DGAP-News: MOLOGEN AG / Key word(s): 9-month figures
MOLOGEN AG: Q3 2015 defined by study progress (news with additional
features)
12.11.2015 / 06:55
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PRESS RELEASE N 19 / 2015 of 11/12/2015
MOLOGEN AG: Q3 2015 defined by study progress
- Patient recruitment for lung cancer and HIV studies completed
- R&D expenses were on a par with reference period
- Outlook for 2015 unchanged
Berlin, 12 November 2015 - In the first nine months of 2015, the
biotechnology company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock
Exchange Prime Standard: MGN) achieved significant progress in its study
program with lead product immunotherapy MGN1703. By completing patient
recruitment for the randomized IMPULSE study (indication small cell lung
cancer) and the phase I cooperative study TEACH (indication HIV), the
company has reached a significant milestone in the development of MGN1703.
Patient enrollment for the pivotal IMPALA study (colorectal cancer)
proceeded in line with expectations. As in the same period of the previous
year, research and development expenses totaling EUR 10.4 million were
reported today for the first nine months of the 2015 financial year. In
view of the operational developments, the outlook for the year as a whole
has been confirmed.
Two recruitment phases completed successfully
MOLOGEN's research and development (R&D) activities in the third quarter of
2015 were above all influenced by three ongoing clinical trials for
MGN1703: the pivotal IMPALA study (indication colorectal cancer), the
randomized IMPULSE study (indication small cell lung cancer) and the
cooperative study TEACH (indication HIV). At the end of October 2015, the
IMPULSE study had recruited the required number of patients, 100. Patient
enrollment for the TEACH study was also completed in September 2015. The
recruitment of up to 540 colorectal cancer patients for the much larger
pivotal IMPALA study progressed well in the third quarter and is set to be
concluded in the second half of 2016.
CEO of MOLOGEN AG, Dr. Mariola Söhngen: "All ongoing clinical trials are
progressing well and we remain confident of achieving our targets within
the planned time frame. We are still predicting a rise in R&D expenses for
the year as a whole, which was already taken into account in our outlook
for 2015." Dr. Söhngen has been in her role as CEO since 1 November 2015.
In the third quarter, updated data from a patient subgroup in the completed
phase II IMPACT study was presented at the European Cancer Congress (ECC
2015) in Vienna, Austria. At the time of the evaluation in August 2015, the
long-term progression-free survival (PFS) of this subgroup was between 47
and 55 months.
R&D expenditure on a par with reference period
In the first nine months of the 2015, MOLOGEN AG spent EUR 10.4 million on
research and development. R&D expenditure is therefore on a similar level
to the same period of the previous year. Accordingly, the operating result
(EBIT) was EUR -13.3 million, unchanged from the reference period.
On account of the capital increase totaling approximately EUR 28 million
carried out in April 2015, cash and cash equivalents amounted to EUR 30.5
million as at September 30, 2015. The company projects that this will be
sufficient to finance the continuation of current research and study
programs up to the end of 2016 at least.
Outlook for the financial year unchanged
MOLOGEN AG confirms its outlook for the 2015 financial year. In view of the
progress made in ongoing study programs, a significant year-on-year
increase in R&D expenses is still expected for the 2015 financial year.
This will lead to a higher net loss for 2015.
The complete MOLOGEN AG report dated September 30, 2015 is available at our
website: www.mologen.com.
MOLOGEN AG
With new and unique technologies and active substances, the biotech company
MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a
focus on immuno-oncology, MOLOGEN also develops immunotherapies for the
treatment of infectious diseases.
The cancer immunotherapy MGN1703 is the company's lead product and
best-in-class TLR9 agonist. Treatment with MGN1703 triggers a broad and
strong activation of the immune system. Due to this mechanism of action,
MGN1703 has the potential to be applied to various indications. MGN1703 is
currently being developed for first-line maintenance treatment of
colorectal cancer (pivotal study) and small cell lung cancer (randomized
controlled trial). Furthermore it is also being investigated in a phase I
study in HIV.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat
diseases for which there is a high medical need.
MOLOGEN AG is listed on the stock exchange and its headquarters are located
in Berlin, Germany.
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), EnanDIM(R) and MOLOGEN(R) are registered trademarks of
MOLOGEN AG.
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
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.
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Additional features:
Document: http://n.equitystory.com/c/fncls.ssp?u=VJNKRNHKFM
Document title: MOLOGEN AG: Q3 2015 defined by study progress
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12.11.2015 Dissemination of a Corporate News, transmitted by DGAP - a
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Language: English
Company: MOLOGEN AG
FabeckstraÃe 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart
End of News DGAP News Service
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412103 12.11.2015
DGAP-News: MOLOGEN AG: Q3 2015 defined by study progress (news with additional features)
| Source: EQS Group AG