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Sygnis Pharma AG increases capital

SYGNIS Pharma AG reported its financial results for the third quarter and the first nine months of the fiscal year 2008/2009. In the reporting period which ended December 31, 2008, the company improved its cash position significantly as a result of a successful capital increase. Following the capital increase the stake of dievini Hopp BioTech in SYGNIS Pharma AG increased to approximately 44.90% of the total share capital. The preparations for the phase II efficacy trial of its lead candidate AX200 in acute ischemic stroke (AIS) continue to make good progress with a planned start in spring 2009.

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
© SYGNIS Pharma AG

dievini Hopp BioTech increases stakes

Following the capital increase in November, when Hopp BioTech stakes in SYGNIS Pharma AG increased to more than 36% of the voting rights, Hopp BioTech made a mandatory offer.
During the course of the offer, which terminated on January 20, 2009, a total of 3,609,129 shares were tendered at a price of 1.44 Euro. Consequently, the stake of dievini Hopp BioTech in SYGNIS Pharma AG increased to a total of 18,526,822 shares and approximately 44.90% of the total share capital respectively. dievini Hopp BioTech thus remains the largest shareholder of SYGNIS Pharma AG, followed by BASF SE with 13.49%, Bayer AG with 3.39% and Dr. Friedrich von Bohlen und Halbach with 5.10%. Accordingly the free float of SYNGIS Pharma AG is 32.96% of the issued share capital.

Capabilities increased significantly through acquisition of Amnestix

In June, SYGNIS acquired Amnestix Inc., a US pioneer in neurogenomics and neurotherapeutics, with an important business relationship to the worldrenowned Translational Genomics Research Institute (TGen). Through the addition of Amnestix’ drug discovery capabilities to SYGNIS’ development expertise, the company has created a discovery engine that will fuel SYGNIS’ pipeline in the future with innovative projects for neurodegenerative diseases.

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. On March 24 2009 the USPTO granted the patent for AX200 for the treatment of stroke patients. The patent was issued as U.S. Patent No. 7,507,705.

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.


Premises Sygnis Pharma AG © Sygnis

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.

Alongside its development in SYGNIS’ lead indication of acute stroke, AX200 has received Orphan Drug Designation for Amyotrophic Lateral Sclerosis as well as Spinal Cord Injury. In Spring 2009 SYGNIS will decide on the future development of AX200 in those indications and the next steps with respect to clinical development.

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