• Research published in ACS Chemical Biology and BioDesign Research describes new approaches for producing tryptamine and MDMA-derived compounds

CAMBRIDGE, Mass. / Sep 17, 2025 / Business Wire / 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 the publication of two peer-reviewed research papers describing innovative bioproduction strategies for creating therapeutic compounds. While Enveric’s lead candidate EB-003 is manufactured using established synthetic chemistry methods common to the pharmaceutical industry, these publications highlight the Company’s broader scientific leadership in pioneering bioproduction approaches that expand the tools available for drug discovery. The papers were published in ACS Chemical Biology and BioDesign Research.

The first paper, published in ACS Chemical Biology and titled, “Bioproduction of a Large-Scale Library of Tryptamine Derivatives for Neuropsychiatric Drug Screening,” describes how researchers engineered microbial systems to produce a wide range of indolethylamine derivatives relevant to neuroplastogen drug discovery. In total, the effort generated 279 compounds, including 17 novel N-acetylated molecules that were purified and tested for activity across receptors linked to psychiatric disease. Nearly all showed interaction with the melatonin (MT1) receptor, and several also engaged serotonin receptor subtypes. The results show that microbial bioproduction can efficiently generate large, diverse libraries of molecules suitable for high-throughput screening in neuropsychiatric research.

The second paper, published in BioDesign Research and titled, “Bioproduction of 3,4-Methylenedioxymethamphetamine and Derivatives,” reports the first bioproduction method for MDMA and related compounds. The team developed an integrated approach using engineered yeast and enzymatic processing to create phenylacetylcarbinol (PAC) derivatives, which were then advanced through a streamlined pathway that ultimately yielded MDMA and the analog 6-chloro-MDMA. This approach provides a novel alternative to traditional chemical synthesis, which depends on controlled precursor materials, and establishes a foundation for further optimization of microbial methods to produce psychoactive derivatives under investigation for conditions such as post-traumatic stress disorder (PTSD).

“These publications reflect the innovative work of our scientific team and highlight the progress being made in applying bioproduction approaches to neuropsychiatric drug discovery,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “By demonstrating that microbial systems can generate diverse compound libraries and even complex molecules such as MDMA, we are broadening the tools available for identifying new therapeutic candidates. These advances strengthen the scientific foundation of our pipeline and support Enveric’s mission to develop next-generation treatments for psychiatric and neurological disorders.”

Enveric’s development team designed and characterized its lead candidate EB-003, aiming to deliver the therapeutic benefits of neuroplastogens while minimizing hallucinatory effects. Enveric recently announced that EB-003 is believed to be the first representative of a novel potential pharmacological class of neuroplastogens, defined by dual engagement of the 5-HT₂_A and 5-HT₁_B receptors. With encouraging preclinical data supporting its differentiated profile, the company is advancing EB-003 toward an Investigational New Drug (IND) submission, with first-in-human studies anticipated in 2026.

References

1. Bioproduction of a Large-Scale Library of Tryptamine Derivatives for Neuropsychiatric Drug Screening. ACS Chemical Biology. 2025. https://doi.org/10.1021/acschembio.4c00857
2. Bioproduction of 3,4-Methylenedioxymethamphetamine and Derivatives. BioDesign Research. 2025. https://doi.org/10.1016/j.bidere.2025.100011

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-HT₂_A and 5-HT₁_B 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.