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MOLOGEN AG: Top line results from IMPALA study expected in August 2019

DGAP-News: MOLOGEN AG / Key word(s): Study/AGM/EGM

12.07.2019 / 15:28
The issuer is solely responsible for the content of this announcement.

PRESS RELEASE N 11 / 2019 of 07/12/2019

MOLOGEN AG: Top line results from IMPALA study expected in August 2019

Berlin, 12 July 2019 - The Executive Board of biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900 / SIN A2LQ90) ("the Company") today announced that preparations for the read-out of the pivotal phase III study IMPALA are in an advanced stage and thus the top line results are expected to become available in August 2019. The Company wishes to present and discuss these results with the shareholders at the Annual General Meeting, now scheduled for end of August 2019.

Dr Baumann (CMO): "We await the top line results from IMPALA with excitement and high hopes for a positive outcome. This is of course a very important milestone for the Company. With lefitolimod we are pursuing further promising approaches beyond the IMPALA trial, for example in anti-cancer and anti-HIV combination studies. Furthermore, we are confident to be able to advance a molecule from the next-generation technology EnanDIM(R) into clinical development by end of 2019. We are convinced that this strategy will significantly drive the value of our Company."

In order to maximize the chances to be able to discuss the study data and further actions with the shareholders, the Annual General Meeting, originally planned for 22 August 2019, will now be held on 29 August 2019. The invitation to the Annual General Meeting will be published, in accordance with the legal requirements, in the Federal Gazette (Bundesanzeiger) and on the Company's website in due course.

MOLOGEN AG is a biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of infectious diseases.

The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM(R).

The immunotherapeutic agent lefitolimod is the Company's lead compound and is currently being investigated in a pivotal trial. It is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published.
In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-oncology.

MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.

MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.

Claudia Nickolaus

Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 37
Fax: +49 - 30 - 84 17 88 - 50

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.


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Language: English
Fabeckstra├če 30
14195 Berlin
Phone: 030 / 841788-0
Fax: 030 / 841788-50
ISIN: DE000A2LQ900
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 840743

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Last Updated: 12-Jul-2019