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Hansa Biopharma's Third Quarter Financial Results

On October 30, 2025, Hansa Biopharma AB (Nasdaq Stockholm: HNSA) released its interim report for the third quarter and year-to-date results. The report highlighted pivotal advancements in their clinical trials and financial performance, reflecting significant growth despite challenges.

Key Milestones in Clinical Development

Hansa's CEO, Renée Aguiar-Lucander, emphasized a landmark achievement in the ongoing U.S. Phase 3 ConfIdeS trial, where the company’s breakthrough drug, imlifidase, met its primary endpoint. The trial results revealed a remarkable improvement in the mean estimated glomerular filtration rate (eGFR) at the 12-month mark for patients undergoing kidney transplantation. Specifically, the imlifidase group demonstrated a mean eGFR of 51.5 mL/min/1.73m², significantly better than the control group's 19.3 mL/min/1.73m²—a clinically meaningful difference of 32.2 mL/min/1.73m² (p < 0.0001).

This result not only highlights the efficacy of imlifidase as a desensitization therapy for highly sensitized kidney transplant patients but also underscores the urgent clinical needs within this demographic. Aguiar-Lucander expressed hope, stating these results provide options for patients who have otherwise faced extensive waiting times on dialysis.

Further supporting their gene therapy initiatives, interim findings from the trials sponsored by Sarepta and Genethon showed imlifidase’s ability to significantly decrease anti-AAV antibodies, facilitating gene therapy administration.

Financial Overview

Regarding financial performance, Hansa Biopharma reported a year-to-date product sales total of 143.6 million SEK—an increase of 29.1 million SEK (25.4%) compared to the previous year. However, the third quarter saw a decline in product sales, totaling 30.1 million SEK, down from 39.8 million SEK year-over-year. This downturn was attributed to a reduction in kidney transplants during the summer months, a pause in Germany's Eurotransplant Prioritized Program, and reimbursement issues in Catalunya, Spain.

Despite these setbacks, the company plans to launch various initiatives aiming to capture market potential and bolster growth moving into 2026. Hansa targets filing a Biologics License Application (BLA) with the FDA before the end of 2025, seeking Priority Review based on its recent trial successes.

Comparative Financial Summary

Here's a snapshot of Hansa Biopharma’s recent financial performance:

• - Q3 2025 Revenue: 30.8 million SEK
• - Q3 2024 Revenue: 48.7 million SEK
• - Year-to-Date 2025 Sales: 146.3 million SEK
• - Year-to-Date 2024 Sales: 139.0 million SEK
• - Loss from Operations: 147.6 million SEK in Q3 2025 versus 116.9 million SEK in Q3 2024
• - Net Loss for the Period: 148.3 million SEK in Q3 2025 compared with 103.8 million SEK in Q3 2024

The loss was accompanied by high spending on research and development initiatives, which totaled 70.2 million SEK in Q3 2025, down from 79.6 million SEK the previous year.

Upcoming Virtual Conference

In light of these developments, Hansa Biopharma will hold a telephone conference on the same day as the report release, featuring key executives including CEO Renée Aguiar-Lucander and CFO Evan Ballantyne. The conference is aimed at discussing the report's highlights and addressing investor inquiries, indicating the company’s commitment to transparency and investor engagement.

Conclusion

Hansa Biopharma emerges from Q3 2025 with notable accomplishments that emphasize its position in the biopharmaceutical sector. With promising trial results and a solid foundation for future growth, the company is positioned to advance its therapies aimed at addressing significant healthcare challenges. Investors and stakeholders will be keenly awaiting the upcoming BLA submission and the potential offerings in 2026 and beyond.