Mr. Doug Drysdale reports

CYBIN PROVIDES CORPORATE UPDATE ON UPCOMING CLINICAL MILESTONES

Cybin Inc. has provided an update on recent clinical accomplishments and key coming clinical milestones.

"We are making rapid advancements in our two lead clinical programs: CYB003, our proprietary deuterated psilocin program in development for the adjunctive treatment of major depressive disorder, and CYB004, our proprietary deuterated dimethyltryptamine program for the treatment of generalized anxiety disorder. We have made significant progress in preparing for our upcoming phase 3 programs and have appointed two experienced drug development experts, Dr. Atul R. Mahableshwarkar and Dr. Tom Macek, to lead our CYB003 and CYB004 programs, respectively. As we evolve into a phase 3 company, we are well positioned among the top tier in our sector and believe that we have the potential to deliver innovative, next-generation approaches to address these challenging mental health disorders," said Doug Drysdale, chief executive officer of Cybin.

CYB003: A proprietary deuterated psilocin program with Food and Drug Administration breakthrough therapy designation for the adjunctive treatment of MDD

CYB003 is the company's lead program that is preparing to enter phase 3 development and has received FDA breakthrough therapy designation, which validates CYB003's potential for significant clinical improvements over existing treatments based on preliminary results and serves to expedite CYB003's development pathway toward commercialization.

In August, 2024, the company held a productive Type B initial breakthrough therapy meeting with the U.S. Food and Drug Administration in preparation for the imminent commencement of its CYB003 pivotal program in MDD. For the coming phase 3 study, Cybin has selected 30 high-quality clinical sites across the United States and Europe. The phase 3 pivotal trial design incorporates several elements to address critical methodological issues such as functional unblinding that are considered important for drugs in this class.

To date, results from a completed phase 2 MDD study of CYB003 have shown rapid, robust improvements in symptoms of depression with a single dose and durable effects four months after two doses with a 75-per-cent remission rate in the 16-milligram dose group. The company expects to report 12-month phase 2 efficacy data in early fourth quarter 2024, providing further insights into CYB003's potential to provide long-lasting relief for MDD patients.

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 (12 milligrams and 16 milligrams pooled) and placebo at three weeks;
• Incremental benefit of second dose with greater-than-75-per-cent response rates and up-to-80-per-cent remission rates (12 mg) after second dose;
• Efficacy sustained at four months after two doses, with a mean 22-point reduction in MADRS scores from baseline and robust remission rates of 60 per cent (12 mg) and 75 per cent (16 mg);
• Excellent safety and tolerability profile, with all reported adverse events mild to moderate.

CYB004: a proprietary deuterated N,N-dimethyltryptamine program in development for the treatment of GAD

CYB004 is being developed as a highly scalable intermittent treatment with an intramuscular formulation designed to optimize the delivery of CYB004, with acute effects lasting approximately 90 minutes. Dosing is under way in a phase 2 study of IM CYB004 in participants with moderate to severe GAD. The phase 2 results are expected to provide proof of concept for CYB004's efficacy in GAD, time to onset of effects and durability of effects to one year. The company plans to report top-line safety and efficacy results at year-end 2024 or early first quarter 2025.

CYB004 phase 2 program outline:

• Randomized, double-blind study in 36 participants with moderate to severe GAD with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed;
• Two IM doses, three weeks apart versus two low-dose controls;
• Primary end point is change in Hamilton anxiety rating scale score from baseline at six weeks following second dose;
• Other end points include the Montgomery-Asberg depression rating scale depression assessment, safety assessments, MEQ30 (psychedelic experience assessment) and EQ-5D-5L (quality of life assessment);
• Participants will be followed up initially for a period of three months, with additional follow-up assessments up to a year.

Strengthened research and development team with two key additions:

• Dr. Atul R. Mahableshwarkar, MD, DLFAPA, senior vice-president, clinical development: Dr. Mahableshwarkar is leading the CYB003 program, Cybin's proprietary deuterated psilocin program in development for the adjunctive treatment of MDD. Dr. Mahableshwarkar is a board-certified psychiatrist and accomplished drug development executive with experience in both large global and small start-up companies. He brings varied experiences from academia and industry as a site principal investigator for industry-sponsored studies, and has submitted several investigational new drugs and new drug applications leading to drug approvals.
• Dr. Tom Macek, PharmD, PhD, senior vice-president, clinical development: Dr. Macek is leading the CYB004 program, Cybin's proprietary deuterated dimethyltryptamine program in development for the treatment of GAD. Dr. Macek brings decades of pharmaceutical industry experience in new drug development across all phases of research (preinvestigational new drug to postapproval) across diverse treatment modalities, and has submitted or supported several INDs and NDAs/biologic licence applications leading to drug approvals.

About Cybin Inc.

Cybin is a clinical-stage breakthrough neuropsychiatry company on a mission to create safe and effective next-generation 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 health care is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocin program for the treatment of major depressive disorder, and CYB004, a proprietary deuterated dimethyltryptamine program for generalized anxiety disorder, and has a research pipeline of investigational 5-HT-receptor-focused compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland.

We seek Safe Harbor.