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Enveric Biosciences Selects EB-003 as Lead Drug Candidate from EVM301 Series Enveric to initiate preclinical development of EB-003 in 2024 in preparation for IND submission

Key Takeaway: Enveric Biosciences has chosen EB-003 as its lead drug candidate from the EVM301 series, aimed at treating difficult mental health disorders. The selection is based on its potential for promoting neuroplasticity without inducing hallucinogenic effects. The company plans to start preclinical development of EB-003 in early 2024, preparing for an Investigational New Drug application. This decision signifies a key transition for Enveric from a discovery-focused company to a drug development entity.

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POSITIVE FACTORS

  • EB-003 is selected as the lead drug candidate from EVM301 series.
  • Promotes neuroplasticity without inducing hallucinations.
  • The selection marks a transformative step for Enveric's development pipeline.
  • Plans to initiate preclinical development and file an IND application in 2024.

Full Press Release Details

Biosciences Selects EB-003 as Lead Drug Candidate from EVM301 Series
to initiate preclinical development of EB-003 in 2024 in preparation for IND submission
Mass., December 28, 2023 - 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 named EB-003 as its lead drug candidate from the Company's next-generation
EVM301 Series. EB-003 was selected based on data analyses suggesting the molecule's potential to be a first-in-class approach to
addressing difficult-to-treat mental health disorders by promoting neuroplasticity without inducing hallucinations. Enveric plans to
initiate preclinical development of EB-003 in early 2024 in preparation for an Investigational New Drug (IND) application for a first-in-human
was identified following a rigorous selection process during which Enveric utilized its proprietary computational chemistry and artificial
intelligence (AI) drug-discovery platform, PsyAI , to simulate interactions between indolethylamine derivatives and the 5-HT2A
receptor to design novel molecules with reduced head-twitch response (HTR) in mice. HTR is a rodent behavioral model used to predict
whether a molecule is likely to produce hallucinogenic effects in humans. In total, 51 proprietary indolethylamine analogs were screened,
from which three candidates were selected based on the molecules' ability to bind to the 5-HT2A receptor and induce neuroplasticity
while eliciting no significant HTR across a wide dose range.
the top three candidates, EB-003 was chosen as lead based on its superiority in numerous relevant measures.
Revealed high membrane permeability in assays, indicating the potential for excellent blood brain barrier permeability, an important consideration for drugs that target receptors in the brain.
Overall toxicity parameters were similar to or below those for DMT and psilocin.
of EB-003 as the lead development candidate from our EVM301 Series is an important inflection point for Enveric and our mission to develop
groundbreaking, psychedelic-inspired drug technologies that offer the potential to treat severe mental health disorders without the hallucinogenic
effect typically associated with psychedelic-based molecules," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Importantly,
moving EB-003 into our development pipeline marks a transformative step for Enveric as we complete our period as a discovery phase company
and fully transition to the next phase as a drug development company. With EB-003, we have identified a novel, neuroplastogenic molecule
that exhibits several key properties that align with favorable tolerability and efficacy in relevant animal models. We now look forward
to initiating IND enabling activities in early 2024 that will enable us to file an IND and start clinical trials of EB-003 as we seek
to introduce a new treatment paradigm for depression and anxiety disorders."
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, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing
the first product from the EVM201 Series - EB-373 - for the treatment of psychiatric disorders. Enveric is also advancing
its second product, EB-003, as a first-in-class approach to the treatment of difficult-to-address mental health disorders by promoting
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.
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," "is expected,"
"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, 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: 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 cannabinoid clinical development pipeline assets; continue as a going concern; and manage its future growth
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.
Strategic Advisors, Inc.
Strategic Advisors, Inc.

Frequently Asked Questions

What is EB-003?

EB-003 is Enveric Biosciences' lead drug candidate targeting mental health disorders.

When will preclinical development of EB-003 begin?

Preclinical development of EB-003 is scheduled to start in early 2024.

How was EB-003 selected as the lead candidate?

EB-003 was chosen based on its promise in promoting neuroplasticity and low hallucinogenic potential.

What disorders is EB-003 aimed to treat?

EB-003 aims to treat depression, anxiety, and addiction disorders.

Where is Enveric Biosciences headquartered?

Enveric Biosciences is headquartered in Naples, Florida.

Last updated: Dec 28, 2023