January – September 2015 in summary
Significant events during the third quarter
· Hansa Medical received FDA Orphan Drug Designation for IdeS in solid organ
transplant patients
· First patient treated and transplanted with IdeS in US Phase II study at
Cedars-Sinai Medical Center, Los Angeles
· Positive IdeS Phase I data published in scientific journal PLOS ONE
· Data from Hansa Medical’s first Phase II study of IdeS in Sensitized Kidney
Transplantation Patients presented at an oral session at ESOT 2015
· Results from a clinical multicenter trial with HBP-assay published in
Critical Care Medicine
Financial Summary Third Quarter and Year to Date
· Net sales for the group in Q3 amounted to MSEK 0.5 (0). YTD: MSEK 4.9 (1.5)
· Operating result in Q3 was MSEK -13.9 (-5.4). YTD: MSEK -47.1 (-16.2)
· Consolidated net result in Q3 was MSEK -13.9 (-5.4). YTD: MSEK -47.2 (-16.3)
· Earnings per share before and after dilution in Q3 was SEK -0,43 (-0,20).
YTD: SEK -1,54 (-0,62)
· Cash position on September 30, 2015, of MSEK 192.6
CEO Statement
In the third quarter, we continued to make good progress with our prioritized
projects, with the ultimate aim to build a, sustainable biopharmaceutical
company with pharmaceuticals that significantly improve health outcomes in
patients.
A lot of our work is focused on our lead project IdeS, which continues to
attract attention in the international scientific community. The results from
the earlier clinical Phase I trial of IdeS were published in the scientific
journal PLOS ONE in July. The study results showed that a single dose of IdeS
rapidly and efficiently inactivates IgG in humans, which makes it an attractive
therapeutic approach for acute IgG-mediated conditions.
In September, data from the first Phase II study with IdeS in sensitized kidney
transplantation patients were presented at the 17th Congress of the European
Society for Organ Transplantation (ESOT) in Brussels. The data clearly support
further development in transplantation, and we are pleased that the
investigators were given the opportunity to present these interesting and
encouraging data. IdeS effect in reducing anti-HLA antibodies to levels
acceptable for transplantation has gained a lot of attention in the scientific
community, which of course strengthens our belief in this exciting project.
In parallel with the ongoing Phase II study in Sweden, further studies are
ongoing or planned, one of which is run by Professor Stanley Jordan, a leading
expert in transplant immunology, at Cedars-Sinai Medical Center in Los Angeles.
It is an open-label study to assess the safety and efficacy of IdeS in
eliminating donor specific antibodies and thus prevent antibody-mediated
rejection in highly sensitized patients. In August, the first patient in this
study was successfully treated and transplanted with IdeS.
We now plan to initiate further pilot studies within transplantation and life
threatening autoimmune diseases, including Phase II studies addressing antibody
mediated graft rejection and very highly/ broadly sensitized patients.
Furthermore, we will continue to further broaden the potential disease
indications that can be treated with IdeS, including rare and serious acute
autoimmune diseases within neurology, nephrology and hematology.
During the period, we also received Orphan Drug Designation for IdeS for the
prevention of antibody mediated organ rejection in patients undergoing all
types of solid organ transplants. Approximately 30 percent of the patients on
the waiting lists for kidney, heart, lung and pancreas transplantation,
equivalent to approximately 35,000 patients in the US alone, are sensitized to
Human Leukocyte Antigen (HLA). HLA sensitization constitutes a significant
barrier for transplantation for thousands of patients annually.
Our partnership project HBP-assay in severe sepsis also continued to develop in
a positive way. In August, results from a clinical multicenter study were
published ahead of print in the scientific journal Critical Care Medicine. The
study results show that the diagnostic method for assessing Heparin Binding
Protein (HBP) predicts severe sepsis with significantly higher accuracy than
other biomarkers available today. The study demonstrates that the HBP-assay has
the potential to become a significant tool to help predict severe sepsis at
emergency departments and infectious disease clinics.
We furthermore continued to strengthen the organization in the company as we
advance our clinical programs, but also for the change to Nasdaq Stockholm’s
main list. The first day of trading is on November 2, 2015. This upgrade will
hopefully make Hansa Medical even more attractive to existing and new potential
investors.
On November 13, 2015, interested shareholders and research partners can join us
at our Capital Markets Day in Stockholm where we plan to go into more detail to
describe our portfolio and its possibilities. Also, some of the prominent US and
European clinical experts with whom we collaborate will give us a review from
their daily practice and present their view on the potential of IdeS. For more
information about the event, visit our website www.hansamedical.com.
Looking back at the year so far, I believe we took a number of important steps
– strategically, financially and scientifically. And what is most important: we
continued to drive our clinical projects to get all the cornerstones in place
for future growth. It is my firm belief that we have exciting times ahead of us.
Göran Arvidson
President and CEO
The information in this press release is disclosed pursuant to the Securities
Markets Act or the Financial Instruments Trading Act. The information was
released for public disclosure on October 28, 2015 at 08.00 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About Hansa Medical
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 First North Premier in Stockholm with Remium Nordic AB as
Certified Adviser.
