DGAP-News: MOLOGEN AG / Key word(s): Half Year Results
09.08.2018 / 07:15
The issuer is solely responsible for the content of this announcement.
Press Release No 17 / 2018 dated 08/09/2018
MOLOGEN AG with positive developments in the first half of 2018: successful financing measures and continuation of clinical studies
– Ongoing clinical studies with lefitolimod on track, new studies in preparation
– License and development cooperation agreement signed with ONCOLOGIE; initial revenues generated under license agreement
– Dr Ignacio Faus new Chief Executive Officer (CEO) since 1 August 2018
– Successful financing measures
– Forecast for fiscal year 2018 confirmed
Berlin, 9 August 2018 – In the first half of 2018 the biopharmaceutical company MOLOGEN AG recorded a positive development in many respects. The “Next Level” corporate strategy continued to be implemented according to schedule in the first half of the year. The most important strategic milestone was the conclusion of the license and development cooperation agreement with the U.S. drug development company ONCOLOGIE. Under the agreement, MOLOGEN received an initial license payment of EUR3 million. The financing measures implemented in the fourth quarter of 2017 and in the reporting period – a framework agreement on convertible bonds of up to EUR12 million and a cash capital increase with gross proceeds of around EUR5 million – will initially secure the Company’s financing plans until the end of 2018. As a result of the reverse stock split in July 2018, MOLOGEN will be able to make use of the financing instruments already agreed.
The clinical studies with MOLOGEN’s lead compound, the immunotherapeutic lefitolimod, also proceeded according to plan. In particular, the time of evaluation of the colorectal cancer study IMPALA was substantiated and the final evaluation of the explorative phase II study IMPULSE in the indication of small cell lung cancer was performed. Here the positive signals of the initial evaluation in predefined subgroups were confirmed. In addition, new studies in various indications are in preparation, including the TITAN study in the indication HIV. MOLOGEN also presented the first impressive preclinical data on lefitolimod and its follow-up molecules EnanDIM(R) in the field of immuno-oncology and tumor microenvironment (TME).
Dr Ignacio Faus has taken over the CEO position of MOLOGEN AG since 1 August. He succeeds Dr Mariola Söhngen, who decided not to extend her contract for personal reasons.
“I’m delighted to be on board such an exciting company as MOLOGEN and to be able to contribute my experience in the pharmaceutical sector. In the last six months, many positive things have happened at MOLOGEN: we concluded the first license agreement for the lead compound lefitolimod, successfully implemented important measures to secure corporate financing and continued to drive the clinical trials forward as planned. My goal is to enter into further partnerships with pharmaceutical companies and to bring MOLOGEN’s innovative products to market maturity as quickly as possible,” said Dr Ignacio Faus, CEO of MOLOGEN AG.
Progress in ongoing clinical studies and further studies at the planning stage
The exploratory phase II study IMPULSE in the indication of small cell lung cancer (SCLC), the main results of which MOLOGEN had already published in April 2017, was finally evaluated in the first quarter of 2018. The positive results already presented were confirmed in predefined patient subgroups. The study showed remarkable overall survival results in two relevant patient subgroups compared to the control group. The results support the hypothesis that activated B cells as biomarkers can contribute to the future development of lefitolimod in this relevant subgroup of patients with small cell lung cancer in advanced stages.
Patient recruitment for the phase I combination study with the checkpoint inhibitor Yervoy(R) in collaboration with the MD Anderson Cancer Center in Texas is also making further progress. It is expected that the first part of the study to evaluate the safety of the combination of lefitolimod with checkpoint inhibitors and the determination of the highest tolerated dose of lefitolimod will be completed by 2018. The study will then be continued in 2019 to explore further insights into the combination of lefitolimod with checkpoint inhibitors.
In April, MOLOGEN presented impressive preclinical tumor microenvironment data on lefitolimod and its follow-up molecules EnanDIM(R) at the AACR conference (American Association for Cancer Research) in Chicago and at the ASCO GI (Annual Gastrointestinal Cancers Symposium) in San Francisco in January. Accordingly, monotherapy with lefitolimod leads to an advantageous modulation of the tumor microenvironment, which is accompanied by reduced tumor growth in a colorectal cancer model. These results underscore the strong potential of lefitolimod as a cancer immunotherapeutic agent.
Most important strategic milestone reached: first license agreement for lefitolimod
Successful financing measures and capital consolidation
This was followed by a rights issue of EUR5 million from authorized capital, which was successfully completed and fully placed in March 2018.
On 20 February 2018, MOLOGEN concluded a contract with the Luxembourg-based financing provider European High Growth Opportunities Securitization Fund (EHGO), which is advised by Alpha Blue Ocean Advisors. Under this agreement, MOLOGEN can call convertible bonds with a total value of up to EUR12 million in 24 tranches of EUR500,000 each from the investor over a period of two years. So far, MOLOGEN has drawn down two tranches (in March 2018). These have already been fully converted by EHGO. In total, the Company thus received approx. EUR6.5 million in cash and cash equivalents in the reporting period.
In mid-July the 5:1 capital consolidation under a resolution adopted at the MOLOGEN Annual General Meeting on 8 June 2018 was implemented. Since then, the Company’s share capital has reached EUR7,537,287, divided into 7,537,287 bearer shares (before capital consolidation: 37,686,439 shares). The reverse stock split will make MOLOGEN financially viable again and the financing measures already agreed can continue to be implemented.
The capital measures and framework agreements implemented in the fourth quarter of 2017 and in the first quarter of 2018 are expected to allow the financing of the Company until the end of 2018.
Lower research and development expenses and significant improvement in earnings
Personnel changes on the Executive Board and Supervisory Board
In addition, Dr Michael Schultz, independent expert and consultant for pharmaceutical and biotechnology companies, was elected as a new member of the Supervisory Board of MOLOGEN AG at the 2018 Annual General Meeting.
Forecast for full-year 2018 confirmed
MOLOGEN AG’s complete 2018 half-year report is available on the Company’s website at 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, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.
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