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LUND, Sweden – Hansa Biopharma, a leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced a business update for the fourth quarter of 2023. The company expects to report SEK 50 million in total revenue, with SEK 43 million stemming from sales of its product Idefirix®. This surge in revenue is attributed to market growth in the U.K., Germany, and Spain.
The company has also entered into a commercial partnership with NewBridge Pharmaceuticals to supply Idefirix® to kidney transplant patients in the Middle East and North Africa, leveraging the existing European conditional marketing authorization and pending approvals in the MENA region.
In clinical developments, Hansa’s US ConfIdeS phase 3 trial for kidney transplantation has enrolled 101 patients, with a significant portion already randomized. The GOOD-IDES-02 phase 3 trial for anti-GBM disease has enrolled 16 of the targeted 50 patients, with completion expected in 2025. Furthermore, an investigator-initiated phase 2 trial in ANCA-associated vasculitis is underway with 3 out of 10 patients enrolled.
A significant milestone was the initiation of the first-in-human trial for HNSA-5487, a candidate from the Novel Immunoglobulin Cleaving Enzymes for Repeat Dosing (NiceR) program. After observing positive results, further analysis on IgG recovery and immunogenicity is being conducted to inform future clinical development. Additionally, in December 2023, a phase 1b trial of imlifidase as a pre-treatment to Sarepta’s SRP-9001 gene therapy in Duchenne Muscular Dystrophy began.
Preliminary financials for the fourth quarter and full year 2023 reveal an operating loss of SEK 177 million for the quarter and SEK 790 million for the year, with research and development expenses reaching SEK 411 million. Despite these losses, the company maintains a solid cash position with SEK 732 million in cash and short-term investments as of December 31, 2023.
Key financial milestones for 2024 include the first high-level data readout from the phase 1b study in DMD with Sarepta and the completion of randomization for the U.S. ConfIdeS phase 3 trial. The full interim report for the fourth quarter of 2023 will be published on February 2, 2024.
The company’s management will be available for meetings during the J.P. Morgan Conference week from January 8-11, 2024. This business update is based on a press release statement.
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