ATLANTA, July 29, 2020 /PRNewswire/ -- AMERI
Holdings, Inc. (NASDAQ: AMRH) ("Ameri"), announced that its
proposed amalgamation partner Jay Pharma Inc. ("Jay Pharma" or "the
Company") has announced the addition of new senior staff as the
Company prepares to file two new investigational new drug (IND)
applications for the treatment of radiodermatitis and glioblastoma
multiforme (GBM).
Dr. Robert Wilkins is joining Jay
Pharma as Chief Medical Officer. He will begin in the role
immediately.
"Jay Pharma is seeking to bring oncology drugs to the market
through FDA approval," said Dave
Johnson, Jay Pharma's CEO-elect. "With Dr. Wilkins, we are
bringing in the skillset necessary to enhance our organization and
allow us to navigate the IND process with confidence."
Over the course of a 30-year career, Wilkins has held leadership
positions in medical affairs, product development, marketing,
commercialization, and business development at leading
pharmaceutical companies, such as Abbott, Baxter, and Battelle. Since 2001, Wilkins has
consulted with multiple innovators in the medical and
pharmaceutical space, such as valve replacement system Endovalve
and glucose monitoring equipment GlucoLight.
"Jay Pharma is poised to enter an exciting new stage of growth,
and I am delighted to be a part of it," Wilkins said.
Johnson described Wilkins as an "excellent steward" to advance
the Company's plans for filing two INDs: a combination therapy drug
for the treatment of GBM, and a topical radiodermatitis
treatment.
"We recently announced Investigational Review Board (IRB)
approval for a GBM study at the Rabin Institute in Israel, and we plan to commence a study for
radiodermatitis in the U.S.," Johnson said. "Bob will be crucial to
advancing both of these initiatives."
In addition to Dr. Wilkins, Jay Pharma is pleased to announce
the signing of Dr. Steven Weisman
and Innovative Science Solutions (ISS) Regulatory Services. Steve
and the ISS team have decades of experience developing regulatory
strategies, product development, preclinical and clinical testing
programs, regulatory submissions, and product defense/communication
strategies for drugs, foods, cosmetics, and dietary supplements.
Weisman also has specialty knowledge in analyzing the scientific
and regulatory aspects of potential new products and the
development of responses to FDA rule-makings.
"Steve will be an important voice in the preparation of our
INDs, and our quality systems," said Wilkins. "We will work
closely to ensure Jay Pharma is properly structured to work with
the FDA and other regulatory agencies around the world."
The IND program, administered by the U.S. Food and Drug
Administration (FDA), is the process through which a Company
receives authorization to conduct human clinical trials in the U.S.
According to Johnson, the Company plans to enter clinical trials
for both its radiodermatitis and GBM formulations upon receipt of
FDA clearance.
The radiodermatitis topical formulation has been designed to
utilize the Company's proprietary cannabidiol (CBD) formula with
the cannabinoid Cannabigerol (CBG) and other ingredients to help
alleviate the discomfort caused by radiodermatitis, a skin
condition that is a consequence of radiation therapy. It is one of
the most common side effects experienced by cancer patients. The
topical product is intended to be both preventative and to treat
existing radiodermatitis.
A rare and aggressive form of brain cancer, glioblastoma
multiforme (GBM) is notoriously resistant to currently available
cancer treatments. Phase I/II human clinical trials in Israel will administer the Company's
proprietary synthetic CBD formula to 40 enrollees: half of whom
will be treated with the CBD formula, and the other half will be
treated with the formula in combination with clomiphene, an
estrogen binding site inhibitor.
"Our goal is to advance novel treatments that will improve the
lives of cancer patients around the world," Johnson said. "With the
additions of Dr. Wilkins and Dr. Weisman to the Jay Pharma team, we
believe that we have the right individuals to help lead us into
this next phase of the Company."
ABOUT JAY PHARMA:
Jay Pharma is dedicated to
developing innovative, evidence-based medicines and combination
therapies to address unmet needs in cancer care. Our mission is to
improve the lives of patients suffering from cancer, initially by
developing products for people dealing with the side effects of
cancer and cancer treatments, and longer term by advancing a
pipeline of novel combination therapies as an adjunct to standard
of care cancer treatments.
ABOUT AMERI100:
Ameri is a specialized SAP® cloud,
digital and enterprise solutions company that provides SAP®
services to customers worldwide. Headquartered in Suwanee, Georgia, Ameri has offices in the
U.S. and Canada. The Company also
has global delivery centers in India. With its bespoke engagement model,
Ameri delivers transformational value to its clients across
industry verticals. For further information, visit
www.ameri100.com
On January 10, 2020, Ameri entered
into an Amalgamation Agreement (the "Merger Agreement") with Jay
Pharma, Jay Pharma Merger Sub, Inc., a company organized under the
laws of Canada and a wholly-owned
subsidiary of Ameri ("Merger Sub"), 1236567
B.C. Unlimited Liability Company, a company organized under
the laws of British Columbia and a
wholly-owned subsidiary of Ameri ("ExchangeCo"), and Barry Kostiner, as the Ameri representative,
pursuant to which, among other matters, and subject to the
satisfaction or waiver of the conditions set forth in the
Amalgamation Agreement, including, but not limited to, the approval
of the proposed transaction by the shareholders of each of Ameri
and Jay Pharma, Merger Sub and Jay Pharma will be amalgamated and
will continue as one corporation, which shall become a direct
wholly-owned subsidiary of ExchangeCo and an indirect wholly-owned
subsidiary of Ameri (the "Amalgamation"). In connection with the
Amalgamation, Ameri intends to sell substantially all of its
current assets, change its name to Jay Pharma and Jay Pharma's
business is intended to become the sole business of the combined
company following this transaction.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transactions, Ameri has filed
with the SEC a registration statement on Form S-4 that includes a
preliminary joint proxy statement of Ameri and Jay Pharma that also
constitutes a prospectus of Ameri and the definitive joint proxy
statement statement/prospectus will be mailed to shareholders of
Ameri and Jay Pharma. Ameri and Jay Pharma also plan to file other
relevant documents with the SEC regarding the proposed transaction.
AMERI URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS
CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT AMERI, THE PROPOSED
TRANSACTIONS AND RELATED MATTERS. Investors and shareholders will
be able to obtain free copies of the proxy statement, prospectus
and other documents filed by the Company with the SEC (when they
become available) through the website maintained by the SEC at
www.sec.gov. In addition, investors and shareholders will be able
to obtain free copies of the proxy statement, prospectus and other
documents filed by Ameri with the SEC by contacting Investor
Relations by mail at 4080 McGinnis Ferry Road, Suite 1306,
Alpharetta, Georgia. Stockholders
are urged to read the proxy statement, prospectus and the other
relevant materials when they become available before making any
voting or investment decision with respect to the proposed
transactions.
Participants in the Solicitation
Ameri and Jay Pharma, as well as each of their respective
directors and executive officers and certain of their other members
of management and employees, may be deemed to be participants in
the solicitation of proxies in connection with the proposed
transactions. Additional information regarding these persons and
their interests in the transaction will be included in the
definitive joint proxy statement/prospectus and other relevant
documents filed with the SEC if and when they become available.
Investors should read the definitive joint proxy
statement/prospectus carefully when it becomes available before
making any voting or investment decisions. These documents can be
obtained free of charge from the sources indicated above.
No Offer or Solicitation
This press release does not constitute a solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed transaction. This press release also
does not constitute an offer to sell or the solicitation of an
offer to buy any securities, nor will there be any sale of
securities in any states or jurisdictions in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended.
Forward-Looking Statements
This press release contains forward-looking statements and
forward-looking information within the meaning of applicable
securities laws. These statements relate to future events or future
performance. All statements other than statements of historical
fact may be forward-looking statements or information. Generally,
forward-looking statements and information may be identified by the
use of forward-looking terminology such as "plans", " expects" or
"does not expect", "proposed", "is expected", "budgets",
"scheduled", "estimates", "forecasts", "intends", "anticipates" or
"does not anticipate", or "believes", or variations of such words
and phrases, or by the use of words or phrases which state that
certain actions, events or results may, could, would, or might
occur or be achieved. More particularly and without limitation,
this news release contains forward-looking statements and
information concerning the Amalgamation. Forward-looking statements
consist of statements that are not purely historical, including any
statements regarding beliefs, plans, expectations or intentions
regarding the future. Readers are cautioned not to place undue
reliance on forward-looking statements, as there can be no
assurance that the Amalgamation will be consummated or that the
parties other plans, intentions or expectations upon which they are
based will occur. By their nature, forward-looking statements
involve numerous assumptions, known and unknown risks and
uncertainties, both general and specific that contribute to the
possibility that the predictions, estimates, forecasts, projections
and other forward-looking statements will not occur.
The forward-looking statements contained in this press release
are made as of the date of this press release. Except as required
by law, Ameri disclaims any intention and assumes no obligation to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Additionally, Ameri undertakes no obligation to comment on the
expectations of, or statements made by, third parties in respect of
the matters discussed above.
Corporate Contact:
Barry
Kostiner, Chief Financial Officer
IR@ameri100.com
Ameri Holdings Investor Relations Contact:
Sanjay M. Hurry
LHA Investor Relations
(212) 838-3777
IR@ameri100.com
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