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.