Hansa Biopharma (HNSA) Corporate presentation summary

Platform and strategic focus

• Imlifidase rapidly cleaves all IgG classes intra- and extravascularly, reducing IgG by >95% within 2–6 hours.

• HNSA-5487 is a next-generation IgG-cleaving enzyme targeting GBS; IND submission and clinical program initiation were planned before YE 2026.

• Core programs span kidney transplant desensitization, pre-treatment to enable AAV gene therapy, and rare autoimmune disease.

Kidney transplant evidence and market

• In the 64-patient US ConfideS Phase 3 study, 12-month mean eGFR was 51.5 vs 19.3 mL/min/1.73 m² for imlifidase vs control (p<0.0001); dialysis dependency was 5 vs 18 patients (p=0.0007).

• PAES topline results: 90% failure-free graft survival at 12 months, 92% graft survival, 98% patient survival and eGFR of 52.4 mL/min/1.73 m².

• Long-term follow-up showed 82% five-year graft survival, 90% patient survival and eGFR of 50 mL/min/m².

• US market figures include ~100,000 people on the kidney transplant waitlist, ~15,000 with cPRA >80%, and wait times exceeding 7 years for cPRA >99.9%.

• Commercial plans include a focused transplant-center strategy, Medicare DRG and outlier payments, an NTAP application planned for 2026, and an expected field team of ~20 FTEs.

Regulatory and partnership milestones

• Idefirix has conditional approval in Europe and the UK and provisional approval in Australia; EMA filing for full approval was targeted for Q4 2026, with a €5 million payment upon acceptance.

• A €110 million out-licensing transaction with SERB closed July 1, 2026, covering Europe, the UK, selected neighboring markets and MENA.

• US PDUFA date for imlifidase was December 19, 2026, followed by a potential commercial launch subject to approval.

• Gene therapy collaborations include Sarepta Therapeutics for DMD and Généthon for Crigler-Najjar syndrome; reported data included supportive DMD results in 3 patients and first successful treatment of a Crigler-Najjar patient with pre-existing AAV8 antibodies.