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Hansa Medical AB (publ) - Interim report January 1 - June 30 2012

Regulatory information

Financial information

  • Net sales for the Group amounted to SEK 1.3 (0.4) M
  • The Group reported a loss of SEK -11.9 (-10.5) M
  • The Group’s operating loss amounted to SEK -11.9 (-10.4) M
  • The loss per share was SEK 0.59 (loss 1.28)

The period in brief

  • Hansa Medical collaboration partner, Axis-Shield, finalizes clinical part of HMD-301 multi-center study. The analysis of the extensive patient material continues.
  • Extensive analysis of the results of toxicity studies with IdeS has been performed. Supplementary analysis work is ongoing.
  • Hansa Medical has been granted patents for the medical use of IdeS in both Europe and the US.
  • Hansa Medical has been granted a European patent for the diagnosis of severe sepsis with HMD-301.
  • Published clinical research results indicate that HBP assay is a good biomarker for the diagnosis of urinary tract infections.
  • Directed share issue to venture capital company, NXT2B, followed by a preferential rights issue raises in total SEK 46 million

CEOs comments
During the spring of 2012, we have worked, in full force, with our primary project, IdeS, towards the goal of initiating clinical studies. A premise for initiating clinical Phase I studies is that the preclinical studies have been completed and that our application to the Swedish Medical Products Agency has been finalized and approved. The GMP-production of IdeS and a large portion of the toxicity studies have been completed. The toxicity studies have generated many answers and raised some additional questions to be answered regarding, for example, suitable dosing in initiating the clinical studies. During the first half of 2012, we have analyzed and summarized a large portion of the data generated by the toxicity studies. We have also designed and, partially, completed supplementary analyses and development work in order to find answers to the new questions raised from the toxicity studies. Our aim is to present an application covering the clinical Phase I studies to the Swedish Medical Products Agency as soon as all of the conclusions have been made and all data has been correctly documented.

The clinical study with HMD-301, performed by our collaboration partner Axis-Shield is in the documentation and evaluation phase. More than 700 patients in Sweden and the US have been included in the study. A large number of clinical variables have been monitored per patient and a large number of blood tests have been taken. As soon as all of the data is in place and the conclusions have been determined, we look forward to announcing the outcome. The goal is to launch a CE marked product in Europe and also, in the long term, to apply for FDA’s approval for marketing in the US.

Our clinical collaboration partners within infection medicine at Skåne’s university hospital in Lund have published data showing that HMD-310 has potential for use in the diagnosis of urinary tract infections in children. This is a very exciting new possibility for HMD-301 patented by Hansa Medical. Further clinical investigations regarding the diagnosis of urinary tract infections in adults is ongoing studies.

During the first half year 2012, we have also been granted three important patents in the US and Europe. The medical use of IdeS, and similar substances, for treatment in conjunction with organ transplantations and the treatment of autoimmune diseases, has been granted in both the US and Europe. A patent regarding the diagnosis and prognosis of patients with severe sepsis based on the quantification of the protein HBP has been granted in Europe. These patents are very central to Hansa Medical’s possibility to commercialise the pharmaceutical candidate, IdeS, and the diagnostic method, HMD-301.


Emanuel Björne, CEO Hansa Medical AB (publ)

(For complete Interim report in Swedish, se attached PDF)