Cybin Inc. announced that it has received a may proceed letter and Investigational New Drug Application ("IND") clearance from the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003. CYB003 is a proprietary deuterated psilocybin analog that is being developed for the potential treatment of major depressive disorder (MDD). This milestone marks the industry's first ever novel psilocybin analog to enter clinical development.

The Company will begin recruiting patients immediately and expects to provide an interim pharmacokinetic (PK) and safety data readout in Fourth Quarter 2022.