Enveric Biosciences Signs Non-Binding Term Sheets to Pursue the Exclusive Out-Licensing of New Chemical Entities for Pharmaceutical and Non-Pharmaceutical Applications in Joint Disease
March 19 2024 - 7:00AM
Business Wire
Second biotechnology company to potentially
out-license novel compounds from Enveric’s portfolio of assets with
possible significant milestone payments and royalties
Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”),
a biotechnology company dedicated to the development of novel
neuroplastogenic small-molecule therapeutics for the treatment of
depression, anxiety, and addiction disorders, is pleased to
announce that it has signed two non-binding term sheets with an
undisclosed biotechnology company to pursue the out-licensing of
cannabinoid-COX-2 conjugate compounds for both pharmaceutical and
non-pharmaceutical applications for treatment of joint
diseases.
The term sheets contemplate that, for all human and animal joint
pathology, such as osteoarthritis, rheumatoid arthritis, and other
joint pathology applications, the undisclosed licensee would assume
responsibility for all future product development efforts and in
return would receive exclusive, royalty-bearing global licenses to
develop, market and sublicense the compounds. The compounds are new
chemical entities that include cannabinoids in conjugate form with
COX-2 inhibitors and cannabinoids in conjugate form with selected
steroids.
The pharmaceutical application term sheet provides that Enveric
could be eligible to receive future development and sales milestone
payments that in total could add up to approximately $61 million,
assuming certain conditions are met, including receiving approval
for the investigational new drug (IND) application and completing
Phases I through III testing of the licensed product. Royalty rates
could range from 2.5% up to 10% on future sales, depending on
meeting certain sales criteria.
The non-pharmaceutical application term sheet provides that
Enveric could be eligible to receive future development and sales
milestone payments, which in total could add up to approximately
$21 million and with royalty rates ranging from 0.25% up to 7%,
assuming certain conditions are met, including successful product
development and commercial launch and on meeting certain sales
criteria.
Together, through the out-licensing of the two assets and
meeting various development and sales milestones, Enveric could
potentially receive milestone payments that total up to
approximately $82 million.
“We are pleased to announce that a second biotechnology company
has stepped forward looking to join Enveric in moving some of the
Company’s promising assets forward,” said Joseph Tucker, Ph.D.,
Director and CEO of Enveric. “We look forward to working with our
partner, and we are confident in their leadership and capabilities
to continue the development of these compounds for both
pharmaceutical and non-pharmaceutical applications to advance joint
disease treatment options for patients. Ultimately, we believe the
definitive licensing agreements, once negotiated and finalized,
could represent an excellent potential source of revenue for
Enveric, and continue to demonstrate the value of Enveric’s
extensive portfolio of assets.”
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company
dedicated to the development of novel neuroplastogenic
small-molecule therapeutics for the treatment of depression,
anxiety, and addiction disorders. Leveraging its unique discovery
and development platform, Psybrary™, Enveric has created a robust
intellectual property portfolio of new chemical entities for
specific mental health indications. Enveric’s lead program, EB-003,
is a first-in-class approach to the treatment of
difficult-to-address mental health disorders designed to promote
neuroplasticity without inducing hallucinations in the patient.
Enveric is also developing EB-002, formerly EB-373, a next
generation synthetic prodrug of the active metabolite, psilocin,
being studied as a treatment of psychiatric disorders. Enveric is
headquartered in Naples, FL with offices in Cambridge, MA and
Calgary, AB Canada. For more information, please visit
www.enveric.com.
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, should, would, or
might occur or be achieved. Forward-looking statements may include
historical statements and statements regarding beliefs, plans,
expectations, or intentions regarding the future and are based on
the beliefs of management as well as assumptions made by and
information currently available to management. Actual results could
differ materially from those contemplated by the forward-looking
statements as a result of certain factors, including, but not
limited to, the ability of Enveric to: negotiate and finalize
definitive agreements based on the any of its out-licensing term
sheets, including the two identified herein, and perform pursuant
to the terms thereof; carry out successful clinical programs in
Australia; achieve the value creation contemplated by technical
developments; avoid delays in planned clinical trials; establish
that potential products are efficacious or safe in preclinical or
clinical trials; establish or maintain collaborations for the
development of therapeutic candidates; obtain appropriate or
necessary governmental approvals to market potential products;
obtain future funding for product development and working capital
on commercially reasonable terms; scale-up manufacture of product
candidates; respond to changes in the size and nature of
competitors; hire and retain key executives and scientists; secure
and enforce legal rights related to Enveric’s products, including
patent protection; identify and pursue alternative routes to
capture value from its research and development pipeline assets;
continue as a going concern; and manage its future growth
effectively. The two out-licensing term sheets identified herein
are non-binding and may not result in definitive agreements or
attainment of the licensing fees referenced therein.
A discussion of these and other factors, including risks and
uncertainties with respect to Enveric, is set forth in Enveric’s
filings with the Securities and Exchange Commission, including
Enveric’s Annual Report on Form 10-K and its Quarterly Reports on
Form 10-Q. Enveric disclaims any intention or obligation to revise
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
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Investor Relations Tiberend Strategic Advisors, Inc.
Daniel Kontoh-Boateng (862) 213-1398
dboateng@tiberend.com
Media Relations Tiberend Strategic Advisors, Inc.
Casey McDonald (646) 577-8520 cmcdonald@tiberend.com
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