Cybin Highlights Neuropsychiatry Platform and 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 through proprietary drug discovery platforms and innovative delivery systems, today highlights significant clinical and regulatory milestones and upcoming value-driving catalysts as the Company advances multiple programs towards potential commercialization.

"We have established a leading position in the psychedelic therapeutics space through Cybin’s proprietary drug discovery platforms that combine novel deuterated molecules with innovative drug delivery systems. Our intellectual property portfolio represents one of the most comprehensive collections of patents in the neuropsychiatry sector, providing a potentially significant competitive moat across multiple indications and expected exclusivity until 2041," said Eric So, Interim Chief Executive Officer of Cybin.

Key Neuropsychiatry Platform Differentiators:

• Novel Drug Delivery Systems: Advanced formulation approaches, including oral and intramuscular delivery mechanisms, are optimized for clinical and commercial scalability.
• Scalable Manufacturing Partnerships: Thermo Fisher Scientific has been engaged to provide U.S.-based commercial-scale manufacturing capabilities for the CYB003 program.

Upcoming Milestones

CYB003 Phase 3 PARADIGM Program in MDD - Key Catalysts:

• APPROACH Study: Enrollment of 220 participants across 45 clinical sites in the U.S., with topline data expected in the fourth quarter of 2026
• EMBRACE Study: Initiation expected in Q4 2025, targeting 330 participants with moderate to severe MDD. EMBRACE has been granted approval to initiate in Australia, Ireland, Poland, Greece, and the United Kingdom
• EXTEND Long-Term Extension Study: Patient rollovers have begun, providing critical long-term safety and durability data
• FDA Breakthrough Therapy Designation provides expedited regulatory pathway and enhanced FDA guidance throughout development
• Phase 2 Durability: 100% response rates and 71% remission rates maintained at 12 months following two 16mg doses

CYB004 Phase 2 Program in GAD - Near-Term Value Catalyst: