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Hansa Medical Interim report January – June 2015

Regulatory information

January – June 2015 in summary 

Operations Summary 

Q1 
Phase II clinical study of IdeS in highly sensitized patients awaiting kidney transplantation successfully completed
Cooperation initiated with leading US transplantation expert Dr Stanley Jordan at Cedars-Sinai Medical Center, Los Angeles
Development of a new generation of IdeS molecules for repeat dosing initiated
Preliminary application for listing on Nasdaq Stockholm submitted 

Q2 
IdeS Phase II study initiated at Uppsala University Hospital and Karolinska University Hospital. The first patient treated with IdeS was subsequently transplanted from a deceased donor
Investigator sponsored Phase II study with IdeS initiated at Cedars-Sinai Medical Center, US
Hansa Medical established a US medical advisory board
Göran Arvidson new President and CEO of Hansa Medical
Hansa Medical secured MSEK 246 in funding through a fully subscribed rights issue 

Financial Summary Q2 and Year to Date 
Net sales for the group in Q2 amounted to MSEK 0.5 (0.3). YTD: MSEK 4.4 (1.5)
Operating result in Q2 was MSEK -22.5 (-4.8). YTD: MSEK -33.2 (-10.7)
Consolidated net result in Q2 was MSEK -22.5 (-4.8). YTD: MSEK -33.2 (-10.8)
Earnings per share before and after dilution in Q2 was SEK -0.70 (-0.18). YTD: SEK -1.11 (-0.42)
Cash position on June 30, 2015, of MSEK 209.1 

Significant events after the reporting period 
IdeS Phase I data published in the scientific journal PLOS ONE
First patient treated with IdeS and subsequently transplanted in an investigator sponsored US Phase II study at Cedars-Sinai Medical Center, Los Angeles 

CEO Statement 
In the second quarter of 2015, we continued to build on the good start of the year, when we took some important steps – both financially and in clinical development – to shape Hansa Medical’s future. Ultimately, we want to create a strong biopharmaceutical company with life-saving pharmaceuticals on the market. I feel certain that we are on the right track. 

Our lead project IdeS has attracted a lot of attention in the international scientific community. The results from the earlier clinical Phase I trial of IdeS were published in the scientific journal PLOS ONE in July. Among other things, the study results showed that a single dose of IdeS rapidly and efficiently inactivates IgG in humans, which could make it a very attractive therapeutic approach for acute IgG driven conditions. 

In June, we announced that the first patient after treatment with IdeS in a clinical Phase II study was successfully transplanted from a deceased donor. The study will evaluate the safety, tolerability and efficacy of IdeS in kidney transplantation of sensitized patients. It is also aimed at identifying the appropriate dose that in the majority of patients will result in anti-HLA antibody levels acceptable for transplantation within 24 hours from dosing. 

In parallel with the ongoing Phase II study in Sweden, other studies are being initiated, one of which is run by Professor Stanley Jordan, a leading expert in transplant immunology, at Cedars-Sinai Medical Center in Los Angeles. It is an open-label study to assess the safety and efficacy of IdeS in eliminating donor specific antibodies and thus prevent antibody-mediated rejection in sensitized patients. 

This important collaboration with Dr Jordan is a further acknowledgement that IdeS is an exciting project, quoting Dr Jordan: “IdeS has the potential to revolutionize the whole area of transplantation, especially in sensitized patients.” We are also planning for further studies in transplantation and other IgG mediated indications where there is a significant unmet medical need. 

As you will see in this report, we have summarized and in more detail explained our projects and the various studies we have conducted and are conducting at the moment. We will continuously update this information on the website. 

During the period, we also strengthened our scientific network. In May, we announced the formation of a US medical advisory board for IdeS in kidney transplantation. This board is connected with the previously initiated advisory board of leading transplantation experts in Europe. These advisory boards are valuable components in establishing IdeS as a potential pharmaceutical product of great importance. 

Early in April, we announced that the MSEK 246 rights issue was fully subscribed, which means that we now have the means to finance the next exciting phase, the clinical development of IdeS and our other research projects. We believe that IdeS has other potential medical indications, including relatively rare and serious – even life-threatening – acute immune diseases. 

We have also continued to strengthen the organisation in and around the company, in time for the planned change of market place to Nasdaq Stockholm’s main market. At the annual general meeting on 2 June, Hans Schikan was elected new board member, adding more first-class biotech experience to the board. The management was also strengthened with Steven Glazer as CMO and Eva-Maria Joed as CFO. 

On November 13, 2015, we will have the honor to summon interested shareholders and research partners to a combined investor and research day in Stockholm. During this event some of the prominent US and European clinical experts we collaborate with will give us a review from their daily practice and present their view on the potential of IdeS. We will get back shortly with more details about this event and how to attend. 

The development of Hansa Medical in the first half of this year shows that we are in an excellent position to build a biopharmaceutical company of lasting value with important, life-saving products. 

Göran Arvidson 
President and CEO