Cybin Inc. Announces Key Clinical Milestones and Regulatory Progress for Neuropsychiatry Pipeline

Cybin Inc., a clinical-stage neuropsychiatry company, has detailed its progress across multiple drug development programs and upcoming regulatory milestones. The company's intellectual property portfolio extends through 2041, providing long-term protection for its innovative treatments. A key strategic partnership with Thermo Fisher Scientific enables scalable manufacturing capabilities for the CYB003 program, ensuring production capacity meets potential future demand.

The company's near-term pipeline includes several important clinical catalysts. Topline data from the CYB004 Phase 2 program in generalized anxiety disorder is expected in the first quarter of 2026. This program represents a novel approach to treating anxiety disorders using Cybin's proprietary deuterated N, N-dimethyltryptamine molecule. The CYB003 program, which has received FDA Breakthrough Therapy Designation, is advancing through Phase 3 studies for major depressive disorder with topline readouts from the APPROACH study anticipated in the fourth quarter of 2026.

Earlier Phase 2 data for CYB003 demonstrated impressive results, with 100% response rates and 71% remission rates maintained at 12 months. These findings suggest the potential for durable treatment effects in patients with major depressive disorder. The company plans to initiate the Phase 3 EMBRACE study in the fourth quarter of 2025, with approvals already secured across multiple international clinical sites. Ongoing enrollment continues in the EXTEND long-term safety study, which will provide additional safety data for regulatory submissions.

The company maintains operational presence across key markets including Canada, the United States, the United Kingdom, and Ireland. Additional information about Cybin's developments is available through the company's newsroom at https://ibn.fm/CYBN. The press release detailing these milestones was distributed through InvestorWire, a specialized communications platform that provides advanced wire-grade press release syndication services. InvestorWire operates as part of the Dynamic Brand Portfolio@IBN, offering comprehensive corporate communications solutions through their website at https://www.InvestorWire.com.

These developments represent significant progress in the neuropsychiatry field, where current treatment options often fall short in providing durable relief for patients. The Breakthrough Therapy Designation for CYB003 underscores the potential importance of this treatment approach and facilitates expedited development and regulatory review. The company's focus on developing next-generation psychedelic-inspired therapeutics addresses substantial unmet needs in mental healthcare, particularly for conditions that have proven resistant to conventional treatments.

The timing of these clinical milestones positions Cybin to potentially bring novel treatments to market within the next several years. The combination of strong early clinical data, strategic manufacturing partnerships, and protected intellectual property creates a foundation for potential commercial success. As mental health disorders continue to represent a growing global health concern, the development of effective new treatments could have substantial impact on patient outcomes and healthcare systems worldwide.