Hansa Biopharma (HNSA) 44th Annual J.P. Morgan Healthcare Conference summary

Technology and clinical development

• Proprietary IgG-cleaving enzyme platform targets acute immune-mediated diseases, with rapid and effective IgG reduction demonstrated in clinical settings.

• Differentiated from FcRn inhibitors, the enzyme addresses desensitization in highly sensitized kidney transplant candidates and expands to gene therapy and autoimmune indications.

• Late-stage trials in Guillain-Barré syndrome (GBS) are planned, with prior phase II success and conditional approval in Europe for the lead compound.

• U.S. phase III trial completed, BLA submitted in December, with priority review requested and potential PDUFA date in February.

• Next-generation enzyme (5487) shows lower immunogenicity and similar efficacy, with phase I data supporting further development.

Market opportunity and patient need

• U.S. kidney transplant waitlist includes 100,000 patients, with 15,000 highly sensitized and 7,000 at extreme sensitization (CPRA ≥98%).

• Median wait time for highly sensitized patients is seven years, with a five-year dialysis survival rate of 40%.

• 2,500 highly sensitized patients annually die or become ineligible for transplant due to comorbidities.

• 200 U.S. transplant centers, with 100 handling 80% of volume; commercial launch will target these efficiently.

• European market is fragmented, but reimbursement achieved in 20 countries at $300,000–$350,000 per treatment.

Clinical trial results and physician response

• U.S. phase III trial (64 patients) showed significant benefit in transplantation rates and dialysis independence for Imlifidase, with strong statistical significance.

• Long-term outcomes for cross-matched positive transplants are comparable to natural matches.

• European phase III trial (50 patients) fully recruited, with data readout expected mid-2026.

• U.S. KOLs express strong enthusiasm, citing lack of effective alternatives and high unmet need.

• Safety profile is consistent, with main risk being transient immunosuppression; dosing is a 15-minute infusion, with rare need for redosing.