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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
July
10, 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
1.01 Entry Into a Material Definitive Agreement
On
July 10, 2024, Enveric Biosciences, Inc.’s wholly-owned subsidiary, Akos Biosciences, Inc., a Delaware corporation (“Akos”)
entered into an Exclusive License Agreement (the “Agreement”) with Aries Science and Technology, LLC, an Ohio limited liability
company (“Aries”), pursuant to which Akos granted Aries a license of Akos’s patented radiation dermatitis topical product.
The license allows Akos to use the patented formulation to develop pharmaceutical or non-pharmaceutical products for treating radiation
dermatitis suitable for administration to humans or animals. The license is exclusive (subject to certain exceptions contained in the
Agreement), worldwide, royalty-bearing, and includes the right to sublicense. Akos is entitled to potential license payments, milestone
payments and royalties based on net revenues of the Licensed Product on a licensed product-by-licensed product and country-by-country
basis pursuant to the terms of the Agreement. Aries has the option during the license term, to purchase the rights to each licensed product
(on a licensed product-by-licensed product basis) in the form of an exclusive (as to the applicable licensed product), fully paid, transferable
right and license to the licensed product.
The
description of the terms and conditions of the Agreement set forth herein do not purport to be complete and are qualified in their entirety
by the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for
the period ended September 30, 2024.
Item
8.01 Other Events.
On
July 15, 2024, the Company issued a press release regarding the transaction described above under Item 1.01 of this Current Report on
Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
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:
July 15, 2024 |
ENVERIC
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Joseph Tucker |
|
|
Joseph
Tucker, Ph.D. |
|
|
Chief
Executive Officer |
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/890821/000149315224027235/ex99-1_001.jpg)
Aries
Science & Technology and Enveric Biosciences Announce Licensing Agreement
Aries
to clinically develop and market Enveric’s patented product for radiation dermatitis
CAMBRIDGE,
Mass., July 15, 2024 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to
the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, and Aries Science & Technology (“Aries”),
a developer of encapsulation technologies, today announced a licensing agreement for the clinical development of Enveric’s patented
radiation dermatitis topical product.
Radiation
dermatitis is a side effect of radiation treatment that impacts roughly two million cancer patients per year and has a market opportunity
estimated at $400 million annually. The formulation licensed to Aries is protected by an allowed US patent application, as well as a
pending PCT application.
“This
product offers the potential to provide much needed relief to cancer patients suffering from the painful side effects of radiation therapy,”
said Ram Lalgudi, Ph.D., CEO of Aries. “We are excited by the opportunity to advance this promising molecule to clinical trials.”
Dr.
Lalgudi announced: “Aries has nominated Hari Harikumar, Ph.D., as Chairman-elect of an Aries subsidiary being formed to advance
this opportunity. Dr. Harikumar is a techno-commercial entrepreneur having experience with multiple companies, including his current
role as VP for Performance Additives in CHASM Advanced Materials and earlier roles as CEO of QM Power, and VP, Innovation, Sustainability
and Technology for Ingersoll Rand/TRANE, and President & CTO for USHA, a leading consumer brand in India. We look forward to great
success under his leadership.”
Joseph
Tucker, Ph.D., CEO of Enveric, stated: “With its proven expertise in encapsulation solutions and strong management team, we believe
Aries is the ideal partner to continue the development of this cancer support care product while Enveric sharpens its focus on neuropsychiatric
indications.”
Under
the terms of the agreement, executed through Enveric’s subsidiary, Akos Biosciences, Inc., Enveric will be eligible to receive
aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales, if all conditions
are met.
About
Aries Science and Technology LLC
Aries
has research laboratories In Columbus, Ohio and possesses deep technical expertise relevant to the envisioned product forms. Aries is
planning to establish an investable subsidiary focused on completing development, commercialization and launch of the topical product
and projects a potential product pipeline featuring multiple patented formulations.
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.
![](https://www.sec.gov/Archives/edgar/data/890821/000149315224027235/ex99-1_001.jpg)
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,” “budgets,” “explores,”
“scheduled,” “seeks,” “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 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; 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.
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)
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から 8 2023 まで 8 2024