Hansa Biopharma publishes 2025 Annual and Sustainability Reports

Lund, Sweden, 26 March 2026. Hansa Biopharma AB, “Hansa” or the “Company” (Nasdaq Stockholm: HNSA), today published its Annual and Sustainability Reports for 2025.

Peter Nicklin, Chair of the Board, Hansa Biopharma, said: “2025 was a year of transformation for Hansa Biopharma, marked by the appointment of Renée Aguiar‑Lucander as our new CEO with a clear mandate to reshape the company for sustainable growth. Under her leadership, we strengthened our foundations by improving our financial resilience and assembling a substantially new leadership team of proven, high‑performing leaders. At the same time, we achieved major scientific progress, including highly positive results from the pivotal U.S. Phase 3 imlifidase trial, supporting our preparations for a potential U.S. launch. Complementing this progress, decisive organizational changes have further sharpened our strategic focus and strengthened our capabilities. With strong clinical momentum and a more resilient platform for growth, Hansa is well‑positioned to deliver meaningful impact for patients and long‑term value for shareholders.”

Renée Aguiar‑Lucander, CEO, Hansa Biopharma, said, “2025 was a year of meaningful progress for Hansa. We advanced our science, significantly improved our financial robustness, and positioned the company for long-term growth. The highly statistically significant ConfIdeS results and our BLA submission of imlifidase, marked major steps toward addressing the urgent unmet needs of highly sensitized kidney transplant patients in one of the largest global transplant markets. In Europe, access to IDEFIRIX continued to grow, reflected by a 46% increase in product revenue. We also progressed our gene therapy programs, took a strategic decision to advance our next generation enzyme HNSA-5487 in autoimmune diseases, and continued to embed sustainability across our strategy. As we look ahead to a potential U.S. approval and further pipeline developments in 2026, I am proud of the dedication of our employees and partners and confident in our ability to deliver transformative therapies to patients who need them most.”

2025 highlights

Pivotal U.S. Phase 3 Success
Hansa reported positive topline results from ConfIdeS, its pivotal U.S. Phase 3 trial of imlifidase. The study met its primary endpoint with strong statistical significance (p<0.0001), demonstrating that imlifidase can enable transplantation for highly sensitized patients who otherwise face years on dialysis with very limited or no access to compatible organs. ConfIdeS is the first large, randomized trial of imlifidase and reinforces the clinical relevance of Hansa’s IgG cleaving enzyme platform.

BLA Submission to the FDA
Building on the ConfIdeS results, Hansa submitted a Biologics License Application (BLA) to the FDA in December 2025, seeking approval under the accelerated pathway, a major milestone toward a potential U.S. launch.

European Commercial Momentum
Across Europe, IDEFIRIX product revenue grew by 46%, driven by increased adoption, two new national guidelines (Spain and Belgium), and expanded reimbursement, which now covers 24 countries.

Strengthening Financial Position
Hansa significantly strengthened its financial profile by raising approximately USD 96 million and completing a debt restructuring with NovaQuest. These actions enabled continued investment in regulatory activities, commercial readiness for a potential U.S. launch, and advancement of pipeline programs.

Pipeline Advancement: HNSA-5487
Hansa made the strategic decision to advance its next generation enzyme HNSA-5487 into development for Guillain–Barré syndrome (GBS), with FDA interactions planned for first half of 2026.

Strengthened Leadership to Support Next Phase of Growth
To drive execution of its strategy, Hansa strengthened its executive leadership team with appointments across key roles, including a new CEO, COO & President U.S., Chief Medical Officer, Chief Legal Officer & Corporate Secretary, Chief Human Resources Officer, and SVP Regulatory Affairs. These additions enhance operational depth and support the company’s growth ambitions.

This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00 AM CET on 26 March 2026.​