Hansa Biopharma (HNSA) investor relations material

Innovative IgG-cleaving enzyme platform

• Proprietary enzymes rapidly and effectively reduce IgG levels, enabling life-saving treatments in transplantation, gene therapy, and autoimmune diseases.

• Imlifidase and next-gen HNSA-5487 target both intra- and extravascular IgG, with HNSA-5487 advancing in GBS clinical development.

• Eleven clinical programs have been run from preclinical to market, demonstrating broad applicability.

Transplantation: Addressing high unmet need

• IDEFIRIX® conditionally approved in the EU for kidney transplant desensitization, with 2025 sales of ~204.7 MSEK (~$22.8m).

• US BLA accepted in Feb 2026, PDUFA date set for Dec 19, 2026, following a positive Phase 3 trial (p<0.0001).

• Over 21 countries have reimbursement; 117 clinics in Europe equipped, ~70% repeat utilization.

• Long-term data show 82% five-year graft survival and 90% patient survival.

Market opportunity and commercialization

• US and EU kidney transplant desensitization market opportunity exceeds $2bn, with 17,000–25,000 target patients.

• Highly sensitized patients face long wait times; ~15% of US waitlist are highly sensitized, with significant mortality.

• Robust US commercialization strategy with experienced team, focused on 200 transplant centers and Medicare as primary payer.