Cybin Company Presentation

Medicinal TITLE: A Phase 2, Randomized, Parallel Group, Bioequivalence (BE) Study of Psilocybin 1 mg, 3 mg, 5 mg and 7 mg administered with Buccal Film to 25 mg Oral Capsule Followed by Placebo-Controlled Safety and Efficacy Trial with Selected Dose in Patients with Major Depressive Disorder (MDD) Cybin aims to become the first life sciences company to bring a psilocybin drug to market targeting major depressive disorder (1) Cybin Clinical Trial to be conducted in Patients with Major Depressive Disorder in Jamaica (MDD) (1) (2) 13 P r i v a t e & C o n f i d e n t i a l THIS STUDY IS EXPECTED TO EXAMINE THE BIOEQUIVALENCE (BE) DATA AGAINST ORAL SAFE AND EFFICACIOUS DOSE AND SAFETY AND EFFICACY OF PSILOCYBIN FOR A 4 MONTH PERIOD IN MDD PATIENTS Study Subjects: Phase 2a: 4 buccal film doses to be studied in 10 patients per arm against oral 25 mg capsule with moderate depression (MADRS score 18-34) each, total 50 patients. Patients will be followed for 4 months for safety and efficacy. Phase 2b: Additional 120 patients will be enrolled in safety and efficacy trial with proven BE dose (80 in psilocybin, 40 in placebo group) commencing immediately after Phase 2a study: both under same regulatory clinical trial approval potentially saving 4-5 months in development time. In total 120 patients will be studied with psilocybin buccal film. Objectives Primary: Phase 2a study: Choose the BE dose of Psilocybin administered with Buccal Film to 25 mg oral capsule in Subjects with MDD. Phase 2b: Evaluate clinical efficacy by MADRS (Montgomery–Åsberg Depression Rating Scale) score change post-dosing with buccal psilocybin film in comparison to placebo film. Secondary: Phase 2a and 2b: Evaluate the safety and tolerability of Psilocybin. (1) Forward-looking statements are subject to various risks and assumptions. See “Cautionary Statement Regarding Forward-Looking Information” on page 2 of this presentation. (2) Subject to receipt of all necessary regulatory approvals in Jamaica from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Cybin is working for its clinical trials. Marketing authorization submission will be targeted within 12 months in Jamaica (1) (2) Clinical Trial will be conducted through the University of West Indies (1) We aim to commence the study in 2020 which will be funded and owned by Cybin (1)