Cybin Provides Corporate Update on Upcoming Clinical Milestones

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported recent clinical accomplishments and key upcoming clinical milestones.

“We are making rapid advancements in our two lead clinical programs – CYB003, our proprietary deuterated psilocin program in development for the adjunctive treatment of Major Depressive Disorder and CYB004, our proprietary deuterated dimethyltryptamine program for the treatment of Generalized Anxiety Disorder. We have made significant progress in preparing for our upcoming Phase 3 programs and have appointed two experienced drug development experts, Dr. Atul R. Mahableshwarkar, and Dr. Tom Macek, to lead our CYB003 and CYB004 programs, respectively. As we evolve into a Phase 3 Company, we are well positioned among the top tier in our sector and believe that we have the potential to deliver innovative, next-generation approaches to address these challenging mental health disorders,” said Doug Drysdale, Chief Executive Officer of Cybin.

CYB003: A proprietary deuterated psilocin program with FDA Breakthrough Therapy Designation for the adjunctive treatment of MDD

CYB003 is the Company’s lead program that is preparing to enter Phase 3 development and has received FDA Breakthrough Therapy Designation (“BTD”), which validates CYB003's potential for significant clinical improvements over existing treatments based on preliminary results and serves to expedite CYB003’s development pathway towards commercialization.

In August 2024, the Company held a productive Type B Initial Breakthrough Therapy Meeting with the U.S. Food and Drug Administration (“FDA”) in preparation for the imminent commencement of its CYB003 pivotal program in MDD. For the upcoming Phase 3 study, Cybin has selected 30 high quality clinical sites across the United States and Europe. The Phase 3 pivotal trial design incorporates several elements to address critical methodological issues such as functional unblinding that are considered important for drugs in this class.

To date, results from a completed Phase 2 MDD study of CYB003 have shown rapid, robust improvements in symptoms of depression with a single dose, and durable effects four months after two doses with a 75% remission rate in the 16mg dose group. The Company expects to report 12-month Phase 2 efficacy data in early Q4 2024, providing further insights into CYB003’s potential to provide long-lasting relief for MDD patients.