Hansa Biopharma (HNSA) investor relations material

Study background and objectives

• The PAES study evaluated imlifidase (Idefirix) in highly sensitized kidney transplant patients with positive cross-match to deceased donors, using an open-label, multicenter design across 22 centers in 11 EU countries and the UK.

• The primary objective was one-year graft failure-free survival after imlifidase pre-treatment to convert positive to negative crossmatch; secondary objectives included renal function, patient survival, graft survival, and safety.

• The study included an imlifidase treatment group and two non-comparative reference cohorts (concurrent and historical).

• Patients in the imlifidase group were highly sensitized (cPRA ≥95%) and cross-match positive; reference groups were less or not sensitized and cross-match negative.

• 51 patients were enrolled, with 48 included in the ITT analysis; patient retention exceeded 90%.

Patient population and study design details

• Imlifidase cohort: 48 patients, mean age 49.8, 60.4% male, all on dialysis at baseline.

• Majority of imlifidase patients had at least one previous transplant; about one-third had two or more.

• Most imlifidase patients received one dose (91.7%), with a small proportion receiving two doses.

• Retention in the study exceeded 90% for both main cohorts.

• Concurrent reference cohort: 61 patients, mean age 55.4, 60.7% male, not sensitized, 88.5% on dialysis.

Key efficacy and safety results

• One-year graft failure-free survival in the imlifidase group was 89.6%–90%, meeting the primary endpoint.

• Patient survival at one year was 97.9%–98% in the imlifidase group.

• Graft survival at one year was 91.6%–92% for imlifidase-treated patients.

• Mean eGFR at one year was 52.4 mL/min/1.73 m² in the imlifidase group.

• Outcomes were similar between highly sensitized and non-sensitized cohorts.