Enveric Biosciences Successfully Completes Key Manufacturing Milestones in Support of Planned IND and Clinical Trials

Key CMC achievements advance EB-003 on the path to first-in-human trials

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(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 significant progress in the chemistry, manufacturing, and controls (CMC) development of its lead candidate, EB-003. Important steps in scaling production and preparing the drug for required regulatory activities have been achieved, advancing EB-003 toward the critical milestone of initiating human clinical trials.

As part of its CMC program, Enveric has recently completed the following key activities:

• Identified and produced a pharmaceutically compatible salt form designed to potentially improve drug effectiveness and stability
• Developed and implemented a scalable, reproducible synthetic route for EB-003 suitable for both current and future manufacturing needs
• Successfully produced a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support upcoming Investigational New Drug (IND) application activities, including GLP toxicology studies and drug product formulation work

“These manufacturing and formulation milestones are essential for positioning EB-003 to enter clinical development,” said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric Biosciences. “By demonstrating that EB-003 can be synthesized at scale in a pharmaceutically acceptable salt form and manufactured in kilogram quantities, we are reducing development risks and accelerating our path to human trials.”

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