investor event asco 2017* - morphosys...morphosys’s clinical development programs for...

Investor Event ASCO 2017*

JUNE 5, 2017

* FOR INVESTORS ONLY. DO NOT DISSEMINATE.

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.

© MorphoSys AG, Investor Event, June 5, 2017 2

Agenda


6:30 Simon Moroney, D.Phil., Chief Executive Officer, MorphoSys

MorphoSys’s growing proprietary portfolio of investigational biopharmaceuticals

6:35 Malte Peters, M.D., Chief Development Officer, MorphoSys

MorphoSys’s clinical development programs for hematological malignancies,

MOR208 and MOR202 (Overview)

6:40 Kami Maddocks, M.D., Division of Hematology Department of Internal Medicine,

The Ohio State University

MOR208, an investigational Fc-enhanced CD19 antibody in clinical development in

DLCBL and CLL


A Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with

Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple

Myeloma

7:15 Q&A Session

PROGRAM PARTNER TARGET DISEASE AREA PHASE 1 PHASE 2 PHASE 3 REGISTRATION

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

MOR208 - CD19 DLBCL, CLL/SLL

Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors

BHQ880 Novartis DKK-1 Multiple myeloma

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases

BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

Elgemtumab (LJM716) Novartis HER3 Cancer

MOR103/GSK3196165** GSK GM-CSF Inflammation

MOR202 - CD38 Multiple myeloma

Tesidolumab (LFG316) Novartis C5 Eye diseases

Utomilumab (PF-05082566) Pfizer 4-1BB Solid tumors

VAY736 Novartis BAFF-R Inflammation

Xentuzumab (BI-836845) BI IGF-1 Solid tumors

BAY1093884 Bayer TFPI Hemophilia

MOR106 Galapagos IL-17C Inflammation

MOR107 (LP2-3) Lanthio Pharma AT2-R Not disclosed

MOR209/ES414 Aptevo PSMA/CD3 Prostate cancer

NOV–7 Novartis - Eye diseases

NOV–8 Novartis - Inflammation

NOV-9 Novartis - Diabetic eye diseases

NOV-10 Novartis - Cancer

NOV-11 Novartis - Blood disorders

NOV-12 Novartis - Prevention of thrombosis

NOV-13 Novartis - Cancer

NOV-14 Novartis - Asthma

Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors

Our Pipeline

29 Clinical Product Candidates*

© MorphoSys AG, Investor Event, June 5, 2017

13

13

* All product candidates are investigational and have not yet been established as safe and

effective by regulatory authorities

** MOR103/GSK3196165 out-licensed to GSK on completion of phase 2a at MorphoSys

Partnered Discovery Programs

Proprietary Development Programs

4

Other News


MARCH 2017

Roche to start two phase 3 trials in prodromal & mild Alzheimer’s

diseaseGANTENERUMAB

MAY 2017: J&J Pharmaceutical Business Review Day

Possible Q3 2017 launch in psoriasis, subject to FDA approval

Phase 3 study head-to-head vs. Cosentyx started

New phase 3 studies in psoriatic arthritis and Crohn’s disease

GUSELKUMAB

MAY 2017

First part of phase 1 trial in healthy volunteers successfully

completedMOR107

JANUARY 2017

Novartis starts phase 2 trial in obese patients with type 2 diabetesBIMAGRUMAB

5

TODAY

Our Vision for the Future


OUR FUTURE

First product application submitted

for partnered antibody in the US and

Europe

Maturing clinical pipeline

set to deliver clinical data

Powerful technology platform

delivering differentiated

drug candidates

Marketed products delivering lucrative

royalty stream

Revenues fuel pipeline and R&D engine

First commercial footprint established

6

Agenda










DLCBL and CLL




Myeloma

7:15 Q&A Session

AN INVESTIGATIONAL CD38 ANTIBODY IN CLINICAL STUDIES IN R/R MULTIPLE MYELOMA

MOR202 - OverviewA Differentiated Antibody Being Investigated for Multiple Myeloma

Targeting CD38, a highly expressed and validated target in multiple myeloma

Currently under clinical investigation in ongoing phase 1/2a study as a potential alternative for RRMM

Central role and growing substantial market for CD38 mAbs in MM treatment in all lines according to analysts forecast

KEY FEATURES & POSITIONING

Short infusion time: MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg in current trial.

Occurrence of IRRs in low proportion of patients (6%, grades 1 or 2) observed in current trial.

Responses and PFS-values observed suggest further development of MOR202 as a representative of the CD38-class

Most responses observed to deepen over time, in all combinations with Dex, LEN/Dex, POM/Dex.

Long durability of responses: Responses ongoing in 65% of patients, the longest response ongoing >19 months.

Biomarker data suggest expression of CD38 was preserved on bone marrow plasma cells during MOR202 treatment

Data generated reflects development potential also in other oncology indications (NSCLC) and inflammation.

STATUS / NEXT DATA

Enrollment to current Phase 1/2a study completed

Updated clinical data reported at ASCO 2017


AN INVESTIGATIONAL FC-ENHANCED ANTIBODY TARGETING CD19

MOR208 - OverviewFc-modified Antibody to Treat B Cell Lymphoma


CD19 is preserved after treatment with B cell targeted therapies, suggested by results from clinical/preclinical testing

Fc-modification may enhance B cell depletion by ADCC, ADCP and direct cytotoxicity, suggested by preclinical models

KEY FEATURES & POSITIONING & NEXT STEPS

R/R DLBCL (L-MIND study):

− Combination of MOR208 with lenalidomide shows preliminary activity in transplant-ineligible patients with R/R

DLBCL who have a poor prognosis and a median age of 73 years

− ORR 56%; CR 32%.

− No IRRs reported for MOR208. No unexpected safety related effects observed for the combination.

− More mature analysis expected at ASH 2017

R/R DLBCL (B-MIND study):

− Pivotal, randomized, phase 3 study, comparing bendamustine/MOR208 with bendamustine/rituximab in transplant-

ineligible R-R DLBCL now open for recruitment

− Interim analysis expected in 2018

CLL:

− COSMOS study: Phase 1b/2 study in R/R CLL post-ibrutinib in combination with venetoclax or idelalisib

− IIT at Ohio State in collaboration w/ John Byrd in various CLL patient-groups including molecular relapse to ibrutinib

Agenda










DLCBL and CLL




Myeloma

7:15 Q&A Session

MOR208, an investigational Fc-modified CD19 antibody in clinical development in

DLBCL and CLL

Kami J. Maddocks

Division of Hematology, The Ohio State

University Comprehensive Cancer Center,

Columbus, OH


• MOR208 is an Fc-modified monoclonal antibody that targets CD19

• Fc-enhancement of MOR208 leads to a potentiation of ADCC and

ADCP

• MOR208 induces direct cytotoxicity

MOR208

Fc-enhancement

ADCC

ADCP

direct

cytotoxicity

MOR208: An Modified CD19 Antibody

ADCC, antigen-dependent

cell-mediated cytotoxicity;

ADCP, antigen-dependent

cell-mediated phagocytosis

Horton HM et al. Cancer Res 2008; 68:8049-57


Fujimoto M, et al. Semin Immunol 1998;10:267-77

Fujimoto M, et al. Immunity 2000;13:47-57

Poe JC, et al. J Immunol;2012:2318-25

CD19 and Tumor Cell Survival

BCR, B-cell receptor; BTK, Bruton's tyrosine kinase; PI3K,

phosphatidylinositol 3-kinase; PIP2, phosphatidylinositol 4,5-

bisphosphate; PIP3, phosphatidylinositol 3,4,5-triphosphate

CD19 enhances B-cell antigen receptor signaling by amplification of PI3K and BTK activity


L-MIND

Relapsed/refractory DLBCL ineligible for HDCT and ASCT

NCT02399085

Currently recruiting patients

B-MIND

Relapsed/refractory DLBCL ineligible for HDCT and ASCT

NCT02763319


COSMOS

Relapsed/refractory CLL or SLL following BTKi failure

NCT02639910


L-MIND

B-MIND

COSMOS

Ongoing Studies MOR208 in DLBCL and CLL


Kami J. Maddocks, Eva González Barca, Wojciech Jurczak, Anna Marina Liberati,

Johannes Duell, Zsolt Nagy, Tomáš Papajík, Marc Andre, Nagesh Kalakonda,

Martin H. Dreyling, Pier Luigi Zinzani, Sumeet Vijay Ambarkhane,

Johannes Weirather, Gilles A. Salles

L-MIND: MOR208 combined with lenalidomide (LEN) in

patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL)

– a single-arm phase II study


Primary

• Objective response rate (complete responses + partial responses)

Secondary

• progression-free survival

• duration of response, overall survival

• peripheral B-, T- and NK cell counts and gene expression profiling

analysis for cell of origin subtyping

Endpoints


Key inclusion criteria

• Age ≥18 years with histologically confirmed relapsed and/or refractory

DLBCL

• At least one but not more than three previous systemic regimens

• One therapy line must have included a CD20-targeted therapy

(e.g., rituximab)

• Not eligible for high-dose chemotherapy

Key exclusion criteria

• Primary refractory DLBCL, a history of “double/triple hit” DLBCL,

central nervous system lymphoma involvement

Methods


*An additional loading dose was administered on day 4 of cycle 1. Safety data from the first six patients were evaluated in a

safety run-in to determine the starting dose of LEN for the remainder of study.

ASCT, autologous stem cell transplant; EOT, end of treatment; HDCT, high-dose chemotherapy; R/R DLBCL, relapsed or

refractory diffuse large B-cell lymphoma; SD, stable disease, IV, intravenous; PO, per os.

Study design


• As of March 06, 2017, a total of 44 patients had been enrolled

in the study of which 34 qualified for efficacy assessment

• The enrollment of 80 patients is planned; recruitment is

ongoing.

Current Status


Baseline Characteristics

Maddocks et al., ASCO2017


• The objective response rate was 56% with a complete response rate of 32%

• With a median follow-up of 5.6 months, 16 out of 19 responses are ongoing

Preliminary Efficacy Evaluation



CR, complete response;

PD, progressive disease;

PR, partial response;

SD, stable disease; NE,

not evaluable.

Time on Study and Duration of Response



CR, complete response;

PD, progressive disease;

PR, partial response;

SD, stable disease;

NE, not evaluable.

Preliminary Safety Evaluation


• As of now no unexpected toxicities were observed compared to the known

toxicity profiles of lenalidomide or MOR208 monotherapy.

• Treatment-related serious adverse events occurred in six patients

(pneumonia, febrile neutropenia, agranulocytosis, bronchitis, tumor flare,

pyrexia; all six patients recovered).

• No infusion-related reactions for MOR208 were reported in this trial.

Preliminary Safety Evaluation

Infusion Tolerability

Lenalidomide Dose Reductions



• MOR208 in combination with LEN showed preliminary activity

in patients with R/R DLBCL, ineligible for transplantation,

with a poor prognosis, and a median age of 73 years

• The preliminary objective response rate was 56% with a

complete response rate of 32%

• MOR208 in combination with LEN appears to be well tolerated,

27% patients required a reduction of LEN dose due to toxicity

• Accrual and follow-up of patients (including continued study

treatment) is ongoing, as are cell of origin and other subgroup

analyses.

Preliminary Study Conclusions



LEN monoWitzig et al. 2011

RTX+LENWang et al. 2013

Obinutuzumab+LENMorschhauser et al. ASH 2016

L-MINDMaddocks et al. ASCO

2017

Number of

patients

N=108 N=32 N=71 N=34

ORR 28% 28% 45% 56%

CR 7% 22% 16% 32%

median PFS,

months

2.7 3.7 4.1 not yet available

R/R DLBCL LEN Approaches - Literature Data

B-Mind: Phase II/III Trial in R/R DLBCL

recruitment ongoing

Phase III part of the trial has been opened for recruitment in June 2017


COSMOS Phase II Trial: MOR208 in CLL

recruitment ongoing© MorphoSys AG, Investor Event, June 5, 2017 28

We deeply thank the patients, families, clinical

researchers, hospitals, and clinics that participate in

clinical trials testing the MOR208 drug candidate


Agenda










DLCBL and CLL




Myeloma

7:15 Q&A Session

Raab et al., ASCO 2017

A Phase I/IIa Study of the CD38 Antibody MOR202

Alone and in Combination with Pomalidomide or

Lenalidomide in Patients with Relapsed or Refractory

Multiple Myeloma


Fully human monoclonal IgG1 antibody

directed against CD38

MOR202 appears to induces potent immune

effector mechanisms: ADCC and ADCP

MOR202

MOR202 Assumed Mechanisms of Action

ADCC, antigen-dependent cell-mediated cytotoxicity;

ADCP, antigen-dependent cell-mediated phagocytosis


STUDY DESIGN

Phase 1/2a multi-center, open-label, dose escalation study

3+3 design plus expansion cohorts

11 sites in Germany and Austria

PATIENT POPULATION

Patients with relapsed/refractory myeloma

MOR202 +/- Dex: failure of ≥ 2 prior therapies

Combination with Pomalidomide (POM)/Dex: failure of ≥ 2 prior therapies

MOR202 combination with Lenalidomide (LEN)/Dex: failure of ≥ 1 prior therapy

OUTCOME MEASURES

Determination of MTD, recommended dose, regimen

Safety profile

Immunogenicity

Pharmacokinetic

Preliminary efficacy

MOR202Phase 1/2a in Relapsed/Refractory MM


Raab et al, ASCO 2017

5

PRIMARY

Assess the safety profile and establish the maximum tolerated dose (MTD) and/or

recommended dose of MOR202 in patients with RRMM:

− As monotherapy

− In combination with Dex

− In combination with pomalidomide (POM)/Dex

− In combination with lenalidomide (LEN)/Dex

Assess immunogenicity of MOR202

SECONDARY

Assess preliminary efficacy, pharmacokinetics and pharmacodynamics of MOR202

monotherapy and in combination with Dex, POM/Dex and LEN/Dex in patients with RRMM

Objectives

MTD, maximum tolerated dose; RRMM, relapsed or refractory multiple myeloma



MOR202: Phase 1/2a Patient Characteristics of Clinically Relevant Cohorts



MOR202 – Phase 1/2a Trial Preliminary Safety Evaluation


• Two patients

(G4 thrombocytopenia and

serious G3 bacterial

infection) discontinued in

these cohorts due to AEs

with a suspected causal

relationship to MOR202.

• No MOR202 treatment-

related deaths


Preliminary Efficacy EvaluationBest Maximum Change in M-Protein in Study



Serum M-protein data are shown. In case serum M-protein is not available urine M-protein data are used.

Dex, dexamethasone; IMiD, immunomodulatory drug; LEN, lenalidomide; POM, pomalidomide; q1w, weekly; S, serum; U, urine.

Preliminary Efficacy EvaluationTime on Study by Best Response

© MorphoSys AG, Investor Event, June 5, 2017 Slide 38

ITT population of 18 patients

including 1 no-response evaluable patient (NE); reason for discontinuation: AE (patient 17006)

CR, complete response; MR, marginal response; ORR, objective response rate; PD, progressive disease; PR, partial response;

SD, stable disease; VGPR, very good partial response

modified from Raab et al, ASCO 2017

Preliminary Efficacy EvaluationTime on Study by Best Response



including 3 no-response evaluable patients (NE); reason for discontinuation: 2x consent withdrawn (patients 12025, 16005), 1x SAE (patient 12039)




Preliminary Efficacy Evaluation Time on Study by Best Response



including 2 no-response evaluable (NE) patients; reason for discontinuation: 1x ConMed (patient 11014), 1x Pom-related fatal SAE (patient 12041)




MOR202 Preliminary Efficacy EvaluationProgression Free Survival



*Confidence intervals (CI) for median PFS 1.5 – not evaluable (NE), 5.1 – NE and 2.8 – NE for MOR202 + Dex, MOR202 + LEN/Dex and MOR202 +

POM/Dex, respectively. Dex, dexamethasone; LEN, lenalidomide; PFS, progression-free survival; POM, pomalidomide.

IRRs occurred in 6% of patients and were limited to grade 1 or 2.

No unexpected safety signals were observed.

Median PFS of MOR/Dex, LEN/Dex and POM/Dex was 4.7 months, not reached and

17.1 months with a median follow-up of 22.2, 7.5 and 8.5 months, respectively.

ORR was 29% in the MOR/Dex, 86% in the LEN/Dex and 55% in the POM/Dex

cohort, based on the efficacy evaluable patients.

Responses are ongoing in 15 of 23 patients, with the longest response ongoing for

more than 19 months.

Most responses were observed to deepen over time.

Summary of Preliminary Results



We deeply thank the patients, families, clinical

researchers, hospitals, and clinics that participate

in clinical trials testing the MOR202 drug candidate


Agenda










DLCBL and CLL




Myeloma

7:15 Q&A Session

Q & A Session


SIMON MORONEY, D.PHIL., MORPHOSYS AG

MALTE PETERS, M.D., MORPHOSYS AG

KAMI MADDOCKS, M.D., THE OHIO STATE UNIVERSITY


Appendix

Expected Pipeline Newsflow

Up to 35 Clinical Data Points Expected in remaining 2017*


PHASE 1 PHASE 2 PHASE 3 REGISTRATION

Anetumab RavtansineCancer

Anetumab RavtansineAdvanced Malignancies

(Japan)

Anetumab RavtansineMesothelioma (MPM)

Elgemtumab (LJM716)Esophageal cancer

(+ BYL716)

GuselkumabPsoriasis (VOYAGE 2)

GuselkumabPsoriasis

BAY-1093884Bleeding disorders

Elgemtumab (LJM716)Breast/gastric cancer

GuselkumabActive psoriatic arthritis

(PsA)

MOR103/GSK3196165Osteoarthritis

GuselkumabPsoriasis (NAVIGATE)

Elgemtumab (LJM716)Breast cancer

(+ BYL716/trastuzumab)

Gantenerumab Alzheimer’s disease (sc)

MOR103/GSK3196165Rheumatiod arthritis


(Japan)

GuselkumabModerate to severe plaque

psoriasis (POLARIS)

GantenerumabAlzheimer’s disease

(sc, impact of speed)

MOR106Inflammation


MOR202Multiple Myeloma

GuselkumabSevere plaque psoriasis

MOR107Not disclosed

NOV-7Eye diseases

MOR208CLL (+ lenalidomide)

Tarextumab

(OMP-59R5)Small cell lung cancer

Tesidolumab

(LFG316) Kidney Transplantation

Utomilumab

(PF-05082566)NHL/solid tumors

(+ rituximab)

Tesidolumab (LFG316) Geographic atrophy

(+ CLG561)

Tesidolumab (LFG316) Paroxysmal nocturnal

hemoglobinuria

Utomilumab

(PF-05082566)

Solid tumors

(+ mogamulizumab)

Utomilumab

(PF-05082566)Solid tumors (+ MK-3475)

Tesidolumab (LFG316) Panuveitis

VAY736Rheumatoid arthritis

Vantictumab

(OMP-18R5)Lung Cancer (NSCLC)

Vantictumab

(OMP-18R5)Pancreatic cancer

Xentuzumab

(BI-836845)Prostate cancer

(+ enzalutamide)

Xentuzumab

(BI-836845)Breast cancer

Xentuzumab

(BI-836845)Multiple cancer types

(EGFR mutant NSCLC)

Vantictumab

(OMP-18R5)Breast cancer

Partnered Discovery Programs

Proprietary Development Programs

* Anticipated data readouts and/or primary completion dates,

according to clinicaltrials.gov and/or MorphoSys‘s own estimates

Positive data readout

Negative data readout

Covering Analysts


INSTITUTION CONTACT

Baader Helvea Bruno Bulic

Berenberg Klara Fernandes

Bryan Garnier TBD

Commerzbank Daniel Wendorff

Deutsche Bank Gunnar Romer

Edison Maxim Jacobs

Goldman Sachs Tim Woodward

HSBC Stephen McGarry

Independent Research GmbH Bernhard Weininger

J.P. Morgan Cazenove James Gordon

Kempen & Co. Anastasia Karpova

Landesbank Baden-Württemberg Timo Kürschner

Oddo Seydler Igor Kim

www.morphosys.com

Thank You

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.

Anke Linnartz

Head of Corporate Communications & IR

Phone +49 (0)89 / 899 27-404

Fax +49 (0)89 / 899 27-5404

Email [email protected]


investor event asco 2017* - morphosys...morphosys’s clinical development programs for...

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