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1 GERMAN FALL CONFERENCE EQUITY FORUM DR STEFAN M. MANTH CHIEF EXECUTIVE OFFICER FRANKFURT, 3 SEPTEMBER 2019

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Page 1: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

1

GERMAN FALL

CONFERENCE –

EQUITY FORUM

DR STEFAN M. MANTH

CHIEF EXECUTIVE OFFICER

FRANKFURT, 3 SEPTEMBER 2019

Page 2: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

2

THE THREE REASONS TO INVEST IN MOLOGEN NOW

• Well seasoned Management Team

• Solid strategy post phase III failure

• Lucrative entry level

Page 3: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

3

WELL SEASONED MANAGEMENT TEAM

Dr Stefan M. Manth, CEO

More than 30 years industry

experience

20 years career in the Roche

Group, incl. Global Business

Director Oncology, Biotech

Product development, strategy,

business, turn-around and

change management, Boards

Dr Matthias Baumann, CMO

Almost 30 years industry

expertise

R&D and corporate leader-

ship positions in pharma,

CRO and biotech

Boehringer Mannheim,

Roche, FOCUS, NOXXON

C-Level plus eVP-like Level:

all highly experienced pharma- and biotech-professionals

Page 4: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

4

LEFITOLIMOD JUST FAILED IN A PHASE III TRIAL (IMPALA)

Randomized, prospective, multi-centric, multi-national trial (around 100 trial sites

in 8 EU-countries)

Lefitolimod as single agent versus standard maintenance treatment in

metastatic colorectal cancer (mCRC) patients who responded to 1L standard

induction therapy

Primary objective of the trial: prolongation of overall survival

Secondary endpoints: PFS (progression-free survival, overall response rates,

pharmacodynamics, safety and tolerability)

A steering board made up of the top opinion leaders in the field

Tried and tested safety monitoring board

549 patients enrolled between September 2014 and May 2017

A major achievement in and of itself for a small biotech

Page 5: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

5

IMPALA TRIAL RESULTS INFORM THE WAY FORWARD

The destilled essentials

1. Lefitolimod (MGN1703) did not top standard maintenance treatment in mCRC as single

agent

2. The very favorable safety and tolerability profile of lefitolimod was once again

convincingly confirmed

3. Immunemonitoring of the patients on trial clearly confirms the biologic activity

(pharmacodynamics) of the TLR9-agonist lefitolimod

What does that tell us?

• TRL9 remains a valid molecular target for therapeutic activation of immunity

• We will concentrate all efforts on developing combination immunotherapeutic approaches

in anti-cancer and anti-HIV treatment going forward

Page 6: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

6

THE WAY FORWARD:

PURE-PLAY COMBINATION STRATEGY

Compliant close-out of the IMPALA trial by year end 2019

Lefitolimod

anti-HIV: Opportunistic support of renowned academic research institutions in the area of HIV/AIDS TITAN-trial with Aarhus University, Denmark Another two trials in collaboration with US-based researchers in advanced stage of planning,

combining lefitolimod with highly innovative immunotherapeutic approaches

anti-cancer: In combination with Yervoy® (Ipilimumab) at MD Anderson Cancer Center in Houston, Texas/USA In combination with a (marketed) CPI-inhibitor with a reputable European trial center (ex

IMPALA-site) in collaboration with our strategic partner Oncologie International Inc., Boston, Massachusetts/USA and Shanghai/China

Further smaller, explorative clinical studies to further profile the TLR9-principle for its immune-activating and TME-modulating capacity

EnanDIM®

First clinical candidate expected to be phase I-ready by year end 2019, projected to start

Phase I clinical testing with a pure-play combination development strategy in oncology

On-going funding and partnering efforts revolve around this strategy

Page 7: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

7

Pre-clinical

Data1

Data generated

by other TLR9

Agonists4

Safety- &

pharmaco-

dynamic-Data3

Clinical

evidence,

MD Anderson2

TLR9 agonists +

checkpoint inhibitors

Promising clinical data

on positive modulation

of the Tumor Micro-

environment (TME)

Clinical evidence of

enhanced anti-tumor

activity in malignant

melanoma

Lefitolimod

Confirmed safety in

433 cancer-, 20 HIV-

patients and 13

healthy volunteers

Positive

immunomodulatory

activity in 7 clinical

trials

Lefitolimod &

Ipilimumab

Favorable

modulation of tumor

mircorenvironment in

humans

Safely combined

with a commercial

checkpoint inhibitor

Combination approaches

for lefitolimod and EnanDIM®

1Kapp, J ImmuoTher Cancer, 2019; Kapp, OncoImmunol, 2019; 2Reilley, ASCO, 2019;

3PD – Pharmacodynamik, Quelle: Mologen AG; 4Wang, 2016; Ribas, 2018; Wang, 2018;

Diab, 2018; Milhem, 2018

STRONG PRE-CLINICAL + CLINICAL EVIDENCE IN

SUPPORT OF TLR9 COMBINATION APPROACHES

Lefitolimod,

EnanDIM®

Modulation of Tumor

Microenvironment

(TME)

Clear evidence of

enhancement of

other agents

immunogenic

efficacy

Page 8: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

8

PUBLISHED HIGHLIGHTS

1Kapp, OncoImmunol, 2019; 2Kapp,, ESMO-IO, 2017; 3Kapp, J ImmunoTher Cancer, 2019

Pre-clinical Data: Lefitolimod and EnanDIM®

Advantageous immune modulation of the tumor micro-environment 1-3

Striking enhancement of the anti-tumor effect of checkpoint-inhibitors1,2

EnanDIM® Vehicle EnanDIM® Vehicle

Lefitolimod

IgG + EnanDIM®

aPD-1 + EnanDIM®

aPD-1

IgG

Fold

vs.

CE

F

EnanDIM®

Page 9: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

9

MD Anderson Cancer Center:

Clinical trial – Lefitolimod in combination with Ipilimumab (Yervoy®)

Also in this combination, lefitolimod is well tolerated and safely administrable1

Clear evidence of immuno-modulating activity in patients1

PUBLISHED HIGHLIGHTS

1Reilley, ASCO, 2019

Advantageous modulation of the tumor micro-environment

Reilley, 2019

Paired biopsies in 5 patients show

evidence of T-cell activation with

combination therapy.

Tumor cell immune infiltrates shows

increased proportion and activation of

cytotoxic T lymphocytes.

PD-1 expression increased after

treatment suggesting potential benefit

from additional PD-1 blockade.

Page 10: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

10

PUBLISHED HIGHLIGHTS

1Thomas, Ann Oncol, 2018; 2Schmoll, J Cancer Res Clin Oncol, 2014

PD - Pharmacodynamik

Combined clinical data package for lefitolimod: safety and pharmacodynamics

Advantageous immuno-modulating activity in diverse clinical settings1,2

Favorable safety and tolerability profile1,2

Systemic immune activation

Th

om

as e

t a

l., A

nn

On

co

l, 2

01

8

10.3-

fach

3.3-

fach

2.1-

fach

1.5-

fach

Mode of Action

Page 11: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

11

STRONG BASIS ALSO FOR COMBINATION APPROACHES

IN HIV – PUBLISHED HIGHLIGHTS

Clinical Daten from TEACH A und B Studies

Advantageous immuno-modulating activity1-4

Favorable safety profile in HIV-patients1,2

1Vibholm, Clin Infect Dis, 2017; 2Vibholm, AIDS, 2019, 3Krarup, Mucosal

Immunol, 2017; 4Schleimann, E Bio Med, 2019

Type-I Interferon response in colon biopsies

Safety and Tolerability

Systemic immune activation

We conclude that 24 weeks of MGN1703 dosing,

concomitant with cART or alone during the ATI, was

safe and well tolerated.

Activated

NK cells

IFNa2a

Vibholm, 2019

Page 12: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

12

TITAN – LEFITOLIMOD ON ITS WAY TO

CLINICAL PROOF OF CONCEPT (POC) IN HIV

1www.clinicaltrials.gov, NCT03837756, 2019; 2Lu, Science, 2016; 3Bruel, Nat Comm, 2016; 4Scheid,

Nature, 2016; 5Caskey, Nat Med, 2017; 6Borducchi, Nature 2018; 7Gaudinski, CROI, 2018; 8Stephenson, CROI, 2019; 9Bar, New Endl J Med, 2016

TITAN Study: Lefitolimod in combination with broadly neutralizing monoclonal

antibodies

General information:

Sponsor: University of Aarhus/Denmark, funded by GILEAD

Start of this Investigator Initiated Trial in several Danish trial sites and additional centers to come

on-line from USA and Australia

Co-operation partnerships with the Rockefeller University and GILEAD Science Inc.

Study design / Rationale

Study objective: to achieve viral control1

Design based on data from the TEACH trial and more recent pre-clinical and clinical evidence

pertaining to neutralizing antibodies2-9

Synergistic effects expected by combining both immunotherapeutic modalities

+ Another two immunotherapeutic combination trials with renowned US academic

study groups in HIV/AIDS in the making

Page 13: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

13

STRATEGIC ALLIANCE WITH

Strategic alliance forged by MOLOGEN with OncologiE International Inc. in Feb. 2018

• License to develop, manufacture and commercialize lead compound lefitolimod in

China, Hong Kong, Macao, Taiwan, and Singapore

• Global Co-development agreement with a focus on immunotherapeutic combination

approaches

Company Profile (www.oncologie.international):

• Series B financing round closed this summer with proceeds of US$ 80 million

• On a mission to build a global immuno-oncology therapy development presence

• Clinical development team on ground in China, building global organization

• Staffed with and managed by industry professionals with in total over 60 man years

of experience in global oncology drug development

• Headquartered in Boston, USA, with operations in Boston and Shanghai

The partnership is alive and productive:

at present, jointly designing first combination trials

Page 14: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

14

Study

TEACH/

TITAN/

ASET

MGN1601 (paused)

Renal Cell Carcinoma

Solid Tumors

IO Combination5

HIV MonoTX / Combination3,4

Pre-clinic Phase I Phase II Phase III

LEFITOLIMOD

HIV

MD

Anderson

EnanDIM®

EnanDIM®

Candidates: Oncology

EnanDIM®

Candidates: HIV

Advanced Solid Tumors

IO Combination1,2

Oncology

Study

TEACH/

TITAN/

ASET

MGN1601 (paused)

Renal Cell Carcinoma

Solid Tumors

IO Combination6

HIV Combination5

HIV MonoTX / Combination3,4

Pre-clinic Phase I Phase II Phase III

LEFITOLIMOD

HIV

MD

Anderson

EnanDIM®

EnanDIM®

Candidates: Oncology

EnanDIM®

Candidates: HIV

Advanced Solid Tumors

IO Combination1,2

Oncology

PIPELINE

1cooperation with MD Anderson Cancer Center, Texas, USA; 2combinaton with Yervoy®/Ipilimumab; 3cooperation with

Universitätsklinikum Aarhus, Denmark; 4combination with virus-neutralizing antibodies in TITAN and various combination

approaches in other studies; 5studies in preparation; abbreviation: IO - immuno-oncology

TITAN

others

Study

TEACH/

TITAN/

ASET

MGN1601 (paused)

Renal Cell Carcinoma

Solid Tumors

IO Combination5

HIV MonoTX / Combination3,4

Pre-clinic Phase I Phase II Phase III

LEFITOLIMOD

HIV

MD

Anderson

EnanDIM®

EnanDIM®

Candidates: Oncology

EnanDIM®

Candidates: HIV

Advanced Solid Tumors

IO Combination1,2

Oncology

TEACH

Study

TEACH/

TITAN/

ASET

MGN1601 (paused)

Renal Cell Carcinoma

Solid Tumors

IO Combination5

HIV MonoTX / Combination3,4

Pre-clinic Phase I Phase II Phase III

LEFITOLIMOD

HIV

MD

Anderson

EnanDIM®

EnanDIM®

Candidates: Oncology

EnanDIM®

Candidates: HIV

Advanced Solid Tumors

IO Combination1,2

Oncology

Study

TEACH/

TITAN/

ASET

MGN1601 (paused)

Renal Cell Carcinoma

Solid Tumors

IO Combination5

HIV MonoTX / Combination3,4

Pre-clinic Phase I Phase II Phase III

LEFITOLIMOD

HIV

MD

Anderson

EnanDIM®

EnanDIM®

Candidates: Oncology

EnanDIM®

Candidates: HIV

Advanced Solid Tumors

IO Combination1,2

Oncology

Page 15: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

15

ENANDIM® –

NEXT GENERATION INNOVATIVE TLR9 AGONISTS

Kapp,, ESMO-IO, 2017; Kapp, J ImmunoTher Cancer, 2019

Broad activation of immunity with expected

favorable safety and tolerability profile based

on unique molecular design

Pure, natural DNA

Pronounced induction of Type I-Interferon

pathway without inflammation

No toxicities frequently seen with other

chemically-modified TLR9 agonists

Broad therapeutic window (larger dosing

range)

Systemic and intratumoral application

possible

Amenable to high-dose long-term treatments

Activation of both, the innate and the adaptive

immunity

Herausragende Eigenschaften

Family of linear DNA Molecules

Potent immune activating sequences without any

chemically modified components (using enantiomeric

sugar moieties)

Resistant to enzymatic degradation through

enantiomeric modifications at the 3’ end

Unique immunomodulating properties

Indication specific molecular Design

5‘ 3‘

Natural DNA backbone

Non-methylated CG-motif

L-deoxyribose containing nucleotides

Unique molecular design Exceptional Features

Page 16: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

16

ENANDIM® – FIRST CLINICAL CANDIDATE ON ITS WAY TO

PROOF OF CONCEPT (POC) IN COMBINATION WITH CPI

EnanDIM® - ideally suited for combination immunotherapeutic approaches

Dual mechanism of action activates both, the innate as well as the adaptive immunity

Safety and tolerability profile no add-on toxicities to be expected

Meaningful combination approaches

Immunotherapeutic combination approaches with complementary modes of action , e.g.

checkpoint inhibition (CPI)

Planned clinical development strategy:

Phase 1 / 2:

Dose ranging and definition of RP2D

Confirmation of safety profile

Phase 2: Clinical Proof-of-concept

in combination with checkpoint inhibition in several relevant oncology indications in parallel

Page 17: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

17

KEY FINANCIALS 2018 AND HY2019

In million € 2018 2017 ∆%* 6M

2019

6M

2018 ∆%*

Revenues 3.0 0.0 n.a. 0.1 3.0 -97

R&D expenses 10.3 14.0 26% 5.0 5.6 +11

EBIT -11.3 -18.7 40% -7.5 -4.5 -67

CF from operating activities -13.7 -19.1 28% -8.7 -6.5 -34

CF from financing activities 15.2 5.1 198% 6.6 6.2 +6

Monthly burn-rate 1.1 1.7 35% 1.4 1.1 +27

In million € 31.12.

2018

31.12.

2017 ∆%*

30.06.

2019

31.12.

2018 ∆%*

Total assets 9.4 8.1 16% 7.7 9.4 18

Cash and cash equivalents 8.0 6.5 23% 6.0 8.0 25

Equity -0.9 -4.9 n.a. -2.6 -0.9 -189

Equity Ratio -10% -60% n.a. -34% -10% -240

Staff employed 50 52 -4% 47 50 -6

Notes: R&D Research & Development | CF Cash flows; accuracy of the %-deviations corresponds to the rounded values

*Economic view/ minus = neg. impact, plus = pos. impact

Page 18: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

18

ONGOING RESTRUCTURING PROGRAM

Key elements of the plan

• Closing down of the IMPALA trial in compliance with all applicable rules and

regulations

• Clinical development focus for EnanDIM® and lefitolimod on combination

immunotherapies; lefitolimod program going forward exclusively in support of IITs

(anti-cancer and anti-HIV)

• Patent-Portfolio management in search of saving potentials

• Downsizing the organization in line with operational needs to run the program

• Reduction of other operational costs corresponding to resized organization and

program focus

• Moving quotation from PRIME Standard to GENERAL Standard under evaluation

Page 19: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

19

EXPECTED RESULTS FROM RESTRUCTURING EFFORTS

Results

• Reduction of personnel costs by about 60% yoy in 2020 (as a result of normal fluctuation and terminations)

• IMPALA closure savings 1.7 million EUR

• Corresponding to downsizing further savings in G&A

• Monthly burn-rate reduction from on average of 1.4 million EUR in 2019

to on average 0.8 million EUR in 2020

• Funding needs till end of 2020 around 10 million EUR

Page 20: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

20

PERFORMANCE OF MOLOGEN SHARES –

2 JANUARY - 16 AUGUST 2019

0%

50%

100%

150%

200%

250%

300%

MOLOGEN AG (XETRA) DAX sub Biotech Perf. Tec DAX

12.07.

announcement of

postponement of

AGM due to IMPALA

readout date

19.02.

Start Coverage

MainFirst

28.02.

creditors

meeting

27.03.

new CEO announced

02.04.

Results of capital

raise announced

11.04.

Definite

Cancellation of

EGM

05.08.

IMPALA

top-line

results

announced

13.03.

Announcement

date of capital

raise

Page 21: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

21

SHAREHOLDER STRUCTURE AUGUST 2019

<25%

<5%

70%

Global Derivative Trading GmbH, DE

Deutsche Balaton Aktiengesellschaft, DE

Streubesitz

Page 22: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

22

CONCLUSIONS

1. The TLR9 principle remains a valid principle and molecular target in

immunotherapy in oncology and HIV/AIDS

2. The IMPALA trial marks the end of the single-agent approach for lefitolimod in

anti-cancer immunotherapy; the study will be closed early in compliance with all

rules and regulations

3. In order to reap the full potential of our TLR9 agonist portfolio (dSLIM and

EnanDIM®), we will focus exclusively on combination immunotherapeutic

approaches going forward

4. The ongoing anti-HIV program is a new focal area in our portfolio, where

lefitolimod is tested in clinical trials in combination with other highly innovative

anti-HIV treatment modalities

5. We continue the ongoing pre-clinical program to make the first EnanDIM®

clinical candidate phase I-ready by year end 2019 and to launch it into clinical

testing for combination anti-cancer immunotherapy in 2020.

6. Our ongoing licensing and funding efforts revolve around this strategic

approach

Page 23: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

23

THANK YOU FOR YOUR ATTENTION QUESTIONS?

Page 24: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

24

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 may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securities 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 the 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 25: GERMAN FALL CONFERENCE EQUITY FORUM · 2019-09-03  · Group, incl. Global Business Director Oncology, Biotech Product development, strategy, business, turn-around and change management,

25

GERMAN FALL

CONFERENCE –

EQUITY FORUM

DR STEFAN M. MANTH

CHIEF EXECUTIVE OFFICER

FRANKFURT, 3 SEPTEMBER 2019