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lefitolimod (MGN1703)

Products Next higher product group TLR agonist
Period Status 2016-04-01 development p3 existent
Organisation Organisation Mologen AG
  Group Mologen (Group)

Mologen AG. (8/14/12). "Press Release: Mologen AG. Great Success with Product Pipeline and Capital Measures – Healf-year Report Presented".

> Outstanding study results with cancer therapies MGN1703 and MGN1601

> Further development of the pipeline through lung cancer study and research cooperation

> Company's largest capital increase successfully placed

During the first six months of 2012, MOLOGEN AG achieved significant successes in the further development of the product pipeline. Important study results for both main product candidates, MGN1703 (colorectal cancer) and MGN1601 (renal cancer), exceeded expectations. A phase II study with MGN1703 for lung cancer, one of the most common cancers in the world, was also applied for. The preclinical work on MGN1331, a vaccine candidate against leishmaniasis, was completed as planned. As the next step, a clinical study is also planned for this compound. MOLOGEN also concluded a cooperation agreement with the Charité and the Max Delbrück Center of Berlin. A MIDGE®-based cancer immunotherapy shall be clinically tested in the treatment of malignant melanoma in the course of the cooperation. The study is currently under preparation.

MOLOGEN AG also strengthened its financial base considerably with two capital increases. In particular, the largest capital increase in the history of the company, which was resolved in June 2012 and carried out in July, contributed to the total of 25 million euros in new funds at the disposal of MOLOGEN AG. "This has fundamentally improved MOLOGEN's base of operations for the further development of the company. We are on the verge of the first phase III study with a MOLOGEN product. We are well-equipped financially to carry out this and all other planned research work," said Jörg Petraß, chief financial officer of MOLOGEN AG.

In addition to the scientific success, the study results currently being achieved are also improving the economic prospects for MOLOGEN. The initial analysis of the phase II colorectal cancer study showed a significant prolongation of progression-free survival for the study patients treated with the MOLOGEN compound MGN1703. An unexpectedly clear reduction of the risk of tumor progression (hazard ratio) was observed at the same time. Dr. Matthias Schroff, chief executive officer, notes that the outstanding study results also lead to an increased interest of large pharmaceutical companies.

Company results for the first six months on target

Altogether, MOLOGEN AG achieved revenue of 0.1 million euros (first half of 2011: 0.1 million euros) and other operating income of 0.2 million euros (first half of 2011: 0.4 million euros) for the period from January to June 2012, which was in line with expectations. As expected, the loss for the reporting period increased correspondingly, from 3.2 million euros in the first half of 2011 to the current 3.6 million euros. Apart from the lower operating income, the primary factors driving this were the advances in the area of research and development. They led to increased expenses in this area, particularly in the cost of materials for the clinical studies in progress, during the first six months of 2012. While R&D expenses totaled 2.6 million euros during the first half of the previous year, they increased to 2.8 million euros for the first half of 2012.

MOLOGEN AG had cash and cash equivalents totaling 6.5 million euros as of June 30, 2012 (12/31/11: 7.5 million euros). This does not yet include the capital increase carried out in July, after the end of the reporting period, from which MOLOGEN AG received gross proceeds of 22 million euros.

Pursuit of objectives for fiscal year 2012 to continue according to plan

MOLOGEN AG is continuing to pursue the objectives formulated at the beginning of the year during the ongoing 2012 fiscal year. These objectives include, in particular, the continuation of the ongoing clinical studies with the cancer drugs MGN1703 and MGN1601, the start of the clinical study with MGN1703 in the indication of lung cancer, and the application for an additional clinical study with MGN1601 in the indication of renal cancer. The MGN1333 project in the area of infectious diseases will be carried out according to plan.

In addition, licensing discussions with pharmaceutical companies regarding cancer medicine MGN1703 are continuing to be expedited on the basis of the extraordinarily positive results of the colorectal cancer study.


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 are listed in the Prime Standard of the German stock exchange (ISIN DE0006637200).

Memberships in associations:
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

Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50

External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
Tel: +49 - 40 - 60 91 86 - 18
Fax: +49 - 40 - 60 91 86 -16

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.

Record changed: 2019-08-07


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