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): January 18, 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 January 18, 2022, Enveric Biosciences, Inc. (the “Company”) issued a press release containing a letter from the Company’s CEO providing a 2021 year in review and 2022 outlook. A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

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 Exchange Act 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 January 18, 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:	January 19, 2022	By:	/s/ Joseph Tucker
			Joseph Tucker
			Chief Executive Officer

EX-99.1

Exhibit 99.1

Enveric Biosciences CEO, Dr. Joseph Tucker, Provides 2021 Year in

Review and 2022 Outlook in Letter to Shareholders

NAPLES, Fla., January 18, 2022 /PRNewswire/ — Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-centric biotechnology company, today released a letter to shareholders from Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences.

Dear Enveric Shareholders and Partners:

Reflecting on 2021, I am both extremely impressed with all the accomplishments and progress made and humbled and energized to tackle the opportunities that lie ahead. 2021 was a foundational year that set the stage for our Company by assembling a talented and expert team to execute our strategy for the future. As we move forward in 2022, we find ourselves strategically positioned with a strengthened balance sheet, a deep bench of experienced industry professionals, a platform for new drug discovery, a robust IP portfolio and a growing pipeline of what we believe to be promising drug candidates. We are energized to engage with what I believe will be yet another transformative year for the company.

2021 Year in Review

Enveric launched as a patient-centric biotechnology company, employing innovation and scientific leadership as core principles. Notable highlights from 2021 include:

● Capital Markets: Raised $25 million; added to AdvisorShares Psychedelics ETF (NYSE:PSIL)

● M&A and Licensing: Acquired MagicMed Industries Inc.; Exclusively licensed novel molecules from Diverse Biotech

● Platform Technology Development: Filed 15 patent applications with claims directed to millions of individual molecules; Launched PsyAI^TM, a proprietary artificial intelligence platform.

As of September 30, 2021, we had $21 million in cash, no debt related to loans payable, and working capital of approximately $20 million, enabling us to continue executing on our business plan.

Looking Forward to 2022

The foundation of Enveric’s growth in 2022 will be built upon three pillars: our Drug Development pipeline, Drug Discovery process, and Intellectual Property strategy.

● Drug Development:

○ Most importantly, our psychedelic-based drug discovery engine is operating in full force to address many targeted unmet needs, starting with the planned execution of a Phase II clinical trial in Cancer Related Distress (CRD), our lead indication, with a 1^st generation psychedelic asset, EVM-101.

○ Our second-generation psychedelic-derived suite of products in our Discovery Research is slated to progress towards nominating our lead Development Candidate, EVM-201, and to proceed towards completing a host of CMC (Chemistry Manufacturing and Controls), Pharmacology, and Toxicology experiments, leading to planned INTERACT and Pre-IND meetings with the FDA.

● Drug Discovery:

○	Design of hundreds of potential lead drug candidates for enriching our second generation and third generation pipeline programs with the aim of progressing towards several future Development Candidate nominations in target undisclosed indications.
○	Focused, enriched and targeted drug discovery engine employing Artificial Intelligence screening to identify top candidates for each program based on drug-like properties, predicted pharmaceutical activity and intellectual property strength.

● Intellectual Property:

○	Continue to invent new drug candidates and employ internationally filed patent applications to claim the compositions, methods of manufacture, and clinical uses.
○	12 international Patent Cooperation Treaty (PCT) Patent Applications are expected to publish.
○	7 Provisional US Patent Applications are expected to be converted to international PCT Patent Applications.
○	2 additional Provisional US Patent Applications are expected to be filed.

With the new company structure, strengthened by the foundational achievements in 2021 including the assembly of an expert team with the passion and drive for drug development, I am confident in Enveric’s ability to execute on our programs in 2022 and beyond.

On behalf of the Enveric management team and Board of Directors, I thank you for your continued support of the company and I look forward to providing you with further updates as our progress continues.

Sincerely,

Dr. Joseph Tucker,

Chief Executive Officer, Director

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 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

416.706.6364       

ndolphin@enveric.com

XML

Cover	Jan. 18, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 18, 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