8-K

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): February 8, 2022

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

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))

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 8, 2022, Enveric Biosciences, Inc. (the “Company”) issued a press release announcing the successful synthesis and filing of a provisional patent for EV104 – Cannabinoid + Celecoxib Conjugate. 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 Current Report on Form 8-K, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for the purposes of Section 18 of 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 Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release, issued February 8, 2022 (furnished pursuant to Item 7.01)
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

* * *

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:	February 9, 2022	By:	/s/ Joseph Tucker
			Joseph Tucker
			Chief Executive Officer

EX-99.1

Exhibit 99.1

 

Enveric Biosciences Announces Successful Synthesis and Filing of

Provisional Patent for EV104 – Cannabinoid + Celecoxib Conjugate

Target Indications include Osteoarthritis and Other Pain Conditions

NAPLES, Fla., February 8, 2022 - Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a neuroscience company developing next-generation, psychedelic-inspired mental health, and oncology treatments, today announced the development of EV104a and EV104b, new molecular conjugates for Osteoarthritis (“OA”) and other pain indications.

The treatment paradigm for OA, as reflected in a recent review “Future Directions for the Management of Pain in Osteoarthritis” by Nidhi Sofat, is largely unsatisfactory and based on alleviating pain using NSAIDs and other pharmacotherapies or intra-articular injection of corticosteroids, or hyaluronic acid. Newer therapeutic alternatives, including combination treatments, are needed for optimal control of symptoms. Enveric recently licensed an Innovative Platform technology from Diverse Biotech that led to the successful synthesis of EV104a, and EV104b, two new chemical entity conjugates of cannabidiol (CBD) linked to celecoxib.

EV104a and EV104b are specifically designed to optimize pharmacokinetics and therapeutic synergy via improved delivery, targeting abilities, and potency to potentially be more efficacious and display fewer side effects than current treatments. Enveric has confirmed the stability of the molecules and the robustness of the manufacturing method. Pre-clinical in vitro testing and characterization of these molecules is underway. This program aims to create a new treatment with improved tolerability, decreased toxicity, fewer side effects, and enhanced long-term efficacy.

The EV104 celecoxib-cannabinoid conjugates are protected by a recently filed provisional United States patent application claiming the compositions, methods of synthesis, and methods of treatment for inflammatory medical conditions.

“We are pleased to announce the creation of EV104a and EV104b for the potential treatment of OA and other pain indications. Despite available therapies, individuals with OA continue to suffer and look for new treatments to remediate their pain. As the Company moves forward to execute our clinical development plans, we believe our assets have the potential to demonstrate superior efficacy with a more favorable safety profile compared to current standards of treatment,” said Dr. Joseph Tucker, CEO of Enveric Biosciences.

Osteoarthritis is the most common form of arthritis and a leading cause of disability, resulting in a reduced quality of life. Enveric’s EV104 program entered pre-clinical testing to advance into clinical development with the hope of offering better options for patients living with pain.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is an innovative biotechnology company developing next-generation mental health and oncology treatments and clinical discovery platform, leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body. Enveric’s robust pipeline supports drug discovery efforts and clinical development programs to enable the potential commercialization of effective treatments for millions of patients in need around the world. For more information, please visit www.enveric.com.

 

Cautionary Statement Regarding 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 consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements 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 to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. 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 (SEC), including the Company’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.

Investor Contacts

Valter Pinto / Allison Soss

KCSA Strategic Communications

212.896.1254 / 212.896.1267

valter@kcsa.com / asoss@kcsa.com

Media Contacts

Natalie Dolphin

Enveric Biosciences Inc.

416.706.6364

ndolphin@enveric.com

XML

Cover	Feb. 08, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 08, 2022
Entity File Number	001-38286
Entity Registrant Name	Enveric Biosciences, Inc.
Entity Central Index Key	0000890821
Entity Tax Identification Number	95-4484725
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	4851 Tamiami Trail N
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Naples
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34103
City Area Code	(239)
Local Phone Number	302-1707
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, par value $0.01 per share
Trading Symbol	ENVB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false