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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
February
29, 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 February 29, 2024, Enveric Biosciences, Inc. (the “Company”)
published a press release announcing entering into three non-binding term sheets to pursue the exclusive out-licensing of three classes
of compounds. 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:
February 29, 2024 |
ENVERIC
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Joseph Tucker |
|
|
Joseph
Tucker, Ph.D. |
|
|
Chief
Executive Officer |
Exhibit
99.1
Enveric
Biosciences Signs Non-Binding Term Sheets to Pursue the Exclusive Out-Licensing of Three Classes of Compounds
Potentially
significant milestone payments and execution fees if all development and sales criteria are met for all three agreements.
CAMBRIDGE,
Mass., February 29, 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, is pleased to announce that it has signed three non-binding term sheets with an undisclosed biotechnology company
to pursue the out-licensing of three classes of compounds. The compounds come from Enveric’s extensive library of over 1,000 novel
molecules generated using the Company’s Psybrary™ platform and proprietary computational chemistry and artificial intelligence
(AI) drug-discovery system (PsyAI™).
The
three term sheets contemplate that the undisclosed licensee would receive exclusive, royalty-bearing global licenses to develop and sublicense
the assets, along with cash buyout options and future option rights to substantially related assets in the Enveric portfolio. The licensee
would assume responsibility for all future preclinical and clinical development for all human and/or animal pharmaceutical applications.
The
term sheets further provide that Enveric could be eligible to receive future development and sales milestone payments and execution
fees for the three licenses, which in total could add up to $200 million, assuming certain conditions are met, including receiving approval
for the investigational new drug (IND) applications and completing Phases I through III testing of the licensed products. Royalty rates
on each of the three licenses could range from 2.5% up to 10% on future sales, depending on meeting certain sales criteria. The compound
classes under the term sheets come from two of the seven portfolios of preclinical molecules that Enveric recently unveiled as available
for out-licensing. Numerous molecules and classes remain available for additional out-licensing opportunities.
“Patients
living with serious mental health conditions have seen insufficient innovation for far too long, and we are excited for the opportunity
to progress several of the novel compounds generated using our drug discovery engine,” said Joseph Tucker, Ph.D., Director and
CEO of Enveric. “We look forward to working with our partner, and we are confident in their leadership and capabilities to work
on further developing these drug candidates to advance treatment options for patients. Ultimately, we believe the definitive licensing
agreements, once negotiated and finalized, could represent an excellent potential source of revenue for Enveric, and could demonstrate
the value creation from Enveric’s discovery capabilities and proprietary PsyAI™ and Psybrary™ platforms, which have
already generated an impressive library of compounds targeting a variety of CNS disorders.”
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 also developing EB-002, formerly EB-373, a next generation
synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. 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, should, 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: negotiate and finalize definitive agreements based on the three out-licensing term sheets and perform pursuant
to the terms thereof; 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 research and development pipeline assets; continue as a going concern; and manage its future growth effectively.
The three out-licensing term sheets identified herein are non-binding and may not result in definitive agreements or attainment of the
licensing fees referenced therein.
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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