DGAP-News: MOLOGEN AG: Q3 2015 defined by study progress

DGAP-News: MOLOGEN AG / Key word(s): 9-month figures MOLOGEN AG: Q3 2015 defined by study progress (news with additional features) 12.11.2015 / 06:55 --------------------------------------------------------------------- PRESS RELEASE N 19 / 2015 of 11/12/2015 MOLOGEN AG: Q3 2015 defined by study progress - Patient recruitment for lung cancer and HIV studies completed - R&D expenses were on a par with reference period - Outlook for 2015 unchanged Berlin, 12 November 2015 - In the first nine months of 2015, the biotechnology company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) achieved significant progress in its study program with lead product immunotherapy MGN1703. By completing patient recruitment for the randomized IMPULSE study (indication small cell lung cancer) and the phase I cooperative study TEACH (indication HIV), the company has reached a significant milestone in the development of MGN1703. Patient enrollment for the pivotal IMPALA study (colorectal cancer) proceeded in line with expectations. As in the same period of the previous year, research and development expenses totaling EUR 10.4 million were reported today for the first nine months of the 2015 financial year. In view of the operational developments, the outlook for the year as a whole has been confirmed. Two recruitment phases completed successfully MOLOGEN's research and development (R&D) activities in the third quarter of 2015 were above all influenced by three ongoing clinical trials for MGN1703: the pivotal IMPALA study (indication colorectal cancer), the randomized IMPULSE study (indication small cell lung cancer) and the cooperative study TEACH (indication HIV). At the end of October 2015, the IMPULSE study had recruited the required number of patients, 100. Patient enrollment for the TEACH study was also completed in September 2015. The recruitment of up to 540 colorectal cancer patients for the much larger pivotal IMPALA study progressed well in the third quarter and is set to be concluded in the second half of 2016. CEO of MOLOGEN AG, Dr. Mariola Söhngen: "All ongoing clinical trials are progressing well and we remain confident of achieving our targets within the planned time frame. We are still predicting a rise in R&D expenses for the year as a whole, which was already taken into account in our outlook for 2015." Dr. Söhngen has been in her role as CEO since 1 November 2015. In the third quarter, updated data from a patient subgroup in the completed phase II IMPACT study was presented at the European Cancer Congress (ECC 2015) in Vienna, Austria. At the time of the evaluation in August 2015, the long-term progression-free survival (PFS) of this subgroup was between 47 and 55 months. R&D expenditure on a par with reference period In the first nine months of the 2015, MOLOGEN AG spent EUR 10.4 million on research and development. R&D expenditure is therefore on a similar level to the same period of the previous year. Accordingly, the operating result (EBIT) was EUR -13.3 million, unchanged from the reference period. On account of the capital increase totaling approximately EUR 28 million carried out in April 2015, cash and cash equivalents amounted to EUR 30.5 million as at September 30, 2015. The company projects that this will be sufficient to finance the continuation of current research and study programs up to the end of 2016 at least. Outlook for the financial year unchanged MOLOGEN AG confirms its outlook for the 2015 financial year. In view of the progress made in ongoing study programs, a significant year-on-year increase in R&D expenses is still expected for the 2015 financial year. This will lead to a higher net loss for 2015. The complete MOLOGEN AG report dated September 30, 2015 is available at our website: www.mologen.com. MOLOGEN AG With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases. The cancer immunotherapy MGN1703 is the company's lead product and best-in-class TLR9 agonist. Treatment with MGN1703 triggers a broad and strong activation of the immune system. Due to this mechanism of action, MGN1703 has the potential to be applied to various indications. MGN1703 is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore it is also being investigated in a phase I study in HIV. MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need. MOLOGEN AG is listed on the stock exchange and its headquarters are located in Berlin, Germany. 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(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) 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. +++++ Additional features: Document: http://n.equitystory.com/c/fncls.ssp?u=VJNKRNHKFM Document title: MOLOGEN AG: Q3 2015 defined by study progress --------------------------------------------------------------------- 12.11.2015 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- Language: English Company: MOLOGEN AG Fabeckstraße 30 14195 Berlin Germany Phone: 030 / 841788-0 Fax: 030 / 841788-50 E-mail: presse@mologen.com Internet: www.mologen.com ISIN: DE0006637200 WKN: 663720 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service --------------------------------------------------------------------- 412103 12.11.2015