Advanced pre-IND activities and research for
lead candidate, EB-003, a novel neuroplastogenic molecule designed
to treat severe mental health disorders
Announced the expansion of patent protection
for a broad range of molecules in its EVM301 portfolio, including
five previously unannounced US patents
Out-licensed patented radiation dermatitis
topical product to Aries Science & Technology
Out-licensed EVM201 Program including EB-002
Candidate to MycoMedica Life Sciences
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 third
quarter ended September 30, 2024.
“The third quarter of 2024 was highlighted by important progress
in the development of EB-003, our neuroplastogenic molecule that is
designed to address 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. “Among the key
achievements, data confirmed that EB-003 has the potential to be
delivered via oral administration and penetrate the brain at levels
expected to elicit the desired therapeutic effect. Additionally,
preclinical safety and pharmacology studies confirmed that EB-003
targets desired serotonergic receptors while minimizing potentially
harmful, off-target interactions common to serotonin-like drug
compounds. These are clear differentiators for EB-003, which we
believe will add to its value potential.”
Dr. Tucker added: “Since the June FDA Advisory Committee hearing
that raised numerous questions around the potential to approve MDMA
for post-traumatic stress disorder, Enveric helped lead the
discussion for how neuroplastogens with no or limited
hallucinogenic effects might safely progress through clinical
trials and gain approval for these patients in need while avoiding
the challenges and complexities inherent to running trials with
hallucination-inducing compounds. We chose to focus Enveric’s
AI-backed drug development platform on reducing and removing
hallucinations for our various candidates to mitigate these
challenges during clinical development and to reduce barriers to
wide adoption by physicians post approval.”
Dr. Tucker continued: “In our opinion, drug technologies that
minimize or eliminate the hallucinogenic effect in molecules
targeting the 5-HT2A receptor have the potential to become the gold
standard in one or more neuropsychiatric indications, given the
advantages such compounds would offer, 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. Recognizing this, we are working to
finalize the data package for the EB-003 Investigational New Drug
(IND) application, which we anticipate submitting to the U.S. Food
and Drug Administration in the second half of 2025.”
Dr. Tucker concluded: “In parallel with our EB-003 development
efforts, Enveric continues to seek to identify opportunities to
secure out-licensing agreements for our other proprietary drug
candidates. On this front, we were pleased to enter into separate
licensing agreements with Aries Science & Technology and
MycoMedica Life Sciences, and we anticipate announcing additional
agreements over the coming months. These agreements not only
validate the Company’s platform but also generate non-dilutive
revenue to support the development of EB-003 and further building
stockholder value.”
THIRD QUARTER AND RECENT UPDATES
Corporate, Product and Business Development
Highlights:
- Confirmed oral bioavailability and significant brain exposure
in preclinical studies of EB-003, supporting expedited development
with IND filing and first patient dosed expected in 2025
- Announced positive results from preclinical safety and
pharmacology studies of EB-003, confirming the drug’s selective
activity with desired serotonergic neuroreceptors and ability to
minimize potential adverse cardiovascular and CNS events
- Presented foundational research involving EB-003 at the 7th
Neuropsychiatric Drug Summit and the European Behavioral
Pharmacology Society Biennial Workshop
- Strengthened intellectual property estate for EVM301 portfolio
and announced the issuance of five additional U.S. patents
- Executed licensing agreement with Aries Science &
Technology to clinically develop and market Enveric’s patented
product for radiation dermatitis
- Executed licensing agreement with MycoMedica Life Sciences to
clinically develop and market Enveric’s EB-002 drug candidate
THIRD QUARTER FINANCIAL RESULTS
Net loss attributable to stockholders was $2.1 million for the
third quarter ended September 30, 2024, including $0.5 million in
net non-cash expense, with a basic and diluted loss per share of
$0.24, as compared to a net loss of $2.8 million, including $0.2
million in net non-cash income, with a basic and diluted loss per
share of $1.30 for the quarter ended September 30, 2023. The
Company had cash-on-hand of $3.1 million for the quarter ended
September 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 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,” “schedules,”
“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
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/20241114246333/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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