MOLOGEN AG. Pioneering Immune Therapy. Annual Results Analysts Call March 25, 2014

Transcription

1 Pioneering Immune Therapy Annual Results 2013 Analysts Call March 25, 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 Ü Milestones 2013 Ü Product Pipeline Overview MGN1703 cancer immune therapy MGN1601 therapeutic vaccination against cancer Ü Key financials Ü Outlook

4 Milestones 2013 MGN1703 Ü Final analysis of IMPACT trial (phase II in colorectal cancer) confirmed preliminary findings Ü Application for IMPULSE trial (randomized controlled trial in lung cancer) submitted Ü Preparations for IMPALA trial (pivotal study in colorectal cancer) almost completed Ü IND submitted to FDA, treatment phase of safety trial completed MGN1601 Ü ASET trial (phase I/II in renal cancer) confirmed preliminary findings MGN1404 Ü Clinical development phase initiated (first-in-man safety trial in skin cancer) Executive Board expanded by Chief Medical Officer Ü Dr. Alfredo Zurlo, oncologist and former Medical Director at Roche, with >10 years extensive experience in clinical drug development and medical strategy

5 Advanced product pipeline with strong focus on cancer immune therapies Research Pre-clinic Phase I Phase II Phase III Approval Oncology MGN colorectal cancer MGN small cell lung cancer MGN other solid tumors Pivotal randomized trial, being prepared Randomized controlled trial, study started MGN1601 renal cancer Phase I/II completed MGN malignant melanoma First patient enrolled Infectious Diseases MGN1331 leishmaniasis MGN1333 hepatitis B 1 IND filed in U.S.; safety trial in U.S.: treatment phase completed 2 in collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin IND Investigational New Drug (IND) application

6 cancer immune therapy MGN

7 MGN1703 IMPACT trial: Successful phase II colorectal cancer study The primary endpoint was progression-free survival (PFS) from randomization 59 patients were enrolled Trial Treatment Period Induction CT months Maintenance Metastatic colorectal cancer patients treated first-line with FOLFOX/XELOX or FOLFIRI +/- Bevacizumab* * at investigators discretion At least SD Screening Randomization 2:1 Experimental arm 60mg MGN1703 twice weekly s.c. Placebo twice weekly s.c. PD** PD** CT chemotherapy SD stable disease PD progressive disease s.c. subcutaneous injection ** Treatment after PD at investigators discretion

8 MGN1703 Primary endpoint: PFS from randomization PFS according to local assessment mpfs [95% CI] MGN1703 (n=43) 2.8 months [ ] Placebo (n=16) 2.6 months [ ] HR=0.55 [95% CI: ] Log-rank p=0.04 HR Hazard ratio CI Confidence interval mpfs median progression free survival

9 MGN1703 Secondary endpoint: OS from randomization Results are not yet mature as more than 50% of patients are still censored mos [95% CI] MGN1703 (n=43) 22.6 months [ ] Placebo (n=16) 15.1 months [10.6- ] Log-rank test p= HR=0.63 [95% CI: ] HR Hazard ratio CI Confidence interval mos median overall survival

10 MGN1703 Immunotherapies are showing comparable effects on progression-free survival (PFS) The Kaplan-Meier curves only open after the median Subgroup of patients (10%) shows huge benefit in terms of PFS Clinical trial MDX ( with Ipilimumab in melanoma (Yervoy ) 1 IMPACT trial with MGN1703 in colorectal cancer Hazard Ratio 0.64 P<0.001 Hazard Ratio 0.55 P=0.04 Median PFS Ipilimumab (137 patients) Median PFS MGN1703 Control group (gp100, 136 patients) Control group (Placebo) 1 Hodi et al., N Engl J Med 2010; 363: (modified) Yervoy is a registered trademark of Bristol-Myers Squibb

11 MGN1703 and overall survival (OS) The Kaplan-Meier curves open before the median Subgroup of patients (20%) shows huge benefit in terms of OS Clinical trial MDX with Ipilimumab in melanoma (Yervoy ) 1 IMPACT trial with MGN1703 in colorectal cancer (OS results not mature yet) Hazard Ratio 0.66 P=0.003 Hazard Ratio 0.63 P=0.29 Median OS Median OS Ipilimumab Control group (Placebo) MGN1703 Control group (gp100) 1 Hodi et al., N Engl J Med 2010; 363: (modified) Yervoy is a registered trademark of Bristol-Myers Squibb

12 MGN1703 Excellent safety and tolerability Treatment with MGN1703 does not add any burden to cancer patients quality of life Superior safety and tolerability compared to most other cancer immune therapies, antibody therapies, and chemotherapies: Ü Very good tolerability Ü Mild and transient fever as typical signs of an immune response Ü Long term treatment over many months is safe and well tolerated

13 MGN1703 IMPACT trial provides proof of efficacy Final analysis was presented at ESMO 15th World Congress on Gastrointestinal Cancer in July 2013* (database lock end of March 2013) Hazard Ratio of 0.55 (p=0.04) on primary progression-free survival (PFS) on maintenance therapy endpoint 10% long-term responders (>15-30 months) in the MGN1703 arm, follow-up ongoing, updated data will be presented at an upcoming cancer conference Promising trend in overall survival Ü Hazard ratio of 0.63 (p=0.29) Ü median overall survival of 22.6 months (MGN1703) vs.15.1 months (placebo) (after a median follow-up in excess of 17 months approx. 65% of patients in the MGN1703 arm and 50% of patients in the placebo arm were still alive ) *recognised by ESMO as one of the most important contributions of the conference (

14 MGN1703 Predictive biomarkers identified Exploratory subgroup analyses identified potential predictive biomarkers for an increased treatment effect with MGN1703: Ü normal CEA levels Ü reduction of tumor by induction therapy Ü activated Natural Killer T (NKT) cells These findings are in line with the biological mode-of-action of an immunemodulating drug CEA carcinoembryonic antigen - a tumor marker for colorectal cancer

15 MGN1703 IMPALA trial: Pivotal randomized study in CRC Pre-final design The primary endpoint will be overall survival from randomization 540 patients to be randomized CEA levels and activation of NKT cells will be used as stratification factors Trial Treatment Period Standard first line chemotherapy for mcrc Maintenance Re-Induction Induction CT (14-28 weeks) PR/CR Responder Screening Randomization 1:1 MGN1703 Control Group PD PD MGN1703 with Induction CT Induction CT PD PD Start of 2 nd Line mcrc metastatic colorectal cancer CEA Carcinoembryonic antigen - a tumor marker for colorectal cancer NKT Natural Killer T cells CT chemotherapy PR partial response CR complete response PD progressive disease

16 MGN1703 IMPULSE trial: Randomized controlled study in SCLC The primary endpoint is overall survival from randomization 100 patients to be randomized NSE levels and activation of NKT cells are used as stratification factors Trial Treatment Period Standard first line chemotherapy for Extensive Disease SCLC Maintenance Induction CT (4 cycles of platinumbased therapy) PR/CR Responder Screening Randomization 3:2 Experimental arm: 5th cycle of platinum based chemotherapy followed by MGN1703 maintenance Control group: 5th cycle of platinum based chemotherapy followed by local practice PD PD Start of 2 nd Line 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 PD progressive disease

17 MGN1703 MGN1703 clinical development program Colorectal cancer: Protocol approval from Regulatory Authorities is currently being sought for the pivotal trial in colorectal cancer Timelines: First Patient In (FPI) QIII 2014; recruitment 24 months; primary analysis expected in QIII/QIV 2017; filing/approval possible in 2018 Target population for a marketing authorization includes patients with a response to any prior induction therapy (50-60% of patients treated in first line). Small cell lung cancer: Protocol approval from Regulatory Authorities for the IMPULSE trial obtained Timelines: FPI March 2014; recruitment 12 months; primary analysis expected in QIV

18 therapeutic vaccination against cancer MGN

19 MGN1601 ASET trial: Successful early phase renal cancer study Open-label, multi-center clinical trial phase I/II (safety study) 19 patients enrolled 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 PD progressive disease i.d. intradermal injection

20 MGN1601 ASET trial Final analysis performed in Sep 2013 Data confirm the preliminary findings presented at last year s "ESMO 2012 Congress Ü Primary endpoints safety and tolerability were met Ü Subgroup of patients showed promising benefit from the treatment with MGN1601 Ü Some of these patients were still alive, follow-up ongoing Findings from the evaluation of T-cell responses in subgroups of patients showed Ü first evidence of cytotoxic antitumor immune response after MGN1601 vaccination Ü significant improvement of cellular immune function during the course of treatment. The full data set from this analysis was presented in Jan 2014 at ASCO GU

21 MGN1601 ASET trial: Overall survival data ITT group: all patients who received at least one vaccination PP group: patients received eight vaccinations within twelve weeks as planned Non-PP group: patients dropped out before finalizing the 12 weeks course of treatment Overall survival PP non-pp ITT OS rate OS time [weeks]

22 KEY FINANCIALS AND SHARE INFORMATION

23 Key financials 2013 (IFRS) Cash: 14.8 million (31 Dec 2012: 23.8 million) Average monthly cash utilization: 0.75 million (2012: 0.74 million) 58 employees (headcount; 31 Dec 2012: 53) [in million] 12/31/ /31/2012 Cash and cash equivalents Balance sheet total Equity ratio 94% 97% [in million] 1/1/2013 to 12/31/2013 1/1/2012 to 12/31/2012 Revenues R&D expenses (7.9) (6.0) Profit/loss for the year (10.8) (8.0) Monthly cash burn

24 OUTLOOK 2014 AND SUMMARY

25 MOLOGEN Milestones 2014 MGN1703 Ü Randomized trial in small cell lung cancer start recruitment ü Ü Cardiac safety trial finalize study report Ü Pivotal randomized trial in colorectal cancer start recruitment Ü Maximize value and market access through partnering discussions MGN1601 Ü Clinical trial in renal cancer Planning and preparation of study MGN1404* Ü Phase I in skin cancer finish trial Successful capital increase, gross proceeds of 15.7 million ü * Collaboration with Max-Delbrueck-Center for Molecular Medicine Berlin and Charité Universitaetsmedizin Berlin

26 MOLOGEN well prepared for the future 1. Strong focus on cancer immune therapies 2. Lead product MGN1703 ready to enter pivotal trial in colorectal cancer 3. Broad product pipeline with high market potential: colorectal cancer small cell lung cancer renal cancer malignant melanoma 4. Solid financial basis

27 Corporate calendar March 25, 2014 Annual Financial Statements and Annual Report 2013 May 14, 2014 Quarterly Report as of March 31, 2014 August 13, 2014 Half-Year Report as of June 30, 2014 November 13, 2014 Quarterly Report as of September 30, 2014 November 24-26, 2014 German Equity Forum 2014 Analyst and Investor Conference, Frankfurt/Main, German Fabeckstraße 30 D Berlin Germany Phone: Fax: V MOLOGEN, MIDGE and dslim are registered trademarks of the 26