Company: EDSA
Filing Date: 2025-12-12
Form Type: 10-K
Source: 0001171843-25-007914
Chunk: 129

Company: Edesa Biotech, Inc.
Filing Date: 2025-12-12
Form: 10-K
Item: Item 1
Chunk 129
---
			●

			our ability to obtain additional capital from potential future licensing, collaboration or similar arrangements or from any future offering of our debt or equity securities;

			●

			our ability to identify and enter into potential future licenses or other collaboration arrangements with third parties and the terms of the arrangements;

			●

			our timing to obtain applicable regulatory approvals;

			●

			successful completion of clinical development;

			●

			the ability to provide acceptable evidence demonstrating a product candidates’ safety and efficacy;

			●

			receipt of marketing approvals from applicable regulatory authorities and similar foreign regulatory authorities;

			●

			the availability of raw materials to produce our product candidates;

24

			●

			obtaining and maintaining commercial manufacturing arrangements with third-party manufacturers or establishing commercial-scale manufacturing capabilities;

			●

			obtaining and maintaining patent and trade secret protection and regulatory exclusivity;

			●

			establishing sales, marketing and distribution capabilities;

			●

			generating commercial sales of the product candidate, if and when approved, whether alone or in collaboration with others;

			●

			acceptance of the product candidate, if and when approved, by patients, the medical community and third-party payors;

			●

			effectively competing with other therapies; and

			●

			maintaining an acceptable safety profile of the product candidate following approval.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize any of our product candidates, which would materially harm our business. Many of these factors are beyond our control. Accordingly, we may never be able to generate revenues through the license or sale of any of our product candidates.

Our product development efforts with respect to our product candidates may fail for many reasons, including but not limited to:

			●

			the failure of the product candidate in clinical studies;

			●

			adverse patient reactions to the product candidate or indications of other safety concerns;

			●

			insufficient clinical trial data to support the effectiveness or superiority of the product candidate;

			●

			the inability to manufacture sufficient quantities of the product candidate for development or commercialization activities in a timely and cost-efficient manner; and

			●

			changes in the regulatory environment, including pricing and reimbursement, that make development of a new product or of an existing product