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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
December
27, 2023
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
December 27, 2023, Enveric Biosciences, Inc. (the “Company”) published a press release announcing the GLP Safety and Toxicology
Program of EB-373 is thus far proceeding as planned with favorable results. 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: December 27, 2023 |
ENVERIC
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Joseph Tucker |
|
|
Joseph Tucker |
|
|
Chief Executive Officer |
Exhibit
99.1
Enveric
Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373
The
ongoing GLP Safety and Toxicology Program of EB-373 is thus far proceeding on time with favorable results
CAMBRIDGE,
Mass., December 27, 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 the GLP Safety and Toxicology Program of EB-373 is proceeding as planned thus far with favorable
results.
In-life
portion of the repeat dose toxicology studies have been completed, and the results are being analyzed. In addition, cardiac, respiratory,
CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing
analyses. Enveric expects to finalize all preclinical activities involving EB-373 in the first quarter of 2024 in preparation for a first-in-human
clinical trial.
“Our
research team has continued to diligently advance the preclinical program for our lead novel psilocin prodrug, EB-373, as we anticipate
initiating first in human trials in 2024,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Analyses of data collected
to date have consistently confirmed the safety and oral bioavailability of EB-373, with a dose-dependent increase in EB-373 blood concentration
detected followed by its rapid conversion to the active metabolite psilocin. Further, pharmacological properties observed in preclinical
animal models have validated our AI-backed molecular design aimed at optimal control over the timing and length of the hallucinatory
experience in humans, while also achieving the desired therapeutic effect for difficult-to-treat mental health indications.”
A
summary of the EB-373 preclinical program is as follows:
|
● |
GLP
toxicology studies of EB-373 in orally dosed rats and dogs are currently in advanced stages, with all in-life activities completed.
Preliminary indications suggest a broad margin of safety and tolerability is maintained with repeat dose testing. Complete analysis
and final reporting are expected by the end of Q1 2024. |
|
● |
EB-373
safety pharmacology studies in rats and dogs, employing the core battery of respiratory, CNS and cardiovascular (CV) assessments,
are completed. Preliminary results have demonstrated an acceptable range of safety for each of these vital organ systems in orally
dosed animals. Complete analysis and final reporting are expected by the end of December 2023. |
|
● |
In
vitro assessment of cardiotoxicity potential, involving assays targeting key CV targets including hERG, Cav 1.2 and Nav 1.5 have
been completed. Results suggest an acceptable range of cardiovascular safety well above the proposed clinical dose range. |
|
● |
Non-GLP
in vivo dose range finding (DRF) studies conducted in rats and dogs, completed in August 2023, demonstrated effective oral
bioavailability of EB-373, with dose-dependent increase in psilocin blood concentration detected in both species. |
|
○ |
Key
outcomes from these PK assessments strongly suggest a broad range of tolerance, with a potential for reduced gastrointestinal (GI)
upset and vomiting, as well as a rapid onset of action and systemic clearance, improving on PK characteristics of psilocybin. |
|
● |
In
vitro absorption, distribution, metabolism and excretion toxicology (ADME-tox) studies and a metabolic identification evaluation
have been completed and confirmed minimal potential for adverse drug reactions (ADR), with no toxic metabolites identified, and no
indication of any significant drug-drug interactions. |
|
○ |
Results from this study also demonstrated rapid conversion of EB-373 to the active metabolite psilocin, consistent with previously
reported pharmacokinetic (PK) studies. |
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 program, the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental
health disorders, mediated by the promotion of neuroplasticity without also 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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