• Presentation showcases the profile of EB-003, a non-hallucinogenic, neuroplastogenic DMT analog, which has shown positive outcomes in animal models of anxiety and depression

CAMBRIDGE, Mass. / Sep 25, 2024 / 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 research highlighting the Company’s lead compound, EB-003, is being presented at the 7^th Neuropsychiatric Drug Summit. EB-003 is a promising neuroplastogenic and non-hallucinogenic N,N-Dimethyltryptamine (DMT) analog drug candidate that elicited beneficial outcomes in preclinical models of anxiety and depression. The conference is being held at the Hilton Boston Back Bay in Boston, MA on September 24-26, 2024.

The presentation titled, “Non-hallucinogenic and neuroplastogenic DMT analog imparts positive behavioral outcomes in mice,” addresses the criteria researchers evaluated in the design and development of EB-003 as a non-hallucinogenic derivative of DMT for the treatment of neuropsychiatric disorders, including depression and anxiety. The poster highlights key preclinical data involving EB-003, including two mouse models demonstrating the effectiveness of EB-003 in reducing anxiety and depression, and research examining head twitch response (HTR), a behavioral proxy in rodents for hallucinogenic effects in humans.

This data adds to the library of research supporting the advancement of EB-003 as Enveric’s lead drug candidate. Recently, Enveric reported preclinical data confirming the oral bioavailability of EB-003 and its ability to produce brain exposure at therapeutically relevant levels. Enveric expects to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.

“The research being presented at the 7^th Neuropsychiatric Drug Summit was foundational in our selection of EB-003 as our lead product candidate given its potential ability to treat resistant mental health disorders without the hallucinogenic effect typically associated with DMT-based molecules and related analogs,” said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric. “Coupled with recent evidence demonstrating the ability of EB-003 to achieve optimal brain exposure after oral dosing, this research affirms our belief that EB-003 is highly differentiated from similar drugs in development and has the potential to be a significant value driver for Enveric and our shareholders.”

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, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment for psychiatric disorders. 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,” “schedules,” “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: negotiate and finalize definitive agreements based on the any of its out-licensing term sheets and perform pursuant to the terms thereof; 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.