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Hansa Medical Interim report July – September 2016

9 Nov 2016, 08:30
Regulatory information

Multicenter study initiated with IdeS in transplantation and expansion of clinical program into autoimmunity

Third quarter in brief

Business highlights
›› Preliminary results presented from the Swedish ongoing Phase II study with IdeS in sensitized patients
›› Hansa Medical initiated Highdes, a multicenter study in the US with IdeS for treatment of highly sensitized kidney transplantation patients
›› Hansa Medical investigates cancer immunotherapy applications with IdeS and EndoS through the acquisition of UK based biotech company Immago Biosystems Ltd

Significant events after end of period
›› First patient treated with IdeS in Phase II study in acquired Thrombotic Thrombocytopenic Purpura (TTP)
›› Subject to approval by the Extraordinary General Meeting, the Board of Directors of Hansa Medical decided on a directed share issue of approximately MSEK 185 to selected international and Swedish investors, and a long-term incentive programme (performance share programme) for employees of Hansa Medical

Financial summary
›› Net revenue for the group in Q3 amounted to MSEK 0.5 (0.5). YTD: MSEK 1.6 (4.9).
›› Operating result in Q3 was MSEK -27.0 (-13.9). YTD: MSEK -77.6 (-47.1).
›› Consolidated net result in Q3 was MSEK -26.9 (-13.9). YTD: MSEK -77.6 (-47.2).
›› Earnings per share before and after dilution in Q3 were SEK -0.83 (-0.43). YTD: SEK -2.39 (-1.54).
›› Cash position including short-term investments on September 30, 2016, of MSEK 103.9.

CEO statement
We are convinced that our novel and innovative immunomodulatory enzymes hold significant therapeutic potential for patients either in need of a lifesaving transplantation or with acute and severe autoimmune diseases.

To date, we have demonstrated in more than 30 patients that our lead candidate IdeS effectively and swiftly removes pathogenic IgG-antibodies and thereby enables kidney transplantation in sensitized patients.

In the two ongoing Phase II studies with IdeS in Sweden and the US, treatment with IdeS has enabled kidney transplantation in all patients. So far we can conclude that IdeS, by cleaving IgG-antibodies into two fragments, effectively eliminates the antibody barrier in sensitized patients, which makes it possible to transplant these patients in a similar way as with non-sensitized patients.

We now intend to demonstrate that this mode of action is sufficient also for the most severe cases of HLA-sensitization, in order to enable transplantation for patients that have been too long on the transplant waitlist. In October 2016, we treated the first patient in a clinical study – titled Highdes – that is exclusively aimed at the highly sensitized patients.

The Highdes study will recruit approximately 20 highly sensitized patients in the US and Europe. We anticipate that the Highdes study together with the completed and ongoing studies will provide data to support a Biologics License Application (BLA) in the US and a Marketing Authorization Application (MAA) in the European Union. We are equally determined to pursue the therapeutic potential of IdeS in a number of other indications.

We believe that the fast onset and efficacy of IdeS has the potential to revolutionize the critical care in many acute autoimmune diseases and transplant related indications. Initially, we have narrowed in on a number of carefully selected indications, including Thrombotic Thrombocytopenic Purpura (TTP) and Guillain-Barré syndrome (GBS), in which we believe that IdeS may make a difference. In October 2016, the first patient was treated in a Phase II study in TTP at University College London Hospitals.

In order to fully execute this value creation strategy, we decided to raise SEK 185 million in a directed share issue to selected international specialist investors, as well as from Swedish institutional and strategic investors. The share issue, which will broaden our

shareholder base towards institutional and specialist investors, is to be resolved on an extraordinary general meeting on November 21, 2016. We have already received full subscription of the shares in accordance with separate agreements from the investors.

It has certainly been an exciting 2016 to date. The success of our clinical trials, the hope this is bringing to patients, and the steadily increasing interest from investors and other stakeholders acknowledging our long term value creation strategy, give strength and inspiration to all of us here at Hansa Medical.

We have an exciting time ahead of us.

Göran Arvidson
President and CEO of Hansa Medical

This information is such information that Hansa Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:30 am CEST on 9 November 2016

For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-633 30 42

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focusing on novel immunomodulatory enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Additional projects focus on development of new antibody modulating enzymes, as well as HBP, a diagnostic biomarker for prediction of severe sepsis at emergency departments that is already introduced on the market. The company is based in Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on Nasdaq Stockholm.