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2016-07-21

Hansa Medical: 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.

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http://news.cision.com/hansa-medical/r/hansa-medical-interim-report-apri...
http://mb.cision.com/Main/1219/2049194/542373.pdf

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