Hansa Biopharma (HNSA) investor relations material

Study background and design

• The Confide S/ConfideS Phase III trial was a randomized, controlled, open-label study evaluating imlifidase in highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, enrolling 64 patients across 25 US sites.

• Patients in the imlifidase arm received the drug prior to transplantation to convert crossmatch from positive to negative, while controls received standard or institution-specific desensitization or waited for a compatible organ.

• Demographics were balanced between arms, with a mean age of 45.3 years and representation of both white and Black or African American patients.

• The primary endpoint was kidney graft function at 12 months, measured by mean estimated glomerular filtration rate (eGFR).

• The trial included long-term follow-up and had high patient retention, with over 90% completing the study.

Patient population and unmet need

• Over 800,000 people in the US have end-stage renal disease (ESRD), with 65% on dialysis and high healthcare costs.

• Highly sensitized patients face long wait times and high mortality, with a median wait of up to 7 years and 10,000 dying or becoming too sick annually.

• No approved desensitization therapies exist for this population in the US.

• Around 100,000 patients are on the US kidney transplant list, with 10–15% being highly sensitized and facing significant unmet need.

• Kidney failure affects nearly 2.5 million patients worldwide, with approximately 170,000 on transplant waitlists in the US and Europe.

Efficacy and safety results

• At 12 months, mean eGFR was 51.5 mL/min/1.73m² in the imlifidase arm versus 19.3 mL/min/1.73m² in the control arm, a statistically significant difference (p < 0.0001).

• Dialysis dependency at 12 months was significantly reduced in the imlifidase group (p = 0.0007).

• Imlifidase was well tolerated, with low infusion reaction rates, no interruptions due to reactions, and a safety profile consistent with kidney transplant populations; most serious adverse events were unrelated to treatment.

• No transplant losses due to antibody-mediated rejection (AMR) were observed, and delayed graft function rates were as expected.

• Supportive analyses confirmed the robustness of the primary endpoint.