01:01:31 EST Sun 07 Dec 2025
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Cybin Inc (2)
Symbol CYBN
Shares Issued 23,590,025
Close 2025-09-23 C$ 8.89
Market Cap C$ 209,715,322
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Cybin plans to enroll 220 participants for CYB003 study

2025-09-23 20:08 ET - News Release

Mr. Eric So reports

CYBIN HIGHLIGHTS NEUROPSYCHIATRY PLATFORM AND UPCOMING CLINICAL MILESTONES

Cybin Inc. today highlights significant clinical and regulatory milestones and upcoming value-driving catalysts as the company advances multiple programs toward 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 United States-based commercial-scale manufacturing capabilities for the CYB003 program.

Upcoming milestones

CYB003 phase 3 paradigm program in MDD (major depressive disorder) -- key catalysts:

  • Approach study: enrolment of 220 participants across 45 clinical sites in the United States, with top-line data expected in the fourth quarter of 2026;
  • Embrace study: initiation expected in Q4 (fourth quarter) 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;
  • U.S. Food and Drug Administration (FDA) breakthrough therapy designation provides expedited regulatory pathway and enhanced FDA guidance throughout development;
  • Phase 2 durability: response rates of 100 per cent and remission rates of 71 per cent maintained at 12 months following two 16-milligram doses.

CYB004 phase 2 program in GAD (generalized anxiety disorder) -- near-term value catalyst:

  • Successfully completed enrolment of 36 participants in September, 2025: top-line 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 (merger and acquisition) 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 Mr. 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.

About Cybin Inc.

Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental health care by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.

With promising class-leading data, Cybin is working to change the mental health treatment landscape through the introduction of novel drugs that provide effective and durable results for patients. The company is currently developing CYB003, a proprietary deuterated psilocin analog, in phase 3 studies for the adjunctive treatment of major depressive disorder that has received breakthrough therapy designation from the FDA, and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds.

Founded in 2019, Cybin is operational in Canada, the U.S., the United Kingdom and Ireland.

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