DGAP-News

MOLOGEN AG: New strategic orientation, successful capital measures and notable study progress in 2016 - Seite 2

Dr. Mariola Söhngen, Chief Executive Officer (CEO) of MOLOGEN AG: "For MOLOGEN, 2016 was an eventful and at the same time good year in which we laid the foundations for our future success: with our new "Next Level" corporate strategy, we have set a clear strategic course that will enable us in future to adopt a new positioning as a product-oriented company with a strong lead product, our immunotherapeutic agent lefitolimod. Our principal objective is to prepare lefitolimod for possible market entry. To this end, we pressed on with approval preparation and held further discussions with potential partners. In the past year, we made further significant progress in our clinical studies with lefitolimod. Through the two capital measures in 2016 and the issuance of a second convertible bond in January 2017, we have been able to secure our funding into 2018. On the personnel side, we have gained two extremely experienced and competent new Executive Board members in Walter Miller for the position of CFO and now also Dr. Matthias Baumann as a new CMO. They will both make a positive contribution to advancing the development of the company."

Broad application spectrum for lefitolimod

In the wake of a comprehensive portfolio review, MOLOGEN introduced its new "Next Level" strategy in June 2016. Its aim is the further development of MOLOGEN, shifting the focus of the company from just R&D to a strong product and market orientation, with a particular spotlight on the TLR9 product family with the lead product candidate lefitolimod. The company's primary objective is the out-licensing of lefitolimod. Accordingly, the principal focus is on the four clinical trials with lefitolimod that are being conducted at present: IMPALA, IMPULSE and TEACH in the indications colorectal cancer, small-cell lung cancer and HIV as well as the combination study with the immunotherapy Yervoy^(R) (ipilimumab) in patients with advanced solid tumors.

In 2016, considerable progress was made in terms of patient recruitment for the phase III IMPALA pivotal study. Around 540 patients from approximately 120 centers in eight European countries, including the five largest European pharmaceutical markets, will participate in the study. The intention is to complete patient recruitment in the first few months of 2017. The evaluation of the study is expected to begin around two years after the end of patient enrollment.