Adial Pharmaceuticals, Inc. (NASDAQ: ADIL)
(“Adial” or the “Company”), a clinical-stage biopharmaceutical
company focused on developing therapies for the treatment and
prevention of addiction and related disorders, today provided a
business update and reported its financial results for the first
quarter of 2024.
Cary Claiborne, President and Chief Executive
Officer of Adial, stated, “We are making steady progress as it
relates to AD04. We have initiated new activities related to our
clinical development plan after incorporating favorable feedback
received from the FDA last year. We anticipate conducting two
parallel Phase 3 clinical trials of AD04 to support potential
approval in the shortest timeframe possible while minimizing risk.
To support our efforts, we formally hired Tony Goodman as our Chief
Operating Officer during the quarter. Given his impressive
background as an accomplished pharmaceutical industry executive, as
well as serving on our Board of Directors since 2017, he has played
a key role in advancing our strategic growth initiatives, including
clinical development and commercial planning for AD04, while also
furthering partnership discussions.”
“In addition, we are committed to developing a
robust patent estate around AD04 and have been awarded key patents
from the United States Patent and Trademark Office in 2024. First,
we were awarded patent number 11,905,562, which further protects
AD04 and covers its unique ability to target the serotonin
transporter gene for the potential treatment of opioid use disorder
(OUD). More recently, we were issued patent number 11,957,664,
which covers important aspects of the combination of our
proprietary genetic diagnostic and AD04 to treat alcohol use
disorder (AUD), OUD, and other drug dependencies. These patents are
important given our post hoc analysis identified genotypes that
positively responded to AD04, which represents an addressable
market of approximately $40 billion in the U.S. alone.
Additionally, these patents enable us to expand our focus on AUD in
the future, including advancing AD04 for the potential treatment of
OUD.”
“Overall, we believe we are well positioned to
execute on meaningful milestones ahead, while having preserved a
strong balance sheet. We look forward to updating our shareholders
as developments unfold,” concluded Mr. Claiborne.
Other Developments
Publications
On April 10, 2024, Adial announced the
publication of a peer-reviewed article highlighting the promising
clinical results, strong safety profile and high compliance among
patients administered AD04 (low-dose ondansetron), the Company’s
lead investigational new drug product being developed for the
treatment of Alcohol Use Disorder (AUD). The publication also
reported the results of a new study analyzing the liver safety
profile of AD04 compared with placebo in subjects with AUD in the
Company’s prior Phase 3 clinical trial.
The published study provides a comprehensive
analysis of the liver safety profile of AD04 compared to a placebo
in individuals with AUD and a specific 5-marker genetic profile.
AUD, characterized by compulsive alcohol consumption and loss of
control over intake, poses significant health risks and is a major
contributor to alcohol-associated liver disease (ALD), a leading
cause of liver transplantation and global mortality.
The manuscript entitled, “Safety and compliance
of long-term low-dose ondansetron in alcohol use disorder
treatment,” was published in the European Journal of Internal
Medicine. The publication is available via Open Access
at: https://www.ejinme.com/article/S0953-6205(24)00123-7/fulltext
Warrants
On March 1, 2024 Adial announced entering into a
definitive agreement for the immediate exercise of certain
outstanding warrants to purchase up to an aggregate of 1,150,000
shares of common stock of the Company originally issued in October
2023, having an exercise price of $2.82 per share and eighteen
months term. The gross proceeds to the Company from the
exercise of the warrants were approximately $4.3 million, prior to
deducting placement agent fees and estimated offering expenses.
First
Quarter 2024 Financial Results
- Cash and cash equivalents were $5.0
million as of March 31, 2024, compared to $2.8 million as of
December 31, 2023. During the quarter, the Company received total
gross proceeds of approximately $4.3 million from recent warrant
exercises. Including the proceeds from warrant exercises, the
Company believes that its existing cash and cash equivalents will
allow it to accelerate the development of AD04 and fund its
operating expenses into the first quarter of 2025.
- Research and development expenses
increased by approximately $88 thousand in the three months ended
March 31, 2024, compared to the three months ended March 31, 2023.
This change was due to increases in activities related to drug
development planning, chemistry, and manufacturing expenses, and
for R&D directed personnel salaries. These increases were
partially offset by the decreased expense of regulatory consultants
and direct clinical trial expenses. These changes were the result
of the completion of data analysis and other follow-up activity
associated with our recent ONWARD trial and the ramp up of planning
for the next steps in the development of our drug candidate,
AD04.
- General and administrative expenses
decreased by approximately $512 thousand in the three months ended
March 31, 2024, compared to the three months ended March 31, 2023.
The three months ended March 31, 2024, saw substantial decreases in
expense in several areas, including the salaries of G&A
directed personnel and cash director compensation, corporate legal
expenses, direct patent expenses, and travel expenses.
- Net Loss was $6.5 million for the
three months ended March 31, 2024, compared to a net loss of $2.9
million for the three months ended March 31, 2023. This increase
was more than accounted for by a one-time, non-cash charge of $4.5
million recognized on issuance of new warrants to induce the
exercise of existing warrants by the holder on March 1, 2024.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage
biopharmaceutical company focused on the development of therapies
for the treatment and prevention of addiction and related
disorders. 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)
in heavy drinking patients and was recently investigated in the
Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential
treatment of AUD in subjects with certain target genotypes
identified using the Company’s proprietary companion diagnostic
genetic test. ONWARD showed promising results in reducing heavy
drinking in heavy drinking patients, and no overt safety or
tolerability concerns. AD04 is also believed to have the potential
to treat other addictive disorders such as Opioid Use Disorder,
gambling, and obesity. Additional information is available at
www.adial.com.
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 initiating
new activities related to the Company’s clinical development plan,
conducting two parallel Phase 3 clinical trials of AD04 to support
potential approval in the shortest timeframe possible while
minimizing risk, advancing strategic growth initiatives including
clinical development and commercial planning for AD04 while also
furthering partnership discussions, developing a robust patent
estate around AD04, the Company’s patents enabling it to expand its
focus on AUD in the future including advancing AD04 for the
potential treatment of OUD, being well positioned to execute on
meaningful milestones ahead, updating shareholders as developments
unfold, existing cash and cash equivalents allowing the Company to
accelerate the development of AD04 and fund its operating expenses
into the first quarter of 2025 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 pursue our
regulatory strategy, our ability to advance ongoing partnering
discussions, our ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, our ability to develop strategic
partnership opportunities and maintain collaborations, our ability
to obtain or maintain the capital or grants necessary to fund our
research and development activities, our ability to complete
clinical trials on time and achieve desired results and benefits as
expected, regulatory limitations relating to our ability to promote
or commercialize our product candidates for specific indications,
acceptance of our product candidates in the marketplace and the
successful development, marketing or sale of our products, our
ability to maintain our license agreements, the continued
maintenance and growth of our patent estate 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, 2023,
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, LLCDavid Waldman / Alexandra SchiltTel:
212-671-1020Email: ADIL@crescendo-ir.com
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