April – June 2018 in brief

›› Long-term follow-up data from the 17 patients treated with imlifidase in the investigator-initiated Phase II study in highly sensitized patients was presented at the 2018 American Transplant Congress in early June by Professor Stanley C. Jordan, M.D., Director of Nephrology, Cedars-Sinai Medical Center.

›› Patients show good renal function and minimal evidence of antibody-mediated rejection (AMR) at a mean 19 months post kidney transplantation, with graft and patient survival at 94%.

›› Two-year follow-up data demonstrate good patient and graft survival without increased infection risk and that no serious adverse events related to imlifidase have been reported in the study.

›› The board of directors strengthened its expertise in biopharma commercialization and R&D through the appointments of Anders Gersel Pedersen and Andreas Eggert.

›› Anders Gersel Pedersen, MD, Ph.D, currently serves as Executive Vice President, Research & Development at H. Lundbeck A/S and is a member of the boards of Genmab A/S and Bavarian Nordic A/S.

›› Andreas Eggert, MBA has more than 20 years of crossfunctional leadership experience in biopharma commercialization,including Senior Group Vice President, Global Product Strategy & Portfolio Development at H. Lundbeck A/S and Vice President & Global Business Manager at Wyeth/Pfizer in the US.

›› Hansa Medical formed the US subsidiary Hansa Medical Inc. for the continued build-up of US organization and presence.

Significant events after the end of the reporting period

›› The U.S. Food and Drug Administration (FDA) granted orphan drug designation to imlifidase for the treatment of the rare and

acute kidney disease anti-GBM antibody disease, also known as Goodpastures disease.

›› Orphan drug designation qualifies the sponsor of the drug for various development incentives, including tax credits, protocol assistance and up to seven years of US marketing exclusivity from time of approval of Biologics License Application (BLA).

›› The approval confirms the high unmet medical need and further encourages continued clinical investigations with imlifidase in this devastating disease in which less than one third (5) of the patients survive with a preserved kidney function after six months follow-up.

5. Hellmark et al., Journal of Autoimmunity 48-49 (2014) 108e112. “Diagnosis and classification of Goodpasture’s disease (anti-GBM)”

Financial summary for the Group

CEO statement
It has been a pleasure to join Hansa Medical. I am impressed by what has been accomplished to date, and the more I learn, the more I see how strongly positioned we are to bring a unique treatment to market and build a global biopharma enterprise. This impression has not only been gained through interactions with our teams in Sweden and the US, but also through my meetings with key opinion leaders and with healthcare specialist investors across the US and Europe.

Step by step we have continued to progress our strategy and I feel confident that we will be able to launch a lifesaving product. Since I joined Hansa Medical in March, we have continued to expand the organization in order to develop our capabilities to launch imlifidase (formerly called IdeS) on our own. We have also continued to grow the R&D team in order to initiate and complete additional clinical studies in antibody-mediated kidney transplant rejection (kidney AMR) and the devastating acute neurological disease Guillain-Barré syndrome.

The development of imlifidase continues to progress according to plan. To date, we have successfully designed and managed a series of clinical studies, demonstrating its ability to enable lifesaving kidney transplantation in highly sensitized patients, an indication where there is significant unmet medical need.

Earlier this year, we completed patient enrollment in the two ongoing Phase II studies with imlifidase in highly sensitized kidney transplant patients. A total of 18 patients were enrolled in the international multicenter study Highdes, and 17 patients were enrolled in the US investigator-initiated study at Cedars-Sinai Medical Center, led by principal investigator Professor Stanley Jordan.

The objective, to enable kidney transplantation for highly sensitized patients with donor-specific antibodies, was achieved in all 35 patients in the two studies. The patients’ cross-match tests for donor specific antibodies have all been shifted from positive to negative following the treatment with imlifidase. At the 2018 American Transplant Congress in early June, Professor Jordan presented follow-up data from the 17 patients treated in the Cedars-Sinai study. The results from the study demonstrate that patients show good renal function and minimal evidence of antibody-mediated rejection (AMR) at a mean 19 months post kidney transplantation, with graft and patient survival at 94 percent. In addition, Professor Jordan highlighted that the two-year follow-up data demonstrate good patient and graft survival, with no evidence of increased infection risk. Additionally, no serious adverse events related to imlifidase were reported in his study.

These results are very encouraging. The patients treated in the Cedars-Sinai study exhibited extensive sensitization with a median calculated Panel Reactive Antibody (cPRA- a measure of sensitization for transplant candidates) score of 95 percent and we have managed to enable transplantation for patients who have been on dialysis for more than 20 years.

We continue to follow the 18 patients who have been treated with imlifidase and subsequently transplanted in the Highdes study. All treated patients are to be monitored for six months to collect follow-up data with respect to safety, kidney function and management of rejection episodes. We expect to have access to six-month follow up data from the 18 patients in the Highdes study and the 17 patients in the Cedars Sinai study, by the end of the third quarter this year. This is going to be a very important milestone for us and the continued development program with imlifidase.

Ahead of this, we are preparing meetings with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to discuss a potential route towards filing of a Biologics License Application (BLA) in the US and the filing of an Market Authorization Application (MAA) in Europe at the end of 2018 or early 2019. In addition to the six-month follow-up data, important items for these discussions will be the positive data demonstrating the efficacy and safety of imlifidase to enable kidney transplantations,the validation of the manufacturing process for imlifidase, and most importantly, the significant medical need for these highly sensitized patients who today have very limited chances, if any, to be transplanted.

We are determined to bring imlifidase to market in kidney transplantation as soon as possible. Our long-term vision is to bring imlifidase to a wide range of patients suffering from acute IgG-mediated diseases. To us and many key opinion leaders, it is quite apparent that imlifidase has the potential to significantly contribute to the critical care in acute autoimmune diseases and several additional transplant-related indications. Today, many of these conditions are acutely treated with plasma exchange or immunoglobulin therapy in order to remove or modulate pathogenic IgG, which can be lengthy and inefficient processes. We believe imlifidase can potentially eliminate pathogenic IgG significantly faster and more effectively in these acute diseases.

Consequently, we continue to increase our engagement in the evaluation of imlifidase in these conditions. Currently, a Phase II study is ongoing in the acute kidney disease severe anti-GBM, a disease in which two-thirds [5] of the patients lose their kidneys,requiring chronic dialysis and the need for kidney transplantation. This study is ongoing in Denmark, Sweden and Austria and soon clinics in France, UK and the Czech Republic will join the study. Around 15 patients are to be enrolled and to date seven patients have been treated and responded favorably with a good safety profile. In early July, the FDA approved our application for orphan drug designation for imlifidase and the treatment of anti-GBM (Goodpastures disease). The approval confirms the high unmet medical need and further encourages us to continue clinical investigations with imlifidase in this devastating disease.

In addition, we are preparing the initiation of two more Phase II studies in the fall. The first study to be initiated is likely to be treatment of antibody-mediated kidney transplant rejection. We are aiming at enrolling 15-25 patients to this study in the US and in Europe. The second study will be a Phase II study in the acute neurological disease Guillain-Barré syndrome (GBS), to which we aim to enroll around 30 patients, primarily in Europe.

With a growing body of clinical evidence, different opportunities to broaden the use of imlifidase to a multitude of indications, and a number of next-generation drug candidates in development, I believe we are well-positioned to become a global biopharmaceutical company providing unique, proprietary and life-saving IgG-eliminating drugs to patients across a range of conditions where IgG plays a key role in disease progression or forms a barrier for patients to receive appropriate treatment. I look forward to updating you on our continued progress.

Søren Tulstrup
President and CEO of Hansa Medical
Lund, Sweden, July 19, 2018