SYGNIS advances development of AX200 in Q1 2009/2010

14-Aug-2009 - Germany

SYGNIS Pharma AG published its financial results for the first quarter of the fiscal year 2009/2010, which ended on 30 June 2009. Cash including marketable securities amounted to €19.4 million (€15.2 million Q1 08/09). Long term financial liabilities amounted to €8.0 million resulting from a loan which is not due for repayment before 2015. As a result of expanded research & development activities, total operating expenses increased by €0.6 million to €2.5 million at the end of June 2009 compared to the same period of the last fiscal year. The net loss in the first quarter was lower than anticipated and amounted to € -2.3 million (€ -1.7 million Q1 08/09).

In May 2009, after successful completion of all necessary scientific and clinical prerequisites, as well as obtaining necessary regulatory approvals, SYGNIS initiated a phase II efficacy study of its lead compound, AX200, for the treatment of acute ischemic stroke. Around 65 centres in Germany, Austria, Belgium, Czech Republic, Slovakia, Spain and Sweden have been recruited to participate in this double-blinded efficacy-trial with approximately 350 patients. Half of the patients will be treated with AX200, while the other half will be administered a placebo. The trial data are expected to be available mid 2011.

With regard to KIBRA, a gene significantly associated with learning and memory processes, SYGNIS proceeded with its preclinical research which resulted in additional intellectual property filings.

The Company’s core focus in the fiscal year 2009/2010 will be on the execution of the clinical phase II efficacy trial of AX200 in acute stroke, the further development of the product pipeline and the initiation of partnerships for our clinical and pre-clinical R&D programs. Following the capital inflow in late 2008, our financial position is on a solid basis. To accelerate growth SYGNIS is further evaluating the options for raising additional capital. For the fiscal year 2009/2010 the Company expects a net loss and a liquidity outflow in the range of the original planning.

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