Proceeds from Offering Expected to Fully Fund Initial
Phase 3 Trial of AD04
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL;ADILW), a
clinical-stage biopharmaceutical company focused on the development
of medicines for addiction, announces the closing of its previously
announced underwritten public offering of 2,845,000 shares of its
common stock and warrants to purchase up to 2,133,750 shares of the
Company's common stock, which included 370,000 shares of common
stock and warrants to purchase up to 277,500 shares of common stock
issued upon the partial exercise of the underwriters’ option to
purchase additional securities to cover over-allotments. Each share
of common stock was sold together with a warrant to purchase 0.75
of one share of common stock at a combined price to the public of
$3.25.The warrants are immediately exercisable at a price of
$4.0625 per share of common stock (subject to adjustment) and will
expire five years from the date of issuance Gross proceeds, before
underwriting discounts and commissions and estimated offering
expenses, are expected to be approximately $9.2 million. With the
proceeds from this offering, the Company intends to fully fund the
initial Phase 3 trial of AD04 for the treatment of alcohol use
disorder.
Maxim Group LLC acted as the book-running
manager and Joseph Gunnar & Co. acted as a co-manager in
connection with the offering.
The offering is being conducted pursuant to the
Company's registration statement on Form S-1 (File No. 333-229615)
previously filed with and subsequently declared effective by the
Securities and Exchange Commission ("SEC"). A prospectus relating
to the offering was filed with the SEC and is available on the
SEC's website at http://www.sec.gov. Electronic copies of the
prospectus relating to this offering also may be obtained from
Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY
10174, at (212) 895-3745. Before investing in this offering,
interested parties should read in their entirety the prospectus and
the other documents that Adial Pharmaceuticals, Inc. has filed with
the SEC that are incorporated by reference in such prospectus,
which provide more information about Adial Pharmaceuticals, Inc.
and such offering.
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy these securities,
nor shall there be any sale of these securities in any state or
other jurisdiction in which such offer, solicitation or sale would
be unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction.
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). 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). The Company plans to commence a Phase 3 clinical
trial using AD04 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. AD04 is
also believed to have the potential to treat other addictive
disorders such as opioid use disorder, gambling, and obesity.
About Alcohol Use Disorder
According to an article in the widely respected
publication, The Lancet, alcohol use is the number one cause of
death globally among both men and women ages 15 to 49 years. In the
United States alone, it is estimated that approximately 35 million
people have AUD resulting in significant health, social and
financial costs (NIAAA Alcohol Facts & Statistics). AUD
contributes to over 200 different diseases, and 10% of children
live with a person that has an alcohol problem. According to the
American Society of Clinical Oncologists, 5-6% of new cancers and
cancer deaths globally are directly attributable to alcohol. The
Centers for Disease Control (CDC) has reported that AUD costs the
U.S. economy about $250 billion annually, with heavy drinking
accounting for greater than 75% of the social and health related
costs. In addition, according to the Journal of the American
Medical Association (“JAMA”), the problem in the United States
appears to be growing with an approximately 50% increase in AUD
prevalence between 2002 and 2013.
Despite the high prevalence and high costs,
according to an article in the JAMA 2015 publication, only 7.7% of
patients (i.e., approximately 2.7 million people) with AUD are
estimated to have been treated in any way and only 3.6% by a
physician (i.e., approximately 1.3 million people). The most common
treatments for AUD are directed at achieving abstinence, and
typical treatments include psychological and social interventions.
Most therapies require abstinence even prior to initiating therapy.
Abstinence requires dramatic lifestyle changes often with serious
work and social consequences. Significant side effects of current
pharmacologic therapies include mental side effects such as
psychiatric disorders and depressive symptoms and physical side
effects such as nausea, dizziness, vomiting, abdominal pain,
arthritis and joint fitness. These problems with the currently
available therapies appear to limit the willingness of people with
AUD to seek treatment and then to limit compliance with treatment
requirements and, therefore, the ultimate results for many people
attempting currently available therapies.
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. These statements are based upon current beliefs,
expectations and assumptions and include statements regarding the
public offering, the plans to commence a Phase 3 clinical trial
using AD04 for the potential treatment of AUD in subjects with
certain target genotypes, the belief that AD04 has the potential to
treat other addictive disorders such as opioid use disorder,
gambling, and obesity and the expectation that the funds from the
financing will fully fund the initial Phase 3 trial of AD04 for the
treatment of alcohol use disorder. Any forward-looking statements
included herein reflect our current views, and they involve certain
risks and uncertainties, including, among others, the ability of a
serotonin-3 receptor antagonist AD04 to modulate the physiology and
neuro-transmitters involved in opioid addiction; the ability of
AD04 to provide a potential treatment option for OUD patients; our
ability to commence the Phase 3 clinical trials in the first half
of 2019, the ability of AD04 therapy to perform as designed, to
demonstrate safety and efficacy, as well as results that are
consistent with prior results, the contribution of our SAB in
advancing our Phase 3 clinical trial of AD04, the ability to enroll
patients and complete the clinical trials on time and achieve
desired results and benefits, the sufficiency of the proceeds from
this offering to support our operations and fund our current and
future clinical trials, and if needed, our ability to obtain
additional funding on favorable terms, 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 registration statement on Form S-1 that we have
filed with the SEC and the final prospectus and our Current Report
on Form 10-K for the year ended December 31, 2018. 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 WaldmanTel:
212-671-1021Email: dwaldman@crescendo-ir.com
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