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Press Release; Berlin, November 14th, 2007

 

MOLOGEN AG announces results for the first nine months of 2007

 

- Revenue and earnings in line with planning
- Key advances reached in product pipeline
- Financial resources remain solid

 

Berlin, November 14, 2007 – The biotech company MOLOGEN, Berlin, today published its results for the first nine months of 2007 as calculated in line with the Handelsgesetzbuch (HGB – German Commercial Code).

 

Results Jan. 1 – Sept. 30, 2007 (unaudited; comparative period of previous year: Jan. 1 – Sept. 30, 2006):
Operating result (EBIT) EUR -4.1 million (previous year: EUR -2.4 million). Net loss for the period EUR -3.9 million (previous year: EUR -2.3 million). Revenues EUR 0.1 million (previous year: EUR 0.1 million). Other operating expenses EUR -2.0 million (previous year: EUR -1.1 million). Operating income EUR 0.7 million (previous year: EUR 0.4 million). Cash funds EUR 9.4 million (Dec. 31, 2006: EUR 6.4 million). Equity ratio 95% (Dec. 31, 2006: 92%).

 

The key factors influencing earnings development in the first nine months were the rise in expenses for pre-clinical tests and clinical studies as part of the R&D program.
With cash funds of around EUR 9.4 million, MOLOGEN AG still has sound financial resources. In order to keep current cash requirements at as low a level as possible, resources were focused at the clinical development and the market access of Company's key value drivers.

 

By the end of the third quarter, MOLOGEN achieved key progress in the development of its product pipeline.

 

Pre-clinical testing for the use of the highly innovative immune modulator dSLIM® for the treatment of cancer has been largely concluded. In preparation for licensing-related studies, MOLOGEN conducted constructive talks with the responsible authority (Bundesamt für Arzneimittelsicherheit (BfArM – German Federal Office for Drug Safety) in the third quarter. Phase Ib and IIa clinical studies are in planning to investigate the safety and efficacy of dSLIM® in the treatment of colon cancer. The appropriate applications are to be submitted before the end of this year. The start is expected to begin as soon as approval has been granted by the responsible authority – provisionally at the start of 2008.

 

The most recent pre-clinical studies for the use of cell-based gene therapy against cancer are fully underway. Preparatory talks with the office responsible for allowing the clinical study (Paul-Ehrlich-Institut - PEI) have been held in the last few months. The start of the Phase I/II clinical study requiring authorization is scheduled for the second half of next year.

 

The development of the MIDGE®-based vaccine against Leishmaniasis by our cooperation partner, a leading US veterinary pharmaceutical company, is proceeding as planned. We expect to reach our next contractually agreed milestone next year.

 

MOLOGEN is working together with leading experts in the field of preventing of and treating of Leishmaniasis in humans. The aim of this cooperation is to develop a prophylactic and therapeutic vaccination against visceral leishmaniosis, a severe and often fatal infectious disease.
Funding for the forthcoming pre-clinical tests has been applied for as part of the 7th EU Framework Program. A decision on this project that is planned to take three years is expected in the first half of 2008. If the funding is granted, MOLOGEN's role in the project would be to work on the optimization of the MIDGE®-based vaccine, produce the vaccine and conduct pre-clinical safety tests.

 

In the third quarter, the Indian health authorities authorized the use of cell-based gene therapy against cancer an essential milestone in commercializing of cell-based gene therapy. The necessary foundations in the areas of production and logistics were laid to supply therapy components in time to India.

 

Commenting on business performance, Prof. Burghardt Wittig, Chief Executive Officer of MOLOGEN AG said: "We have made key progress in the development of our diversified and risk-balanced product pipeline this year. On the one hand, our aim was to establish a sound regulatory basis for the upcoming clinical development. On the other, we had to make ready several products for clinical development at a quality enabling the best possible clinical trial concept to measure their therapeutic efficacy. This is meant in terms of significance in clinical outcomes as well as minimal development risks. "

   

About MOLOGEN

MOLOGEN AG, a biopharmaceutical company based in Berlin, specializes in the research and development of innovative medicines based on DNA structures (DNA: deoxyribonucleic acid).

 

Its patented DNA-based technology platforms MIDGE® and dSLIM® form a universal foundation with a wide range of possible applications. Activities focus on product developments for the treatment of cancer and vaccines for serious infections in humans and animals.

 

MOLOGEN was founded in 1998 and was the first German biotechnology company to go public. MOLOGEN AG shares are listed in the General Standard of Deutsche Börse (ISIN DE 0006637200).

 

Disclaimer concerning prognoses

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.

 

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