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
it has completed the $5,000,002 private placement of 1,666,668
shares of common stock at a price of $3.00 per share (the “Shares”)
on August 4, 2021. The private placement was led by Bespoke Growth
Partners, Inc., which invested $2,500,000, and is a company
controlled by Mark Peikin, Adial’s Chief Strategy Officer, and also
included Richard Gilliam, founder of Cumberland Resources, and
Keystone Capital Partners LLC, all of whom were previous investors
in the Company. No warrants were issued in this financing, and
Brookline Capital Markets, a division of Arcadia Securities, LLC,
acted as an advisor on the transaction.
As previously disclosed, the Company received
$500,002 upon the parties’ execution of their respective Securities
Purchase Agreements and has now received the balance of $4,500,000
following the U.S. Securities and Exchange Commission declaring the
registration statement on Form S-3, registering the resale of the
private placement shares, effective on July 29, 2021.
In combination with the private placement
previously announced on June 3, 2021, this transaction marks the
completion of a set of financings totaling $7.1 million.
William Stilley, Adial’s Chief Executive
Officer, commented, “We are pleased to close this last piece of our
$7.1 million in private placements, and we appreciate the support
of the participating investors. We believe this latest financing
illustrates the tremendous confidence and support of our existing
shareholders, as well as our conviction in the positive outlook for
the business. This funding is anticipated to provide us more than
sufficient capital to complete the ONWARD™ Phase 3 trial of AD04 as
a genetically targeted treatment for Alcohol Use Disorder through
data read-out. Additionally, it is expected to allow us to achieve
key milestones for our pre-clinical adenosine program for
non-opiate pain relief.”
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, serotonin-3 receptor
antagonist, therapeutic agent for the treatment of Alcohol Use
Disorder (AUD) and is currently being investigated in the Company’s
landmark ONWARD™ pivotal Phase 3 clinical trial 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. The
Company is also developing adenosine analogs for the treatment of
pain and other disorders. Additional information is available at
www.adialpharma.com.
About the Landmark ONWARD™ Pivotal Phase
3 Clinical Trial
The ONWARD trial is a 24-week, multicenter,
randomized, double-blind, placebo-controlled, parallel group, Phase
3 clinical study to evaluate the efficacy, safety and tolerability
of AD04 in patients with Alcohol Use Disorder (AUD) and selected
polymorphisms in the serotonin transporter and receptor genes.
Patients are genetically screened prior to enrollment in the ONWARD
trial so that only genetically positive patients are enrolled. The
primary endpoint for analysis of efficacy is the change from
baseline in the monthly number of heavy drinking days during the
last 8 weeks of the 24-week treatment period. ONWARD is currently
being conducted in 25 clinical sites in seven countries in
Scandinavia and Central and Eastern Europe (Sweden, Finland,
Poland, Latvia, Estonia, Bulgaria and Croatia). The principal
investigator is Professor Hannu E.R. Alho, Emeritus Professor of
Addiction Medicine at the University of Helsinki.
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 financing illustrating the tremendous confidence and
support of our existing shareholders, as well as our conviction in
the positive outlook for the business, the funding providing us
more than sufficient capital to complete the ONWARD™ Phase 3 trial
of AD04 as a genetically targeted treatment for Alcohol Use
Disorder through data read-out, this funding allowing us to achieve
key milestones for our pre-clinical adenosine program for
non-opiate pain relief 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 maintain the confidence and
support of our existing shareholders, as well as our
conviction in the positive outlook for the business, our ability to
complete the ONWARD™ Phase 3 trial of AD04 as a genetically
targeted treatment for Alcohol Use Disorder through data read-out
as planned, our ability to achieve key milestones for our
pre-clinical adenosine program for non-opiate pain relief, our
ability to enroll patients within the timelines anticipated 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 its product candidates in the
marketplace and the successful development, marketing or sale of
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 its 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, 2020, 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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