Hansa Medical Interim report April – June 2016

Continued positive development of IdeS in clinical studies
Second quarter in brief

Business highlights
›› US Food and Drug Administration (FDA) cleared Hansa Medical’s IND application
for a study with IdeS in kidney transplantation

›› All patients are recruited and successfully desensitized in Swedish Phase II
study with IdeS in kidney transplantation

›› Successful desensitization with IdeS in all recruited patients in ongoing US
Phase II study with kidney transplantation

›› Hansa Medical appointed Henk Doude van Troostwijk as Vice President,
Commercial Operations

›› Annual General Meeting elected Ulf Wiinberg as new chairman of the board and
Angelica Loskog as new member of the board

Significant events after the period
›› Hansa Medical initiated a pivotal multicenter U.S. study with IdeS for
treatment of refractory highly sensitized kidney patients

›› Hansa Medical acquired rights to cancer immunotherapy using antibody
modulating enzymes

Financial summary
›› Net revenue for the group in Q2 amounted to MSEK 0.5 (0.5). YTD: MSEK 1.1
(4.4).

›› Operating result in Q2 was MSEK -30.7 (-22.5). YTD: MSEK -50.6 (-33.2).

›› Consolidated net result in Q2 was MSEK -30.7 (-22.5). YTD: MSEK -50.6 (
-33.2).

›› Earnings per share before and after dilution in Q2 were SEK -0.95 (-0.70).
YTD: SEK -1.56 (-1.11).

›› Cash position including short-term investments on June 30, 2016, of MSEK
133.7.

CEO statement
I am very pleased to report that all Phase II studies are progressing nicely as
planned. The advancement includes the start of a Hansa sponsored multicenter
study initiated at Cedars-Sinai Medical Center in Los Angeles. The IND clearance
from the FDA sets the path towards product approval in the US. We are now about
to start clinical studies with IdeS in other orphan indications and we will
explore combination use in cancer immunotherapy.

As previously announced, the Swedish study is now fully recruited. This,
together with the interim results that we have been able to present, as well as
encouraging progress of the investigator initiated study in the US, gives me
great reason to be very optimistic about the future of our lead candidate IdeS.
And of Hansa Medical.

The FDA clearance of the IND and the start of a pivotal clinical study – HighdeS
– in the US to evaluate the efficacy of IdeS in making highly sensitized kidney
patients with positive crossmatches eligible for transplantation by removing
donor specific antibodies are important milestones for Hansa Medical, which are
two more benchmarks that are helping to define the path toward product approval.

In June, Professor Stanley Jordan, who heads the investigator-sponsored Phase II
clinical study at Cedars-Sinai Medical Center, presented initial data from the
trial at the 2016 American Transplant Congress in Boston. The data showed that
IdeS completely eliminates donor specific antibodies and allows for kidney
transplantation in all sensitized patients. All ten included patients have been
successfully desensitized and subsequently transplanted.

We are of course very encouraged by these results. Equally uplifting are the
interim results from our Swedish Phase II clinical study, conducted at Uppsala
University Hospital and Karolinska University Hospital, Huddinge. The study,
which was fully recruited in the second quarter of this year, primarily
evaluates safety and tolerability of IdeS in sensitized kidney transplantation
patients. Dr. Tomas Lorant, who is the principal investigator, will present the
results at the 26th International Congress of the Transplantation Society in
Hong Kong in August of this year. In the abstract published ahead of the
presentation, Dr. Lorant and co-authors conclude that IdeS treatment
significantly reduced the level of HLA antibodies and eliminated complement
(C1q) binding antibodies.

Hansa Medical’s clinical development program of IdeS is currently focused on
treatment prior to kidney transplantation, but our vision is to establish IdeS
as an IgG-eliminating therapy in several IgG-driven autoimmune diseases and in
several sub-sets of transplant indications.

The effective and fast IgG-cleaving mode-of-action makes treatment with IdeS
highly relevant to evaluating the efficacy and safety in many IgG-driven rare
autoimmune indications. The three acute conditions TTP (Thrombotic
Thrombocytopenic Purpura), GBS (Guillain-Barré syndrome) and anti-GBM disease
are among a number of diseases in which it is relevant to evaluate the treatment
potential of IdeS. We aim to initiate Phase II clinical studies for proof-of
-concept in these devastating acute conditions, starting with TTP.

Our preclinical programs are progressing nicely as well. Under the project name
NiceR (Novel immunoglobulin cleaving enzymes for Repeat dosing) we are
developing completely new IgG-degrading enzymes aimed for repeat dosing in
autoimmune diseases. Further on, EndoS is an enzyme that modulates IgG
antibodies by cleaving the important Fc bound glycan in IgG. EndoS has proven
effective in a range of autoimmune preclinical models and confirmatory
mechanistic studies are ongoing as well as preparations for toxicology studies.

EnzE - Enzyme based antibody Enhancement – is a recently added development
program. Preclinical research performed at the University of Oxford indicated
that using IdeS or EndoS prior to an antibody based cancer immunotherapy, like
anti-CD20 in the treatment of lymphoma and leukemia, has the potential to
increase the efficacy and improve outcome for patients suffering from cancer
diseases. Our researchers have independently verified and extended the research
findings on the EnzE concept and in July 2016, we subsequently acquired all
patent rights to these findings through the acquisition of UK-based Immago
Biosystems.

Taken together, these research programs give me great hope for an exciting time
ahead of us. We plan to share more details on all these programs when we host
our annual Capital Markets Day later this year. More information regarding our
annual Capital Markets Day will follow.

At the Annual General Meeting on May 11, Ulf Wiinberg and Angelica Loskog were
elected new board members. Ulf, who was elected new chairman, and Angelica bring
both strength and expertise to the company.

Over the last twelve months, we have continued to build a strong team at Hansa
Medical. We are now 21 employees in all, and plan to add more competence to 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 creating market access, pricing and reimbursement
strategies for the company. The appointment of Henk comes at a deciding time
when we have passed several important scientific milestones on our road to take
product to market. This will benefit all our stakeholders, not the least the
patients.

Göran Arvidson
President and CEO of Hansa Medical

The information in this interim report is disclosed pursuant to the EU Market
Abuse Regulation and the Securities Markets Act. The information was released
for public disclosure through the agency of the contact person below on July 21
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 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.