Hansa Biopharma (HNSA) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Key product and clinical insights

• Imlifidase is an IgG-cleaving enzyme approved in Europe, with a U.S. BLA filed and a PDUFA date in December; it addresses the unmet need for highly sensitized kidney transplant patients who face long wait times due to high antibody profiles.

• Off-label desensitization methods in the U.S. are slow and ineffective, while imlifidase rapidly reduces IgG antibodies within hours, enabling timely transplantation, especially for deceased donor kidneys.

• The ConfIdeS phase III trial showed only 3 of 32 control patients received a transplant versus a much higher rate in the imlifidase arm, with significant improvement in eGFR at 12 months (51 vs. 19, p=0.001).

• Additional data from secondary endpoints and safety analyses will be released at ATC in June.

Market opportunity and launch strategy

• In the U.S., 100,000 patients await kidney transplants, with 15% highly sensitized (CPRA >80%) and 7,000 with CPRA >98%; initial focus will be on the highest-need segment, with potential for broader use as experience grows.

• The U.S. launch benefits from more robust clinical data, broader center participation, and greater KOL engagement compared to the fragmented and slower European rollout.

• France's early adoption was driven by clinical trial participation and early access programs, leading to expanded use and reimbursement, including for lung transplants.

Recent business developments and financial impact

• Announced out-licensing of European, U.K., Swiss, and MENA rights for imlifidase to SERB for up to EUR 150 million, providing non-dilutive financing.

• Proceeds will support a robust U.S. launch and pipeline development, including advancing HNSA-5487 for GBS and other autoimmune indications.

• The capital relieves debt pressure and enables investment in commercial activities and R&D, with the field team size remaining stable due to the concentrated U.S. transplant market.