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 particular, data were presented on long-term treated patients, some of whom still had no cancer progression for more than 32 - 40 months. Similarly, the final data for the phase I/II ASET renal cancer study with the cancer immunotherapy MGN1601 were presented. The study reported promising results for the overall survival in addition to the excellent safety and tolerability of the compound.
"Our cancer immunotherapy MGN1703 is now right at the start of the pivotal phase III IMPALA study. We are one of the few German biotech companies to have brought a drug into a pivotal study which was self-developed in-house and financed exclusively by our shareholders. The feedback from experts on our research results, the leading oncology experts who support the IMPALA study as investigators, and the broad application of the product – all confirm the blockbuster potential of MGN1703", said Dr. Matthias Schroff, Chairman of the Executive Board of MOLOGEN AG.
Expenses for research and development (R&D) for the first half of 2014 increased to 5.9 million euros and therefore exceeded the value in the same period last year by 3.1 million euros. Decisive factors were mainly the increased material requirements and a higher number of employees in connection with the preparation and initiation of new clinical studies. The net loss for the first half of 2014 amounted to 7.9 million euros, an increase of 3.6 million euros compared to the previous year.
A successful capital increase performed in February led to an increase in available cash and cash equivalents for MOLOGEN AG compared to the first half of 2013. The cash and cash equivalents as of June 30, 2014, amounted to 22.9 million euros and allow for continued solid financing of the company’s current operations.
MOLOGEN confirmed its outlook for 2014 and expects a net loss significantly higher than that of the same period last year. The extensive program of studies leads to higher R&D expenses, which will be reflected accordingly in the annual results.
The relevant documents on the completed first half 2014 are available on the website of MOLOGEN AG via www.mologen.com/en/investor-relations.
About 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 trial). 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.
MOLOGEN AG
Claudia Nickolaus
Head of Investor Relations
Tel: +49 - 30 - 84 17 88 - 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
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