|
07.11.2016 07:09:56
|
DGAP-News: MOLOGEN AG
DGAP-News: MOLOGEN AG presents nine month result: Focus on implementation of 'Next Level' strategy following successful capital increase
- Capital increase and convertible bond with gross proceeds of presumably EUR 16.1 million
- Further implementation of the "Next Level" corporate strategy
- Advancement of the four clinical studies with the lead product lefitolimod (MGN1703)
- Progress in these trials affects financial result
- Outlook unchanged for full-year 2016
- First anti-tumor data of the TLR9 agonist EnanDIM(R) in a murine model
Berlin, 7 November 2016 - Today, biotechnology company MOLOGEN (ISIN DE0006637200; Frankfurter Stock Exchange Prime Standard: MGN) presented its result for the first nine months of the current financial year. During the third quarter, the focus was above all on the further implementation of the new "Next Level" corporate strategy announced in June 2016 and therefore also the further development of the lead product lefitolimod (MGN1703) in the four ongoing clinical studies. This resulted in higher operating expenses with a slight increase of costs, especially for the clinical development. The capital increase, which was significantly oversubscribed, was completed with gross proceeds amounting to EUR13.6 million in October 2016. Together with the convertible bond with a volume of EUR2.5 million, which is to be issued in November 2016, financing of the company has been secured presumably until the fourth quarter of 2017. MOLOGEN presented first preliminary data on its EnanDIM(R)-technology in a murine tumor model at a scientific congress in September in New York, US..
Dr. Mariola Söhngen, CEO of MOLOGEN AG: "Since the beginning of the year we have achieved significant milestones - both strategic and at development and financing level. With our new "Next Level" strategy, we pursue a clearly defined objective: the focus on our lead product lefitolimod and preparing for a potential market entry. In this regard, additional key advances were made in the ongoing clinical studies. Moreover, the capital measures were very successfully concluded. As a result we will therefore be presumably financed up to the fourth quarter 2017."
Further implementation of the new "Next Level" corporate strategy Particularly during the third quarter of 2016, MOLOGEN further advanced the new "Next Level" strategy. The new strategy contains a clear focus on the further development of the most advanced lead product the immunotherapy lefitolimod (MGN1703) in addition to its successor molecules EnanDIM(R). The four clinical studies with lefitolimod (MGN1703) IMPALA, IMPULSE and TEACH in the indications colorectal cancer, small cell lung cancer and HIV in addition to the combination study with the immunotherapy Yervoy(R) (ipilimumab) in patients with advanced solid tumors proceeded as planned. In particular, progress in terms of patient recruitment was made in the phase III IMPALA study.
Due to positive results recorded in the first phase of the TEACH study in the indication HIV, the continuation of the trial into an extended phase was announced in March 2016. In this extension phase of the study, patients will be treated with lefitolimod (MGN1703) over a longer period of time. Patient recruitment began at the end of June 2016. The first results are expected in mid-2017. Patient recruitment for the first combination study with lefitolimod with the Checkpoint-Inhibitor Yervoy(R), which MOLOGEN is carrying out in cooperation with the MD Anderson Cancer Center Texas, started in July 2016.
In September 2016, MOLOGEN presented preliminary anti-tumor data on the lefitolimod successor molecules EnanDIM(R) in a murine tumor model at the second international CRI-CIMT-EATI-AACR Cancer Immunotherapy Conference in New York, US.. The pre-clinical in vivo data showed that EnanDIM(R) can reduce tumor growth and thus prolong survival. It has been shown previously that EnanDIM(R) molecules broadly activate immune cells in vitro and revealed no signs of toxicity after the administration of maximal feasible doses in vivo. These data constitute the next pre-clinical step towards a clinical development program of EnanDIM(R) in the treatment of cancer.
Intensive continuation of clinical studies requires increased expenses The continuation of the clinical studies with lefitolimod, in particular both the IMPALA and IMPULSE studies, will result in higher operating expenses with a slight rise in expenses for research & development (R&D) to EUR10.5 million (9M 2015: EUR10.4 million). At EUR-14.3 million, EBIT correspondingly was below the previous year's value of EUR-13.3 million as a result of the rise on operating expenses.
Capital increase presumably secures financing up to fourth quarter of 2017 As of 30 September 2016, MOLOGEN AG's cash and cash equivalents totaled EUR10.2 million (31 December 2015: EUR24.6 million). MOLOGEN AG's shareholder's equity as of 30 September 2016 amounted to EUR4.9 million (31 December 2015: EUR19.5 million) with an equity ratio of 44 percent (31 December 2015: 74 percent).
Following the successfully concluded capital increase in October 2016 and a currently ongoing convertible bond issuance after the end of the reporting period, the company receives gross proceeds of presumably EUR16.1 million. Corporate financing is therefore secured presumably up to the fourth quarter of 2017. With the acquired funds, MOLOGEN plans to continue implementing the "Next Level" strategy. As such, the majority of available financial resources will go into the further development of lefitolimod (MGN1703) and the successor agent molecules EnanDIM(R).
Forecast for fullyear 2016 confirmed The statements contained in the Annual Report 2015 with regard to objectives in the fields of research and development, cooperations and partnerships in addition to the earnings and liquidity development remain valid. The company expects that expenses for R&D in 2016 will be above those in financial year 2015 on account of study progress and that profit will be accordingly lower than in the previous year. Expenses arising as a result of the restructuring carried out in the wake of the new corporate strategy will have no noteworthy influence on the current outlook.
MOLOGEN AG's interim statement for the first nine months of 2016 can be found on the company's website at: 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
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.
---------------------------------------------------------------------------
07.11.2016 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 ---------------------------------------------------------------------------
517799 07.11.2016
DGAP-News: MOLOGEN AG / Key word(s): 9-month figures
MOLOGEN AG presents nine month result: Focus on implementation of 'Next
Level' strategy following successful capital increase
07.11.2016 / 07:09
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
PRESS RELEASE N 17 / 2016 of 11/7/2016
MOLOGEN AG presents nine month result: Focus on implementation of "Next
Level" strategy following successful capital increase
- Capital increase and convertible bond with gross proceeds of presumably EUR 16.1 million
- Further implementation of the "Next Level" corporate strategy
- Advancement of the four clinical studies with the lead product lefitolimod (MGN1703)
- Progress in these trials affects financial result
- Outlook unchanged for full-year 2016
- First anti-tumor data of the TLR9 agonist EnanDIM(R) in a murine model
Berlin, 7 November 2016 - Today, biotechnology company MOLOGEN (ISIN DE0006637200; Frankfurter Stock Exchange Prime Standard: MGN) presented its result for the first nine months of the current financial year. During the third quarter, the focus was above all on the further implementation of the new "Next Level" corporate strategy announced in June 2016 and therefore also the further development of the lead product lefitolimod (MGN1703) in the four ongoing clinical studies. This resulted in higher operating expenses with a slight increase of costs, especially for the clinical development. The capital increase, which was significantly oversubscribed, was completed with gross proceeds amounting to EUR13.6 million in October 2016. Together with the convertible bond with a volume of EUR2.5 million, which is to be issued in November 2016, financing of the company has been secured presumably until the fourth quarter of 2017. MOLOGEN presented first preliminary data on its EnanDIM(R)-technology in a murine tumor model at a scientific congress in September in New York, US..
Dr. Mariola Söhngen, CEO of MOLOGEN AG: "Since the beginning of the year we have achieved significant milestones - both strategic and at development and financing level. With our new "Next Level" strategy, we pursue a clearly defined objective: the focus on our lead product lefitolimod and preparing for a potential market entry. In this regard, additional key advances were made in the ongoing clinical studies. Moreover, the capital measures were very successfully concluded. As a result we will therefore be presumably financed up to the fourth quarter 2017."
Further implementation of the new "Next Level" corporate strategy Particularly during the third quarter of 2016, MOLOGEN further advanced the new "Next Level" strategy. The new strategy contains a clear focus on the further development of the most advanced lead product the immunotherapy lefitolimod (MGN1703) in addition to its successor molecules EnanDIM(R). The four clinical studies with lefitolimod (MGN1703) IMPALA, IMPULSE and TEACH in the indications colorectal cancer, small cell lung cancer and HIV in addition to the combination study with the immunotherapy Yervoy(R) (ipilimumab) in patients with advanced solid tumors proceeded as planned. In particular, progress in terms of patient recruitment was made in the phase III IMPALA study.
Due to positive results recorded in the first phase of the TEACH study in the indication HIV, the continuation of the trial into an extended phase was announced in March 2016. In this extension phase of the study, patients will be treated with lefitolimod (MGN1703) over a longer period of time. Patient recruitment began at the end of June 2016. The first results are expected in mid-2017. Patient recruitment for the first combination study with lefitolimod with the Checkpoint-Inhibitor Yervoy(R), which MOLOGEN is carrying out in cooperation with the MD Anderson Cancer Center Texas, started in July 2016.
In September 2016, MOLOGEN presented preliminary anti-tumor data on the lefitolimod successor molecules EnanDIM(R) in a murine tumor model at the second international CRI-CIMT-EATI-AACR Cancer Immunotherapy Conference in New York, US.. The pre-clinical in vivo data showed that EnanDIM(R) can reduce tumor growth and thus prolong survival. It has been shown previously that EnanDIM(R) molecules broadly activate immune cells in vitro and revealed no signs of toxicity after the administration of maximal feasible doses in vivo. These data constitute the next pre-clinical step towards a clinical development program of EnanDIM(R) in the treatment of cancer.
Intensive continuation of clinical studies requires increased expenses The continuation of the clinical studies with lefitolimod, in particular both the IMPALA and IMPULSE studies, will result in higher operating expenses with a slight rise in expenses for research & development (R&D) to EUR10.5 million (9M 2015: EUR10.4 million). At EUR-14.3 million, EBIT correspondingly was below the previous year's value of EUR-13.3 million as a result of the rise on operating expenses.
Capital increase presumably secures financing up to fourth quarter of 2017 As of 30 September 2016, MOLOGEN AG's cash and cash equivalents totaled EUR10.2 million (31 December 2015: EUR24.6 million). MOLOGEN AG's shareholder's equity as of 30 September 2016 amounted to EUR4.9 million (31 December 2015: EUR19.5 million) with an equity ratio of 44 percent (31 December 2015: 74 percent).
Following the successfully concluded capital increase in October 2016 and a currently ongoing convertible bond issuance after the end of the reporting period, the company receives gross proceeds of presumably EUR16.1 million. Corporate financing is therefore secured presumably up to the fourth quarter of 2017. With the acquired funds, MOLOGEN plans to continue implementing the "Next Level" strategy. As such, the majority of available financial resources will go into the further development of lefitolimod (MGN1703) and the successor agent molecules EnanDIM(R).
Forecast for fullyear 2016 confirmed The statements contained in the Annual Report 2015 with regard to objectives in the fields of research and development, cooperations and partnerships in addition to the earnings and liquidity development remain valid. The company expects that expenses for R&D in 2016 will be above those in financial year 2015 on account of study progress and that profit will be accordingly lower than in the previous year. Expenses arising as a result of the restructuring carried out in the wake of the new corporate strategy will have no noteworthy influence on the current outlook.
MOLOGEN AG's interim statement for the first nine months of 2016 can be found on the company's website at: 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
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.
---------------------------------------------------------------------------
07.11.2016 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 ---------------------------------------------------------------------------
517799 07.11.2016
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu MOLOGEN AGmehr Nachrichten
| Keine Nachrichten verfügbar. |
Analysen zu MOLOGEN AGmehr Analysen
Nachrichten
ETF-Sparplan
Oskar ist der einfache und intelligente ETF-Sparplan. Er übernimmt die ETF-Auswahl, ist steuersmart, transparent und kostengünstig.