CEO Statement

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It is currently twelve months given that I joined Hansa, and also I’m incredibly proud of all we completed this past year to demonstrate the potential of our immunomodulatory enzyme innovation and imlifidase. Our major concern is getting our lead substance imlifidase to market to enable lifesaving kidney transplants for very animated clients, that presently can not obtain this standard of care treatment. At the same time, we proceed establishing our exclusive enzymology system in other rare, dangerous illness.

In February, EMA accepted our MAA for review of IDEFIRIX (imlifidase). This acceptance notes the start of the governing review process for IDEFIRIX in the EU. In our most recent conference the FDA in December 2018, the company supplied total favorable feedback on the information produced on imlifidase to day and also recognized the high unmet clinical demand of very sensitized individuals who currently can’t access kidney hair transplant. Hansa has currently decided to do complementary analyses relative to transplantability for highly sensitized individuals, based upon data from the successfully completed Phase 2 studies of imlifidase and matched controls from the U.S. transplant computer registry (SRTR/OPTN). Our company believe these analyses will certainly aid even more show the worth of imlifidase in the U.S. medical care system. As quickly as the analyses are concluded, Hansa will schedule a succeeding conference with the FDA, expected to happen in the second fifty percent of 2019. In this conference, the discussion with the FDA will be continued to figure out the path ahead for regulative declaring and also authorization in the united state for imlifidase in kidney transplantation of extremely animated patients.

Imlifidase might have possible applications in hair transplant of various other organs and also tissue along with a variety of severe autoimmune indications, consisting of Acute Kidney Antibody Moderated Rejection (AMR) message transplantation. In March, we received Clinical Test Application and Ethics Committee authorizations for our Phase 2 research study of imlifidase in acute AMR in kidney transplantation. Intense AMR is one of the most difficult negative events after kidney hair transplant, taking place in 10-15% of people, and is the major cause for graft disorder. In April we obtained a similar approval for the initiation of a Stage 2 Research of imlifidase in Guillain Barré Disorder (GBS). GBS is a rare, severe inflammatory disease of the peripheral nervous system that affects 1-2 in 100,000 individuals yearly.

Our program of next generation IgG-cleaving enzymes, NiceR, also advanced recently with the selection of a lead prospect for medical growth. The brand-new medicine candidate may have broader value as a potential therapy for unmet needs that might benefit from repeat application, including relapsing autoimmune diseases, chronic transplant denial, oncology as well as gene therapy.

Mid-April we unloaded our shareholding in Genovis to a team of Swedish institutional capitalists. The transaction gives a lucrative leave for Hansa Biopharma, and also the funds created will be utilized as functioning funding to more expedite our encouraging medical pipeline of possible therapies for rare IgG-mediated illness.

As part of the ongoing development of our organization, we assigned Mr. Donato Spota as new Chief Financial Officer, reliable May 15, 2019, and Ms. Anne Säfström Lanner as Vice President, Global Human Resources. We are delighted to invite Donato as well as Anne as we grow Hansa Biopharma right into a worldwide commercial-stage biopharma company. They will certainly be really useful additions to our team as we continue the transformation of Hansa and also expand our procedures as well as organization.

Based on the progression so far this year, I believe we are positioned for ongoing success in 2019, with an expanding body of medical proof supporting the efficacy of imlifidase, several opportunities in added indicators, and also a potential pipe of next-generation medicine prospects. I anticipate upgrading you on our ongoing development.


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