Company: EDSA
Filing Date: 2025-12-12
Form Type: 10-K
Source: 0001171843-25-007914
Chunk: 92

Company: Edesa Biotech, Inc.
Filing Date: 2025-12-12
Form: 10-K
Item: Item 1
Chunk 92
---
innate immune response). Furthermore, neutralization of CXCL10 has been demonstrated to both prevent and reverse depigmentation in animal models.

We believe that EB06 has a number of anticipated advantages compared to other treatments available and under development for vitiligo, including: a) EB06’s mechanism of action addresses both the adaptive and innate immune systems’ roles in disease maintenance and progression; b) EB06 is designed to treat both lesional and non-lesional skin; c) as a systemic therapy, EB06 can treat larger body surface areas, including patients with lesions on >10% of their body surface area; d) EB06 is administered less frequently than topicals and oral medications; and e) targeted immunotherapies, like EB06, are designed to provide patients a safer and more effective option than drugs with known off-target effects or even Black Box warnings.

We have approval from Health Canada to conduct a Phase 2 study of EB06 in moderate to severe nonsegmental vitiligo patients. As planned, the double-blind, placebo-controlled trial will evaluate the safety and efficacy of EB06 in approximately 150 subjects, who will be administered intravenous infusions of either EB06 or placebo during the treatment period, followed by a follow-up period. The primary efficacy outcome measurement will be the percentage of patients achieving ≥50% decrease (improvement) from baseline in facial Vitiligo Area Scoring Index (“F-VASI50”). F-VASI is a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches. Before proceeding with enrollment in Canada, we may modify our current Canadian study design with Health Canada to conform the protocol with other jurisdictions. To conduct the planned study at U.S. investigational centers, we must first complete the manufacturing of the drug and submit related data to the FDA as part of an investigational new drug application (“IND”). To date, we have completed a process confirmation batch of EB06 and intend to initiate engineering and clinical-grade (“GMP”) manufacturing runs in the coming weeks. We anticipate data from these activities to be submitted to the FDA once the work is completed. Subject to regulatory approval, we anticipate initiating recruitment by midyear 2026. We anticipate topline results for this Phase 2 study could be available within as few as 9 to 12 months following regulatory clearance in the U.S.

In three previous clinical studies of 65 healthy volunteers and non-vitiligo subjects in total, EB06 has demonstrated a