Company: EDSA
Filing Date: 2025-09-30
Form Type: 8-K
Source: 0001171843-25-006188
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Company: Edesa Biotech, Inc.
Filing Date: 2025-09-30
Form: 8-K
Item: Item 1.01
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Item 1.01 Entry into a Material Definitive Agreement

As previously disclosed, on October 12, 2023, Edesa Biotech Research, Inc.
(“ Edesa Biotech Research”), a wholly owned subsidiary of Edesa Biotech, Inc. (the “ Company”), and the Company,
as guarantor, entered into a multi-year contribution agreement (the “ Agreement”) with the Government of Canada, pursuant to
which the Government of Canada committed up to CAD $23 million ($17 million USD) in partially repayable funding toward (i) conducting
and completing the Company’s Phase 3 clinical study of its experimental drug EB05 (paridiprubart) in critical-care patients with
Acute Respiratory Distress Syndrome (ARDS) caused by Covid-19 or other infectious agents, (ii) submitting EB05 for governmental approvals
and manufacturing scale-up, following, and subject to, completing the Phase 3 study and (iii) conducting two non-clinical safety studies
to assess the potential long-term impact of EB05 exposure (the “ Project”).

On September 30, 2025, Edesa Biotech Research, the Company and the Government
of Canada entered into Amendment Agreement No. 1 to the Agreement (the “ Amendment”) to reflect a change in the Company’s
clinical focus for EB05 to general ARDS from Covid-19 induced ARDS, and to benefit from a fully funded U. S. government platform study
of host directed therapeutics, including EB05. The Amendment, among other things (i) extends the Project completion date to December 31,
2028 (from December 31, 2025), (ii) amends the expiration date of the Agreement to the later of December 31, 2045 (from December 31, 2042)
or the date of the last repayment, unless earlier terminated, (iii) adds certain additional reporting requirements relating to other similar
EB05 development projects, (iv) replaces the Statement of Work to reflect the updated scope, milestones and timelines for the Project
and (v) amends the repayment schedule such that the first annual repayment would due in 2032 (from 2029), provided that repayment will
only begin if the Company earns gross revenue. Except as amended by the Amendment, the terms of the Agreement remain in full force and
effect.

The foregoing summary and description of the Agreement and the
Amendment do not purport to be complete and are qualified in