Company: EDSA
Filing Date: 2025-12-12
Form Type: 10-K
Source: 0001171843-25-007914
Chunk: 164

Company: Edesa Biotech, Inc.
Filing Date: 2025-12-12
Form: 10-K
Item: Item 1
Chunk 164
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 and reimbursements of eligible R&D expenses under the 2023 SIF Agreement may not be sufficient to fund our operating expenses for one year after the date of this filing, unless the Company raises additional capital or delays its current EB06 development program. Accordingly, management has concluded that substantial doubt exists about our ability to continue as a going concern. We will need to raise additional capital and/or reduce our operating expenses to support the Company’s operations for at least the next 12 months.

As a clinical-stage biopharmaceutical company, we expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek marketing approvals for our product candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States and Canada. To fund operations, we may seek additional financing through the sale of equity, government grants, debt financings or other capital sources, including potential future licensing, collaboration or similar arrangements with third parties or other strategic transactions.

Results of Operations

Fiscal Year Ended September 30, 2025 Compared to the Fiscal Year Ended September 30, 2024

Our total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025 compared to $7.0 million for the prior year.

			●

			The following table summarizes our R&D expenses incurred for the years ended September 30, 2025 and 2024, together with the dollar increase or decrease in those items:

			Fiscal Year End

			Change

			September 30, 2025

			September 30, 2024

			Program-specific external costs:

			EB06

			$
			339,816

			$
			-

			$
			339,816

			EB05

			1,929,023

			1,444,949

			484,074

			Other development and discovery programs

			133,347

			218,391

			(85,044
			)

			Total program-specific costs

			2,402,186

			1,663,340

			738,846

			Unallocated internal costs

			Non-program specific external costs

			1,206

			9,652

			(8,446