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H1 2016 RESULTS BERLIN, 11 AUGUST 2016

H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

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Page 1: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

H1 2016 RESULTS

BERLIN, 11 AUGUST 2016

Page 2: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 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

United States of America (the “United States”), Australia, Canada or Japan or in any jurisdiction. The securities referred to in this announcement

will not be and have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”) and ma y not be offered or

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

Japan. The offer and sale of the securities referred to in this announcement has not been and will not be registered under th e U.S. Securities Act

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.

Page 3: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 2

MOLOGEN AG

Agenda

Highlights H1 2016 Onwards

New Strategy and Update Operations

Key Financials H1 2016 and Outlook 2016

Appendix

Page 4: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 3

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

Page 5: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 4

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

Page 6: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 5

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

Page 7: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 6

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

Page 8: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 7

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

Page 9: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 8

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

Page 10: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 9

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

Page 11: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 10

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

Page 12: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 11

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%

Page 13: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 12

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%

Page 14: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 13

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

Page 15: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 14

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)

Page 16: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 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

[email protected]

www.mologen.com

MOLOGEN®, MIDGE®, dSLIM®, and EnanDIM® are registered trademarks of the MOLOGEN AG

Page 17: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 16

MOLOGEN AG

Agenda

Highlights H1 2016 Onwards

Update Operations

Key Financials H1 2016 and Outlook 2016

Appendix

Page 18: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 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

Page 19: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 18

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

Page 20: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 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

Page 21: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 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

24%

6%

6%

5%

5%

54%

Global Derivative Trading GmbH

Baloise Holding

Deutscher Ring Krankenversicherungsverein a.G.

Salvator Vermoegensverwaltungs GmbH

Deutsche Balaton Aktiengesellschaft

Freefloat

Page 22: H1 2016 RESULTS...2016/08/11  · Key Financials H1 2016 •Increased R&D expenses as a result of the advanced study program •Accordingly increased cash burn •Main items impacted

© 2016 21

MOLOGEN AG

H1 2016 RESULTS

BERLIN, 11 AUGUST 2016