Financials
- Cash including marketable securities amounted to € 9.0 million (€ 16.4 million Q3 2009/2010). 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 the Company’s expanded research and development activities, total operating expenses in the third quarter of the fiscal year 2010/2011 increased by € 1.3 million to € 3.7 million compared to the same period of the last fiscal year. These expenses include one-time restructuring costs of € 0.2 million.
- The net loss for the first nine months of the fiscal year 2010/2011 amounted to € -9.0 million (€ -9.2 million first nine months 2009/2010).
- On the basis of the resolution of the Annual General Meeting held on 30 November 2010 SYGNIS reduced the share capital from € 41,258,643 to € 13,752,881 and consolidated the shares in a 3:1 ratio. The released capital of € 27.5 million was used to reduce the accumulated loss.
Operational Summary
- SYGNIS is primarily focused on the completion of the AXIS 2 clinical trial and research on the KIBRA pathway. Following restructure of the business and the resulting long-term reduction in costs, the Company is optimally positioned for future strategic transactions.
- AXIS 2:
- On 9 December 2010, the Data Safety Monitoring Board (DSMB) held its second interim review regarding the safety and tolerability of AXIS 2. Based on the data of 50% of the AXIS 2-patients, the DSMB recommended the continuation of the study without any modification or restriction.
- Patient recruitment significantly improved during the third quarter. Currently, more than two-thirds of the total AXIS 2 patients have been enrolled and SYGNIS expects to report top-line data in the second half of 2011.
- Based on the already established in vitro and in vivo proof of principle for the role of KIBRA in learning and memory, SYGNIS has begun a screening program, applying its proprietary assay, for the identification of suitable compounds, which could have an effect on the KIBRA activity. SYGNIS expects to have a nominated candidate during the third quarter of 2011.
Outlook
Following the strategic restructuring, SYGNIS is focused on completing the ongoing clinical development of AX200, its lead compound for the treatment of acute stroke, currently in a phase II efficacy trial and the internal research on KIBRA. SYGNIS aims to expand its research data on KIBRA and to identify strong drug candidates that will attract potential pharma partners.
Operating expenses (without any extraordinary write downs) and the liquidity outflow for the current fiscal year 2010/2011 will be lower than originally expected.
On 9 February 2011 SYGNIS announced that it has licensed the exclusive rights of a European patent with regard to its lead candidate AX200. The licence covers an issued patent which provides broad protection with regard to the use of G-CSF for the reorganisation of neural tissue affected by neurodegenerative diseases, especially stroke or trauma. The patent has a scheduled expiry date of 2022, not including any potential extensions. This licence strengthens the Company’s IP-position around AX200 and enables it to maximise the market potential of the drug.
The report on the third quarter which ended on 31 December 2010 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 and development of innovative therapies for the treatment of disorders of the Central Nervous System. SYGNIS’ core projects are currently Acute Stroke for which SYGNIS’ lead clinical programme is AX200 as well as the preclinical KIBRA-project for the treatment of different forms of dementia. 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. SYGNIS’ strategy for growth includes the development of new products from its own research and through in-licensing and acquisitions.
For further information please contact:
SYGNIS Pharma AG:
Dr. Franz-Werner Haas sen. Vice President Operations +49 (0) 6221 454 812 franz-werner.haas@sygnis.de
Media-Contact: Julia Phillips Financial Dynamics Tel.: +44 (0) 20 7269 7187
