Company: EDSA
Filing Date: 2025-03-11
Form Type: 424B3
Source: 0001171843-25-001403
Chunk: 3

Company: Edesa Biotech, Inc.
Filing Date: 2025-03-11
Form: 424B3
Chunk 3
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 efforts on
disease indications where there is compelling scientific rationale, no approved therapies or where there are unmet medical needs, and
where there are large addressable market opportunities, among other factors. Our clinical pipeline is focused on two therapeutic areas:
Medical Dermatology and Respiratory.

In Medical
Dermatology we are developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder
that causes skin to lose its color in patches. CXCL10 has been shown to play a key role in the disease, and neutralization of CXCL10
has been demonstrated to both prevent and reverse depigmentation in animal models. To date, EB06 has demonstrated a favorable safety
and tolerability profile. We have received regulatory approval from Health Canada to conduct a Phase 2 proof of concept study of EB06
in patients with moderate-to-severe nonsegmental vitiligo and we are in discussions with the U.S. Food and Drug Administration (“FDA”)
for the same study. Preparation for the manufacturing campaign is underway, with data anticipated to be submitted to the FDA during the
middle of 2025. Our medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as
a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (“ACD”), a common occupational skin condition.
This asset is at the partnering stage.

Our most advanced Respiratory drug candidate is EB05 (paridiprubart). Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (“HDTs”) that are designed to modulate the body’s own immune response when confronted with infectious diseases or even chemical agents. EB05 is currently being evaluated in a U.S. government-funded platform study investigating three novel threat-agnostic HDTs in hospitalized adult patients with Acute Respiratory Distress Syndrome (“ARDS”), a life-threatening form of respiratory failure. Certain development expenses, including manufacturing scale-up, for our EB05 program are also eligible for reimbursement from the Government of Canada under a 2023 grant and funding award. In addition to EB05, we are also preparing an investigational new drug application (“IND”) in the United States to conduct a future Phase 2 study for EB07 (paridiprubart) in patients with pulmonary fibrosis.

#### Recent Developments
Private Placement

On February 12, 202