Mr. Doug Drysdale reports

CYBIN RECEIVES AUSTRALIAN APPROVAL FOR EMBRACE, A MULTINATIONAL PIVOTAL STUDY EVALUATING CYB003 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER

Cybin Inc. has received approval in Australia to conduct the Embrace study. Embrace is the second pivotal study in Paradigm, the company's phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analogue. The company has received approval through the clinical trial notification scheme, obtained clearance from multiple ethics committees of the Australian Therapeutics Goods Administration, and the study site research governance offices, thus allowing the commencement of the Embrace study.

This approval follows two other recent regulatory decisions:

• The Irish Medicines Board, acting as the reference member state, granted approval to initiate the Embrace study in Ireland, Poland and Greece;
• The United Kingdom Medical and Healthcare Products Regulatory Agency approved the commencement of the Embrace study in the United Kingdom.

CYB003 has received breakthrough therapy designation from the United States Food and Drug Administration for the adjunctive treatment of major depressive disorder (MDD).

"Having been granted approval in Australia to commence the Embrace component of Paradigm, we are now cleared to study CYB003 on three continents," said Doug Drysdale, chief executive officer of Cybin. "Initiating the second pivotal study represents an important milestone as we advance and broaden this important clinical program. Embrace is a three-arm study with a high-dose, mid-dose and placebo arm. The study aims to enroll 330 participants with moderate to severe MDD and whose symptoms are inadequately controlled with current antidepressants. We are eager to build on the extraordinary 12-month phase 2 results which showed robust 12-month improvements in depression symptoms after two 16 mg doses of CYB003. Validation from these international regulatory bodies is highly encouraging as we pursue our mission of revolutionizing mental health care by developing safe and effective treatments for a variety of mental health conditions."

Embrace study design:

• Embrace will enroll 330 patients with moderate to severe MDD (MADRS greater than or equal to 24) who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 milligrams, CYB003 eight mg or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart.
• The primary end point will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose.

The phase 3 Paradigm program is expected to enroll a total of 550 participants across three studies: two 12-week randomized, double-blind, placebo-controlled studies, Approach and Embrace, and a long-term extension study, Extend. The first phase 3 trial, Approach, is currently dosing and is taking place at approximately 45 clinical sites across the U.S. The second phase 3 trial, Embrace, is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe and Australia. Participants from Approach and Embrace will have the opportunity to roll over into Extend after completing the 12-week, double-blind, placebo-controlled treatment periods.

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 proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long-lasting results. The company is currently developing CYB003, a proprietary deuterated psilocin analogue, in phase 3 studies for the adjunctive treatment of major depressive disorder 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, the Netherlands and Ireland.

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