Cybin Inc. announced the completion of dosing of the final cohort in its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog program in development for the potential treatment of major depressive disorder ("MDD"). The CYB003 program is supported by a composition of matter patent with protection through 2041. The Company expects to release topline efficacy data in the fourth quarter of this year.

The following doses were evaluated in the six cohorts: 1mg, 3mg, 8mg, 10mg, 12mg, and 16mg. To date, CYB003 has been shown to be safe and tolerable at all doses evaluated with no serious adverse events or discontinuations due to adverse events having been observed in the final dose cohort. Cybin's preparation for the next stage of development include: Commencement of dosing with capsule formulation in the bio equivalence cohort to enable more convenient dosing in Phase 3;.

End of Phase 2 meeting expected in First Quarter 2024, to review the Phase 3 study design; Developing EMBARK for Clinical Trials ("EMBARKCT") as a scalable model of psychedelic facilitation training to support future pivotal studies; and partnering with Worldwide Clinical Trials, a global, full-service contract research organization with a successful track record managing clinical trials for mental health conditions, including MDD; and. Initiating preparations for good manufacturing practices ("GMP") production of a capsule formulation of CYB003 - a robust solid dosage capsule form designed to be stable, dose flexible, patient-friendly, and commercially scalable, to be evaluated in a potential Phase 3 trial.