Edesa Biotech, Inc.

Edesa Biotech, Inc. is a biopharmaceutical company that develops treatments for inflammatory and immune-related diseases. The company focuses on acquiring, developing, and commercializing drug candidates based on mechanisms of action that have shown proof-of-concept in human subjects. Edesa Biotech prioritizes diseases with strong scientific rationale, no approved therapies or unmet medical needs, and large addressable market opportunities. The company's clinical pipeline is concentrated in two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa Biotech is developing EB06, an anti-CXCL10 monoclonal antibody candidate, for vitiligo, an autoimmune disorder causing skin depigmentation. CXCL10 is known to be involved in vitiligo, and its neutralization has prevented and reversed depigmentation in animal models. EB06 has shown a favorable safety and tolerability profile. Health Canada has approved a Phase 2 proof-of-concept study of EB06 in patients with moderate-to-severe nonsegmental vitiligo, and discussions are ongoing with the U.S. Food and Drug Administration (FDA) for the same study. Enrollment is anticipated to begin by midyear 2026, subject to regulatory approval. The Medical Dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), which is currently at the partnering stage. Edesa Biotech's most advanced Respiratory drug candidate is EB05 (paridiprubart), a Host-Directed Therapeutic (HDT) designed to modulate the body's immune response to infectious diseases or chemical agents. In October 2025, paridiprubart met primary and secondary endpoints with statistical significance, showing clinically meaningful improvement in survival and recovery, in a truncated Phase 3 clinical study of hospitalized patients with Acute Respiratory Distress Syndrome (ARDS). Paridiprubart is also being evaluated in an ongoing U.S. study.