Comments to CEO presentation at Redeye on 17 February 2015 at 18.30

The presentation made by Hansa Medical AB (publ) CEO Fredrik Lindgren contained
certain data relating to Hansa Medical’s phase I study. This press release
contains certain clarifications and supplementary information relating to the
study.
Hansa Medical completed a phase I study in healthy subjects in 2013. This first
-in-human study was a double blind and randomized study with single ascending
doses of IdeS. The study was conducted in Lund, Sweden after approval from
Swedish regulatory and ethical authorities. The objective was to assess safety,
efficacy, pharmacokinetics, and immunogenicity of IdeS in healthy human subjects
following intravenous administration over 15 minutes. Each dose group consisted
of 4 subjects receiving IdeS and 2 subjects receiving placebo and in total five
dose groups were exposed. The starting dose was 0.01 mg/kg body weight (BW) and
the highest dose group received 0.24 mg/kg BW.

In total 20 subjects were exposed to IdeS and already at the lowest dose a
partial effect, i.e. single cleaved IgG, could be observed in occasional
subjects. Full IgG cleavage within a few hours after dosing was achieved at 0.12
and 0.24 mg/kg BW in all subjects and noteworthy single cleaved IgG was observed
already during dosing. IdeS created an IgG-free window of between one and two
weeks after which newly synthesized IgG started to appear. IdeS had a short
serum half-life and the main fraction of IdeS was eliminated during the first 24
hours after treatment. As expected, anti-drug antibodies developed dosing. The
antibodies reached peak levels two to four weeks after dosing and were
normalized within 6-12 months. No severe adverse events were reported and the
proportion of adverse events was comparable between IdeS and placebo treated
subjects.

The conclusion based on the first-in-human study was that IdeS proved to be
safe, well tolerated and effective.

“This phase I study is the proof-of-concept study for IdeS and forms the basis
for further development of IdeS in various IgG-mediated conditions. The study
has generated additional patent opportunities and it will be available in its
full extent through publication in a peer reviewed journal.” says Christian
Kjellman, Chief Scientific Officer of Hansa Medical AB.

About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that
cleaves human IgG antibodies. IdeS degrades all IgG specifically, swiftly and
efficiently. IdeS has been tested for safety and efficacy in numerous in vitro
and in vivo models. During 2013, a Phase I clinical trial on 29 healthy subjects
was conducted, demonstrating IdeS as efficacious and well tolerated with a
favorable safety profile. During 2014 and 2015, a Phase II clinical trial in
sensitized patients awaiting kidney transplantation has been conducted.
Preliminary data shows that IdeS has very good efficacy in highly sensitized
patients on the kidney transplant waitlist. The study shows that IdeS has the
capacity to make sensitized patients eligible for transplantation by decreasing
HLA antibodies to levels acceptable for transplantation. In addition to
transplantation, IdeS has potential indications within a variety of rare
autoimmune diseases including anti-GBM disease. IdeS is protected by several
patents and has been published in numerous peer review journals.
For further information, please contact:
Hansa Medical AB
Fredrik Lindgren, President and CEO
Mobile: 46 705 61 61 77
E-mail: fredrik.lindgren@hansamedical.com
www.hansamedical.com
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused
on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading
enzyme in clinical development, with potential use in transplantation and rare
autoimmune diseases. Other projects include HBP (a market introduced diagnostic
marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in
pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's
share (HMED) is listed on NASDAQ First North in Stockholm with Remium Nordic AB
as Certified Adviser. Major shareholders are Farstorps Gård AB and Nexttobe AB.