MOLOGEN AG: Focusing on combination therapies
DGAP-News: MOLOGEN AG
/ Key word(s): Quarterly / Interim Statement
PRESS RELEASE No. 20 / 2019 of 7 November 2019
MOLOGEN AG: Focusing on combination therapies
Berlin, 7 November 2019 - In the first nine months of 2019, the biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900, SIN A2L Q90) has placed its strategic focus in all ongoing and planned studies on the treatment of cancer and HIV patients. In the HIV/AIDS indication field the Phase IIa combination trial TITAN, financed by Gilead, has begun with the dosing of the first study participants.
"According to the findings of the IMPALA study, we will focus exclusively on combination approaches in the future, where we perceive great potential. This applies to the further development of lefitolimod and its successor molecules of the EnanDIM(R) platform for cancer and HIV patients. The recently launched TITAN study is an important step as part of our new strategy," says Dr Stefan M. Manth M.D., CEO of MOLOGEN AG.
Moreover, in October 2019 the company announced the start of collaboration with the Amfar (American Foundation for AIDS Research) and the Institute for HIV Cure at the University of California, San Francisco, with the aim of conducting a further clinical combination trial in HIV patients.
In the oncology indication field, the combination study with the checkpoint inhibitor Ipilimumab (Yervoy(R)) continues after successfully finalising the dose escalation phase. In addition, plans are well advanced for a clinical combination study with another checkpoint inhibitor to be conducted in cooperation with Oncologie Inc., a strategic partner based in Boston, USA.
A first TLR9 agonist from the EnanDIM(R) successor technology platform has successfully completed the preclinical program agreed with the authorities. The results and plans for early clinical development were presented and confirmed during a consultation with the Paul Ehrlich Institute. Preparations for the production of the investigational drug are progressing on schedule and the initiation of the Phase I trial for first application in oncological patients is planned for early 2020.
Election of a new Supervisory Board member at the Annual General Meeting
On 29 August 2019, the Company hosted the 2019 Annual General Meeting in Berlin. In addition to the usual agenda items, the election of a Supervisory Board member and the creation of new capital were on the agenda. Dr Friederike Zahm was elected as a member of the Supervisory Board to succeed Gerhard Greif, who was appointed by the court in June. Moreover, the agenda items for the creation of new authorised and contingent capital were widely approved by the shareholders present.
Decreasing research & development spending
R&D expenditure in the period under review amounted to EUR 6.5m (9M 2018: EUR 8.4m), of which EUR1.5m accrued in the third quarter of 2019. The IMPALA study still is the most cost-intensive. The operating result (EBIT) for the period January-September 2019 amounted to -EUR 10.3m, of which -EUR 2.8m was recorded in the third quarter of 2019. EBIT in the third quarter was 35% higher year on year. This change can be explained by the decline in costs for clinical activities.
Monthly cash burn is at a comparable level with the previous year. It averaged EUR1.2m in the period from January to September 2019 and EUR1.1m in the third quarter of 2019. As at the reporting deadline, MOLOGEN AG had EUR 2,833k in cash & cash equivalents and short-term investments (31 December 2018: EUR8,021k).
The downsizing of the organisation, which began immediately after the announcement of the IMPALA results, will reduce the workforce to around one third by mid-2020, as planned. Furthermore, preparatory measures were taken to outsource essential specialist departments and to reduce the number of operating sites from currently three to one.
Financial forecast for full fiscal 2019 affirmed
The statements made in the Management Report for the 2018 financial year in the forecast report for the targets in the areas of research and development, cooperative ventures and partnerships, market preparation and commercialisation as well as the development of earnings and liquidity continue to be valid, with the top-line results of the IMPALA study being announced at the beginning of August 2019 - above all, the unsuccessful proof of the therapeutic superiority of lefitolimod as a monotherapy for metastatic colorectal cancer over standard treatment procedures - have a substantial influence on the further corporate and development strategy.
As regards the expected pre-tax result for 2019, which was forecast in the half-year financial report as of 30 June 2019 at -EUR 14.5m to -EUR16.5m, the Company now expects a result ranging between -EUR 14.0m and -EUR 15.5m.
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.
The focus of MOLOGEN's development is on DNA-based TLR9 agonists. 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 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.
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.
07.11.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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