Hansa Medical Interim report April – June 2016

Continued positive development of IdeS in clinical studies

Second quarter in brief

Business highlights
›› US Food and Drug Administration (FDA) cleared Hansa Medical’s IND application for a study with IdeS in kidney transplantation

›› All patients are recruited and successfully desensitized in Swedish Phase II study with IdeS in kidney transplantation

›› Successful desensitization with IdeS in all recruited patients in ongoing US Phase II study with kidney transplantation

›› Hansa Medical appointed Henk Doude van Troostwijk as Vice President, Commercial Operations

›› Annual General Meeting elected Ulf Wiinberg as new chairman of the board and Angelica Loskog as new member of the board

Significant events after the period
›› Hansa Medical initiated a pivotal multicenter U.S. study with IdeS for treatment of refractory highly sensitized kidney patients

›› Hansa Medical acquired rights to cancer immunotherapy using antibody modulating enzymes

Financial summary
›› Net revenue for the group in Q2 amounted to MSEK 0.5 (0.5). YTD: MSEK 1.1 (4.4).

›› Operating result in Q2 was MSEK -30.7 (-22.5). YTD: MSEK -50.6 (-33.2).

›› Consolidated net result in Q2 was MSEK -30.7 (-22.5). YTD: MSEK -50.6 (-33.2).

›› Earnings per share before and after dilution in Q2 were SEK -0.95 (-0.70). YTD: SEK -1.56 (-1.11).

›› Cash position including short-term investments on June 30, 2016, of MSEK 133.7.

CEO statement
I am very pleased to report that all Phase II studies are progressing nicely as planned. The advancement includes the start of a Hansa sponsored multicenter study initiated at Cedars-Sinai Medical Center in Los Angeles. The IND clearance from the FDA sets the path towards product approval in the US. We are now about to start clinical studies with IdeS in other orphan indications and we will explore combination use in cancer immunotherapy.

As previously announced, the Swedish study is now fully recruited. This, together with the interim results that we have been able to present, as well as encouraging progress of the investigator initiated study in the US, gives me great reason to be very optimistic about the future of our lead candidate IdeS. And of Hansa Medical.

The FDA clearance of the IND and the start of a pivotal clinical study – HighdeS – in the US to evaluate the efficacy of IdeS in making highly sensitized kidney patients with positive crossmatches eligible for transplantation by removing donor specific antibodies are important milestones for Hansa Medical, which are two more benchmarks that are helping to define the path toward product approval.

In June, Professor Stanley Jordan, who heads the investigator-sponsored Phase II clinical study at Cedars-Sinai Medical Center, presented initial data from the trial at the 2016 American Transplant Congress in Boston. The data showed that IdeS completely eliminates donor specific antibodies and allows for kidney transplantation in all sensitized patients. All ten included patients have been successfully desensitized and subsequently transplanted.

We are of course very encouraged by these results. Equally uplifting are the interim results from our Swedish Phase II clinical study, conducted at Uppsala University Hospital and Karolinska University Hospital, Huddinge. The study, which was fully recruited in the second quarter of this year, primarily evaluates safety and tolerability of IdeS in sensitized kidney transplantation patients. Dr. Tomas Lorant, who is the principal investigator, will present the results at the 26th International Congress of the Transplantation Society in Hong Kong in August of this year. In the abstract published ahead of the presentation, Dr. Lorant and co-authors conclude that IdeS treatment significantly reduced the level of HLA antibodies and eliminated complement (C1q) binding antibodies.

Hansa Medical’s clinical development program of IdeS is currently focused on treatment prior to kidney transplantation, but our vision is to establish IdeS as an IgG-eliminating therapy in several IgG-driven autoimmune diseases and in several sub-sets of transplant indications.

The effective and fast IgG-cleaving mode-of-action makes treatment with IdeS highly relevant to evaluating the efficacy and safety in many IgG-driven rare autoimmune indications. The three acute conditions TTP (Thrombotic Thrombocytopenic 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 aim to initiate Phase II clinical studies for proof-of-concept in these devastating acute conditions, starting with TTP.

Our preclinical programs are progressing nicely as well. Under the project name NiceR (Novel immunoglobulin cleaving enzymes for Repeat dosing) we are developing completely new IgG-degrading enzymes aimed for repeat dosing in autoimmune diseases. Further on, EndoS is an enzyme that modulates IgG antibodies by cleaving the important Fc bound glycan in IgG. EndoS has proven effective in a range of autoimmune preclinical models and confirmatory mechanistic studies are ongoing as well as preparations for toxicology studies.

EnzE - Enzyme based antibody Enhancement – is a recently added development program. Preclinical research performed at the University of Oxford indicated that using IdeS or EndoS prior to an antibody based cancer immunotherapy, like anti-CD20 in the treatment of lymphoma and leukemia, has the potential to increase the efficacy and improve outcome for patients suffering from cancer diseases. Our researchers have independently verified and extended the research findings on the EnzE concept and in July 2016, we subsequently acquired all patent rights to these findings through the acquisition of UK-based Immago Biosystems.

Taken together, these research programs give me great hope for an exciting time ahead of us. We plan to share more details on all these programs when we host our annual Capital Markets Day later this year. More information regarding our annual Capital Markets Day will follow.

At the Annual General Meeting on May 11, Ulf Wiinberg and Angelica Loskog were elected new board members. Ulf, who was elected new chairman, and Angelica bring both strength and expertise to the company.

Over the last twelve months, we have continued to build a strong team at Hansa Medical. We are now 21 employees in all, and plan to add more competence to the organization, as we get closer to the commercialization phase. In the second quarter, we appointed Henk Doude van Troostwijk as Vice President of Commercial Operations. His focus includes creating market access, pricing and reimbursement strategies for the company. The appointment of Henk comes at a deciding time when we have passed several important scientific milestones on our road to take product to market. This will benefit all our stakeholders, not the least the patients.

Göran Arvidson
President and CEO of Hansa Medical

The information in this interim report is disclosed pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was released for public disclosure through the agency of the contact person below on July 21 2016, at 08.30 CET.

For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-633 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com

About Hansa Medical AB
Hansa Medical 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 Stockholm.

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About Us

Hansa Medical is a biopharmaceutical company focused on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Other projects include HBP (a market introduced diagnostic marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's share (HMED) is listed on Nasdaq First North in Stockholm with Remium Nordic AB as Certified Adviser.