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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): January 17, 2024
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) |
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
January 17, 2024, Adial Pharmaceuticals, Inc. (the “Company”) entered into a Statement of Work #2 (“SOW#2”) to
its Master Services Agreement, dated March 15, 2023 (the “Services Agreement”), with The Keswick Group, LLC, of which Tony
Goodman, a director of the Company, is the founder and principal, pursuant to which Mr. Goodman has agreed to serve in the capacity as
Chief Operating Officer of the Corporation at a compensation of $25,000 per month and devote no less than 75% of his business time to
performing this role. The foregoing description of SOW#2 and the Services Agreement does not purport to be complete and is subject to,
and is qualified in its entirety by, reference to the provisions of such SOW#2 and Services Agreement which are attached hereto as Exhibits
10.1 and 10.2 and incorporated herein by reference.
Item
7.01 Regulation FD Disclosure
On
January 18, 2024, the Company issued a press release announcing the appointment of Mr. Goodman as Chief Operating Officer of the Corporation.
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.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit No. |
|
Description |
10.1 |
|
Master Services Agreement between Adial Pharmaceuticals, Inc. and The Keswick Group, LLC, dated March 15, 2023 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K as filed by the Registrant with the Securities and Exchange Commission on March 21, 2023 (File No. 001-38323) |
| 10.2 |
|
Statement of Work #2, dated January 17, 2024, to Master Services Agreement between Adial Pharmaceuticals, Inc. and The Keswick Group, LLC, dated March 15, 2023 |
| 99.1 |
|
Press Release issued by Adial Pharmaceuticals, Inc. |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
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:
January 18, 2024 |
ADIAL
PHARMACEUTICALS, INC. |
| |
|
| |
By: |
/s/
Cary J. Claiborne |
| |
Name: |
Cary
J. Claiborne |
| |
Title: |
President
and Chief Executive Officer |
*
* *
2
Exhibit 10.2
Attachment “A”
Statement of Work #2
This Statement of Work #2 dated January 17, 2024
(this “SOW#2”) and all services performed hereunder shall be governed by and incorporated by reference into the terms and
conditions of that certain Master Services Agreement and SOW#1 dated March 15, 2023 (collectively, the “Agreement”) between
Adial Pharmaceuticals, Inc. (“Company”) and The Keswick Group, LLC (“Contractor”). For the sake of clarity, the
terms and conditions of SOW#1 remain binding unless expressly amended in this SOW#2, and are included in the use of the defined term “Agreement”
herein. Capitalized words not defined in this SOW#2 shall have the meanings defined in the Agreement.
Project Contacts:
| For Company: |
For Contractor: |
| Adial Pharmaceuticals, Inc. |
The Keswick Group, LLC |
| 1180 Seminole Trail, Suite 495 |
1358 Queenscroft |
| Charlottesville, VA 22901 |
Keswick, VA 22947 |
| Attn: Cary Claiborne |
Attn: Tony Goodman |
| Tel: 410-370-8139 |
Tel: 804-201-7962 |
| Email: cclaiborne@adialpharma.com |
Email: tony@thekeswickgroupllc.com |
Scope of Work:
| 1. | Tony Goodman is hereby appointed as Chief Operating Officer
(“COO”) of the Company, an executive officer position. |
| 2. | The primary objectives of the COO position will be the following: |
| a. | Support and advise Company’s CEO in decision making,
setting and driving organizational vision, operations strategy, and hiring of key personnel to achieve organizational and AD04 development
objectives. |
| b. | Working with Company’s head of R&D, create and
oversee the implementation of the Clinical Development Plan: |
| i. | Plan required studies to meet the regulatory requirements
for submission and approval of AD04 in the US. |
| 2. | Finalize the CRO/partner selection for completion of the
Phase 1 clinical pharmacology program. |
| 3. | Finalize CRO selection for Phase 3 clinical program. |
| 4. | Develop and implement the (Genetic Test) PGx clinical plan
along with selection of the PGx vendors. |
| c. | Create a capital plan, FP&A function/capability to allow
for budgets, monthly invoice schedules for everything related to operations and clinical development/R&D. |
| d. | In conjunction with the CFO, determine cash needs by month
for the next two years with rollups by quarter tied to underlying development plans and milestones for AD04. |
| e. | Translate overall plan into defined workstreams, with assigned
accountability, and performance measures tied to clear, business value generating KPI’s. |
| f. | Oversee company operations and employee productivity, building
a highly inclusive culture that ensures team members can thrive and that organizational goals are met. |
| g. | Ensure effective recruiting, onboarding, professional development,
performance management, and retention. |
| h. | Ensure compliance with national and local business regulations
and take appropriate action when necessary. |
| 3. | The primary responsibilities of the COO position will be
the following: |
| a. | Analyze internal operations and identify change areas for
efficiency tied to development goals of AD04. |
| b. | Implement business strategies and plans that align with the short- and long-term objectives developed
in tandem with CEO. |
| c. | Oversee operations, business development, intellectual property, facilities and HR, and partner with CEO
to align functions with Adial’s corporate objectives and overall plan targets both near term, intermediate and longer term. |
| d. | Manage capital investments in infrastructure and expenses aggressively to ensure that the company achieves
defined development goals. |
| e. | Establish effective decision-making processes that will enable the organization to achieve its long- and
short-term goals and objectives. |
| 4. | The parties agree the foregoing will be in addition to the
“Scope of Work” provided for in SOW#1. |
Term:
1. The parties agree that the Term of SOW#1 remained
in effect beyond the estimated date of December 15, 2023, and will be replaced upon Contractor’s signature of this SOW#2 with the
Term provided for in this SOW#2. This SOW#2 shall become effective on the date Contractor signs it.
2. Notwithstanding Section 1 of the Agreement
which provides that the terms of the Agreement shall govern any conflict between the Agreement and a SOW, with regard to the Term of this
SOW#2, the parties agree that either party may terminate the Agreement at any time for any or no reason upon the expiration of not less
than one hundred twenty (120) days following written notice by Company or Contractor, subject to Section 8 of the Agreement.
Compensation:
1. Contractor to receive an all-in flat monthly
rate of Twenty-Five Thousand Dollars ($25,000), payable twice each month in accordance with Company’s regular payment schedule,
in exchange for Contractor devoting no less than seventy-five percent (75%) of his business time to performing the role of COO. The parties
agree the foregoing will replace the Compensation provided for in SOW#1.
2. Subject to Adial Board of Directors approval,
upon the full execution of a material partner agreement with Company on or before December 31, 2024 through Contractor’s efforts,
Company will grant Contractor no less than Four Thousand (4,000) restricted shares of Adial common stock. For the sake of illustration
only, such partner agreement may include a partnership, collaboration, co-development, license, strategic alliance, consolidation, merger,
or acquisition.
Acceptance: This SOW#2 is made pursuant
to the Agreement. Upon execution by both parties, this SOW#2 is incorporated by reference in to and is made a part of said Agreement,
and is subject to the terms and conditions of said Agreement.
| AGREED TO AND ACCEPTED: |
|
|
| |
|
|
|
|
| Adial Pharmaceuticals, Inc. (“Company”) |
|
The Keswick Group, LLC (“Contractor”) |
| |
|
|
|
|
| By: |
/s/ Cary Claiborne |
|
By: |
/s/ Tony Goodman |
| Name: |
Cary Claiborne |
|
Name: |
Tony Goodman |
| Title: |
CEO |
|
Title: |
Founder, Principal Consultant |
| Date: |
January 17, 2024 |
|
Date: |
January 17, 2024 |
| |
/s/ Tony Goodman (Tony Goodman, Individual) |
Page 2 of 2
Exhibit 99.1
Adial Announces Appointment of Tony Goodman
as Chief Operating Officer
Highly Experienced Pharma Commercial and
Business Development Executive in Addiction Treatment Space Joins Leadership Team While Continuing as Board Member
Charlottesville, VA, – Jan. xx, 2024
– 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 the appointment
of Tony Goodman as Chief Operating Officer.
A highly accomplished pharmaceutical industry
executive and member of Adial’s Board of Directors since 2017, Mr. Goodman will oversee the Company’s strategic growth initiatives,
including clinical development and commercial planning for AD04, as well as business development initiatives focused on partnership opportunities
in the area of addiction treatment. He will continue to serve on Adial’s Board.
Cary J. Claiborne, Adial’s Chief Executive
Officer, stated, “We welcome Tony to the senior management team at this pivotal time for the Company. He brings senior leadership
and business development experience from his past work with several pharmaceutical companies, including Indivior, where he and I worked
closely together. The addition of Tony to the Adial team enables us to more fully benefit from his extensive experience and successful
track record within the biopharmaceutical industry, especially within the addiction space, as we approach the next phase in our advancement
of the AD04 clinical program and begin preparations for potential commercialization for the treatment of alcohol use disorder (“AUD”).
We look forward to Tony executing in his new role as we move toward completion of our partnering activities and advance the AUD program
into the next stage of clinical development.”
Mr. Goodman commented, “After supporting
Cary and Adial with strategic partnering initiatives following the ONWARD™ trial, I strongly believe in the value that AD04 can
bring to patients struggling with AUD. AD04 is a unique asset, and our post hoc analyses bring new hope that the next trials will prove
the clinical relevance of AD04 in treating AUD. I look forward to leading the efforts to bring this much needed treatment to patients.”
Mr. Goodman’s career spans more than 23
years in the pharmaceutical and biotech industries. He is the founder and Managing Director of The Keswick Group LLC, a strategic commercial
and business development advisory firm. From October 2014 until February 2017, he served as the Chief Business Development Officer of
Indivior PLC (INDV, FTSE 500) and a member of the executive team that brought it public as a de-merger from Reckitt Benckiser Inc., the
parent company of Reckitt Benckiser Pharmaceuticals (“RBP”). Mr. Goodman held many leadership positions at RBP and Indivior
from 2006 until 2017 that included Global Director, Commercial Development and Strategic Planning; Global Head, Category Development;
Director of US Business Development; and Director of US Commercial Managed Care. During his time at RBP, revenue grew to more than $1
billion annually in the addiction market. He has also served as the Director of Strategic Marketing and Business Development at PRA International.
Mr. Goodman graduated from Marshall University with a degree in Business Administration and is currently a Full Board Executive with the
National Association of Corporate Directors (“NACD”).
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on the development of 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 AUD in heavy drinking patients and was recently investigated in the Company’s 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 Company’s 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. 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 addition of Mr. Goodman enabling the Company to more fully benefit from his
extensive experience and successful track record within the biopharmaceutical industry as the Company approaches the next phase in its
advancement of the AD04 clinical program and begins preparations for potential commercialization for the treatment of AUD, the Company
moving toward completion of its partnering activities and advancing the AUD program into the next stage of clinical development, the value
that AD04 can bring to patients struggling with AUD, the next trials proving the clinical relevance of AD04 in treating AUD, bringing
this much needed treatment to patients 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 pursue our partnering activities and regulatory strategy, our ability to maintain our Nasdaq listing,
our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates
or to comply with ongoing regulatory requirements, our ability to develop strategic
partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research
and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical
trials on time and achieve desired results and benefits as expected, 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 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: 212-671-1020
Email: ADIL@crescendo-ir.com
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Grafico Azioni Adial Pharmaceuticals (NASDAQ:ADIL)
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Da Ott 2024 a Nov 2024
Grafico Azioni Adial Pharmaceuticals (NASDAQ:ADIL)
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