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  • Professor Andrea M. Armani, University of Southern California
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  • Professor Stefan Witte, Delft University of Technology

Enveric Biosciences Receives Notice of Allowance for Lead Drug Candidate EB-003 from United States Patent and Trademark Office

Allowed claims protect composition of matter and methods of use for EB-003, a neuroplastogen targeting undertreated mental health indications

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 it has received a Notice of Allowance (NOA) from the United States Patent and Trademark Office (USPTO) for a patent application pertaining to its EVM301 Series of molecules being developed as potential treatments for mental health disorders.

The USPTO issues a Notice of Allowance after making the determination that a patent should be granted from an application.

The application titled, “N-Hetercycle Substituted Tryptamine Derivatives and Methods of Using,” contains composition of matter and method of use claims for a family of tryptamine derivatives. The allowed claims cover a novel subset of “multi-substituent” tryptamine derivative compounds and also their use to treat brain disorders.

“This NOA is particularly exciting as the allowed claims cover Enveric’s lead candidate, EB-003, which is currently in preclinical development to support an Investigational New Drug (IND) application,” said Joseph Tucker, Ph.D., Director and CEO of Enveric.

Dr. Tucker continued, “EB-003 is intended to target major undertreated mental health indications, including treatment-resistant depression and anxiety. Preclinical testing has shown its potential to promote neuroplasticity without inducing the hallmark hallucinations associated with most psychedelic and psychedelic-inspired molecules.” He added, “EB-003 also potentially offers the opportunity to administer treatment without requiring a healthcare professional to be present during treatment, which would be a paradigm shift compared to first-generation psychedelics.”

The USPTO has granted Enveric a broad range of composition of matter claims for tryptamine derivatives in 12 U.S. patents. Enveric also has 34 national applications pending in the U.S and other countries, and 2 Patent Cooperation Treaty patent applications pending in pursuit of broad national and international patent protection for its key compounds in target countries.

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™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing all other novel, patented Psybrary™ drug candidates to third-party licensees advancing non-competitive market strategies for patient care. 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,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “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, should, would, or might occur or be achieved. Forward-looking statements may include 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: successfully outlicense patented PsybraryTM drug candidates to third-party licensees; negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; 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 research and 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.

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