Company Update - MorphoSys AG
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Deutsches Eigenkapitalforum 2015 Company Update November 24, 2015
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. © MorphoSys AG, Company Update - November 2015 2
The MorphoSys Pipeline
25 Clinical Product Candidates, 104 Total
Most advanced development stage
Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3
Bimagrumab (BYM338) Novartis ActRIIB sIBM (musculoskeletal)
Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis
Gantenerumab Roche Amyloid-ß Alzheimer’s disease
MOR208 - CD19 ALL, CLL, NHL
MOR103/GSK3196165 GSK GM-CSF Inflammation
MOR202 - CD38 Multiple myeloma
BHQ880 Novartis DKK-1 Multiple myeloma
CNTO3157 Janssen - Inflammation
CNTO6785 Janssen - Inflammation
LFG316 Novartis C5 Eye diseases
LJM716 Novartis HER3 Cancer
BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome
Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors
VAY736 Novartis BAFF-R Inflammation
MOR209/ES414 Emergent PSMA/CD3 Prostate cancer
Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors
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
PF-05082566 Pfizer 4-1BB Solid tumors
Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors
MOR106 Galapagos - Inflammation
MOR107 (LP2) - AT2-R Fibrosis
Immuno-oncology program Merck Serono - Cancer 90 Partnered Programs
Immuno-oncology program Immatics - Cancer 13 MOR Programs
6 MOR programs - - Various 1 Outlicensed Program
In addition, 26 partnered programs in pre-clinic, and 43 partnered programs in discovery
© MorphoSys AG, Company Update - November 2015 3
The MOR Portfolio
Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3
Unpartnered
MOR208 NHL FTD, orphan status US & EU
CLL CD19 Orphan status US & EU
ALL
MOR202 Multiple myeloma CD38
MOR107 Fibrosis AT2-R
Immuno-oncology
program Cancer Various
(Immatics)
6 Programs Various Various
Co-development & co-promotion
MOR209/ES414 Prostate cancer PSMA / CD3
(Emergent)
MOR106 Inflammation Undisclosed
(Galapagos)
Immuno-oncology
program Cancer Undisclosed
(Merck Serono)
© MorphoSys AG, Company Update - November 2015 4
MOR208 First- & Best-in Class Potential Fc-enhanced, humanized IgG1 antibody targeting CD19 CD19 is target of choice for B-cell malignancies CD20 down-regulated after anti-CD20 treatment CD19 down-regulation not described Fc modification leads to dramatically enhanced B cell depletion antibody dependent cellular cytotoxicity (ADCC) phagocytosis direct cytotoxicity Convenient dosing schedule, straightforward manufacturing Strong pre-clinical support for combo therapy Major medical need in DLBCL and CLL DLBCL: Ca. 40% treated with chemo-immune therapy/ASCT eventually relapse, becoming refractory to current agents* CLL: Patients who are discontinued after BTKi treatment relapse very quickly and have a very poor prognosis © MorphoSys AG, Company Update - November 2015 5
MOR208
Comprehensive Clinical Development Plan
Indication 2015 2016 2017 2018
NHL
MOR208 (12 mg/kg); N=92
DLBCL
MOR208 (12mg/kg) + lenalidomide; 2nd line R/R; N=80
Safety evaluation leading into anticipated pivotal study
MOR208 (12 mg/kg) + bendamustine; 2nd line R/R; N~320
CLL
MOR208 (12mg/kg) + idelalisib; BTKi-failures; N=120
MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s Transformation; N=50 (Ohio State Univ. IIT)
ALL
MOR208 (12mg/kg) + NK cells; pediatric ALL; N=13 (St Jude’s IIT)
Phase 2
Phase 2/3
IIT: Investigator-initiated trial
© MorphoSys AG, Company Update - November 2015 6
MOR202 A Novel Antibody for Multiple Myeloma HuCAL IgG1 antibody binding unique epitope on CD38 One of only three CD38 antibodies in clinic Potent ADCC and ADCP Full killing of MM cells Low killing of healthy/effector cells Strongly synergistic with IMiDs and proteasome inhibitors in pre-clinical models Best-in-class infusion tolerability as consistent 2-hour infusion Multiple myeloma (MM) treatment: a large commercial opportunity Leading therapies already generate over $5.0bn in worldwide sales Estimated to reach $10.2bn by 2020 © MorphoSys AG, Company Update - November 2015 7
MOR202
Clinical Development Plan
Indication 2015 2016 2017 2018
MOR202 monotherapy, dose escalation &
confirmation cohorts; N~62*
MOR202 (8 & 16mg/kg) + lenalidomide & confirmation cohorts; N~24**
Multiple
myeloma
MOR202 (8 & 16mg/kg) + pomalidomide & confirmation cohorts; N~24*
MOR202 combo study to be based on Phase 2
Phase 2 * Patients who have failed at least 2 prior therapies
Phase 2/3 ** Patients who have failed at least 1 prior therapy
© MorphoSys AG, Company Update - November 2015 8MOR209/ES414
A Novel Bi-specific Antibody for Prostate Cancer
Bi-specific ADAPTIR antibody targeting
PSMA on prostate cancer cells, levels increase with progression
CD3 on cytotoxic T cells
Compelling pre-clinical data
Encouraging activity in vitro and in vivo
Less cytokine release on T cell activation in pre-clinical models
compared to other formats
Prolonged half-life in mouse and NHP compared to other
formats
Indication 2015 2016 2017 2018
MOR209/ES414: Phase 1/2 dose escalation (N~50)
mCRPC*
MOR209/ES414: Phase 1/2 dose extension (N~80)
Phase 3 preparations
Phase 1/2a
Phase 3 * Metastatic castration-resistant prostate cancer
© MorphoSys AG, Company Update - November 2015 9Clinical Programs Pursued by Partners (I)
Program Partner Target Indication Phase 1 Phase 2 Phase 3
Bimagrumab Novartis ActRIIB sIBM (52 weeks)
(BYM338) sIBM (extension)
sIBM (long-term study)
Hip fracture surgery
Sarcopenia
Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1)
(CNTO1959) Psoriasis (VOYAGE 2)
Psoriasis (NAVIGATE)
Pustular/Erythrodermic Psoriasis
Moderate to severe psoriasis
Active psoriatic arthritis
Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s disease
Prodromal Alzheimer‘s disease
Genetically predisposed
BHQ880 Novartis DKK-1 MM (renal insufficiency)
Smoldering MM
BPS804 Mereo/Novartis Sclerostin Osteoporosis
Hypophosphatasia (HPP)
Osteogenesis Imperfecta
CNTO3157 Janssen/J&J n.d. Asthma
Safety/Pharmacokinetic
CNTO6785 Janssen/J&J n.d. COPD
Rheumatoid arthritis
LFG316 Novartis C5 Age-related AMD
Geographic atrophy
Panuveitis
Paroxysmal nocturnal hemoglobinuria
LJM716 Novartis HER3 ESCC (combo with BYL719)
HER2+ cancer (combo BYL719 & trastuzumab)
HER2+ cancer, combo with trastuzumab
Partnered discovery programs
© MorphoSys AG, Company Update - November 2015 10Clinical Programs Pursued by Partners (II)
Program Partner Target Indication Phase 1 Phase 2 Phase 3
MOR103/GSK3196165 GlaxoSmithKline GM-CSF Rheumatoid Arthritis
Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE)
(OMP-59R5) Small cell lung cancer (Pinnacle)
Solid tumors
BAY1093884 Bayer TFPI Bleeding disorders
BAY94-9343 Bayer Mesothelin Solid tumors
Anetumab Ravtansine Advanced malignancies (Japan)
BI-836845 BI IGF-1 Solid tumors, Japanese patients
EGFR mutant NSCLC
Breast cancer
CRPC + enzalutamide
Various solid cancer
Advanced solid tumors
NOV-7 Novartis n.d. Eye disease
NOV-8 Novartis n.d. Inflammation
NOV-9 Novartis n.d. Diabetic eye disease
NOV-10 Novartis n.d. Cancer
NOV-11 Novartis n.d. Blood disorders
PF-05082566 Pfizer 4-1BB Solid tumors, NHL (+rituximab)
Solid tumors, combo with PD-1i MK-3475
Advanced solid tumors, with mogamulizumab
Advanced malignancies, with avelumab
VAY736 Novartis BAFF-R Pemphigus vulgaris
Primary Sjögren‘s syndrome
Primary Sjögren‘s syndrome
Vantictumab Oncomed/Bayer Fzd 7 Solid tumors
(OMP-18R5) Breast cancer
Pancreatic cancer
NSCL
Out-licensed program
Partnered discovery programs
© MorphoSys AG, Company Update - November 2015 11MOR103/GSK3196165
Anti-inflammatory Program Licensed to GSK
MOR103/GSK3196165 GM-CSF plays a key role in
HuCAL antibody specific for GM-CSF activation of macrophages at the
GM-CSF is important in every step of macrophage site of injury or inflammation
production and infiltration in the tissues
Indications
Lead indication: Rheumatoid arthritis (RA)
Potential for disease modification & analgesic activity in
hand osteoarthritis (HOA)
Current Status
BAROQUE (RA phase 2b) ongoing
Initial clinical read-out 2016
Phase 2 in hand osteoarthritis to start in 2016
© MorphoSys AG, Company Update - November 2015 12Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
Bimagrumab
HuCAL antibody specific for ActRIIB, antagonizes
myostatin binding
Lead indication: sporadic inclusion body myositis (sIBM)
FDA breakthrough therapy designation
Orphan drug designation
Current Status
Pivotal study in sIBM with 240 patients ongoing,
completion scheduled for Q4 2015
Phase 3 data expected in H1 2016
Listed by Novartis as “planned filing 2016”
Phase 2 read-outs in sarcopenia expected in 2016
M. Schuelke at al, N Engl J Med 2004;350:2682-8
© MorphoSys AG, Company Update - November 2015 13Guselkumab (CNTO1959)
A Janssen Anti-Inflammatory Program
Guselkumab
A HuCAL antibody specific for IL-23, does not bind IL-12
IL-23 blockade inhibits production of multiple cytokines
beyond IL-17A and preserves Th1 & Treg regulatory pathways
Being developed in psoriasis and psoriatic arthritis
Current Status
Five Phase 3 clinical trials ongoing
First Phase 3 data expected in 2016
Anticipated filing in 2016
Source: Jetten AM, Nucl Recept Signal, 2009
© MorphoSys AG, Company Update - November 2015 14Clinical Trials Scheduled for Completion
Guselkumab
PHASE 3
Psoriasis (VOYAGE 1)
Bimagrumab Guselkumab Guselkumab
sIBM Psoriasis (VOYAGE 2) Psoriasis (NAVIGATE)
CNTO6785 MOR202 Bimagrumab
Rheumatoid arthritis Multiple myeloma √ Sarcopenia
PHASE 2
CNTO6785 MOR208 LFG316 LJM716
COPD NHL (mono - update) √ Panuveitis ESCC, combo w/BYL719
LFG316 MOR208 - IST LFG316 Tarextumab
Age-related AMD CLL (combo with len) PNH Pancreatic cancer
BI-836845
Advanced solid tumors
PHASE 1
BAY94-9343 Tarextumab BI-836845 MOR209
Solid tumors Solid tumors √ NSCLC Prostate cancer
LJM716 Vantictumab BI-836845 Vantictumab
Advanced solid tumors NSCLC Solid tumors (Japan) Breast cancer
LJM716 Vantictumab BI-836845 Vantictumab
HER2+ cancer (combo) √ Pancreatic cancer Various solid cancer Solid tumors
2015 2016
Partnered Discovery Programs
Potential data events based on clinical trial design & MorphoSys estimates
MOR Programs
© MorphoSys AG, Company Update - November 2015 15Financial Guidance 2015
in € million 2014A 9M 2015 Guidance 2015
Group Revenues 64.0 93.9 101 to 106
Proprietary R&D Expenses
36.4 39.9 56 to 63
(incl. Technology Development)
EBIT -5.9 34.7 9 to 16
Cash, cash equivalents & marketable securities
as well as other short-term and long-term financial 352.8 317.7
assets
© MorphoSys AG, Company Update - November 2015 16What to Expect?
Updated data from phase 2 mono-therapy trial at ASH 2015
DLBCL: Phase 2 lenalidomide combo trial to start in Q4 2015
MOR208 Phase 3 bendamustine combo trial expected to start in 2017
CLL: Phase 2 idelalisib combo trial to start in Q1 2016
ALL: Phase 2 pediatric IIT with NK cell transfusion to start in H1 2016
MOR202 Updated data from phase 1/2a trial at ASH 2015
MOR209 First phase 1 data expected in 2016
Data from pivotal trial in sporadic inclusion body myositis expected early 2016
Bimagrumab
Filing expected in 2016
Data from 3 pivotal trials in psoriasis expected 2016
Guselkumab
Filing expected in 2016
MOR106 & MOR107 to start clinical development in 2016
Pipeline
Potential in-licensing of additional compounds
© MorphoSys AG, Company Update - November 2015 17Thank You www.morphosys.com Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / 899 27-122 Fax +49 (0)89 / 899 27-5122 Email investors@morphosys.com 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.
You can also read
