Enveric Biosciences Reports New Preclinical Data Supporting the Non-Hallucinogenic Profile of Lead Candidate EB-003

Key Terms

camp assay technical

A cAMP assay measures the level of cyclic adenosine monophosphate (cAMP), a common cellular messenger that carries signals from receptors on the cell surface into the cell’s interior. Think of cAMP as a relay baton: the assay tells researchers whether a drug or molecule makes cells pass the baton faster, slower, or not at all. For investors, results from cAMP assays indicate how candidate drugs interact with target receptors and help gauge early-stage pharmacology and mechanism-of-action data that can affect drug development risk and value.

bret assay technical

A BRET assay is a laboratory technique that detects when two molecules come close together inside living cells by measuring light energy transferred from a luciferase enzyme (which glows) to a nearby fluorescent tag. Think of it like a tiny flashlight passing its beam to a light-up sticker only when they touch; the glow strength indicates interaction. Investors care because it’s widely used in drug discovery and diagnostics to validate biological targets and screen compounds, influencing the pace and reliability of R&D.

5-ht2a receptor medical

A 5-HT2A receptor is a specific protein on the surface of certain brain and body cells that binds the neurotransmitter serotonin and helps control mood, perception, and cognition. It matters to investors because many psychiatric and neurological drugs—such as antidepressants, antipsychotics, and certain experiential or psychedelic therapies—work by targeting this receptor; think of it as a light switch that drug developers aim to turn on or off to change how brain circuits behave, which can affect a treatment's market value and regulatory path.

gi activation medical

Activation of the Gi pathway means a drug or molecule engages a type of G protein (called Gi) tied to cell-surface receptors, which typically lowers the cell’s production of cyclic AMP and changes downstream signaling. For investors reading clinical or regulatory updates, reports of Gi activation indicate a specific mechanism of action and target engagement—like flipping a switch that slows certain cellular signals—which can help explain expected effects, side-effect profiles, and how a therapy differs from competitors.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

GloSensor™ assay findings align with previously reported BRET assay data as EB-003 advances toward planned Phase 1 clinical 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 new preclinical data that further supports the growing body of evidence reinforcing the non-hallucinogenic profile of its lead candidate, EB-003.

Preclinical testing of EB-003 was conducted using a targeted, highly sensitive GloSensor™ cAMP assay, which has been previously described in peer-reviewed scientific literature (Wang et al., 2022)¹. The Promega GloSensor™ cAMP assay is a highly sensitive live-cell test designed to detect subtle Gi-coupled receptor responses in real time.

The study evaluated EB-003 alongside known hallucinogenic and non-hallucinogenic reference compounds and produced results that the Company believes are consistent with recently published Nature research (Xu et al., 2026)², which identified signaling characteristics that distinguish compounds predicted to be hallucinogenic from those expected to be non-hallucinogenic in humans. The 2026 Nature paper by Xu and colleagues linked 5-HT_2A receptor-mediated Gi activation with hallucinogenic compounds, suggesting that the strength of this signaling response may help predict whether a drug will be hallucinogenic in humans. In Enveric’s study evaluations, EB-003 consistently fell within the non-hallucinogenic range.

The new findings, together with Enveric's previously reported BRET assay results, provide complementary evidence supporting Enveric's differentiated approach to developing non-hallucinogenic neuroplastogenic therapeutics. The expanding body of preclinical evidence supports the Company's development strategy as it advances EB-003 toward a first-in-human clinical trial.

"These new findings further support our previous studies regarding the differentiated design of EB-003 and its non-hallucinogenic profile," said Joseph Tucker, Ph.D., CEO of Enveric Biosciences. "The consistency of the data across multiple independent assay platforms provides important validation of our approach as we prepare to advance EB-003 into Phase 1 clinical development. As the FDA continues to define the regulatory framework for psychedelic-inspired therapies, we believe compounds designed to preserve the therapeutic potential of neuroplasticity without requiring a hallucinogenic experience could offer meaningful advantages in clinical development while supporting broader patient access and potential commercial adoption.”

The U.S. Food and Drug Administration (FDA) recently issued final guidance outlining the unique clinical, operational and regulatory considerations associated with the development of hallucinogenic psychedelic therapies. The guidance discusses challenges related to functional unblinding, patient monitoring, psychotherapy requirements, and trial design. If EB-003's non-hallucinogenic profile is confirmed in human studies, Enveric believes the drug may avoid or mitigate many of these complexities, potentially enabling more conventional blinded clinical trials, a simpler outpatient treatment paradigm, and broader commercial scalability, if approved.

1.		Wang FI, Ding G, Ng GS, Dixon SJ, Chidiac P. Luciferase-based GloSensor™ cAMP assay: Temperature optimization and application to cell-based kinetic studies. Methods. 2022 Jul;203:249-258. doi: 10.1016/j.ymeth.2021.10.009. Epub 2021 Nov 2. PMID: 34737032.
2.		Xu, Z., Wang, H., Yu, J. et al. Psychedelics elicit their effects by 5-HT2A receptor-mediated Gi signalling. Nature (2026). https://doi.org/10.1038/s41586-025-10061-7.

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, including, without limitation, statements regarding Enveric’s development of EB-003, the Company’s planned IND submission and planned Phase 1 clinical development of EB-003, the potential implications of the preclinical GloSensor™ cAMP assay results and previously reported BRET assay results, the potential implications of EB-003’s design, receptor activity and preclinical profile, the potential for EB-003 to be non-hallucinogenic in humans, and Enveric’s beliefs regarding the potential implications of FDA guidance for psychedelic drugs to EB-003 and its planned clinical development. 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; receive clearance to initiate clinical trials; confirm in human clinical trials any non-hallucinogenic, safety, tolerability, efficacy, durability, dosing, treatment-delivery or outpatient-use profile suggested by preclinical studies; 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 or update 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/20260805599685/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