Prioritized EB-003 as lead development
candidate. EB-003 is a novel, non-hallucinogenic neuroplastogenic
molecule designed to treat severe mental health disorders
Announced preclinical results confirming oral
bioavailability and significant brain exposure of EB-003,
supporting expedited development strategy
Expanded business development activities to
maximize assets developed using AI-backed drug discovery engine,
with multiple deals in advanced stages offering potential to
contribute value to stockholders
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 provided a
corporate update and reported financial results for the second
quarter ended June 30, 2024.
“The second quarter of 2024 was marked by the prioritization of
EB-003 as our lead development candidate. This strategic decision
was made based on the potential for EB-003 to be a first-in-class
neuroplastogenic molecule that can address multiple,
difficult-to-treat mental health disorders without inducing the
hallucinogenic effect common to N,N-Dimethyltryptamine (DMT) and
related analogs,” said Joseph Tucker, Ph.D., Director and CEO of
Enveric. “We believe EB-003’s differentiated properties set it
apart from other drugs in this class and address many of the
challenges facing psychedelic-derived drugs, including the ability
to conduct truly blinded placebo-controlled clinical trials and the
potential to administer the therapy in an outpatient setting
without psychotherapy support. Adding to the excitement with
EB-003, recently completed pre-clinical research indicated the
potential for the drug candidate to be delivered via oral
administration and penetrate the brain at levels expected to elicit
the desired therapeutic effect.”
Dr. Tucker continued, “Given the value potential of EB-003, we
are accelerating its evaluation in several in vivo animal efficacy
models to determine the optimal therapeutic indication for clinical
development and expected dose range as we prepare for a
pre-Investigational New Drug (“IND”) meeting with the U.S. Food and
Drug Administration in early 2025. This timeline should then allow
for the filing of an IND application by the third quarter of 2025
and initiation of a first-in-human clinical trial of EB-003 by the
end of 2025.”
Dr. Tucker concluded, “Complementing our EB-003 development
efforts, during the second quarter we expanded our initiative to
secure out-licensing opportunities involving proprietary drug
candidates identified through Enveric’s drug discovery engine and
other compounds owned by the company. We were pleased to enter into
a licensing agreement with Aries Science & Technology for our
patented radiation dermatitis topical product and enter into a
number of non-binding term sheets, which collectively have the
potential to generate non-dilutive revenue, which could support
Enveric’s ability to advance its lead asset, EB-003, and further
build stockholder value.”
SECOND QUARTER AND RECENT UPDATES
Corporate, Product and Business Development
Highlights:
- Signed non-binding term sheets to pursue the exclusive
out-licensing of new chemical entities for pharmaceutical and
non-pharmaceutical applications in joint disease
- Signed non-binding term sheet with undisclosed licensee for the
exclusive license to patented methods of treating breast and other
cancers using cannabinoids
- Provided strategic outlook and pipeline update, elevating
EB-003 to lead development candidate
- Confirmed oral bioavailability and significant brain exposure
preclinical studies of EB-003, supporting expedited development
with IND filing and first patient dosed expected in 2025
- Announced patent granted for drug candidate
- Signed licensing agreement with Aries Science & Technology
with plans to clinically develop and market Enveric’s patented
product for radiation dermatitis
SECOND QUARTER FINANCIAL RESULTS
Net loss attributable to stockholders was $1.7 million for the
second quarter ended June 30, 2024, including $0.4 million in net
non-cash expense, with a basic and diluted loss per share of $0.23,
as compared to a net loss of $6.40 million, including $1.6 million
in net non-cash expense, with a basic and diluted loss per share of
$3.04 for the quarter ended June 30, 2023. The Company had
cash-on-hand of $3.5 million for the quarter ended June 30,
2024.
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,” “proposes,” “budgets,” “explores,” “schedules,”
“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
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 and 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/20240812797182/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
Enveric Biosciences (NASDAQ:ENVB)
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