Berlin, March 30, 2009 - The Berlin-based biotechnology company MOLOGEN is looking back at a very successful 2008 fiscal year. By beginning the clinical trial the Company reached an important milestone in the development of its cancer drugs and vaccines and business development was in line with expectations. Mologen is among the few biotechnology companies in the world with well-tolerated, DNA-based cancer treatment in the clinical development stage. With a successful capital increase, the Company has formed a solid basis for the further development of drugs.
Income and Financial Position
In 2008 Mologen has invested primarily in research activities. Therefore costs for R&D grew to EUR 4.4 million after EUR 4.1 million in the previous year. Extensive activities to further develop the product pipeline were most relevant. Nevertheless, the net loss for the year improved compared to the previous year and came in at EUR -6.1 million (previous year: EUR -6.5 million). Liquid funds as of the end of the year amounted to EUR 3.3 million (previous year: EUR 8.0 million).
Advances in Research
The Company’s research and development activities in the 2008 fiscal year focused on the preparation for and start of the phase I clinical trial. In this phase, the tolerability of the drug for colorectal cancer (MGN1703) is examined. After receiving the official approval the trial began in July 2008 with the recruitment of patients. In the course of the study the drug has exhibited a positive safety profile and good tolerability. The dosing regimen specified in the study plan could therefore be followed without modification. MOLOGEN expects the clinical trial to be concluded in the second quarter of 2009 and is currently intensively engaged in preparing additional clinical trials investigating the efficacy of MGN1703 (phase II).
Other Highlights from the Fiscal Year
1. From 2009 to 2011, MOLOGEN will receive financial subsidies of EUR 1.2 million overall from the European Union. This will be used to preclinically develop a vaccine for the infectious disease leishmaniasis of humans.
2. Preclinical work on a cell-based gene therapy for the treatment of renal cancer (MGN1601) has largely been concluded. An approval relevant clinical trial is being prepared. The drug MGN1601 was granted so-called “orphan drug” status by the European Medicines Agency (EMEA). During the clinical development phase of the drug MOLOGEN can revert to intensive advisory support by the EMEA. Further the drug receives a ten year marketing exclusivity starting with its approval.
3. The Company has received a significant extension to the authorization to manufacture MIDGE®-based DNA active ingredients itself for clinical trials from the responsible authorities. A separate and very time-consuming application for approval to manufacture individual active ingredients is now no longer necessary. MOLOGEN can now produce the DNA active substances that are required for the clinical development programs in the required quality and amounts.
These milestones are the foundation for the further positive development of the Company.
Capital Increase
The Executive Board of MOLOGEN AG successfully finalized a capital increase for contributions in cash with the exclusion of the subscription right on March 27, 2009 and prepared to record this in the register of companies. A total of 425,000 ordinary bearer shares (approximately 4.5% of the ordinary share capital) were placed with institutional investors. At an issuing price of EUR 6.50 per share, this provides the Company with cash totaling approximately EUR 2.8 million. The proceeds will be used specifically for the further development of the product pipeline.
“We have managed to successfully carry out a capital increase in an extremely difficult stock market environment and win over new investors. The fact that the new shares were subscribed at a premium to the current share price shows that the investors, like us, are convinced of the enormous potential of Mologen,” stated Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG.
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.
