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Interim report January – March 2017

Regulatory information

January-March 2017 in brief
›› Positive top-line results from the US clinical study with Hansa Medical’s lead candidate IdeS demonstrated that treatment with IdeS completely eliminates donor specific antibodies (DSAs), enabling transplantation of all 15 reported HLA incompatible patients. The clinical results will be presented at the American Transplant Congress (ATC) in Chicago, Illinois, on 30 April, 2017.

›› A Phase II study with IdeS in the rare autoimmune kidney disease anti-GBM antibody disease (anti-GBM) has been initiated. The study is investigator initiated at several European nephrology clinics.

›› Novel published preclinical data demonstrated that treatment with IdeS could be a novel therapeutic strategy for the treatment of Guillain-Barré syndrome (GBS).

›› Hansa Medical appointed Dr. Sam Agus as new Chief Medical Officer. Dr. Agus has extensive experience in medical strategy, multidisciplinary team leadership and medical marketing. His experience will form a central part in the company’s next phase and the commercialization strategy for IdeS.

Financial summary – First quarter

KSEK, unless otherwise stated Q1 2017 Q1 2016 Year 2016 
Net revenue 1 058 5872 579
Operating profit/loss -44 827-19 946-111 135
Net profit/loss -45 004-19 976-111 152
Earnings per share before and after dilution (SEK-1,28-0,61-3,39
Shareholders’ equity 240 065190 922283 693
Cash flow from operating activities-43 739-17 560-94 563
Cash and cash equivalents including short term invesments209 351158 080253 578

CEO statement
During the first quarter of 2017, we have remained focused on our strategy and continued to create value and to strengthen our platform, as we reached several important milestones and accomplished many important objectives.

We continued the development of our novel and innovative immunomodulatory enzymes. Through the ground-breaking work with our lead candidate IdeS, enabling transplantation in sensitized patients, we have seen a lot of interest for our research in the scientific and medical communities. Results from the recent studies with IdeS have been presented by the principal investigators at several renowned scientific and medical meetings, with more to come this year.

In March, we announced top-line clinical results from the ongoing investigator initiated US study with IdeS that will be presented in an oral session at the American Transplant Congress (ATC) in Chicago on 30 April. These results demonstrated that treatment with IdeS eliminates donor specific antibodies (DSAs) and enables transplantation of HLA incompatible patients.

The IdeS treatment resulted in total IgG and HLA antibody elimination. 14 of 15 patients were successfully transplanted without discernible adverse events. Antibody mediated rejection episodes occurred in four patients and all four responded to anti-rejection treatment. One graft loss occurred due to non-HLA IgM and IgA antibodies. A comparison of the levels of donor specific antibodies before IdeS treatment and one month after IdeS treatment shows a significant reduction.

These results support our belief that IdeS has the potential to become the first therapy to enable highly HLA sensitized kidney disease patients to be transplanted. HLA sensitization impacts approximately 30 percent of patients with kidney disease and is a significant barrier to kidney transplantation.

In parallel with our ground-breaking work in organ transplantation, we are equally determined to pursue the therapeutic potential of IdeS in several other indications. We believe that the fast onset and efficacy of IdeS has the potential to significantly contribute to the critical care in several transplant-related indications and acute autoimmune diseases.

In February, we presented novel pre-clinical in vivo data that demonstrate the treatment potential of IdeS in the acute autoimmune disease Guillain-Barré syndrome (GBS), by reducing the degeneration of peripheral nerves. The data was presented in an article which was published in the scientific journal Experimental Neurology. The data covered by this publication demonstrate that our IdeS treatment could be a promising therapeutic strategy for the treatment of GBS.

Over the last 12 months, we have also continued to build a strong, committed team at Hansa Medical, in order to prepare ourselves for the next exciting phase of the company’s growth. In March, we announced the recruitment of Dr. Sam Agus as Chief Medical Officer. He is a board-certified neurologist and has extensive experience in medical marketing as well as clinical trial design and product launches.

Dr. Agus’ key focus will be on the company’s lead project IdeS, and we are very pleased to have him joining our team in this truly exciting phase for Hansa Medical. His experience from building and leading strong teams will be key in this next phase.

To summarize, Hansa Medical has reached several important clinical and regulatory milestones. And although we set our objectives high, we have managed to meet them according to plan. But what is most important – and trigger us to increase our efforts even further – is the fact that to date, more than 30 patients have been treated with IdeS and subsequently transplanted in the US and Europe. We strongly believe that this drug has shown significant potential to become a novel treatment option to enable patients to receive the lifesaving transplantation they desperately need.

Göran Arvidson
President and CEO of Hansa Medical

The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the contact person stated below on April 26, 2017 at 08.00 CET.