Current Report Filing (8-k)
October 22 2021 - 9:01AM
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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): October 21, 2021
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, 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:
☐
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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 (§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
7.01 Regulation FD Disclosure.
On
October 21, 2021, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release providing an update regarding certain
advancements and positive pre-clinical data for its adenosine analog development platform being developed by Purnovate, Inc. (“Purnovate”),
a division of the Company.
The
information in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this
Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference
into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.
The
press release attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the
Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking”
rather than historical.
The
Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it
may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports
or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
Item
8.01 – Other Events.
On
October 21, 2021, the Company issued a press release providing an update regarding certain advancements and positive pre-clinical data
for its adenosine analog development platform being developed by Purnovate. The information in the Press Release included the following:
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●
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Positive
Pre-Clinical Data of Purnovate’s PNV-5030 suggest the potential of PNV-5030 as both
a standalone therapy and opioid-combination therapy to achieve meaningful pain reduction.
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Solubility
more than 50 times greater than other known selective adenosine compounds of the same class
has been demonstrated.
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PNV-5030
was tested in a mouse model of somatic nociceptive pain.
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Response
groups of 12 mice were analyzed with a control group receiving vehicle alone (i.e., liquid
dosing solution without any drug) and other groups receiving different doses of morphine
alone, PNV-5030 alone or different doses of morphine and PNV-5030.
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-
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PNV-5030
alone exhibited a significant pain reduction as compared to the control group.
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-
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PNV-5030
also demonstrated a significant effect when administered with 1 mg/kg of morphine as compared
to administering 1 mg/kg of morphine alone.
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-
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When
combined with 1 mg/kg of morphine, PNV-5030 reached a similar level of pain reduction as
the one obtained with 2mg of morphine which could indicate the possibility of lowering the
opioid dose to achieve a similar pain reduction level.
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●
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Purnovate
intends to commence a clinical trial of PNV-5030 in 2022.
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Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
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:
October 22, 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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2
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