MOLOGEN AG. Pioneering Immune Therapy. Q1 Results 2014 Conference Call. Dr. Matthias Schroff, CEO

Transcription

1 Pioneering Immune Therapy Q1 Results 2014 Conference Call Dr. Matthias Schroff, CEO Berlin, 14 May 2014

2 V1-6 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

3 Agenda Highlights Q Capital increase Product pipeline MGN1703 cancer immune therapy MGN1601 therapeutic vaccination against cancer Key financials Q Outlook

4 Highlights Q Capital increase Gross proceeds of around 16 million, predominantly to be used to finance the pivotal trial IMPALA Free float and international institutional investor base increased MGN1703 Application for IMPALA trial submitted (pivotal study in mcrc) IMPULSE trial started (randomized study in SCLC) Final data of phase I safety trial in the U.S. MGN1601 Final results of ASET trial (phase I/II in renal cancer) confirmed safety and tolerability

5 Capital increase enables start of pivotal study with MGN1703 Issuance of 1,541,244 new no-par-bearer shares at per new share 10% increase of share capital to 16,960,756 Gross proceeds of around 16 million Predominantly used to finance the IMPALA with MGN1703 in colorectal cancer Free float increased to ca. 53% Broader international institutional investor base

6 cancer immune therapy MGN

7 MGN1703 IMPALA trial: Pivotal randomized study in mcrc Application for trial submitted Use of findings from IMPACT trial, e.g. patient stratification based on biomarkers Primary endpoint: OS Standard first-line chemotherapy for mcrc Induction CT (14-28 weeks) PR/CR Responder Screening Randomization 1:1 Trial Treatment Period Maintenance MGN1703 Control Group P D P D Re-Induction MGN1703 with Induction CT Induction CT P D P D Start of 2 nd Line Open-label, randomized controlled two-arm, multinational phase III trial 540 patients 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

8 MGN1703 IMPULSE trial in SCLC started Trial application approved in Belgium and start of recruitment Additional applications submitted to authorities in Germany, Austria, Spain Standard firstline chemotherapy for Extensive Disease SCLC Induction CT (4 cycles of platinumbased therapy) PR/CR Responder Screening Randomization 3:2 Trial Treatment Period Maintenance Experimental arm: 5th cycle of platinum based CT followed by MGN1703 mainten. Control group: 5th cycle of platinum based CT followed by local practice P D P D Start of 2 nd Line Primary endpoint: OS Randomized controlled two-arm, multinational trial with 100 patients 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

9 MGN1703 MGN1703: Successful safety trial in the U.S. Placebo-controlled, double-blind phase I study in healthy volunteers Evaluation of cardiac safety, pharmacokinetics and pharmacodynamics Favorable safety, tolerability and pharmacokinetic profile Consistent immune activation Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA) for MGN1703 in solid tumors IND enables inclusion of the U.S. in the future MGN1703 development program

10 MGN1703 MGN1703 clinical development program Colorectal cancer IMPALA trial: Clinical trial applications submitted Expected timelines: First Patient In (FPI) Q3 2014; recruitment 24 months; primary analysis H2 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 IMPULSE trial: Protocol approved in Belgium, study started and first patient included Austria, Spain and Germany will follow Expected timelines: recruitment 12 months; primary analysis in late

11 therapeutic vaccination against cancer MGN

12 MGN1601 ASET: Promising data from renal cancer trial with tumor vaccine MGN1601 Final data set presented in a poster at ASCO GU and CIMT: Favorable safety and tolerability profile Promising overall survival data in subgroup of patients Evaluation of T-cell responses in subgroup: cytotoxic antitumor immune response and improved cellular immune function Patients with advanced renal cell cancer No standard therapy available Trial inclusion Treatment per protocol (TPP) 8 applications of MGN1601 in 12 weeks i.d. Trial Treatment Period Disease Control Extension phase Max. 5 applications in week 24, 36, 48, 72, and 120 PD** PD** Primary endpoints met: safety and tolerability Open-label, proof-ofprinciple, multi-center phase I/II trial 19 patients with advanced renal cell carcinoma who failed prior systemic ** Treatment after PD at investigators discretion therapies PD progressive disease i.d. intradermal injection CIMT Association for Cancer Immunotherapy, Germany

13 KEY FINANCIALS Q

14 Key financials Q1 2014: Strong cash inflow from capital increase [in million] Q Dec Cash and cash equivalents % Balance sheet total % Balance sheet dominated by cash inflow from capital increase of around 16 million Equity ratio 95% 94% 1% [in million] Q Q R&D expenses (2.9) (1.4) 107% Profit/loss for the year (4.1) (2.2) 86% Cash flow from operating activities Cash flow from financing activities (3.2) (2.0) 60% 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

15 OUTLOOK 2014 AND SUMMARY

16 FY 2014: Unchanged outlook and forecast Development of product pipeline well on track Intensify 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 at a higher level compared to 2013 Clinical trials progress will lead to increased R&D expenses

17 Corporate calendar 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, Germany Fabeckstraße 30 D Berlin Germany Phone: Fax: MOLOGEN, MIDGE and dslim are registered trademarks of the 16

18 APPENDIX

19 Advanced product pipeline with strong focus on cancer immune therapies Research Pre-clinic Phase I Phase II Phase III Approval Oncology MGN MGN MGN colorectal cancer small cell lung cancer 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 MGN1333 leishmaniasis hepatitis B 1 IND filed in U.S.; safety trial in U.S.: final analysis completed 2 in collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin IND Investigational New Drug (IND) application

20 MGN1703 IMPACT: Successful phase II colorectal cancer trial 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. No maintenance 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

21 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 Hazard ratio of 0.63 (p=0.29) 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 (

22 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: Very good tolerability Mild and transient fever as typical signs of an immune response Long term treatment over many months is safe and well tolerated

23 MGN1703 IMPACT study: Predictive biomarkers identified Exploratory subgroup analyses identified potential predictive biomarkers for an increased treatment effect with MGN1703: normal CEA levels reduction of tumor by induction therapy 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