Full Press Release Details
Adial Pharmaceuticals and BioLab Sciences
Enter into Distribution Agreement
for COVID-19 Antibody Tests
Antibody Testing Available for Landmark
ONWARD Pivotal Phase 3 Trial Participants
BioLab Sciences Grants Adial Exclusive
Rights to Sell and Distribute Rapid Result COVID-19 Antibody Tests to Designated Channel Partners
Charlottesville, VA - June 8,
2020 - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) ("Adial"), a clinical-stage biopharmaceutical company
focused on the development of treatments for addiction, and BioLab Sciences, Inc. ("BioLab"), a regenerative biotechnology
company, which manufactures and sells Rapid Result COVID-19 antibody test kits, announced that they have entered into a Distribution
Agreement (the "Agreement") by which Adial has purchased Rapid Result COVID-19 antibody test kits from BioLab for use
in Adial's landmark ONWARD pivotal Phase 3 clinical trial of its lead drug
candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) and BioLab has granted Adial exclusive rights to sell Rapid Result
COVID-19 antibody test kits to designated channel partners.
The Rapid Result COVID-19 test is a 10-minute,
instant' point-of-care test device for the qualitative detection of lgG and lgM antibodies specific to 2019-nCoV in
human whole blood, serum or plasma specimens. During testing, the specimen reacts with 2019-nCoV antigen coated particles in the
test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.
IgG antibodies develop in most
patients within 7 to 10 days after COVID-19 symptoms begin. IgG antibodies remain in the blood after an infection has passed and
indicate that the patient may have had COVID-19 in the recent past and may have developed protective antibodies.
The IgM antibody is usually the
first antibody produced when the virus attacks. A positive IgM test indicates that you may have been infected with COVID-19 and
that your immune system has started responding to the virus and you may still be infected or recently recovered from COVID-19.
Under the Agreement, Adial secured access
to the Rapid Result COVID-19 antibody test kits manufactured by BioLab for use as an indicator of whether subjects participating
in clinical trials conducted by Adial have developed the antibodies associated with an immune response to the SARS-Cov-2 virus
(i.e., the virus that causes COVID-19). Adial initially purchased 500 Rapid Result COVID-19 antibody tests, which are intended
to be used to test subjects enrolled in Adial's landmark ONWARD pivotal Phase 3 clinical trial. The Agreement also
provides Adial exclusive rights to sell Rapid Result COVID-19 antibody test kits to designated channel partners.
William Stilley, Chief Executive Officer
of Adial Pharmaceuticals, commented, "The safety of our clinical trial subjects is of the utmost importance to Adial. In
addition to advancing our goal to protect the health of our study subjects, securing access to a large quantity of Rapid Result
COVID-19 antibody test kits is expected to allow us to identify people in our studies that potentially have less or greater risk
of a COVID-19 infection so that we may potentially tailor visits and other trial activities to maintain the safest environment
reasonably possible for our participants. Our plan is to offer the test to each subject enrolled in our landmark ONWARD
pivotal Phase 3 clinical trial four times during the trial to enhance both safety and trial retention rates. We believe the impact
on retention rates due to providing this service to our trial participants could be material."
"BioLab Sciences is pleased to partner
with Adial for the distribution of the Rapid Result COVID-19 antibody test kits we manufacture. Our high-quality tests are in high
demand as our country continues to reopen and return to work. We are pleased to see the Rapid Result COVID-19 antibody test kits
being utilized in such an important Phase 3 trial and we look forward to building a large and important distribution relationship
to serve Adial's partners," said Jaime Leija, Co-Founder and Chief Commercialization Officer of BioLab Sciences.
"As part of securing distribution
rights for BioLab's state-of-the-art Rapid Result COVID-19 antibody tests, Adial has also secured exclusive rights for the
Rapid Result COVID-19 antibody test kits for sale to certain partners that have demand for these tests," continued Mr. Stilley.
"While our ONWARD pivotal Phase 3 clinical trial is Adial's primary
focus for these antibody tests, in procuring the tests for our trial, we took the decision to leverage our expertise and sales
capabilities to make these important tests for a safe return to the workplace and for understanding our community's exposure
to the virus more widely available to Adial's channel partners and other qualified purchasers."
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. www.adialpharma.com
About BioLab Sciences, Inc.
BioLab Sciences is a regenerative medicine
company focused on creating new ways to regenerate the body for optimal performance. Headquartered in Scottsdale, Arizona, BioLab
Sciences is expanding the human body's ability to regenerate by developing and manufacturing human cell and tissue therapies
as an alternative to invasive, painful and expensive treatment protocols. Through research and innovation, BioLab Sciences is uncovering
better ways to address orthopedic injuries, wound care, pain management, aesthetic medicine, respiratory ailments, cardiovascular
indications, ophthalmic issues, and more. Learn more at www.biolabsciences.net.
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 maintaining the safest environment reasonably possible for our participants in our ONWARD pivotal Phase
3 clinical trial, offering the test to each subject enrolled in the ONWARD pivotal Phase 3 clinical trial four times during
the trial, the impact on retention rates due to providing this service to our trial participants, 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 enhance both
safety and trial retention rates in our ONWARD pivotal Phase 3 clinical trial, our ability to expand the use of AD04 for
use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed,
to demonstrate safety and efficacy, as well as results that are consistent with prior results, our 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 Annual Report on Form 10-K for the year ended December 31, 2019, 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.
Crescendo Communications, LLC