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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
January
3, 2024
Date
of Report (Date of earliest event reported)
Enveric
Biosciences, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-38286 |
|
95-4484725 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
Enveric
Biosciences, Inc.
4851
Tamiami Trail N, Suite 200
Naples,
FL 34103
(Address
of principal executive offices) (Zip code)
Registrant’s
telephone number, including area code: (239) 302-1707
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, par value $0.01 per share |
|
ENVB |
|
The
Nasdaq Stock Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
January 3, 2024, Enveric Biosciences, Inc. (the “Company”) published a press release updating key data underpinning selection
of EB-003 as the lead drug candidate from the EVM301 Series. A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated
by reference herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in
such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute
a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination
of such information is required by Regulation FD.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date: January 3, 2024 |
ENVERIC
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Joseph Tucker |
|
|
Joseph Tucker |
|
|
Chief Executive Officer |
Exhibit
99.1
Enveric
Biosciences Updates Key Data Underpinning Selection of EB-003 as Lead Drug Candidate from EVM301 Series
Enveric
to initiate preclinical development of EB-003 in 2024 in preparation for IND submission
CAMBRIDGE,
Mass., January 3, 2024 – 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 an update on data underpinning the selection of EB-003 as its lead drug candidate from the Company’s
next-generation EVM301 Series. As previously announced, 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.
Importantly,
EB-003:
|
● |
Exhibited
partial agonism of the 5-HT2A receptor, binding with a Ki of 0.2 µM (micromolar), which is within the range of binding
affinity of the known 5-HT2A agonists DMT and psilocin. |
|
● |
Bound
the 5-HT1A receptor with a Ki of 3.3 µM. |
These
data points correct previously announced information which stated 0.2 mM and 3.3 mM respectively and indicate a 1000x greater binding
affinity compared to what was previously reported. 5-HT2A is the key receptor correlated to the neuroplastogenic activity of this emerging
class of novel drugs. 5-HT1A is a known important therapeutic target because other, already-approved medications for neuropsychiatric
indications are known to bind this receptor.
“Selection
of EB-003 as the lead development candidate from our EVM301 Series is an important inflection point for Enveric, and the updated data
highlight its potential to be a novel, neuroplastogenic molecule that exhibits several key properties that align with favorable tolerability
and efficacy in relevant animal models,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We 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.”
EB-003
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 EB-003 was selected based on key properties including the molecule’s ability to bind to the 5-HT2A receptor and induce
neuroplasticity while eliciting no significant HTR across a wide dose range.
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, 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.
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,” “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
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.
Contact
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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Enveric Biosciences (NASDAQ:ENVB)
過去 株価チャート
から 5 2024 まで 6 2024
Enveric Biosciences (NASDAQ:ENVB)
過去 株価チャート
から 6 2023 まで 6 2024