Enveric Biosciences Initiates Investigational New Drug (IND)-enabling Genotoxicity Studies of Lead Neuroplastogen Candidate EB-003

Key Terms

investigational new drug (ind) regulatory

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

genotoxicity medical

Genotoxicity is the ability of a chemical or drug to damage DNA or other genetic material in cells, like making cuts or smudges in an instruction manual that can cause mistakes when cells copy themselves. Investors care because evidence of genotoxicity often triggers stricter regulatory reviews, clinical setbacks, product recalls, or liability risks that can delay or reduce the commercial value of a therapy or chemical product.

good laboratory practice (glp) technical

Good Laboratory Practice (GLP) is a set of rules and record-keeping standards that ensure nonclinical laboratory studies—such as safety and toxicity tests—are done consistently, documented fully, and traceable. For investors, GLP compliance signals that preclinical data are reliable and less likely to be rejected by regulators, reducing development and regulatory risk much like a detailed recipe and audit trail make a complex dish repeatable and verifiable.

international council for harmonisation (ich) s2(r1) regulatory

An international regulatory guideline that explains how drug developers should test and interpret whether a compound can damage DNA (genotoxicity) before human use. Think of it as a standardized safety checklist regulators expect for assessing DNA-related risks; following it shapes which lab tests are needed, how results are judged, and can affect development timelines, regulatory reviews, and investment risk in a drug program.

bacterial reverse mutation assay medical

A bacterial reverse mutation assay is a laboratory test that exposes specially engineered bacteria to a substance to see whether the substance causes DNA changes that restore a lost function — like testing whether a broken lock can be picked open by a new key. For investors, the test is a routine early safety check: a positive result can indicate potential genetic risk, prompting extra testing, regulatory scrutiny, higher development costs or limits on market approval.

ames test medical

Ames test is a laboratory assay that checks whether a chemical can cause mutations in DNA by exposing specially engineered bacteria to the substance; it is like a crash test that looks for genetic damage rather than broken parts. Investors pay attention because a positive Ames test can signal potential safety, regulatory or liability problems for products or manufacturing processes, which may lead to extra testing, restrictions, or costs that affect a company’s value.

micronucleus assay medical

A micronucleus assay is a laboratory test that checks whether a drug, chemical or other substance damages a cell’s DNA by counting tiny, extra nuclear fragments called micronuclei in treated cells. Think of it as inspecting a repaired machine for stray parts that fell off — finding micronuclei signals possible genetic harm, which matters to investors because such safety signals can affect regulatory approval, development costs, and commercial risk.

phase 1 clinical trials medical

Phase 1 clinical trials are the first tests of a new drug or medical treatment in humans, done with a small number of volunteers to check safety, side effects, and how the body handles the treatment (such as dosing). For investors, phase 1 is an early de‑risking milestone: successful results let a program advance to larger trials and reduce uncertainty, while safety problems or poor dosing results can sharply affect a drug’s value and development timeline — think of it as the first road test of a prototype.

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Studies are designed to evaluate the potential for the compound to interact with DNA and cause genetic mutations, a critical measure of safety required for IND submission

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 the Initiation of Investigational New Drug (IND)-enabling Genotoxicity studies of its lead candidate neuroplastogen, EB-003.

The initiated Good Laboratory Practice (GLP) studies will evaluate the potential for the compound to interact with DNA and cause genetic mutations, a critical measure of safety required for IND submission. The studies will include a standard battery of tests in compliance with the International Council for Harmonisation (ICH) S2(R1) guidelines including the Bacterial Reverse Mutation Assay/Ames Test and the Micronucleus Assay.

“Initiating these genotoxicity studies marks a significant milestone in the development of EB-003,” said Joseph Tucker, Ph.D., CEO of Enveric Biosciences. “With the recent Executive Order signed by the President on April 18, 2026, the landscape has shifted, potentially expediting research for compounds in the psychedelic and neuroplastogen field. Our preclinical studies are pivotal to ensuring we continue to meet the highest standards of safety as we progress towards first-in-human Phase 1 clinical trials.”

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 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 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 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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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