2014-11-20 mologen ag - jefferies final print v-2 · © 2014 10 mologen ag standard first-line...
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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.
© 2014 2
MOLOGEN AGAgenda
Business overview
MGN1703 – cancer immune therapy
MGN1601 – therapeutic vaccination against cancer
EnanDIM - new generation of immunomodulators
Key financials and summary
© 2014 3
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
MGN1703 – cancer immune therapy
MGN1601 – therapeutic vaccination against cancer
EnanDIM - new generation of immunomodulators
Key financials and summary
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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
Trial Treatment Period
Induction CT4 cycles of platinum-based therapy
PR/CRResponder
Screening/Randomization 3:2
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
MGN1703 – cancer immune therapy
MGN1601 – therapeutic vaccination against cancer
EnanDIM - new generation of immunomodulators
Key financials and summary
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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
MGN1703 – cancer immune therapy
MGN1601 – therapeutic vaccination against cancer
EnanDIM - new generation of immunomodulators
Key financials and summary
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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 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 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
APPENDIX
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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**
Trial Treatment Period
mCRC patients treated first-line with FOLFOX/ XELOX or FOLFIRI +/- Bevacizumab*
* at investigators discretion
At least SD
Screening/Randomization 1:1
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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**
Trial Treatment Period
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)