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MOLOGEN AG: 2013 annual financial statements submitted - pivotal study for MGN1703 under preparation - Seite 2
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
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
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