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Hansa Biopharma interim report January-March 2024

Strong sales performance and solid momentum with the Phase 3 trial in anti-GBM disease Cash runway extended into 2026 Evan Ballantyne joins Hansa Biopharma as Chief Financial Officer LUND, Sweden, April 18, 2024 /PRNewswire/ -- Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and year-end report for January to March 2024. Highlights for the first quarter of 2024      Strong commercial performance. Total Q1 revenue of SEK 56m including product sales of SEK 47m - sales growth during Q1 2024 was driven by product sales in our largest European markets including France, UK, and Germany, as well as initial sales in Belgium. Represents first time Company has delivered two consecutive quarters of strong growth. IDEFIRIX has achieved pricing and reimbursement in 75% of the European kidney transplant market; Ongoing HTA processes in 11 countries including, most recently, in Ireland. Evan Ballantyne joined Hansa Biopharma as Chief Financial Officer effective March 1, 2024. Previously served as CFO of Gain Therapeutics, Inc., a U.S. based biotech company. Evan brings to Hansa more than 30 years of international experience as a senior financial executive in both public and private life science companies. Clinical pipeline update US ConfIdeS trial (kidney transplantation): 122 patients have been enrolled with 49 of 64 targeted patients randomized in this pivotal, Phase 3 U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation. Post Approval Study (kidney transplantation): 36 patients have been treated (72% completion). The study will support full marketing authorization in Europe and is expected to be completed by 2025. Phase 3 (anti-GBM disease): 25 of 50 targeted patients enrolled in global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Completion of enrollment is expected in 2025. Investigator-initiated phase 2 trial (ANCA-associated vasculitis): 3 of 10 targeted patients enrolled. Events after closing period Cash runway extended into 2026: Raised SEK ~372m (USD ~34.6m) in a directed share issue targeting mainly high-quality international healthcare specialist investors. Financial summary SEKm, unless otherwise stated - unaudited Q1 2024 Q1 2023 FY 2023 Revenue 56.0 24.2 134.1 - thereof: Product sales 47.4 14.3 103.7 SG&A expenses (91.3) (103.3) (450.5) R&D expenses (103.0) (92.8) (411.3) Loss from operation (159.4) (182.3) (788.5)