MorphoSys Proprietary Development Update

Transcription

1 September 8, 2015 MorphoSys Proprietary Development Update 1

2 Safe Harbor This presentation includes forward-looking statements. Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing. These and other risks and uncertainties are detailed in the Company s Annual Report. 2

3 Today on the Call Simon Moroney Jens Holstein Arndt Schottelius Marlies Sproll CEO CFO CDO CSO Claudia Gutjahr-Löser Head of Corporate Communications & IR 3

4 Company Development Towards a Fully-integrated Biopharmaceutical Company Technology driven License Agreements Tech Transfer Funded Research Product driven Out-licensing Co-Development Product and target driven In-licensing Co-Discovery / Co-Development Innovation Capital M&A 5 th stage: Fully-integrated biopharmaceutical company 1 st stage: Technology commercialization 2 nd stage: Pure outlicensing 3 rd stage: Co-development deals 4 th stage: In-licensing Time 4

5 MOR208 Significant Medical Need Exists OPPORTUNITY MOR208 addresses central gaps in current B cell cancer treatment options, including CD20 down-regulation, TKI relapses, and treatment in patients unable to manage side effects of TKIs Significant medical need in treatment of Non-Hodgkin s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL): DLBCL: 26,000 new cases and 7,300 deaths in 2015 in the US 1,2 CLL: 14,620 new cases and 4,650 deaths in 2015 in the US 1 Anti-CD20 approaches (rituximab) improved the prognosis for many CLL/NHL patients Some patients can be cured but the majority of patients do not respond to therapy or relapse ~40% of DLBCL patients cannot be cured by chemoimmunotherapy and/or autologous stem cell transplantation and eventually relapse 3 CLL patients cannot be cured, chemoimmunotherapy leads to treatment-free intervals of more than 5 years but the majority of patients cannot tolerate this treatment 4 1: Cancer.gov 2: Decision Resources 3: Mounier et al. Best Pract Res Clin Haematol : Hallek et al. Ann Oncol Best in Class Potential in Several B cell Malignancies MorphoSys - September

6 MOR208 Multiple Studies Commencing in Late 2015 and 2016 NEXT STEPS Phase 2 trial with LEN in 2 nd line R/R DLBCL to start in Q Phase 2 trial with IDE in CLL in BTKi-failures to start in Q Phase 3 combo trial with BEN in 2 nd line R/R DLBCL aimed to start in 2017 Update on NHL monotherapy planned at ASH 2015 NHL DLBCL * Phase 2: MOR208 mono (N=92) Phase 2: MOR208 (12mg/kg) plus lenalidomide (N=80) Safety evaluation leading into anticipated pivotal study (12 mg/kg MOR208 plus bendamustine), N~320 CLL Phase 2: MOR208 (12mg/kg) plus idelalisib, BTKi-failures, N=120 Ph. 2 (ongoing OSU IIT): R/R & naive CLL & Richter s Transformation, MOR208 (9mg/kg) plus LEN, N=50 ALL Phase 2 (St. Jude s IIT): Pedriatic ALL, MOR208 (12mg/kg) plus NK cells, N=13 Phase 3 Phase 2 IIT *no outlook given beyond

7 MOR202 Clinical Development Plan STATUS Phase 1/2a clinical trial in MM ongoing Cohorts with 16mg/kg weekly dosing + Dex and combination cohorts (MOR202 + LEN + Dex and MOR202 + POM + Dex) are ongoing Encouraging early signs of activity already at low doses Higher level of activity expected at further dose escalation allowing full target saturation * MM Phase 1/2a MOR202 mono, dose escalation, plus confirmation cohorts (N~62) Phase 1/2a MOR202 (8 and 16mg/kg) plus lenalidomide or pomalidomide and confirmation cohorts (N~24) Phase 3: MOR202 combination therapy Phase 2 Phase 3 *no outlook given beyond

8 MOR209/ES414 New Treatment Option in mcrpc STATUS NEXT Preclinical studies successfully concluded, promising results presented in 2013 Pharmacologically active and well tolerated Shows activity at very low doses Increased half-life due to bi-specific ADAPTIR-structure Phase 1 in mcrpc in the U.S. and Australia ongoing Stage 1: identify MTD of MOR209/ES414 administered iv Stage 2: evaluate clinical activity in patients that have or have not received prior chemotherapy First clinical data expected in * mcrp MOR209/ES414: Phase 1/2 dose escalation (N~50) MOR209/ES414: Phase 1/2 dose extension (N~80) Phase 2 Phase 3 Phase 3 preparations *no outlook given beyond

9 Leveraging Technology Leadership Inflammation Peptides GPCR targets Immuno-oncology Galapagos Lanthio Heptares/Sosei Merck Serono Co-development alliance MOR106 to enter clinical development in 2016 in inflammation Stabilized peptide technology complements existing antibody drug discovery platform MOR107 to enter clinical development in 2016 in fibrotic diseases Delivers challenging GPCRs in stabilized form as drug targets G7 Therapeutics Delivers tailor-made GPCRs as drug targets Developing antibodies against immune checkpoints Immatics Developing antibodybased therapies targeting tumorassociated peptides Short-Term Clinical Output Mid/Long-Term Clinical Output 9

10 MorphoSys Proprietary Development Update Q&A Session

11 Thank You Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / [email protected] HuCAL, HuCAL GOLD, HuCAL PLATINUM, CysDisplay, RapMAT, aryla, Ylanthia and 100 billion high potentials are registered trademarks of MorphoSys AG. Slonomics is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.