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Mologen AG. (3/25/14). "Press Release: 2013 Annual Financial Statements Submitted – Pivotal Study for MGN1703 Under Preparation. For the First Time Three Product Candidates in Clinical Development Phase".

Organisations Organisation Mologen AG
  Group Mologen (Group)
  Organisation 2 Charité – Universitätsmedizin Berlin (Charité University Hospital)
  Group Humboldt University Berlin
Products Product lefitolimod (MGN1703)
  Product 2 MGN1601 (Mologen)
Persons Person Schroff, Matthias (Vaximm 201609– CEO before Mologen CEO)
  Person 2 Petraß, Jörg (Mologen –201512 CFO LEFT 12/15)
     


> For the first time three product candidates in clinical development phase

> Final evaluations of the clinical trials provide positive data

> Cash consumption at level of previous year despite increased research activity

> Clinical phase III study for cancer immunotherapy MGN1703 is being prepared


MOLOGEN AG completed a successful financial year 2013 with three different product candidates in clinical development for the first time. The final evaluations for the completed clinical trials of MGN1703 and MGN1601 provided very positive data, and with MGN1404 (a product that combats malignant melanoma) the clinical development phase of another product candidate was launched within the framework of a cooperation and is therefore contributing to an expansion of the pipeline.

The company closed the financial year 2013 with a net loss of 10.8 million euros, 7.9 million euros of which accounted for research and development costs. On the reporting date as of December 31, 2013, MOLOGEN AG had liquid funds in the total amount of 14.8 million euros. An additional 15.7 million euros could be raised with the capital increase carried out in February 2014. MOLOGEN's financial position is therefore solid in terms of the planned research projects.

Research results confirm the potential of products - pivotal study being prepared

After launching a clinical phase I study in October 2013 in cooperation with institutions of the Charité Universitätsmedizin and the Max Delbrück Center, MOLOGEN's pipeline now contains three product candidates in clinical development in the field of cancer immunotherapies: MGN1703, MGN1601 and new MGN1404. While MGN1404 is currently being tested in the malignant melanoma indication, the final evaluations of the completed clinical trials of MGN1601 and MGN1703 could be presented in financial year 2013.

MOLOGEN was able to confirm the preliminary data collected from the phase I/II trials with MGN1601 in the indication of renal cancer (ASET study). The results showed a good safety and tolerability for this therapeutic cancer vaccine, meaning that the primary study endpoint was achieved. In addition, the promising data in terms of the overall survival of patients in a subgroup exceeded the expectations.

With MOLOGEN's most advanced product candidate, the cancer immunotherapy MGN1703, very positive clinical data from the final evaluation of a phase II trial in the indication of colorectal cancer (IMPACT study) was also able to be presented in 2013. In addition to the convincing results for progression-free survival immunological biomarkers were also analyzed. This resulted in valuable scientific findings with regard to the further development of MGN1703, for example, on the question of which patients could benefit from a treatment. Overall, the final evaluation provided evidence of the efficacy of MGN1703 together with an exceptionally good tolerability. The preparations for a phase III pivotal study in this indication were completed for the most part in the course of the last financial year.

At the same time, an application was made in 2013 for a phase II trial using the same product in the indication of small cell lung cancer (IMPULSE study), another cancer with a high demand for medical treatment. That could extend the scope of application of MGN1703 in addition to colorectal cancer.

Towards the end of the financial year a safety study with MGN1703 was also conducted in the United States, and its treatment phase was concluded. The study forms the basis for also being able to promote the further clinical development of MGN1703 in parallel in the United States.

Finances

In financial year 2013 sales remained at a low level of 0.2 million euros (2012: 0.1 million euros). Since, as expected, no subsidies were able to be collected or realized in 2013, no significant additional other income was recorded (2012: 0.3 million euros). On the costs side the expenses for research and development increased to 7.9 million euros (2012: 6.0 million euros). This is essentially due to higher costs of materials, which are incurred in connection with the preparation and implementation of the clinical trials, as well as to an increase in personnel costs. However, the average cash consumption rate was able to remain stable. At 0.75 million euros per month, the 2013 value was on a par with the level of the previous year (2012: 0.74 million euros). Overall, the annual net loss increased to 10.8 million euros and was therefore around 2.8 million euros higher than in the previous year.

With 14.8 million euros as of December 31, 2013, the liquid funds at MOLOGEN AG were lower than those of the previous year (2012: 23.8 million euros). In February 2014 the company was also able to receive gross proceeds of 15.7 million euros through a capital increase.

Outlook

MOLOGEN is planning to submit an application for a pivotal phase III study in colorectal cancer with MGN1703 to the competent authorities in 2014 (IMPALA study). Should the necessary permits be granted in due time, the company expects to begin this study in the current year. At the same time, discussions are ongoing with regard to an outlicensing for this product candidate.

In addition, MOLOGEN is planning the launch of the IMPULSE study for 2014, a randomized and controlled study with MGN1703 in small cell lung cancer. Planning and preparation of an advanced clinical trial for MGN1601 is also scheduled.

As a result of these research activities, MOLOGEN assumes that there will be a significant increase in the costs of research and development and the associated outflow of liquid funds in financial year 2014. Overall, the Executive Board expects another negative annual result. A possible out-licensing of the drug candidate MGN1703 is not taken into consideration in this scenario and could have significant positive effects on results and on the liquidity situation.

Dr. Matthias Schroff, chairman of the Executive Board of MOLOGEN AG says, "Due to the results we presented relating to the study of our cancer immunotherapy MGN1703 in the application against colorectal cancer, which were also well-received in professional circles, we have great faith in the pivotal study for this product candidate. MOLOGEN is therefore one of the few biotech companies in Germany which is able to bring a product into a phase III study completely independently. In addition, the MOLOGEN pipeline contains other drug candidates, particularly in the field of cancer immunotherapies, which all have a large market potential. Against this background, we are very confident with regard to the current financial year 2014."

The complete 2013 annual report of MOLOGEN AG is available for download from the company's website: www.mologen.com/en/investor-relations/publications/financial-reports.html [geholt als AR via http://www.mologen.com/fileadmin/user_upload/Berichte/EN/MOLOGEN_GB2013_EN.pdf ; ML]


About MOLOGEN AG

MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company's most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development.

With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies.

MOLOGEN AG shares (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®, EnanDIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.


MOLOGEN AG

PRESS SERVICE:
Prof. h.c. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
huebner@mologen.com

INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com

External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
Tel: +49 - 40 - 60 91 86 - 18
Fax: +49 - 40 - 60 91 86 -16
sebastian.bucher@kirchhoff.de


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: 2017-04-02

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