Hansa Biopharma (HNSA) Corporate presentation summary

Technology and clinical platform

• Proprietary IgG-cleaving enzyme platform enables rapid, targeted reduction of IgG, facilitating transplantation, gene therapy, and treatment of autoimmune diseases.

• Imlifidase achieves >95% IgG reduction in 2–6 hours and has been tested in 8 clinical programs.

• Next-generation enzyme HNSA-5487 shows lower immunogenicity and robust IgG reduction, with Phase 1 data supporting further development.

• Platform uniquely addresses serious immune-mediated diseases due to unmatched speed in IgG reduction.

Transplantation and desensitization

• IDEFIRIX® (imlifidase) is conditionally approved in the EU for kidney transplant desensitization, with 9M 2025 sales of ~SEK 144m.

• US Phase 3 ConfideS trial showed significant improvement in 12-month eGFR (51.5 vs 19.3 mL/min/1.73m², p<0.0001) and reduced dialysis dependency.

• 82% five-year graft survival and 90% patient survival demonstrated in long-term follow-up.

• US BLA submission planned for end of Q4 2025, with commercialization strategy targeting ~200 transplant centers.

• Market opportunity for desensitization exceeds $2bn in Europe and the US, addressing a large unmet need among highly sensitized patients.

Gene therapy partnerships and market

• Gene therapy market expected to grow from $2bn in 2024 to $23.9bn by 2028, with 195 ongoing AAV vector-based clinical trials.

• Partnerships with Sarepta (DMD, Limb-Girdle) and Genethon (Crigler-Najjar) aim to enable gene therapy for patients with high anti-AAV antibodies.

• Clinical data supports the platform's ability to cleave AAV antibodies, enabling gene therapy dosing for previously ineligible patients.

• Existing partnerships estimated to address ~6,000 patients with high anti-AAV antibodies.