02. Unregistered Sales of Equity
Securities.
The information set forth in Item 1.01
of this Current Report on Form 8-K is incorporated herein by reference into this Item 3.02 in its entirety. The Stock Consideration
was offered and sold to the Members on January 26, 2021 in a transaction exempt from registration under the Securities Act of 1933,
as amended (the “Securities Act”), in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder.
Each of the Members represented that such Member was an “accredited investor,” as defined in Regulation D, and was
acquiring the Stock Consideration for investment only and not with a view towards, or for resale in connection with, the public
sale or distribution thereof. Accordingly, the Stock Consideration has not been registered under the Securities Act and the Stock
Consideration may not be offered or sold in the United States absent registration or an exemption from registration under the Securities
Act and any applicable state securities laws. Neither this Current Report on Form 8-K nor the exhibits attached hereto is an offer
to sell or the solicitation of an offer to buy shares of common stock or any other securities of Adial.
Item 8.01. Other Events.
On January 26, 2021, Adial issued the press release attached hereto
as Exhibit 99.1 announcing the closing of the transactions contemplated by the Purchase Agreement.
Item 9.01. Financial Statements and Exhibits.
The following exhibits are filed with this
Current Report on Form 8-K.
Exhibit
Number
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Description
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10.1
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Equity Purchase Agreement, dated December 7, 2020, by and among Adial Pharmaceuticals, Inc., Purnovate, LLC, the members of Purnovate, LLC and Robert D. Thompson, as member representative (Incorporated by reference to the Form 8-K filed with the Securities and Exchange Commission on December 10, 2020 (File No. 001-38323).
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10.2
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Amendment, dated January 25, 2021, by and among Adial Pharmaceuticals, Inc., Purnovate, Inc., a wholly owned subsidiary of Adial, PNV Conversion Corp. as successor-in interest to Purnovate, LLC, and Robert D. Thompson, as member representative, to the Equity Purchase Agreement, dated December 7, 2020.
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99.1
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Press Release, dated January 26, 2021
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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.
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Dated: February 1, 2021
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ADIAL PHARMACEUTICALS, INC.
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By:
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/s/ William B. Stilley, III
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Name:
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William B. Stilley
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Title:
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President and Chief Executive Officer
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Exhibit
10.2
AMENDMENT
TO EQUITY PURCHASE AGREEMENT
This
AMENDMENT (the “Amendment”) is made and entered into as of the 25th day of January,
2021, to the EQUITY PURCHASE AGREEMENT, dated December 7, 2020 (the “Agreement”), by and among
Adial Pharmaceuticals, Inc., a Delaware corporation (the “Purchaser”), Purnovate, Inc., a Delaware corporation
and wholly owned subsidiary of Purchaser (“Merger Sub”), PNV Conversion Corp., a Virginia corporation,
as successor-in-interest to Purnovate, LLC, a Virginia limited liability company (the “Company”), each
of the members of the Company (collectively, the “Members”) and Robert D. Thompson, as representative
of the Members (the “Members’ Representative”). Capitalized terms used and not defined herein
shall have the meanings ascribed to them in the Agreement.
WHEREAS,
Section 12.3 of the Agreement provides that prior to the Closing the Agreement may be amended by written agreement among the Purchaser,
the Company and the Members’ Representative.
WHEREAS,
the Purchaser and the Company intend the proposed acquisition to be characterized as a Type “A” tax free merger;
NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
1.
Notwithstanding anything to the contrary contained in the Agreement, the parties agree that the sale and transfer of the Purchased
Interests as contemplated by the Agreement, shall be effected by the merger (the “Merger”) of the Company
with and into Merger Sub.
2.
Section 1.1 of the Agreement is hereby deleted in its entirety.
3.
Section 1.2(b) of the Agreement is hereby deleted in its entirety.
4.
The definition of Consideration Percentage is hereby amended to read as follows: “Consideration Percentage”
means the quotient obtained by dividing: (i) the number of membership interests in the Company to be sold to Purchaser by the
Member (as calculated pursuant to Section 1.2(a)) by (ii) the aggregate Purchased Interests; provided,
however, that when the Company is converted to a Virginia corporation prior to the Effective Time, the Consideration Percentage
shall thereafter mean the quotient obtained by dividing: (i) the number of shares of common stock of the Company to be exchanged
in the Merger by the shareholder by (ii) the aggregate Purchased Interests.
5.
The Agreement is hereby amended by the inclusion therein of the following ARTICLE 1(A). MERGER.
ARTICLE
1(A) THE MERGER
Section
1.1 The Merger. Upon the terms and subject to the conditions set forth in this Agreement, at the Effective Time,
Merger Sub shall be merged with and into the Company, and the separate existence of the Company shall cease. The Merger Sub will
continue as the surviving corporation in the Merger (the “Surviving Corporation”).
Section
1.2 Effects of the Merger. The Merger shall have the effects set forth in this Agreement, the Certificate of Merger
and in the applicable provisions of Delaware and Virginia law. As a result of the Merger, the Company will become a wholly owned
subsidiary of Purchaser.
Section
1.3 Closing; Effective Time. At the Closing, the Parties shall cause the Merger to be consummated by executing and
filing with the Secretaries of State of the States of Delaware and Virginia a certificate of merger with respect to the Merger,
satisfying the applicable requirements of Delaware and Virginia law and in a form reasonably acceptable to Purchaser and the Company
(the “Certificate of Merger”). The Merger shall become effective at the time of the filing of such Certificate
of Merger or at such later time as may be specified in such Certificate of Merger with the consent of Purchaser and the Company
(the time the Merger becomes effective is referred to herein as the “Effective Time”).
Section
1.4 (A) Certificate of Incorporation and Bylaws; Directors and Officers. At the
Effective
Time:
(a)
the certificate of incorporation and bylaws of the Surviving Corporation shall be identical to the certificate of incorporation
and bylaws of Merger Sub as in effect immediately prior to the Effective Time, until thereafter amended as provided by the Delaware
General Corporation Law (“DGCL”) and such certificate of incorporation and bylaws;
(b)
the directors and officers of the Surviving Corporation, each to hold office in accordance with the certificate of incorporation
and bylaws of the Surviving Corporation, shall be designated by Purchaser.
Section
1.5 (A) Conversion of Shares.
(a)
At the Effective Time, by virtue of the Merger and without any further action on the part of Purchaser, Merger Sub, the Company,
any Member or Purchaser, for each share (or shares) of the Company’s common stock outstanding immediately prior to the Effective
Time, such share(s) (Purchased Interest) shall be automatically converted into and exchanged for solely the right to receive,
in accordance with Section 1.2 above and subject to the escrow contemplated thereby: (i) an amount of Closing Cash equal to the
quotient obtained by dividing (A) $350,000 by (B) the total number of Purchased Interests; and (ii) a number of Closing Shares
(rounded down to the nearest whole share of Purchaser Common Stock) equal to the quotient obtained by dividing (A) the total number
of Closing Shares to be issued by the Purchaser by (B) the total number of Purchased Interests.
(b)
No fractional shares of Purchaser Common Stock shall be issued in connection with the Merger, and no certificates or scrip for
any such fractional shares shall be issued. Any holder of Purchased Interests who would otherwise be entitled to receive a fraction
of a share of Purchaser Common Stock (after aggregating all fractional shares of Purchaser Common Stock issuable to such holder)
shall, in lieu of such fraction of a share be paid in cash the dollar amount (rounded to the nearest whole cent) without interest,
based on the fair market value of the Purchaser Common Stock (as determined in good faith by Purchaser), so that no more than
the whole number of shares represented by the Closing Shares shall be issued.
Section
1.6 (A) Company Member Approval. The Company hereby represents and warrants the Company’s directors and shareholders
have each duly approved the terms and conditions of the Merger, as herein contemplated by the Amendment.
Section
1.7 (A) Purchaser Approval. Purchaser hereby represents and warrants that the board of directors of Purchaser and
Merger Sub, and that the Purchaser, in its capacity as the sole shareholder of Merger Sub, have each duly approved the terms and
conditions of the Merger, as herein contemplated by the Amendment.
6.
A new paragraph (f) shall be added to Section 5.8 of the Agreement as follows:
5.8
(f)
The Purchaser, the Company, and the Members will use best efforts to have the Merger meet the requirements of a tax-free merger
and consolidation as outlined in Section 368(a)(1)(A) of the Internal Revenue Code.
7.
All other terms of the Agreement shall remain in full force and effect. The Agreement, as amended by this Amendment, constitutes
the entire agreement between the parties with respect to the subject matter thereof.
8.
This Amendment may be executed in two or more identical counterparts, all of which shall be
considered
one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other
party; provided that a facsimile signature shall be considered due execution and shall be binding upon the signatory thereto with
the same force and effect as if the signature were an original, not a facsimile signature.
[Signature
Page Follows]
IN
WITNESS WHEREOF, the parties have executed this Amendment to the Agreement as of the date first written above.
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ADIAL
PHARMACEUTICALS, INC.
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By:
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/s/
Joseph Truluck
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Name:
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Joseph
Truluck
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Title:
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Chief
Financial Officer
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PURNOVATE,
INC.
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By:
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/s/
Joseph Truluck
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Name:
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Joseph
Truluck
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Title:
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Treasurer
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THE
COMPANY:
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PNV
CONVERSION CORP.
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By:
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/s/
Robert D. Thompson
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Name:
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Robert
D. Thompson
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Title:
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President
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MEMBERS’
REPRESENTATIVE:
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By:
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/s/
Robert D. Thompson
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Name:
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Robert
D. Thompson
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Title:
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Members’
Representative
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Exhibit
99.1
Adial
Pharmaceuticals Closes Acquisition of Purnovate
Acquisition
Expands Adial’s Portfolio with Drug Candidates
for
Treatment of Pain and Addiction
Charlottesville,
VA – January 26, 2021 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”),
a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, has closed the acquisition
of Purnovate, LLC (“Purnovate”), a pharmaceutical development company focused on developing novel, drug candidates
for non-opioid pain reduction, as well as the treatment of addiction and other diseases through targeted use of adenosine analogs.
Adenosine,
one of the most powerful molecules that is naturally occurring in almost all cells in the body, is a signaling molecule that triggers
numerous physiological responses. Adenosine analogs are chemical compounds with similar elemental composition to adenosine. Purnovate
has extensively studied adenosine analogs as potential therapies for non-opioid pain reduction and the treatment of cocaine addiction.
Purnovate has also explored the application of adenosine analogs and other chemical compounds referred to as purines, which are
found throughout the body, including in DNA and RNA, to address other disease states.
Commenting
on the closing of the transaction, William Stilley, CEO of Adial, stated, “The acquisition of Purnovate is transformative
for Adial in terms of expansion and diversification of our addiction-related pipeline. Our lead product, AD04, is currently being
administered to patients in the landmark ONWARD™ Phase 3 pivotal trial, which is nearly 50% enrolled, as a genetically targeted
therapeutic agent for the treatment of Alcohol Use Disorder (AUD), and we are planning to test AD04 in Phase 2 clinical trials
for Opioid Use Disorder and other addictive disorders. Adial’s review of specific and proprietary adenosine analog compounds
developed by Purnovate as non-opioid alternatives for the treatment of pain, as well as cocaine addiction, appear promising and
the addition of Purnovate’s fully operational laboratory and chemicals library, as well as its intellectual property, substantially
increase the value of assets owned and controlled by Adial.”
“We
are also pleased to announce that in connection with the acquisition, Purnovate’s CEO, Robert D. Thompson, will join Adial’s
team as its Vice President, Chemistry,” continued Mr. Stilley. “Dr. Thompson is a world-renowned adenosine chemist
and the inventor of more than 20 adenosine analog patents covering tens of thousands of novel molecules and he has authored dozens
of scientific publications. Dr. Thompson and his team bring additional expertise to Adial in chemistry, analytics and manufacturing,
which we expect will be accretive to our expansion of Adial’s drug pipeline, both on the ’supply side of addiction’
through the introduction of novel therapeutics for non-opioid pain management, a multi-billion-dollar market, as well as the treatment
of cocaine addiction and potentially other forms of addiction. We also expect that the acquisition of Purnovate and the addition
of Dr. Thompson to our team will advance our planned formulation of a once-a-day, extended-release AD04 tablet for the treatment
of AUD.”
“Purnovate
was founded with the goal of developing drug candidates that can unlock the potential scientists have been confident existed,
if only they could be made available to the appropriate tissue with the required potency and selectivity,” commented Dr.
Thompson. “We have made substantial progress towards this goal by designing selective adenosine analogs as an attractive
pathway to the treatment of pain without the use of opioids. Adial provides an ideal platform for drug development based on these
pathways given its core focus as the ‘medicines for addiction’ company.”
“The
acquisition of Purnovate and Dr. Thompson joining our management team are important steps in the advancement of Adial’s mission
to build the world’s leading, addiction-focused pharmaceutical company and to drive value for our shareholders,” concluded
Mr. Stilley. “We remain steadfast in this mission and we are committed to our goals of bringing AD04 to market upon successful
completion of the ONWARDÔ trial and to develop and commercialize additional novel treatments for pain and addiction.”
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
About
Purnovate, Inc.
Purnovate,
Inc., a wholly owned subsidiary of Adial Pharamceuticals, 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. 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 plans to test AD04 in Phase 2 clinical trials for Opioid Use Disorder and other addictive disorders,
Dr. Thompson and his team’s additional expertise in chemistry, analytics and manufacturing being accretive to the expansion
of Adial’s drug pipeline, advancing our planned formulation of a once-a-day, extended-release AD04 tablet for the treatment
of AUD,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,
the contribution of Dr. Thompson and his team ’s expertise in chemistry, analytics and manufacturing to the expansion of
Adial’s drug pipeline, the ability Purnovate’s platform to provide Adial a non-opioid program for treating pain using
novel and patentable compounds our ability to prepare for commercial manufacturing, as well as develop new formulations of AD04,
our ability to enroll patients 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 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:
adil@crescendo-ir.com
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