Top line results from the Swedish ongoing Phase II study with IdeS in sensitized patients presented

Hansa Medical AB (publ) today announced that preliminary results of the Sweden
based ongoing Phase II study of IdeS were presented today by Professor Gunnar
Tufveson at the 26th International Congress of the Transplantation Society in
Hong Kong on August 23, 2016. The results show that IdeS has enabled kidney
transplantation in all 10 out of 10 included sensitized patients. The Phase II
study also shows that IdeS treatment resulted in negative cross match test in
all patients, none of the transplanted patients experienced delayed graft
function and all 10 transplantations resulted in very good creatinine levels.
The ongoing and fully recruited Phase II study at Uppsala University Hospital
and Karolinska University Hospital in Huddinge, Sweden, includes 10 patients who
received a single dose of IdeS (0.25 or 0.5 mg/kg) before kidney
transplantation. The study’s primary focus is to evaluate safety and
tolerability of Hansa Medical’s candidate drug IdeS in sensitized kidney
transplantation patients. The study is also aimed at identifying an IdeS dose
that results in anti-HLA antibody levels acceptable for transplantation within
24 hours from dosing.  Patients in the study are followed for six months after
transplantation to continue to evaluate drug safety and kidney function.  The
study is expected to be finalized in Q4 2016.

Professor Tufveson concludes in his presentation that IdeS treatment is a
suitable way to achieve rapid and effective desensitization allowing
transplantation in immunized patients and that a dose level of 0.25 mg/kg body
weight is a suitable dose.

Two additional clinical studies with IdeS in sensitized patients are ongoing: an
investigator initiated Phase II study at Cedars-Sinai Medical Center in Los
Angeles and a pivotal multicenter study in the US with IdeS in refractory highly
sensitized patients. Results from the multicenter study hold the potential to
form the basis for filing a Biologics License Application, which is an
application to the US Food and Drug Administration (FDA) for authorization to
commercialize IdeS in the US. In addition, Hansa Medical is evaluating the
possibility of adding various European sites to this multicenter study to better
support the regulatory process at the European Medicines Agency, EMA, to gain
marketing authorization of IdeS in the European market.

The information in this press release is disclosed pursuant to the EU Market
Abuse Regulation. The information was released for public disclosure through the
agency of the contact person stated below on  August 23, 2016 at 08.30 CET.
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
About IdeS

IdeS, a unique molecule with a novel mechanism, is an enzyme that specifically
cleaves human IgG antibodies. During 2013, a Phase I clinical trial including 29
healthy subjects was conducted, demonstrating IdeS as efficacious and well
tolerated with a favorable safety profile. During 2014, a Phase II study in 8
sensitized patients awaiting kidney transplantation was conducted. Data from the
study show that IdeS is effective in reducing anti-HLA antibody levels in highly
sensitized patients to levels acceptable for transplantation. The efficacy and
safety of IdeS in transplantation are currently investigated in three on-going
clinical trials in sensitized kidney patients in Sweden and in the US. In
addition to transplantation, IdeS has potential applications in a variety of
rare autoimmune diseases. IdeS is protected by several patents and results of
studies with IdeS have been published in a number of peer reviewed scientific
journals.

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.