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Hansa Medical AB (publ) - Interim report January 1 - June 30 2014

Regulatory information
Brief summary

· Successfully completed Phase I study with IdeS
· Swedish Medical Products Agency approves Hansa Medical’s clinical Phase II-study application with IdeS
· Rights issue subscribed at 137 percent
· Medical Advisory Board appointed
· Net sales for the Group amounted to: SEK 3,0 (0.6) M
· The Group’s net loss amounted to: SEK -10.8 (-8.6) M
· Operating income for the Group amounted to: -10,7 (-8.6) M
· Earnings per share amounted to: SEK 0.46 (-0.39)

Dear Shareholders,

As of now, the Phase II study with the drug candidate IdeS has been initiated. This is a great moment for Hansa Medical, but more so for the healthcare system and for all those patients waiting for an efficient treatment method, rapidly inactivating harmful IgG antibodies prior to life changing transplantation. We would never have got this far, had it not been for the patience and endurance of our shareholders, and for the determination, creativity and hard work demonstrated by my colleagues.

We develop IdeS for rapid and effective inactivation of IgG antibodies in sensitized kidney transplantation patients. We strive to enable kidney transplantation to thousands of patients within minutes after distributing an intravenous injection of IdeS. In January 2014, we finalized a successful Phase I trial that included 29 healthy subjects. The results from this study demonstrated that IdeS is effective and well tolerated with a favorable safety profile.

The Phase II study’s objective is to survey IdeS’ safety and efficacy on antibodies directed against the surface protein HLA in sensitized kidney-patients, awaiting transplantation. For the third quarter of 2014, we intend to initiate an additional Phase II study to examine IdeS’ efficacy and safety in sensitized kidney patients undergoing transplantation. In total, the two studies will last for an estimated twelve months. The scope of our studies is to pave way for pivotal Phase III trials.

Through spring and summer this year, we have demonstrated the clinical outcome of IdeS to potential partners at the World Orphan Drug Congress in Washington D.C and at the BIO International Convention in San Diego, USA. The interest in the drug candidate IdeS has increased significantly after completion of the Phase I study.

If we, through Phase II studies, manage to show that IdeS effectively and safely inactivate anti-HLA antibodies in sensitized patients, then I am certain that we will have the opportunity to negotiate attractive licensing deals with major biotechnology companies, well established on the market and with focus on transplantation or rare diseases.

The second choice to present itself in such a scenario is to develop IdeS in-house and to launch this unique product onto a vast market, focusing sales on a relatively limited number of specialized clinics.

Furthermore, earlier this year we attracted a highly skilled and experienced Medical Advisory Board to commit itself to Hansa Medical in order to further strengthen the quality of our development work as well as enhancing the international credibility of the IdeS Development Program. Hansa Medical’s growing international network of transplant surgeons and clinical experts in rare autoimmune diseases, indicate an increasing interest in the IdeS’ concept and its potential to help thousands of patients.

Marketing the HBP-assay, the efficient method for predicting severe sepsis in emergency departments, continues as planned under management of our partner Axis-Shield Diagnostics. Significant to a successful marketing strategy is the publication of comprehensive clinical study-data from the IMPRESSED-study, conducted by Axis-Shield Diagnostics. The study included 763 patients in Sweden and in the USA. A finalized article including complete clinical study data has been submitted to a scientific journal for publication.

Emanuel Björne
CEO Hansa Medical AB (publ)

Attached, please find the full interim report in Swedish.