Hansa Biopharma AB successfully secured $24.3 million in new funding and restructured its debt obligations while reporting strong commercial growth for its lead product IDEFIRIX in the second quarter of 2025. The Swedish biopharmaceutical company's Q2 IDEFIRIX sales reached 47.8 MSEK, representing a 76% increase compared to the same period in 2024.
Financial Restructuring Extends Operational Runway
The company completed a directed cash share issue of approximately 232 MSEK (US $24.3M) with support from both new and existing shareholders. As part of the financing arrangement, Hansa restructured its debt agreement with NovaQuest, offsetting US $14.9M of outstanding debt through the issuance of new shares. The remaining debt will be paid through fixed cash payments scheduled for June 2027, June 2028, and June 2029.
Additionally, a true-up payment of approximately US $14.9M is due on January 31, 2026, which may be settled in cash or equity at the company's discretion. The successful capital raise extends Hansa's cash runway into Q2 2026, providing financial stability for upcoming clinical milestones.
IDEFIRIX Commercial Performance Accelerates
IDEFIRIX demonstrated robust commercial momentum in the first half of 2025, with total sales reaching 113.5 MSEK, representing a 52% increase over the same period in 2024. This first-half performance represents approximately 80% of the company's full-year 2024 product sales, indicating significant acceleration in market adoption.
The strong commercial performance reflects growing demand for IDEFIRIX in Europe, where the company continues to focus its commercialization efforts. CEO Renée Aguiar-Lucander emphasized the company's ability to "focus on near term catalysts, strategic pipeline decisions and driving the continued commercialization of IDEFIRIX in Europe."
Phase 3 Trial Readouts Approaching
Hansa remains on track to report data from two critical Phase 3 trials in the second half of 2025. The 20-HMedIdeS-17 study (ConfIdeS), a US pivotal trial in kidney transplantation, is expected to generate data that will support a Biologics License Application (BLA) submission to the FDA in the second half of 2025.
The company is also preparing to report results from the GOOD-IDES-02 trial in anti-GBM (anti-glomerular basement membrane disease). These readouts represent key value inflection points for the company's clinical development program.
Expanding Pipeline Development
Beyond the Phase 3 programs, Hansa continues to advance its broader pipeline based on its proprietary IgG-cleaving enzyme technology platform. The company presented positive data from the 15-HMedIdeS-09 Phase 2 trial, including an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS), at the Peripheral Nerve Society annual meeting in May.
Enrollment is ongoing in the GNT-018-IDES Phase 2 trial in Crigler Najjar, which evaluates the efficacy and safety of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase. The Phase 1b trial SRP-9001-104 with Sarepta remains on track for an initial data readout later this year.
Financial Position and Outlook
For Q2 2025, Hansa reported total revenue of 49.1 MSEK, with product sales accounting for 47.8 MSEK. The company's selling, general and administrative expenses totaled 90.5 MSEK, while research and development expenses reached 95.8 MSEK. The company reported a loss from operations of 154.8 MSEK and net cash used in operations of 111.7 MSEK. Cash and short-term investments stood at 354.4 MSEK at the end of the quarter.
The funding will specifically support the two Phase 3 trial readouts scheduled for the second half of 2025, positioning the company for potential regulatory submissions and continued commercial expansion of IDEFIRIX in its approved markets.
