Mr. Doug Drysdale reports

CYBIN APPLAUDS FDA COMMISSIONER DR. MARTIN MAKARY'S CALL TO ACCELERATE AND PRIORITIZE RESEARCH ON PSYCHEDELIC THERAPEUTICS

Cybin Inc. applauds recent comments made by Dr. Martin Makary, commissioner of the United States Food and Drug Administration, relating to the importance of accelerating and prioritizing research on the clinical benefits of psychedelic therapeutics.

"It is gratifying that the FDA commissioner shares our belief in the potential therapeutic value of these innovative treatments -- a long-held belief that stands at the core of Cybin's mission," said Doug Drysdale, chief executive officer of Cybin. "We are doing the rigorous investigative clinical work to unlock the potential of this class of drugs to effectively treat a variety of disorders, including major depressive disorder and generalized anxiety disorder. We agree wholeheartedly that the time is now to address the mental-health crisis, and we applaud Dr. Makary's commitment to expedite the regulatory review process for product candidates in development and to get them into the hands of providers and patients as soon as possible.

"Cybin is committed to advancing its clinical-stage programs toward potential regulatory review and approval. Our CYB003 deuterated psilocin program, which is currently in phase 3 development, has been granted FDA breakthrough therapy designation for the adjunctive treatment of MDD, which could expedite drug development timelines. We are encouraged by our ongoing positive interactions with the FDA and by the agency's stated focus and openness to innovative treatments that show promise, even when they challenge traditional standards of care. This public endorsement that psychedelics are a 'frontier area' with compelling scientific evidence is welcome validation for the work we do every day."

Clinical program summary

CYB003 -- deuterated psilocin program

Status:  dosing continues in phase 3 Approach study in MDD. Approach is the first pivotal study in Cybin's phase 3 Paradigm program, which includes two 12-week, randomized, placebo-controlled studies (Approach and Embrace) and a long-term extension study (Extend)

Summary of positive phase 2 12-month efficacy data in MDD patients:

• One hundred per cent of participants receiving two doses of 16 milligrams were responders.
• Seventy-one per cent of participants receiving two doses of 16 milligrams were in remission.
• Mean change from baseline in MADRS (Montgomery–Asberg Depression Rating Scale) was approximately minus-23 points after two doses of 16 milligrams.

Upcoming milestones:  initiate second pivotal phase 3 study, Embrace, around mid-2025

CYB004 -- deuterated DMT (dimethyltryptamine) program

Status:  dosing is continuing in a phase 2 study in generalized anxiety disorder

Upcoming milestones:  phase 2 GAD study is expected to complete mid-2025

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 industry-leading 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 analog, in phase 3 studies for the adjunctive treatment of major depressive disorder, and CYB004, a proprietary deuterated 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.

We seek Safe Harbor.