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Hansa Medical AB (publ) - Interim report January 1 - June 30 2010

29 Jul 2010, 08:00
Regulatory information
Financial information

• Net sales for the Group amounted to SEK 0.3 M (2.8)

• The Group reported a loss of SEK 8.6 M (loss: 6.2)

• The Group’s operating loss amounted to SEK 7.5 M (loss: 6.2)

• The loss per share was SEK 1.11 (loss: 1.61)

The period in brief

• Rights issue totaling SEK 27 M oversubscribed by 22.4 percent

• Partnership with Axis-Shield proceeded according to plan, and clinical registration study is planned to start during autumn 2010

• Large number of drug candidates generated through the partnership with Alere Inc. (formerly Inverness Medical Innovations Inc.)

• Paula Zeilon new Board member of Hansa Medical

• Changed Articles of Association and authorization by the Annual General Meeting entitling the Board of Directors the right to decide on new share issues

• Internally developed production process for IdeS transferred to Contract Manufacturing Organization

• Patent granted for IdeS in the US

• Registration of the IDESENS® brand approved in the US, Europe and Australia

• Research studies with IdeS and EndoS published in scientific journals

CEO’s comments

“Through an oversubscribed right issue, our shareholders have showed great confidence in our business and we now have the strength to continue developing our three projects – anti-alpha-11, IdeS and HMD-301 towards the next value-generating goals. We have taken a major step in our IdeS project and completed the transfer of our internally developed production process to a contract manufacturing organization. The next step in this work is to produce a full-scale batch for our planned pre-clinical toxicity and safety studies. The goal for project IdeS is to submit an application to conduct a clinical phase I study to the Medical Products Agency during the first half of 2011.

“Our partnership agreements with Alere (formerly Inverness Medical Innovations) and Axis-Shield are both proceeding according to plan with respect to both time and development activities. Alere has generated a large number of anti-alpha-11 antibodies that Hansa Medical is now characterizing, evaluating and gaining patent protection on. This evaluation work is extensive, and we will devote much of the autumn to carefully selecting a small number of antibodies for further development. In recent months, the Axis-Shield collaboration has focused on further development of Hansa Medical’s analysis prototype, HMD-301, for diagnosis and prognosis of severe sepsis. In addition, extensive planning work was conducted to have all logistical pieces in place prior to the clinical registration trial of HMD-301. The study will be conducted at emergency clinics in Sweden and the US. The clinical study is planned to start during autumn 2010, and the goal of achieving market launch of an initial version of the analysis method by the end of 2011 remains.” Emanuel Björne, CEO of Hansa Medical (publ).

 (For complete Interim report, se attached PDF)

For further information:

Emanuel Björne, CEO
Tel: +46 707 17 54 77

Hansa Medical is a biotech development company focused on inflammation. The company primarily conducts three development projects in pre-clinical and early clinical phases: IdeS, anti-alpha-11 and HMD-301, of which two are partnerships. IdeS is a drug candidate for treatment in conjunction with organ transplantation and autoimmune disease. Anti-alpha-11 is a novel treatment method under development for rheumatoid arthritis. HMD-301 is a method for diagnosis of severe sepsis. Hansa Medical is publicly traded on First North, which is part of NASDAQ OMX. Remium AB is the company’s financial adviser.