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(April 25, 2018)
DGAP-News: MOLOGEN AG / Key word(s): Final Results
Press Release N 11 / 2018 dated 04/25/2018
- First licensing agreement for lead compound lefitolimod concluded
- Significant progress in studies
- Company funding secured until the end of 2018 through successful capital measures
Berlin, 25 April 2018 - The biopharmaceutical Company MOLOGEN AG reached key strategic milestones in 2017: one major development was the preparation of a first licensing and cooperation contract for the further development and commercialization of the lead compound lefitolimod in China, which was successfully concluded with the U.S. company ONCOLOGIE Inc. beginning of 2018. The sustainable funding of the Company was once again a focus in 2017: following the successful issuance of a convertible bond in January 2017 as well as the Share Subscription Facility with the U.S. investor Global Corporate Finance, further convertible bonds were issued after the end of the reporting period to the Luxembourg-based European High Growth Opportunities Securitization Fund (EHGO) and a further successful capital increase was carried out. As a result, the financing of MOLOGEN has been presumably secured until the end of 2018.
Alongside the financial and strategic successes, the Company also made some significant progress in the area of research and development in 2017. Key data was presented for two clinical studies: the phase II IMPULSE study in the indication of small cell lung cancer and the phase Ib/IIa TEACH extension study in HIV, which has been conducted in collaboration with the Aarhus University Hospital in Denmark. In 2018, MOLOGEN is planning to start a further clinical study in the indication HIV together with the partners in Aarhus and further prominent international centers, and which will be funded by the U.S. biopharmaceutical company Gilead Sciences Inc.. In this study, lefitolimod will be tested in combination with innovative virus-neutralizing antibodies.
"We have had an eventful and productive 2017, a year in which we have continued to consistently implement the Next Level corporate strategy and made sustained progress in our product development program. We were particularly pleased that we were able to conclude a licensing contract for our lead compound lefitolimod for the first time at the beginning of 2018. In ONCOLOGIE, we have found a right partner to further develop our product candidate and prepare it for market entry. The focus will continue to be on the ongoing development of our product pipeline and the international commercialization of lefitolimod in 2018," comments Dr Mariola Soehngen, Chief Executive Officer (CEO) of MOLOGEN AG.
Signing of first licensing contract for lead compound lefitolimod
First notable results in the TEACH and IMPULSE clinical studies
The key data from the exploratory phase II IMPULSE clinical trial in patients suffering from an extensive disease stage of small cell lung cancer presented for the first time in April 2017 was confirmed in a final evaluation in the first quarter of 2018: the study showed notable results with regard to overall survival in two patient subgroups when compared with the control group. These findings indicate that activated B cells may serve as a valid biomarker in the potential further development of lefitolimod in patients with extensive-disease small cell lung cancer. The clinical phase III IMPALA pivotal study in the indication of metastatic colorectal cancer progressed as planned. Patient recruitment was completed in May 2017. The evaluation of the study results is expected to commence in 2019.
In addition, lefitolimod is being tested in a phase I combination study with the checkpoint inhibitor Yervoy(R), which MOLOGEN is conducting in cooperation with the MD Anderson Cancer Center Texas, U.S.. In 2017, progress continued to be made with patient enrollment.
MOLOGEN has also successfully carried out preclinical combination studies with lefitolimod and other immuno-oncological approaches, which are known as checkpoint inhibitors, as well as with the next-generation molecules from the EnanDIM(R) family. In discussions with potential partners, it is currently reviewing the option of conducting clinical combination trials.
In November 2017, an international consortium to which MOLOGEN belongs was awarded a grant from Global Health Innovative Technology (GHIT) Fund, Tokyo, for the further development of a leishmaniasis vaccine based on MIDGE(R) technology. Of this grant, MOLOGEN is to receive around EUR2.2 million. Pursuant to the Next Level strategy, MOLOGEN continued with the planned spin-off or sale of the MIDGE(R) technology.
Funding secured until the end of 2018: first-time involvement of U.S. investor
"We have successfully diversified the funding of MOLOGEN and, by means of capital measures in 2017 and early 2018 as well as the licensing agreement, we have secured financing presumably until the end of 2018, based on current planning," comments Walter Miller, Chief Financial Officer (CFO) of MOLOGEN AG.
Cash and cash equivalents amounted to EUR6.5 million as of 31 December 2017 (31 December 2016: EUR20.5 million). This decrease is due to the cash utilized within the scope of operating activities. As a result of the increased accumulated deficit, MOLOGEN AG's shareholder's equity amounted to EUR-4.9 million as at the reporting date of 31 December 2017 (31 December 2016: EUR11.8 million).
The development of the financial performance and financial position of MOLOGEN AG in fiscal year 2018 essentially depends on the continued success of commercialization activities for the product candidate lefitolimod as well as (pre-)clinical progress and the successful execution of market preparation. The required additional expenditure in the area of clinical development is expected to remain at a high level, but down on the costs of the financial year under review. Alongside the further funding of the Company, the commercialization, specifically the conclusion of further license agreement for additional regions, will therefore continue to be a central task for 2018.
The capital measures and the additionally concluded framework agreements in 2017 and the first quarter of 2018 together with the first payment from the licensing and development cooperation contract concluded with ONCOLOGIE in February 2018 have presumably secured the financing of the Company until the end of 2018.
The full 2017 Annual Report of MOLOGEN AG is available on the Company's website at: www.mologen.com.
The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM(R).
The immunotherapeutic agent lefitolimod is the Company's lead compound and is currently being investigated in a pivotal trial. It is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in small cell lung cancer have been announced in April 2017, and the final analysis in the first quarter 2018 confirmed the data. Furthermore, data from the extension phase of the TEACH study in HIV have also been published in 2017. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-oncology.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN DE0006637200, SIN 663720) are listed in the Prime Standard of the German Stock Exchange.
Note about risk for future predictions
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