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Interim report according to Article 37 of the WpHG
Successful start to the 2008 financial year for MOLOGEN AG
- 1st quarter revenues and earnings in line with planning - Experimental approval for MGN1703 cancer drug - Important progress in the field of cell-based gene therapy to fight cancer
Results for the period Jan 1 - March 31, 2008, prepared in accordance with IFRS accounting principles as they are applied in the EU (unaudited; comparative figure for the previous year: Jan 1 – March 31 2007): Operating result for the period EUR -1.46 million (previous year: EUR -1.57 million). Net loss for the period EUR -1.40 million (previous year: EUR -1.52 million). Revenues EUR 0.06 million (previous year: EUR 0.03 million). Other operating expenses EUR -0.50 million (previous year: EUR -0.44 million). Operating income EUR 0.01 million (previous year: EUR 0.02 million). Cash funds EUR 6.46 million (December 31, 2007: EUR 8.04 million). Equity ratio 94% (December 31, 2007: 93%).
Wide-ranging expenses incurred by MOLOGEN’s development program had a considerable influence on earnings development in the first financial quarter. This included increased measures for preparation of clinical studies for the MGN1703 cancer drug, which received official approval at the start of May.
At the end of the first quarter, cash funds were around EUR 6.5 million. MOLOGEN thus continues to exhibit a very solid financial position. The clinical studies with MGN1703 which start in the next few weeks will be completely financed from our own funds.
The approval for clinical studies on the MGN1703 cancer drug is a significant milestone in MOLOGEN’s development program. MGN1703 is based on the innovative immunomodulator dSLIM®, developed by MOLOGEN. The study forms the basis of a comprehensive clinical development program. MOLOGEN is planning to establish an effective, compatible cancer therapy with MGN1703. According to forecasts by experts, there is a global market worth several billion dollars for innovative immunomodulative cancer therapies.
For cell-based gene therapy to combat renal cell cancer (MGN1601), further development work has been carried out in order to prepare for a clinical study. The goal is to submit an application for clinical tests by the European Medicines Agency (EMEA) this year. MGN1601 has orphan drug status at the EMEA.
The marketing activities for cell-based gene therapy to combat the most frequently occurring cancer illnesses are carried out primarily in
Furthermore, in the first quarter of 2008, saw an application for funding which MOLOGEN submitted together with an international consortium, being awarded the highest possible rating at the 7th EU Framework Program. The project to develop a preventative and therapeutic DNA vaccine to combat leishmaniasis of internal organs, a serious and often fatal infection received the best rating following examination by scientists across the world. This accolade emphatically supports our negotiating position with the EU.
Commenting on these developments, Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG said “We had a very good start to the new financial year. We are now focusing primarily on the planned start of clinical studies with MGN1703, our innovative cancer drug“.
MGN1703/dSLIM® - an innovative TLR9 agonist MOLOGEN has developed a new type of TLR9 agonist in the form of the DNA immunomodulator dSLIM® (double stem loop Immunomodulator). The use of dSLIM® activates the immune system to protect against tumor-associated antigens by targeting the TLR9 receptor on certain immune cells. As a result of chemotherapy and radiotherapy treatment, tumor-associated antigens are released by cancer cells. The immune system activated by dSLIM® is in a position to overcome its fatal tolerance towards cancer cells and advance against the strategically.
Cell-based gene therapy to combat cancer MOLOGEN has developed an innovative cell-based gene therapy based on human allogeneic tumor cells. The allogeneic tumor cells are turned into a very effective gene therapy as a result of gene modification and combining them with immunomodulative molecules.
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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