DGAP-News: MOLOGEN AG / Key word(s): Quarterly / Interim Statement/Quarter Results
15.05.2018 / 07:05
The issuer is solely responsible for the content of this announcement.
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
In the first quarter of 2018, MOLOGEN made further progress in the ongoing clinical trials with the lead compound, the immunotherapy lefitolimod. In fact, a final evaluation was completed of the results from the exploratory IMPULSE phase II clinical trial in patients suffering from extensive stage small cell lung cancer that had already been published in April 2017. This confirmed the positive news from the initial evaluation for predefined subgroups. The study delivered notable results with regard to overall survival in two relevant patient groups when compared with the control. These findings therefore support the hypothesis that activated B cells may serve as a valid biomarker in the further development of lefitolimod in small cell lung cancer.
MOLOGEN presented strong pre-clinical tumor microenvironment (TME) data on lefitolimod's follow-up molecules EnanDIM(R) at the AACR Annual Meeting 2018 (American Association for Cancer Research) which took place in Chicago in April and at the ITOC-5 Immunotherapy of Cancer Conference in Berlin in March. This showed that monotherapy in murine tumor models resulted in beneficial modulation of the TME, translating into remarkable anti-tumor effects with highly increased survival rates. In two cancer models, complete tumor regression was observed in the majority of mice. The presented data clearly reveals the enormous potential of the EnanDIM(R) product family in immuno-oncology.
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.
Further progress was also made in patient recruitment for the phase I combination study with the checkpoint inhibitor Yervoy(R), which MOLOGEN is carrying out in cooperation with the MD Anderson Cancer Center Texas, U.S.
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
In February 2018, MOLOGEN reached a key strategic milestone by concluding a cooperation contract with ONCOLOGIE, a drug development company from the U.S., regarding the licensing, development, manufacture and commercialization of lefitolimod. The agreement with cancer drug specialist ONCOLOGIE comprises the development, manufacturing and commercialization of lefitolimod in China and further Asian countries as well as a global development cooperation. Pursuant to the contract, MOLOGEN has already received a first payment of EUR3 million. In addition, an equity investment of EUR2 million which becomes due within 12 months of contract signature, plus development and sales-related milestone payments as well as royalties were agreed.
Additional capital measures successfully completed
In the reporting period, MOLOGEN successfully carried out additional capital measures. In February, a second capital increase was carried out in line with the Share Subscription Facility with the U.S. investor Global Corporate Finance (GCF) concluded in October 2017 and raised gross proceeds of EUR445,000. In conjunction with the first exercise in 2017, MOLOGEN has now received a total sum of around EUR1 million.
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.
The capital measures carried out in 2017 and in the first quarter of 2018 as well as the first payment of EUR3 million from ONCOLOGIE have probably secured the financing of MOLOGEN until the end of 2018. Furthermore, other measures for financing of the Company's business activities will be taken.
Research and development expenses
Expenses relating to research and development in the first quarter of 2018 amounted to EUR2.9 million and were therefore down on the previous year's value (EUR3.9 million). In the reporting period, expenses were primarily attributable to costs incurred in connection with conducting pivotal phase III IMPALA study, while the prior year included expenses for trials that have in the meantime been completed. At EUR-0.7 million, the operating result (EBIT) was notably higher than in the first quarter of 2017, when it totaled EUR-5.1 million. As of 31 March 2018, the liquid funds of MOLOGEN AG amounted to EUR8.3 million (12/31/2017: EUR6.5 million). Through the capital measures that were successfully completed, MOLOGEN AG's shareholder's equity was positive and amounted to EUR0.2 million as of reporting date of 31 March 2018 (12/31/2017:
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
Based on the planned progress for 2018 in all areas of the Company, primarily regarding the clinical development programs as well as in commercialization, the Company is expecting a positive development for the current year. In overall terms, the Executive Board of MOLOGEN AG confirms the statements made in the Annual Report 2017 on the objectives in the areas of research and development, collaboration and partnerships, earnings and liquidity development as well as personnel for fiscal year 2018.
The complete MOLOGEN AG report for the first quarter of 2018 is available on the website: www.mologen.com.
MOLOGEN AG is a biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of infectious diseases.
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's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.
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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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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