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     109  0 Kommentare Cybin Provides Corporate Update and Highlights Upcoming Clinical Milestones 

    Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, provides a corporate update highlighting recent clinical accomplishments and key upcoming catalysts across its development pipeline.

    “With the prevalence and burden of mental health conditions at an all-time high, there is an urgent and growing need for improved treatments for depression and anxiety. Our team is dedicated to turning the tide of the mental health crisis through our clinical-stage programs,” said Doug Drysdale, Chief Executive Officer of Cybin. “The past several months have been pivotal with FDA Breakthrough Therapy Designation for CYB003 and alignment on the Phase 3 design in major depressive disorder, and the start of our Phase 2 study of CYB004 in Generalized Anxiety Disorder. We are progressing quickly with both programs and expect the coming months to be transformative for Cybin, with a Phase 3 trial of CYB003 in MDD expected to begin this summer, and Phase 2 topline efficacy data for CYB004 in Q4 2024. The recent funding round provides us with the runway to achieve these important milestones.”

    CYB003: Lead program with FDA Breakthrough Therapy Designation for the adjunctive treatment of MDD

    CYB003 is the first ever deuterated psilocybin analog program to enter clinical development and has demonstrated rapid and robust improvements in symptoms of depression with a single dose in a Phase 2 MDD study, with an incremental clinical benefit from a second dose and durable effects which were sustained to four months. The BTD by the FDA validates CYB003's potential to show significant clinical improvements over existing treatments based on preliminary results and serves to expedite CYB003’s development pathway towards commercialization. Having achieved BTD and FDA alignment on a Phase 3 program design for CYB003, the Company plans to initiate a multinational, multisite Phase 3 MDD study in the summer of 2024.

    Positive Phase 2 Results for CYB003 in MDD

    • Rapid and large improvements in symptoms of depression after single doses with average 13.75 point difference in MADRS score reduction between CYB003 (12mg and 16mg pooled) and placebo at 3 weeks (p<0.0001)
    • Incremental benefit of second dose with >75% response rates and up to 80% remission rates (12 mg) after second dose
    • Efficacy sustained at 4 months after 2 doses, with a mean 22-point reduction in MADRS scores from baseline and robust remission rates of 60% (12 mg) and 75% (16 mg)
    • Excellent safety and tolerability profile, with all reported AEs mild to moderate

    CYB004: A proprietary deuterated N,N-dimethyltryptamine (“DMT”) program in development for the treatment of GAD

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    Cybin Provides Corporate Update and Highlights Upcoming Clinical Milestones  Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment …

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