•Patient recruitment progresses for pivotal study on colorectal cancer and phase II trial in small cell lung cancer
• Cooperation with Aarhus University hospital agreed: study on the use of MGN1703 against HIV
•Capital increase with a volume of around € 28 million completed
Berlin, May 12, 2015 – Biotechnology company MOLOGEN AG made progress in the first quarter of 2015 with regard to patient recruitment for its current clinical trials with the MGN1703 immunotherapy, which is the company’s main product candidate. MOLOGEN’s quarterly report, published today, stated a slight decrease in research and development (R&D) expenses. In addition, MOLOGEN reported the successful completion of a capital increase shortly after the end of the reporting period that generated gross proceeds totaling approximately € 28.3 million.
Clinical research program in immuno-oncology advances
In the first three months of the financial year 2015, activities in MOLOGEN’s clinical development program primarily focused on patient recruitment for the two ongoing trials with the MGN1703 immunotherapy. A total of 540 patients are to be included in the pivotal IMPALA study, where MGN1703 is used to treat colorectal cancer. More than 100 research centers in eight European countries will be involved in the study, which is being implemented in cooperation with leading oncologists of international standing.
The IMPULSE phase II trial with MGN1703 in the indication of small cell lung cancer is designed to include 100 patients. Its recruitment phase is to be concluded by the end of this year.
In the first quarter of 2015, research and development results were presented at key international scientific conferences. This included additional data on the safety trial with MGN1703, conducted in the US in 2013. The data and findings presented support the dosage regimen used in the ongoing IMPULSE and IMPALA trials.
HIV patients to receive MGN1703
As part of a cooperation agreement with Aarhus University Hospital in Denmark, the University Hospital will conduct an early phase trial with the MGN1703 immunotherapy involving HIV-infected patients. Aarhus University Hospital has already received funding from the American Foundation for AIDS Research (amfAR). MOLOGEN will make available the study drug MGN1703. The trial is scheduled to start in a few weeks.
Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, stated, “The trial to be conducted at Aarhus University Hospital demonstrates the wide range of possible applications of our MGN1703 immunotherapy. In addition to the field of immuno-oncology, on which our own activities focus, infectious diseases represent another field with substantial potential. We are delighted about this cooperation and look forward to the findings that will be obtained in the study.”
R&D expenses determine trend in EBIT
In the first quarter of 2015, R&D expenses amounted to € 2.4 million and were below the previous year’s figure of € 2.9 million. Accordingly, the loss from operations (EBIT) was reduced from € 4.1 million in the previous year to € 3.2 million in the current reporting period. This development was partly due to the higher cost of materials in the first quarter of 2014. R&D expenses for 2015 as a whole are expected to be higher than in the previous year in view of ongoing progress with the current studies.
Dr. Schroff went on to explain, “Our activities will continue to focus on progressing further with the two oncological trials for our MGN1703 immunotherapy. Although we achieved a minor improvement in our financial results in the first quarter of this year, we still expect R&D expenses to increase over the full year because of the advanced study program. Operating results will reflect this accordingly. Consequently, our forecast for 2015 as a whole remains unchanged.”
Significant increase in cash and cash equivalents following capital increase
At the end of the first quarter of 2015, the company reported cash and cash equivalents totaling € 10.7 million compared with € 13.6 million as of December 31, 2014. After the end of the reporting period, MOLOGEN benefited from an inflow of funds of around € 28 million from the capital increase the company concluded in April 2015.
Outlook for 2015
The outlook for the full year remains unchanged compared with the statements and figures reported when the results for 2014 were published. Patient recruitment for the two ongoing clinical trials, IMPALA and IMPULSE, is to be advanced in the current financial year. The recruitment phase for the IMPULSE small cell lung cancer trial is to be completed by year-end 2015. In view of the advanced status of the study program, a proportionate increase is expected in R&D expenses. This is set to result in a higher loss for the year compared with 2014. The capital increase implemented has secured financing for the next steps in the ongoing IMPULSE and IMPALA trials.
The financial statements for the first quarter of 2015 are available on the company website at www.mologen.com.
About MGN1703
MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN that broadly activates the immune system. This activation can be utilized to enable the immune system to increase the recognition and combat of cancer cells. Due to this mechanism of action, it is predicted that MGN1703 can be applied to a number of diseases.
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 TLR9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and small cell 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.
For more information on the trials please visit www.clinicaltrials.gov.
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.
• Cooperation with Aarhus University hospital agreed: study on the use of MGN1703 against HIV
•Capital increase with a volume of around € 28 million completed
Berlin, May 12, 2015 – Biotechnology company MOLOGEN AG made progress in the first quarter of 2015 with regard to patient recruitment for its current clinical trials with the MGN1703 immunotherapy, which is the company’s main product candidate. MOLOGEN’s quarterly report, published today, stated a slight decrease in research and development (R&D) expenses. In addition, MOLOGEN reported the successful completion of a capital increase shortly after the end of the reporting period that generated gross proceeds totaling approximately € 28.3 million.
Clinical research program in immuno-oncology advances
In the first three months of the financial year 2015, activities in MOLOGEN’s clinical development program primarily focused on patient recruitment for the two ongoing trials with the MGN1703 immunotherapy. A total of 540 patients are to be included in the pivotal IMPALA study, where MGN1703 is used to treat colorectal cancer. More than 100 research centers in eight European countries will be involved in the study, which is being implemented in cooperation with leading oncologists of international standing.
The IMPULSE phase II trial with MGN1703 in the indication of small cell lung cancer is designed to include 100 patients. Its recruitment phase is to be concluded by the end of this year.
In the first quarter of 2015, research and development results were presented at key international scientific conferences. This included additional data on the safety trial with MGN1703, conducted in the US in 2013. The data and findings presented support the dosage regimen used in the ongoing IMPULSE and IMPALA trials.
HIV patients to receive MGN1703
As part of a cooperation agreement with Aarhus University Hospital in Denmark, the University Hospital will conduct an early phase trial with the MGN1703 immunotherapy involving HIV-infected patients. Aarhus University Hospital has already received funding from the American Foundation for AIDS Research (amfAR). MOLOGEN will make available the study drug MGN1703. The trial is scheduled to start in a few weeks.
Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, stated, “The trial to be conducted at Aarhus University Hospital demonstrates the wide range of possible applications of our MGN1703 immunotherapy. In addition to the field of immuno-oncology, on which our own activities focus, infectious diseases represent another field with substantial potential. We are delighted about this cooperation and look forward to the findings that will be obtained in the study.”
R&D expenses determine trend in EBIT
In the first quarter of 2015, R&D expenses amounted to € 2.4 million and were below the previous year’s figure of € 2.9 million. Accordingly, the loss from operations (EBIT) was reduced from € 4.1 million in the previous year to € 3.2 million in the current reporting period. This development was partly due to the higher cost of materials in the first quarter of 2014. R&D expenses for 2015 as a whole are expected to be higher than in the previous year in view of ongoing progress with the current studies.
Dr. Schroff went on to explain, “Our activities will continue to focus on progressing further with the two oncological trials for our MGN1703 immunotherapy. Although we achieved a minor improvement in our financial results in the first quarter of this year, we still expect R&D expenses to increase over the full year because of the advanced study program. Operating results will reflect this accordingly. Consequently, our forecast for 2015 as a whole remains unchanged.”
Significant increase in cash and cash equivalents following capital increase
At the end of the first quarter of 2015, the company reported cash and cash equivalents totaling € 10.7 million compared with € 13.6 million as of December 31, 2014. After the end of the reporting period, MOLOGEN benefited from an inflow of funds of around € 28 million from the capital increase the company concluded in April 2015.
Outlook for 2015
The outlook for the full year remains unchanged compared with the statements and figures reported when the results for 2014 were published. Patient recruitment for the two ongoing clinical trials, IMPALA and IMPULSE, is to be advanced in the current financial year. The recruitment phase for the IMPULSE small cell lung cancer trial is to be completed by year-end 2015. In view of the advanced status of the study program, a proportionate increase is expected in R&D expenses. This is set to result in a higher loss for the year compared with 2014. The capital increase implemented has secured financing for the next steps in the ongoing IMPULSE and IMPALA trials.
The financial statements for the first quarter of 2015 are available on the company website at www.mologen.com.
About MGN1703
MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN that broadly activates the immune system. This activation can be utilized to enable the immune system to increase the recognition and combat of cancer cells. Due to this mechanism of action, it is predicted that MGN1703 can be applied to a number of diseases.
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 TLR9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and small cell 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.
For more information on the trials please visit www.clinicaltrials.gov.
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.
