2014-11-20 mologen ag - jefferies final print v-2 · © 2014 10 mologen ag standard first-line...

MOLOGEN AG

Jefferies 2014 London Healthcare Conference

London | 20 November 2014

© 2014 1

MOLOGEN AGV

1-6

DisclaimerCertain statements in this presentation contain formulations or terms referring to the future or future developments, as well as negations of suchformulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this presentationregarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or otherfinancial 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 theseforward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day ofpublication.

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MOLOGEN AGAgenda

Business overview

MGN1703 – cancer immune therapy

MGN1601 – therapeutic vaccination against cancer

EnanDIM - new generation of immunomodulators

Key financials and summary

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MOLOGEN AGCompany overview

• Biotechnology company pioneering in cancer immuno-therapies and DNA vaccines

• Two unique proprietary lead products

MGN1703 – DNA immunomodulator

MGN1601 – therapeutic vaccination

• Solid financing and cash inflow from capital increase in February 2014

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MOLOGEN AGMOLOGEN: Pioneering cancer immune therapies

MGN1703

Immunomodulator and TLR-9 agonist

• Colorectal cancer (mCRC)

• Small Cell Lung Cancer (SCLC)

• Other solid tumors

MGN1601

Therapeutic cancer vaccination

• Renal cancer

• Other solid tumors

• Proof of efficacy (mCRC)

• Superior safety and tolerability

• Currently, two trials ongoing:

1. IMPALA: pivotal Phase III in mCRC

2. IMPULSE randomized in SCLC

ASET: Successful study phase I/II completed

• Superior safety and tolerability

• Promising overall survival data

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MOLOGEN AGAgenda

Business overview





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MOLOGEN AGCancer immunotherapies: New megatrend

Science Magazine: “Breakthrough of the Year 2013“

Cancer immunotherapy is the use of the immune system or components of it to treat cancer

MGN1703

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MOLOGEN AG

• No open ends - protection against degradation

• Only natural DNA components

• No chemical modifications

• High stability

• Broad activation of the immune system

• Only minimal side effects

• No dose-limiting toxicity

• High dosing over long periods of time

MGN1703: ‘Best in Class’ TLR-9 Agonist

Light blue area : recognized by TLR-9 receptor

MGN1703

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MOLOGEN AGActivate the immune system to fight cancer

MGN1703

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

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MOLOGEN AG

• Primary endpoint met: Progression Free Survival (Hazard ratio: 0.55; p=0.04)

• 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 32-40 months as of April 2014

Excellent safety and tolerability, also when treated long-term

Secondary endpoint “overall survival”: results are not yet mature

• Predictive biomarkers identified: CEA level, tumor reduction by induction therapy, activated NKTs

Findings from subgroup analyses used to optimize the IMPALA study design

IMPACT phase II study in colorectal cancer: Outstanding long-term responses

CEA carcinoembryonic antigen - a tumor marker for colorectal cancer | NKT Natural Killer T cells

MGN1703

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MOLOGEN AG

Standard first-line chemotherapy for mCRC

Maintenance

PD Start of 2nd line

Trial Treatment Period

Induction CT14-28 weeks

PR/CRResponder

Screening/Randomization 1:1

PD

PD

PD

MGN1703

Control group

Re-Induction

MGN1703withinduction CT

Induction CT

mCRC metastatic colorectal cancer | CT chemotherapy | PR partial response | CR complete response | PD progressive disease | OS overall survival | QoL quality of life

IMPALA: Pivotal study started in September 2014

• Primary endpoint: OS• Secondary endpoints: e.g. progression-free survival, QoL, toxicity and safety• Open-label, randomized controlled two-arm, multinational phase III trial • 540 patients with metastatic colorectal cancer in more than 100 sites in eight European

countries, including Top 5 European pharma markets

MGN1703

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MOLOGEN AGIMPULSE study started in March 2014

SCLC small cell lung cancer | NSE neuron specific enolase - a tumor marker for lung cancer | NKT Natural Killer T cellsCT chemotherapy | PR partial response | CR complete response | OS overall survival | PD progressive disease

• Primary endpoint: OS• Secondary endpoint: progression-free survival• Randomized controlled two-arm, multinational trial with 100 patients with

extensive disease small cell lung cancer in Belgium, Austria, Germany and Spain• Biomarkers are used as stratification factors: NSE levels and NKTs

Standard first-line chemotherapy for Extensive Disease SCLC

Maintenance

PD Start of 2nd line


Induction CT4 cycles of platinum-based therapy

PR/CRResponder


PD

Experimental arm: 5th cycle of platinum based CT followed by MGN1703 maintenance

Control group: 5th cycle of platinum based CT followed by local practice

MGN1703

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MOLOGEN AGMGN1703: Successful safety trial in the U.S.

• Placebo-controlled, double-blind phase I study in healthy volunteers

• Favorable safety, tolerability and pharmacokinetic profile • Consistent immune activation• Investigational New Drug (IND) application approved by

FDA for MGN1703 in solid tumors

IND enables inclusion of the U.S. in the future MGN1703 development program

MGN1703

FDA US Food and Drug Administration

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MOLOGEN AGMGN1703 – Milestones

PEP primary endpoint | OS overall survival

2014 2015 2016 2017 / 2018

IMPULSE(randomized, controlled trial) First patient in,PEP: OS

IMPULSE Primary analyses (OS)

IMPALA Primary analyses (OS), Filing/Approval

IMPULSE Recruitment completed

IMPALA Recruitment completed

IMPACT (Phase II trial)OS data expected

IMPALA (Phase III trial) First patient in,PEP: OS

Metastatic Colorectal Cancer (mCRC)

Small Cell Lung Cancer (SCLC)

MGN1703

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MOLOGEN AGAgenda

Business overview





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MOLOGEN AGTherapeutic vaccination against cancer – MGN1601

Orphan Drug Status in EU

MGN1601

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MOLOGEN AG

• Final data set from ASET phase I/II study presented at scientific conferences in H1 2014:

Primary endpoint met: Favorable safety and tolerability profile

Promising overall survival data in subgroup of patients

Identification of potential biomarkers

• Orphan Drug designation from EMA

EMA European Medicines Agency

ASET: Promising data from renal cancer trial with tumor vaccine MGN1601

MGN1601

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MOLOGEN AGAgenda

Business overview





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MOLOGEN AGEnanDIM: New generation of immunomodulators

• Combining advantages of two types of TLR-9 agonists• Broad immune activation shown in pre-clinical trials• Potential application in the fields of cancer and anti-infective therapies

• 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

MGN1703

EnanDIM® = Enantiomeric DNA-based ImmunoModulator

New structural featureProtection 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”)

EnanDIM

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MOLOGEN AG

[in € million] Sep 302014

Dec 312013 ∆

Cash & cash equiv. 17.8 14.8 20%

Balance sheet total 19.8 15.9 25%

Equity ratio 86% 94% -9%

[in € million] 9M 2014

9M 2013 ∆

R&D expenses 10.5 4.5 133%

EBIT -13.3 -6.8 96%

Cash flow from operating activities -11.5 -6.1 89%

Cash flow from financing activities 14.7 0 100%

Monthly cash burn 1.4 0.7 100%

• Balance sheet dominated by cash inflow from capital increase of around € 16m

• Preparation of IMPALA and start of IMPULSE studies main drivers of increased R&D costs

• Monthly cash burn increased accordingly

• CF from financing activities includes capital increase

Key financials 9M 2014: Strong cash inflow from capital increase

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MOLOGEN AGLead products: Unique profile and huge market potential

First-line maintenance

Long-term treatment

Usable for various indications

Superior safety and tolerability

Suitable for mono- and combination therapy

MGN1703 MGN1601

Patient selection via biomarker

Blockbuster Potential

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MOLOGEN AG

• March 25, 2015Financial Year 2014

• May 12, 2015Quarterly Report as of March 31, 2015

• August 13, 2015Quarterly Report as of June 30, 2015

• November 12, 2015Quarterly Report as of September 30, 2015

Claudia Nickolaus Head of IR & CommunicationsPhone: +49-30-841788-86Fax: [email protected]

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

Corporate calendar and contact details

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MOLOGEN AG

EnanDIMOncology &

Anti-infectives

Advanced product pipeline with strong focus on cancer immune therapies

Pre-clinic Phase II Phase III/ Approval

MGN17031

Small cell lungcancer

MGN17031

Colorectal cancer

OncologyInfectious diseasesOncology & Infectious diseases

Phase I

1 IND (Investigational New Drug) filed in U.S.; safety trial in U.S. completed2 Collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin

MGN17031

Other solid tumors

MGN1601Renal cancer

MGN14042

Malignant melanoma

MGN1331Leishmaniasis

MGN1333Hepatitis B

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MOLOGEN AGIMPACT study design

• Primary endpoint met: PFS• Secondary endpoint: OS• Double-blind, randomized, placebo-controlled, two-arm, multinational phase II trial in 59 patients with

mCRC from six European countries• Predictive biomarkers identified: CEA level, tumor reduction by induction therapy, activated NKTs• Start: June 2010 – primary completion date: February 2013

CT chemotherapy | SD stable disease | PD progressive disease | s.c. subcutaneous injection | OS overall survival | CEA carcinoembryonicantigen - a tumor marker for colorectal cancer | NKT Natural Killer T cells | mCRC metastatic colorectal cancer | PFS progression free survival

** Treatment after PD at investigators discretion

Induction CT 4.5-6 months

Maintenance

Experimental arm:60mg MGN1703 twice weekly

s.c.

No maintenance Placebo

twice weekly s.c.

PD**

PD**


mCRC patients treated first-line with FOLFOX/ XELOX or FOLFIRI +/- Bevacizumab*

* at investigators discretion

At least SD


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MOLOGEN AGASET study design

PD progressive disease | i.d. intradermal injection | EMA European Medicines Agency

Treatment per protocol

(TPP)

8 applicationsof MGN1601in 12 weeks

i.d.

PD**


Patients with advanced renal cell cancer

Trial inclusion

No standard therapy available

Disease Control

Max. 5 applications in week 24, 36, 48, 72, and 120

Extension phase

• 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

** Treatment after PD at investigators discretion

PD**

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MOLOGEN AG

• ISIN DE0006637200

• Shares issued: 16,973,626

• Max. 1.6 million share options (employee stock option plans)

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

MOLOGEN shares

Free float 53%

Private investor, Germany 24%

Deutscher Ring Krankenversicherungsverein a.G., Germany 8%

Baloise Holding, Switzerland 8%

Salvator Vermoegensverwaltungs GmbH, Germany 7%

Distribution of shares (estimates)

2014-11-20 mologen ag - jefferies final print v-2 · © 2014 10 mologen ag standard first-line...

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