Something from Mologen and Oncologie
Press Release N 11 / 2018 dated 04/25/2018
MOLOGEN reached key strategic milestones and successfully implements
capital measures in 2017
• First licensing agreement for lead compound lefitolimod concluded
• Significant progress in studies
• Company funding secured until the end of 2018 through successful capital measures
Berlin, 25 April 2018 - The biopharmaceutical Company MOLOGEN AG reached
key strategic milestones in 2017: one major development was the
preparation of a first licensing and cooperation contract for the further
development and commercialization of the lead compound lefitolimod in
China, which was successfully concluded with the U.S. company ONCOLOGIE
Inc. beginning of 2018. The sustainable funding of the Company was once
again a focus in 2017: following the successful issuance of a convertible
bond in January 2017 as well as the Share Subscription Facility with the
U.S. investor Global Corporate Finance, further convertible bonds were
issued after the end of the reporting period to the Luxembourg-based
European High Growth Opportunities Securitization Fund (EHGO) and a
further successful capital increase was carried out. As a result, the
financing of MOLOGEN has been presumably secured until the end of 2018.
Alongside the financial and strategic successes, the Company also made
some significant progress in the area of research and development in 2017.
Key data was presented for two clinical studies: the phase II IMPULSE
study in the indication of small cell lung cancer and the phase Ib/IIa
TEACH extension study in HIV, which has been conducted in collaboration
with the Aarhus University Hospital in Denmark. In 2018, MOLOGEN is
planning to start a further clinical study in the indication HIV together
with the partners in Aarhus and further prominent international centers,
and which will be funded by the U.S. biopharmaceutical company Gilead
Sciences Inc.. In this study, lefitolimod will be tested in combination
with innovative virus-neutralizing antibodies.
"We have had an eventful and productive 2017, a year in which we have
continued to consistently implement the Next Level corporate strategy and
made sustained progress in our product development program. We were
particularly pleased that we were able to conclude a licensing contract
for our lead compound lefitolimod for the first time at the beginning of
2018. In ONCOLOGIE, we have found a right partner to further develop our
product candidate and prepare it for market entry. The focus will continue
to be on the ongoing development of our product pipeline and the
international commercialization of lefitolimod in 2018," comments Dr
Mariola Soehngen, Chief Executive Officer (CEO) of MOLOGEN AG.
The successful further product development is above all owing to the
efforts of the new Chief Medical Officer, Dr Matthias Baumann, who joined
the Executive Board of MOLOGEN in May 2017.
Signing of first licensing contract for lead compound lefitolimod
Fiscal year 2017 was characterized by activities relating to the potential
out-licensing of the lead compound lefitolimod. In February 2018, this
important milestone was reached on conclusion of the contract with
ONCOLOGIE Inc., which has operations established in Boston, Massachusetts
U.S., as well as in Shanghai, China. The company specializes in cancer
treatments and intends to develop innovative personalized drugs in the
area of immuno-oncology. The contract with ONCOLOGIE comprises the
development, manufacturing and commercialization of lefitolimod in the
markets of China and other regions in Asia as well as a global development
cooperation. On conclusion of the contract, MOLOGEN received a first
payment in the amount of EUR3 million. A capital contribution of EUR2
million becomes due to MOLOGEN within 12 months of the contract being
signed. Furthermore, the agreement sets out further milestone payments,
which are paid on reaching certain development targets, on attaining
market approval for lefitolimod and on achieving certain sales thresholds.
The total of these payments could amount to more than EUR100 million over
the course of several years. Additionally, MOLOGEN will be receiving low
double-digit royalties on sales.
First notable results in the TEACH and IMPULSE clinical studies
At the beginning of August, MOLOGEN presented key findings from the phase
Ib/IIa TEACH extension study in the indication HIV, which was carried out
in collaboration with the Aarhus University Hospital in Denmark. The study
provided positive findings with regard to the safety profile and the
effects o the reactivation of the immune system in HIV. This suggests that
lefitolimod could play an important role in combination therapies for the
treatment of HIV in the future. In January 2017, the Danish Aarhus
University had already received a grant of US$2.75million from the U.S.
biopharmaceutical company Gilead Sciences, Inc. to finance a clinical
study in patients with HIV on antiretroviral therapy, in which MOLOGEN's
TLR9 agonist lefitolimod will be investigated in combination with
innovative virus-neutralizing antibodies. Preparations are currently
underway for the study to start presumably in 2018.
The key data from the exploratory phase II IMPULSE clinical trial in
patients suffering from an extensive disease stage of small cell lung
cancer presented for the first time in April 2017 was confirmed in a final
evaluation in the first quarter of 2018: the study showed notable results
with regard to overall survival in two patient subgroups when compared
with the control group. These findings indicate that activated B cells may
serve as a valid biomarker in the potential further development of
lefitolimod in patients with extensive-disease small cell lung cancer. The
clinical phase III IMPALA pivotal study in the indication of metastatic
colorectal cancer progressed as planned. Patient recruitment was completed
in May 2017. The evaluation of the study results is expected to commence
in 2019.
In addition, lefitolimod is being tested in a phase I combination study
with the checkpoint inhibitor Yervoy^(R), which MOLOGEN is conducting in
cooperation with the MD Anderson Cancer Center Texas, U.S.. In 2017,
progress continued to be made with patient enrollment.
MOLOGEN has also successfully carried out preclinical combination studies
with lefitolimod and other immuno-oncological approaches, which are known
as checkpoint inhibitors, as well as with the next-generation molecules
from the EnanDIM^(R) family. In discussions with potential partners, it is
currently reviewing the option of conducting clinical combination trials.
In November 2017, an international consortium to which MOLOGEN belongs was
awarded a grant from Global Health Innovative Technology (GHIT) Fund,
Tokyo, for the further development of a leishmaniasis vaccine based on
MIDGE^(R) technology. Of this grant, MOLOGEN is to receive around EUR2.2
million. Pursuant to the Next Level strategy, MOLOGEN continued with the
planned spin-off or sale of the MIDGE^(R) technology.
Funding secured until the end of 2018: first-time involvement of U.S.
investor
Following the successful issuance of a convertible bond at the beginning
of 2017, which had an issuance volume of EUR4.99 million, a further
important step was taken in October 2017 with regard to the financing of
the Company: with Global Corporate Finance, a relevant investor for the
Company was found in the U.S. for the first time and a Share Subscription
Facility signed for the commitment to purchase up to 10% of the share
capital of MOLOGEN. MOLOGEN has the right to draw down shares in the
amount of up to EUR1 million each for a period of up to 30 months. By
drawing the first two tranches at the end of 2017 and beginning of
February 2018, MOLOGEN has already raised around EUR1 million from this
capital increase. After the end of the reporting period, MOLOGEN concluded
a contract with the Luxembourg-based financing provider European High
Growth Opportunities Securitization Fund. Pursuant to this agreement,
MOLOGEN can place convertible bonds in an aggregate amount of up to EUR12
million with the investor over a period of two years. To date, EUR1
million in convertible bonds have been issued. In March 2018, MOLOGEN
successfully concluded a further capital increase from authorized capital
and generated gross proceeds in the amount of EUR4.99 million.
"We have successfully diversified the funding of MOLOGEN and, by means of
capital measures in 2017 and early 2018 as well as the licensing
agreement, we have secured financing presumably until the end of 2018,
based on current planning," comments Walter Miller, Chief Financial
Officer (CFO) of MOLOGEN AG.
Reduced expenses for research and development
In fiscal year 2017, research and development expenses amounted to EUR14.0
million and were therefore down year on year (previous year: EUR17.0
million). This development was above all owing to the lower study costs
for the concluded IMPULSE study and the IMPALA study, which has recruited
all payments required. Owing to the lower research and development
expenses, EBIT improved to EUR-18.7 million (previous year: EUR-21.0
million).
Cash and cash equivalents amounted to EUR6.5 million as of 31 December
2017 (31 December 2016: EUR20.5 million). This decrease is due to the cash
utilized within the scope of operating activities. As a result of the
increased accumulated deficit, MOLOGEN AG's shareholder's equity amounted
to EUR-4.9 million as at the reporting date of 31 December 2017 (31
December 2016: EUR11.8 million).
Confident outlook for Full Year 2018
The successful development of the product pipeline so far, the further
steps in the implementation of the Next Level corporate strategy and the
commencement of commercialization activities provide the foundation for
the continued positive development of MOLOGEN.
The development of the financial performance and financial position of
MOLOGEN AG in fiscal year 2018 essentially depends on the continued
success of commercialization activities for the product candidate
lefitolimod as well as (pre-)clinical progress and the successful
execution of market preparation. The required additional expenditure in
the area of clinical development is expected to remain at a high level,
but down on the costs of the financial year under review. Alongside the
further funding of the Company, the commercialization, specifically the
conclusion of further license agreement for additional regions, will
therefore continue to be a central task for 2018.
The capital measures and the additionally concluded framework agreements
in 2017 and the first quarter of 2018 together with the first payment from
the licensing and development cooperation contract concluded with
ONCOLOGIE in February 2018 have presumably secured the financing of the
Company until the end of 2018.
The full 2017 Annual Report of MOLOGEN AG is available on the Company's
website at: 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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