Revealed seven classes of promising novel drug
candidates discovered using Enveric’s Psybrary™ and PsyAI™ drug
discovery and artificial intelligence (AI) platforms
Launched business development campaign that
resulted in the execution of seven non-binding term sheets with
four strategic partners that upon entering into definitive
agreements and performing pursuant to the terms thereof could
potentially total up to approximately $410 Million in milestone
payments, plus future royalties
Leading non-hallucinogenic neuroplastogen drug
candidate, EB-003, continues to advance toward IND filing and
subsequent Phase 1 clinical trial
Proceeds raised from the exercise of warrants,
preferred investment options, and inducement warrants total $4.5
million
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 first
quarter of 2024 ended March 31, 2024.
“We believe the first quarter of 2024 was a highly productive
period for Enveric as the Company continued to advance development
of the lead neuroplastogen drug candidate, EB-003, in preparation
for an Investigational New Drug (IND) application and the expected
initiation of a planned clinical development program,” said Joseph
Tucker, Ph.D., Director and CEO of Enveric. “We continue to receive
significant interest from strategic partners in the pharmaceutical
industry for new drug candidates that target depression and anxiety
disorders. We believe there is a need for new therapeutics that
could potentially provide the anxiolytic and antidepressant
properties clinically reported in the literature for certain
psychedelic compounds without, at the same time, inducing the
hallmark hallucinatory effects that defines such agents.”
Tucker continued, “Enveric anticipates that eliminating the
hallucinogenic activity could allow for more convenient outpatient
dosing and result in more predictable and durable treatment benefit
to patients. EB-003 was designed specifically to address this major
safety profile deficiency in the first-generation psychedelic
approach to treating neuropsychiatric illness, and we are excited
to advance its development.”
Tucker added, “In addition to progress with EB-003, we believe
the first quarter confirmed the value produced by Enveric’s drug
discovery engine with the unveiling of more than one thousand
proprietary drug candidates generated to date, around which the
Company has built a substantial intellectual property estate.
Through the first quarter and moving into the second quarter of
2024, we have received interest from potential strategic
out-licensing partners in these molecules by executing seven
distinct non-binding terms sheets with four separate biotechnology
companies. The new business relationships, if finalized in
definitive agreements, offer a potential source of non-dilutive
revenue through the Company meeting certain development and sales
milestones, which could support Enveric’s ability to advance its
lead asset, EB-003, and further build shareholder value.”
FIRST QUARTER AND RECENT UPDATES
Corporate, Product and Business Development
Highlights:
- Unveiled library of drug candidates, protected by Enveric’s
intellectual property portfolio, that spans seven distinct molecule
classes
- Launched targeted business development campaign to unlock value
from Enveric’s library of drug candidates through potential
out-licensing
- Executed seven non-binding out-license term sheets distributed
among four strategic partners. The drug candidates to be
potentially out-licensed are derived from both psychedelic and
cannabinoid structures, and target cancer, joint disease, and
neuropsychiatric indications
- The seven term sheets, if converted into definitive agreements
and the Company performs pursuant to the terms thereof, could
represent an aggregate in milestone payments that could total up to
approximately $410 Million, plus future royalties
- Further advanced Enveric’s lead preclinical asset, EB-003, in
support of upcoming IND submission and subsequent initiation of a
Phase 1 clinical trial
FOURTH QUARTER AND FISCAL YEAR ENDED 2023 FINANCIAL
RESULTS
Net loss attributable to stockholders was $2.46 million for the
first quarter ended March 31, 2024, including $0.42 million in net
non-cash expense, with a basic and diluted loss per share of $0.61,
as compared to a net loss of $4.80 million, including $.46 million
in net non-cash expense, with a basic and diluted loss per share of
$2.31 for the quarter ended March 31, 2023. The Company had
cash-on-hand of $6.36 million for the quarter ended March 31,
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,” “proposed,” “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
any of its 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.
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/20240514374351/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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