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Hansa Medical AB (publ) - Interim report January 1 - June 30 2011

Regulatory information
 

Financial information
-
Net sales for the Group amounted to SEK0.4 M (0.3)

- The Group reported a loss of SEK10.5 M (loss: 8.6)
- The Group’s operating loss amounted to SEK10.4 M (loss: 7.5)
- The loss per share was SEK 1.28 (loss: 1.11) SEK

The period in brief
-
Hansa Medical’s collaboration partner Axis-Shield entered into an option agreement with Bio-Rad Laboratories for the commercialisation of Heparin Binding Protein (HMD-301)

- Clinical multi-center study with HBP assay for the diagnosis of severe sepsis initiated
- Published clinical research results indicate that HBP is also a good biomarker for the diagnosis of bacterial meningitis
- Rights issue totalling SEK 29 million oversubscribed
- Development of the project IdeS continues according to plan
- Development of the project anti-alpha-11 continues according to plan

CEO's comment
We are developing three promising product candidates; IdeS, for treatment in conjunction with organ transplants and emergency treatment of autoimmune conditions, anti-alpha-11 for a more effective treatment of rheumatoid arthritis and the diagnostic method HMD-301 for the prevention and diagnosis of severe sepsis at emergency departments across the globe. These are bold and innovative projects, within all three of which we have made forward progress during the first six months of 2011. The most notable step forward is the initiation of the pivotal study for HMD-301, under the management of our collaboration partner Axis-Shield. This comprehensive clinical multi-center study is intended to confirm our initial study which was undertaken in Lund, as well as to for the basis for registration. If the results of the study are positive, a first version of this diagnostic could be on the market by the beginning of 2012. During the first six months of the year, we have also implemented further process developments which will enable the production of a first clinical batch of the biopharmaceutical candidate IdeS. We intend to produce a first clinical batch of IdeS during the second half of 2011. Hansa Medical’s collaboration with Alere Inc. within the project anti-alpha-11 is progressing well and a number of promising antibodies have been identified through this joint development work. Continuous evaluations and further developments of these antibodies have taken place during 2011. Our rights issue totalling SEK 29 M was subscribed at 116%. This implies the we can now continue to work towards the significant developmental targets which are approaching relatively soon:


- Toxicity and safety study for IdeS during 2011
- Production of a clinical batch of IdeS during 2011
- Initiate and complete phase I studies with IdeS during 2012
- Apply for and be granted orphan drug status for IdeS during 2011 from the European Medicines Agency
- Identify an early anti-alpha-11 pharmaceutical candidate during 2012
- Further strengthen the pre-clinical documentationen regarding alpha-11 as a new, promising drug target for the treatment of rheumatoid arthritis during 2011 and 2012
- Conduct clinical multi-center study in Sweden and the USA with Axis- Shield regarding HBP assay during 2011
- Together with Axis-Shield, launch a CE marked first version of HBP assay during 2012
- Reach further licensing agreements with major diagnostics companies with market presence as regards HBP assay during 2011 and 2011

Our overriding objective is to make Hansa Medical a profitable pharmaceutical company with a positive cash flow as soon as possible. We continually evaluate strategic acquisitions as a means towards achieving this objective sooner.
Emanuel Björne, CEO Hansa Medical AB (publ)

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

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