Enveric Biosciences Reports Positive Preclinical Results for EB-003 and Corporate Updates

Enveric Biosciences has reported positive preclinical results for its lead drug candidate EB-003 and provided corporate updates following the filing of its 10-K on March 27, 2026, which reported financial results for the fourth quarter and year ended December 31, 2025. The biotechnology company is advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, with EB-003 showing statistically significant improvements in animal models of severe chronic depression and despair and in post-traumatic stress disorder (PTSD).

The company has received FDA response allowing for streamlined plans for EB-003 IND submission and successfully completed pre-IND dose range finding studies establishing maximum tolerated dose, supporting progression toward IND-enabling studies and first-in-human clinical trials. In preclinical, exposure-based therapeutic models for PTSD, EB-003 showed significantly decreased context-induced freezing behavior one-hour post-dose.

Proprietary bioluminescence resonance energy transfer (BRET) assays developed by Enveric demonstrate that EB-003 engages both Gq and β-arrestin signaling pathways at 5-HT₂A receptors, pathways linked in peer-reviewed studies to antidepressant and anxiolytic effects. The data indicate that EB-003 exhibits a modest preference toward β-arrestin over Gq signaling relative to serotonin, the native ligand of the receptor.

A recently published study in Nature employing BRET assays and complementary techniques provides additional mechanistic clarity regarding signaling downstream of 5-HT₂A. The study reports that Gi signaling downstream of 5-HT₂A was required for hallucinogenic effects in the experimental models evaluated, while Gq signaling mediated antidepressant- and anxiolytic-like benefits in preclinical systems. These findings indicate that therapeutic benefit and hallucinations may arise from distinct intracellular pathways.

The company's CEO stated that 2025 was a year of important scientific progress as they further strengthened the mechanistic rationale for EB-003, a non-hallucinogenic neuroplastogen being developed for the treatment of underserved mental health conditions. The research team has continued to produce novel data, confirming EB-003's dual-mechanism of action and its ability to promote neuroplasticity without hallucinogenic effects in animal models.

Enveric is now in the process of completing IND-supporting studies in preparation for submitting an IND application to the FDA. In 2026, the company is working towards a streamlined IND application for EB-003 in preparation of the initiation of a first-in-human Phase 1 clinical trial. With the dual mechanism of action that engages both 5-HT2A and 5-HT1B receptors, the company is optimistic that its research has the potential to profoundly impact mental health disease where innovation has been lacking for decades.

On the corporate front, Enveric announced the withdrawal of the Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric's issued U.S. Patent No. 12,138,276, which appears relevant to the bretisilocin (GM-2505) molecule acquired by AbbVie, Inc. The company has continued to strengthen its expansive IP portfolio directed to molecules intended to provide non-hallucinogenic treatment options, with multiple patents and notices of allowance issued for its EVM301 Series and EVM401 Series.

The company has also identified neuroplastogen candidates with potential to promote brain-derived neurotrophic factor (BDNF) signaling, an established therapeutic target for neurodegenerative disease. EB-003 is being developed to be a non-hallucinogenic neuroplastogen intended to support streamlined treatment paradigms, including potential at-home administration, and is the first known compound designed to selectively engage both 5-HT₂A and 5-HT₁B receptors with the potential to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.