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Hansa Medical AB (publ) - Year-End Report 2015

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Several significant milestones reached in 2015

January – December 2015 in summary – Highlights

October – December

  • Hansa Medical’s shares began trading on Nasdaq Stockholm on November 2, 2015
  • Data from the first patient in the ongoing US study with IdeS in highly sensitized patients presented at Hansa Medical’s Capital Markets Day on November 13, 2015, showed that one dose of IdeS effectively inactivates donor specific antibodies
  • Data published in Journal of Immunology shows that IdeS temporarily can silence B-cells, preventing B-cells from developing into antibody producing cells

January – September

  • Phase II clinical study of IdeS in highly sensitized patients awaiting kidney transplantation successfully completed
  • Development of new generation of IdeS molecules for repeat dosing announced
  • US medical advisory board established
  • First patient in second IdeS Phase II study at Uppsala University Hospital transplanted
  • Positive data on IdeS Phase I study published in scientific journal PLOS ONE
  • First patient treated and transplanted with IdeS in investigator sponsored US Phase II study at Cedars-Sinai Medical Center, Los Angeles
  • FDA Orphan Drug Designation for IdeS in solid organ transplant patients received
  • First Phase II study of IdeS in sensitized kidney transplantation patients presented at ESOT 2015
  • Hansa Medical secured MSEK 246 in funding through a fully subscribed rights issue
  • Göran Arvidson appointed new President and CEO of Hansa Medical
  • Results from a clinical multicenter trial with HBP-assay published in Critical Care Medicine

Financial summary Fourth quarter and Full Year

  • Net revenue for the group in Q4 amounted to MSEK 0.5 (0.2).
  • Full year: MSEK 5.4 (1.6)
  • Operating result in Q4 was MSEK -19.1 (-8.6).
  • Full year: MSEK -66.2 (-24.7)
  • Consolidated net result in Q4 was MSEK -19.1 (-12.8).
  • Full year: MSEK -66.3 (-29.0)
  • Earnings per share before and after dilution in Q4 were SEK -0.59 (-0.47). Full year: SEK -2.13 (-1.09)
  • Cash position on December 31, 2015, of MSEK 175.7 (10.2)

“We are very pleased with the progress and preliminary results of the two ongoing clinical studies and expect patient enrollment to be completed in Q1 and Q2 2016, respectively. To date, 11 sensitized patients have been treated with IdeS and then transplanted.” Göran Arvidson, President and CEO of Hansa Medical

For full Year-End Report, follow link below.

For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: +46 70-633 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com

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.

Tags:

Transplantation enzyme kidney Rare Disease Hansa Medical Hansa Medical AB IdeS Sensitized Desensitization IgG-degrading enzyme of Streptococcus pyogenes IgG-degrading donor specific antibodies Göran Arvidson Stanley Jordan

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