Adial Pharmaceuticals, Inc. (NASDAQ:ADIL;ADILW), a
clinical-stage biopharmaceutical company focused on the development
of medicines for addiction, today announced the pricing of an
underwritten public offering of 2,475,000 shares of its common
stock and warrants to purchase up to 1,856,250 shares of the
Company's common stock. Each share of common stock is being
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.
Gross proceeds, before underwriting discounts and commissions and
estimated offering expenses, are expected to be approximately $8.0
million.
The warrants will be immediately exercisable at
a price of $4.0625 per share of common stock and will expire five
years from the date of issuance. The shares of common stock
and the accompanying warrants can only be purchased together in the
offering but will be issued separately and will be immediately
separable upon issuance. The offering is expected to close on
or about February 25, 2019, subject to customary closing
conditions.
Maxim Group LLC is acting as the book-running
manager and Joseph Gunnar & Co. is acting as a co-manager in
connection with the offering.
Adial also has granted to the underwriter a
45-day option to purchase up to an additional 371,250 shares of
common stock and/or warrants to purchase up to 278,437 shares of
common stock, at the public offering price less discounts and
commissions.
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 will be filed with the SEC and will be available on
the SEC's website at http://www.sec.gov. Electronic copies of
the prospectus relating to this offering, when available, 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
proposed 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, and the belief that AD04 has the
potential 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, whether the
proposed offering is completed, the satisfaction of customary
closing conditions related to the proposed offering, 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 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, 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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