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Funding of the Phase II study with IdeS secured

14 Feb 2014, 14:03
Regulatory information
Hansa Medical’s Board of Directors summons to an extraordinary meeting, March 5, 2014. The Board proposes a fully guaranteed preferential rights issue yielding Hansa Medical a total of SEK 37 million. This will ensure sufficient funding for the upcoming IdeS Phase II trial in kidney transplantation, and further development of secondary indications for IdeS. Hansa Medical’s principal shareholders, representing 72 per cent of the shares, have undertaken subscription and will guarantee the rights issue in full. The guarantee is conditional upon resolution of the preferential rights issue by two thirds of the shares represented at the extraordinary meeting, excluding shares represented by concerned guarantee provider. The Board proposes that one existing share on the record day, shall entitle to one subscription right.  Six subscription rights entitle subscription of one new share at SEK 10 per share. Further details of the rights issue are presented in the summons to the extraordinary meeting.

Background and motive
The successful Phase I-study with IdeS in 2013 demonstrated IdeS as safe, fast and efficient in inactivating antibodies. These characteristics are much anticipated by transplantation surgeons around the world as this has the potential to enable transplantation of thousands of patients with donor specific antibodies. The rights issue will provide means to pursue a Phase II-study starting in spring 2014 aiming to make patients with donor specific antibodies eligible for transplantation. IdeS’ Phase II-study will be performed at Uppsala University Hospital, with an anticipated duration of approximately one year. Intermediate accomplishment will be communicated to some extent during the study year. Filing of the Phase II-application with the Swedish Medical Products Agency is scheduled for the first quarter of 2014.

IdeS is an enzyme specifically inactivating IgG-antibodies. Donor-specific antibodies are of the IgG-type and Hansa Medical envisions a single dose intravenous injection of IdeS being dispensed prior to kidney transplantation in patients with donor specific antibodies. IdeS has the potential to remove the antibody barrier within minutes after dosage, hence enabling transplantation of patients today referred to long-term dialysis treatment. Long-term dialysis is costly and is associated with a significantly increased risk of death caused by stroke and/or heart disease. Approximately one third of sensitized patients decease while waiting for a transplant.

Preliminary schedule for preferential rights issue
5 March 2014                           Extraordinary meeting of shareholders
17 March 2014                        Publication of prospectus
18 March 2014                        Last day of share trading with the right to subscribe
21 March 2014                        Record day for the receipt of subscription rights
25 March– 8 April 2014        Subscription period
3 April 2014                               Last day for subscription rights trading
11 April 2014                            Public notice of outcome

For further information, please contact:
Emanuel Björne, CEO Hansa Medical AB
Mobile: +46 707 17 54 77

The information in this press release is such information that Hansa Medical AB (publ) is obliged to disclose under the Securities Market Act and/or the Financial Instruments Trading Act. The information was made public on February 14, 2014 at 14:00 am CET.

Hansa Medical pursues clinical development and commercialization of innovative pharmaceuticals and diagnostic methods for the benefit of patients with serious and rare inflammatory diseases. The portfolio includes a marketed diagnostic product, a drug candidate in clinical development, and a preclinical research project. Major shareholders are Bo Håkansson via Farstorps Gård AB, and Bengt Ågerup via Nexttobe AB. Hansa Medical is listed on NASDAQ OMX First North (HMED) and Remium Nordic AB is the company’s Certified Adviser.