MALMÖ, Sweden--(BUSINESS WIRE)--Regulatory News:
Hansa Medical (STO:HMED)
Multicenter study initiated with IdeS in transplantation and expansion
of clinical program into autoimmunity
Third quarter in brief
›› Preliminary results presented from the
Swedish ongoing Phase II study with IdeS in sensitized patients
Hansa Medical initiated Highdes, a multicenter study in the US with IdeS
for treatment of highly sensitized kidney transplantation patients
Hansa Medical investigates cancer immunotherapy applications with IdeS
and EndoS through the acquisition of UK based biotech company Immago
Significant events after end of period
›› First patient
treated with IdeS in Phase II study in acquired
Thrombotic Thrombocytopenic Purpura (TTP)
›› Subject to
approval by the Extraordinary General Meeting, the Board of Directors of
Hansa Medical decided on a directed share issue of approximately MSEK
185 to selected international and Swedish investors, and a long-term
incentive programme (performance share programme) for employees of Hansa
›› Net revenue for the group in Q3 amounted
to MSEK 0.5 (0.5). YTD: MSEK 1.6 (4.9).
›› Operating result
in Q3 was MSEK -27.0 (-13.9). YTD: MSEK -77.6 (-47.1).
Consolidated net result in Q3 was MSEK -26.9 (-13.9). YTD: MSEK -77.6
›› Earnings per share before and after dilution in
Q3 were SEK -0.83 (-0.43). YTD: SEK -2.39 (-1.54).
position including short-term investments on September 30, 2016, of MSEK
We are convinced that our novel and innovative
immunomodulatory enzymes hold significant therapeutic potential for
patients either in need of a lifesaving transplantation or with acute
and severe autoimmune diseases.
To date, we have demonstrated in more than 30 patients that our lead
candidate IdeS effectively and swiftly removes pathogenic IgG-antibodies
and thereby enables kidney transplantation in sensitized patients.
In the two ongoing Phase II studies with IdeS in Sweden and the US,
treatment with IdeS has enabled kidney transplantation in all patients.
So far we can conclude that IdeS, by cleaving IgG-antibodies into two
fragments, effectively eliminates the antibody barrier in sensitized
patients, which makes it possible to transplant these patients in a
similar way as with non-sensitized patients.
We now intend to demonstrate that this mode of action is sufficient also
for the most severe cases of HLA-sensitization, in order to enable
transplantation for patients that have been too long on the transplant
waitlist. In October 2016, we treated the first patient in a clinical
study – titled Highdes – that is exclusively aimed at the highly
The Highdes study will recruit approximately 20 highly sensitized
patients in the US and Europe. We anticipate that the Highdes study
together with the 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 European Union. We are equally
determined to pursue the therapeutic potential of IdeS in a number of
We believe that the fast onset and efficacy of IdeS has the potential to
revolutionize the critical care in many acute autoimmune diseases and
transplant related indications. Initially, we have narrowed in on a
number of carefully selected indications, including Thrombotic
Thrombocytopenic Purpura (TTP) and Guillain-Barré syndrome (GBS), in
which we believe that IdeS may make a difference. In October 2016, the
first patient was treated in a Phase II study in TTP at University
College London Hospitals.
In order to fully execute this value creation strategy, we decided to
raise SEK 185 million in a directed share issue to selected
international specialist investors, as well as from Swedish
institutional and strategic investors. The share issue, which will
shareholder base towards institutional and specialist investors, is to
be resolved on an extraordinary general meeting on November 21, 2016. We
have already received full subscription of the shares in accordance with
separate agreements from the investors.
It has certainly been an exciting 2016 to date. The success of our
clinical trials, the hope this is bringing to patients, and the steadily
increasing interest from investors and other stakeholders acknowledging
our long term value creation strategy, give strength and inspiration to
all of us here at Hansa Medical.
We have an exciting time ahead of us.
President and CEO of Hansa Medical
This information is such information that Hansa Medical AB (publ) is
obliged to make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of the
contact person set out above, at 8:30 am CEST on 9 November 2016
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
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