Financial information

• Net sales for the Group amounted to SEK 1.3 (4.4) M
• The Group reported a loss of SEK -24.6 (-18.8) M
• The Group’s operating loss amounted to SEK -24.5 (-20.0) M
• The loss per share was SEK 2.26 (loss 2.44)

The year in brief

• Hansa Medical and Axis-Shield accompmlish a clinical multi-center study in Sweden and the USA with HMD-301 (HBP assay) for the diagnosis of severe sepsis.
• Published clinical research results indicate that HBP has potential as biomarker for the diagnosis of bacterial meningitis
• A preferential rights issue of SEK 29 M was oversubscribed
• Hansa Medical and its collaboration partner, Alere Inc., terminated the development project, anti-alpha-11 for the treatment of rheumatoid arthritis
• Development resources focused on the clinical development of enzyme-based treatment of unusual diseases
• The development of the GMP process for the production of IdeS for clinical studies was finalized
• Toxicity and safety studies were executed with IdeS

Significant events after the end of the financial year

• Hansa Medical executed in January 2012 a directed new share issue to Bengt Ågerup’s investment company, NXT2B, for SEK 27.5 M. Also, a subsequent preferential new share issue of SEK 18.5 M is to be accomplished in march 2012. In total, Hansa Medical raises SEK 46 M.

CEO’s comments
We have now reached a position where we are able to commence clinical studies with our drug candidate IdeS in the middle of 2012. The groundwork for making this possible was laid during 2011, including the establishment of a quality-assured production process under GMP, as well as the implementation of toxicity and safety studies. The toxicity study has been completed in its entirety, although the final reports are not yet finalaized, due to a large number of ongoing laboratory analyses. The preliminary results looks promising and it is our aim to announce the final results in conjunction with the submission of our application for clinical studies to the Swedish Medical Products Agency. We have also prepared the forthcoming Phase 1 study in mid 2012, by further strengthening the pre-clinical documentation and substantiating the experimental support, for safe administration of IdeS.

Together with our collaboration partner Alere Inc., we chose to close our engagement in the early drug development program anti-alpha-11 during the latter part of 2011. We acquired the anti-alpha-11 project in 2008 for two reasons: 1) Promising research data which identified anti-alpha-11 as an innovative drug target for the treatment of rheumatoid arthritis, and 2) the large pharmaceutical companies’ sustained interest for new drug candidates for rheumatoid arthritis. At the end of 2011, it was clear to us that we had not succeeded, in a timely manner, in unambiguously reproducing the previous research results. We will not invest resources in this project from now on. We will, however, maintain basic patent rights for alpha-11, and cooperate with university researchers conducting research on alpha-11 as a drug target for diseases other than rheumatoid arthritis. This is an interesting research area definitely worthwhile monitoring. The release of internal resources from the anti-alpha-11 project was also a necessity in order to be able to focus on the preparations for the Phase 1 studies with IdeS during 2012.

During 2011, we have, together with the British-Norwegian company, Axis-Shield, implemented a comprehensive clinical study with approximately 700 patients in Sweden and the United States with the diagnostic method HMD-301. HMD-301 is an assay for the diagnosis of severe sepsis at emergency clinics. Evaluation of the comprehensive patient material is still ongoing and we look forward to announcing the outcome as soon as analyses, evaluation and reporting are completed. If the result from the study confirms the potential of HBP as a biomarker for severe sepsis, then Axis-Shield intends to launch a commercial assay based on these data. Hans Medical has the opportunity to receive milestone payments and royalty compensation from the product candidate and Axis-Shield. Axis-Shield bears the costs for the project.

When Phase 1 studies with IdeS commence, which we assume will take place in mid 2012, it will be possible for internal resources to be invested in the new pre-clinical project EndoS. The enzyme EndoS modifies the so called glycosylation of antibodies and a series of early preclinical research results indicates the potential of EndoS for the treatment of rare autoimmune diseases. EndoS and IdeS are both immunomodulating enzymes of bacterial origin. The promising research results with EndoS combined with significant know-how from the IdeS project forms the basis for our decision to dedicate development resources to the EndoS project as well.
Emanuel Björne, CEO Hansa Medical AB (publ)