Company: CYBN
Filing Date: 2025-09-17
Form Type: F-10/A
Source: 0001062993-25-015680
Chunk: 51

Company: CYBIN INC.
Filing Date: 2025-09-17
Form: F-10/A
Chunk 51
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 placebo-controlled treatment periods. During EXTEND, all participants who did not respond to treatment in the APPROACH and EMBRACE studies or who relapse during the EXTEND study will be eligible to receive an additional two doses of CYB003 (16 mg) administered three weeks apart. Participants who do not respond to these two doses or relapse again will be eligible to receive an additional single 16 mg dose of CYB003. The Corporation has engaged Worldwide Clinical Trials Inc, a full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Phase 3 pivotal studies of CYB003. The Corporation cannot at this time estimate the cost of bringing CYB003 drug candidate to market as much of the associated costs depend on the outcomes of the phase III pivotal clinical trials. Further, there is no assurance that the aforementioned timelines will be met or that such studies will be completed. Anticipated timelines regarding drug development and recruitment of patients for participation in clinical trials are dependent on various factors and are based on reasonable assumptions informed by current knowledge and information available to the Corporation. Such statements are informed by, among other things, eligibility and exclusion criteria for the trial, design of the clinical trial, competition with other companies for clinical sites or patients, perceived risks and benefits of the prescription drug product candidate, the number, availability, location and accessibility of clinical trial sites, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Corporation's development efforts to date.

(6)Includes personnel costs, professional services, overhead expenses and general expenses to be incurred by the Corporation in the normal course of business. In addition, the Corporation intends to use a portion of these proceeds to continue funding both its Deuterated Psilocin Program and Deuterated Dimethyltryptamine Program. The allocation between and specific milestones within these programs have not yet been determined.

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(7)The Corporation will progress the Phase 3 study EMBRACE and Phase 3 study EXTEND over the next 12 months however, these studies are not anticipated to be completed within the 12 month timeframe.

(8)The Corporation has updated the anticipated timeline for completion of this milestone. The Corporation had previously expected it would complete this milestone around mid-year 2025. There was a minor change in