• Start of patient enrolment for IMPALA (phase III) colorectal cancer study
• New generation of immunomodulators introduced for the first time
•Financial situation remains stable
Berlin, 13 November 2014 – The biotechnology company MOLOGEN AG today presented its nine month report for 2014. Considerable progress has been made in the clinical development of the cancer immunotherapy MGN1703. This included the launch of a randomized trial in the area of small cell lung cancer as well as a phase III pivotal study in the field of colorectal cancer. In addition, the company presented EnanDIM, a new generation of immunomodulators, to the scientific community for the first time at the beginning of October 2014. These advancements are reflected in the increased expenses for research and development activities.
“We have reached a key milestone in the clinical development of our lead product candidate MGN1703,” comments Dr Matthias Schroff, CEO of MOLOGEN. “In the third quarter, our company has started the treatment of first patients in the IMPALA study, which is our pivotal study for colorectal cancer.”
The IMPALA study will include 540 patients from eight European countries. The study is being conducted in cooperation with globally renowned oncology experts as investigators.
Patient enrolment for the randomized IMPULSE study, which was launched at the end of the first quarter, continues. The study is investigating the efficacy of MGN1703 in the indication of small cell lung cancer.
EnanDIM: a new generation of immunomodulator
In October 2014, MOLOGEN presented preclinical data for the immunotherapy EnanDIM for the first time. This new generation of active agent is expected to trigger a broad immune activation while at the same time being well tolerated. “We are filling our pipeline from the bottom up, and in doing so we are demonstrating the innovative strength of our research and our good position in the promising field of immunotherapy,” explains Dr Schroff.
MGN1601, a therapeutic vaccine against renal cancer, is a further product candidate in clinical development. In the third quarter, data from a completed clinical phase I/II trial (ASET) on MGN1601 was presented at the international ESMO Congress (European Society for Medical Oncology).
Research expenses have increased due to the ongoing studies.
The interim report of MOLOGEN as of September 30, 2014 accounts for the extensive work on the study program and at the same time reflects the sound financial situation. As expected, expenses for research and development (R&D) increased over the first nine months of 2014, to 10.5 million Euros. In the previous year the amount of 4.5 million Euros had been invested. This rise reflects the enhanced efforts for the preparation and initiation of clinical trials, with a view to making further progress for the product candidates. The higher R&D expenses have resulted in a corresponding loss of 13.3 million Euros for the reporting period (same period of the previous year: -6.8 million Euros).
MOLOGEN continues to have stable finances as a result of a capital increase that was implemented in February. As at the end of third quarter of 2014, MOLOGEN AG had cash and cash equivalents of around 18 million Euros.
The nine month report published today confirms our forecast for the year as a whole, as stated in previous quarterly reports. The Executive Board is expecting the net loss for the year to be considerably above the comparable figure for the previous year on account of the increased R&D investments. The complete MOLOGEN report as of September 30, 2014 can be found online at: http://www.mologen.com/de/investoren-presse.html.
MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immune therapies and DNA vaccines against infectious diseases.
The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 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.
With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies.
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.
www.mologen.com
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 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Help employers find you! Check out all the jobs and post your resume.
• New generation of immunomodulators introduced for the first time
•Financial situation remains stable
Berlin, 13 November 2014 – The biotechnology company MOLOGEN AG today presented its nine month report for 2014. Considerable progress has been made in the clinical development of the cancer immunotherapy MGN1703. This included the launch of a randomized trial in the area of small cell lung cancer as well as a phase III pivotal study in the field of colorectal cancer. In addition, the company presented EnanDIM, a new generation of immunomodulators, to the scientific community for the first time at the beginning of October 2014. These advancements are reflected in the increased expenses for research and development activities.
“We have reached a key milestone in the clinical development of our lead product candidate MGN1703,” comments Dr Matthias Schroff, CEO of MOLOGEN. “In the third quarter, our company has started the treatment of first patients in the IMPALA study, which is our pivotal study for colorectal cancer.”
The IMPALA study will include 540 patients from eight European countries. The study is being conducted in cooperation with globally renowned oncology experts as investigators.
Patient enrolment for the randomized IMPULSE study, which was launched at the end of the first quarter, continues. The study is investigating the efficacy of MGN1703 in the indication of small cell lung cancer.
EnanDIM: a new generation of immunomodulator
In October 2014, MOLOGEN presented preclinical data for the immunotherapy EnanDIM for the first time. This new generation of active agent is expected to trigger a broad immune activation while at the same time being well tolerated. “We are filling our pipeline from the bottom up, and in doing so we are demonstrating the innovative strength of our research and our good position in the promising field of immunotherapy,” explains Dr Schroff.
MGN1601, a therapeutic vaccine against renal cancer, is a further product candidate in clinical development. In the third quarter, data from a completed clinical phase I/II trial (ASET) on MGN1601 was presented at the international ESMO Congress (European Society for Medical Oncology).
Research expenses have increased due to the ongoing studies.
The interim report of MOLOGEN as of September 30, 2014 accounts for the extensive work on the study program and at the same time reflects the sound financial situation. As expected, expenses for research and development (R&D) increased over the first nine months of 2014, to 10.5 million Euros. In the previous year the amount of 4.5 million Euros had been invested. This rise reflects the enhanced efforts for the preparation and initiation of clinical trials, with a view to making further progress for the product candidates. The higher R&D expenses have resulted in a corresponding loss of 13.3 million Euros for the reporting period (same period of the previous year: -6.8 million Euros).
MOLOGEN continues to have stable finances as a result of a capital increase that was implemented in February. As at the end of third quarter of 2014, MOLOGEN AG had cash and cash equivalents of around 18 million Euros.
The nine month report published today confirms our forecast for the year as a whole, as stated in previous quarterly reports. The Executive Board is expecting the net loss for the year to be considerably above the comparable figure for the previous year on account of the increased R&D investments. The complete MOLOGEN report as of September 30, 2014 can be found online at: http://www.mologen.com/de/investoren-presse.html.
MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immune therapies and DNA vaccines against infectious diseases.
The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 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.
With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies.
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.
www.mologen.com
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 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Help employers find you! Check out all the jobs and post your resume.
