Cybin plans to enroll 220 participants for CYB003 study

Executive Summary

• Cybin Inc. highlights its neuropsychiatry platform, emphasizing proprietary deuterated molecules and innovative drug delivery systems, while outlining upcoming clinical catalysts for its lead programs CYB003 and CYB004.
• The company announced key milestones for CYB003 (MDD), including the initiation of the Embrace study in Q4 2025, top-line data expected from the Approach study in Q4 2026, and the commencement of the Extend long-term extension study.
• Strategic partnerships were highlighted, including a manufacturing agreement with Thermo Fisher Scientific for U.S.-based commercial-scale production and a commercial preparation partnership with Osmind to access over 800 U.S. psychiatry clinics.

Key Details

• CYB003 (MDD) Program Catalysts:
  • Approach Study: Enrolment of 220 participants across 45 clinical sites in the U.S.; top-line data expected in Q4 2026.
  • Embrace Study: Initiation expected in Q4 2025; targets 330 participants with moderate to severe MDD. Approval to initiate granted in Australia, Ireland, Poland, Greece, and the United Kingdom.
  • Extend Study: Patient rollovers have begun for long-term safety and durability data.
  • FDA Status: Holds Breakthrough Therapy Designation for expedited regulatory pathway.
  • Phase 2 Durability Data: Response rates of 100% and remission rates of 71% maintained at 12 months following two 16-milligram doses.
• CYB004 (GAD) Program Catalysts:
  • Enrolment: Successfully completed enrolment of 36 participants in September 2025.
  • Data Timeline: Top-line data expected in Q1 2026.
  • Delivery Mechanism: Utilizes intramuscular delivery optimized for clinical and commercial scalability.
  • Strategic Potential: Data may position Cybin for dual indication development across MDD and GAD.
• Manufacturing & Infrastructure:
  • Partnered with Thermo Fisher Scientific for U.S.-based commercial-scale manufacturing of drug substance and product (capsules).
  • Strategy includes two dedicated facilities for Phase 3 clinical supply and future commercialization.
• Commercial Strategy:
  • Partnered with Osmind to accelerate commercial preparation.
  • Partnership provides access to over 800 psychiatry clinics in the U.S., point-of-care software, and real-world data capabilities.
• Intellectual Property:
  • IP portfolio includes patents providing expected exclusivity until 2041.
  • CEO Eric So cited the AbbVie acquisition of Gilgamesh Pharmaceuticals as market validation for the value of IP and novel drug development platforms in neuropsychiatry.

Notable Quotes

• "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." — Eric So, Interim CEO
• "The recent acquisition by AbbVie of Gilgamesh Pharmaceuticals' bretisilocin program supports our long-held thesis that IP and novel drug development platforms are fundamental value drivers in the neuropsychiatry space... Broader recognition of the potential benefits of these therapeutics, together with this market momentum, are highly encouraging." — Eric So, Interim CEO