Berlin, March 21, 2013 – The Berlin biotechnology company MOLOGEN AG looks back on an extremely successful 2012 financial year. The company made great progress with regard to both research activities for the core product candidates, MGN1703 and MGN1601, and company financing. Other milestones were achieved during the past financial year with the successful conclusion of preclinical work on the leishmaniasis vaccine MGN1331 and the start of the cooperation with Charité Berlin and the Max Delbrück Centrum for the clinical testing of an immunotherapy against malignant melanoma.
On the financial side, thanks to the capital increases successfully carried out in 2012, MOLOGEN was able to secure financing for activities planned in the medium term and to more than triple the company’s cash and cash equivalents compared to the previous year, from € 7.5 million at the end of 2011 to € 23.8 million at the end of the 2012 financial year.
Further development of the product pipeline provides convincing clinical and preclinical data
In the area of clinical development programs, MOLOGEN was able to present outstanding results from an initial evaluation of the colorectal cancer study with MGN1703. The evaluation, which was performed in May 2012, provided imposing verification of the efficacy of MGN1703 as a maintenance therapy for metastasized colorectal cancer. In a defined subgroup, it could be demonstrated that both the progression-free survival and the hazard ratio were improved considerably and statistically significantly.
There are also plans for the future to examine the efficacy of MGN1703 in the treatment of lung cancer. Application has already been made for a corresponding phase II clinical study, and work in this regard is currently moving forward.
Promising actualized data from the renal cancer study with MGN1601 was presented in October 2012. In patients who were able to completely finish the prescribed therapy regimen of the study, the data shows a clear survival advantage over patients who had to terminate the treatment prematurely due to their severe cancer.
Both the MGN1703 and MGN1601 study results were presented at the international congress of the European Society for Medical Oncology (ESMO) in October 2012. They generated great interest among scientific industry professionals.
MOLOGEN also continued to intensify its activities regarding the licensing of MGN1703 during the past financial year. The MGN1703 clinical data has generated great interest in the pharmaceutical companies.
In the area of vaccine candidates, MOLOGEN was able to complete the preclinical work on the MIDGE®-based leishmaniasis vaccine candidate MGN1331 with good results in June 2012. The preclinical work on vaccine MGN1333 for treating hepatitis B was also carried out as planned in 2012 and was nearly finished at the end of the year. The data collected can thus now be evaluated.
Results of operations developing according to plan
As in the previous year, the annual revenue of MOLOGEN AG in 2012 of € 0.1 million was, as expected, at a low level. Other operating income was € 0.3 million, which was lower than the € 0.7 million of the previous year. At € 5.9 million, research and development expenses were, as planned, somewhat lower than in the previous year (2011: € 6.1 million). The loss for the 2012 financial year of € 7.8 million was consequently slightly larger (2011: € 7.5 million).
As of December 31, 2012, MOLOGEN AG had cash and cash equivalents in the amount of
€ 23.8 million (12/31/2011: € 7.5 million) and is therefore well-equipped to finance the company’s activities planned for the medium term. The majority of the cash and cash equivalents resulted from the two successful capital increases carried out by MOLOGEN in 2012.
MOLOGEN plans to move forward with the clinical development of its product candidates, especially MGN1703 and MGN1601.The measures and investments necessary for this will result in a loss for 2013 comparable to the past financial year. However, the company assumes that, should the out-licensing activities proceed successfully and objectives be achieved as planned, the results of operations and financial position will trend positively. In particular, the intended conclusion of a licensing agreement with a partner from the pharmaceutical industry for the further development and later marketing of the cancer drug MGN1703 – depending on the accounting treatment of such a contract – would also positively affect future results of operations.
“The successful further development of our product pipeline in 2012 and the good financial basis of our company form a solid basis for the continued positive development of MOLOGEN AG. Our company strategy is clearly focused on continuing to move forward with the product pipeline, both with pharmaceutical partners and on our own. We have therefore started the new financial year with good prospects for success,” says Dr. Matthias Schroff, chief executive officer of MOLOGEN AG.
The complete 2012 annual report of MOLOGEN AG is available for download from the company’s website, www.mologen.com.
About MOLOGEN AG
MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin specializes in the research and development of innovative medications on the basis of DNA structures. The activities focus on numerous product developments which are relevant to the immune system; on the one hand vaccines against infectious diseases and on the other hand cancer medications. MOLOGEN AG is globally one of the few biotechnology companies with well tolerated DNA-based cancer treatment in the clinical development phase.
The stocks of MOLOGEN AG (ISIN DE0006637200) are listed in the Prime Standard of the German stock exchange.
Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)
MIDGE®, dSLIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
Tel: +49 - 30 - 84 17 88 - 13
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External Investor Relations:
Kirchhoff Consult AG
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Note about risk for future predictions
Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.