MOLOGEN AG: first half of 2015 defined by study progress and capital increase

  • Progress in the colorectal and lung cancer study; partner starts HIV study with lead product MGN1703
  • Cash inflow of € 28.3 million following capital increase
  • Forecast for 2015 financial year confirmed
  • Dr. Mariola Söhngen appointed as new Chief Executive Officer (CEO); further changes in Executive Board
  • Oliver Krautscheid re-elected as member and Chairman of the Supervisory Board

In the first half of 2015, the operating activities of the biotech company MOLOGEN AG essentially focused on the study program with the lead product, immunotherapy MGN1703. Patient enrollment for the pivotal IMPALA study (colorectal cancer) and the phase II IMPULSE study (small cell lung cancer) continued in line with expectations. Furthermore, the Danish Aarhus University Hospital started the cooperative study with a phase I TEACH clinical trial for the treatment of HIV (Human Immunodeficiency Virus) in June 2015. The company received gross proceeds of € 28.3 million through a capital increase, which was successfully carried out in April 2015. The outlook for the 2015 financial year has been confirmed. Shortly after the end of the reporting period, MOLOGEN announced the appointment of Dr. Mariola Söhngen as the new Chief Executive Officer (CEO), with effect from November 1, 2015. At this year’s MOLOGEN Annual General Meeting, Oliver Krautscheid was re-elected as a member of the Supervisory Board. 

Progress was made in the enrollment of patients for studies with lead product MGN1703 

MOLOGEN’s lead product, immunomodulator MGN1703, is currently being tested in three clinical trials for different indications. All three studies are in the patient recruitment phase at present. The IMPALA pivotal study, which is investigating MGN1703 for the treatment of colorectal cancer, is expected to recruit about 540 patients and to be carried out in more than 120 study centers in eight European countries. The plan is to complete patient enrollment in the second half of 2016. 

The phase II IMPULSE study with MGN1703 in the indication small cell lung cancer intends to enroll 100 patients across four European countries. The recruitment phase is expected to be completed still this year.

Dr. Matthias Schroff, Chief Executive Officer (CEO) of MOLOGEN AG: “We are making good progress with patient recruitment, not least because of the excellent support from the investigators involved. We are expecting to conclude recruitment within the scheduled time frame.”

As part of a cooperation with MOLOGEN, the Danish Aarhus University Hospital has started patient recruitment for an early-phase TEACH study to test the immunotherapy MGN1703 in HIV patients. It has received funding for this purpose from the American Foundation for AIDS research (amfAR). MOLOGEN is providing the investigational medicinal product MGN1703 for the trial. 

In the first half of 2015, the company again presented research and development results at major international scientific conferences. At the start of June 2015, updated data on the concluded colorectal cancer IMPACT study was presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA.

Capital increase secures funding for research programs up to end of 2016 at least 

The capital increase that was successfully carried out in April 2015 raised gross issue proceeds in the amount of € 28.3 million for the company. MOLOGEN issued approximately 5.7 million new shares overall, which were subscribed by existing shareholders and also placed with new institutional investors. As at June 30, 2015, the company consequently had cash and cash equivalents of just under € 35 million available, compared with around € 14 million as at the end of 2014. 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.

R&D expenditure to shape EBIT development

In the first half of 2015, R&D expenditure amounted to € 5.2 million and was therefore below the previous year’s figure of € 5.9 million. The operating result (EBIT) also improved accordingly, from € -7.9 million in the first half of the previous year to € -6.9 million. 

Outlook for full-year 2015 confirmed

The outlook for the full 2015 fiscal year remains unchanged since our previous publication of the 2014 Annual Report. The focus of operating activity will continue to be patient recruitment for both the ongoing clinical IMPALA and IMPULSE studies. The recruitment phase of the IMPULSE trial will be completed by the end of 2015. Owing to the advanced study program, R&D expenses are expected to record a corresponding increase, which will generate a higher net loss for the year than in 2014. The capital increase has secured the funding required for the next intermediate stages of the current IMPULSE and IMPALA studies. 

New Chief Executive Officer from November 1, 2015 and re-election of Oliver Krautscheid as member and Chairman of the Supervisory Board

After the end of the period under review, the Supervisory Board appointed Dr. Mariola Söhngen as the Chief Executive Officer (CEO) with effect from November 1, 2015. The current CEO, Dr. Matthias Schroff, will be leaving the company with effect from December 31, 2015. Jörg Petraß, Chief Financial Officer (CFO), has decided not to extend his contract and will also be leaving the company on expiration of his contract.

This year's Annual General Meeting in Berlin on July 29, 2015 re-elected Oliver Krautscheid to the Supervisory Board. In addition, the Supervisory Board once again elected Oliver Krautscheid as Chairman of the Supervisory Board.

The complete report of MOLOGEN AG for the first half of 2015 is available at the company’s website www.mologen.com.


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. The shares of the company are listed on the Prime Standard at the Frankfurt Stock Exchange (ISIN DE0006637200).


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.


Claudia Nickolaus

Head of Investor Relations & Corporate Communications

Tel: +49 - 30 - 84 17 88 – 38

Fax: +49 - 30 - 84 17 88 - 50

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.