DGAP-News: MOLOGEN AG further advances product pipeline - half-year figures presented
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Half Year Results
MOLOGEN AG further advances product pipeline - half-year figures
presented
14.08.2013 / 08:00
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PRESS RELEASE N 7 / 2013 of 08/14/2013
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.
Key data
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: EUR 23.8 million).
Executive Board
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.
Supervisory Board
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.
Outlook
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.
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(R), dSLIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG.
MOLOGEN AG
PRESS SERVICE:
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
huebner(at)mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50
investor(at)mologen.com
External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
Tel: +49 - 40 - 60 91 86 - 18
Fax: +49 - 40 - 60 91 86 -16
sebastian.bucher(at)kirchhoff.de
Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
planned or future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.
End of Corporate News
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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: info(at)mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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