Enveric Biosciences Reports Differentiated Brain Activity Profile for EB-003 in Preclinical qEEG Study

EB-003 did not produce the epileptic-like EEG activity or acute body spasms observed with DMT in mice.

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Findings support central nervous system penetration and functional brain activity differentiated from the classic psychedelic DMT

Results support use of qEEG as a potential pharmacodynamic biomarker in first-in-human development

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 results from a quantitative electroencephalography (qEEG) study of its lead candidate, EB-003, in mice. The study demonstrated modulation of brain activity in prefrontal and parietal regions of the cortex, providing functional evidence of central nervous system penetration and revealing a neurophysiological profile differentiated from dimethyltryptamine (DMT), a classic hallucinogenic psychedelic.

The study evaluated EB-003 in mice using continuous qEEG recording across a broad range of brain-wave frequency bands, with DMT included as a comparator. The study achieved its primary objective of establishing a translational pharmacodynamic measure of EB-003’s effects on cortical brain-wave oscillations. Additionally, in the study, DMT induced notable epileptic-like EEG activity and acute body spasms. EB-003 did not elicit similar findings, indicating a more favorable neurophysiological profile.

Quantitative EEG measures the brain’s electrical activity across different frequency bands, and maps them across brain regions, providing a method to characterize how a drug affects brain electrical function. The results generated in this study strengthen the rationale for evaluating qEEG in EB-003’s planned first-in-human program, where it could complement safety and pharmacokinetic assessments and help inform dose selection for later studies.

“These results demonstrate EB-003 induces measurable activity in relevant brain regions with a profile differentiated from DMT, providing additional evidence of EB-003’s unique pharmacological profile and mechanism of action,” said Joseph Tucker, Ph.D., Director and Chief Executive Officer of Enveric Biosciences. “The research has also identified qEEG as a suitable objective biomarker that we can utilize in upcoming human studies. As we advance toward our planned Phase 1 clinical trial of EB-003, the ability to correlate drug exposure to changes in brain activity on qEEG could help us identify biologically active doses and make more informed decisions for subsequent trials.”

Key findings included:

• Functional brain activity: EB-003 modulated brain-wave oscillations in prefrontal and parietal cortical regions, providing an objective measure of its effects on brain function.
• Differentiated neurophysiological signature: EB-003 produced a brain-wave profile different from DMT, adding a new dimension to the evidence supporting its differentiated pharmacology.
• Favorable safety observations: EB-003 did not induce abnormal epileptiform brain activity or disruptive sedation patterns. These findings complement the promising safety profile observed previously in animal toxicology studies.
• A potential bridge to clinical development: The findings of this study support evaluation of qEEG as a pharmacodynamic biomarker in first-in-human trials, with the potential to correlate drug exposure to functional effects in the brain.

EB-003, Enveric’s lead neuroplastogen candidate, is designed to engage both 5-HT_2A and 5-HT_1B receptors with the potential to promote neuroplasticity without hallucinogenic effects. The new qEEG findings expand the preclinical evidence supporting EB-003’s differentiated profile as the Company advances toward clinical development.

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-HT_2A and 5-HT_1B 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 interpretation and potential significance of the preclinical qEEG study results; the potential central nervous system, neuroplastogenic, non-hallucinogenic, therapeutic or other properties of EB-003; the potential use of qEEG as a pharmacodynamic biomarker; the potential ability to correlate drug exposure with changes in brain activity, identify biologically active doses or inform dose selection; the timing or completion of IND-enabling studies or an IND submission; the initiation, design, timing or results of a planned Phase 1 clinical trial; and Enveric’s development plans and regulatory strategy for EB-003. 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.

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

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
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Source: Enveric Biosciences

Key Terms

quantitative electroencephalography medical

Quantitative electroencephalography (qEEG) is a technique that takes raw EEG brainwave recordings and uses mathematical and statistical methods to turn them into quantified measures, visual maps and comparisons against reference databases. Think of it like converting raw audio into a visual equalizer and numerical scores that highlight patterns. It matters to investors because qEEG is used as an objective biomarker in clinical research, medical device development, diagnostic tools and regulatory submissions, affecting product claims, market size and reimbursement potential.

pharmacodynamic biomarker medical

A pharmacodynamic biomarker is a measurable biological change that shows a drug is having an effect on its intended target, pathway, or biological process in the body. It can be a molecule, cell count, enzyme activity, imaging signal, or other laboratory measure that changes after dosing and is used to demonstrate target engagement, dose–response, or proof of mechanism; it does not by itself prove clinical benefit unless separately validated as a surrogate endpoint. Pharmacodynamic biomarkers are distinct from pharmacokinetic measures (which track the drug’s concentration over time) and from clinical outcome measures (which track symptoms, function, or survival).

pharmacokinetic medical

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

epileptiform medical

Describing brain electrical activity that resembles patterns seen in epilepsy—typically spikes, sharp waves, or sudden repetitive discharges on an electroencephalogram (EEG). Epileptiform activity indicates abnormal, hyper-excitable neuronal firing associated with increased likelihood of seizures, but it is a physiological pattern on a test result rather than a standalone diagnosis; it can appear without clinical seizures and can be transient or provoked by medications, sleep deprivation, metabolic disturbances or acute brain injury.