H1 2016 RESULTS
BERLIN, 11 AUGUST 2016
© 2016 1
MOLOGEN AG
Disclaimer
This presentation does not constitute an offer to buy shares or other securities of MOLOGEN AG and does not replace the prospectus. This
announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the
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sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securi ties Act. There will
be no public offer of the securities in the United States. Subject to certain exceptions, the securities referred to in this announcement may not be
offered or sold in Australia, Canada or Japan, or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or
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or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States.
Note about risk for future predictions
Certain statements in this presentation 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 presentation
regarding planned or future results of business segments, financial classification numbers, 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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MOLOGEN AG
Agenda
Highlights H1 2016 Onwards
New Strategy and Update Operations
Key Financials H1 2016 and Outlook 2016
Appendix
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MOLOGEN AG
Highlights H1 2016 Onwards
Operations:
lefitolimod
(MGN1703)
Financials
Study progress resulted in higher R&D expenses; EBIT declined
accordingly
Liquid funds decreased in line with study progress
Clinical study program advanced:
Progress in patient recruitment for pivotal study
Continuation of TEACH study in HIV based on good results from
initial phase: extension phase started in June 2016
Collaboration with MD Anderson Cancer Center, US, Texas: first
combination trial with checkpoint inhibitor started in July 2016
New strategy “Next Level” presented: based on portfolio review
Partnering discussions ongoing
Executive Board New CFO on Board
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MOLOGEN AG
New Strategy “Next Level” – Shift from Research- to
Product- and Market-Oriented Company
• Strong market- and product-oriented strategy program
• Focus on close-to-market compounds:
• Lead product immunomodulator lefitolimod (MGN1703)
• EnanDIM®: Lefitolimod successor molecules and new generation
technology
• MGN1601: Shelve clinical development – backup compound
• MIDGE® technology: Divestment or spin-off
• Streamline company’s organizational structure
• Accelerate commercialization of products via out-licensing
Create added value
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MOLOGEN AG
Target Portfolio: Focus on Lead Product Lefitolimod and
Its Next-Generation Compound EnanDIM®
DNA-based TLR9
agonists (ISRs)
• Bind to TLR9 receptors
• Several Immune
Surveillance Reactivators
(ISR) in development:
• Lefitolimod (MGN1703):
Four trials
• EnanDIM: New class of
linear TLR9 agonists
• Suitable for mono- and
combination therapies
• DNA-based, non-viral
vector system: gene ferries
• Three products in
development:
• MGN1404 (malignant
melanoma)
• MGN1331
(leishmaniasis)
• MGN1333
(hepatitis B)
• Genetically modified human
renal cancer cell line using
MIDGE® platform –
combined with low-dose
lefitolimod as adjuvant
• Phase I/II data available
• Orphan drug status
Cell-based therapeutic
vaccination (MGN1601)
MIDGE® Vector System
Focus Divestment/Spin-off Backup
ISR Immune Surveillance Reactivator
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MOLOGEN AG
Target Product Portfolio – Special Focus on Cancer
Immunotherapies
Platform Compound Indications PC PH I PH II PH III Study Cooperation
partners
DNA-
based
TLR9
agonists
(ISR)
Lefitolimod
(MGN1703)
Metastatic colorectal
cancer (mCRC) IMPALA -
Small cell lung
cancer (SCLC) IMPULSE -
HIV TEACH Aarhus University
Hospital
Advanced solid
malignancies
Lefitolimod &
ipilimumab
MD Anderson
Cancer Center
EnanDIM Cancer / anti-
infective therapies
Therapeutic
Vaccine
(cell-line)
MGN 1601 Renal cancer On hold: backup compound
ISR Immune Surveillance Reactivator I PC pre-clinical
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MOLOGEN AG
Lefitolimod (MGN1703) – Ongoing Clinical Trials
IMPALA IMPULSE TEACH
• Pivotal trial
(phase III)
• 540 patients
• 8 European
countries:
Austria, Belgium,
Estonia, France,
Germany, Italy,
Spain, UK
• Currently
Recruiting
• Randomized
study
• 100 patients
• 4 European
countries:
Austria, Belgium,
Germany, Spain
• Recruitment
completed (Oct
2015)
• Phase I
• 15 patients
(first phase);
15 patients in
extension phase
• Denmark
• Extension phase:
first patients
enrolled
Metastatic Colorectal
Cancer (mCRC)
Small Cell Lung
Cancer (SCLC)
HIV
(Infectious Disease)
Combination trial
• Lefitolimod
(MGN1703)
+ ipilimumab
(Yervoy®)
• Phase I
• 50-60 patients
• Texas, US
• Study started
Advanced Solid
Malignancies
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MOLOGEN AG
TEACH – Phase I Study in HIV
Extension Phase Started in June 2016
• Collaboration agreement with Aarhus University Hospital, DK conducting the
study; funding received from the American Foundation for AIDS research (amfAR)
• MOLOGEN provides lefitolimod (MGN1703)
• Extension phase with a longer treatment period started in June 2016 - based on
the broad activation of immune system induced by lefitolimod shown in first phase:
Activation of plasmacytoid dendritic cells (pDC), natural killer cells (NK)
and T cells in HIV patients during the antiretroviral therapy (ART)
• Final results expected in Q2 2017
Potential expansion of applications
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MOLOGEN AG
Start of Combination Trial with Lefitolimod (MGN1703)
and Ipilimumab (Yervoy®) in July 2016
• Collaboration with MD Anderson Cancer Center, US, Texas
• First combination study of lefitolimod (MGN1703) with checkpoint inhibitor,
commercially available ipilimumab (Yervoy®), manufactured by Bristol-Myers
Squibb Co.
• MD Anderson Cancer Center conducts the trial; MOLOGEN provides lefitolimod
(MGN1703) and funding for the trial
• Phase I trial in 50-60 patients with advanced solid malignancies, mainly melanoma
Potential expansion of applications
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MOLOGEN AG
Lefitolimod (MGN1703) – Milestones Clinical Trials
IMPALA (mCRC) –
Pivotal study
IMPULSE (SCLC) –
Randomized study
TEACH (HIV) –
Phase I
First patient in (FPI)
Recruitment
completed
Start of primary
analyses
Results
Start/end of first
phase
Initial results of first
phase; start extension
Final results
2014
2015
2016
2017
2018
First patient in (FPI)
Recruitment completed
Start primary endpoint
analysis (OS)
End of recruitment
Combination trial –
Phase I
First patient in (FPI)
Start of primary
analyses Results 2019
mCRC metastatic colorectal cancer | SCLC small cell lung cancer
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MOLOGEN AG
Key Financials H1 2016
• Increased R&D expenses as a result of the advanced study program
• Accordingly increased cash burn
• Main items impacted by study progress; cash outflows accordingly
In € million H1 2016 H1 2015 ∆
R&D expenses 7.1 5.2 37%
EBIT -9.8 -6.9 42%
Cash flows from operating activities -9.2 -4.7 96%
Cash flows from financing activities 0 26.1 -100%
Monthly cash burn 1.5 1.2 25%
In € million 30 Jun 2016 31 Dec 2015 ∆
Total assets 16.5 26.4 -37%
Cash & cash equivalents 15.3 24.6 -38%
Equity ratio 59% 74% -20%
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MOLOGEN AG
Key Financials Q2 2016
• R&D expenses increased due to advanced study program
• Accordingly increase of cash burn
• Main items impacted by study progress; cash outflows accordingly
In € million Q2 2016 Q2 2015 ∆
R&D expenses 3.4 2.8 21%
EBIT -5.3 -3.7 43%
Cash flows from operating activities -4.8 -2.5 92%
Cash flows from financing activities 0,0 26.8 -100%
Monthly cash burn 1.6 1.4 14%
In € million 30 Jun 2016 31 Dec 2015 ∆
Total assets 16.5 26.4 -37%
Cash & cash equivalents 15.3 24.6 -38%
Equity ratio 59% 74% -20%
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MOLOGEN AG
Outlook 2016 Confirmed
• Intensify product development
Focus on lefitolimod (MGN1703)
• IMPULSE study: start of analyses towards end of 2016
• IMPALA study: finalize patient recruitment end of 2016 /
beginning of 2017
• Continue TEACH study with extension phase
• Start combination study with ipilimumab (Yervoy®) in patients
with solid cancers in cooperation with the MD Anderson
• Evaluation of additional combination studies
• Evaluate and prioritize pipeline
• Continue partnering discussions
• R&D expenses increased due to study progress; results accordingly
below FY 2015
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MOLOGEN AG
Next Steps
• Capital increase in H2 2016
• Intensify partnering discussions
• Start analyses of IMPULSE study (lung cancer) at the end of 2016
• Push forward patient recruitment for IMPALA (colorectal cancer)
© 2016 15
MOLOGEN AG
Financial Calendar and Contact Details
• 12 May 2016
Quarterly Statement as of 31 March 2016
• 11 August 2016
Annual General Meeting
• 11 August 2016
Half-Yearly Financial Report as of 30 June 2016
• 07 November 2016
Quarterly Statement as of 30 September 2016
Claudia Nickolaus
Head of Investor Relations &
Corporate Communications
Phone: +49-30-841788-38
Fax: +49-30-841788-50
www.mologen.com
MOLOGEN®, MIDGE®, dSLIM®, and EnanDIM® are registered trademarks of the MOLOGEN AG
© 2016 16
MOLOGEN AG
Agenda
Highlights H1 2016 Onwards
Update Operations
Key Financials H1 2016 and Outlook 2016
Appendix
© 2016 17
MOLOGEN AG
IMPALA – Pivotal Phase II Study in mCRC
PD
Lefitolimod
(MGN1703)
Maintenance Re-Induction
Trial Treatment Period
Induction CT
12–30 weeks
Standard first-line
CT for mCRC
PR/CR
Responder
Screening/
Randomization
1:1 Control
group PD
Lefitolimod
(MGN1703)
with
induction CT
Induction
CT
PD
Start of
2nd line
• Primary endpoint: Overall survival
• Open-label, randomized, controlled, two-arm, multinational phase III trial
• 540 patients in around 120 sites in eight European countries, including Top 5
European pharma markets
• Biomarkers used as stratification factors: CEA level and NKT activation
PD
CT chemotherapy | CR complete response | PR partial response | PD progressive disease | mCRC metastatic colorectal cancer |
CEA carcinoembryonic antigen - a tumor marker for colorectal cancer | NKT Natural Killer T cells
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MOLOGEN AG
IMPULSE - SCLC Randomized Study
• Primary endpoint: Overall survival
• Randomized, controlled, two-arm, multinational trial with 100 patients in Belgium,
Austria, Germany and Spain
• Biomarkers used as stratification factors: NSE level and NKT activation
• Patient enrollment completed: End of October 2015
Maintenance
Trial Treatment Period
Induction CT
4 cycles of
platinum-based
therapy
Standard first-line
CT for extensive
disease SCLC
PR/CR
Responder
Screening/
Randomization
3:2
Experimental Group:
5th cycle of platinum based
CT followed by lefitolimod
(MGN1703) maintenance
Control Group:
5th cycle of platinum
based CT followed by
local practice
PD
PD
Start of
2nd line
CR complete response | CT chemotherapy | NKT Natural Killer T cells | NSE neuron specific enolase - a tumor marker for lung cancer |
PD progressive disease | PR partial response | SCLC small cell lung cancer
© 2016 19
MOLOGEN AG
Quarterly Key Financials
[in € million] Q2
2016
Q1
2016
Q4
2015
Q3
2015
Q2
2015
Q1
2015
Q4
2014
Q3
2014
Q2
2014 2015 2014
R&D expenses 3.4 3.7 6.4 5.2 2.8 2.4 2.8 4.6 3.0 16.8 13.3
EBIT -5.3 -4.5 -7.2 -6.4 -3.7 -3.2 -3.8 -5.4 -3.8 -20.5 -17.1
CF from oper-
ating activities -4.8 -4.4 -6.1 -4.3 -2.5 -2.2 -4.1 -5.0 -3.3 -15.1 -15.6
CF from finan-
cing activities 0.0 0.0 0.1 0.0 26.8 -0.7 -0.2 - -0.1 26.2 14.5
Monthly cash
burn 1.6 1.5 2.0 1.5 1.4 1.0 1.4 1.7 1.1 1.4 1.4
© 2016 20
MOLOGEN AG
MOLOGEN Shares
• ISIN DE0006637200
• Shares issued: 22,631,501
• Market capitalization 66.5m (30 June 2016)
• Frankfurt Stock Exchange (Prime Standard): MGN | Reuters: MGNG.DE
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54%
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© 2016 21
MOLOGEN AG
H1 2016 RESULTS
BERLIN, 11 AUGUST 2016