Agreement includes development and sales
milestones payments potentially totaling up to $62 million as well
as tiered single digit royalties on future sales
Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the
“Company”), a biotechnology company dedicated to the development of
novel neuroplastogen small-molecule therapeutics for the treatment
of depression, anxiety, and addiction disorders, today announced
that the Company has executed a licensing agreement with MycoMedica
Life Sciences, out-licensing the Company’s EVM201 program,
including drug candidate EB-002.
Pursuant to the terms of licensing agreement, MycoMedica will
seek to develop EB-002, formerly EB-373, a synthetic prodrug of the
active metabolite psilocin, in treatment of neuropsychiatric
disorders such as depression. MycoMedica will receive an exclusive,
global license to the formulations, drugs, method of use, and
medical devices developed by Enveric to utilize the compound.
MycoMedica would assume responsibility for all future preclinical,
clinical, and commercial development on a royalty-bearing basis for
all human and animal pharmaceutical applications. As part of the
license agreement, if certain conditions are met, Enveric is
eligible to receive upfront, development, and sales milestones
potentially totaling up to $62 million, plus tiered single digit
royalties on all future sales. The license grants sublicensing
rights and cash buyout options to MycoMedica.
Enveric has established a strong foundation of intellectual
property supporting the value potential for the EVM201 program,
including EB-002, with numerous patents issued in the U.S. and
applied for internationally.
“Given Enveric’s strategic decision to prioritize EB-003, our
novel, non-hallucinogenic neuroplastogen drug candidate, we have
entered into a definitive license agreement with MycoMedica to
out-license EB-002 with modest upfront payments that allow the
EB-002 technology to move forward, followed by potentially
transformational milestone and royalty payments. Doing so enables
Enveric to fully allocate its operations and development resources
to the advancement of EB-003, while creating excellent potential
for realization of longer-term revenue from EB-002,” said Joseph
Tucker, Ph.D., CEO of Enveric.
“We are excited to enter into this licensing agreement with
Enveric and continue the development of EB-002 as we seek to
advance new treatment options for patients with neuropsychiatric
disorders,” said Sanjay Dubé M.D., MycoMedica’s Chief Executive
Officer and Chief Medical Officer.
Enveric’s efforts are now focused on the development of EB-003,
the Company’s novel, potentially first-in-class, neuroplastogen,
with the intention to file an Investigational New Drug application
in 2025.
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 molecule,
EB-003, is a potential first-in-class neuroplastogen designed to
promote neuroplasticity, without inducing hallucinations, in
patients suffering from difficult-to-address mental health
disorders. Enveric is focused on advancing EB-003 towards clinical
trials for the treatment of neuropsychiatric disorders while
out-licensing all other novel, patented Psybrary™ drug candidates
to third-party licensees advancing non-competitive market
strategies for patient care. Enveric is headquartered in Naples, FL
with offices in Cambridge, MA and Calgary, AB Canada. For more
information, please visit www.enveric.com.
About MycoMedica Life Sciences, PBC
MycoMedica Life Sciences is a clinical-stage biotech company
with a mission to provide better treatment solutions for patients
with neuropsychiatric disorders. Its clinical trials are designed
to evaluate the safety of low doses of psilocybin, utilizing a
novel dosing paradigm to optimize pharmacology while maximizing
access and reducing the burden for patients and providers.
MycoMedica’s first candidate is for the treatment of pre-menstrual
dysphoric disorder (PMDD).
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,” “budgets,” “explores,” “scheduled,”
“seeks,” “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 any of its out-licensing term sheets
and for licensees to perform pursuant to the terms thereof; carry
out successful clinical programs; 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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20241112278673/en/
Investor Relations Tiberend Strategic Advisors, Inc.
David Irish (231) 632-0002 dirish@tiberend.com
Media Relations Tiberend Strategic Advisors, Inc. Casey
McDonald (646) 577-8520 cmcdonald@tiberend.com
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