DGAP-News: MOLOGEN AG / Key word(s): Quarterly / Interim Statement/Quarter Results
15.05.2018 / 07:05
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Press Release N 13 / 2018 dated 05/15/2018
MOLOGEN AG: significant progress in clinical studies and successful funding and licensing activities dominated first quarter of 2018
– Next Level corporate strategy being implemented according to plan
– Progress made in ongoing clinical trials and preparations underway for new studies in various indications
– A licensing and development cooperation contract signed with ONCOLOGIE; first payment received
– Additional capital measures successfully completed
– Confirmation of forecast for fiscal year 2018
Berlin, 15 May 2018 – In the first quarter of 2018, biopharmaceutical company MOLOGEN AG has continued to consistently implement the Next Level strategy, especially in relation to preparatory activities for the potential market approval of lefitolimod. In addition, clinical studies with the lead product candidate lefitolimod also continued successfully and further strong pre-clinical data on the potential of lefitolimod and the next-generation molecules EnanDIM(R) in immuno-oncology were presented.
Further successes were achieved in partnering activities and the associated commercialization of lefitolimod: a licensing and development contract was concluded with ONCOLOGIE, a U.S. drug development company, with MOLOGEN receiving the first contractual payment of EUR3 million. The ongoing financing requirements of the Company were also an important focus over the first quarter of 2018: financing has presumably been secured until the end of 2018 through the implementation of various capital measures.
“Much has happened at MOLOGEN in the first three months of the year and we were able to achieve some key targets. The greatest success was undoubtedly the signing of a contract with ONCOLOGIE, which is a significant step towards our primary aim – the licensing and international commercialization of lefitolimod. However, securing the ongoing funding of our Company through various capital measures was also a major achievement in the first quarter of the year,” comments Dr Mariola Soehngen, Chief Executive Officer (CEO) of MOLOGEN AG.
Significant progress in current clinical studies and planning of new trials
The pivotal IMPALA study in the indication of colorectal cancer again moved forward as planned. In April 2018, an initial data-based forecast was published for the expected date for the primary analysis of the study. Based on patient data collected and using adequate statistical methodology, the results on the primary endpoint of the study are expected to be available in April 2020. This statistical forecast involves a degree of uncertainty, reflected in the 95% confidence interval of plus/minus five months. This translates into a time window from year-end 2019 to summer 2020 in which the time point for the analysis will fall with a high probability.
In 2018, MOLOGEN is starting a further clinical trial in the indication HIV together with Aarhus University Hospital and other prominent international centers, which is being funded by the U.S. biopharmaceutical company, Gilead Sciences Inc. In this trial, lefitolimod will be tested in combination with innovative virus-neutralizing antibodies. Preparatory work for the start of this follow-up study, which is entitled TITAN is currently underway. Other new studies in the area of immuno-oncology are also in the pipeline.
First licensing and development cooperation with lead compound lefitolimod
Additional capital measures successfully completed
Also in February, MOLOGEN entered into an agreement with the Luxembourg financing provider European High Growth Opportunities Securitization Fund (EHGO), a fund advised by Alpha Blue Ocean Advisors (ABO). Pursuant to this agreement, MOLOGEN can place convertible bonds in an aggregate amount of up to EUR12 million in up to 24 tranches of EUR500,000 each with the investor over a period of two years. So far, MOLOGEN has obtained two tranches in March 2018 and generated gross proceeds of EUR1 million as a result.
In March, MOLOGEN also successfully concluded a further capital increase from authorized capital. In the course of the capital increase that was fully placed with national and international investors, MOLOGEN received gross proceeds amounting to approximately EUR5 million.
Research and development expenses
On the personnel side, MOLOGEN AG announced shortly after the end of the reporting period that for personal reasons, CEO Dr Mariola Soehngen will not extend her contract after the expiry date 31 October 2018. The Executive Board and Supervisory Board accepted this decision with great regret.
Confirmation of forecast for fiscal year 2018
The complete MOLOGEN AG report for the first quarter of 2018 is available on the website: www.mologen.com.
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.
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