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Hansa Medical Interim report July – September 2017

14 Nov 2017, 08:00
Regulatory information

July-September in brief

Combined data from three independent clinical Phase II studies with Hansa Medical’s lead candidate IdeS was published in The New England Journal of Medicine 2017;377:442-53, August 3, 2017 issue. Data from these studies show that IdeS effectively reduces HLA antibodies and enables patients with very poor prognosis, who are unlikely to find a kidney donor, to be transplanted. Importantly, patients were doing well with good kidney function at last follow up.

Patient enrollment on target to have all patients recruited and treated by the end of 2017 in two ongoing Phase II studies with lead candidate IdeS in highly sensitized patients in the US and Europe. All treated patients will be monitored for six months post treatment.

Continued strengthening of the organization in preparation for additional Phase II studies with lead candidate IdeS.

Significant events after the end of the reporting period

On November 8, 2017, Hansa Medical announced the sudden and unexpected passing of CEO Göran Arvidson. Ulf Wiinberg, chairman of Hansa Medical, will serve as acting CEO and board member Birgit Stattin Norinder will take over the role as chairman of the board until further notice.

Updates on the clinical progress of IdeS in kidney transplant program were presented at Hansa Medical’s well attended Capital Markets Days in Stockholm (October 3) and London (October 4). As of October 3, the number of patients treated with IdeS prior to kidney transplantation was 42. Follow-up data on the first patient transplanted after desensitization with IdeS in 2014 was presented, demonstrating continuous normalized creatinine levels three years’ post kidney transplantation.

Continued patient enrollment in the investigator initiated Phase II study with IdeS in anti-GBM, a rare kidney disease. As of November 14, five patients had been included in the study. Limited follow-up data is currently available from three of these five patients who have responded favorably. IdeS appears to be well tolerated in these patients so far. Patients enrolled in the study will be monitored for six months.

Q3 January – September  Year
KSEK, unless otherwise stated 20172016201720162016
Net revenue 678 9072 4292 0362 579
Operating profit/loss -37 434-26 954-127 162-77 573-111 135
Net profit/loss -37 527-26 926-127 672-77 573-111 129
Earnings per share before and after   dilution-1,07-0,83-3,64-2,39-3,39
Shareholders’ equity 167 890138 806167 890138 806283 693
Cash flow from operating activities-38 427-27 775-120 963-67 378-94 563
Cash and cash equivalents including short term investments130 871103 948130 871103 948253 578

CEO statement
We are very grateful for the time we had Göran at the helm of Hansa Medical. Through his inspiring and genuine commitment, he has built a strong growing biopharmaceutical company with clear and ambitious strategic plans and a dedicated organization capable of executing and delivering on milestone targets. Göran will be greatly missed by all of us, as a true professional and as a warm and inspiring person. We are firmly dedicated to continue the development of our company in the direction outlined by Göran and the board of directors. Göran’s work in collaboration with the team in Lund and in the US, has taken us to a very strong position in the development of innovative immunomodulatory enzymes.

During the third quarter, we received further evidence that IdeS has great potential as a new and innovative treatment to enable life-saving kidney transplantation. In our ongoing clinical Phase II studies with IdeS a total of 42 patients have been transplanted, which reinforces our view that IdeS could represent an entirely new approach for eliminating HLA antibodies to enable transplantation for highly sensitized patients.

In line with the clinical progress, we have also gained increased attention from in the medical research community and among other stakeholders. In August, data was published from three independent clinical Phase II studies with IdeS in the high impact medical journal The New England Journal of Medicine. The article, titled IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation, concludes that treatment with IdeS effectively reduces donor-specific antibodies (DSAs) to levels that enable life-saving transplantation for highly sensitized kidney transplant patients. This is a very important milestone for highly sensitized patients awaiting a kidney transplant and for us as a company.

In October, we hosted Capital Markets Days in Stockholm and in London, where we shared these important study results with our shareholders and provided details of our strategy for the company’s next phase of development. During the events, senior management from Hansa Medical and leading transplant experts gave an update on our projects and the latest research findings. The interest from both our shareholders and the research community, further supports the relevance and medical importance of our research and development of immunomodulatory enzymes.

This year, in parallel with our innovative work in organ transplantation, we have taken the first important clinical steps to broaden the use of IdeS. We believe there is significant therapeutic potential for the fast and efficient IgG cleaving mechanism of action of IdeS in both serious transplant-related indications and acute autoimmune diseases, such as anti-GBM antibody disease.

As of today (November 14, 2017) five patients have been treated with IdeS in an ongoing investigator-initiated Phase II study in severe anti-GBM antibody disease, a rare and acute autoimmune disease in which the kidneys often are irreversibly damaged resulting in the need for dialysis treatment or kidney transplantation. Limited follow-up data is currently available from three of these five patients, who have responded favorably. IdeS appears to be well tolerated so far in these patients. In addition, prior to initiation of this clinical study, three patients with anti-GBM antibody disease were treated on a named patient basis in Sweden. Hence, a total of eight patients with anti-GBM disease have been treated with IdeS as of November 14, 2017.

In total, approximately 15 patients will be recruited to the anti-GBM study at up to 15 clinics in Europe. This may provide evidence that IdeS has the potential to be an important treatment in additional serious, acute IgG-mediated diseases for which no approved treatments exist today.

During this year, we have continued to build a strong and committed team expanding broadly in both R&D and marketing as well as in the medical department to which we recently hired two seasoned senior medical science liaisons in the US, to support our increasing presence in this important market for future anticipated launches. We have increased the number of co-workers significantly and are now around 40.

We have made significant investments in the IdeS production process during 2017 and we continue to prepare product supply for commercialization of IdeS. The processes have been transferred to manufacturers in Europe suitable for commercialization and the product we are preparing for launch is going to be a lyophilized product for easy off the shelf use and for convenient and effective world-wide distribution.

Naturally, we still have several milestones to achieve until we have a product on the market, but the overall progress in recent months is very encouraging and has further strengthened our belief in the future of IdeS. Our position to become a pharmaceutical company with important, life-saving products on the market is becoming more prominent for every milestone we reach and I look forward to updating you on our continued development.

Ulf Wiinberg
Acting CEO 

For further information, please contact:
Emanuel Björne, Vice President Business Development and Investor Relations, Hansa Medical AB (publ)
Mobile: 46707175477

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 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.