Cybin Highlights Neuropsychiatry Platform And Upcoming Clinical Milestones; Completes Enrollment Of 36 Participants In Phase 2 Study Of CYB004; Continues To Advance CYB003, The Company's Proprietary Deuterated Psilocin Analog, In Phase 3 Studies For The Adjunctive Treatment Of Major Depressive Disorder; Dosing Is Ongoing In The First Pivotal Study, APPROACH , With Expected Enrollment Of 220 Patients Across 45 U.S. Clinical Sites

Author: Benzinga Newsdesk | September 23, 2025 05:16pm

- Successfully completed enrollment of 36 participants in Phase 2 study of CYB004, the Company's deuterated dimethyltryptamine ("DMT") program for the treatment of Generalized Anxiety Disorder ("GAD"). Topline data expected Q1 2026 -

- Continues to advance CYB003, the Company's proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder ("MDD"). Dosing is ongoing in the first pivotal study, APPROACH, with expected enrollment of 220 patients across 45 U.S. clinical sites -

- Sector-leading intellectual property portfolio with 100+ granted patents and 250+ pending applications positions Cybin as a leader in Phase 3 psychedelic therapeutics -

Cybin Inc. (NYSE: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:

• Successfully completed enrollment of 36 participants in September 2025
• Topline data expected first quarter of 2026
• Differentiated delivery: Intramuscular delivery mechanisms optimized for clinical and commercial scalability
• Market expansion opportunity: Data may position Cybin for dual indication development across MDD and GAD

Strategic Market Validation Through Recent M&A Activity

"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," continued So. "Cybin's extensive patent portfolio and proprietary deuteration technology provide us with significant competitive advantages as we advance toward potential regulatory approvals and commercial launch - all with the aim of addressing the substantial unmet need for improved mental health treatments. Broader recognition of the potential benefits of these therapeutics, together with this market momentum, are highly encouraging."

Commercial Infrastructure and Partnership Strategy

Manufacturing Excellence:

Cybin has established its manufacturing operations in the U.S. through its partnership with Thermo Fisher Scientific, encompassing both drug substance production and drug product capsule manufacturing. The Company's manufacturing strategy includes two dedicated facilities for Phase 3 clinical supply and future commercialization.

Commercial Preparation:

The Company has strategically partnered with Osmind, a leading service provider to psychiatry practices, to accelerate commercial preparation across its clinical-stage pipeline. This partnership provides access to over 800 psychiatry clinics in the U.S., point-of-care software, and real-world data capabilities.

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