Press release N 9/2019 of 30 April 2019
MOLOGEN AG: Clinical studies progress as planned and successful funding measures in fiscal year 2018
- Clinical and pre-clinical studies proceed according to plan
- Top line data for phase III IMPALA study expected as early as summer 2019
- Conclusion of the first licensing and development agreement for the marketing of lefitolimod
- Successful implementation of funding measures
- Lower R&D costs and improved EBIT
- Personnel changes at Executive Board and Supervisory Board level
Berlin, 30 April 2019 - For the biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900 / SIN A2LQ90), fiscal year 2018 has brought both positive developments and its fair share of challenges. The preclinical and clinical studies with the lead product candidate lefitolimod in addition to pre-clinical studies with the lefitolimod follow-up molecules EnanDIM(R) were successfully progressed. A particular success was the conclusion of the first licensing and development agreement with the US drug developer ONCOLOGIE for the marketing of lefitolimod in China and other countries in Asia. By successfully implementing various capital measures in 2018 and early 2019, MOLOGEN was able to secure the ongoing financing of the Company. In 2018 and at the start of the new fiscal year, there were also personnel changes at Executive Board and Supervisory Board level. Dr Stefan M. Manth, so far Deputy Chairman of the Supervisory Board, will succeed Dr Ignacio Faus as CEO in addition to assuming the CFO functions, a role previously filled by Walter Miller, from 1 May 2019 on - both Dr Faus and Walter Miller left the Company effective 31 March 2019.
Dr Matthias Baumann, Chief Medical Officer (CMO): "2018 was an exciting and challenging year for MOLOGEN and we have achieved a fair deal. In particular, we have secured the Company's financing presumably until the end of 2019. The next important milestone will be the read-out of the top line data of our phase III IMPALA pivotal study with the lead product lefitolimod this summer. In addition, we are planning further studies with lefitolimod and its follow-up molecules EnanDIM(R), which we are aiming to have ready for clinical development by the end of the year".
Successful further development of the clinical and pre-clinical studies - top line IMPALA study data expected as early as summer 2019
In 2018, the clinical studies with the lead compound lefitolimod progressed according to plan: We are eagerly anticipating the evaluation of the top line data of the phase III IMPALA pivotal study in the indication of metastatic colorectal cancer in particular. The Company expects that this data will be ready sooner than expected, potentially even as early as summer 2019. In the first quarter of 2018, the IMPULSE study in the indication of advanced small cell lung cancer was finally evaluated and the results presented at the ESMO Congress (European Society for Medical Oncology), as well as being published in the Annals of Oncology, the ESMO's high-ranking, peer-reviewed journal. MOLOGEN has also presented detailed study results from the extension phase of the phase Ib/IIa TEACH study in the indication HIV. The further development strategy in this indication plans to use lefitolimod in the context of combination therapies. The TITAN combination study, funded by Gilead Sciences, USA, is set to begin in spring 2019. Progress also continues to be made with regard to the first combination study of lefitolimod with the checkpoint inhibitor Yervoy(R) (Ipilimumab) in patients with solid tumors in collaboration with MD Anderson Cancer Center at the University of Texas, USA. The first study phase, which above all served to ascertain dosage and offer an initial evaluation of safety profile as well as early signs of potential efficacy, has been successfully completed and the results were presented at the SITC 2018 Congress (The Society for Immunotherapy of Cancer) in Washington, USA.
Moreover, in 2018 and early 2019, promising research and development results on the further immunological profiling of lefitolimod and its follow-up molecules EnanDIM(R) were presented at various international conferences and published in high-ranking scientific journals. The data which MOLOGEN presented on EnanDIM(R) in April 2019 was especially promising: Accordingly, monotherapy with one of the EnanDIM(R) candidates in murine tumor models led to a sustained immunological memory, which demonstrably not only triggers specific immune responses against the original tumor but also recognizes and fights against tumors of a different origin. The available data supports the assumption that lefitolimod and EnanDIM(R) successfully create 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.
Continual implementation of the strategy for the out-licensing of lefitolimod
The implementation of the strategy, particularly with regard to a potential out-licensing of the lead product lefitolimod, was the focus of business activity in 2018, alongside continued progress in the clinical studies. This includes talks with potential cooperation and licensing partners in particular as well as preparatory activities on the possible approval of lefitolimod. The conclusion of a licensing agreement for China and additional Asian countries with the US drug developer ONCOLGIE in February 2018 was a first important success. MOLOGEN is holding talks with its partner regarding the structure of the global development cooperation, particularly with regard to the associated study program.
Inflow of liquidity of around EUR27 million
As a result of several successfully implemented capital measures in the past fiscal year and up to and including April 2019 as well as initial payments from the licensing and development cooperation agreement with ONCOLOGIE, a cash inflow of around EUR27 million has been achieved. Group financing is expected to be assured until the end of 2019. The acquired funds will mainly be used to finance ongoing business operations, and in particular the funding of the IMPALA study. The individual funding measures have been outlined in detail in the 2018 Annual Report.
Following negotiations with the main bond creditors and subsequent adjustments to the bond conditions, MOLOGEN was able to avert the threat of an early repayment obligation of the convertible bonds 2016/2024 and 2017/2025 in the amount of EUR6.4 million falling due on account of a contractually agreed exceptional right of termination on the part of the main creditors in the event of a capital reduction. The result of these negotiations and the associated measures were presented to all creditors of the convertible bond 2017/2025 during a meeting of creditors on 28 February 2019 put to the vote and accepted by a large majority.
Reduction of R&D costs and a further improvement in EBIT
In fiscal year 2018, MOLOGEN generated revenues totaling EUR3.05 million, considerably up on the prior year (2017: EUR0.05 million). They essentially resulted from an initial payment in conjunction with the licensing agreement with ONCOLOGIE. At EUR10.3 million, expenditure and investment in the area of R&D during 2018 stood significantly below that of the previous year (2017: EUR14.0 million). This is due in particular to the conclusion of the TEACH and IMPULSE clinical studies, as well as the advanced stage of the IMPALA study. The average monthly cash consumption was accordingly lower in 2018 at EUR1.1 million (2017: EUR1.7 million).
Our earnings before tax (EBIT) developed positively: Including the initial payment in the context of the ONCOLOGIE licensing agreement, EBIT amounted to EUR-11.3 million compared with
EUR-18.7 million in the previous year. As of 31 December 2018, the Company's liquid funds stood at EUR8.0 million. (12/31/2017: EUR6.5 million).
At EUR15.2 million, cash flow from financing activity was also significantly higher than the previous year's figure (2017: EUR5.1 million) and was influenced by the cash inflows from the issuance of the convertible bonds and the cash capital increases.
Personnel changes on the Executive Board and Supervisory Board
On 01 August 2018, Dr Ignacio Faus replaced Dr Mariola Soehngen, who left the Company on 31 October 2018, as CEO. Dr Faus left the Company ahead of schedule on 31 March 2019. CFO Walter Miller also departed MOLOGEN at the end of March 2019 upon expiration of his contract. Dr Stefan M. Manth is expected to take over the role of CEO and the CFO functions on 01 May 2019. Before moving to the Executive Board, Dr Manth had been Deputy Chairman of the Supervisory Board of MOLOGEN AG since 2014. Dr Manth's successor in the Supervisory Board will be promptly announced in due course. Dr Michael Schultz has been the new member of the Supervisory Board since June 04, 2018.
Outlook for whole year 2019
The development of the financial performance and financial position of MOLOGEN in fiscal year 2019 essentially depends on the continued success of development and commercialization activities for the product candidate lefitolimod as well as additional (pre)clinical progress and the successful realization of market preparations. The success of commercialization activities for lefitolimod is closely linked to the top line results of the IMPALA study, which the Company expects to have by the summer of the current fiscal year. Further expenditure in the area of clinical development is expected to remain at a high level, but down on the costs recorded in this area during the previous fiscal year. If the ongoing licensing and partnership talks lead to further contracts in 2019, this could have a notable positive impact on the financial performance and financial position of the Company.
The complete 2018 Annual Report of MOLOGEN AG is available on the Company's website: www.mologen.com.
MOLOGEN AG is a biopharmaceutical company and considered 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 our development work is on the product family of DNA-based TLR9 agonists. This includes the immunotherapy lefitolimod and its follow-up molecules EnanDIM(R).
The immunotherapy lefitolimod is the Company's lead product and is currently being tested in a phase III study. It is regarded as a "best in class" TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. Due to this mechanism of action, lefitolimod has the potential to be applied to a number of different indications. Lefitolimod is currently being developed within the scope of a pivotal study for first-line maintenance treatment of colorectal cancer. Important data on the phase II study IMPULSE in advanced single cell lung cancer (ES-SCLC) and the extension phase of the TEACH study in HIV has been announced. In addition, lefitolimod is being investigated with the checkpoint inhibitor ipilimumab (Yervoy(R)) in various cancer indications within the scope of a phase I combination study. Alongside various checkpoint inhibitors, lefitolimod is one of the few product candidates in the field of immuno-oncology which is close to market. It is currently in a clinical phase III pivotal study.
MOLOGEN's pipeline focus is on new innovative immunotherapies in particular to treat diseases for which there is a great medical demand.
MOLOGEN AG is headquartered in Berlin and is listed on the stock exchange. The shares of the Company (ISIN DE000A2LQ900/WKN: A2L Q90) are listed on the Prime Standard at the Frankfurt Stock Exchange (ISIN Q90).
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Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The Company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The Company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.
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