Company: EDSA
Filing Date: 2025-12-12
Form Type: 10-K
Source: 0001171843-25-007914
Chunk: 270

Company: Edesa Biotech, Inc.
Filing Date: 2025-12-12
Form: 10-K
Item: Item 1A
Chunk 270
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 three drug candidates for evaluation in a U.S. government-funded Phase 2 platform study. We are providing drug products to the study as well as technical support at our own expense.

Any failures on our part to satisfy any of our obligations under the above agreements could adversely affect or terminate our development of EB05.

We depend heavily on the success of our drug product candidates. If we are unable to obtain regulatory approval or commercialize one or more of these experimental treatments, or experience significant delays in doing so, our business will be materially harmed. We cannot give any assurance that we will receive regulatory approval for such product candidates or any other product candidates, which is necessary before they can be commercialized.

We have not completed development of and/or obtained regulatory approval for any of our product candidates. Development will require the commitment of substantial financial resources, extensive product candidate development, and clinical trials. This process takes years of effort without any assurance of ultimate success.

Our ability to generate product revenues, which may not occur for multiple years, if at all, will depend heavily on the successful development and commercialization of our drug product candidates. The success of our product candidates will depend on a number of factors, including, but not limited to:

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			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;

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

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			our timing to obtain applicable regulatory approvals;

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			successful completion of clinical development;

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

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

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			the availability of raw materials to produce our product candidates;

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

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

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			establishing sales, marketing and distribution capabilities;

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

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