Company: CYBN
Filing Date: 2025-09-17
Form Type: F-10/A
Source: 0001062993-25-015680
Chunk: 50

Company: CYBIN INC.
Filing Date: 2025-09-17
Form: F-10/A
Chunk 50
---
 is working.

(2)Effective April 1, 2025, the Corporation changed its presentation currency from the Canadian dollar to the United States dollar . The change in presentation currency was made to better reflect the Corporation’s operations, align with the currency in which the majority of cash based expenses are denominated, and improve comparability of its financial results with other publicly traded businesses in the industry. As a result, all amounts presented under the heading “ Sources and Uses of Capital” are in United States dollar unless otherwise stated.

(3)Represents proceeds from private placements and offerings previously disclosed.

(4)Anticipated timeline for completion is based on the calendar year. Anticipated spending and timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Corporation.

(5)The Corporation's APPROACH trial participants (n=220) will be randomized 1:1 to receive 16 mg of CYB003 (n=110), or inactive placebo (n=110). Each arm will evaluate a two-dose regimen, with doses administered three weeks apart. The study will enroll patients suffering from moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately. The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose. APPROACH is expected to enroll at approximately 45 clinical sites across the U.S. The Corporation's EMBRACE trial participants (n=330) will be randomized 1:1:1 to receive 16 mg of CYB003 (n=110), 8 mg of CYB003 (n=110), or inactive placebo (n=110). Each arm will evaluate a two-dose regimen, with doses administered three weeks apart. The study will enroll patients suffering from moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately. The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose. EMBRACE is expected to enroll at approximately 60 clinical sites, with minimal site overlap with the APPROACH study. Participants (up to n=550) from APPROACH and EMBRACE will roll over into EXTEND, the Corporation's Phase 3 Pivotal study 3 trial, after the completion of the 12-week, double-blind,