STRATEGY PROGRAM NEXT LEVEL BERLIN, 9 JUNE 2016



Similar documents
MOLOGEN AG German Equity Forum 2015

MOLOGEN AG. Q1 Results 2015 Conference Call Dr. Matthias Schroff Chief Executive Officer. Berlin, 12 May 2015

COMPANY PRESENTATION JUNE 2016

MOLOGEN AG. Dr. Matthias Schroff Chief Executive Officer Dr. Alfredo Zurlo Chief Medical Officer. Roadshow Abu Dhabi, Dubai April 2015

THE POWER OF IMMUNOTHERAPIES THE POWER OF IMMUNO- THERAPIES

MOLOGEN AG interim report as of September 30, 2015 Key data 2. Patient recruitment for lung cancer and HIV studies successfully completed

MOLOGEN AG interim report as of June 30, 2015 Key data 2. H H Change % Revenues Profit (loss) from operations (EBIT)

MOLOGEN AG interim report as of March 31, 2015 Key data 2

Novel Targeted Immunotherapy Approach for Metastatic Melanoma Under Phase 3 Investigation

Pfizer Forms Global Alliance with Merck KGaA, Darmstadt, Germany to Accelerate Presence in Immuno-Oncology. November 17, 2014

Malignant Mesothelioma - Pipeline Review, H2 2014

IMMUNOMEDICS, 300 The American Road, Morris Plains, New Jersey (973) Fax (973)

IMMUNOMEDICS, INC. February Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases

Biotech Short Profile

Malignant Pleural Mesothelioma - Pipeline Review, H2 2014

Transgene Presents Additional Positive Clinical Data from Phase 2b Part of TIME Trial with TG4010 at ESMO

A Letter from MabVax Therapeutics President and Chief Executive Officer

MOLOGEN. Our research - for you. Interim Report as of March 31, 2013

MOLOGEN: Our research for you. Interim financial statements as of June 30, 2011

Domanda di innovazione nel mondo industriale. Modalità di interazione tra pubblico e privato

Corporate Presentation June 2, 2015

Ending cancer. Together.

SORRENTO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

EVT Execute & EVT Innovate World-class drug discovery

10 th EADO Congress Vilnius, 7-10 May Ipilimumab update. Michele Maio

Oxford BioMedica. Annual Results 2008

SMALL BUSINESS INNOVATION RESEARCH (SBIR) SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS

EVT Execute & EVT Innovate Leading drug discovery

NEW CLINICAL RESEARCH OPTIONS IN PANCREATIC CANCER IMMUNOTHERAPY. Alan Melcher Professor of Clinical Oncology and Biotherapy Leeds

Q PRESENTATION February 9, 2016 Per Walday, CEO Ronny Skuggedal, CFO

Aeterna Zentaris. 11 th Annual Needham Healthcare Conference April 3, Committed to cure

Overview of Phase 1 Oncology Trials of Biologic Therapeutics

Valneva Reports Preliminary FY 2013 Revenues of EUR 36.0m and Cash Position of EUR 40.2m at End of 2013

Avastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022

Transgene in 2007: Partnership and Refinancing Position the Company for its Future Development

Targeted Therapy What the Surgeon Needs to Know

Biotest AG. Company Presentation. July Company Presentation EU. Biotest AG

Genomic Medicine The Future of Cancer Care. Shayma Master Kazmi, M.D. Medical Oncology/Hematology Cancer Treatment Centers of America

Groundbreaking Collaborative Clinical Trial Launched

Acute Myeloid Leukemia Therapeutics Market to 2020

Automating Cell Biology Annual general meeting, September 7, Phase Holographic Imaging

Adaptimmune Reports Full Fiscal Year 2015 Financial Results. - Conference call to be held today at 8:00 AM ET (1:00 PM BST) -

Company Presentation June 2011 Biotest AG 0

Building A Focused Oncology Business

News Release. Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma

Increasing Innovation in R&D - Seizing early stage external growth opportunities

What You Need to Know About Lung Cancer Immunotherapy

Clinical Trials: The Crux of Cancer Innovation

The Cell Therapy Catapult UK Clinical Trials Database

Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development

Oncology Central MEDIA PACK 2016 SPONSORSHIP ADVERTISING NETWORKING

Strategic Consulting Services

Nuevas tecnologías basadas en biomarcadores para oncología

Immunovaccine Inc. (TSX: IMV) (OTCQX: IMMVF)

Achievements Report CURING CANCER. Of all the questions addressed to CPRIT, the toughest is: When are you going to find a cure for

TABLE OF CONTENTS. Introduction...1. Chapter1 AdvancesinTreatment...2. Chapter2 MedicinesinDevelopment Chapter3 ValueandSpending...

Job Profile Clinical Research Associate III (CRA)

Eudendron: an Innovative Biotech Start-up

August 28, Company Update Commerzbank Sector Conference Week

Company presentation. 7 th European Life Science CEO Forum Zurich, 4-5 March Paolo Bassanini Business Development & IR

PEDIATRIC MEDICINES: GLOBAL MARKETS

Data from an interim analysis from the pivotal Phase 3 trial of YONDELIS in soft tissue sarcoma, SAR-3007, will be presented in an oral presentation

BNC105 PHASE II RENAL CANCER TRIAL RESULTS

Exelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference

Commercial Insight: Cancer Targeted Therapies and Immunotherapies -Top monoclonal antibody brands will resist competitive pressures through to 2019

Affitech A/S reports financial result for the first six months of 2012

Servier Exercises Exclusive Worldwide Licensing Option with Cellectis for UCART19, an Allogeneic CAR-T Cell Therapy for Hematological Malignancies

Bringing Biotech and Specialty Chemical Expertise to Our Customers

Advances in Treatment of Malignant Pleural Mesothelioma: A Reason for Hope

CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early

BNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED

Issues. Does the academe have as a goal or an obligation, the development of its discoveries for human benefit?

a Phase 2 prostate cancer clinical trial is ongoing. Table 2: Squalamine vs Standard-of-care literature

Sommaire projets sélectionnés mesure 29: Soutien à la recherche translationnelle

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

Cancer Immunotherapy: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies - Overview

Bioinformatics for cancer immunology and immunotherapy

Localised Cancer Treatment. PCI Biotech. Amphinex a new product for localised cancer treatment

Join our scientific talent community

Abbott Diagnostics. Durable Growth Business

Improving Life Transforming Value. May 1 st, 2015

Immune Therapy for Pancreatic Cancer

Building innovative drug discovery alliances. Profitable. Growth Go

Galapagos reports largest cash balance ever

The University of Texas Health Science Center at San Antonio Tobacco Funds Budget Fiscal Year Ending August 31, 2015

EVT Execute & EVT Innovate Innovation Efficiency

Systematic Drug Repurposing: Some Successes, Caveats, and Directions

2 nd Quarter 2009 Results

How To Learn More About Melanoma

A survey conducted by: The Swedish Drug Development Pipeline May 2011

Moving forward, where are we with Clinical Trials?

FOR NEGLECTED DISEASES

Stem Cell-based Therapies and FDA Regulations

Santhera Reports Successful 2006

Therapeutic Systems Immunology

Immunotherapy Concept Turned Reality

Attached from the following page is the press release made by BMS for your information.

The Past, Present & Future of Cancer Immunotherapy:

18.5 Percent Overall Response Rate Observed in Pembrolizumab-Treated Patients with this Aggressive Form of Breast Cancer

Bayer Invests Heavily in R&D and is committed to innovation Sustained Innovation Output from all Subgroups

Transcription:

STRATEGY PROGRAM NEXT LEVEL BERLIN, 9 JUNE 2016

Disclaimer 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 forwardlooking 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. 2016 1

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 2016 2

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 MIDGE Vector System DNA-based, non-viral vector system: gene ferries Three products in development: MGN1404 (malignant melanoma) MGN1331 (leishmaniasis) MGN1333 (hepatitis B) Cell-based therapeutic vaccination (MGN1601) 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 Focus Divestment/Spin-off Backup 2016 3

Target Product Portfolio Focus on TLR9 Product Family: Lefitolimod and EnanDIM Platform Compound Indications PC PH I PH II PH III Study Cooperation partners Metastatic colorectal cancer (mcrc) IMPALA - DNAbased TLR9 agonists (ISR) Lefitolimod (MGN1703) Small cell lung cancer (SCLC) HIV IMPULSE - TEACH Aarhus University Hospital Advanced solid malignancies Lefitolimod & ipilimumab MD Anderson Cancer Center EnanDIM Cancer / antiinfective therapies Therapeutic Vaccine (cell-line) MGN 1601 Renal cancer On hold: backup compound ISR Immune Surveillance Reactivator I PC pre-clinical 2016 4

Lean and Effective Corporate Structure MOLOGEN AG Focus on products in late-stage and clinical development Shut down majority of research activities and outsource where still necessary Shut down own production activities and outsource to enable larger production volume (upscale) for a potential market entry Reduce headcount Variability of costs and increased flexibility 2016 5

Next Steps MOLOGEN AG Complete reorganization by the end of 2016 Ensure financing based on the new strategy Continue partnering discussions Supported by external Pharma and Biotech Business Development Team No substantial impact on guidance for FY 2016 2016 6

Financial Calendar and Contact Details MOLOGEN AG 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 investor@mologen.com www.mologen.com 2016 MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the MOLOGEN AG 7

Appendix MOLOGEN AG 2016 8

Advanced Product Pipeline with Strong Focus on Cancer Immunotherapies (As May 2016) Preclinical Phase I Phase II Phase III EnanDIM 1 Oncology & Anti-infectives Lefitolimod (MGN1703) 1 Other solid tumors Lefitolimod (MGN1703) 1 SCLC Lefitolimod (MGN1703) 1 Colorectal cancer MGN1331 2 Leishmaniasis 5 MGN1333 2 Hepatitis B Lefitolimod (MGN1703) 1,6 HIV Lefitolimod (MGN1703) 1 + ipilimumab (Yervoy ) 7 Advanced solid malignancies Oncology Infectious diseases Oncology & Infectious diseases Oncology combination trials SCLC small cell lung cancer MGN1601 3 Renal cancer MGN1404 2,4 Malignant melanoma 1 Immune Surveillance Reactivator and 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 shortly 2016 9

Lefitolimod (MGN1703) Ongoing Clinical Trials IMPALA IMPULSE TEACH Metastatic Colorectal Cancer (mcrc) Pivotal trial (phase III) 540 patients 8 European countries: Austria, Belgium, Estonia, France, Germany, Italy, Spain, UK Currently Recruiting Small Cell Lung Cancer (SCLC) Randomized study 100 patients 4 European countries: Austria, Belgium, Germany, Spain Recruitment completed (Oct 2015) HIV (Infectious Disease) Early Stage Study (phase I) 15 patients (first phase); 15 patients in extension phase Denmark Extension phase to start shortly Combination trial Advanced Solid Malignancies Lefitolimod (MGN1703) + ipilimumab (Yervoy ) Early Stage Study (phase I) 50-60 patients Texas, US Study expected to start shortly 2016 10

Lefitolimod (MGN1703) Milestones Clinical Trials IMPALA (mcrc) Pivotal study IMPULSE (SCLC) Randomized study TEACH (HIV) Phase I Combination trial Phase I 2014 First patient in (FPI) First patient in (FPI) 2015 Recruitment completed Start/end of first phase 2016 Recruitment completed Start of primary analyses Initial results of first phase; start extension First patient in (FPI) * 2017 2018 Start primary endpoint analysis (OS) Results Final results End of recruitment mcrc metastatic colorectal cancer SCLC small cell lung cancer I * Study expected to start shortly 2016 11

STRATEGY PROGRAM NEXT LEVEL BERLIN, 9 JUNE 2016