december 12, 2017 conference call l-mind data · changes in business, economic competitive...

Conference Call L-MIND dataMorphoSys AG

DECEMBER 12, 2017

Dr. Malte Peters

CDO

Today on the Call

© MorphoSys AG, Investor and Analyst Call after ASH 2017

Dr. Simon Moroney

CEO

Jens Holstein

CFO

2

Anke Linnartz

Head of

Corporate

Communications

& IR

This presentation includes forward-looking statements.

© MorphoSys AG, Investor and Analyst Call after ASH 2017

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.

The compounds discussed in this slide presentation are investigational

products being developed by MorphoSys and its partners and are not currently

approved by the U.S. Food and Drug Administration (FDA), European Medicine

Agency (EMA) or any other regulatory authority.

3

Agenda

© MorphoSys AG, Investor and Analyst Call after ASH 2017 4

INTRODUCTION1.

MOR208 – THE DRUG CANDIDATE2.

L-MIND TRIAL DATA3.

4.

TAKE AWAY MESSAGES5.

Q&A


Dr. Simon Moroney

Introduction


Dr. Malte Peters

MOR208

MOR208: Anti-CD19 studied in Hematological CancersAn Investigational Antibody Program for B Cell Malignancies


W Jurczak et al.; ASH 2016

BACKGROUND

IgG1k antibody

In-licensed from Xencor

Humanized and affinity optimized with Xencor

technology

Fc-engineered for enhanced ADCC &

phagocytosis

MODE OF ACTION

ADCC, phagocytosis, direct cytotoxicity

STRONG PRECLINICAL PACKAGE

Highly active as single agent in vitro and in vivo

Strong rationale for multiple combination

therapies

MOR208

Fc-enhancement

ADCC

ADCP

directcytotoxicity

ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity

ADCP: Antibody-Dependent Cell-Mediated Phagocytosis

MOR208: Development PlanOpportunity Across Spectrum of B Cell Malignancies

8© MorphoSys AG, Investor and Analyst Call after ASH 2017

INDICATION TRIAL / PHASE DESIGN TIMELINE

DLBCL L-MIND

Phase 2

Lenalidomide + MOR208 (12mg/kg) in

relapsed or refractory DLBCL pts ineligible

for HDCT and ASCT; N=80

Under discussion

with FDA (Q1 2018)

B-MIND

Phase 2/3

Bendamustine + MOR208 (12mg/kg) vs.

bendamustine + rituximab in relapsed or

refractory DLBCL pts ineligible for HDCT and

ASCT; N~330

Primary endpoint:

Q4 2019

CLL COSMOS

Phase 2

MOR208 (12mg/kg) + idelalisib in relapsed or

refractory CLL BTKi-failures

MOR208 (12mg/kg) + venetoclax in relapsed

or refractory CLL BTKi-failures

Updates at medical

conferences 2018

DLBCL Front line Under evaluation

Indolent

lymphomas

Under evaluation


Lenalidomide with MOR208: Phase 2 in R/R DLBCL

Official Title:

A Phase 2, single-arm, open-label, multicentre study to evaluate the safety

and efficacy of lenalidomide combined with MOR208 in patients

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

L-MINDStudy Design


ASCT, autologous stem cell transplant; HDCT, high-dose chemotherapy; R/R DLBCL, relapsed or refractory diffuse large B cell lymphoma; SD, stable disease, IV,

intravenous; PO, per os.

Response assessment after cycles 2, 4, 6 and 12, thereafter every 3 cycles.

PATIENTS WITH

R/R DLBCL:

have received

1-3 prior

regimens

are not

eligible for

HDCT and

ASCT

MOR208

12mg/kg IV

Days 1,15

MOR208

12mg/kg IV

Days

1,8,15,22

Lenalidomide

25mg PO

Days 1-21

Cycle 1 - 3 Cycle 4 -12

Disease

control

(≥SD)

Additional

antibody

treatment

phase

Survival

follow-up

MOR208

12mg/kg IV

Days 1,15

L-MINDBaseline Characteristics


CHARACTERISTIC N (%) N=51

Age, years Median (range) 73.5 (47-82)

Sex Female/Male 27 (53) /24 (47)

Ann-Arbor III-IV 30 (59)

ECOG-PS 0-1 47 (92)

2 3 (6)

Currently unknown 1 (2)

R-IPI Intermediate (1-2) 21 (41)

Poor (3-5) 24 (47)


Prior therapies 1 26 (51)

≥2 24 (47)


LDH level Elevated 28 (55)

Not elevated 18 (35)


Refractory to rituximab Yes 18 (27)


Refractory to last prior line Yes 20 (39)


Prior ASCT Yes 2 (5)

First relapse post diagnosis <12 months 8 (16)

>12 months 30 (59)


L-MIND Response RatesMOR208 + Lenalidomide: ORR of 52% in a Phase 2 Study in R/R DLBCL* Patients


*R/R= relapsed/refractory; DLBCL = Diffuse Large B-cell Lymphoma. ** Differences due to rounding

CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.

Single-Arm phase 2 study of MOR208 combined with lenalidomide in patients with R/R DLBCL: L-MIND, ASH Abstract 2017 as of November 1, 2017

CR: 32% (n=14)

PR: 20% (n=9)

SD: 14% (n=6)

NE: 14% (n=6)

0

20

40

60

80

100

n=44

Objective response

rate (ORR): 52%Best

Overa

ll R

esp

onse

(%

)**

PD: 21%

(n=9)

Long Duration of Response

19 (83%) of 23 responder patients still on treatment with ongoing responses


Time on Study (months)

PD

PD

PR

NE

SD

CR

PD

PR

NE

PD

SD

PD

NE

CR

CR

CR

SD

CR

CR

PR

CR

CR

PR

SD

PR

NE

CR

PR

PR

CR

PD

SD

NE

CR

NE

PD

CR

CR

CR

PR

PD

SD

PR

NE

Best

Overa

llResp

onse

2 4 6 8 10 12 14

Median Progression Free Survival of 11.3 months


Salles et al., ASH 2017

Preliminary Analysis (Kaplan Meier)

Comparison of Previous Lenalidomide Approaches in R/R DLBCL

Comparison to Literature Data*


L-MIND

MOR208 + LEN

Salles et al.,

2017**

LEN mono

Witzig et al.

2011

LEN mono

Czuzcman et

al.

2017

RTX + LEN

Wang et al.

2013

OBI + LEN

Morschhauser

et al.

ASH 2016

Number of

patients

N=44 N=108 N=51 N=32 N=71

ORR 52% 28% 28% 28% 45%

CR 32% 7% 10% 22% 16%

median PFS,

month

11.3

(preliminary)

2.7 3.2 3.7 4.1

*Please note limitations of cross-trial comparisons. ** Cut-off date June 13, 2017

R/R= relapsed/refractory; DLBCL = Diffuse Large B-cell Lymphoma, LEN, lenalidomide; RTX, rituximab; OBI, obinutuzumab;

CR, complete response;; ORR, objective response rate; PFS, progression-free survival; .

Existing and Upcoming Approaches in R/R DLBCL


*Please note limitations of cross-trial comparisons. **Cut off June 13, 2017. ***NR = not reached.

Parameter L-MIND

Salles et al.,

2017**

Dang et al.,

2014

Sehn et al.,

2017

Scholar-1

Crump et

al., 2017

Juliet

Schuster et al.

2017

Zuma-1

Neelapu et

al., 2017

Compound(s) MOR208 +

lenalidomideRTX +

bendamustine

Polatuzumab +

RTX +

bendamustine

Salvage

chemotherapies

+ radiation

Tisagenlecleucel

(CTL019)

Axi-CEL (CD19

CAR-T)

Phase II III II Retrospective

study

II II

Evaluable

patient

population

R/R DLBCL

n=44R/R DLBCL

n=135

R/R DLBCL

n=40

R/R DLBCL

n=635

R/R DLBCL

n=81

R/R DLBCL

n=101

Objective

response rate

52% 49% 70% 26% 53%/37%

Best/@6M

82%/48%

Best/@6M

Complete

response rate

32% 18% 58% 8% 40%/30%

Best/@6M

54%/ 46%

Best/@6M

Median PFS,

months

11.3

(preliminary)3.7 6.7 n/a 3.2 5.8

Median overall

survival,

months

NR**** 9.5 11.8 6.6 NR NR***

Comparison to Literature Data*

MOR208/Lenalidomide – Safety Evaluation


* Differences due to rounding

Most frequently observed

adverse event was

neutropenia (36%)

No infusion-related reactions

were reported for MOR208

Addition of MOR208 did not

result in increased

lenalidomide toxicity

Lenalidomide dose reductions

were required in 45% of

patients

Most commonly reported TEAEs occurring in ≥8% of patients; n (%) N=51.

8

8

8

8

10

8

4

2

14

12

16

8

16

14

22

12

20

2

6

8

2

8

2

6

8

4

22

2

2

2

2

14

0 5 10 15 20 25 30 35 40

Cramps

Vomiting

Creatinine increased

Hypotension

Urinary tract infection

Bronchitis

Hypokalemia

Pneumonia

Nausea

Cough

Asthenia

Leukopenia

Pyrexia

Rashes

Diarrhea

Thrombocytopenia

Anemia

Neutropenia

Patients (%)*

Grade 1/2

Grade 3

Grade 4

Upcoming Events and Potential Newsflow MOR208


*Including futility analysis. No publication of data expected.

MOR208

October 2017

FDA granted Breaktrough Therapy Designation

End of 2017

Recruitment for L-MIND complete (analysis ongoing)

Q1 2018

Update on Breakthrough Therapy designation

2018

Complete Analysis L-MIND

2018

CLL phase 2 data

2018

B-MIND Interim analysis*


Q&A-Session


Dr. Simon Moroney

Take-Away Messages

MOR208 HAS THE POTENTIAL TO OFFER A NEW TREATMENT OPTION IN R/R DLBCL

MOR208 combination with lenalidomide in R/R DLBCL showed an objective response rate

(ORR) of 52% and a complete remission rate (CR) of 32%

The preliminary median progression-free survival mounts up to 11.3 months

No unexpected toxicities were observed for the combination and no infusion-related reactions

were reported for MOR208

INTENTION TO BRING MOR208 TO MARKET AS QUICKLY AS POSSIBLE

Based on preliminary L-MIND data FDA granted Breakthrough Therapy Designation in Oct. 2017

FDA now grants support by a senior management team and helps to streamline further

development activities

We are committed to develop MOR208 in close interaction with the FDA as quickly as possible

Take-Away Messages


www.morphosys.com

Thank You

MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational drugs and have not been

approved by the FDA or other ex-US regulatory agencies. HuCAL® , HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high

potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.

TremfyaTM and STELARA® are trademarks of Janssen Research & Development, LLC; Humira® is a trademark of Abbvie Inc.; Cosentyx® is a trademark of Novartis AG;

Dupixent® is a trademark of Sanofi Biotechnology; Cimzia® is a trademark of UCB Pharma, S.A.; Enbrel® is a trademark of Immunex Corporation/Wyeth LLC; Remicade®

is a trademark of Janssen Biotech, Inc./Centocor Inc.; Simponi® is a trademark of Johnson & Johnson; Siliq® is a trademark of Amgen Inc.; Taltz ® is a trademark of Eli

Lilly and Company.

Anke Linnartz

Head of Corporate Communications & IR

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

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

Email [email protected]


december 12, 2017 conference call l-mind data · changes in business, economic competitive...

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