MOLOGEN AG further advances product pipeline – half-year figures presented
• Final evaluation of colorectal cancer study with MGN1703 confirms positive preliminary results
• Result for the period in the amount of -4.2 million euros
Berlin, August 14, 2013 – MOLOGEN AG looks at the results achieved from the research and development work with great confidence and enters the second half of the financial year with a continuous good financial basis.
As the Berlin biotechnology company announced today with the presentation of the half-year report, it has been able to successfully clear another hurdle toward marketability through the final evaluation of the phase II colorectal cancer clinical study with the most advanced product candidate, MGN1703. The key financial performance indicators as of June 30, 2013, show a loss as planned of 4.2 million euros. At the same time, cash and cash equivalents in the amount of 19.9 million euros give the company a solid financial basis.
MGN1703 study results
The results of the final evaluation of the colorectal cancer study with MGN1703 completely confirm the promising preliminary efficacy data. In addition, some of the total of 59 colorectal cancer patients treated showed extremely long response times to the treatment with MGN1703.
“A long-lasting response is rather unusual for conventional chemotherapeutic cancer treatment. However, such effects are being increasingly observed worldwide with therapies that focus on activating the immune system. This and, of course, our own results for MGN1703 are encouraging us in our immunotherapeutic approach, which we follow with all our product candidates,” said Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG.
The final evaluation of the IMPACT study with MGN1703 was presented, among others, to experts at the ESMO World Congress on Gastrointestinal Cancer 2013. The corresponding abstract was classified there as “one of the most noteworthy works.”
Parallel to this, MOLOGEN continued its out-licensing activities with this very promising product candidate during the first six months of 2013.
Additional research activities
In addition to the concrete scientific results on MGN1703, MOLOGEN worked on the final evaluation of the phase I/II study (ASET study) in the indication of renal cancer with the second product candidate, MGN1601, during the first six months of 2013.The company expects the final data in the coming weeks.
Preparations for a new phase II study with MGN1703 in the indication lung cancer and the approval for a phase I study with MGN1404 in the indication skin cancer as part of the cooperation with Charité-Universitaetsmedizin Berlin and the Max Delbrueck Centrum Berlin also took place during the reporting period.
At 0.2 million euros, MOLOGEN AG’s revenue for the first half of 2013, although higher than the 0.1 million euros in the first half of 2012, was at a low level, as expected. R&D expenses totaled 2.8 million euros and were thus at the level of the same period of the previous year. The augmentation of the Executive Board by a Chief Medical Officer, additional employees, stock option expenditures and other measures led to an increase in personnel costs in the reporting period compared to the previous year of 0.4 million euros, to approximately 2.0 million euros. This, as well as a slight increase in other operating expenses and lower other operating income allowed the loss for the period grow larger by 0.4 million euros compared to the comparable 2012 value, to -4.2 million euros. As of June 30, 2013, cash and cash equivalents totaled approximately 19.9 million euros (12/31/12: 23.8 million euros).
In April 2013, Alfredo Zurlo, M.D., joined the Executive Board of MOLOGEN AG. He is an oncologist with recognized expertise in the areas of drug development, regulation and execution of clinical trials. As Chief Medical Officer, Alfredo Zurlo is responsible for the strategy and design of the clinical development programs and the management of current and future clinical studies of MOLOGEN.
After the end of the reporting period, Mr. Stefan ten Doornkaat was appointed as a new member of the Supervisory Board, after Dr. Mathias P. Schlichting, who was chairman of the Supervisory Board for many years, resigned for health reasons. The Supervisory Board elected Mr. Gregor Kunz as its new chairman.
The company will continue to use the established objectives as a starting point for the ongoing 2013 financial year. These primarily include the continuation of the clinical development programs for product candidates MGN1703 and MGN1601. The activities and investments that are necessary for this will continue to encumber short-term earnings growth in 2013 and 2014. With this in mind, MOLOGEN continues to expect a net annual loss and expects the loss to grow larger for 2013 in particular. In the area of cooperations and partnerships, MOLOGEN is seeking to finalize a licensing agreement for the cancer drug MGN1703 with a partner from the pharmaceutical industry.
About MOLOGEN AG
MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company’s most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development.
With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies.
MOLOGEN AG shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.
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)
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Prof. Peter W. Huebner
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Posted: August 2013