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Hansa Medical Interim report April-June 2017

20 Jul 2017, 08:00
Regulatory information

April – June 2017 in brief
›› Continued patient enrolment in two ongoing Phase II studies with lead candidate IdeS in highly sensitized patients in the US and Europe. The objective is to have all 40 patients recruited and treated in the two separate studies by the end of 2017. All treated patients will be monitored for six months post treatment.

›› First patient treated in Phase II study with IdeS for acute renal failure in anti-GBM antibody disease. Approximately 15 patients will be recruited in this investigator initiated study at up to 15 clinics in Europe. The primary objective of this study is to evaluate the safety and tolerability of IdeS, as well as efficacy assessed by evaluating renal function at six months after IdeS treatment.

›› Published preclinical results confirm IdeS’ potential in cancer immunotherapy. The published findings demonstrate how pre-treatment with IdeS in tumour animal models can increase the efficacy of currently available antibody based cancer therapies.

›› The European Medicines Agency (EMA) grants access to its Priority Medicines (PRIME) scheme for IdeS in enabling kidney transplantation for highly sensitized patients. Access to PRIME allows for accelerated development of IdeS, a potentially transformative treatment option for patients in need of lifesaving kidney transplantations.

›› Lead candidate IdeS discussed in a two-day workshop titled Antibody Mediated Rejection in Kidney Transplantation, organized by the U.S. Food and Drug Administration (FDA). Transcripts from the workshop have been released and are available on the FDA website. Presenters and audience engaged in extensive discussions around the potential of IdeS in kidney transplantation.

Financial summary for the Group (KSEK)

KSEK, unless otherwise stated  Q2 H1 Year 
2017 2016 2017 2016 2016 
Net revenue693 5421,7511,1292,579
Operating profit/loss-44,901-30,674-89,728-50,619-111,135
Net profit/loss-45,151-30,672-90,145-50,647-111,129
Earnings per share before and after dilution (SEK)-1.29-0.94-2.57-1.56-3.39
Shareholders’ equity198,600160,201198,600160,201283,693
Cash flow from operating activities-38,797-22,043-82,536-39,603-94,563
Cash and cash equivalents including short term investments169,953133,686169,953133,686253,578

CEO statement
The first six months of 2017 were characterized by the continued development of our program around novel and innovative immunomodulatory enzymes. As we reached several important milestones during this period, we remained focused on our strategy around our lead candidate IdeS and continue to advance our clinical development. As our program continued to develop according to plan, we noticed an increasing interest by the medical and scientific communities. As a result, principal investigators have been able to present data from our recent studies with IdeS at several renowned scientific and medical meetings.

On April 30, top-line clinical results from the ongoing investigator initiated US study with IdeS were presented at the American Transplant Congress (ATC) in Chicago. These encouraging results demonstrate that treatment with IdeS eliminates donor specific antibodies (DSAs) and enables transplantation of HLA incompatible patients. They also support our belief that IdeS has the potential to become the first approved therapy to enable highly sensitized kidney disease patients to be transplanted.

IdeS was also in focus at a two-day workshop titled Antibody Mediated Rejection in Kidney Transplantation arranged by the US Food and Drug Administration (FDA). In the workshop, novel opportunities for the treatment and prevention of Antibody Mediated Rejection (ABMR) were discussed. The discussions covered the potential risk-benefit profile of IdeS as a desensitization treatment and the treatment of severe ABMR in kidney transplantation. Presenters and audience engaged in extensive discussions around the potential of IdeS in kidney transplantation.

This adds to our firm belief that IdeS has a significant potential to become a novel treatment option to enable patients to receive the lifesaving transplantation they desperately need. We continue to make progress and are committed to spread more knowledge about the profile of IdeS.

In May, the European Medicines Agency (EMA) granted access to its Priority Medicines (PRIME) scheme for IdeS. PRIME is intended to enhance support for the development of medicines that target an unmet medical need. The designation was based on data from four independent Phase II studies in the US and Europe, including data from 30 HLA sensitized patients who received IdeS immediately before transplantation. The access to PRIME allows us to continue to accelerate the development of IdeS.

In parallel with our pioneering work in organ transplantation, we are also pursuing the therapeutic potential of IdeS in several other indications. We believe that the fast onset and efficacy of IdeS has the potential to bring significant contribution to the critical care in several transplant-related indications and acute autoimmune diseases, including Anti-GBM antibody disease, also known as Goodpasture disease.

In June, we announced that the first patient had been treated with IdeS in an investigator-initiated Phase II study in severe anti-GBM antibody disease. In total, approximately 15 patients will be recruited to the study at up to 15 clinics across Europe.

We also see opportunities with IdeS as a potential treatment in cancer immunotherapy. Pre-clinical data, published in the peer-reviewed journal Molecular Cancer Therapeutics (Järnum et al., Mol Cancer Ther May 22 2017 DOI: 10.1158/1535-7163.MCT-17-0108), confirm this potential of IdeS and demonstrate how pre-treatment with IdeS in tumor animal models can increase the efficacy of currently available antibody-based cancer therapies.

In preparation of the next phase of the company’s growth, we are continuously building a strong, committed team. We are further establishing our footprint in the US via recruitment of two senior medical affairs professionals.

In short, encouraged both by the positive development of IdeS and the reception we have so far received from the medical community, I feel that Hansa Medical is in a strong position to continue the journey to become a biopharmaceutical company with important lifesaving products. I look forward to providing further updates about our exciting development.

Göran Arvidson
President and CEO of Hansa Medical

For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: +46 70-633 30 42

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead project IdeS is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications. The company also has a strong pipeline of preclinical assets that may provide a second wave of potential drugs. Under the project name NiceR, novel immunoglobulin cleaving enzymes are developed for repeat dosing translating the Hansa Medical technology into relapsing autoimmune diseases and oncology. Hansa Medical is based in Lund, Sweden, its shares (ticker: HMED) are listed on Nasdaq Stockholm.