Cybin Inc. Highlights Clinical and Regulatory Milestones for Neuropsychiatry Pipeline

Cybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN) has outlined key clinical and regulatory milestones across its neuropsychiatry pipeline, emphasizing intellectual property protection extending through 2041 and manufacturing scalability through its partnership with Thermo Fisher Scientific for the CYB003 program. The company's near-term catalysts include topline data from the CYB004 Phase 2 program in generalized anxiety disorder expected in Q1 2026, positioning Cybin as a leader in developing novel treatments for mental health conditions. Earlier Phase 2 data from CYB003 demonstrated sustained efficacy with 100% response rates and 71% remission rates maintained at 12 months, supporting the program's FDA Breakthrough Therapy Designation for expedited development.

The company's regulatory strategy includes multiple international approvals for its Phase 3 EMBRACE study initiation in Q4 2025, while the ongoing EXTEND long-term safety study continues enrollment. Cybin's approach to mental healthcare focuses on developing next-generation treatment options that address large unmet needs, with current development programs including CYB003, a proprietary deuterated psilocin analog in Phase 3 studies for adjunctive treatment of major depressive disorder. The company maintains operational presence across Canada, the United States, the United Kingdom and Ireland, leveraging its research pipeline of investigational, 5-HT-receptor focused compounds. Additional information about the company's progress is available through its newsroom at https://ibn.fm/CYBN.

Topline readouts from the CYB003 Phase 3 APPROACH study in major depressive disorder are anticipated in Q4 2026, representing a significant milestone in the psychiatric treatment landscape. Cybin's commitment to revolutionizing mental healthcare through novel drug development is supported by its class-leading data and scalable manufacturing capabilities. The company's intellectual property portfolio provides protection through 2041, ensuring long-term value creation for its breakthrough neuropsychiatry programs. InvestorWire, the specialized communications platform that distributed this announcement, provides advanced wire-grade press release syndication as part of the Dynamic Brand Portfolio that includes access to extensive distribution networks and corporate communications solutions detailed at https://www.InvestorWire.com.