EB-003 / Enveric Biosci - LARVOL DELTA

Enveric Biosciences Successfully Completes Key Manufacturing Milestones in Support of Planned IND and Clinical Trials (Enveric Press Release) - "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"

Preclinical • CNS Disorders

Enveric Biosciences Receives FDA Response and Streamlines Plans for EB-003 IND Submission (Businesswire) - "Enveric expects to file Investigational New Drug application for EB-003 in early 2026....In its response, the FDA indicated that the questions for the pre-IND meeting proposed by Enveric were a matter for IND application review and FDA recommends that Enveric proceed to submitting its IND application and protocol for review. Enveric interprets this outcome as consistent with the view that the Company is sufficiently advanced in its development strategy to proceed past the pre-IND meeting milestone."

FDA event • IND • Depression • Post-traumatic Stress Disorder

Enveric Biosciences Lead Drug Candidate EB-003 Demonstrates Positive Effects in Preclinical Model of Post-Traumatic Stress Disorder (PTSD) (Businesswire) - "Enveric Biosciences...announced positive results in a preclinical, exposure-based therapeutic model for post-traumatic stress disorder (PTSD). In fear conditioned mice, oral administration of EB-003 significantly decreased context-induced freezing behavior when measured one-hour post-dose (p < 0.05) indicating a positive therapeutic effect with extinction of contextual fear after a single dose. These results were in line with the therapeutic effects observed with MDMA, which was used as a positive control in this study."

Preclinical • Post-traumatic Stress Disorder

Enveric Biosciences Participating in BIO-Europe Spring (Businesswire) - "Enveric Biosciences...today announced its participation in BIO-Europe Spring, which is being held in Milan, Italy, March 17-19, 2025...During the Spring partnering event, members of Enveric’s management team are conducting one-on-one meetings with registered investors and potential partners, showcasing the company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones....'We anticipate a highly productive meeting at BIO-Europe Spring as we continue to garner interest in our strategic approach to developing neuroplastogenic molecules, led by EB-003, for the treatment of underserved mental health conditions.'"

Pipeline update • CNS Disorders

Enveric Biosciences Receives Notice of Allowance for Lead Drug Candidate EB-003 from United States Patent and Trademark Office (Businesswire) - "Enveric Biosciences...announced that it has received a Notice of Allowance (NOA) from the United States Patent and Trademark Office (USPTO) for a patent application pertaining to its EVM301 Series of molecules being developed as potential treatments for mental health disorders....The application titled, 'N-Hetercycle Substituted Tryptamine Derivatives and Methods of Using', contains composition of matter and method of use claims for a family of tryptamine derivatives. The allowed claims cover a novel subset of 'multi-substituent' tryptamine derivative compounds and also their use to treat brain disorders....'This NOA is particularly exciting as the allowed claims cover Enveric’s lead candidate, EB-003, which is currently in preclinical development to support an Investigational New Drug (IND) application'."

Patent • CNS Disorders

Enveric Biosciences Announces Poster Presentations of Lead Programs at the 2022 International Neurology & Brain Disorders Conference (Businesswire) - “Enveric Biosciences…announced the presentation of results from its lead programs at the 6th International Neurology & Brain Disorders Conference (INBC) to be held on October 24-26, 2022, in Orlando, Florida…Enveric’s first poster presentation, related to the EVM201 development program, describes the screening and pharmacological characterization of a portfolio of novel psilocin prodrugs, comprising of nine distinct prodrug classes….Enveric’s second poster presentation, related to the EVM301 development program, describes the discovery and characterization of novel methods and tools to accelerate the future discovery of additional promising neuroactive drug candidates.”

Clinical data • CNS Disorders