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MOLOGEN AG: Preparation and launch of new studies characterized the first half-year 2014

DGAP-News: MOLOGEN AG / Key word(s): Half Year Results
MOLOGEN AG: Preparation and launch of new studies characterized the
first half-year 2014

13.08.2014 / 07:00

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MOLOGEN AG: Preparation and launch of new studies characterized the first
half-year 2014

- Application process initiated for phase III colorectal cancer study
with MGN1703

- IMPULSE lung cancer study with MGN1703 started

- Increased expenses for research and development with continued solid
liquidity position

- Forecast for 2014 confirmed


Berlin, August 13, 2014 - The first half of 2014 of MOLOGEN AG was
characterized by expanded research and development activities. In
particular, the clinical development program for cancer immunotherapy
MGN1703 in the indications of colorectal cancer and lung cancer was
associated with significantly increased spending on research and
development. The phase III IMPALA colorectal cancer study was applied for
in eight European countries. Furthermore, the randomized IMPULSE lung
cancer study was started and patients are currently being enrolled. In the
first half of 2014, expenses for research and development amounted to 5.9
million euros. Together with the additional funds from the capital increase
performed in the first quarter of 2014, the Berlin-based biotech company
has cash in the amount of 22.9 million euros as of June 30, 2014. MOLOGEN
confirms its outlook for the current financial year.

The approval process for the IMPALA pivotal study, assessing in eight
European countries the efficacy of MGN1703 in patients with metastatic
colorectal cancer, was initiated in the second quarter of 2014. First
approvals in the countries involved have already been granted at the time
of today's publication of the interim report.

The IMPULSE study, aiming to explore the efficacy of MGN1703 in a different
tumor type, has already begun recruitment of patients with an aggressive
form of lung cancer- the so-called small cell lung cancer. The primary
endpoint of the randomized study is overall survival.

In addition, the final evaluation of the study conducted on healthy
volunteers in the USA has been submitted to the FDA. The collaboration
partners Charité Universitätsmedizin and Max-Delbrueck-Center for Molecular
Medicine are also continuing the phase I study with the product candidate
MGN1404 in the indication of malignant melanoma.

Further clinical data from the phase II IMPACT colorectal cancer study with
MGN1703 were presented at medical conferences with great success. In