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MOLOGEN AG Company Presentation April 2016

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Page 1: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

MOLOGEN AG

Company Presentation

April 2016

Page 2: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 1

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

Page 3: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 2

MOLOGEN AG

MOLOGEN Snapshot

• Based in Berlin, Germany; founded 1998

• ~ 65 employees

Management Board

Extensive expertise and experience in the biotechnological and pharmaceutical industry

Co-founder of the biopharmaceutical company PAION AG, Germany

Extensive expertise in the biotechnological and pharmaceutical industry (Nuvisan GmbH,

Santhera Pharmaceuticals Group)

Long-standing experience in finance and management

Ad interim

Long-standing and extensive expertise in the pharmaceutical industry

Previous experience at MOLOGEN as a Medical Director

Dr. Mariola Soehngen, CEO (since Nov 2015)

Walter Miller, CFO (since Apr 2016)

Dr. Ronald Carter, Senior Medical Officer ‘‘acting CMO’’ (since Apr 2016)

Page 4: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 3

MOLOGEN AG

MOLOGEN Shares

24%

6%

6%

5%

5%

54%

Global Derivative Trading GmbH

Baloise Holding

Deutscher Ring Krankenversicherungsverein a.G.

Salvator Vermoegensverwaltungs GmbH

Deutsche Balaton Aktiengesellschaft

Freefloat

• ISIN DE0006637200

• Shares issued: 22,631,501

• Market capitalization ~ €106m (30 Dec 2015)

• Frankfurt Stock Exchange (Prime Standard): MGN | Reuters: MGNG.DE

Page 5: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 4

MOLOGEN AG

Close network with scientific

institutions & experts

Biotechnology company with

focus on immunotherapies

• One of the pioneers in

immunotherapies

Highly qualified &

dedicated team

• Long-term experience, in

particular in R&D of DNA- and

cell-based products

Advanced products /

promising pipeline

• Lead product lefitolimod

(MGN1703) in registration study

• Three proprietary immunotherapy

platforms

Highly attractive markets

• Immunotherapies: A new

megatrend

• Cancer treatments: A multi-billion

US-$ market

MOLOGEN AG

Company Overview

Page 6: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 5

MOLOGEN AG

MOLOGEN’s Proprietary Immunotherapy Platforms

DNA-based TLR9

agonists

• Bind to TLR9 receptors

• Several products in

development:

• Immune Surveillance

Reactivator ISR

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

Page 7: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 6

MOLOGEN AG

Advanced Product Pipeline with

Strong Focus on Cancer Immunotherapies

Lefitolimod

(MGN1703)1,6

HIV

EnanDIM1

Oncology &

Anti-infectives

Preclinical Phase II Phase III

Lefitolimod

(MGN1703)1

SCLC

Lefitolimod

(MGN1703)1

Colorectal cancer

Phase I

1 TLR9 agonist

2 MIDGE® vector system

3 Cell line modified using MIDGE technology with adjuvant low-dose

Lefitolimod

4 Collaboration with Max-Delbrueck-Center for Molecular Medicine and

Charité Universitaetsmedizin, Berlin

5 Various diseases caused by parasites; mainly present in subtropical and

tropical regions (major neglected disease)

6 Collaboration with University Hospital Aarhus, Denmark

7 Collaboration with MD Anderson Cancer Center, Texas, US; study is

expected to start in H1 2016

Lefitolimod

(MGN1703)1

Other solid tumors

Lefitolimod (MGN1703)1

+ ipilimumab (Yervoy®)7

Advanced solid malignancies

MGN16013

Renal cancer

MGN13312

Leishmaniasis5

MGN13332

Hepatitis B

SCLC small cell lung cancer

MGN14042,4

Malignant melanoma

Oncology

Infectious diseases

Oncology & Infectious diseases

Oncology combination trials

Page 8: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 7

MOLOGEN AG

Strategic Focus: Outlicensing of Products to Generate

High Returns

High returns in the mid- and long-term

Partnering agreement for

lefitolimod (MGN1703)

Continue clinical development

of MGN1601 Unique proprietary technology

High market potential Ensure funding of lefitolimod

(MGN1703) until filing/approval

Initiate new projects Initiate combi trials; extend and advance

product pipeline: ensure long-term growth

Develop vaccine candidates Support to treat diseases with high unmet

medical need: Leishmaniasis & hepatitis B

Page 9: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 8

MOLOGEN AG

Achievements 2015 Until Today

,

Significant progress in patient recruitment for pivotal study IMPALA

Randomized study IMPULSE (SCLC) – Patient recruitment finalized

Continued partnering discussions

Initiated agreement with MD Anderson Cancer Center, US to conduct

combination study with lefitolimod (MGN1703) + ipilimumab (Yervoy®)

Successful capital increase

mCRC metastatic colorectal cancer | SCLC small cell lung cancer

Presented positive clinical data at scientific congresses

TEACH – Completion first phase; start of prolonged treatment phase in Q2 2016

Page 10: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 9

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

Page 11: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 10

MOLOGEN AG

Oncology Market: Leading Therapy Category

Business Overview

Market

lefitolimod (MGN1703) – Cancer Immunotherapy

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2015

Appendix

Worldwide Prescription Drugs in US$ billion Worldwide Oncology Drugs in US$ billion

• Pharmaceutical Industry and prescription

drug sales return to growth

• “Patent cliff” overcome

• Oncology remains the largest segment vs.

outlook 2013

• Highest growth rate & strongest sales increase

worldwide in the long-term

• Immunotherapies represent emerging field =>

new mega-trend with US$ 35 billion market

potential

2014 2020

743

987 CAGR

+4.8%

2014 2020

CAGR

+11.6%

Source: EvaluatePharma 2015 | CAGR Compound Annual Growth Rate

153

79

Page 12: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 11

MOLOGEN AG

Colorectal Cancer & Lung Cancer: High Growth Expected

Colorectal Cancer

Sales in US$ billion1 Lung Cancer

Sales in $US billion2

SCLC

Sales in $US billion3

• Launch of premium-priced

adjuvant / maintenance

therapies will extend first-line

treatment

• Most common cancer worldwide

in terms of incidence and death

• High income countries have

more than double the lung

cancer incidence of low income

countries

• Main drivers for growth: novel

immunotherapies

8.3

9.4

2013 2020

CAGR

+1.8%

4

13

2010 2020

CAGR

+12.5%

0.2

2.3

2014 2024

CAGR

+27.7%

1 5EU, US, Japan & Canada; Source: ResearchandMarkets Jan 2015 2 G7 Countries; Source: MarketsandMarkets Nov 2011 | 3 5EU, US, Japan;

Source: GlobalData, Jan 2016| CAGR Compound Annual Growth Rate I SCLC small cell lung cancer

Page 13: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 12

MOLOGEN AG

Combination Therapies: The Next Opportunity

• Combination therapies are expected to be launched in

increasing numbers in the coming years

• Treatment options will increase with launch of new

immunotherapeutic agents

• Combination of immunotherapy with chemotherapy offer new

potential for breaktrough outcomes

Source: IMS Institute for Healthcare Informatics: “Global Oncology Trend Report 2015 “

New partnering opportunities

Page 14: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 13

MOLOGEN AG

Incidences Oncology1 Incidences by Oncology indication 20122

• Aging populations will increase incident case

rates in all markets covered

• Cancer rates for all cancers combined rise with

increasing levels of country income

• Total number of estimated cancer

cases: 14.1 million

Oncology Market: Sharp Increase of Incidences

14m

20m

2012 2025

+40% 1.8m

1.7m

1.4m 9.2m

Lung

Breast

Colorectum

Other

1 World, Source: IARC “World Cancer Report 2014“ | 2 World, Source: WHO GLOBOCAN 2012 (IARC)

Page 15: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 14

MOLOGEN AG

Cancer Immunotherapies: New Megatrend

Science Magazine:

“Breakthrough of the Year 2013“

US$ 35,000,000,000

market potential*

*Source: Citi-Bank 2013 – estimated peak sales

Page 16: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 15

MOLOGEN AG

Immunotherapy: Superior Treatment Immunotherapy: Superior Treatment

Chemotherapy

• Fast effect in many patients

• Effect not lasting

Immunotherapy

• Needs time to be effective

• Long-lasting effect in a minority

of patients

Control

group

Chemotherapy

time

Patients

alive in %

Immunotherapy

Control

group time

Patients

alive in %

Source: "Immuno-oncology: The new weapon in the war against cancer”, Alistair Campbell; Berenberg Equity Highlights, February 2014

10%

Page 17: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 16

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

Page 18: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 17

MOLOGEN AG

Lefitolimod (MGN1703): ‘Best in Class’ TLR9 Agonist

• Activation profile and chemical structure supports application in

cancer therapy

• High dosing over long periods of time without major toxic effects

• Clinical strategy optimized for lefitolimod (MGN1703) TLR9

activation pattern

Light blue area: recognized by TLR9 receptor

Maximized probability of success compared to other TLR9 agonists

Page 19: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 18

MOLOGEN AG

Activating the Immune System to Fight Cancer

mDC myeloid dendritic cell | NK cell natural killer cell | NKT cell natural killer T cell | pDC plasmacytoid dendritic cell

Cancer

patient

Page 20: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 19

MOLOGEN AG

IMPACT – Phase II Study in Colorectal Cancer

Generated Sustained Long-Term Responses

• Primary endpoint met: Progression free survival

• Secondary endpoint “Overall Survival”: Median OS 22.6 (lefitolimod (MGN1703))

vs. 15.1 months (p=ns)

• Predictive biomarkers identified: Tumor reduction by induction therapy, CEA level,

presence of activated NKTs

• Follow-up of four patients who continued MGN1703 treatment in compassionate use

programs since no relapse at end of study:

Three patients progression-free in excess of 47-55 months as of August 2015

Excellent safety and tolerability, also when treated long-term

Findings from subgroup analyses were used to optimize the phase III study design

CEA carcinoembryonic antigen - a tumor marker for colorectal cancer | NKT Natural Killer T cells | ns not significant

Page 21: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 20

MOLOGEN AG

IMPACT – Sustained Efficacy

April 2010: Patient 049 – Initial diagnosis

• Colon carcinoma with multiple liver metastases

December 2010: After induction chemotherapy

• 06/2010 - 11/2010: 9 courses of CT (FOLFIRI) +

bevacizumab (biologic)

• 12/2010: Response to induction CT: PR*

March 2015: Under maintenance therapy

• Since 12/2010: Lefitolimod (MGN1703) maintenance

therapy

• New PR* after 9 months

• Still ongoing PR (46 months as of August 2015)

• Good medical condition, mild local skin reactions, no

further toxicities

CT chemotherapy | PR partial response | *confirmed by two independent radiologists

Page 22: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 21

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)

• Early Stage

Study (phase I)

• 15 patients

(first phase);

additional 10-11

patients

(extension)

• Denmark

• Extension phase

to start in Q2

2016

Metastatic Colorectal

Cancer (mCRC)

Small Cell Lung

Cancer (SCLC) HIV

(Infectious Disease)

Combination trial

• Lefitolimod

(MGN1703)

+ ipilimumab

(Yervoy®)

• Early Stage

Study (phase I)

• 50-60 patients

• Texas, US

• Study expected

to start in Q2

2016

Advanced solid

malignancies

Page 23: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 22

MOLOGEN AG

IMPALA – Pivotal Phase III 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

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

PD

Page 24: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 23

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

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

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

Page 25: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 24

MOLOGEN AG

TEACH – Phase I Study in HIV

• Collaboration agreement with Aarhus University Hospital, DK conducting the

study; funding received from the American Foundation for AIDS research (amfAR)

• MOLOGEN provides lefitolimod (MGN1703)

• More patients to be treated for 6 months in extension phase based on broad

activation of immune system induced by lefitolimod as 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 26: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 25

MOLOGEN AG

Combination Trial with Lefitolimod (MGN1703) and

Ipilimumab (Yervoy®)

• 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 27: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 26

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

2019

First patient in (FPI)

Recruitment completed

Primary endpoint

analysis (OS)

mCRC metastatic colorectal cancer | SCLC small cell lung cancer I * Study expected to start in Q2 2016

End of recruitment

Combination trial –

Phase I

First patient in (FPI) *

Page 28: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 27

MOLOGEN AG

Conclusion: Late-Stage Product Lefitolimod (MGN1703)

with Unique Profile and Huge Market Potential

Best in class and most advanced in mCRC (pivotal

trial)

Long-term treatment

Usable for various indications (mCRC, SCLC,…)

Superior safety and tolerability

Suitable for mono- and combination therapy

Patient selection via biomarker

Blockbuster

potential

mCRC metastatic colorectal cancer | SCLC small cell lung cancer

Best in class TLR9 agonist and most

advanced in mCRC (pivotal trial)

Long-term treatment

Usable for various indications (mCRC, SCLC,…)

Superior safety and tolerability

Page 29: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 28

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

Page 30: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 29

MOLOGEN AG

MGN1601 – Unique Therapeutic Cancer Vaccination

Page 31: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 30

MOLOGEN AG

ASET Trial with MGN1601: Promising Data

Phase I/II study (12/2010 – 08/2013):

• Open-label, proof-of-principle, multi-center phase I/II trial

• 19 patients with advanced renal cell carcinoma who failed prior

systemic therapies

• Primary endpoint met: Favorable safety and tolerability profile

• Promising overall survival data in subgroup of patients

• Identification of potential biomarkers

Page 32: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 31

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

Page 33: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 32

MOLOGEN AG

EnanDIM® – New Generation of Immunomodulators…

• New class of linear TLR9 agonists

Combines advantages of molecules containing only natural DNA

components with benefits from linear molecules

Specific structure protects against degradation - no chemical

modifications needed

• Broad immune activation shown in pre-clinical models

• Potential application in the fields of cancer and anti-infective therapies

Page 34: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 33

MOLOGEN AG

…Combining Advantages of Two Types of Agonists:

Linear and Not Chemically Modified Structure

• Linear molecules

• Easy and cost-effective production

• Chemically modified structure ( )

Linear

DNA-structure

• Closed, dumbbell-shaped structure

• Only natural DNA components

• Good safety and tolerability profile

• One additional production step

lefitolimod

(MGN1703)

EnanDIM® = Enantiomeric DNA-based ImmunoModulator

New structural feature

Protection against

degradation

• Linear molecules

• No chemical modifications

• Good safety and tolerability profile expected

• Easy and cost-effective production

DNA sequence essential

for function

(so-called “CG motifs”)

Page 35: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 34

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

Page 36: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 35

MOLOGEN AG

Key Financials FY 2015

In € million FY 2015 FY 2014 ∆

R&D expenses 16.8 13.3 26 %

EBIT -20.5 -17.1 20%

Cash flows from operating

activities -15.1 -15.6 -3%

Cash flows from financing

activities 26.2 14.5 81%

Monthly cash burn 1.4 1.4 0%

• R&D expenses increased

due to positive study progress

• Capital increase reflected in

financing cash flows

• Main items impacted by

capital increase In € million 31 Dec 2015 31 Dec 2014 ∆

Total assets 26.4 15.1 75%

Cash & cash equivalents 24.6 13.6 81%

Equity ratio 74% 88% -16%

Page 37: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 36

MOLOGEN AG

Outlook 2016

• Intensify product development

Focus on lefitolimod (MGN1703)

• IMPULSE study: start of analyses towards end of 2016

• IMPALA study: finalize patient recruitment in H2 2016

• 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 increase due to study progress; results accordingly below FY 2015

Page 38: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 37

MOLOGEN AG

• 12 May 2016

Quarterly Statement as of 31 March 2016

• 31 May 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

Financial Calendar and Contact Details

Page 39: Company Presentation April 2016 - MOLOGEN AG · 2018-12-13 · • Lead product lefitolimod (MGN1703) in registration study • Three proprietary immunotherapy ... new mega-trend

© 2016 38

MOLOGEN AG

Agenda

Business Overview

Market

Lefitolimod (MGN1703)

MGN1601 – Therapeutic Vaccination against Cancer

EnanDIM – New Generation of Immunomodulators

Key Financials and Outlook 2016

Appendix

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IMPACT – Phase II Study Design and Results

• Primary endpoint: Progression-free survival

• Double-blind, randomized, placebo-controlled, two-arm, multinational phase II trial with 59 mCRC patients

• Predictive biomarkers identified: Tumor reduction by induction therapy, CEA level, NKT activation

• Start: June 2010 – primary completion date: February 2013

CEA carcinoembryonic antigen - a tumor marker for colorectal cancer | CT chemotherapy | mCRC metastatic colorectal cancer | NKT Natural

Killer T cells | PD progressive disease | s.c. subcutaneous injection | SD stable disease

*at investigators discretion

Maintenance

Trial Treatment Period

Induction CT

4.5-6 months

mCRC patients

treated first-line

with FOLFOX /

XELOX or

FOLFIRI +/-

bevacizumab*

At least

SD

Experimental Group:

60mg lefitolimod

(MGN1703)

twice weekly s.c.

No maintenance

Placebo

Twice weekly s.c.

Screening /

Randomization

2:1

PD**

PD**

** Treatment

after PD at

investigators

discretion

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MOLOGEN AG

Lefitolimod (MGN1703) – Established Mode of Action

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MOLOGEN AG

MGN1601 – ASET Study Design

• Primary endpoints met: safety and tolerability

• Open-label, proof-of-principle, multi-center phase I/II trial

• 19 patients with advanced renal cell carcinoma who failed prior systemic therapies

• Orphan drug designation from EMA

• Start: December 2010 – primary completion date: August 2013

DC Disease Control | EMA European Medicines Agency | i.d. intradermal injection | PD progressive disease | TPP Treatment per protocol

TPP Extension phase

Patients

with

advanced

renal cell

cancer

No

standard

therapy

available

Trial

inclusion

8 applications

of MGN1601

in 12

weeks i.d.

DC

Max. 5

applications in

week 24, 36, 48,

72 and 120

Trial Treatment Period

DC PD**

PD**

** Treatment

after PD at

investigators

discretion 8 applications

of MGN1601

in 12

weeks i.d.

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MOLOGEN AG

MGN1601 – ASET Study Results

Trial

inclusion

DC DC PD**

PD**

• Median OS: 24.8 weeks (ITT group): 115.3 weeks (PP group)

• Potential biomarker identified

MSKCC Score & NLR may have predictive value for longer OS

First evidence of cytotoxic antitumor immune response after

MGN1601 vaccination (in patient subgroup)

Significant improvement of cellular immune function during treatment

(in patient subgroup)

MSKCC Memorial Sloan–Kettering Cancer Center | NLR Neutrophil-Lymphocyte Ratios

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MOLOGEN AG

[in € million] Q4

2015

Q3

2015

Q2

2015

Q1

2015

Q4

2014

Q3

2014

Q2

2014

Q1

2014 2015 2014

R&D expenses 6.4 5.2 2.8 2.4 2.8 4.6 3.0 2.9 16.8 13.3

EBIT -7.2 -6.4 -3.7 -3.2 -3.8 -5.4 -3.8 -4.1 -20.5 -17.1

Cash flow from

operating activities -6.1 -4.3 -2.5 -2.2 -4.1 -5.0 -3.3 -3.2 -15.1 -15.6

Cash flow from

financing activities 0.1 0 26.8 -0.7 -0.2 - -0.1 14.8 26.2 14.5

Monthly cash burn 2.0 1.5 1.4 1.0 1.4 1.7 1.1 1.4 1.4 1.4

Quarterly Key Financials

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MOLOGEN AG

Q3

Quirin Champ. Frankfurt

HSBC HCC Frankfurt

ASCO Chicago, US

WCLC Vienna

EKF FFM

SITC US New

Harbour

EACR UK

Keystone CA, US

DE Krebs- kongress

Berlin

Scientific Conferences Financial Reporting Investor Conferences Clinical Trials

ODDO Frankfurt

AACR New Orleans, US

ODDO Lyon

Q1

Q2

TEACH Topline results

AGM

IMPULSE Start Primary analyses (OS)

FY 2014

JPM HCC SanFran,

US HIV Conf

Boston, US

ASGCT Washington, US

BioEquity, DK

CIMT Mainz ESMO WCGIC

Barcelona Berenberg GS Conf.

MUC

ESMO IO Copenhagen

IMPALA Recruitment completed

Q4

2016

Main Events 2016

Q1 Q2 Q3

CROI Conference on Retroviruses and Opportunistic Infections | ASGCT American Society of Gene Cell Therapy | CIMT Cancer Immunotherapy | EACR European Association of Cancer Research | WCLC World Conference on Lung Cancer | SITC Society for Immunotherapy of Cancer

ASCO GI, SanFran

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MOLOGEN AG

Company Presentation

April 2016