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Tuesday, 05/15/2018 3:31:48 AM

Tuesday, May 15, 2018 3:31:48 AM

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Mologen AG / Onkologie

: MOLOGEN AG: significant progress in clinical studies and successful funding and licensing activities dominated first quarter of 2018 - EQS Group
15-May-2018 07:05:02
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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:
EUR-4.9 million).
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
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.
1 www.mologen.com
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
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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15.05.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Regulated Market in Frankfurt (Prime Standard); Regulated
Listed: Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange
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