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MOLOGEN AG / Interim announcement: MOLOGEN AG publishes results for the first nine months of 2008 and gives an overview of R&D activities Publication of an interim announcement acc. to §37x WpHG (the German Securities Trading Act) processed and transmitted by Hugin. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- --------------
- Increased focus on product development raises the company profile - Important advances in clinical tests with cancer therapy MGN1703 - Promising activities for the expansion of the product pipeline - Results development on schedule
Berlin, 13 November 2008 - The Berlin-based Biotech company, MOLOGEN AG, significantly raised its company profile in the first nine months of the 2008 fiscal year with increased focus on the development of its own product candidates.
By focussing on clinical development of its own patented therapy approaches for diseases that require a high level of medical treatment, the company is set to significantly increase its value. Positive clinical data strengthen the negotiating position with regard to potential licensees and allow for attractive licence conditions.
Important advances in clinical tests with cancer drug MGN1703 Important steps have been made in the current clinical study (phase I) to investigate the safety, compatibility and immunological effect of MGN1703 in the treatment of various cancers. The study has been very promising to date. Subject to a further scheduled study, MOLOGEN expects to complete the clinical tests in the first quarter of 2009. At present, an application is being prepared for subsequent clinical studies of phase II in order to investigate the efficacy of MGN1703.
Promising activities for expansion of the product pipeline Further milestones in the expansion of the product pipeline are expected to be reached before the end of the current fiscal year.
Pre-clinical development work for the preparations of a clinical study with cell-based gene therapy against renal cell cancer (MGN1601) is almost complete. Plans for an approval-related phase I/II study with MGN1601 are already in the advanced stages. Furthermore Mologen could announce recently that the Russian patent office is going to grant the patent for cell based gene therapy against cancer. The EMEA has assigned MGN1601 Orphan Drug Status. Orphan Drug Status secures a 10-year commercialisation exclusivity within the European Union. Furthermore, during the licensing procedure the company is granted the advice and support of the EMEA.
As part of the development of a prophylactic and therapeutic DNA immunization against visceral leishmaniasis, a serious, often fatal infectious disease, MOLOGEN is in advanced negotiations for the guarantee of subsidies by the European Union. In the first quarter of 2008, a corresponding grant application to the 7th EU Framework Programme, which MOLOGEN submitted together with an international consortium, has been reviewed with maximum possible score. The project was awarded the perfect grade after assessment through international scientific experts.
Results development on schedule The results development of MOLOGEN AG ran as scheduled in the first nine months of the 2008 fiscal year.
Important figures for the period from 1 January to 30 September 2008 according to IFRS (unaudited, comparative period of previous year: 1 Jan to 30 Sep 2007, unaudited):
Operating result (EBIT) for the period EUR -4.8 million (previous year: EUR -4.4 million). Net loss for the period EUR -4.6 million (previous year: EUR -4.2 million). Revenues EUR 0.1 million (previous year: EUR 0.1 million). Other operating expenses EUR -1.6 million (previous year: EUR -1.7 million). Other operating income EUR 0.0 million (previous year: EUR 0.7 million). Cash funds EUR 4.3 million (31 Dec 2007: EUR 8.0 million). Equity ratio 92% (31 Dec 2007: 93%).
The result's figures are influenced by high expenditure as part of the MOLOGEN AG research and development programme. Compared to the previous period however, the overall expenditure fell by approx. EUR 0.2 million despite rising R&D costs.
Commenting on the business development of the first nine months of 2008, Dr Matthias Schroff, CEO of MOLOGEN AG, said: "Our focus on the essential pipeline projects has paid off. In the last few months we have been able to make important progress in this area and intend to reach further milestones before the end of the year."
Information about the clinical study with MGN1703 The study (Phase I) of the safety, compatibility and immunological effect of MGN1703 in the treatment of various cancers is a major milestone for a comprehensive clinical development program. MOLOGEN plans to establish an effective, compatible treatment for the treatment of the most frequent cancers in the form of MGN1703. The study is performed at the renowned cancer centers in university hospitals in Essen and Cologne, and will last around six months.
dSLIM® - an innovative TLR9 agonist In dSLIM® ("double Stem Loop Immunomodulator"), MOLOGEN has developed an innovative TLR9 agonist. 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, 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 them strategically.
Market for immunomodulatory therapies worth billions In terms of efficacy and compatibility, immunomodulatory therapies could mean a real medical breakthrough in the fight against cancer. Experts estimate that there is a global market worth billions of US Dollars for such therapies. Pharmaceutical companies are therefore extremely interested in securing the rights to molecules like TLR9 agonist and testing substances in many different indications. The recent acquisition of a US competitor by a globally operating pharmaceutical group is convincing proof of the great potential attributed internationally to TLR technology.
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 platform technologies 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.
WKN: 663720; ISIN: DE0006637200; Listed: Freiverkehr in Börse Berlin, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, General Standard in Frankfurter Wertpapierbörse, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Stuttgart;
