Bioceltix (BCX) investor relations material

Therapeutic focus and clinical achievements

• Specializes in allogeneic stem cell-based therapies for inflammatory and autoimmune diseases in companion animals, with successful clinical trials in canine and equine osteoarthritis and canine atopic dermatitis.

• Demonstrated clinical safety and efficacy for BCX-CM-AD in reducing skin lesions and pruritus in dogs with atopic dermatitis, with effects lasting up to 168 days.

• Over 70% of owners and veterinarians reported positive outcomes after a single BCX-CM-AD treatment.

Product pipeline and regulatory progress

• Pipeline includes products for osteoarthritis and atopic dermatitis in dogs and horses, with intravenous and intra-articular administration routes.

• Submission to EMA for BCX-CM-J, with additional indications and ongoing regulatory engagement.

Manufacturing and scalability

• Operates a GMP-compliant facility with plans for a new 1,300 m² plant in Wrocław, targeting up to 100,000 therapeutic doses annually.

• Current production capacity is 10-12 campaigns per year, yielding up to 30,000 doses.

• Planned CAPEX for expansion is approximately €9M, with further scaling costs of €0.3M per 100,000 doses.

• Construction and validation of the new facility are scheduled through 2027.