Enveric Biosciences Announces Positive Results from Recently Completed IND-enabling ADMET Studies

Laboratory testing predicted favorable intestinal absorption and suggested reduced potential for drug-drug interactions.

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Completed IND-enabling in vitro Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET) studies, demonstrating favorable and efficient oral absorption and systemic bioavailability

Results further derisk the potential for drug-drug interactions, provide additional data supporting the safety profile of EB-003

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced positive results from recently completed IND-enabling in vitro Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET) studies for its lead non-hallucinogenic, neuroplastogenic candidate EB-003.

The comprehensive in vitro screen, involving a battery of over 70 individual assays, demonstrated favorable properties of EB-003 including:

• Predicted to have favorable intestinal absorption potential when evaluated in human cell-based membrane permeability tests
• Does not show significant in vitro plasma protein binding suggesting favorable biodistribution and clearance properties when the drug enters the bloodstream
• Demonstrates stability when evaluated against liver metabolism enzymes from multiple species, including human
• Is not a substrate of key liver and renal transporters in vitro, suggesting favorable systemic drug exposure and a more predictable drug elimination profile
• Does not show significant inhibition or induction of major metabolic enzymes and multidrug transporter proteins, reducing the possibility of drug-drug interactions

“These results represent an important milestone in the development of EB-003, provide additional support for its preclinical development profile, and support its continued advancement toward a planned first-in-human clinical trial," said Joseph Tucker, Ph.D., Director and Chief Executive Officer of Enveric. “So far, the data generated from our IND enabling studies have showcased a differentiated pharmacological profile for EB-003, with the potential to preserve certain therapeutic benefits associated with neuroplasticity while minimizing safety concerns and hallucinogenic impacts.”

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 with the potential 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, including, without limitation, statements regarding the expected issuance of the allowed patent application; the expected scope, strength, value or enforceability of any patent that may issue; Enveric’s intellectual property strategy; the potential therapeutic, neuroplastogenic, non-hallucinogenic, drug-like, blood-brain-barrier penetration, metabolic stability, oral administration or other properties of compounds in the EVM401 Series; the potential treatment of PTSD or other psychiatric or neurological disorders; the potential relevance of methylone-based therapies or third-party clinical data to Enveric’s development programs; and Enveric’s development plans, regulatory strategy and expectations regarding future preclinical or clinical studies. 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 application 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 sufficient future funding for product development, clinical development activities, working capital and other operating expenses on commercially reasonable terms, or at all; 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/20261021565311/en/

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.com

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com

Source: Enveric Biosciences

Key Terms

admet technical

ADMET is the shorthand for a drug candidate’s absorption, distribution, metabolism, excretion and toxicity — the key ways it behaves and is processed in the body. Investors watch ADMET because favorable results indicate a medicine is likely to reach its target, be safe enough, and survive development and regulatory review; poor ADMET is a common, early reason a program fails, like a car that looks good but won’t run reliably or safely.

systemic bioavailability medical

The fraction of an administered drug dose that reaches the bloodstream in an active form and is available to produce effects throughout the body. It is usually expressed as a percentage of the original dose and is measured by comparing blood concentrations over time (commonly area under the curve, AUC) after the tested route or formulation versus a reference (often intravenous). Systemic bioavailability is distinct from local exposure (which affects only the site of administration) and is affected by formulation, absorption, first‑pass metabolism and clearance.

plasma protein binding medical

Plasma protein binding measures how much of a drug sticks to proteins in the blood versus floats free. Like passengers getting into taxis, only the free passengers can reach destinations—only the unbound portion of a drug can act on tissues or be cleared by the body. For investors, high or variable binding affects a drug’s potency, dosing, side effects and interactions, which influence clinical success and commercial value.

drug-drug interactions medical

When two or more medicines are taken together and one changes how the other works, that is a drug-drug interaction. For investors this matters because such interactions can reduce a drug’s effectiveness or increase side effects, potentially leading to additional testing, label warnings, limits on use, or lost sales—similar to how combining ingredients can ruin a recipe or make it unsafe, altering the product’s value and market prospects.

ind-enabling regulatory

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.