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Mologen AG. (3/25/15). "Press Release: Start of Pivotal Study for Cancer Immunotherapy MGN1703 Influences 2014 Annual Result".

Organisation Organisation Mologen AG
  Group Mologen (Group)
Products Product lefitolimod (MGN1703)
  Product 2 clinical research
  Index term 2 Mologen–SEVERAL: investment, 201402 capital increase €15.7m gross proceeds 1,541,244 shares €10.2/share
Person Person Schroff, Matthias (Vaximm 201609– CEO before Mologen CEO)
     


> Two studies with MGN1703 launched in fiscal year 2014: pivotal study in indication colorectal cancer and phase II study in indication small cell lung cancer

> Increase in R&D expenditure impacts annual result


Biotechnology company MOLOGEN is today publishing its annual results for fiscal year 2014. The company achieved significant progress in the ongoing development of its cancer immunotherapies. In the past financial year, two studies were started with the lead product candidate MGN1703: the IMPALA pivotal study in the indication colorectal cancer and a phase II IMPULSE trial in the indication small cell lung cancer. The net loss for the year of € 17.1 million was essentially attributable to the increase in expenses for research and development (R&D) as a result of these studies. The additional funding requirement was met by a capital increase of around € 16 million carried out in February 2014.


Start of IMPALA pivotal study

In September 2014, treatment of the first patient in the phase III IMPALA study started and further patients have since been enrolled in the study. The trial is expected to recruit about 540 patients from more than 100 study centers in eight European countries and is being conducted in cooperation with leading oncology experts.

"The start of the IMPALA pivotal study was a key milestone for MOLOGEN. Patient enrollment for both this study and the IMPULSE study is now our top priority. Our investigators are established international experts in the field of oncology and will be providing valuable support," comments Dr. Matthias Schroff, Chief Executive Officer (CEO) of MOLOGEN AG.


High impact at international scientific conferences

In fiscal year 2014, MOLOGEN presented a range of data on the company's different product candidates at international scientific conferences. The final data on the clinical phase I trial conducted in the USA confirmed the safety and tolerability of MGN1703 and has enabled MOLOGEN to expand the study program to the USA. The latest data from the concluded phase II study with MGN1703 for the treatment of metastatic colorectal cancer was also presented in 2014. This provided evidence of an exceptionally long positive response to therapy in a subgroup of study patients. In addition, MOLOGEN's final data from a phase I/II clinical study for MGN1601, the cell-based immunotherapy against renal cancer, was able to confirm the extremely good tolerability and safety of the drug. Furthermore, the company presented promising results for overall survival observed in a subgroup of patients treated with MGN1601. MOLOGEN also introduced a new generation of active agents under the name EnanDIM to the scientific community in 2014. This new molecule is part of the class of linear TLR9 agonists and, as is the case with MGN1703, triggers a broad immune activation. With EnanDIM, MOLOGEN is expanding its product pipeline in the field of cancer therapies and anti-infectives.


Rise in R&D expenditure due to start of new MGN1703 studies

The annual result for fiscal year 2014 was impacted by the strong increase in research and development expenses. It amounted to € -17.1 million in 2014, compared with € -10.8 million in 2013. R&D expenditure amounted to € 13.3 million (previous year: € 7.9 million) due to the start of the IMPALA and IMPULSE studies. As in the previous year, no significant sales or other operating income were reported in the annual financial statements.

In the past financial year, the development of liquid funds was influenced by higher R&D expenditure and the inflow of around € 15.7 million as a result of a capital increase in February 2014. As of December 31, 2014, liquid funds amounted to € 13.6 million and were therefore only slightly below the prior year's value of € 14.8 million.


Outlook for 2015

Activity will still be focused on the clinical development programs for MGN1703. While patient enrolment for the IMPALA pivotal study will continue in the current fiscal year, the aim is to conclude patient enrollment for the IMPULSE study. As a result, the company is expecting R&D expenses to increase considerably. In view of this, MOLOGEN is predicting that the net loss for the year in 2015 will be significantly higher than the comparative value for 2014. R&D activities will be funded through cash inflow from the capital increase which was resolved yesterday.

The 2014 annual financial statements are available online under www.mologen.com.


MOLOGEN AG

MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immunotherapies and DNA vaccines against infectious diseases.

The cancer immunotherapy MGN1703 is the company’s lead product and best-in-class TLR9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.

For more information on the trials please visit: www.clinicaltrials.gov.

With unique, patented technologies and innovative products, MOLOGEN is pioneering immunotherapies.

MOLOGEN AG is a publicly listed company, headquartered in Berlin. The 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.


Contact

Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com


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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