8-K
Enveric Biosciences, Inc. (ENVB)
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
May22, 2023
Date
of Report (Date of earliest event reported)
EnvericBiosciences, Inc.
(Exactname of registrant as specified in its charter)
| Delaware | 001-38286 | 95-4484725 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (I.R.S. Employer<br><br> <br>Identification No.) |
EnvericBiosciences, Inc.4851 Tamiami Trail N, Suite 200Naples, FL 34103(Address of principal executive offices) (Zip code)
Registrant’stelephone 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> stock, par value $0.01 per share | ENVB | The<br> 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. ☐
Item7.01 Regulation FD Disclosure.
On May 22, 2023, Enveric Biosciences, Inc. (the “Company”) issued a press release announcing that the Company has submitted for peer-reviewed publication a manuscript detailing the development of novel psilocin prodrugs for the treatment of anxiety and other mental disorders. 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.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release, dated May 22, 2023 (furnished pursuant to Item 7.01) |
| 104 | Cover<br> 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:<br> May 22, 2023 | ENVERIC BIOSCIENCES, INC. | |
|---|---|---|
| By: | /s/ Joseph Tucker | |
| Joseph<br> Tucker | ||
| Chief<br> Executive Officer |
Exhibit99.1
EnvericBiosciences Announces Manuscript Detailing the Development of Novel Psilocin Prodrugs for the Treatment of Anxiety and Other Mental HealthDisorders
Researchhighlights the potential of Enveric’s EVM201 Series aimed at developing psilocin prodrugs with altered metabolic profiles thatoffer superior administration and treatment benefits, but reduce pharmacological exposure
CAMBRIDGE, Mass., May 22, 2023 – 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, has announced new research results detailing the development of novel psilocin prodrug derivatives targeting treatment of mental health disorders. A manuscript describing the research has been submitted for peer-reviewed publication and is currently accessible via the following open access platform: https://biorxiv.org/cgi/content/short/2023.05.16.540994v1
The paper entitled, “Novel psilocin prodrugs with altered pharmacological properties as candidate therapies for treatment-resistant anxiety disorders,” outlines comprehensive research performed by scientists at Enveric, supported by affiliated partners at the University of Calgary, and led by Dr. Peter Facchini, Ph.D., professor of biochemistry and Chief Innovation Officer at Enveric. Foundational to the work was the creation of a library of novel prodrug derivatives of psilocin, the active metabolite responsible for the effects of psilocybin, incorporating a diversity of established and metabolically favorable functional groups that reduce the duration of the psychedelic experience produced by psilocybin, while maintaining the long-term mental health benefits. Beginning with twenty-eight unique compounds representing nine distinct prodrug classes, the researchers screened each molecule to generate five unique prodrug derivatives with properties matching and exceeding psilocybin. Of these active prodrugs, two distinct molecules were selected to proceed further as potential therapies for anxiety disorders.
“Psilocybin has shown therapeutic benefit for the treatment of numerous psychiatric diseases; however, due to the high intensity and duration of the psychedelic experience, there is a significant barrier to its widespread therapeutic application,” said Dr. Facchini. “To address this issue, we designed a series of novel psilocin prodrug derivatives that are able to release therapeutically relevant levels of the psychoactive agent psilocin, with improved pharmacokinetic concentration and profiles. We believe this work has the potential to bring dramatically improved drug candidates to the clinic as potential novel therapies for anxiety disorders.”
“The research described in this manuscript demonstrates the potential of Enveric’s discovery platform and engine to identify and develop novel psilocin prodrugs that offer key improvements over conventional psilocybin-assisted therapies,” said Joseph Tucker, Ph.D., Director and CEO of Enveric Biosciences. “Our lead product candidate, EB-373, which was derived from this important work, offers the potential to elicit a more rapid onset of action, more controlled therapeutic effect, and reduced side-effects, which we believe differentiates it from other drugs as a potential novel treatment for anxiety disorders.”
AboutEnveric Biosciences
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. 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 progressing its lead candidate from the EVM201 Series – EB-373 – for the treatment of anxiety disorders. Enveric is also advancing its second program, the EVM301 Series, 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 inducing hallucinations. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.
Forward-LookingStatements
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: achieve the value creation contemplated by technical developments; avoid delays in planned preclinical and clinical trials; carry out successful clinical programs; raise capital in the future when needed; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations on 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 product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; and 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 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.
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