Heidelberg, 29 June 2009 – SYGNIS Pharma AG (Frankfurt: LIO; ISIN DE0005043509; Prime Standard) today announced the results of the 2008/2009 fiscal year, which ended on 31 March 2009 and presented the milestones of the reporting period. On the way to becoming a product-based pharmaceutical company specialising in the treatment of disorders of the central nervous system (CNS), SYGNIS has taken further steps forward. One of the key milestones of the reporting period is the completion of the preparations for the multinational phase II efficacy study for AX200 for the treatment of acute stroke, which was initiated in spring in the first centres. In addition, the company achieved a second key milestone in terms of its research expertise and value added through the acquisition of Amnestix Inc. in June 2008: Amnestix complements SYGNIS’ CNS expertise with the addition of a new discipline in the form of neurogenomics research, allowing SYGNIS to position itself as a licensing partner for innovative CNS projects in an early development stage.
Financial figures for the 2008/2009 fiscal year
AX200: efficacy study started
The main focus of the year was the continuing development of SYGNIS’ lead compound, AX200, for the treatment of acute stroke. During the preparations for the multinational phase II efficacy study, the material to be used was tested in advance in a clinical study with 36 probands. SYGNIS also finalised the study protocol, which was examined and subsequently approved by the relevant authorities. After all the scientific and regulatory requirements had been complied with at the end of the fiscal year, the first centres were opened in Austria, Belgium and Germany in the course of the last few weeks. In total, more than 60 clinics will be involved from seven European countries, including the Czech Republic, Spain, Sweden and Slovakia, with approximately 350 patients. The trial is expected to be fully recruited within 18 months, and the first results to be available after a further six months.
Amnestix: use of neurogenomics and dementia research for the development of new drugs
In June 2008, SYGNIS acquired the US-based Amnestix Inc. to build a broad research platform that will expedite the discovery of drug candidates for the treatment of CNS disorders. The company has also acquired privileged access to the know-how and selected CNS patent applications of the Translational Genomics Research Institute (TGen). SYGNIS also obtained promising research projects relating to Alzheimer’s disease that is expected to provide the company with access to this growth market.
US patent situation strengthened
With respect to AX200, SYGNIS achieved yet another milestone: the US Patent and Trademark Office issued AX200 the patent for the treatment of stroke patients. Following Europe, SYGNIS now has patent protection for AX200 in the market with the highest demand for innovative treatments for stroke patients.
Award of the Orphan Drug Designation for AX200 in two CNS indications
Parallel to the development of AX200 for stroke patients, SYGNIS continued its investigation into the application of this compound in other CNS indications. In the 2008/2009 fiscal year, the company received the Orphan Drug Designation from the European Commission for AX200 and for the treatment of the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS) and spinal cord injuries.
Capital increase and liquidity inflow of 18.3 million euros
In November 2008, SYGNIS successfully carried out a capital increase and secured an inflow of new financial resources amounting to 18.3 million euros. By issuing 12,694,967 shares from its authorised capital, the equity capital increased from 28,563,676 to 41,258,643 euros.
Dr. Alfred Bach, CEO of SYGNIS Pharma, said: "In this past fiscal year, we have established the basis for a rapid expansion of our product pipeline and a sustainable increase in the value of our company. Our focus is now on moving ahead with the phase II efficacy study for AX200 that has now begun. We will also use our extended CNS research platform and the programmes acquired through Amnestix to extend our portfolio with the addition of attractive projects. This will give us a distinct competitive edge and support our further growth in the long term."
Outlook
SYGNIS expects a net loss of around 14 million euros for the current 2009/2010 fiscal year and a liquidity outflow of some 13 million euros.
Following the acquisition of Amnestix, SYGNIS will now be placing a special focus on the working relationship with TGen to intensify this collaboration and to make the in-licensing of further CNS projects possible. In addition, SYGNIS will continue to strengthen and extend the patent position of AX200 and move ahead with pre-clinical projects relating to KIBRA and the neuronal stem cell programme. The company’s goal is to set up collaborations for these projects with pharmaceutical partners in the coming months. The effective execution of the multinational phase II efficacy study is also a key focus.
| Financial figures for financial year 2008/09 ended March 31, 2009 and corresponding figures (IFRS) | ||
| Numbers in million euros | 2008/09 | 2007/08 |
| Revenue | 0,4 | 0,5 |
| Total costs | 11,2 | 7,8 |
| EBIT | -10,8 | -7,2 |
| Result of the period | -10,3 | -6,3 |
| Intangible assets | 22,2 | 17,8 |
| Liquidity at year end | 22,3 | 19,5 |
| Equity (equity ratio in %) | 36,2 (72) | 29,5 (71) |
| Long-term financial liabilities | 8,0 | 8,0 |
| Operational Cash Flow | -9,3 | -5,3 |
For the annual report for the fiscal year ended 31 March 2009 and a presentation on SYGNIS’ annual results, please visit www.sygnis.de.