Hansa Biopharma reports strong fourth quarter results with revenue of SEK 50 million

Lund, Sweden – Hansa Biopharma, a leader in immunomodulatory enzyme technologies for the treatment of rare IgG-mediated diseases, announced a business update for the fourth quarter of 2023. The company expects total revenue of SEK 50 million, of which SEK 43 million will come from sales of Idefirix® products. The increase in revenue was attributed to market growth in the UK, Germany and Spain.

The company also has a commercial partnership with NewBridge Pharmaceuticals to provide Idefirix® to kidney transplant patients in the Middle East and North Africa, leveraging existing conditional marketing authorization in Europe and pending approval in the Middle East and North Africa region.

In clinical development, Hansa’s kidney transplant Phase 3 ConfIdeS trial has enrolled 101 patients, a significant proportion of whom have been randomized. The phase 3 GOOD-IDES-02 trial against GBM has enrolled 16 of 50 targeted patients and is expected to be completed in 2025. Additionally, an investigator-initiated phase 2 trial in ANCA-associated vasculitis is ongoing in 3 of 10 enrolled patients.

An important milestone is the initiation of first-in-human testing of HNSA-5487, a drug candidate in the repeat-dose novel immunoglobulin cleaving enzyme (NiceR) program. Following the observation of positive results, further analysis of IgG recovery and immunogenicity is ongoing to inform future clinical development. Additionally, in December 2023, a Phase 1b trial began with imlifidase as a pretreatment for Sarepta’s SRP-9001 gene therapy in Duchenne muscular dystrophy.

The preliminary financial report for the fourth quarter and full year of 2023 shows an operating loss of SEK 177 million in the quarter, an operating loss of SEK 790 million for the full year, and R&D costs reaching SEK 411 million. Despite these losses, the company maintained a strong cash position as of December 31, 2023, with SEK 732 million in cash and short-term investments.

Key financial milestones in 2024 include the first high-level readout from the DMD Phase 1b study with Sarepta and completion of randomization in the U.S. ConfIdeS Phase 3 trial. The interim report for the fourth quarter of 2023 will be released on February 2, 2024.

Company leadership will participate in meetings during J.P. Morgan Conference Week, January 8-11, 2024. This business update is based on a press release statement.

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