July – September 2018 in brief

›› Hansa successfully completed two Phase 2 clinical studies evaluating imlifidase for kidney transplantation in highly sensitized patients, with imlifidase enabling transplantation in all 35 patients.

›› Imlifidase met all primary and secondary endpoints in each study.

›› Treatment with imlifidase enabled highly sensitized patients to receive life-saving transplants.

›› Hansa plans to submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings by Q1 2019, with their potential acceptance of submission within 60 days.

›› Hansa initiated a long-term observational prospective follow-up study. The primary objective of the study is evaluation of graft survival in patients who have undergone kidney transplantation after treatment with imlifidase. The study aims to encompass all patients from the four completed Phase 2 studies evaluating imlifidase in sensitized kidney transplantation patients. The study will provide regular follow-up data on graft survival for up to five years and interim results will be available on an ongoing basis.

›› 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 Goodpasture’s 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 the BLA.

›› Vincenza Nigro was appointed as Vice President, Global Medical Affairs. Ms. Nigro brings more than two decades of international life sciences industry experience in medical affairs, clinical development and commercial leadership roles, including significant expertise in transplantation and orphan diseases.

Significant events after the end of the reporting period

›› The U.S. Food and Drug Administration (FDA) granted imlifidase Fast Track Designation for the investigation of imlifidase for transplantation. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs to treat serious or life-threatening conditions that demonstrate the potential to address an unmet medical need.

›› The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on Orphan Drug Designation for imlifidase in the treatment of anti-GBM antibody disease. A positive opinion by the COMP precedes official designation by the European Commission.

Financial summary for the Group

CEO statement
Since I joined Hansa a little over six months ago, I have been continuously impressed by what has been accomplished by our skilled team and distinguished collaborators. 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 around our proprietary program of immunomodulatory enzymes for organ transplantation and acute autoimmune conditions.

The development of our lead candidate imlifidase, formerly known as IdeS, continues to progress according to plan. To date, we have successfully designed and managed a series of clinical studies, demonstrating its ability to enable life-saving kidney transplantation in highly sensitized patients, an indication where there is significant unmet medical need. At the end of the quarter, we announced the successful completion of two Phase 2 clinical studies of imlifidase for kidney transplantation in highly sensitized patients, in which imlifidase enabled transplantation in all 35 evaluated patients.

The outcome of these studies, which are described in greater detail on page 7 in this report, demonstrates that imlifidase is capable of enabling organ transplantation for highly sensitized patients who would otherwise remain on dialysis, associated with high cost, a poor quality of life and an increased mortality rate. In October the U.S. Food and Drug Administration (FDA) granted imlifidase Fast Track Designation for the investigation of imlifidase for transplantation. This designation is further validation of imlifidase’s potential to address the significant unmet medical need for these highly sensitized patients. We continue to actively engage with the regulatory agencies and anticipate submitting a Biologic License Application (BLA), as well as a Marketing Authorisation Application (MAA) by the first quarter of 2019, with their potential acceptance of submission with 60 days.

Beyond the six-month follow-up data, the filings will include positive data collected across four Phase 2 clinical studies demonstrating the efficacy and safety of imlifidase to enable kidney transplantations, the validation of the manufacturing process for imlifidase and evidence of the significant medical need for these highly sensitized patients who today have a limited opportunity for transplantation.

We are determined to bring imlifidase to market in kidney transplantation as soon as possible. In parallel, our long-term vision is to offer imlifidase to a wide range of patients suffering from acute, IgG-mediated diseases. We believe imlifidase can eliminate IgG in these acute diseases which may potentially translate into significant clinical benefit for these patients.

In early July, the FDA granted Orphan Drug Designation to imlifidase for the treatment of anti-GBM antibody disease (anti-GBM) and in October the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) issued a positive opinion on Orphan Drug Designation for imlifidase in the treatment of anti-GBM antibody disease. We believe imlifidase, with the ability to rapidly, effectively and tolerably eliminate IgG, has the potential to help preserve kidney function and prevent progression to dialysis for individuals with anti-GBM. We believe the receipt of Orphan Drug Designation confirms this high unmet medical need, and we remain committed to the clinical advancement of imlifidase for the treatment of this devastating disease.

In June 2017, an open-label, investigator-initiated Phase 2 study in severe anti-GBM was initiated with Professor Mårten Segelmark at Linköping University Hospital as coordinating principal investigator and sponsor. The aim is to enroll approximately 15 patients in Sweden, Denmark, Austria, Czech Republic, France and the UK.

We continue to increase our engagement in the evaluation of imlifidase in other acute autoimmune conditions. We are preparing the initiation of enrollment for two more Phase 2 studies during the fourth quarter of 2018. The first study will be a Phase 2 study to evaluate the treatment of antibody-mediated kidney transplant rejection, with a target enrollment of approximately 30 patients across the U.S. and Europe. The second study will be a Phase 2 study in the acute neurological disease Guillain-Barré syndrome (GBS), which is designed to enroll approximately 30 patients, primarily in Europe. To support imlifidase’s clinical development across these indications, we have continued to grow the R&D team.

We have also continued to expand our commercial organization in advance of the potential commercial launch of imlifidase. In September, we were very fortunate to appoint Vincenza Nigro as Vice President, Global Medical Affairs. Vincenza brings more than two decades of international life sciences industry expertise in medical affairs, clinical development and commercial leadership roles, including deep experience in transplantation and orphan diseases.

With her extensive experience building and leading high-performance medical affairs teams and of life cycle management of innovative transplant-related and immunology products, she will be a strong and valuable addition to our team as we transform Hansa into a full-fledged, global, commercial-stage biotech company.

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 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, November 1, 2018