October-December in brief

• Swedish Phase II study successfully completed with lead candidate IdeS in sensitized kidney transplantation patients
• Application for EU Orphan Drug Designation for IdeS received positive opinion from EMA and the designation was formally granted by the European Commission in January 2017
• First patient treated with IdeS in US and EU multicenter Highdes study in highly sensitized kidney transplantation patients
• Phase II study in asymptomatic patients with Thrombotic Thrombocytopenic Purpura (TTP) was discontinued as initial results demonstrated a non-favorable risk benefit profile
• Completed a directed share issue of approximately SEK 185 m to selected international and Swedish investors
• Nasdaq Stockholm announced Hansa Medical to be traded in the Mid Cap segment as of January 2, 2017 

January-September in brief

• Hansa Medical acquired UK-based biotech company Immago Biosystems Ltd to investigate cancer immunotherapy applications with IdeS and EndoS
• Promising initial results from investigator-initiated US Phase II study with IdeS in highly sensitized kidney transplantation patients were presented at the American Transplant Congress
• Henk Doude van Troostwijk appointed Vice President of Commercial Operations and Karin Aschan appointed Vice President of   Regulatory Affairs
• Ulf Wiinberg elected new chairman and Angelica Loskog elected new board member

Financial summary – Fourth quarter and full year

    
CEO statement
   
2016 was in many ways a defining year for Hansa Medical. We successfully continued the development of our novel and innovative immunomodulatory enzymes, in particular our lead candidate, IdeS, enabling transplantation in sensitized patients.
     
Our unique business opportunity and value-creating strategy has been recognized by a number of investors with substantial investment experience in the life science industry. Furthermore, we have met a lot of interest for our research in the scientific and medical community, which has resulted in the presentation of the results from our clinical trials at several scientific and medical congresses. This was an exciting year – we continued to move our pipeline programs forward and delivered on our milestones. I am convinced we are well-positioned for the future.
    
In December, we announced the completion of the second Swedish open-label Phase II study with IdeS, conducted at Uppsala University Hospital and Karolinska University Hospital, Huddinge. In the study, 10 sensitized kidney patients were given IdeS prior to transplantation. The study met its primary and secondary objectives, and further supports our belief that IdeS holds significant therapeutic value for sensitized patients in need of a lifesaving transplantation.
    
In the completed and ongoing Phase II studies with IdeS in Sweden and the US, treatment with IdeS has effectively eliminated the antibody barrier in all sensitized patients. Fast and effective elimination of anti-HLA IgG antibodies enables kidney transplantation for sensitized patients, who otherwise would not be considered for kidney transplantation due to the apparent risk of hyperacute rejection.
     
Results from the recent studies with IdeS were presented by the principal investigators at a number of renowned scientific and medical meetings.
      
In June, Professor Stanley Jordan presented initial data from one of the US studies at the 2016 American Transplant Congress in Boston, and in August, Professor Gunnar Tufveson presented equally encouraging results from one of the Swedish studies at the 26th International Congress of the Transplantation Society in Hong Kong.
    
Our objective is now to demonstrate that the mode of action of IdeS is equally relevant for the more severe cases of HLA-sensitization, in order to enable transplantation for patients that have been on the waitlist far too long. In October, the first patient in our multicenter clinical study, Highdes, was treated with IdeS and subsequently transplanted. The Highdes study is exclusively aimed at highly sensitized patients and approximately 20 patients will be recruited in the US and Europe
    
We believe that the Highdes study, together with the already 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 EU.
     
We have also obtained Orphan Drug Designation (ODD) for IdeS from the European Commission for the prevention of graft rejection following solid organ transplantation. IdeS was previously granted ODD by the US Food and Drug Administration. These are important regulatory milestones that will provide us with development and commercial incentives, including 10 years of market exclusivity in the EU, protocol assistance on the development of the drug, including clinical studies, and certain exemptions from or reductions in regulatory fees.
    
In parallel with our groundbreaking work in organ transplantation, 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 several transplant-related indications and acute autoimmune diseases, including Anti-GBM antibody disease and Guillain-Barré syndrome (GBS).
     
A clinical study in asymptomatic Thrombotic Thrombocytopenic Purpura (TTP) was discontinued in December after review of initial data from treatment of two patients since we were not able to demonstrate a convincing risk-benefit profile in these patients. We are optimistic about the clinical development of IdeS in our lead programs and the decision to end the study has no impact on Hansa Medical's ongoing studies with IdeS in kidney transplant or planned studies in other autoimmune indications.
    
In October, we decided to raise SEK 185 million in a directed share issue to selected international specialist investors, as well as Swedish institutional and strategic investors, in order to fully execute our strategy and continue developing our programs. The share issue was well-received and has broadened our shareholder base.
    
Over the last twelve months, we have also continued to build a strong, committed team at Hansa Medical. We are now more than 30 co-workers and plan to further strengthen the organization, as we get closer to the commercialization phase. In the second quarter, we appointed Henk Doude van Troostwijk as Vice President of Commercial Operations. His focus includes developing and executing our strategies for market access, pricing and reimbursement. In the third quarter we appointed Karin Aschan as Vice President of Regulatory Affairs. Karin brings many years of experience from regulatory strategy development.
     
At the Annual General Meeting on May 11, Ulf Wiinberg and Angelica Loskog were elected new board members. Ulf, who was also elected new chairman, and Angelica bring both strength and industry expertise to the company.

Looking back at 2016, I feel that we have accomplished many important things, both scientifically and operationally.
    
Outlook
We achieved several important scientific and regulatory milestones in 2016 with our lead candidate, IdeS. This drug has shown significant potential to become an important new treatment option to enable patients to receive the lifesaving transplant they desperately need.
    
We have a solid and exciting value-creation strategy in place, and our novel immunomodulatory enzymes have the potential to deliver significant value. Furthermore, we have strengthened the company and have the right team in place to continue progressing our programs, benefiting all our stakeholders and, most importantly, the patients. With data expected from a number of clinical studies this year, we look forward to 2017 with continued optimism.
     
Göran Arvidson
President and CEO of Hansa Medical