Financial Highlights
• Cash including marketable securities amounted to €26.0 million as of December 31, 2008 (€21.3 million Q3 2007/2008). 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 increased clinical development expenses, total operating expenses increased to €3.2 million in the third quarter 2008/2009 (€2.1 million Q3 07/08); in the first nine months they amounted to €7.3 million (9 months 2007/2008: €5.9 million)
• Revenues in the first nine months of fiscal year 2008/2009 amounted to €0.4 million (9 months 2007/2008: €0.4 million)
• The net result for the first nine months of 2008/2009 amounted to €-6.7 million (9 months 2007/2008: €-4.7 million)
• Following the capital increase in November, SYGNIS sold 12,694,967 newly issued shares from authorized capital. Accordingly, SYGNIS’ total registered share capital increased from €28,563,676.00 to €41,258,643.00
Operational Highlights
• In December 2008 the US Patent and Trademark Office (USPTO) published a Notice of Allowance for the patent application which protects the treatment of stroke patients with AX200 thus strengthening SYGNIS’ patent position in the US
• Scientific Preparations for the upcoming multinational phase II efficacy study of AX200 in acute ischemic stroke have been successfully completed. To date, SYGNIS has agreed with over 60 stroke centres in several European countries to participate in the study. In addition, a clinical trial was completed in which the safety and tolerability of the new material supplied by Dr. Reddy’s was proven in the dose range planned for the upcoming phase II efficacy study. The trial included 36 volunteers and was successfully finished in December. In the third quarter SYGNIS finalized the study protocol together with a Steering Committee made up of leading international stroke experts
Outlook
Based on its solid financial position, as well as on the completed preparations for the phase II efficacy trial, SYGNIS’ management believes the company is in a strong position to make further operational progress during 2009. The company anticipates the net loss for fiscal year 2008/2009 to be lower than originally expected. In the upcoming months, SYGNIS will, in coordination with the competent authorities, concentrate on the initiation of the phase II efficacy trial. The additional focus of the company’s operational activities will be on increasing its business development activities and continuing its development programmes.
The report on the third quarter which ended on December 31, 2008 is available at the SYGNIS webpage at www.sygnis.de.
About SYGNIS Pharma
SYGNIS Pharma AG, headquartered in Heidelberg, is a specialty pharmaceutical Company listed on the Prime Standard of the German stock exchange. The Company is focused on the research, development and marketing of innovative therapies for the treatment of disorders of the Central Nervous System. These include Stroke, Amyotrophic Lateral Sclerosis (ALS) and neurological disorders resulting from injuries of the brain or spinal cord. All these disorders are characterized by the fact that, as the disease progresses, nerve cells are damaged and die. Although there is great medical demand, there are currently no or only inadequate treatment options available.
One of the central elements in this value-creation chain is the continued development of the existing product pipeline. This is achieved by testing the Company’s proprietary compounds, which are already under development, in a number of further CNS indications and forms of administration (“line extension”). By means of specific R&D programs at SYGNIS, new pre-clinical drug candidates are identified and evaluated and suitable CNS product candidates are also systematically tested for the purpose of acquisition or in-licensing.
