Investor Reception ASCO 2016 - MorphoSys AG...Its utility as a predictive biomarker will be further investigated. MOR208 was well tolerated with a favorable safety profile including

Investor Reception

ASCO 2016

June 6, 2016

1© MorphoSys - ASCO - June 6, 2016

Safe Harbor

© MorphoSys - ASCO - June 6, 2016

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

Agenda

© MorphoSys - ASCO - June 6, 2016 3

6:30 Welcome by Arndt Schottelius, M.D. PhD

Chief Development Officer of MorphoSys AG

MorphoSys‘s growing proprietary portfolio of

biopharmaceuticals

Introduction of speakers

6:35 MOR208

Grzegorz S. Nowakowski, M.D.

Mayo Clinic, Rochester, MN (US)

6:50 MOR202

Manik Chatterjee, M.D. PhD

University Hospital of Würzburg, Germany

7:05 Q&A Session


Grzegorz S. Nowakowski, M.D .

Arndt Schottelius, M.D. PhD, CDO

Steffen Heeger, M.D. PhD, Head of Clinical Development

7:25 Closing Remarks

Food, Drinks


The MorphoSys Pipeline

26 Clinical Product Candidates, 104 Total

Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

MOR208 - CD19 ALL, CLL, NHL

MOR202 - CD38 Multiple myeloma

MOR103/GSK3196165 GSK GM-CSF Inflammation

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

BHQ880 Novartis DKK-1 Multiple myeloma

BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

LFG316 Novartis C5 Eye diseases

LJM716 Novartis HER3 Cancer

Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors

VAY736 Novartis BAFF-R Inflammation

MOR209/ES414 Emergent PSMA/CD3 Prostate cancer

MOR106 Galapagos - Inflammation

BAY1093884 Bayer TFPI Hemophilia

BI–836845 BI IGF-1 Solid tumors

NOV–7 Novartis - Eye diseases

NOV–8 Novartis - Inflammation

NOV-9 Novartis - Diabetic eye diseases

NOV-10 Novartis - Cancer

NOV-11 Novartis - Blood disorders

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

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

MOR107 (LP2) - AT2-R Fibrosis

Immuno-oncology program Merck - Cancer

Immuno-oncology program Immatics - Cancer

6 MOR programs - - Various

90 Partnered Discovery Programs

13 MOR Programs

1 Outlicensed Program

Most advanced development stage

In addition, 24 partnered programs in pre-clinic, and 45 partnered programs in discovery

The MOR Portfolio

5 Clinical Product Candidates, 14 Total


Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3

Unpartnered

MOR208 DLBCLCD19

CLL

MOR202 Multiple myeloma CD38

MOR107 Fibrosis AT2-R

Immuno-oncology program

CancerMHC-associated peptides

6 Programs Various Various

Co-development & co-promotion

MOR209/ES414 (Emergent)

Prostate cancer PSMA / CD3

MOR106(Galapagos)

Inflammation Undisclosed

Immuno-oncology program(Merck Serono)

Cancer Undisclosed

Outlicensed to GSK

MOR103/GSK3196165

RA

GM-CSFOsteoarthritis of the hand

FTD, orphan status US & EU

Orphan status US & EU


Subgroup analyses of

diffuse large B-cell lymphoma (DLBCL) and

indolent lymphoma cohorts from a phase IIa study

of single-agent MOR208 in patients with relapsed or

refractory non-Hodgkin’s lymphoma (R-R NHL)


Mayo Clinic, Minnesota, USA

6

MOR208

Inroduction


CD19, a B-lymphocyte lineage specific surface

antigen

the earliest and most broadly expressed

selective B cell marker

highly expressed in most NHL

Recognized importance of CD19 signaling

B cell survival via PI3K/AKT and c-Myc

attractive target antigen in B-cell malignancies,

especially for an extended treatment

MOR208 is an Fc-engineered humanized monoclonal

CD19 antibody leading to NK cell-mediated ADCC,

ADCP and direct cytotoxicity

We previously reported MOR208 to be well tolerated

with preliminary single-agent activity in patients with

R-R CLL and R-R NHL

We now present data from DLBCL and indolent NHL

(iNHL) cohorts and planned subgroup analyses of

prognostic and predictive biomarkers in the phase II

study in R-R NHL

ADCC

MOR208 in R/R NHL

Study Design and Aims of the Subgroup Analyses


Study Design and Treatment

Aims of the Subgroup Analyses

To assess the response to MOR208 in DLBCL and iNHL patient cohorts, focusing on objective response

rate (ORR), disease control rate (DCR), duration of response (DoR) and tumor shrinkage

To assess key secondary endpoints, progression-free survival (PFS) and safety in DLBCL and iNHL

cohorts

Preliminary analysis of efficacy in patient subgroups defined by baseline characteristics and

potentially prognostic and/or predictive biomarkers

* Until disease progression

MOR208 in R/R NHL

Results


92 patients were enrolled in the study including 35 (38%) with DLBCL and 45 (49%) with iNHL

Data are n (%) unless otherwise stated

Rituximab-refractory was defined as patients who demonstrated less than a partial response or response lasting less than 6 months to a prior

rituximab-containing regimen.

*Includes follicular lymphoma and other indolent NHLs

Data are n (%); *Investigator assessed. †Includes follicular lymphoma and other indolent NHLs

‡Post-baseline response assessment not performed/data unavailable; §n=25, 40, 11 and 76, respectively

MOR208 in R/R NHL

Objective Response


ORRs in DLBCL and iNHL cohorts were 26% and 29%, the DCRs 40% and 73%, respectively

Initial partial responses could deepen over the course of the treatment

MOR208 in R/R NHL

Tumor Shrinkage in NHL Subtypes


Percentage change from baseline in sum of product diameters. Central read with 2 readers; results of only 1 reader are displayed and best

response indicated (local assessment). Correlation between readers for relative change of target lesion at all time points demonstrated by

Spearman’s r=0.89

*Includes follicular lymphoma and other indolent NHLs. Data cutoff August 2015

Change in indicator lesions for individual patients in DLBCL and iNHL cohorts (central

assessment) during the course of study

Target lesion shrinkage was also observed in the majority of patients with stable disease

(5/6 DLBCL and 12/16 iNHL)

MOR208 in R/R NHL

Disease Control Rate (DCR)


DCR was considered to be a relevant efficacy endpoint as the majority of patients with stable

disease had marked target lesion shrinkage but as per study design were not treated beyond cycle 3

Subgroup analyses of DCR in DLBCL and iNHL patients showed significant differences according to:

prior lines of therapy

NK cell count and CD16 expression

international prognostic index score and DoR to prior treatment

but not to FcyR high and low affinity variants

Observed DCRs were equally encouraging for patients with rituximab-refractory and non-refractory

disease. In DLBCL, 5 out of 9 responders were rituximab-refractory, as were 5 out of 13 iNHL

responders

DCR did not differ across FcyR polymorphism subgroups

Time to response and DoR :

Median DoR in DLBCL was 20 months (95% CI 11.3–NA) with 3 ongoing responses

Median DoR was not reached in iNHL patients (95% CI 8.0–NA), with 72% of responders without

disease progression at 16 months and 6 responses ongoing (Kaplan-Meier estimates)

Disease Control Rate in Patients

with DLBCL or iNHL


Rituximab-refractory was defined as patients who

demonstrated less than a partial response or

response lasting less than 6 months to a prior

rituximab-containing regimen

†Clopper-Pearson confidence intervals

‡Includes follicular lymphoma and other indolent

NHLs. *p<0.05, **p<0.01.

MOR208 in R/R NHLLong Duration of Responses in DLBCL and FL/iNHL

* Includes follicular lymphoma and other indolent NHLs. One patient with stable disease had a late response (PR) after

17 months in follow-up. This patient is not shown in the figure.

© MorphoSys AG, Company Update - June 2016

Jurczak et al., Abstract #7545, ASCO 2016

Long-lasting responses,

up to >26 months

PFS rate:

>40% at 12 months

14

CR, complete response; DLBCL, diffuse large B-cell lymphoma;

NHL, non-Hodgkin’s lymphoma; PR, partial response

MOR208 in R/R NHL

Progression-free survival in NHL subgroups

© MorphoSys AG, Company Update - June 2016 15

Patients without post-baseline radiological tumor assessment were censored at baseline

The 12-months PFS rate as 40% in both DLBCL and iNHL. The 2-years PFS rate was 22% in DLBCL

and 35% in iNHL.

In the subgroup of evaluable patients with LBCL and iNHL:

PFS was significantly longer in patients with a baseline NK cell count >100 cells/μl

vs ≤100 cells/μl

PFS was similar in patients with rituximab non-refractory and refractory tumors

Jurczak et al., Abstract #7545, ASCO 2016

MOR208 in R/R NHL

Safety


The incidence of grade ≥3 hematologic treatment-emergent adverse events was low:

DLBCL: 9/35 (26%)

iNHL: 4/45 (9%)

including neutropenia, anemia and thrombocytopenia in 14%, 9% and 6% of DLBCL and 4%, 0% and

0% of iNHL patients

Infusion-related reactions were seen in 3/35 (9%) and 4/45 (9%) patients with DLBCL and iNHL

respectively; mostly of grade 1–2 (with one grade 4 dyspnea)

There were no treatment-related deaths and no trend towards late toxicity

MOR208 in R-R NHL

Conclusions


MOR208 12 mg/kg showed encouraging preliminary single-agent activity in patients with R-R DLBCL

or R-R iNHL

Objective response rates were 26% in the DLBCL cohort and 29% in iNHL cohort

Target lesion shrinkage demonstrated a clinical benefit in the majority of DLBCL and iNHL patients

with stable disease

Long-lasting responses were seen in DLBCL and iNHL, up to >26 months, and a PFS rate of 40% at 12

months

Subgroup analyses of DCR and PFS are hypothesis generating for prognostic or predictive biomarkers

and suggest:

MOR208 was equally efficacious in NHL patients with rituximab refractory and non-refractory

disease

Patients with a high peripheral NK cell count at baseline benefited more from MOR208 treatment.

Its utility as a predictive biomarker will be further investigated.

MOR208 was well tolerated with a favorable safety profile including patients on long-term

maintenance.


MOR202 alone and in combination

with pomalidomide or lenalidomide

in relapsed or refractory multiple myeloma:

Data from clinically relevant cohorts from a

phase I/IIa study



18

MOR202

Introduction

CD38 is a 45 kDa type II transmembrane

glycoprotein widely expressed in many

hematological malignancies including multiple

myeloma

MOR202 is a HuCAL-derived human

immunoglobulin G1 CD38 antibody that has

demonstrated high in vitro and in vivo efficacy in

preclinical models of MM

The main mode of action for MOR202-induced

lysis of MM cells is ADCC and ADCP

MOR202 does not induce CDC; CDC is suspected

to be a major contributor to infusion-related

reactions (IRRs)

We now present further data from this study of

patient cohorts treated with MOR202 in

combination with dexamethasone (Dex) or with

an immunomodulatory drug (IMiD) + Dex


MOR202: Objectives of the Phase 1/2a Study in

R-R Multiple Myeloma


Primary

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

dose of MOR202 in patients with R-R MM

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 R-R MM

MOR202: Phase I/IIa, Open-label, Multicenter,

Dose-escalation Study in R-R MM


Standard 3+3 dose escalation study starting with MOR202 monotherapy of 0.01 mg/kg every two

weeks (q2w) up to 16 mg/kg q2w and 8 mg/kg every week (q1w), followed by the combination

cohorts with Dex only, and in combination with POM/Dex or LEN/Dex

On completion of the dose escalation phase, confirmatory cohorts are planned to validate the MTD

and/or recommended dose/schedule of MOR202 + Dex, and in combination with POM/Dex or

LEN/Dex

Patients had to have received at least two prior lines of therapy for the MOR202 + Dex and +

POM/Dex cohorts or at least one prior line for the MOR202 + LEN/Dex cohort

MOR202 + Dex

2-hour IV infusion of MOR202*

(4→8→16 mg/kg) q1w

with Dex†

MOR202 + LEN/Dex:


(8→16 mg/kg) q1w

with LEN (25 mg po, d1-21)/Dex†,

MOR202 + POM/Dex


(8→16) mg/kg, q1w

with POM (4mg po, d1-21)/Dex†,

Dose escalation of combination cohorts (3+3 design)

Confirmatory cohorts (≥ 6 patients each)each cohort to be expanded with MTD or recommended dose

* During cycle 1, patients in all cohorts received/will receive a MOR202 loading dose on day 4.

† Low dose Dex was orally administered: 40 mg (≤ 75 years old) or 20 mg (> 75 years old) q1w. An additional dose was administered in cycle 1

on day 4 concomitant with loading dose.

The study is ongoing; this is a

report of interim safety, and

preliminary efficacy data in the

MOR202 treatment combination

cohorts

As of April 6, 2016, a total of 63

patients had been treated with

MOR202 monotherapy including 28

patients treated in combination

with Dex only or an IMiD + Dex

© MorphoSys, MOR202C101 ASCO 2016 Poster Presentation

Baseline characteristics

MOR202 schedule

Dosing, mg/kg

Patient number

Characteristic

q1w + Dex

4–16

n=16

q1w +

POM/Dex

8

n=5

q1w +

LEN/Dex

8, 16

n=7

Median age, years 67 64 60

Gender, %

Male

Female

56

44

40

60

86

14

Karnofsky PS, %

Median 90 90 90

Lines of prior

therapy, n

Median

4 4 2

Prior ASCT, % 81 80 86

Prior therapies, %

Bortezomib

Lenalidomide

Cyclophosphamide

Melphalan

Doxorubicin

Thalidomide

Pomalidomide

Carfilzomib

Panobinostat

100

100

94

94

63

38

13

6

0

100

100

60

100

0

20

20

20

20

100

57

86

100

43

14

0

0

14

Refractory to*, n (%)

Last prior therapy

Any prior therapy

12 (75)

13 (84)

4 (80)

5 (100)

3 (43)

4 (57)

*Refractory is defined as resistance to treatment

due to lack of response or progression of disease

during treatment within 6 months of last therapy

MOR202: Phase I/IIa Study in R-R MM

MOR202: Preliminary Phase 1/2a Data

Time on Study and Best Response*


7 out of 9 responses are ongoing

Median time to response was 4 weeks; most responses deepened over time

Most responses are ongoing, with the longest duration of response currently 44 weeks (ongoing)

To date 4 responses have been seen in the MOR202 + Dex cohorts and 5 responses in cohorts of MOR202 with an IMiD/Dex

In the cohorts of MOR202 with an POM/Dex, 2/5 responders achieved a CR

23


Best Maximum Change in M-protein*


*Updated data from 20 April 2016

CR, complete response; Dex, dexamethasone; LEN, lenalidomide; MR, minor response;

POM, pomalidomide; PD, progressive disease; PR, partial response; q1w, weekly;

SD, stable disease; VGPR, very good partial response.

% C

hange in M

-Pro

tein

24

MOR202

Very Low Rate of Infusion-Related Reactions


Infusion Tolerability and Immunogenicity

A 2-hour IV infusion was feasible in all patients

IRRs occurred in 4 (14%) patients and were mainly limited to the first infusion

Only 1 out of 30 patients (from all cohorts) tested so far developed a transient anti-MOR202

antibody response

Infusion-related Reactions to MOR202

Dex, dexamethasone; G, grade; IRR, infusion-related reaction;

LEN, lenalidomide; n, number of patients; POM, pomalidomide; q1w, weekly.

25

Current Data Suggest CD38 Preservation During

MOR202 Therapy


Baseline Cycle 2 Day 1 (4 weeks)

CD

38 m

ole

cule

s/cell

(ABC)

10000

100000

1000000 Biomarkers

Evaluation of CD38 molecules per cell (ABC)

on MM patient bone marrow plasma cells at

baseline and during MOR202 therapy

Current data suggest CD38 expression is

preserved during MOR202 therapy

Data derived from patients from different

dose cohorts and combination partners with

most of them showing a response to treatment

ABC, antibody bound per cell; Dex, dexamethasone;

LEN, lenalidomide; POM, pomalidomide; q1w, weekly.


Most frequently reported AEs*


MOR202 schedule

Patient number

q1w + Dex

n=16

q1w + POM/Dex

n=5

q1w + LEN/Dex

n=7

AEs, n (%) Grade ≥3 Any ≥3 Any ≥3 Any

Any 14 (88) 16 (100) 5 (100) 5 (100) 7 (100) 7 (100)

Hematological‡

Leukopenia

Neutropenia

Lymphopenia

Thrombocytopenia

Anemia

2 (13)

4 (25)

6 (38)

3 (19)

2 (13)

8 (50)

7 (44)

7 (44)

6 (38)

4 (25)

2 (40)

4 (80)

2 (40)

1 (20)

1 (20)

4 (80)

4 (80)

2 (40)

3 (60)

2 (40)

2 (29)

2 (29)

2 (29)

1 (14)

1 (14)

5 (71)

2 (29)

3 (43)

2 (29)

1 (14)

Non-hematological

Fatigue

Back pain

Muscle spasms

Diarrhea

Nasopharyngitis

Cough

Rash

Constipation

0

0

0

0

0

0

0

0

5 (31)

4 (25)

2 (13)

1 (6)

4 (25)

2 (13)

1 (6)

0

0

0

0

1 (20)

0

0

0

0

2 (40)

3 (60)

2 (40)

2 (40)

1 (20)

2 (40)

3 (60)

2 (40)

0

0

0

0

0

0

0

0

0

0

3 (43)

3 (43)

1 (14)

2 (29)

2 (29)

3 (43)

* Most frequently reported AEs defined as ≥15% in all MOR202 combination treatment cohorts (n=28).‡ Composites of preferred terms included in Medical Dictionary for Regulatory Activities System Organ Classes: Blood and lymphatic system disorders and Investigations.

Only one patient in the combination cohorts discontinued due to AEs with suspected causal relationship to MOR202. This AE (upper respiratory tract infection) had also a suspected causal relationship to LEN and Dex.

There have been no treatment-related deaths.

MOR202 in R-R MM

Conclusions


The MTD of MOR202 alone and in combination has not yet been reached

MOR202 in doses up to 16 mg/kg can be safely administered as a 2-hour IV infusion

MOR202 was well tolerated with a low incidence of IRRs, mainly limited to the first infusion

Current data suggest CD38 expression on MM patient bone marrow plasma cells is preserved during

MOR202 therapy

In this heavily pre-treated RRMM population, MOR202 alone or in combination with IMiDs lead to

encouraging and long lasting responses

A high percentage of complete responses (2/5, 40%) has been observed so far in patients that

receiving MOR202 in combination with POM/Dex

Further cohorts will evaluate MOR202 16 mg/kg q1w in combination with POM/Dex and LEN/Dex

Questions & Answers


Arndt Schottelius, M.D., Ph.D.

Steffen Heeger, M.D., Ph.D.




Mayo Clinic, Minnesota, USA

Update from ASCO 2016


MOR202

MOR208

MOR202 (8 mg/kg) plus Pom/Dex in R/R multiple myeloma patients show two

complete responses (CR) and two minor responses (MR) out of five patients

MOR202 (8 mg/kg) plus Len/Dex in RRMM show one very good partial response

(VGPR) and two partial responses (PR) out of four patients in this combination

cohort with a scheduled response assessment after one treatment cycle

First biomarker data suggest that CD38 expression on MM patient bone marrow

plasma cells was preserved during MOR202 therapy

MOR202 administered in doses of up to 16 mg/kg as a 2-hour intravenous infusion

with low incidence of infusion-related reactions

MOR208 shows disease control rate of 40% in R/R DLBCL and 73% in iNHL patients

Duration of response (CR or PR) of up to 26 months (responses ongoing)

MOR208 leads to reduction in target lesion size also in patients with stable disease

MOR208 shows similar progression-free survival (PFS) in rituximab-refractory and

non-refractory patients

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.

Dr. Claudia Gutjahr-Löser

Head of Corporate Communications & IR

Phone +49 (0)89 / 899 27-122

Fax +49 (0)89 / 899 27-5122

Email [email protected]

Thank You

www.morphosys.com

Documents

Investor Reception ASCO 2016 - MorphoSys AG...Its utility as a predictive biomarker will be further investigated. MOR208 was well tolerated with a favorable safety profile including