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Enveric Biosciences Receives FDA Response and Streamlines Plans for EB-003 IND Submission

By: via Business Wire

Enveric expects to file Investigational New Drug application for EB-003 in early 2026

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) to its request for a Pre-Investigational New Drug (pre-IND) Type B meeting for its lead program, EB-003.

In its response, the FDA indicated that the questions for the pre-IND meeting proposed by Enveric were a matter for IND application review and FDA recommends that Enveric proceed to submitting its IND application and protocol for review. Enveric interprets this outcome as consistent with the view that the Company is sufficiently advanced in its development strategy to proceed past the pre-IND meeting milestone.

As a result, Enveric will streamline its regulatory path by advancing toward the submission of its IND application for EB-003. The Company views this transition as in alignment with its development strategy providing a clear path forward to clinical evaluation.

“We are encouraged by the FDA’s response, which enables us to focus our efforts on advancing EB-003 into clinical development,” said Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences. “The IND submission for EB-003 is an inflection-point for Enveric, and we believe we are well positioned to execute efficiently on our clinical strategy and continue building value across our pipeline.”

EB-003 is Enveric’s lead neuroplastogen, designed as a dual-acting compound with the potential to address depression and anxiety by promoting durable neuroplastic changes without hallucinogenic effects. Enveric’s pipeline is supported by its broad patent estate, which includes 26 issued U.S. patents and 60 pending national and international applications covering multiple differentiated molecules.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric’s lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT₂A and 5-HT₁B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

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: 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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