CEO Statement

It is now twelve months since I joined Hansa, and I’m extremely proud of all we accomplished this past year to demonstrate the potential of our immunomodulatory enzyme technology and imlifidase. Our main priority is getting our lead compound imlifidase to market to enable lifesaving kidney transplants for highly sensitized patients, who currently cannot receive this standard of care treatment. At the same time, we continue developing our proprietary enzymology platform in other rare, life-threatening diseases.

In February, EMA accepted our MAA for review of IDEFIRIX (imlifidase). This acceptance marks the beginning of the regulatory review process for IDEFIRIX in the EU. In our most recent meeting the FDA in December 2018, the agency provided overall positive feedback on the data generated on imlifidase to date and acknowledged the high unmet medical need of highly sensitized patients who currently can’t access kidney transplantation. Hansa has now decided to do complementary analyses with respect to transplantability for highly sensitized patients, based on data from the successfully completed Phase 2 studies of imlifidase and matched controls from the U.S. transplant registry (SRTR/OPTN). We believe these analyses will help further illustrate the value of imlifidase in the U.S. healthcare system. As soon as the analyses are concluded, Hansa will schedule a subsequent meeting with the FDA, expected to take place in the second half of 2019. In this meeting, the dialogue with the FDA will be continued to determine the path forward for regulatory filing and approval in the U.S. for imlifidase in kidney transplantation of highly sensitized patients.

Imlifidase may have potential applications in transplantation of other organs and tissue as well as an array of acute autoimmune indications, including Acute Kidney Antibody Mediated Rejection (AMR) post transplantation. In March, we received Clinical Trial Application and Ethics Committee approvals for our Phase 2 study of imlifidase in acute AMR in kidney transplantation. Acute AMR is one of the most challenging adverse events after kidney transplantation, occurring in 10-15% of patients, and is the main cause for graft dysfunction. In April we got a similar approval for the initiation of a Phase 2 Study of imlifidase in Guillain Barré Syndrome (GBS). GBS is a rare, acute inflammatory disease of the peripheral nervous system that affects 1-2 in 100,000 people annually.

Our program of next generation IgG-cleaving enzymes, NiceR, also advanced recently with the selection of a lead candidate for clinical development. The new drug candidate may have broader value as a potential treatment for unmet needs that may benefit from repeat dosing, including relapsing autoimmune diseases, chronic transplant rejection, oncology and gene therapy.

Mid-April we divested our shareholding in Genovis to a group of Swedish institutional investors. The transaction provides a profitable exit for Hansa Biopharma, and the funds generated will be used as working capital to further expedite our promising clinical pipeline of potential treatments for rare IgG-mediated diseases.

As part of the ongoing expansion of our organization, we appointed Mr. Donato Spota as new Chief Financial Officer, effective May 15, 2019, and Ms. Anne Säfström Lanner as Vice President, Global Human Resources. We are delighted to welcome Donato and Anne as we grow Hansa Biopharma into a global commercial-stage biopharma company. They will be very valuable additions to our team as we continue the transformation of Hansa and grow our operations and organization.

Based on the progress so far this year, I believe we are poised for continued success in 2019, with a growing body of clinical evidence supporting the efficacy of imlifidase, multiple opportunities in additional indications, and a potential pipeline of next-generation drug candidates. I look forward to updating you on our continued progress.

Søren Tulstrup
President and CEO of Hansa Medical
Lund, Sweden, April 29, 2019