Pipeline

Pipeline Programs

EB-003

Program Status and Projected Milestones

Phase 1a Plans

  • SAD in Healthy Volunteers, 8 subjects/dose group (6 + 2 pbo subjects), 4 dose levels
  • Additional safety monitoring for hallucinogenic effects
  • To include biomarkers (e.g., qEEG, monoamine metabolites, prolactin, cortisol, ACTH, BDNF)

Phase 1b Plans

  • MAD in Healthy Volunteers, 8 subjects/group (6+ 2pbo subjects), 4 dose levels, one cohort with food effect, 14-day treatment
  • Additional safety monitoring for hallucinogenic effects
  • Biomarkers (e.g., qEEG,, monoamine metabolites, prolactin, cortisol, ACTH, BDNF)
  • Patient cohorts (diagnosis, number of cohorts, dose and number of patients TBD), 28-day treatment under consideration; early evaluation of efficacy
  • Possible diagnoses include MDD, TRD, GAD, PTSD

Abbreviation Definition
ACTH Adrenocorticotropic hormone
BDNF Brain-derived neurotrophic factor
CMC Chemistry, manufacturing and controls
GAD Generalized anxiety disorder
GLP Good laboratory practice
GMP Good manufacturing practice
IND Investigational new drug
MAD Multiple ascending dose
MDD Major depressive disorder
MOA Mechanism of action
PBO Placebo
PTSD Post-traumatic stress disorder
qEEG Quantitative electroencephalography
SAD Single ascending dose
TRD Treatment-resistant depression

Prescription Model

Highlights

  • Moderate dose
  • Prescription model
  • Taken regularly
  • Minimal side effects and reduced hallucinations
  • Available to a large patient population

EB-003 is a novel neuroplastogen that engages both the 5-HT2A and 5-HT1B receptors, a dual mechanism that may define a new class of neuropsychiatric treatments. This unique pharmacological profile is designed to promote adaptive rewiring of brain circuits while stabilizing emotional and behavioral regulation — potentially enabling durable recovery in patients with post-traumatic stress disorder (PTSD), treatment-resistant depression, and generalized anxiety. Pre-IND results suggest a fast-acting, well-tolerated, non-hallucinogenic therapy for patients underserved by current options, positioning EB-003 as a differentiated candidate in the competitive mental health space.

Key Investment Highlights

  • Differentiated mechanism: Dual engagement of 5-HT2A and 5-HT1B receptors
  • Large addressable market: Multiple high-burden psychiatric conditions with limited effective treatments
  • Compelling preclinical profile: Fast-acting, durable, and non-hallucinogenic
  • Convenience: Oral administration, no in-clinic dosing required
  • Favorable safety signals: Reduced hallucination risk and improved cardiac safety

EVM401

Enveric’s EVM401 series consists of novel phenylalkylamines and indolethylamines, including mescaline-derived compounds, that demonstrate promising interactions with key brain receptors involved in mental health disorders and addiction. Mescaline is a naturally occurring psychedelic alkaloid found in certain cacti, such as peyote and San Pedro, known for its ability to alter perception, cognition, and mood. Early research suggests these compounds may have the potential to help manage opioid withdrawal, attention-deficit/hyperactivity disorder (ADHD), anxiety, depression, and substance use disorders by targeting receptors linked to these conditions.

While Enveric’s primary focus remains on advancing EB-003 toward clinical trials, advancing the EVM401 series reinforces the Company’s commitment to expanding its pipeline and driving innovation in mental health treatment.