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

October 23, 2022

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.

Attached hereto as Exhibit 99.1 to this Current Report and incorporated by reference herein is an investor presentation containing information relating to Enveric Biosciences, Inc., (the “Company”). The Company may, from time to time, present and/or distribute to the investment community and utilize the slide presentation at various industry and other conferences. The investor presentation is posted on the Company’s new website, which launched on October 23, 2022, at https://enveric.com. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

On October 24, 2022, the Company issued a press release announcing the advancement of a lead candidate for the treatment of anxiety disorders to IND-enabling studies. A copy of such press release is attached hereto as Exhibit 99.2 and is incorporated by reference herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.

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 and 99.2, 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

Exhibit Number	Description
99.1	Investor Presentation, Q4 2022 (furnished herewith pursuant to Item 7.01)
99.2	Press release, dated October 24, 2022 (furnished herewith pursuant to Item 7.01)
104	Cover Page Interactive Data File (formatted as Inline XBRL).

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: October 24, 2022	ENVERIC BIOSCIENCES, INC.
	By:	/s/ Joseph Tucker
		Joseph Tucker
		Chief Executive Officer

EX-99.1

Exhibit 99.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EX-99.2

Exhibit 99.2

 

Enveric Biosciences Advances Lead Candidate for the Treatment of Anxiety Disorders to IND-Enabling Studies

— Next Generation Psilocin Prodrug, EB-373, Nominated to Advances to IND-Enabling Studies —

—First Generation EVM101 Program for Cancer Related Distress has been discontinued —

CAMBRIDGE, Mass. – October 24, 2022 - Enveric Biosciences Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders, today announced the nomination of EB-373 as the lead development candidate to emerge from its EVM201 program. EB-373 is under development for the treatment of anxiety disorders.

The announcement of this important milestone coincides with the presentation of preclinical data from EVM201 program at the 6^th International Neurology & Brain Disorders Conference (INBC) being held on October 24 – 26, 2022, in Orlando, Florida.

VALIDATION OF PLATFORM AND DEMONSTRATION OF PHARMACOLOGICAL ACTIVITY

The screening and optimization phase of the EVM201 program has yielded the lead drug development candidate, EB-373, which is currently advancing through several key preclinical studies that will lead to the filing of an Investigational New Drug (IND) application with the Food & Drug Administration (FDA), targeted to occur in the second half of 2023.

Data released today reveals for the first time that the Company’s engineered library of EVM201 drug candidates achieved an intended diversity of psilocin-releasing molecules, based on both in vitro assays and pharmacokinetic profiles in rodents. Additionally, all EVM201 drug candidates showed positive serotonin 5-HT2A receptor stimulation in vivo, revealed by induction of the characteristic Head Twitch Response (HTR) behavioural marker in healthy mice, and produced anxiolytic benefit in chronically stressed mice evaluated using the Marble Burying Test, an animal behavioral model of anxiety.

“The successful outcomes from our synthesis and screening efforts completed during 2022 have positioned the Company very well to advance our drug candidates towards the clinic,” stated Bob Dagher, MD, Chief Medical Officer of Enveric Biosciences. “This announcement marks a major step forward in demonstrating the utility of our technology platform. The nomination of EB-373 as lead candidate opens the door to our mission of delivering on the promise of novel therapies that offer new hope to patients living with common, difficult-to-treat, psychiatric diseases such as anxiety disorders.”

FOCUS ON NEXT GENERATION CANDIDATES, DISCONTINUATION OF 1^st GENERATION PROGRAM

Due to the promising early data from the EVM201 program, the need for work on the original EVM101 classic psilocybin study has been obviated. As such, the first generation EVM101 program of psilocybin targeting Cancer Related Distress has been discontinued.

About Enveric

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders. 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 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

XML

Cover	Oct. 23, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 23, 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	Enveric Biosciences, Inc.
Entity Address, Address Line Two	4851 Tamiami Trail N
Entity Address, Address Line Three	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