Berlin, 30th March 2010. The business year 2009 was extremely eventful for MOLOGEN: The development of the most promising product candidates has been advanced decisively. All other planned activities and clinical studies are financially secured up until 2011.

 

Clinical development of MGN1703

The cancer medicine MGN1703 is currently in the pivotal clinical test phase. After MGN1703 demonstrated its excellent tolerability in the phase 1b study in the previous year, the clinical phase 2 study will investigate the efficacy of the medicine in the treatment of metastatic colorectal cancer. The approval for the phase 2 study was issued in March 2010. The treatment of the first patients will begin shortly.

 

This study shows that MOLOGEN is among the few biotechnology companies in the world with well-tolerated, DNA-based cancer treatment in the clinical development stage.

 

Progress also made with MGN1601

Important progress has also been achieved with other medicines: In November 2009, MOLOGEN submitted an application for the approval of a phase 1/2 clinical study of the cancer medicine MGN1601, a cell-based gene therapy for the treatment of advanced renal cancer.

Another innovative product candidate will therefore soon be entering clinical trials. In 2006, MGN1601 received "Orphan Drug Status” from the European Commission, which ensures exclusive marketing rights for ten years within the European Union.

 

MGN1331 against leishmaniasis

Progress has also been made in the development of the MIDGE®-based DNA vaccine MGN1331 against leishmaniasis in humans. As a member of an international project consortium, MOLOGEN has received funding for the years 2009 to 2011 to develop a DNA vaccine against this infectious disease. The project, running for a period of three years, will be supported with a total of 3 million Euros.

 

Financial situation on target

The economic development of MOLOGEN progressed in the business year 2009 according to plan. Sales revenue was, as in the previous year, low at 0.1 million Euros (previous year: 0.2 million Euros) and was mainly a result of the sale of goods and services for research. In contrast, other operating income increased to 0.3 million Euros primarily due to subsidies received, and was significantly above the value for the previous year (0.0 million Euros).  

 

The net loss for the period under review rose to 6.3 million Euros (previous year: 6.1 million Euros). Extensive activities for the further development of the product pipeline were largely responsible for this development, which were reflected by higher research costs. In total, the company invested 4.8 million Euro in research projects during the recent financial year (previous year: 4.4 million Euros).

 

High liquidity

MOLOGEN’s assets position continues to be characterized by a high proportion of liquid funds in the balance sheet total These liquid funds account for a proportion of 72% (31.12.2008: 54%) of the balance sheet total. The total of cash and cash equivalents stood at 6.2 million Euros on 31st December 2009 (31.12.2008: 3.3 million Euros). This increase is the result of the capital increase in March 2009, the exercising of stock options in July 2009, payments from the agreed but at the reporting date not yet registered capital increase, as well as the receipt of subsidies in March 2009.

 

High R&D expenditure

Expenditure on operating activities was mainly accounted for by research and development, which at 4.8 million Euro stood above the level for the previous year (previous year: 4.4 million Euros). In particular, the preparations for the phase 2 clinical study of MGN1703 led to the increased research expenditure.

 

Promotion to the Prime Standard

Following its admission to the Prime Standard in June 2009, MOLOGEN AG is now listed in the stock market segment of Deutsche Börse with the highest transparency and disclosure requirements. The listing in the Prime Standard should make the company’s shares more interesting in the long-term and increase their liquidity.

 

Optimistic outlook for 2010

The Executive Board is optimistic about the business year 2010, expecting further important progress to be achieved with the company’s clinical development programs.