Hansa Biopharma (HNSA) Status Update summary

Strategic focus and technology overview

• Proprietary IgG-cleaving enzyme platform targets desensitization in transplantation, gene therapy, and rare autoimmune diseases, with imlifidase as the lead asset.

• Imlifidase (Idefirix) is conditionally approved in Europe for kidney transplant desensitization; over 200 patients have been treated.

• Late-stage studies are ongoing for kidney transplantation, anti-GBM, and gene therapy collaborations, with phase III and additional data expected in 2H 2025.

• Next-generation candidate HNSA-5487 shows promise for redosing and broader autoimmune indications.

• Commercial-scale manufacturing and strong IP portfolio support future launches.

Guillain-Barré Syndrome (GBS) background and unmet need

• GBS is an acute, antibody-mediated autoimmune neuropathy, often triggered by infection, leading to rapid paralysis and significant morbidity.

• Current treatments (IVIG, plasma exchange) have not changed in 30 years; no FDA-approved therapy in the US.

• 15–20% of patients experience long-term impairments; 3–7% mortality persists.

• Rapid, targeted immunotherapy is needed due to a short treatment window in the acute phase.

• Disease mechanisms are consistent across GBS subtypes, supporting broad applicability of new therapies.

Phase II study design and results

• Open-label, multicenter phase II trial included 27 severely affected GBS patients, treated early with imlifidase followed by IVIG.

• Imlifidase administered on day 1, followed by IVIG on day 3; rapid IgG reduction observed, with levels restored after IVIG.

• Early and sustained improvements in muscle strength and disability scores; median time to independent walking was 16 days.

• Safety profile was favorable, with no major side effects, treatment discontinuations, or significant adverse events.

• Efficacy assessed via disability and strength scores over 26 weeks.