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Hansa Medical interim report January – March 2016

Regulatory information

Hansa Medical highlights

January – March 2016
›› Article in the New England Journal of Medicine supporting the need for and benefit of desensitization
›› Strengthened shareholder base with several longterm institutional

investors After the period
›› FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation
›› Ulf Wiinberg proposed as new chairman and Angelica Loskog as new board member
›› Patient recruitment completed in Swedish Phase II clinical study with IdeS in kidney transplantation

Financial summary first quarter 2016
›› Net revenue for the group in Q1 amounted to MSEK 0.5 (3.8)
›› Operating result in Q1 was MSEK -19.9 (-10.7)
›› Consolidated net result in Q1 was MSEK -20.0 (-10.7)
›› Earnings per share before and after dilution in Q1 were SEK -0.62 (-0.39)
›› Cash position including short term investments on March 31, 2016, of MSEK 158.1 (7.1)

Hansa Medical in brief
Hansa Medical AB (publ) is a biopharmaceutical company focusing on novel immunomodulatory enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Additional projects focus on development of new antibody modulating enzymes, as well as HBP, a diagnostic biomarker for prediction of severe sepsis at emergency departments that is already introduced on the market. The company is based in Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on Nasdaq OMX Stockholm.

CEO statement
We have already reached several important milestones that I am pleased to share. We finalized the recruitment in the ongoing Phase II study in Sweden. We also gained FDA clearance to start our own clinical study in the US and we broadened our shareholder base with several long-term institutional investors.

We currently have two Phase II studies ongoing in Sweden and the US, as well as additional studies planned for initiation later this year. Recruitment in the Swedish study has been completed and the 10 included patients have all been treated with IdeS and subsequently transplanted. The ongoing US study also progresses as planned. To date, 9 patients have been included in the US study, thus bringing the total to 20 patients that have been treated and transplanted in the ongoing Phase II studies and the finalized Phase I/II study. This, together with the attention we have gained from the scientific community, gives me reason to feel very optimistic about the future of IdeS.

Additionally, The New England Journal of Medicine published an article on March 10 that further strengthens our belief in the potential of IdeS. The study demonstrated a significant survival benefit in 1,025 patients undergoing HLA-incompatible kidney transplantation following desensitization with currently available methods, when compared to non-transplanted patients on the transplant wait list. Although IdeS was not the subject of this study, it highlights the need for and benefit of desensitization in kidney transplantation, and further strengthens our belief that IdeS has the potential to play a very important role in kidney transplantation going forward. Our ultimate vision for IdeS is to make effective desensitization available to sensitized patients and for IdeS to be the preferred desensitization method for HLA-sensitized patients that rely on donation from either deceased or living donors.

Our current focus is on patients with very high levels of broad HLA antibodies and who have been on dialysis for a long time and are therefore in urgent need of transplantation. They have the highest priority for transplantation, however, also have a negligible chance of being transplanted using the current protocols.

In early April, the US Food and Drug Administration (FDA) notified us that they have completed the safety review of our Investigational New Drug application (IND). The FDA concluded that the proposed clinical investigation of IdeS can proceed, which enables us to start a clinical study to primarily evaluate the efficacy of IdeS in making highly sensitized kidney patients with positive crossmatches eligible for transplantation by removing donor specific antibodies.

The FDA clearance of the IND is a milestone for the company defining a potential path toward product approval.

This clinical trial, which will include up to 20 kidney transplantation patients that have either failed on previous attempts of desensitization or in whom effective desensitization using currently available methods is highly unlikely, is scheduled to begin as soon as possible at reputable medical institutions in the US, with the aim to complete recruitment during the first half of 2017.

We are hopeful that successful results from this planned study, in combination with the results from the finalized Phase I/II and the two ongoing Phase II trials will serve as a foundation for market approval for IdeS in this patient group.

The effective and fast IgG cleaving mode-of-action makes it highly relevant to also consider evaluating the efficacy and safety of IdeS in IgG-driven rare autoimmune indications. The three acute conditions TTP (Thrombotic Thromocytopenic Purpura), GBS (Guillain-Barré syndrome) and anti-GBM disease are among a number of diseases in which it is relevant to evaluate the treatment potential of IdeS. We are collaborating with world renowned clinical experts in these diseases with the ambition to run Phase II trials in the near future for proof-of-concept in these devastating acute conditions.

In early March, a group of long-term institutional investors acquired shares from Farstorps Gård AB, which after the divesture still holds shares equivalent to approximately 3 percent of the outstanding shares in Hansa Medical. In the last 12 months, we have gained a lot of investor interest both in Sweden and internationally and we will continue to work actively with both existing and potential investors to show how we can provide greater value to our shareholders and better health outcomes for patients.

Göran Arvidson
President and CEO