Current Report Filing (8-k)
November 03 2020 - 9:55AM
Edgar (US Regulatory)
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 3, 2020
Adial
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in charter)
Delaware
(State
or other jurisdiction of incorporation)
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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☐
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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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☐
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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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☐
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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:
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
7.01. Regulation FD Disclosure.
On
November 3, 2020, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release (the “Press Release”)
providing an update regarding its landmark ONWARD™ Phase 3 pivotal trial (the “Trial”) investigating the Company’s
lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target
genotypes related to the serotonin transporter and receptor genes.
A
copy of the Press Release is attached as Exhibit 99.1 to this Report on Form 8-K. The information contained in the Press Release
is being furnished to the Securities and Exchange Commission (the “Commission”) and shall not be deemed incorporated
by reference into any of the Company’s registration statements or other filings with the Commission.
Item
8.01. Other Events.
On
November 3, 2020, the Company issued the Press Release providing the following highlighted updates on the Trial:
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All
25 planned investigative sites are active.
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40%
of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.
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The
enrollment rate has increased for four consecutive months and the Trial is projected to be fully enrolled during Q2 2021.
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Data
readout is expected in Q4 2021 or earlier.
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AD04
has been well tolerated with no serious adverse events having been reported.
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Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
The
following exhibit is furnished with this Current Report on Form 8-K:
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, 2020
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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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2
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