Enveric Biosciences Announces Signing of Non-Binding Term Sheet with Undisclosed Licensee for Exclusive License to Patented Methods of Treating Breast and Other Cancers Using Cannabinoids
May 08 2024 - 7:00AM
Business Wire
Biotechnology licensee expected to progress
methods targeting breast and other cancers using cannabinoids in
combination with chemotherapeutic drugs
Enveric Biosciences, Inc (NASDAQ: ENVB), a biotechnology company
dedicated to the development of novel neuroplastogenic
small-molecule therapeutics for the treatment of depression,
anxiety, and addiction disorders, today announced that it has
signed a non-binding term sheet with an undisclosed biotechnology
development and commercialization company (“Licensee”) to
exclusively out-license two patent families of Methods for Treating
Breast Cancer and Other Cancers for development through additional
discovery and preclinical stages using cannabinoids in combination
with chemotherapeutic drugs to treat cancer.
In an historic move on Tuesday April 30, 2024, the Biden
administration moved to reschedule marijuana, one source of
cannabinoids, as a Schedule III controlled substance. The action
followed study by the U.S. Department of Health and Human Services
(“HHS”), recommendations by both HHS and the Department of Justice
(“DOJ”), and support from the U.S. Drug Enforcement Agency (“DEA”)
that acknowledge the medical benefits of this class of drugs.
Enveric applauds the move by the Biden administration which enjoys
bi-partisan Congressional support and advances the development of
medical uses of much needed drugs.
Under the terms of the agreement with Enveric, the Licensee will
receive an exclusive, global license to the methods, and devices
and drugs developed to practice the methods, which feature using
cannabinoids in combination with chemotherapeutic drugs and will
assume responsibility for all future preclinical and clinical
development on a royalty-bearing basis for all human and animal
pharmaceutical applications.
Assuming certain conditions are met, the Licensee will pay
Enveric a License Execution Fee and development and sales
milestones up to $61 Million, and royalties (ranging from 2.5% up
to 10%) on all future sales. The Licensee also has a cash Buyout
Option.
Based on preliminary work performed by a renowned UK-based
research hospital, it is believed that the methods of using novel
treatment regimens that include cannabinoids combinations have
potentially a significant impact for patients living with breast
and other cancers. It is anticipated that the Licensee may advance
these methods into the next stages of development, and further into
clinical trials which would demonstrate a major value driver for
both Enveric and the Licensee.
“We are excited to see the Licensee taking this innovative
approach in effort to advance a novel treatment based on our
discovery,” said Joseph Tucker, Ph.D., Director and CEO of Enveric.
“We look forward to partnering with the Licensee and are confident
in their leadership to translate these discoveries into promising
treatments for cancer patients. Importantly, this agreement further
supports Enveric’s discovery capabilities and its ability to
advance novel treatments for cancer and to make them available for
others to pursue commercially outside the company with strong
future potential upside to Enveric.”
Breast Cancer alone has approximately 311,000 new cases
diagnosed annually in the US, and over 4 million women have a
history of, or are in treatment, for breast cancer in the US. The
licensed methods also apply to many other forms of cancer that
afflict millions more patients in the US.
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 out-licensing term sheets 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 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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