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CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On May 24, 2023, Enveric Biosciences, Inc. (the “Company”) issued a press release announcing the Company’s receipt of a notice of allowance from the USPTO for C4-Carboxylic Acid-substituted Tryptamine Derivatives for a next generation psilocin prodrug. 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 May 24, 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: May 24, 2023 | ENVERIC BIOSCIENCES, INC. | |
| By: | /s/ Joseph Tucker | |
| Joseph Tucker | ||
| Chief Executive Officer | ||
Exhibit 99.1

Enveric
Biosciences Receives Notice of Allowance from USPTO for C4-Carboxylic Acid-substituted
Tryptamine Derivatives for Next Generation Psilocin
Prodrug
New composition of matter claims expand intellectual property for Enveric’s EVM201 Series
CAMBRIDGE, Mass., May 24, 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, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application involving its EVM201 Series. This is the second Notice of Allowance from the USPTO for intellectual property governing the EVM201 Series. Notices of Allowance are issued by the USPTO after it has made a determination that a patent should be granted from an application.
The soon-to-issue patent, titled, “C4-Carboxylic Acid-Substituted Tryptamine Derivatives and Methods of Using,” contains composition of matter claims for a family of novel prodrug derivatives of psilocin that is structurally different from the recently announced Notice of Allowance for C4-carbonothioate-substituted tryptamine derivatives. Collectively, it is expected that the two patent families will provide Enveric with a robust intellectual property portfolio governing psilocin prodrugs designed to potentially elicit a more rapid onset of action, more controlled therapeutic effect, and reduced gastrointestinal side-effects compared to conventional psilocin prodrugs, such as psilocybin.
“This latest Notice of Allowance related to our EVM201 Series highlights the unique psilocin prodrug designs being developed by our R&D team, which are differentiated from other psilocybin-assisted therapies in both design and expected function,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Securing intellectual property to protect our technological advances is a critical component to our growth strategy, and we anticipate multiple additional claims in the coming months for both our EVM201 and EVM301 Series.”
In addition to the two EVM201 Series-focused Notices of Allowance, Enveric has filed 10 distinct patent families to date protecting its EVM301 Series. Enveric’s EVM301 Series of small molecule therapies are specifically designed to promote neuroplasticity and show efficacy in animal models of depression and anxiety without inducing the hallmark hallucinations of other psychedelic or psychedelic-inspired agents.
About Enveric 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 developing the first product 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 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; manage its future growth effectively; achieve the intended benefits of the cost reduction plan to the extent or as quickly as anticipated; transition from third-party service providers supporting R&D efforts to internal science teams without any adverse impact on Enveric’s ongoing and planned clinical trials; and engage the cost reduction plan efforts without negatively impacting Enveric’s business operations and reputation.
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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