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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
Date
of Report (Date of earliest event reported): November 13, 2023
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
No.) |
|
(IRS
Employer
Identification
No.) |
Enveric
Biosciences, Inc.
4851
Tamiami Trail N, Suite 200
Naples,
FL 34103
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: (239) 302-1707
(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)) |
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
2.02 Results of Operations and Financial Condition.
On
November 13, 2023, Enveric Biosciences, Inc. issued a press release providing a corporate update and announcing its financial results
for the third quarter ended September 30, 2023. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated
herein by reference.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, that
is furnished pursuant to this Item 2.02 shall not be deemed to be “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, and shall
not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended,
or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
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.
|
ENVERIC
BIOSCIENCES INC. |
|
|
|
Date:
November 13, 2023 |
By: |
/s/
Joseph Tucker |
|
|
Joseph
Tucker |
|
|
Chief
Executive Officer |
Exhibit
99.1
Enveric
Biosciences Reports Third Quarter 2023 Corporate and Financial Results
EVM-301
Series
|
● |
Presented
and published leading scientific research describing development and screening methods for non-hallucinogenic, neuroplastogenic drug
candidates in Enveric’s EVM301 Series of candidates targeting the treatment of mental health disorders |
|
● |
Announced
AI-powered drug candidate generation engine surpassed 1000 compounds discovered and analyzed in Psybrary™ portfolio of psychedelic-inspired
therapeutic candidates |
|
● |
Published
research describing a key cane toad enzyme and its application to the biosynthesis of novel indolethylamine-type drug candidates
with potential use in psychiatric medicine |
|
● |
Granted
U.S. Patent (USPTO No. 11,752,130) providing claims to novel composition of matter and pharmaceutical drug formulations for a family
of carboxylated derivatives of tryptamine-based drug candidates |
EB-373
|
● |
Granted
U.S. Patent (USPTO No. 11,707,447) encompassing novel compositions of matter and pharmaceutical drug formulations for prodrugs utilizing
C4-carbonothioate-substituted tryptamine derivative compounds |
|
● |
Reported
results from preclinical studies exploring the metabolic profile and the safety of lead candidate EB-373, a next generation psilocin
prodrug targeting psychiatric disorders |
|
● |
Highlighted
results from animal studies demonstrating oral bioavailability and favorable safety profile for EB-373 |
|
● |
Completed
manufacturing of EB-373 to supply drug material for completion of preclinical program |
CAMBRIDGE,
Mass., November 13, 2023 – Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology
company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression,
and addiction disorders, today provided a corporate update and reported financial results for the third quarter of 2023 ended September
30, 2023.
“The
third quarter of 2023 was a period of significant progress for our team as we completed several initiatives that served to enhance the
value of our differentiated neuroplastogenic small-molecule therapeutics as we advance towards the clinic,” said Joseph Tucker,
Ph.D., Director and CEO of Enveric. “Key to this effort, we significantly strengthened our IP estate across our development portfolio,
highlighted by new patents from the United States Patent and Trademark Office (USPTO) for our EVM301 Series of novel non-hallucinogenic
molecules and for EB-373, our lead EVM201 Series prodrug product candidate. The patents encompass composition of matter and pharmaceutical
drug formulations related to the EVM301 Series and composition of matter and pharmaceutical drug formulations pertaining to EB-373. Additionally,
we filed six non-U.S. applications related to the EVM301 Series, received several U.S. Notices of Allowance for claims related to the
EVM301 Series and EB-373, and filed a new application for our AI-based computational methods for identifying and optimizing novel tryptamine
derivatives. Our expectation is the USPTO will grant patents based on the Notices of Allowance, which would continue to increase the
value of our technologies and further distinguish Enveric’s science as groundbreaking and unique.”
Dr.
Tucker added: “Through the third quarter of 2023 and into Q4, we have showcased the leading drug discovery and research engine
behind our EVM301 Series of compounds, with several publications and presentations in academic settings, establishing a leading position
in the psychedelic and psychedelic-inspired drug development industry to deliver next-generation treatments, with low- and non-hallucinogenic
compounds. We look forward to several key milestones during the remainder of 2023, including identification of a lead candidate from
the EVM301 Series by year-end. With this lead candidate identified, we anticipate initiating a thorough and expedited preclinical development
program in 2024 in preparation for an Investigational New Drug application.”
“As
part of our objective to ensure clinical readiness, the third quarter was also characterized by completing key manufacturing and preclinical
activities needed to file for regulatory clearance to begin a first in human clinical trial of EB-373. We announced favorable results
from exploratory animal studies, which demonstrated oral bioavailability and well-tolerated side effects for EB-373. The outcome of these
animal studies indicated potential for EB-373 to reduce GI upset and vomiting as well as rapid onset of action and systemic clearance,
improving on the pharmacokinetic characteristics of psilocybin. Additionally, further preclinical work assessing absorption, distribution,
metabolism, and excretion (ADME) assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin,” concluded Dr.
Tucker.
THIRD
QUARTER AND RECENT PROGRAM UPDATES
|
● |
Presented
and published leading scientific research describing development and screening methods for non-hallucinogenic, neuroplastogenic drug
candidates in Enveric’s EVM301 Series of candidates targeting the treatment of mental health disorders |
|
● |
Showcased
drug candidate generation engine surpassing 1000 compounds discovered and analyzed in Psybrary™ Portfolio of psychedelic-inspired
therapeutic candidates |
|
● |
Published
research describing a key cane toad enzyme and its application to the biosynthesis of novel indolethylamine-type drug candidates
with potential use in psychiatric medicine |
|
● |
Reported
results from preclinical studies exploring the metabolic profile and the safety of lead candidate EB-373, a next generation psilocin
prodrug targeting psychiatric disorders. Reported favorable preclinical absorption, distribution, metabolism, and excretion (ADME)
and toxicology assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin |
|
● |
Completed
manufacturing of EB-373 to supply drug material for completion of preclinical program with resulting high purity of prodrug product
that allows Enveric and partners to ship EB-373 without being subject to restrictions required for controlled substances |
|
● |
Continued
to drive value with growing IP portfolio across therapeutic pipeline and filed provisional patent application to support AI-based
computational methods for identifying and optimizing novel tryptamine derivatives |
|
○ |
Granted
USPTO No. 11,707,447 encompassing compositions of matter and pharmaceutical drug formulations for prodrugs utilizing C4-substituted
tryptamine derivatives and C4-carbonothiate-substituted tryptamine derivatives |
|
○ |
Granted
USPTO No. 11,752,130 providing claims to novel composition of matter and pharmaceutical drug formulations for a family of carboxylated
derivatives of tryptamine-based drug candidates |
THIRD
QUARTER 2023 FINANCIAL RESULTS
Net
loss attributable to shareholders was $2.82 million for the third quarter ended September 30, 2023, including $0.16 million in net non-cash
income, with a basic and diluted loss per share of $1.30, as compared to a net loss of $2.60 million and non-cash income of $2.29 million,
with primary and diluted loss per share of $1.46 per share for the quarter ended September 30, 2022.
Net
cash used in operations for the quarter ended September 30, 2023, was $2.98 million, consisting of a $2.82 million net loss, adjusted
by a net of $0.16 million in non-cash income and changes in asset and liability balances of $0.23 million.
As
of September 30, 2023, the Company had cash and cash equivalents of $4.27 million.
About
Enveric
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 on 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; 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; the ability to continue as a going concern; manage its future
growth effectively; achieve the intended benefits of the cost reduction plan to the extent or as quickly as anticipated; transition
from third-party service providers supporting R&D efforts to internal science teams without any adverse impact on Enveric’s
ongoing and planned clinical trials; and engage the cost reduction plan efforts without negatively impacting Enveric’s business
operations and reputation.
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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