Form 8-K - Current report

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 11, 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 October 11, 2023, Enveric Biosciences, Inc. (the “Company”) published a press release announcing that its Chief Innovation Officer, Dr. Peter Facchini, Ph.D., will present two posters at the 6^th Neuropsychiatric Drug Development Summit. 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 October 11, 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: October 11, 2023	ENVERIC BIOSCIENCES, INC.

	By:	/s/ Joseph Tucker
		Joseph Tucker
		Chief Executive Officer

Exhibit 99.1

Enveric Biosciences Announces Two Poster Presentations at the 6^th Neuropsychiatric Drug Development Summit

Presentations highlight research involving Enveric’s EVM301 Series of non-hallucinogenic neuroplastogens and the company’s lead product candidate, EB-373

CAMBRIDGE, Mass., October 11, 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 that its Chief Innovation Officer, Dr. Peter Facchini, Ph.D., will present two posters at the 6^th Neuropsychiatric Drug Development Summit being held in Boston, MA on October 10-12, 2023. One poster provides an update on the Company’s near-term selection of a non-hallucinogenic lead candidate in the EVM301 Series of neuroplastogens and the other highlights key aspects of EB-373, a novel prodrug of psilocin.

The first poster entitled, “Screening for non-hallucinogenic neuroplastogens as drug candidates for the treatment of anxiety, depression, and posttraumatic stress disorder,” presents the underlying strategy, methods, and critical data used by the Company to identify a shortlist of potential candidates in the EVM301 Series program. The design of over 50 tested molecules, aided by the Company’s proprietary PsyAI™ computational chemistry platform, targeted novel indolethylamine derivatives that bind the 5HT2A receptor and display dramatically reduced or possibly absent hallucinogenic effects, while at the same time maintaining the capacity to act as neuroplastogens in the promotion of long-lasting benefits to brain structure and function. The soon-to-be-selected lead candidate is expected to be robustly effective and suitable for development as a prescription medicine for the long-term management of psychiatric conditions. All molecules are protected within Enveric’s wide-reaching IP portfolio, which includes 11 patent families covering a diverse array of indolethylamines based on the backbone structures of psilocin, N,N-dimethyltryptamine (DMT) and related molecules.

The second poster entitled, “Novel psilocin prodrugs with altered pharmacological properties as candidate therapies for treatment-resistant anxiety disorders,” describes the strategy, methods, and critical data underlying the selection of several psilocin-releasing candidates from a library of 28 novel compounds representing nine different prodrug types with respect to chemical structure. Fifteen of these compounds, which included a notable number of ester- and thiocarbonate-based derivatives, were further evaluated in mice for (i) pharmacokinetic (PK) profiles, whereby plasma levels of both the residual prodrug and the released psilocin were monitored, and (ii) psychoactive potential measured by the standard head-twitch response. The data underscored the selection of EB-373 as its lead prodrug candidate, which is advancing through preclinical development. EB-373 is protected by a patent issued on July 25, 2023.

“The two posters being presented at the 6^th Neuropsychiatric Drug Development Summit showcase Enveric’s cutting-edge research into the neuroplastogenic properties of psychoactive compounds, which has been instrumental in the development of our EVM301 Series and the ongoing advancement of EB-373,” said Dr. Joseph Tucker, Ph.D., Director and CEO of Enveric. “Importantly, this research has enabled Enveric to produce a library of novel therapeutic candidates that harness key properties of known psychoactive compounds, but are designed to elicit improved pharmacologic profiles, creating the potential for Enveric to generate new and improved treatments for people living with mental health conditions.”

Details of the poster presentations are as follows:

Title: Screening for non-hallucinogenic neuroplastogens as drug candidates for the treatment of anxiety, depression, and posttraumatic stress disorder

Presenter: Dr. Peter Facchini, Ph.D. Enveric Biosciences

Authors: Jillian M. Hagel, Lisa Yu, Limei Chang, Dhananjaya D., Natali Ozber, Sarah G. Cook, Jaideep Bains, Kaveh Matinkhoo, Glynnis Jensen, David Press, Stanley Opare, Sheetal A. Raithatha, Joseph E. Tucker, Peter J. Facchini

Title: Novel psilocin prodrugs with altered pharmacological properties as candidate therapies for treatment-resistant anxiety disorders

Presenter: Dr. Peter Facchini, Ph.D. Enveric Biosciences

Authors: Sheetal A. Raithatha, Jillian M. Hagel, Kaveh Matinkhoo, Lisa Yu, David Press, Sarah G. Cook, Govinda Sharma, Dhananjaya D, Glynnis Jensen, Jessica B. Lee, Charlie Cai, Jonathan Gallant, Jaideep S. Bains, Joseph E. Tucker and Peter J. Facchini

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, 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

Cover	Oct. 11, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 11, 2023
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