Press release N 14 2019 of 14 August 2019
MOLOGEN AG: Funding measures successfully implemented and important operational milestones achieved in H1 2019
- Successful implementation of two capital measures secure funding
- Lefitolimod: Preparatory measures for read-out of the top-line data of the IMPALA pivotal study: Negative findings regarding efficacy announced after reporting period
- EnanDIM(R): Preclinical trials for the first clinical product candidates carried out as planned
- Strategic focus on combination therapies with lefitolimod and EnanDIM(R) in the indications of oncology and HIV/AIDS
- Advanced plans with strategic partner company Oncologie Inc. to conduct a first joint clinical project
- Phase IIa TITAN study in the indication HIV about to start
- Dr med Stefan M. Manth assumed office as CEO on 01 May
Berlin, 14 August 2019 - The biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900 / WKN A2LQ90) has advanced its study program according to plan in the first half of 2019 and successfully implemented capital measures to secure funding for the Company. Following a diligent approach to processing the study data for the initial evaluation of the Phase III IMPALA pivotal study with lefitolimod in the indication of metastatic colorectal cancer, the read-out of the top-line data was announced at the beginning of August. The primary study goal - a significant prolongation of overall survival of the patients - was not achieved. The beneficial safety profile and good tolerability of lefitolimod were again confirmed. Based on these results, MOLOGEN's future strategy will focus on developing combination therapies. In the indication of HIV/AIDS the Phase IIa TITAN combination study, for which Gilead is providing the funding, is about to start enrolling patients. In the indication of oncology, the combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)) is continuing after the dosing escalation phase was successfully concluded. Furthermore, great progress has been made in plans for a clinical combination study with another checkpoint inhibitor. This would be conducted in collaboration with the strategic partner Oncologie Inc., which is based in Boston, USA.
The preclinical program for the first TLR9 agonist from the next-generation EnanDIM(R) technology will shortly be completed. The preparations for production of the investigational drug have advanced according to plan, with the first clinical trials expected to be initiated at the end of 2019.
During the first six months of 2019, there were personnel changes at the level of Executive Board and Supervisory Board: Chief Financial Officer (CFO) Walter Miller left the Company upon expiration of his contract as planned. Dr Faus terminated his contract prematurely and was replaced as Chief Executive Officer (CEO) by Dr med Stefan M. Manth, a long-standing member of the Supervisory Board. Gerhard Greif was legally appointed by a court to fill the vacancy on the Supervisory Board that arose as a result of Dr med Manth's appointment as CEO until the end of the Annual General Meeting on 29 August 2019.
"The initial evaluation of our phase III IMPALA study, which ultimately delivered a disappointing result, was a key event over the last few months. We had all been hoping for different news. Nevertheless, we can take encouragement from the fact that the biological activity in addition to the exceptional safety profile and good tolerability of lefitolimod were once again proven, allowing us to continue along our chosen path of innovative combination therapies in the area of HIV/AIDS. In the indication of oncological diseases, we will also be focusing exclusively on combination approaches for the first clinical candidates from the EnanDIM(R) family", Dr med Stefan M. Manth, CEO of MOLOGEN AG, commented.
Top-line data for the IMPALA pivotal study released at the start of August
In the first six months of 2019, MOLOGEN carried out clinical and preclinical studies with the lead product candidate lefitolimod as planned. At the beginning of August, the top-line data for the IMPALA study were published. The study compared the TLR9 agonist lefitolimod with the standard maintenance treatment in patients suffering from metastatic colorectal cancer whose tumors have responded to first-line induction therapy. The primary study goal was not achieved. However, the beneficial safety and tolerability profile of lefitolimod was once again impressively confirmed. It can therefore be claimed that lefitolimod is well suited for use as a partner in combination therapies, which will form the basis of the Company's future strategic development focus.
Lefitolimod is currently being investigated in a clinical phase I/II study in combination with the checkpoint inhibitor Yervoy(R) (ipilimumab) across a broad spectrum of solid tumors. The study is being carried out at the renowned MD Anderson Cancer Center, Texas, USA. The most recent, encouraging findings on the desired therapeutic immuno-oncological modulation of the TME were presented at the ASCO Congress in Chicago at the beginning of June 2019.
Initial promising data from the preclinical trials with lefitolimod follow-up molecules EnanDIM(R)
With regard to the lefitolimod follow-up molecules EnanDIM(R), MOLOGEN AG published for the first time at the beginning of 2019 a comprehensive profile of the EnanDIM(R) family including molecular design, mechanism of action and preclinical data in the high-ranking, scientifically renowned Journal for ImmunoTherapy of Cancer. The available data supports the assumption that lefitolimod and EnanDIM(R) successfully generate a beneficial modulation of the tumor microenvironment (TME) and, together with a favorable safety profile, could potentially be perfect partners for immuno-oncological combination approaches. An initial candidate from the EnanDIM(R) platform is currently at an advanced stage of preclinical evaluation, with clinical development in the area of oncology due to begin at the end of 2019.
Strategic focus on combination therapies
The IMPALA study marks the end of the development of lefitolimod as an immunological monotherapy treatment for cancer. In light of these results, MOLOGEN will therefore in future place a strategic focus on combination approaches to treat cancer and HIV patients for both lefitolimod and the initial clinical candidates from the EnanDIM(R) family in all current and planned studies. This strategy is also the basis for current licensing and funding efforts.
The phase IIa TITAN combination study in the indication of HIV, which MOLOGEN will carry out together with Aarhus University, Denmark, is about to start enrolling patients. In this study, the TLR9 agonist lefitolimod will be investigated in combination with innovative, virus-neutralizing antibodies developed by Rockefeller University, New York, USA. Moreover, plans for further clinical combination studies in conjunction with a renowned US Center for HIV are at a very advanced stage. Furthermore, two combination studies with other immuno-oncological approaches in solid tumors are also at an advanced stage of planning and could begin in 2019, provided the necessary funding is obtained.
Successful capital measures secure funding
In January, the convertible bond 2019/2027 was placed in full with an issue volume of EUR2.7 million. In April 2019, MOLOGEN also successfully concluded a cash capital increase from authorized capital that was significantly oversubscribed, raising gross proceeds of around EUR4.2 million.
With regard to the previously issued convertible bond 2017/2025, a meeting of creditors on 28 February 2019 approved the agreement reached at the end of October 2018 with the main bond creditor and the associated adjusted bond conditions. The resolutions put forward by the Company were accepted by a large majority.
Lower research and development expenses
Overall, the Company's financial performance and financial position developed in line with expectations: In the first six months of 2019, revenues of EUR0.1 million were realized (H1 2018: EUR3.0 million). In H1 2019, expenditure for research and development stood at EUR5.0 million and therefore below the value of the previous year (EUR5.6 million). The largest proportion of this expenditure was attributable to costs related to conducting the IMPALA study. The operating result (EBIT) fell to EUR-7.5 million (previous year: EUR-4.5 million), as income from licensing agreements amounting to EUR3.0 million was taken into account in the same period of the previous year. Average monthly cash consumption increased to EUR1.4 million per month (previous year: EUR1.1 million). As of 30 June 2019, the Company's cash and cash equivalents stood at EUR6.0 million (12/31/2018: EUR8.0 million).
With effect from 31 March 2019, Dr Ignacio Faus stepped down early as Chief Executive Officer of MOLOGEN, a position he had assumed back in August 2018. On the same date, Chief Financial Officer Walter Miller also ended his term in office on expiration of his contract. Both positions were filled by Dr med Stefan M. Manth as of 01 May 2019, who had been Deputy Chairman of the Supervisory Board of MOLOGEN AG since 2014. The vacancy on the Supervisory Board arising in the wake of Dr med Manth taking up his new position as CEO was filled by attorney Gerhard Greif. He was appointed by the court as new member of the Supervisory Board with effect from 17 June 2019 until the end of the Annual General Meeting on 29 August 2019. In the past, Gerhard Greif has advised the Company in various areas, particularly with regard to approaching investors and capital market funding.
Financial forecast for full year 2019 confirmed
The statements made in the Forecast Report section of Management Report for fiscal year 2018 on the objectives in the areas of research and development, co-operations and partnerships, earnings and liquidity development as well as personnel (cf. Annual Report 2018, page 56 et. seq) remain valid, although it is important to underline that the top-line data pertaining to the IMPALA study published at the beginning of August - above all the failure to demonstrate the superiority of lefitolimod as a monotherapy over standard treatment approaches for metastatic colorectal cancer - will have a substantial influence on the Company's further corporate and development strategy.
MOLOGEN AG's complete 2019 half-year report is available on the Company's website at: www.mologen.com.
MOLOGEN AG is a German 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 HIV and infectious diseases.
The focus of MOLOGEN's development is on DNA-based TLR9 agonists, where it has consistently been ahead of the course. This includes the lead compound, the immunotherapy lefitolimod, and its next generation molecules EnanDIM(R), building the foundation for a next generation immunotherapy platform in areas of unmet need.
Forthcoming milestones include: the start of the TITAN study in HIV, the start of the clinical development of EnanDIM(R) and additional combination studies in cancer, including one with our strategic partner Oncologie Inc., which are in an advanced planning stage.
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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