• Expands its intellectual property portfolio with composition of matter claims governing lead clinical candidate, EB-373, a psilocin prodrug being developed for the treatment of depression and anxiety disorders.

CAMBRIDGE, Mass. / Oct 31, 2023 / Business Wire / 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 involving EB-373, the Company’s new chemical entity (NCE) prodrug of psilocin.

The soon-to-issue patent, titled, “C4-Carbonothioate-substituted Tryptamine Derivatives and Methods of Using,” contains composition of matter claims for a family of novel prodrug derivatives of psilocin, including EB-373, Enveric’s lead product candidate. The USPTO issues an NoA after making the determination that a patent should be granted from an application.

Enveric has filed multiple composition of matter patent applications with the USPTO for psilocin prodrugs, including those comprising a crystalline molecular structure, and has submitted additional filings for companion Patent Cooperation Treaty and non-US national patent applications in an effort to obtain broad protections in target countries for its EVM201 and EVM301 Series of compounds. To date, the USPTO has issued seven NoAs for patent applications claiming compounds in the EVM201 and EVM301 Series. Two applications are now granted patents that specifically protect EB-373; and one application is now a granted patent covering certain EVM301 compounds. We believe the Company is establishing a robust intellectual property position that protects the Company’s lead compounds through this growing portfolio of allowed patent applications and patents.

“Extensive and multilayered IP for our NCE compounds is an important value driver for Enveric as we seek to develop improved treatments for patients living with severe and difficult to treat mental health disorders,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “This recent positive decision from the USPTO strengthens the IP for our lead candidate, EB-373, and highlights the advanced molecular design capabilities of our research team in developing unique and novel psilocin prodrugs. We look forward to bringing EB-373 to clinical trials soon to assess the potential of this compound to elicit a more rapid onset of action, more controlled therapeutic effect, and reduced gastrointestinal side-effects compared to conventional psilocin prodrugs, such as psilocybin.”

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.