MOLOGEN AG
MOLOGEN AG: New strategic orientation, successful capital measures and notable study progress in 2016
DGAP-News: MOLOGEN AG / Key word(s): Final Results MOLOGEN AG: New strategic orientation, successful capital measures and notable study progress in 2016 – Ongoing implementation of the new “Next Level” corporate strategy – Funding secured until the start of 2018 through capital measures – Lead product lefitolimod: significant milestones reached – Changes to Executive Board – Confident forecast for 2017
MOLOGEN secured the future funding – for both the company’s new alignment and the continuation of studies with lefitolimod and the follow-up molecules EnanDIM(R) – through two successfully completed capital measures, with the capital increase and the convertible bond generating gross proceeds of EUR16.1 million in total. Over the past financial year, there were two changes on the Executive Board of MOLOGEN AG: since 1 April 2016, Walter Miller has been the new Chief Financial Officer (CFO) of MOLOGEN AG. On 31 March 2016, the Chief Medical Officer (CMO) Dr. Alfredo Zurlo left the company. He is being succeeded by Dr. Matthias Baumann, who will start in his new position on 1 May 2017. Dr. Mariola Söhngen, Chief Executive Officer (CEO) of MOLOGEN AG: “For MOLOGEN, 2016 was an eventful and at the same time good year in which we laid the foundations for our future success: with our new “Next Level” corporate strategy, we have set a clear strategic course that will enable us in future to adopt a new positioning as a product-oriented company with a strong lead product, our immunotherapeutic agent lefitolimod. Our principal objective is to prepare lefitolimod for possible market entry. To this end, we pressed on with approval preparation and held further discussions with potential partners. In the past year, we made further significant progress in our clinical studies with lefitolimod. Through the two capital measures in 2016 and the issuance of a second convertible bond in January 2017, we have been able to secure our funding into 2018. On the personnel side, we have gained two extremely experienced and competent new Executive Board members in Walter Miller for the position of CFO and now also Dr. Matthias Baumann as a new CMO. They will both make a positive contribution to advancing the development of the company.” Broad application spectrum for lefitolimod In 2016, considerable progress was made in terms of patient recruitment for the phase III IMPALA pivotal study. Around 540 patients from approximately 120 centers in eight European countries, including the five largest European pharmaceutical markets, will participate in the study. The intention is to complete patient recruitment in the first few months of 2017. The evaluation of the study is expected to begin around two years after the end of patient enrollment. Patient recruitment for the phase II IMPULSE trial was already concluded in October 2015. At the end of 2016, the analysis of one-year survival rate in the indication of small-cell lung cancer commenced. The initial results of this exploratory study, which investigates the possible treatment success in different patient sub-groups, are expected to be ready in the second quarter of 2017. The results of the follow-up analysis of patients (two-year survival rate) according to protocol will be available in around one year. MOLOGEN is working together with the Danish Aarhus University Hospital to conduct the phase I/II TEACH study, which is the first time that lefitolimod is being clinically evaluated in patients with a disease other than cancer: HIV. Owing to the favorable results in the first phase of the study, in which a broad activation of the immune system triggered by lefitolimod was observed, the decision was made to continue the study in an extension phase where patients would receive treatment over a longer time frame. Patient recruitment started in June 2016 and the first study results are expected presumably in the middle of 2017. In February of this year, Aarhus University presented further data from the TEACH study, which revealed through colon biopsies that lefitolimod can trigger a local antiviral immune response in patients with HIV who undergo antiretroviral treatment (ART) without inducing inflammation. Consequently, lefitolimod might be used in a “kick and kill” approach. The U.S. biopharmaceutical company Gilead Sciences, Inc. recently issued a grant of US$ 2.75 million to Aarhus University for a further combination study in which lefitolimod will be investigated together with innovative virus-neutralizing antibodies that have been developed by the Rockefeller University in New York, USA. This innovative combination will be the latest approach in the “kick and kill” concept for the treatment of HIV. First positive results from combination study with lefitolimod – expansion of application spectrum In January of this year, MOLOGEN presented data on further combination studies in a mouse model at the Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, USA. The data on tumor models in mice revealed that the combination of checkpoint inhibitors and lefitolimod can significantly boost immunity, noticeably slow tumor growth and effectively prolong life for the animals. These findings confirm the combination approach of lefitolimod with checkpoint inhibitors. Slight increase in R&D expenses Sound basis for continued positive development in 2017 The financial prerequisites for the scheduled development of the company in 2017 have been established through the capital increase in 2016 and the two subsequently placed convertible bonds. MOLOGEN therefore enters the new financial year with good prospects. The development of the financial performance and financial position of MOLOGEN in fiscal year 2017 above all depends on the continued progress of the clinical studies with the lead product candidate lefitolimod as well as the associated out-licensing and partnership efforts. The necessary expenditure in the area of clinical development is expected to be up on those in fiscal year 2016. This is essentially due to the continuation of the IMPALA clinical study, the outsourcing and upscaling of production as well as further activities in licensing and partnerships in relation to lefitolimod. According to our forecast, average monthly cash consumption will increase year on year in 2017. If the present licensing and partnership discussions are successful in 2017, this could have a notable positive impact on the financial performance and financial position. The 2016 Annual Report of MOLOGEN AG is available on the company’s website at: www.mologen.com.
The immunotherapy lefitolimod is the company’s lead product and the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this action mechanism, lefitolimod is an immune surveillance reactivator (ISR) and has the potential to be used in a variety of different indications. At present, ISR lefitolimod is being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small-cell lung cancer (randomized controlled study). In addition, ISR lefitolimod is currently being investigated in an extended phase I trial in HIV and a phase I combination study with the checkpoint inhibitor Yervoy(R) (ipilimumab). Alongside checkpoint inhibitors, lefitolimod is one of the few product candidates in the field of immuno-oncology which is close to market. It is currently in a clinical phase III pivotal study. MOLOGEN’s pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand. Member of the following associations:
22.03.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
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 |
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