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11.08.2016 07:23:26
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DGAP-News: MOLOGEN AG
DGAP-News: MOLOGEN AG: New strategy and major study milestones achieved in first six months of 2016
Press release N 13 / 2016 dated August 11, 2016
MOLOGEN AG: New strategy and major study milestones achieved in first six months of 2016
- Start of implementation of new "Next Level" strategy
- Forecast for full year 2016 unchanged
- Start of combination study with lead product lefitolimod (MGN1703) and checkpoint inhibitor Yervoy(R) in collaboration with MD Anderson Cancer Center
- Extension of TEACH study following good results in initial study phase
Berlin, August 11, 2016 - The biotech company MOLOGEN (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) conducted and completed a portfolio review in the first half of 2016. The company has already started to implement its new "Next Level" strategy as well as the associated virtualization and stronger focus of the company. At the Annual General Meeting taking place today in Berlin, MOLOGEN will present the company's new strategic direction. The forecast for the current financial year remains unchanged.
Additionally, major milestones were achieved in two of the clinical trials with the lead drug candidate lefitolimod (MGN1703) in the first six months of the year. With the enrollment of the first patients the first combination study (phase I study) started in July 2016: lefitolimod (MGN1703) and the checkpoint inhibitor ipilimumab (Yervoy(R)). Moreover, following positive study results from the initial phase, the extension phase of the TEACH study (indication HIV) including more patients and a longer treatment period started in June.
Implementation of new "Next Level" strategy commences
In the first half of the current financial year MOLOGEN dealt in-depth with the review of its existing product pipeline. The new "Next Level" corporate strategy was devised on the basis of the findings of this portfolio review. In future, MOLOGEN will concentrate on the further development of its most advanced lead product, the immunotherapy lefitolimod (MGN1703), as well as its next-generation molecules EnanDIM(R). MOLOGEN has commissioned a consultancy firm, which specializes in establishing partnerships for biotechnology products, to progress the out-licensing of lefitolimod (MGN1703) on an even more targeted basis. Further development of the drug candidate MGN1601, a cell-based therapeutic vaccine against renal cancer, is to be shelved for the time being and is to be continued in the event of the successful outlicensing of lefitolimod (MGN1703) for instance. The platform technology MIDGE(R) together with all corresponding compounds is to be sold or outsourced.
"The new strategy defines the goalposts for the company's continued successful development. Our operating activities clearly focus on the further development of our lead product lefitolimod and its four clinical studies. We are particularly pleased by the start of the combination study with lefitolimod and the checkpoint inhibitor ipilimumab at the University of Texas MD Anderson Cancer Center. We are convinced that patients in future will benefit from this combination of two immunotherapies. The extension of our HIV study with lefitolimod is also a major milestone for MOLOGEN. We are therefore well on track to successfully implementing our new strategy," said Dr. Mariola Söhngen, CEO of MOLOGEN AG.
Start of combination study in collaboration with MD Anderson Cancer Center
In the first half of 2016, MOLOGEN recorded further advances in the ongoing clinical trials with the immune surveillance reactivator (ISR) lefitolimod (MGN1703): in July, the first patient was enrolled in the combination study which MOLOGEN is conducting in collaboration with the University of Texas MD Anderson Cancer Center. In this phase I study, lefitolimod (MGN1703) will be studied in combination with the immunotherapy ipilimumab (Yervoy(R)) in patients with advanced solid tumors. This is the first time lefitolimod (MGN1703) is being evaluated in combination with a checkpoint inhibitor. MOLOGEN and MD Anderson initiated the collaboration in January 2016 on the basis of the idea that combining the two immunotherapies would enhance the therapeutic response in comparison with treatment with the respective monotherapy and therefore lead to broader activation of the immune system. The phase I study will initially assess the tolerability and safety of the combination therapy. The aim is to subsequently analyze the efficacy of the combination of the two therapies in an extension phase.
Extension of HIV study following good results in initial study phase
The extension of the TEACH study in the indication HIV carried out in conjunction with Aarhus University, Denmark and sponsored by the American Foundation for AIDS Research (amfAR) was another success for MOLOGEN in the reporting period. The initial study results showed a broad activation of the immune system in HIV-positive patients treated with lefitolimod (MGN1703). Consequently, following the initial phase of the study, which was conducted with a total of 15 patients over a treatment period of one month, an extension phase of the study started, again with 15 patients and a treatment period of six months. Initial results for the patients treated in the first study phase were presented in March this year at the Keystone HIV Symposia in the USA. The final results are expected in the first half of 2017.
Patient enrollment for the phase III IMPALA study in the indication colorectal cancer, which began in September 2014, also progressed in the first half of 2016 and is likely to be concluded at the end of 2016/ beginning of 2017. Analysis of the phase II IMPULSE study in the indication small-cell lung cancer is set to start at the end of 2016.
Evolution from research-based to product-oriented company
To prepare for the possible market entry of lefitolimod (MGN1703), the new strategy also involves adjusting the organizational structures by the end of 2016. This includes ensuring sufficient production capacity by outsourcing production to subcontractors in order to meet regulatory and market requirements. This means another milestone will be achieved: preparing production for a potential market entry. MOLOGEN's in-house production covered manufacturing of compounds for clinical trials and demand with regard to the clinical trials is met in full. As a result of the focus on lead product lefitolimod (MGN1703) and the associated reduction in the preclinical product portfolio, the production and research activities carried out in-house will be outsourced. The relevant specialists will remain with the company and therefore ensure management of the necessary external research and production activities. Through its new strategic direction, MOLOGEN will evolve from a company involved primarily in research into a primarily product-oriented company.
Higher R&D expenses due to study progress
The financial data of MOLOGEN AG was also characterized by study advances, also in the first half of 2016. Accordingly, expenses for research and development amounted to EUR7.1 million in total, which exceeded the figure in the previous year (H1 2015: EUR5.2 million) and, as expected, EBIT was below the previous year's figure at EUR-9.8 million (H1 2015: EUR-6.9 million). As at June 30, 2016, the available cash and cash equivalents amounted to EUR15.3 million (December 31, 2015: EUR24.6 million). MOLOGEN AG's equity amounted to EUR9.7 million as of June 30, 2016 (December 31, 2015: EUR19.5 million) with an equity ratio of 59 percent (December 31, 2015: 74 percent).
The funding requirement for implementing the new strategy and further developing the pipeline can be met from the existing authorized capital. MOLOGEN intends to carry out a cash capital increase from authorized capital, depending on market conditions and subject to approval of a corresponding securities prospectus. If necessary, the capital increase can be supplemented by measures utilizing the conditional capital. With this, based on the current share price, the financing would be secured beyond the year 2017.
Forecast for full year 2016 confirmed
The statements made in the Annual Report 2015 on the objectives in the areas of research and development, collaboration and partnerships, and earnings and liquidity development remain valid. The company assumes that, as a result of advances in the clinical studies, R&D expenses for 2016 will be higher than those for financial year 2015 and net income for the year will be correspondingly lower than in the previous year. The costs incurred as a result of restructuring as part of the new corporate strategy will not have any notable impact on the current forecast.
The full report for the first six months of 2016 for MOLOGEN AG is available on the company's 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 mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR 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 an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market.
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
DISCLAIMER
This announcement does not constitute an offer to buy shares or other securities of MOLOGEN AG and does not replace the prospectus. This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States of America (the "United States"), Australia, Canada or Japan or in any jurisdiction. The securities referred to in this announcement will not be and have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securities Act. There will be no public offer of the securities in the United States. Subject to certain exceptions, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan, or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to in this announcement has not been and will not be registered under the U.S. Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States.
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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11.08.2016 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. Archive at 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, Tradegate Exchange End of News DGAP News Service ---------------------------------------------------------------------------
491471 11.08.2016
DGAP-News: MOLOGEN AG / Key word(s): Half Year Results
MOLOGEN AG: New strategy and major study milestones achieved in first six
months of 2016
11.08.2016 / 07:23
The issuer is solely responsible for the content of this announcement.
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Press release N 13 / 2016 dated August 11, 2016
MOLOGEN AG: New strategy and major study milestones achieved in first six months of 2016
- Start of implementation of new "Next Level" strategy
- Forecast for full year 2016 unchanged
- Start of combination study with lead product lefitolimod (MGN1703) and checkpoint inhibitor Yervoy(R) in collaboration with MD Anderson Cancer Center
- Extension of TEACH study following good results in initial study phase
Berlin, August 11, 2016 - The biotech company MOLOGEN (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) conducted and completed a portfolio review in the first half of 2016. The company has already started to implement its new "Next Level" strategy as well as the associated virtualization and stronger focus of the company. At the Annual General Meeting taking place today in Berlin, MOLOGEN will present the company's new strategic direction. The forecast for the current financial year remains unchanged.
Additionally, major milestones were achieved in two of the clinical trials with the lead drug candidate lefitolimod (MGN1703) in the first six months of the year. With the enrollment of the first patients the first combination study (phase I study) started in July 2016: lefitolimod (MGN1703) and the checkpoint inhibitor ipilimumab (Yervoy(R)). Moreover, following positive study results from the initial phase, the extension phase of the TEACH study (indication HIV) including more patients and a longer treatment period started in June.
Implementation of new "Next Level" strategy commences
In the first half of the current financial year MOLOGEN dealt in-depth with the review of its existing product pipeline. The new "Next Level" corporate strategy was devised on the basis of the findings of this portfolio review. In future, MOLOGEN will concentrate on the further development of its most advanced lead product, the immunotherapy lefitolimod (MGN1703), as well as its next-generation molecules EnanDIM(R). MOLOGEN has commissioned a consultancy firm, which specializes in establishing partnerships for biotechnology products, to progress the out-licensing of lefitolimod (MGN1703) on an even more targeted basis. Further development of the drug candidate MGN1601, a cell-based therapeutic vaccine against renal cancer, is to be shelved for the time being and is to be continued in the event of the successful outlicensing of lefitolimod (MGN1703) for instance. The platform technology MIDGE(R) together with all corresponding compounds is to be sold or outsourced.
"The new strategy defines the goalposts for the company's continued successful development. Our operating activities clearly focus on the further development of our lead product lefitolimod and its four clinical studies. We are particularly pleased by the start of the combination study with lefitolimod and the checkpoint inhibitor ipilimumab at the University of Texas MD Anderson Cancer Center. We are convinced that patients in future will benefit from this combination of two immunotherapies. The extension of our HIV study with lefitolimod is also a major milestone for MOLOGEN. We are therefore well on track to successfully implementing our new strategy," said Dr. Mariola Söhngen, CEO of MOLOGEN AG.
Start of combination study in collaboration with MD Anderson Cancer Center
In the first half of 2016, MOLOGEN recorded further advances in the ongoing clinical trials with the immune surveillance reactivator (ISR) lefitolimod (MGN1703): in July, the first patient was enrolled in the combination study which MOLOGEN is conducting in collaboration with the University of Texas MD Anderson Cancer Center. In this phase I study, lefitolimod (MGN1703) will be studied in combination with the immunotherapy ipilimumab (Yervoy(R)) in patients with advanced solid tumors. This is the first time lefitolimod (MGN1703) is being evaluated in combination with a checkpoint inhibitor. MOLOGEN and MD Anderson initiated the collaboration in January 2016 on the basis of the idea that combining the two immunotherapies would enhance the therapeutic response in comparison with treatment with the respective monotherapy and therefore lead to broader activation of the immune system. The phase I study will initially assess the tolerability and safety of the combination therapy. The aim is to subsequently analyze the efficacy of the combination of the two therapies in an extension phase.
Extension of HIV study following good results in initial study phase
The extension of the TEACH study in the indication HIV carried out in conjunction with Aarhus University, Denmark and sponsored by the American Foundation for AIDS Research (amfAR) was another success for MOLOGEN in the reporting period. The initial study results showed a broad activation of the immune system in HIV-positive patients treated with lefitolimod (MGN1703). Consequently, following the initial phase of the study, which was conducted with a total of 15 patients over a treatment period of one month, an extension phase of the study started, again with 15 patients and a treatment period of six months. Initial results for the patients treated in the first study phase were presented in March this year at the Keystone HIV Symposia in the USA. The final results are expected in the first half of 2017.
Patient enrollment for the phase III IMPALA study in the indication colorectal cancer, which began in September 2014, also progressed in the first half of 2016 and is likely to be concluded at the end of 2016/ beginning of 2017. Analysis of the phase II IMPULSE study in the indication small-cell lung cancer is set to start at the end of 2016.
Evolution from research-based to product-oriented company
To prepare for the possible market entry of lefitolimod (MGN1703), the new strategy also involves adjusting the organizational structures by the end of 2016. This includes ensuring sufficient production capacity by outsourcing production to subcontractors in order to meet regulatory and market requirements. This means another milestone will be achieved: preparing production for a potential market entry. MOLOGEN's in-house production covered manufacturing of compounds for clinical trials and demand with regard to the clinical trials is met in full. As a result of the focus on lead product lefitolimod (MGN1703) and the associated reduction in the preclinical product portfolio, the production and research activities carried out in-house will be outsourced. The relevant specialists will remain with the company and therefore ensure management of the necessary external research and production activities. Through its new strategic direction, MOLOGEN will evolve from a company involved primarily in research into a primarily product-oriented company.
Higher R&D expenses due to study progress
The financial data of MOLOGEN AG was also characterized by study advances, also in the first half of 2016. Accordingly, expenses for research and development amounted to EUR7.1 million in total, which exceeded the figure in the previous year (H1 2015: EUR5.2 million) and, as expected, EBIT was below the previous year's figure at EUR-9.8 million (H1 2015: EUR-6.9 million). As at June 30, 2016, the available cash and cash equivalents amounted to EUR15.3 million (December 31, 2015: EUR24.6 million). MOLOGEN AG's equity amounted to EUR9.7 million as of June 30, 2016 (December 31, 2015: EUR19.5 million) with an equity ratio of 59 percent (December 31, 2015: 74 percent).
The funding requirement for implementing the new strategy and further developing the pipeline can be met from the existing authorized capital. MOLOGEN intends to carry out a cash capital increase from authorized capital, depending on market conditions and subject to approval of a corresponding securities prospectus. If necessary, the capital increase can be supplemented by measures utilizing the conditional capital. With this, based on the current share price, the financing would be secured beyond the year 2017.
Forecast for full year 2016 confirmed
The statements made in the Annual Report 2015 on the objectives in the areas of research and development, collaboration and partnerships, and earnings and liquidity development remain valid. The company assumes that, as a result of advances in the clinical studies, R&D expenses for 2016 will be higher than those for financial year 2015 and net income for the year will be correspondingly lower than in the previous year. The costs incurred as a result of restructuring as part of the new corporate strategy will not have any notable impact on the current forecast.
The full report for the first six months of 2016 for MOLOGEN AG is available on the company's 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 mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR 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 an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market.
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
DISCLAIMER
This announcement does not constitute an offer to buy shares or other securities of MOLOGEN AG and does not replace the prospectus. This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States of America (the "United States"), Australia, Canada or Japan or in any jurisdiction. The securities referred to in this announcement will not be and have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securities Act. There will be no public offer of the securities in the United States. Subject to certain exceptions, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan, or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to in this announcement has not been and will not be registered under the U.S. Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States.
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.
---------------------------------------------------------------------------
11.08.2016 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. Archive at 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, Tradegate Exchange End of News DGAP News Service ---------------------------------------------------------------------------
491471 11.08.2016
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