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22.03.2016 07:11:26
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DGAP-News: MOLOGEN AG
DGAP-News: MOLOGEN AG: All key milestones achieved in 2015
22.03.2016 / 07:11 The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE N 6 / 2016 of 03/22/2016
MOLOGEN AG: All key milestones achieved in 2015
- Successful further development of the product pipeline with conclusion of the patient enrollment for the IMPULSE study and the first phase of the TEACH study
- Increase in R&D expenses due to study progress
- Successful capital increase with gross proceeds of EUR28.3 million
- Changes in the Executive Board
- Confident forecast for 2016
Berlin, 22 March 2016 - In financial year 2015, the biotechnology company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) achieved all key objectives and developed its product pipeline as planned. The company focused on continuing the three clinical studies involving the lead drug candidate lefitolimod (MGN1703). Patient enrollment was completed as planned for the randomized IMPULSE study (indication small cell lung cancer) and the TEACH study (indication HIV), which the company has been carrying out jointly with Aarhus University Hospital since the second quarter of 2015. Substantial progress was also made in patient enrollment for the phase III IMPALA pivotal study (indication colorectal cancer). The capital increase of EUR28.3 million, which took place in April 2015, was used primarily to fund the research and development program, for the lead product lefitolimod (MGN1703) in particular. The Executive Board expects that the clinical studies will continue as planned over the course of the current financial year 2016.
CEO Dr. Mariola Söhngen: "We are very satisfied with business performance in 2015. With its broad range of applications, its ability to activate the immune system and excellent tolerability, our lead product lefitolimod is an extraordinary product with blockbuster potential within the growing market of immunotherapies. Our primary objective is therefore to make lefitolimod market ready in cancer, explore its potential in HIV further and exploit the potential of our rich pipeline."
Significant progress and broadening of the studies involving the lead product lefitolimod The most advanced product in the MOLOGEN pipeline, MGN1703, has been officially listed by the World Health Organization since January 2016 and has therefore also been granted an international nonproprietary name: "lefitolimod". In addition to the indications colorectal cancer and small cell lung cancer, the immunotherapy has also been used to treat HIV patients in collaboration with the Aarhus University Hospital (Denmark) as part of the phase I/IIa TEACH study since the second quarter of 2015. This is the first time a MOLOGEN active agent is being clinically tested in an indication other than cancer. Initial results showed that lefitolimod (MGN1703) triggers a widespread activation of treated patients' immune systems. Accordingly, the study protocol for the TEACH study was amended and now additional patients will be treated for a longer period of six months with lefitolimod. Recruitment of these patients will start in the next few weeks.
The enrollment of 100 patients for the IMPULSE lung cancer study was completed in October 2015. Progress was also made, as planned, in enrolling patients for the third ongoing clinical study involving lefitolimod (MGN1703), the international phase III IMPALA pivotal study in the indication colorectal cancer. Around 540 patients in more than 100 centers in eight European countries, including the five most important European pharmaceutical markets, are planned to participate in the study. The aim of the study is to show that treatment with lefitolimod (MGN1703) results in a prolongation of overall survival in patients with metastatic colorectal cancer. In February 2016, MOLOGEN reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the development strategy of lefitolimod (MGN1703) with the IMPALA pivotal study within the framework of a scientific consultation.
Successful contract for the combination study with MD Anderson In January 2016, MOLOGEN concluded a cooperation agreement with the renowned MD Anderson Cancer Center at the University of Texas. The agreement relates to a phase I trial with lefitolimod (MGN1703) in combination with the immunotherapy Yervoy(R) in patients with advanced solid tumors, mainly melanoma. Yervoy(R), a recombinant, human monoclonal antibody works as an immune checkpoint inhibitor. Lefitolimod (MGN1703) will therefore be evaluated in combination with a checkpoint inhibitor for the first time. Should the efficacy of Yervoy(R) be boosted, this would also expand the potential range of applications for lefitolimod (MGN1703). The trial is expected to start in the first half of 2016 and include around 50 to 60 patients. MOLOGEN will provide lefitolimod (MGN1703) and funding for the trial.
Presentation of results at international congresses In the last financial year, MOLOGEN presented new research and development results of clinical trials at various renowned international conferences. In November, MOLOGEN presented exploratory immunological data from the first patients recruited in the IMPALA pivotal study at the 2015 Annual Meeting of the Society for Immunotherapy of Cancer in the U.S. Current data from a subgroup of patients treated with lefitolimod in the phase II IMPACT study (indication colorectal cancer), which was completed in 2013, were presented at the 2015 European Cancer Congress. The long-term progression-free survival (PFS) of this subgroup at the evaluation in August 2015 was between 47 and 55 months.
First results from the TEACH study will be presented at the Keystone HIV Symposium, which takes place at the end of March 2016 in the U.S.
Planned increase in R&D expenses Overall, the financial performance and financial position of MOLOGEN AG in financial year 2015 developed according to plan. As in recent years, no significant sales or other operating income was generated. As expected, the increase in research and development expenses for the ongoing clinical studies of EUR16.8 million (2014: EUR13.3 million) resulted in a lower operating result (EBIT) compared with the previous year of EUR-20.5 million (2014: EUR-17.1 million). The capital increase with gross proceeds of EUR28.3 million carried out in April 2015 increased MOLOGEN AG's liquid funds to EUR24.6 million as of December 2015 (2014: EUR13.6 million). At the end of 2015, the equity capital of MOLOGEN AG amounted to EUR19.5 million (2014: EUR13.3 million). The equity ratio stood at 74% (2014: 88%).
Executive Board changes In financial year 2015, Dr. Mariola Söhngen took over as CEO of MOLOGEN AG effective November 1, 2015. Her predecessor Dr. Matthias Schroff and the CFO Jörg Petraß left the company effective December 31, 2015. Walter Miller will take over as CFO from April 1, 2016. Dr Alfredo Zurlo will not prolong his contract as CMO expiring end of March 2016. Talks with successor candidates are ongoing and an internal interim manager will be nominated effective April 1, 2016.
Positive development forecast for 2016 The focus of activities will continue to be on the lead product lefitolimod (MGN1703) in the current financial year. Patient enrollment for the IMPALA colorectal cancer study is planned to be completed by the end of 2016. The evaluation of the IMPULSE lung cancer study is also expected to start by the end of the year leading to the availability of results in the first half of 2017. Final results of the TEACH study are also expected in 2017. A portfolio review is planned to be carried out in the first half of 2016 with the aim of identifying further strategic potential of the research and development pipeline.
The company assumes that the R&D expenses needed for further progress with the clinical studies will exceed those of financial year 2015. Given this, MOLOGEN is assuming an annual net result below previous year's level.
The complete MOLOGEN AG annual report for 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 lefitolimod (MGN1703) is the company's lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications. Lefitolimod (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 and a phase I combination study with the checkpoint inhibitor Yervoy(R) (ipilimumab) is expected to start within the first half 2016.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need.
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), 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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22.03.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English Company: MOLOGEN AG Fabeckstraße 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 ---------------------------------------------------------------------------
447553 22.03.2016
DGAP-News: MOLOGEN AG / Key word(s): Final Results MOLOGEN AG: All key milestones achieved in 2015
22.03.2016 / 07:11 The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
PRESS RELEASE N 6 / 2016 of 03/22/2016
MOLOGEN AG: All key milestones achieved in 2015
- Successful further development of the product pipeline with conclusion of the patient enrollment for the IMPULSE study and the first phase of the TEACH study
- Increase in R&D expenses due to study progress
- Successful capital increase with gross proceeds of EUR28.3 million
- Changes in the Executive Board
- Confident forecast for 2016
Berlin, 22 March 2016 - In financial year 2015, the biotechnology company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) achieved all key objectives and developed its product pipeline as planned. The company focused on continuing the three clinical studies involving the lead drug candidate lefitolimod (MGN1703). Patient enrollment was completed as planned for the randomized IMPULSE study (indication small cell lung cancer) and the TEACH study (indication HIV), which the company has been carrying out jointly with Aarhus University Hospital since the second quarter of 2015. Substantial progress was also made in patient enrollment for the phase III IMPALA pivotal study (indication colorectal cancer). The capital increase of EUR28.3 million, which took place in April 2015, was used primarily to fund the research and development program, for the lead product lefitolimod (MGN1703) in particular. The Executive Board expects that the clinical studies will continue as planned over the course of the current financial year 2016.
CEO Dr. Mariola Söhngen: "We are very satisfied with business performance in 2015. With its broad range of applications, its ability to activate the immune system and excellent tolerability, our lead product lefitolimod is an extraordinary product with blockbuster potential within the growing market of immunotherapies. Our primary objective is therefore to make lefitolimod market ready in cancer, explore its potential in HIV further and exploit the potential of our rich pipeline."
Significant progress and broadening of the studies involving the lead product lefitolimod The most advanced product in the MOLOGEN pipeline, MGN1703, has been officially listed by the World Health Organization since January 2016 and has therefore also been granted an international nonproprietary name: "lefitolimod". In addition to the indications colorectal cancer and small cell lung cancer, the immunotherapy has also been used to treat HIV patients in collaboration with the Aarhus University Hospital (Denmark) as part of the phase I/IIa TEACH study since the second quarter of 2015. This is the first time a MOLOGEN active agent is being clinically tested in an indication other than cancer. Initial results showed that lefitolimod (MGN1703) triggers a widespread activation of treated patients' immune systems. Accordingly, the study protocol for the TEACH study was amended and now additional patients will be treated for a longer period of six months with lefitolimod. Recruitment of these patients will start in the next few weeks.
The enrollment of 100 patients for the IMPULSE lung cancer study was completed in October 2015. Progress was also made, as planned, in enrolling patients for the third ongoing clinical study involving lefitolimod (MGN1703), the international phase III IMPALA pivotal study in the indication colorectal cancer. Around 540 patients in more than 100 centers in eight European countries, including the five most important European pharmaceutical markets, are planned to participate in the study. The aim of the study is to show that treatment with lefitolimod (MGN1703) results in a prolongation of overall survival in patients with metastatic colorectal cancer. In February 2016, MOLOGEN reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the development strategy of lefitolimod (MGN1703) with the IMPALA pivotal study within the framework of a scientific consultation.
Successful contract for the combination study with MD Anderson In January 2016, MOLOGEN concluded a cooperation agreement with the renowned MD Anderson Cancer Center at the University of Texas. The agreement relates to a phase I trial with lefitolimod (MGN1703) in combination with the immunotherapy Yervoy(R) in patients with advanced solid tumors, mainly melanoma. Yervoy(R), a recombinant, human monoclonal antibody works as an immune checkpoint inhibitor. Lefitolimod (MGN1703) will therefore be evaluated in combination with a checkpoint inhibitor for the first time. Should the efficacy of Yervoy(R) be boosted, this would also expand the potential range of applications for lefitolimod (MGN1703). The trial is expected to start in the first half of 2016 and include around 50 to 60 patients. MOLOGEN will provide lefitolimod (MGN1703) and funding for the trial.
Presentation of results at international congresses In the last financial year, MOLOGEN presented new research and development results of clinical trials at various renowned international conferences. In November, MOLOGEN presented exploratory immunological data from the first patients recruited in the IMPALA pivotal study at the 2015 Annual Meeting of the Society for Immunotherapy of Cancer in the U.S. Current data from a subgroup of patients treated with lefitolimod in the phase II IMPACT study (indication colorectal cancer), which was completed in 2013, were presented at the 2015 European Cancer Congress. The long-term progression-free survival (PFS) of this subgroup at the evaluation in August 2015 was between 47 and 55 months.
First results from the TEACH study will be presented at the Keystone HIV Symposium, which takes place at the end of March 2016 in the U.S.
Planned increase in R&D expenses Overall, the financial performance and financial position of MOLOGEN AG in financial year 2015 developed according to plan. As in recent years, no significant sales or other operating income was generated. As expected, the increase in research and development expenses for the ongoing clinical studies of EUR16.8 million (2014: EUR13.3 million) resulted in a lower operating result (EBIT) compared with the previous year of EUR-20.5 million (2014: EUR-17.1 million). The capital increase with gross proceeds of EUR28.3 million carried out in April 2015 increased MOLOGEN AG's liquid funds to EUR24.6 million as of December 2015 (2014: EUR13.6 million). At the end of 2015, the equity capital of MOLOGEN AG amounted to EUR19.5 million (2014: EUR13.3 million). The equity ratio stood at 74% (2014: 88%).
Executive Board changes In financial year 2015, Dr. Mariola Söhngen took over as CEO of MOLOGEN AG effective November 1, 2015. Her predecessor Dr. Matthias Schroff and the CFO Jörg Petraß left the company effective December 31, 2015. Walter Miller will take over as CFO from April 1, 2016. Dr Alfredo Zurlo will not prolong his contract as CMO expiring end of March 2016. Talks with successor candidates are ongoing and an internal interim manager will be nominated effective April 1, 2016.
Positive development forecast for 2016 The focus of activities will continue to be on the lead product lefitolimod (MGN1703) in the current financial year. Patient enrollment for the IMPALA colorectal cancer study is planned to be completed by the end of 2016. The evaluation of the IMPULSE lung cancer study is also expected to start by the end of the year leading to the availability of results in the first half of 2017. Final results of the TEACH study are also expected in 2017. A portfolio review is planned to be carried out in the first half of 2016 with the aim of identifying further strategic potential of the research and development pipeline.
The company assumes that the R&D expenses needed for further progress with the clinical studies will exceed those of financial year 2015. Given this, MOLOGEN is assuming an annual net result below previous year's level.
The complete MOLOGEN AG annual report for 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 lefitolimod (MGN1703) is the company's lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications. Lefitolimod (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 and a phase I combination study with the checkpoint inhibitor Yervoy(R) (ipilimumab) is expected to start within the first half 2016.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need.
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), 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.
---------------------------------------------------------------------------
22.03.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English Company: MOLOGEN AG Fabeckstraße 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 ---------------------------------------------------------------------------
447553 22.03.2016
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