SYGNIS Pharma AG has announced its financial results for the 2010/2011 fiscal year, which ended on 31 March 2011.
Financial figures for the 2010/2011 fiscal year
• Cash including marketable securities was reduced by €8.7 million to €6.8 million (2009/2010: €15.5 million). Long-term financial liabilities amount to €8.0 million resulting from a loan that will not become payable until 2015.
• Net loss for the 2010/2011 fiscal year is -€12.4 million compared to -€10.3 million in the previous year.
• Operational expenditure increased to €13.0 million (2009/2010: €9.2 million) due to higher expenses for the increased rate of patient recruitment in the AXIS 2 study.
• The net financial result amounted to -€0.1 million (2009/2010: -€1.8 million) due to unrealized losses on marketable securities.
• Positive trend of the AXIS 2 Study: In March 2011 the Data Safety Monitoring Board (DSMB) held its third and final interim review of the clinical efficacy study using AX200 for the treatment of acute stroke (AXIS 2 Study) and confirmed there was no indication of any undesired or safety-related findings.
Recruitment for the study continued to improve during second half of 2010/2011 as a result of the amendment to the study-protocol and on 31 March 2011, 75% of the 328 patients were enrolled. Currently more than 90% of the patients have been enrolled.
• Expanded IP-position for AX200: In February 2011, SYGNIS acquired the exclusive rights for a European patent, which has strengthened and prolonged the protection of AX200 for the treatment of acute stroke until at least 2022; in addition it provides protection with regards to the early regeneration phase after acute stroke.
• Screening for KIBRA Modulators: The Company has launched a programme to identify suitable compounds that could have an effect on the KIBRA pathway, which plays a key role in memory disorders, following the results from the in vitro and in vivo ”proof of principle“ studies.
• Focusing on Research and Development: In the course of a corporate restructuring process, SYGNIS decided to focus on the development of its two main projects, AX200 and KIBRA. Furthermore, the execution of the capital reduction by consolidating the SYGNIS shares at a ratio of 3:1 in December 2010 improved the Company’s capital market viability.
Significant events post balance sheet date
• On 15 June 2011, the Company executed a loan agreement with its main shareholder, dievini Hopp, amounting to € 6.0 million. On the basis of the current planning, these additional funds secure the financing of SYGNIS’ operations until the end of calendar year 2012.
• At the beginning of May 2011, the European Patent Office and the US Patent and Trademark Office have given notice that they expect to issue elementary KIBRA patents. The issuing of the first patents in this important future field for the treatment of memory disorders improves the patent position of SYGNIS and thus strengthens the value of the KIBRA project.
Peter Willinger, SYGNIS CFO, said, “The current year will be key for SYGNIS and we have entered it in a stronger position on a number of fronts. Enrolment for the AX200 efficacy-study for the treatment of acute stroke should complete soon and we expect to report the top-line results towards the year end. According to our present plans and including the committed financing of €6 million by dievini Hopp we are in a good financial position from which to progress the further development of our core projects.”
With respect to the research and development activities regarding the two main projects AX200 and KIBRA, SYGNIS expects to report a net loss and a liquidity outflow of around €9 million for the current 2011/2012 fiscal year.
The key operational focus for the upcoming months is the completion of the ongoing AXIS 2 Study and the analysis of the related study results. Initial substantiated results are expected to be available by the end of 2011.
Dependent on these results, the Company will then evaluate the options for any further development of AX200. This will include a possible out-licensing or the further development of the project with its own resources.
SYGNIS expects to receive first results of potential candidates from the KIBRA project in the third quarter of calendar year 2011. These results will form the basis for upcoming research activities.