· PDUFA target date set for December 19 by the FDA

· Runway significantly extended

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Financial Performance

First‑quarter Revenue totalled 34.6 MSEK compared to 66.3 MSEK in Q1 in 2025. IDEFIRIX product sales reached 33.9 MSEK, compared to 65.7 MSEK in Q1 2025.

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Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "In the first quarter of 2026, we continued to execute against our strategic priorities as we advanced imlifidase toward a potential U.S. approval of our Biologics License Application (BLA) with an assigned December 19 PDUFA[*] target date. Preparations for a potential U.S. launch progressed in parallel, while in Europe we saw the expected short term impact of the commercial reorganization and related initiatives. Quarterly revenues remain inherently variable due to structural issues related to organ allocation and as previously communicated we do not expect this to change in the medium term. Consequently, Q2 has had a strong start, and we believe that the benefits of the reorganization will support improved performance from the second quarter onward. During the quarter, we strengthened our financial position through a USD 30.0 million convertible note financing, significantly extending our runway and reinforcing our focus on disciplined financial and operational execution as we approach multiple near term value driving milestones."

Hansa Biopharma Report First Quarter 2026 Financial Results | Hansa Biopharma

(www.hansabiopharma.com)