Cybin’s Psilocybin Drug Candidate Delivers Remarkable Interim Results, Prompt Relief from Depression

Biopharmaceutical company, Cybin Inc. (NYSE American: CYBN), has announced interim results for its Phase 2 clinical trial evaluating CYB003, its proprietary deuterated psilocybin analog. CYB003 demonstrated a rapid, robust and statistically significant reduction in symptoms of major depressive disorder (MDD) three weeks following a single 12mg dose, compared to placebo. CYB

Doug Drysdale, Chief Executive Officer of Cybin, said, “The efficacy demonstrated at [the 12mg] dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments. Our planning continues as we prepare for a larger international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 in people suffering from MDD. This is an exciting time – not only for Cybin, but for the entire psychedelics sector.”

Highlights

The trial showed a  robust response and remission three weeks after a single dose of CYB003, with 53.3% of patients responding and 20% of patients in remission (no longer meeting the clinical definition of depression) versus 0% for placebo.

Interim efficacy data showed rapid and statistically significant improvements in depression symptoms observed after single doses of CYB003. Improvements in depression symptoms evident on the day after dosing, reaching a peak 10 days after dosing, and maintained thereafter, and a robust and statistically significant reduction in depression symptoms compared to placebo at 3 weeks.

CYB003 had a favorable safety and tolerability profile with no treatment-related serious adverse events at the 12 mg dose.

Full topline safety and efficacy data from the CYB003 MDD study is expected by the end Q4 2023, with 12-week durability data anticipated in Q1 2024.

Cybin plans to submit this topline data to the FDA and request an end of Phase 2 meeting to be held in Q1 2024. Recruiting for a CYB003 Phase 3 study is anticipated to begin by the end of Q1 2024.

About Cybin, Inc.

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.