Mr. Eric So reports

CYBIN COMPLETES ENROLLMENT IN PHASE 2 STUDY EVALUATING CYB004 FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER

Cybin Inc. has completed enrolment in its phase 2 study evaluating CYB004, a proprietary deuterated dimethyltryptamine (DMT) program, for the treatment of generalized anxiety disorder (GAD) and reaffirms top-line data guidance expected in the first quarter of 2026.

"Completing enrolment in our phase 2 study of CYB004 marks a significant milestone on our path to bringing forth an effective treatment for GAD," said Eric So, interim chief executive officer of Cybin. "Improved treatments are greatly needed, as anxiety disorders affect more than 300 million people worldwide. GAD is the most common anxiety disorder seen in primary care, with roughly 6.8 million people living with GAD in the United States alone. Unfortunately, half of these patients do not respond to approved treatment with selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors. We are excited about CYB004, and its potential to offer convenient intramuscular dosing for patients in need. We are proud of this work to date, as well as the robust patent protection in support of our CYB004 program and we look forward to sharing top-line data in the first quarter of 2026."

About the phase 2 CYB004 study in GAD

The CYB004-002 phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with moderate to severe GAD (GAD-7 score greater than or equal to 10) and are currently taking concomitant antidepressant or anxiolytic treatments. Participants with co-morbid depression are allowed.

The study is evaluating safety and efficacy at 12 weeks, with an optional follow-up to assess efficacy at 12 months. The study will remain double-blinded through Week 12.

The study has enrolled 36 participants, who were randomized into two groups (randomized 2:1).

The first group received two intramuscular administrations of CYB004 three weeks apart at a dose predicted to be therapeutic (20-milligram CYB004), while the second group received two intramuscular administrations of CYB004 three weeks apart at a lower dose predicted to be subtherapeutic (two mg CYB004).

The primary end point is a change in the HAM-A (Hamilton anxiety rating scale) score from baseline at six weeks following the first administration of CYB004.

Secondary end points include change in HAM-A through the double-blind period (week 12).

Other end points include the HAM-D (Hamilton depression rating scale), safety assessments, MEQ30 (psychedelic experience assessment) and EQ-5D-5L (quality of life assessment).

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 proof-of-concept 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 analogue, in phase 3 studies for the adjunctive treatment of major depressive disorder that has received breakthrough therapy designation from the United States Food and Drug Administration 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 United States, the United Kingdom and Ireland.

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