9M RESULTS 2014 CONFERENCE CALL DR. MATTHIAS SCHROFF, CEO

Transcription

1 9M RESULTS 2014 CONFERENCE CALL DR. MATTHIAS SCHROFF, CEO BERLIN, 13 NOVEMBER, 2014

2 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. V

3 Agenda MOLOGEN AG Highlights 9M 2014 Product pipeline Key financials 9M 2014 Outlook

4 HIGHLIGHTS 9M

5 Highlights 9M 2014 Good progress MOLOGEN AG Clinical development made good progress Operations - Start of two studies with lead product MGN1703: IMPULSE in lung cancer and IMPALA in colorectal cancer - MGN1601: Promising data from ASET trial in renal cancer EnanDIM: New generation of immunomodulators presented for the first time Healthy cash position supported by capital increase Financials Advanced study program led to increased R&D expenses Guidance 2014 confirmed

6 PRODUCT PIPELINE

7 Immunotherapy MGN1703: Most advanced product Phase II study IMPACT colorectal cancer: Outstanding long-term responses Pivotal phase III study IMPALA in colorectal cancer Patient enrolment started in September Switch maintenance therapy to prolong overall survival Study design is based on findings of the phase II IMPACT study Randomized study IMPULSE in small cell lung cancer Patient enrolment started in March Maintenance therapy to prolong overall survival Indication with high unmet medical need Safety and tolerability study in the US Investigational New Drug (IND) application approved enables the expansion of the MGN1703 development program to the US

8 MGN1703 Milestones MOLOGEN AG Metastatic Colorectal Cancer (mcrc) IMPALA (Phase III trial) First patient in, PEP: OS IMPACT (Phase II trial) OS data expected IMPALA Recruitment completed IMPALA Primary analyses (OS), Filing/Approval / 2018 IMPULSE (randomized, controlled trial) First patient in, PEP: OS IMPULSE Recruitment completed IMPULSE Primary analyses (OS) Small Cell Lung Cancer (SCLC) PEP primary endpoint OS overall survival

9 EnanDIM : New generation of immunomodulators New class of linear TLR-9 agonists Combines advantages of molecules containing only natural DNA components with benefits from linear molecules Specific structure protects against degradation - no chemical modifications needed Broad immune activation shown in pre-clinical trials Potential application in the fields of cancer and anti-infective therapies

10 combining advantages of two types of agonists: Linear and not chemically modified structure MGN1703 Linear DNA-structure Closed, dumbbell-shaped structure Only natural DNA components Good safety and tolerability profile One additional production step Linear molecules Easy and cost-effective production Chemically modified structure ( ) EnanDIM =Enantiomeric DNA-based ImmunoModulator 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 ) New structural feature: Protection against degradation

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

12 KEY FINANCIALS 9M

13 Key financials 9M 2014: Strong cash inflow from capital increase MOLOGEN AG [in million] Sep Dec Cash & cash equiv % Balance sheet total % Balance sheet dominated by cash inflow from capital increase of around 16m Equity ratio 86% 94% -9% [in million] 9M M 2013 R&D expenses % EBIT % Cash flow from operating activities % Cash flow from financing activities % Monthly cash burn % 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

14 OUTLOOK

15 FY 2014: Outlook and forecast confirmed MOLOGEN AG Development of product pipeline well on track Intensified clinical development of MGN1703: pivotal study in colorectal cancer and randomized study in small cell lung cancer MGN1601: plan and prepare continuative study in renal cancer Partnering discussions ongoing Loss expected to be higher compared to 2013 due to increased R&D expenses

16 Corporate calendar and contact details MOLOGEN AG November 24-26, 2014 German Equity Forum 2014 Analyst and Investor Conference Frankfurt/Main Claudia Nickolaus Head of IR & Communications Phone: Fax: MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the MOLOGEN AG 16

17 APPENDIX

18 Advanced product pipeline with strong focus on cancer immune therapies Pre-clinic 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 MGN1601 Renal cancer MGN1333 Hepatitis B MGN Malignant melanoma Oncology Infectious diseases Oncology & Infectious diseases 1 IND (Investigational New Drug) filed in U.S.; safety trial in U.S. completed 2 Collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin

19 IMPACT study design MOLOGEN AG Induction CT months Trial Treatment Period Maintenance mcrc patients treated first-line with FOLFOX/ XELOX or FOLFIRI +/- Bevacizumab* * at investigators discretion At least SD Screening/ Randomization 1:1 Experimental arm: 60mg MGN1703 twice weekly s.c. No maintenance Placebo twice weekly s.c. PD ** PD ** ** Treatment after PD at investigators discretion 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 carcinoembryonic antigen - a tumor marker for colorectal cancer NKT Natural Killer T cells mcrc metastatic colorectal cancer PFS progression free survival

20 IMPACT: Outstanding long-term responses MOLOGEN AG 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 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 CEA carcinoembryonic antigen - a tumor marker for colorectal cancer NKT Natural Killer T cells

21 IMPALA study design MOLOGEN AG Standard first-line chemotherapy for mcrc Trial Treatment Period Maintenance Re-Induction Induction CT weeks PR/CR Responder Screening/ Randomization 1:1 MGN1703 PD MGN1703 with induction CT PD Start of 2 nd line Control group PD Induction CT PD 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 mcrc metastatic colorectal cancer CT chemotherapy PR partial response CR complete response PD progressive disease OS overall survival QoL quality of life

22 IMPULSE study design MOLOGEN AG Standard first-line chemotherapy for Extensive Disease SCLC Trial Treatment Period Maintenance Induction CT 4 cycles of platinum-based therapy PR/CR Responder Screening/ Randomization 3:2 Experimental arm: 5th cycle of platinum based CT followed by MGN1703 maintenance PD Start of 2 nd line Control group: 5th cycle of platinum based CT followed by local practice PD 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 SCLC small cell lung cancer NSE neuron specific enolase - a tumor marker for lung cancer NKT Natural Killer T cells CT chemotherapy PR partial response CR complete response OS overall survival PD progressive disease

23 ASET study design MOLOGEN AG Trial Treatment Period Treatment per protocol (TPP) Extension phase Patients with advanced renal cell cancer No standard therapy available Trial inclusion 8 applications of MGN1601 in 12 weeks i.d. Disease Control Max. 5 applications in week 24, 36, 48, 72, and 120 PD** PD** ** Treatment after PD at investigators discretion 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 PD progressive disease i.d. intradermal injection EMA European Medicines Agency