Financials
- Cash including marketable securities amounted to € 11.2 million (€ 18.3 million Q2 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 expanded research and development activities, total operating expenses in the second quarter of the fiscal year 2010/2011 increased by € 0.7 million to € 3.1 million compared to the same period of the last fiscal year.
- The net loss for the first half of the fiscal year 2010/2011 amounted to € -5.3 million (€ -6.9 million first half 2009/2010).
- SYGNIS proposed a reduction in share capital from € 41,258,643 to € 13,752,881 to consolidate the shares in a 3:1 ratio primarily to improve the Company’s ability to interact on the capital markets, to be voted on at SYGNIS’ Annual General Meeting on 30 November 2010.
Operational Summary
- SYGNIS recently executed a comprehensive restructuring to significantly reduce costs and optimally position the Company for future strategic transactions.
- AX200:
- Patient recruitment for the phase II efficacy study of the Company’s lead compound AX200, for the treatment of acute ischemic stroke, was accelerated following the implementation of modification to the AXIS 2 study protocol. SYGNIS expects to report top-line data in the second half of 2011.
- At its first meeting on 2 August 2010, the Data Safety Monitoring Board (DSMB) reviewed the data on the safety and tolerability of the AXIS 2 study medication and advised on the continuation of the study without changes.
- The KIBRA project is ongoing and SYGNIS has, as previously reported, established both in vitro and in vivo proof of principle for the role of KIBRA in learning and memory. The outcome of these proof of principle studies supports SYGNIS’ strategy to use the KIBRA signalling pathway in pharmacological therapy and to develop it further as a new approach for improving the cognitive performance of patients with cognitive deficiencies. Importantly, by deciphering the mode-of- action of KIBRA SYGNIS has also secured crucial intellectual property.
Following the strategic restructuring in October, 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 (AXIS 2). Ahead of the restructuring, Dr Alfred Bach stepped down as CEO with Peter Willinger, CFO, and Dr Frank Rathgeb, Chief Medical Officer, assuming responsibility for the operations of the Company.
The Company is currently continuing the internal research on KIBRA while intensifying its discussions with potential pharma partners.
Operating expenses and the liquidity outflow for the current fiscal year 2010/2011 will be lower than originally expected. Additional non-cash related expenses of up to € 2.5 million could occur with regard to an impairment of intangible assets as a consequence of the restructuring.
In order to maximise capital market opportunities the Company is proposing to reduce its share capital from € 41,258,643 to € 13,752,881 and consolidate the shares in a 3:1 ratio. The proposal will be voted on at the Company’s Annual General Meeting on 30 November 2010.
It is the intent of the Board and Management of SYGNIS to optimally position the Company so that it can take timely advantage of strategic opportunities to create shareholder value.
The report on the second quarter which ended on 30 September 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 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
