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

Transcription

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

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 Onwards / Update Operations Key Financials Q and Outlook 2015 Appendix

4 Highlights Q Onwards Patient recruitment well on track - IMPULSE in lung cancer and IMPALA in colorectal cancer Operations: MGN1703 Administration scheme confirmed comprehensive data presented at scientific conference Collaboration agreement with Aarhus University Hospital - Early stage study with MGN1703 in HIV patients Phasing effect: Lower R&D expenses led to improved EBIT Financials Guidance 2015 unchanged Capital increase in April 2015 with gross proceeds of around 28 m to finalize patient recruitment of ongoing studies with MGN

5 MGN1703 Milestones for Various Clinical Trials / 2018 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 Small Cell Lung Cancer (SCLC) IMPULSE (randomized, controlled trial) First patient in, PEP: OS IMPULSE Recruitment completed IMPULSE Primary analyses (OS) OS overall survival PEP primary endpoint

6 Update MGN1703 Dosing Scheme Confirmed; Collaboration for Clinical Study in HIV Initiated MGN1703 administration scheme efficient in healthy volunteers and cancer patients Comparison of data set of US safety and tolerability study in healthy volunteers with data from two studies with cancer patients Consistent immune activation in both patient groups Findings support dosing scheme of IMPULSE and IMPALA trials TEACH study with MGN1703 in HIV patients Potential expansion of applications Collaboration agreement with Aarhus University Hospital, Denmark Aarhus University Hospital to conduct the early stage study TEACH; funding already received from the American Foundation for AIDS research (amfar) MOLOGEN will provide MGN1703 First time to evaluate MGN1703 in other disease than cancer

7 Key Financials Q [in million] Q Q R&D expenses % EBIT % Cash flow from operating activities % Slight decrease of R&D costs due to lower cost of materials and phasing effects Monthly cash burn decreased accordingly Cash flow from financing activities Monthly cash burn % [in million] March Dec Total assets % Cash & cash equivalents % Total assets decreased as a result of ongoing high cash consumption and increased accumulated losses Equity ratio 81% 88% -8%

8 Capital Increase Ensures Completion of Patient Recruitment for Ongoing Studies with MGN1703 Public offering to existing shareholders and private placement of new shares to international institutional investors Issuance of 5,657,875 new ordinary bearer shares Number of shares increased to now 22,631,501 shares ~ 28 m gross proceeds mainly to be used to finalize patient recruitment for ongoing IMPULSE and IMPALA studies with lead product MGN1703 Free float at approx. 54%

9 FY 2015: Unchanged Outlook 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

10 Corporate Calendar and Contact Details August 13, 2015 Half-year Report as of June 30, 2015 November 12, 2015 Quarterly Report as of Sep 30, 2015 Claudia Nickolaus Head of Investor Relations & Corporate Communications Phone: Fax: MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the 9

11 Appendix Product Pipeline Further information on trials Quarterly Key Financials

12 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 MGN HIV MGN1333 Hepatitis B 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 2 Collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin 3 Collaboration with University Hospital Aarhus, Denmark

13 IMPACT - Phase II Study in Colorectal Cancer Generated Outstanding Long-Term Responses Primary endpoint met: Progression free survival Secondary endpoint Overall Survival : Results are not yet mature (too many patients alive), median OS 22.6 (MGN1703) vs months Predictive biomarkers identified: Tumor reduction by induction therapy, CEA level, presence of activated NKTs 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 September 2014 Excellent safety and tolerability, also when treated long-term Findings from subgroup analyses were used to optimize the phase III study design CEA carcinoembryonic antigen - a tumor marker for colorectal cancer NKT Natural Killer T cells

14 IMPACT - PFS and OS Benefit in Patients Relevant for Phase III Responders to prior induction therapy show encouraging PFS and OS benefit (shown from start of maintenance therapy, time of induction therapy is not included) Data on OS still preliminary due to lack of events [patients alive] MGN1703 n=29 Placebo n=14 HR=0.40; p=0.009 MGN1703 (n=29) Placebo (n=14) mos 24.5 months 15.1 months HR=0.40; p=0.069 (cut-off date: March 2013) HR hazard ratio IT induction therapy mos median overall survival PFS progression-free survival

15 IMPACT Sustained Efficacy Patient 049 At initial diagnosis (04/2010) Colon carcinoma with multiple liver metastases After induction chemotherapy (12/2010) 06/ /2010: 9 courses of CT (FOLFIRI) + Bevacizumab (biologic) 12/2010: Response to induction CT: PR * CT chemotherapy PR partial response *confirmed by two independent radiologists During MGN1703 maintenance (04/2012) Since 12/2010: MGN1703 maintenance therapy New PR * after 9 months Still ongoing PR (40 months as of Jan 2015) Good medical condition, mild local skin reactions, no further toxicities

16 IMPALA - mcrc Pivotal Phase III Study Started in Sep 2014 Trial Treatment Period Maintenance Re-Induction Induction CT weeks Standard first-line CT for mcrc 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 Primary endpoint: Overall survival 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 Biomarkers used as stratification factors: CEA level and NKT activation CR complete response CEA carcinoembryonic antigen - a tumor marker for colorectal cancer CT chemotherapy mcrc metastatic colorectal cancer NKT Natural Killer T cells PR partial response PD progressive disease

17 IMPULSE - SCLC Randomized Study Started in Mar 2014 Trial Treatment Period Maintenance Induction CT 4 cycles of platinum-based therapy Standard first-line CT for extensive disease SCLC PR/CR Responder Screening/ Randomization 3:2 Experimental Group: 5 th cycle of platinum based CT followed by MGN1703 maintenance Control Group: 5 th cycle of platinum based CT followed by local practice PD PD Start of 2 nd line Primary endpoint: Overall survival Randomized, controlled, two-arm, multinational trial with 100 patients in Belgium, Austria, Germany and Spain Biomarkers used as stratification factors: NSE level and NKT activation CR complete response CT chemotherapy NKT Natural Killer T cells NSE neuron specific enolase - a tumor marker for lung cancer PD progressive disease PR partial response SCLC small cell lung cancer

18 MGN ASET Study in Renal Cancer Trial Treatment Period Patients with advanced renal cell cancer No standard therapy available Trial inclusion TPP 8 applications of MGN1601 in 12 weeks i.d. 8 applications of MGN1601 in 12 weeks i.d. Extension phase Max. 5 DC applications in PD ** week 24, 36, 48, 72 and 120 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 DC Disease Control EMA European Medicines Agency i.d. intradermal injection PD progressive disease TPP Treatment per protocol

19 Quarterly Key Financials [in million] Q Q Q Q Q Q Q Q Q R&D expenses EBIT Cash flow from operating activities Cash flow from financing activities Monthly cash burn

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