MindBio to develop the novel psilocin prodrug
for neuropsychiatric indications utilizing microdosing to reduce or
eliminate hallucinogenic impact of psychedelic compounds
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, today announced that
it has signed a non-binding term sheet to out-license a class of
Novel Psilocin Prodrugs (“NPP”) to Vancouver, BC-based MindBio
Therapeutics (CNSX: MBIO)(“MindBio”), a clinical stage biopharma
company, which is pioneering novel treatments for psychiatric
conditions using microdoses of psychedelic medicines.
Enveric’s NPP molecules are designed to be metabolized
specifically to release therapeutic levels of systemic psilocin at
varying rates. Enveric has generated a library of NPP compounds
protected by an issued US patent, and further claimed in two
pending US patent applications and three international Patent
Corporation Treaty (PCT) patent applications. The library of NPP
compounds includes molecules with varying properties such as
enhanced gastrointestinal (GI) stability, increased absorption
properties, and variable cleavable substitutions producing altered
pharmacokinetic properties.
Pursuant to the terms of the non-binding term sheet, MindBio
will seek to advance a drug candidate from the NPP class for
neuropsychiatric indications such as depression. The term sheet
states that upon entering into a definitive agreement, MindBio
would receive an exclusive, global license to the formulations,
drugs, method of use, and devices developed to utilize the compound
from Enveric and would assume responsibility for all future
preclinical, clinical, and commercial development on a
royalty-bearing basis for all human and animal pharmaceutical
applications.
If a definitive agreement is entered into and certain conditions
are met, MindBio would pay Enveric development and sales milestones
up to an aggregate $66.5 Million and royalties (ranging from 2.5%
up to 10%) on all future sales. The license would include the right
to sublicense and cash buyout options.
“We look forward to working with MindBio’s team, which is
pioneering an important part of the exciting psychedelic space,
focused on controlling dose to reduce or eliminate hallucinations
associated with these powerful compounds,” said Joseph Tucker,
Ph.D., Director and CEO of Enveric. “This non-binding term sheet
highlights the potential synergies between the Enveric and MindBio
approaches to leveraging psychedelic-based compounds to target
specific signaling pathways in the brain for the treatment of
neuropsychiatric conditions.”
“We are pleased to explore an opportunity to draw on the
molecular discovery engine at Enveric and believe this novel and
patented asset significantly strengthens our intellectual property
pipeline and aligns with our strategy to develop innovative,
protected compounds with fine-tuned formulation and dosing
strategies,” said Chief Executive Officer of MindBio, Justin Hanka.
“We look forward to the prospect of progressing this asset into
clinical trials as we seek to bring important and beneficial
therapies to patients in need.”
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.
About MindBio Therapeutics
MindBio Therapeutics (CNSX: MBIO) is a leading biotech/biopharma
company focused on creating novel and emerging treatments for
mental health conditions and is conducting world first take-home
Microdosing (MB22001) human clinical trials. MB22001 is MindBio’s
lead candidate drug, a proprietary titratable form of Lysergic Acid
Diethylamide (LSD) designed for take-home microdosing. MindBio is a
leader in microdosing of psychedelic medicines and is advancing its
drug and technology protocols through clinical trials. MindBio has
developed a multi-disciplinary platform for developing treatments
and is involved in psychedelic medicine development and digital
therapeutics, has completed Phase 1 clinical trials in 80 healthy
participants and has completed a Phase 2A clinical trial in
patients with Major Depressive Disorder, both trials with positive
top line data reported. Currently underway are two Phase 2B trials,
one in cancer patients experiencing existential distress and
another in patients with Major Depressive Disorder. The Company is
also approved for multiple Phase 2A/Phase 2B trials in women’s
health. MindBio invests in research that forms the basis for
developing novel and clinically proven treatments including digital
technologies and interventions to treat debilitating health
conditions such as depression, anxiety and other related mental
health conditions.
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 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 sheet
identified herein is non-binding and may not result in a definitive
agreement or attainment of the licensing fees or royalties
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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version on businesswire.com: https://www.businesswire.com/news/home/20240514809396/en/
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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