Hansa Biopharma (HNSA) investor relations material

Innovative IgG-cleaving enzyme platform

• Proprietary enzymes imlifidase and HNSA-5487 enable rapid, targeted IgG reduction, addressing barriers in transplantation, gene therapy, and autoimmune diseases.

• Imlifidase reduces IgG by over 95% within 2-6 hours, facilitating lifesaving treatments.

• HNSA-5487, a next-generation enzyme, targets Guillain-Barré Syndrome (GBS) with FDA interactions planned for 2026.

Clinical and commercial progress in transplantation

• Imlifidase demonstrated statistically significant improvement in kidney function and transplant rates in the US Confides Phase 3 study.

• One-year dialysis dependency was lower in the imlifidase group (5 vs. 17 patients), with no graft loss due to antibody-mediated rejection.

• Long-term follow-up showed 82% five-year graft survival and 90% patient survival, comparable to non-sensitized patients.

• Idefirix conditionally approved in EU/UK; PAES study confirmed 90% failure-free graft survival at 12 months.

Market opportunity and commercialization strategy

• Over 100,000 people in the US await kidney transplants, with a $2B+ market opportunity for highly sensitized patients.

• Robust US commercialization plan includes experienced team, Medicare coverage, and targeted field force.

• Out-licensing agreement with SERB Pharmaceuticals for Idefirix in Europe and MENA valued at €115 million, closed July 2026.