Mr. Doug Drysdale reports

CYBIN RECEIVES INSTITUTIONAL REVIEW BOARD APPROVAL FOR ITS PHASE 1/2A CLINICAL TRIAL EVALUATING CYB003 FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER

Cybin Inc. has received institutional review board (IRB) approval to begin the first-in-human phase 1/2a clinical trial evaluating CYB003, its proprietary deuterated psilocybin analogue for the treatment of major depressive disorder (MDD).

"IRB approval of our trial protocol is a significant regulatory milestone for CYB003 as it leads us one step closer to potentially providing this important treatment option to people in need. The team has worked tirelessly to move this program into the clinic, and we look forward to initiating the study in mid-2022 and further supporting our mission to develop psychedelics into therapeutics," said Doug Drysdale, chief executive officer of Cybin.

In May, 2022, the company announced that it had submitted an investigational new drug application to the U.S. Food and Drug Administration for the phase 1/2a clinical trial. Cybin IRL Ltd., a wholly owned subsidiary of Cybin, has engaged Clinilabs Drug Development Corp., a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the phase 1/2a clinical trial of CYB003.

About the CYB003 phase 1/2a trial

The phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Subjects will receive two administrations (placebo/active and active/active), and a response/remission will be assessed at week three (after single dose) and at week six (after receiving a second dose). Using the Montgomery-Asberg depression rating scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the benefit of more than one administration, and will provide pharmacokinetic and safety data. The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (SSRIs). An optional open-label follow-up study (up to 12 weeks) will allow an assessment of durability of treatment effects.

The detailed phase 1/2a study protocol is available at the clinical trials government website under the identifier No. NCT05385783.

About CYB003

CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analogue designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder and alcohol use disorder.

About Cybin Inc.

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

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