0001493152-23-033836.txt : 20230927 0001493152-23-033836.hdr.sgml : 20230927 20230927080518 ACCESSION NUMBER: 0001493152-23-033836 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230927 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230927 DATE AS OF CHANGE: 20230927 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Enveric Biosciences, Inc. CENTRAL INDEX KEY: 0000890821 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 954484725 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38286 FILM NUMBER: 231281859 BUSINESS ADDRESS: STREET 1: 4851 TAMIAMI TRAIL N, SUITE 200 CITY: NAPLES STATE: FL ZIP: 34103 BUSINESS PHONE: 239-302-1707 MAIL ADDRESS: STREET 1: 4851 TAMIAMI TRAIL N, SUITE 200 CITY: NAPLES STATE: FL ZIP: 34103 FORMER COMPANY: FORMER CONFORMED NAME: AMERI Holdings, Inc. DATE OF NAME CHANGE: 20150527 FORMER COMPANY: FORMER CONFORMED NAME: SPATIALIZER AUDIO LABORATORIES INC DATE OF NAME CHANGE: 19950323 8-K 1 form8-k.htm
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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

 

September 27, 2023

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 September 27, 2023, Enveric Biosciences, Inc. (the “Company”) published a press release announcing the publication of a paper describing a novel bioproduction platform for psychedelic-inspired drug discovery in the Journal of Biological Chemistry. 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

 

Exhibit

Number

  Description
   
99.1   Press Release, dated September 27, 2023 (furnished 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: September 27, 2023 ENVERIC BIOSCIENCES, INC.
     
  By: /s/ Joseph Tucker
    Joseph Tucker
    Chief Executive Officer

 

 

 

EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

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Description automatically generated with low confidence

 

Enveric Biosciences Announces Publication of a Paper Describing a Novel Bioproduction Platform for Psychedelic-Inspired Drug Discovery in the Journal of Biological Chemistry

 

Paper co-authored by Enveric researchers describes the discovery of a key cane toad enzyme and its application to the biosynthesis of novel indolethylamine-type drug candidates with potential use in psychiatric medicine

 

CAMBRIDGE, Mass., September 27, 2023 – 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, today announced publication of a paper in the peer-reviewed journal, Journal of Biological Chemistry, describing the discovery of a new enzyme from cane toad (Rhinella marina) and the successful development of a bioproduction platform for the isolation and pharmacological screening of novel indolethylamines with potential use in psychiatric medicine. Enveric researchers and a team from the University of Calgary co-authored the work, which was led by Peter Facchini, Ph.D., professor and Chief Innovation Officer at Enveric.

 

In the paper titled, “A cane toad (Rhinella marina) N-methyltransferase converts primary indolethylamines to tertiary psychedelic amines,” the authors describe the discovery and biotechnological deployment of a novel enzyme, Rhinella marina N-methyltransferase (RmNMT), isolated from the cane toad. The discovery is important as it represents the first alkaloid biosynthetic gene and cognate enzyme isolated from a psychedelic toad. In comparison to N-methyltransferases isolated from other organisms, RmNMT is an effective and promiscuous catalyst, which makes it uniquely suitable for the biosynthesis of novel psychedelic-inspired neuroplastogens. The research team demonstrated the utility of the enzyme as an important biocatalyst in psychedelic applications by purifying its reaction products and subjecting the compounds, which include novel N,N-dimethyltryptamine (DMT) derivatives, to key receptor binding and metabolic stability assays.

 

“This unique enzyme has proved itself a superior biocatalyst compared with similar enzymes and emerges as a key resource with applications in the synthesis and screening of psychedelic-inspired medicines,” said Dr. Facchini. “We believe our work demonstrates Enveric’s superior and proven capabilities in creating exciting New Chemical Entities (NCEs) inspired by the powerful ability of organisms found in nature to synthesize an enormous diversity of compounds, ranging from hallucinogenic alkaloids to anti-cancer steroids to pesticidal peptides. We expect our bioproduction systems, which mimic the cane toad’s ability to produce psychedelic molecules, to complement our extensive synthetic chemistry capabilities collectively aimed at the development of effective and beneficial new medicines.”

 

   
   

 

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“With this impressive discovery, our team of leading researchers has established an innovative and effective method for the bio-based production, purification, and screening of novel indolethylamine-type drug candidates,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “This innovative work further displays the novel thinking of our research team at Enveric to learn from natural biochemical systems and apply our innovative 3-D modeling technologies backed by AI to design improved neuroplastogenic compounds that are expected to be optimized as treatments for those with mental health disorders like depression, anxiety, and addiction 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, The Psybrary™, Enveric has created a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient. 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, 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: 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 cannabinoid clinical 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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