MOLOGEN AG German Equity Forum 2015

Transcription

1 German Equity Forum 2015 Dr. Mariola Söhngen Chief Executive Officer Frankfurt am Main 24 November 2015

2 We are Pioneers in the Field of Immunotherapies Biotechnology company with focus on immunotherapies Advanced products / promising pipeline Highly attractive markets Highly qualified & dedicated team Close network with scientific institutions & experts

3 Strategic Focus: Outlicensing of Products to Generate High Returns License agreements with pharma companies High returns in the mid- and long-term Prioritize development of lead product MGN1703 High market potential Continue clinical development of MGN1601 Unique proprietary technology Develop vaccine candidates Support to treat diseases with high unmet medical need: Leishmaniasis & hepatitis B Initiate new projects Extend and advance product pipeline to ensure long-term growth

4 Advanced Product Pipeline with Strong Focus on Cancer Immunotherapies Preclinical Phase I Phase II Phase III / Approval EnanDIM Oncology & Anti-infectives MGN Other solid tumors MGN Small cell lung cancer MGN Colorectal cancer MGN1331 Leishmaniasis 3 MGN1333 Hepatitis B MGN HIV MGN1601 Renal cancer MGN Malignant melanoma Oncology Infectious diseases Oncology & Infectious diseases 1 IND (Investigational New Drug) filed in US; safety trial in US completed in Collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin 3 Various diseases caused by parasites; mainly present in subtropical and tropical regions (major neglected disease) 4 Collaboration with University Hospital Aarhus, Denmark

5 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

6 Immunotherapy: Superior Treatment Chemotherapy Fast effect in many patients Effect not lasting Patients alive in % Immunotherapy Needs time to be effective Long-lasting effect in a minority of patients Patients alive in % Chemotherapy Immunotherapy Control group time Control group time Source: "Immuno-oncology: The new weapon in the war against cancer, Alistair Campbell; Berenberg Equity Highlights, February

7 MGN1703: Best in Class TLR9 Agonist Activation profile and chemical structure supports application in cancer therapy High dosing over long periods of time without toxic effects Clinical strategy optimized for MGN1703 TLR9 activation pattern Maximized probability of success compared to other TLR9 agonists Light blue area: recognized by TLR9 receptor

8 Activating the Immune System to Fight Cancer Cancer patient mdc myeloid dendritic cell NK cell natural killer cell NKT cell natural killer T cell pdc plasmacytoid dendritic cell

9 MGN1703 Ongoing Clinical Trials IMPALA IMPULSE TEACH Metastatic Colorectal Cancer (mcrc) Pivotal trial (phase III) Smal Cell Lung Cancer (SCLC) Randomized study (phase II) HIV (Infectious Disease) Early Stage Study (phase I) 540 patients 8 European countries: Austria, Belgium, Estonia, France, Germany, Italy, Spain, UK Currently Recruiting 100 patients 4 European countries: Austria, Belgium, Germany, Spain Recruitment completed (Oct 2015) 16 patients Denmark Recruitment completed (Sep 2015)

10 MGN1703 Milestones Clinical Trials IMPALA IMPULSE TEACH 2014 First patient in (FPI) First patient in (FPI) 2015 Recruitment completed Recruitment started and completed 2016 Recruitment completed Start of Primary analyses Start of Primary analyses Results 2017 Primary analyses First Results 2018 First Results

11 Conclusion: Late-Stage Product MGN1703 with Unique Profile and Huge Market Potential First-line maintenance Long-term treatment Usable for various indications (mcrc, SCLC, ) Superior safety and tolerability Blockbuster potential Suitable for mono- and combination therapy Patient selection via biomarker mcrc metastatic colorectal cancer SCLC small cell lung cancer

12 Key Financials: 9M 2015 defined by study progress In million 9M M 2014 R&D expenses % EBIT % R&D costs almost unchanged Monthly cash burn accordingly Capital increase reflected in financing cash flows Cash flows from operating activities Cash flows from financing activities % % Monthly cash burn % In million 30 Sep Dec 2014 Total assets % Main items impacted by capital increase of 28.3 m gross Cash & cash equivalents % Equity ratio 81% 88% -8%

13 FY 2015: Outlook Confirmed Development of product pipeline well on track Intensify clinical development of MGN1703: Registration study IMPALA: Continue patient recruitment Randomized study IMPULSE: Finalize patient recruitment MGN1601: Plan and prepare continuative study in renal cancer Continue partnering discussions Increase of R&D expenses due to studies with MGN1703, mainly IMPALA

14 Financial Calendar and Contact Details 22 March 2016 Annual Financial Statements and Annual Report May 2016 Quarterly Report as of 31 March August 2016 Half-Year Report as of 30 June November 2016 Quarterly Report as of 30 September 2016 Claudia Nickolaus Head of Investor Relations & Corporate Communications Phone: Fax: MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the 14

15 German Equity Forum 2015 Dr. Mariola Söhngen Chief Executive Officer Frankfurt am Main 24 November