Enveric Biosciences Provides Strategic Outlook and Pipeline Update, Elevating EB-003 to Lead Development Candidate

EB-003 is a novel, neuroplastogenic molecule designed to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based compounds

Enveric is advancing pre-clinical development of EB-003 with a pre-IND meeting targeted for early 2025

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 the Company is prioritizing the development of EB-003, its first-in-class approach to address difficult-to-treat mental health disorders. EB-003 and other neuroplastogens developed by Enveric are designed to promote neuroplasticity without inducing hallucinations, a hallmark side effect of many psychedelic and psychedelic-inspired compounds. Enveric is currently advancing pre-clinical development activities for EB-003 and targeting a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for early 2025.

“EB-003 has the potential to be a breakthrough neuroplastogen drug candidate that offers the ability to treat resistant mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Minimizing the hallucinatory effect is vital for the clinical development of EB-003 since it will allow for truly blinded placebo-controlled clinical trials and eliminate the need for co-administration of psychotherapy. In addition, minimizing the hallucinatory effect will enable the administration of such therapies in an outpatient setting, and support a more widespread acceptance for psychedelic-inspired drugs.”

Dr. Tucker continued, “The potential advantages of EB-003 were underscored during the recent U.S. FDA Psychopharmacologic Drugs Advisory Committee for Lykos Therapeutics’ MDMA-assisted therapy (Lykos Adcom). During the Lykos Adcom meeting, the advisory committee raised several issues that likely will need to be overcome by hallucination-inducing psychedelics currently in development. Notably, ‘expectation bias’ and the inability to adequately blind both patients and study monitors due to the psychedelic properties of the Lykos candidate decreased reviewer confidence in the efficacy data reported from the studies. Reviewers also questioned the relative contributions of the pharmacological treatment versus the supportive psychotherapy to the reported outcomes and expressed concerns regarding the lack of standardization of the psychotherapy. Enveric believes EB-003 is uniquely designed to address these valid concerns of the Advisory Committee and accordingly have determined to elevate EB-003 to be our lead development candidate to accelerate our plans to advance it to human clinical studies.”

Dr. Tucker concluded, “Data produced thus far has demonstrated EB-003’s ability to bind to the 5-HT2A receptor and induce neuroplasticity while eliciting no significant head twitch response in mice, a behavioral model used to predict the likelihood of a molecule to produce hallucinogenic effects in humans. Confirming this observation in humans will be a top priority in designing the EB-003 clinical program."

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, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of 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,” “proposed,” “budgets,” “explores,” “scheduled,” “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: negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240625428098/en/