Molecular Partners: Building Tomorrow’s...
Transcript of Molecular Partners: Building Tomorrow’s...
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Molecular Partners:
BuildingTomorrow’s Breakthroughs
Corporate Presentation
Molecular Partners AG, Switzerland (SIX: MOLN)
March 15, 2019
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Molecular Partners: A Swiss Biotech developing innovative protein drugs
DARPin® platform as source of mono/multi-specific protein drugs
Rapid cycle of innovation to test novel therapeutic design
Validation in >1.8k patients treated to date (mainly Abicipar)
DARPin®
ENGINE
Abicipar: Phase 3 in wet AMD
MP0250: Phase 2 in MM and NSCLC
MP0274: Phase 1 in Her2 positive cancer indications
MP0310: First-in-human in multiple cancer indications in 2019
DARPin®
PIPELINE
TEAM
WORK
130 co-workers – purpose driven, evolutionary organization
Partnership with Allergan on Abicipar, ophthalmology assets
New partnership with Amgen on MP0310
CAPITALMultiple near-term catalysts with significant value creation potential
Well financed: on-track to steady income with Abicipar launch (2020e)$
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Dr. Patrick Amstutz, CEO
Co-founder, former CBO & COO
Member of the Board of Directors
PhD in molecular biology from UZH
Dr. Andreas Harstrick, CMO, MD
30 years of experience in oncology
Developed multiple mAb oncology products
Senior positions at Merck-Serono, Imclone, Eli Lilly
Dr. Michael Stumpp, COO
Co-founder
PhD and postdoc from UZH;
research in Tokyo, London
Andreas Emmenegger, CFO
Former CFO Glycart, Finance Roles at Roche
>20 years experience as CFO of private & listed
companies and in fund raising, IPOs
Dr. Pamela Trail, CSO
>30 years of experience in cancer drug discovery
Senior positions at Regeneron, Medimmune, SGEN,
Bayer, BMS
Experienced Management Team & Board of Directors
Bill Burns, Chairman Former CEO of Roche Pharmaceuticals
Former board member of Roche, Genentech,
Chugai Pharmaceuticals, Shire
Göran Ando, Vice Chairman Former Chairman, Novo Nordisk
Former CSO, Pharmacia
Gwen Fyfe Former VP, Oncology Development at
Genentech
Steven H. Holtzman President and CEO, Decibel Therapeutics
Former EVP, Biogen
William “Bill” Lee EVP Research, Gilead
Petri Vainio Managing Director, Essex Woodlands
Ventures
EX
EC
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MA
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GE
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DARPin® Proteins: Nature’s Choice for Multi-Specific Binding
• Large size: 150 kDa
• Complex architecture: 4 proteins with 12 domains
• Target binding via flexible surface loops (CDRs)
MONOCLONAL ANTIBODIES DARPin® Protein(s)
Binding region /
specificity
15 kDa
150 kDa
SCALE
DARPin® moduleBinding regions /
specificity
Multi-DARPin® product candidate
• High affinity and specificity
• Low immunogenicity potential
• Tunable half life• Small size: 15 kDa (1/10 of monoclonal antibody)
• Simple architecture: 1 protein with 1 domain
• Target binding via rigid surface structure
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DARPin® Engine: Selecting Novel Therapeutic Designs toMatch Desired Function
DARPin® module selection Opening novel Therapeutic
Design Space
Therapeutic Design matches
its function
Selecting the «optimal»
Therapeutic Design
Multi-DARPin® product candidates
DARPin® Library with
1012 modules
Target(s)
Identified DARPin® modules
with high target affinity
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A Balanced and Robust Portfolio
AMD: age-related macular degeneration; DME: diabetic macular edema; NSCLC: non-small cell lung cancer
Preclinical Phase 1 Phase 2 Phase 3Commercial
RightsO
nco
log
yI/
OO
ph
tha
lmo
log
yProduct
CandidatesIndication/
Focus
MP0250 Multiple Myeloma, PI combo
MP0250 EGFR-mutated NSCLC
MP0274 HER2 positive
MP0310 FAP x 4-1BB
Abicipar Neovascular AMD
Abicipar DME
Additional proprietary
DARPin® candidates
Various
in I/O
Additional
DARPin® candidates
Various in
Ophthalmology
MP0250 Multiple Myeloma, IMiD study
DA
RP
in®
Engin
e:
So
urc
e o
f P
rod
uct C
an
did
ate
s
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Tree of Evolution of DARPin® Approaches
Abicipar: Local activity,
high affinity bindingSystemic
validation
Bi-Specifics
MP0250
Incre
asin
g le
ve
l of
Inn
ova
tion &
Diffe
ren
tiatio
n
Direct Tumor
Cell Killers
MP0274
Next level of immune
cell targeting
MHC-peptides
Local
Agonists
MP0310
FAP x CD40
DARPin® Platform
Mono-Specifics
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MP0250: Our First Multi-DARPin® Product Candidate
SOC, standard of care; HSA, human serum albumin.
VEGF
DARPin®HGF
DARPin®
HSA
DARPin®
Medical Need: Some tumors develop adaptive
resistance to SOC by up-regulating VEGF and HGF
MoA: MP0250 inhibits both VEGF and HGF
simultaneously
Blocking these adaptive escape pathways may
restore clinical sensitivity to SOC
Status: Phase 2 in MM and NSCLC ongoing
Phase 1: safe up to 8 mg/kg/3weeks
HSA
DARPin®
HGF
(c-MET)
VEGF
Upregulation of escape
pathways after SOCMedical need: Agents that block
escape pathways to SOC
HGF
(c-MET)
VEGF
MP0250
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50,000 – 100,000
>100,000
MP0250: Potential to Treat Several Indications MM and EGFR-mut NSCLC selected initially
1) Including US/5EU/JP. Datamonitor.
Head and neck
squamous cell
EGFR-mutated
NSCLC
Multiple myeloma
Hepatocellular
carcinoma
Colorectal cancer
Nasopharyngeal
Gastric cancer
Renal cancer
Anal cancer
<50,000
INCIDENCE:1
MP0250
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Unmet Medical Need in Multiple Myeloma (MM)
Relapsed
c-MET
89%
Newly diagnosed
Activa
ted
-c-
ME
T r
ece
pto
r
28%
c-MET
On partial remission
2%
c-MET
Dynamic activation of the HGF pathway during disease progression1. HGF is highly overexpressed in bone marrow
biopsies of multiple myeloma patients
Bone marrow
tumor Score 3+6/8
patient samples
1. Moschetta M, et al. Clin Cancer Res 2013;19:4371-82
Bone marrow
tumor Score 2+
Solid tumor
Score 1+
2/8 patient samples
0/8 patient samples
MP0250
MM remains incurable for most patients as cells acquire adaptive resistance to currently available therapies
Relapse inevitable
Time to relapse shortens with every treatment cycle
Quality of response tends to diminish
No current drug in MM is addressing
adaptive VEGF and HGF resistance
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Testing how MP0250 can revert Adaptive Resistance in MM
1) Hajek, R. Strategies for the Treatment of Multiple Myeloma in 2013: Moving Toward the Cure.
In “Multiple Myeloma: A Quick Reflection on the Fast Progress” (2013).
Illustrative course of disease of a MM patient1
IMiD
PI IMiD
PI
MP0250
MP0250
+
PIor or
our «initial» trial
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MP0250 Phase 2 Study in MM: Promising Signs of Efficacy
Data cut-off: 31 January 2019. dose level: 8mg/kg/3weeks.Partial
Response
Very Good
Partial Response
Stable
Disease
Progressive
Disease
On
Treatment
70 80
Treatment duration (weeks)
Minor
Response
MP0250
Patient population: Patients with MM with
≥ 2 prior lines of treatment, including IMiD and PI,
and no response or early relapse
Treatment regimen: Velcade®/Dexamethasone
plus MP0250
5 of 8 patients with objective responses (cohort 1)
3 of 4 patients coming directly from a PI-based
regimen responded in cohort 1 (*)
Durable remission observed in heavily pretreated
patients
MP0250 (8mg/kg) combined with Velcade® has
shown tolerable safety profile
Study ongoing with additional patients ( )10 20 30
Cohort
1E
xpansio
n
*
**
*
Pt. A
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MP0250 Case Study: Patient A (4th line, coming from PI)
1st line:
Cyclo/Thal/Dex
SD
SD
VGPR
2nd line:
Bor/Dex
4th line:
MP0250/
Bor/Dex
time
Dis
ea
se
se
ve
rity
(co
nce
pti
on
al)
3rd line:
Bor/
Len/
Dex
1 year >1.5 years, ongoing
PD
PD
PD
Female 63y, MM IgG kappa diagnosed in May 2016
Prior MM Therapy:– 1st Line: Cyclo/Thal/Dex; Best Response: SD
– 2nd Line: Bor/Dex; Best Response: SD
– 3rd Line: Bor/Len/Dex; Best Response: PD
Current Treatment: 4th line - MP0250– Start: Aug 2017, ongoing
– Safety: Hypertension, Polyneuropathy
– Best Response: VGPR, ongoing
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MP0250 Positioning in MM and Our «planned» Trials
1. Including US/5EU/JP. Datamonitor, August 2018.
Global market value of
MM treatment:
$13 billion
expected to exceed
$20 billion
by 2022
(CAGR: 13%)1
n 30,0001n >100,0001
1st Line
Therapy
2nd
Line
4th
Line
3rd
Line
IMiDor
mAb
PI+
Transplant
or
mAb
+
PI
IMiD75%
25%
Multiple myeloma: 2nd most common
blood cancer
MP0250
MP0250
+
PI
MP0250
+
IMiD
our «planned» trialsMP0250 has the potential to become
backbone for later lines of treatment
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No targeted drug approved
for patients progressing on Tagrisso®
treatment – high unmet medical need
Phase 2 ongoing in the US
Patient population: Patients with
EGFR-mut NSCLC who have failed to
respond to Tagrisso ®
Treatment regimen: Tagrisso® plus
MP0250
Unmet Need in EGFR-mutated NSCLC
PFS-based data from the FLAURA and AURA3 study;
TKI, Tyrosine Kinase Inhibitor
3rd Line:
Chemotherapy
TREATMENT
OPTION 2
1st Line:
1st Generation TKI
2nd Line:
Tagrisso®
PFS: ~10.2 months PFS: ~8.5 months
PFS: ~18.9 months
TREATMENT
OPTION 1
EGFR-
mutation
T790 -
mutationother - mutations
cMET- amplification
HGF up-regulation/
cMET pathway activation
~10%
Tagrisso Chemotherapy
MP0250
MP0250
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Unique Potential of MP0250 in EGFR-mut NSCLC
1. Including actively treated, Stage IIIb and Stage IV prevalent cases in US/5EU/JP. Datamonitor, August 2018;
Tang et al Oncotarget 2016: Activating EGFR mutations are found in ~40% (Asia), ~20% (US), and ~15% (EU)
Global market value
(EGFR NSCLC):
ca. $2.8 billion
expected to exceed
$3.5 billion
by 2023 (CAGR: 5%)1
n=35,0001 n 15,0001
1st Line
Therapy
2nd
Line
3rd
Line
Tagrisso®
Iressa® or
Tarceva® Tagrisso ®
MP0250
n=20,0001
Tagrisso®
MP0250
Tagrisso ®
Treatment
option 1
Treatment
option 2
4th
Line
+
+
MP0250
P2 Trial
MP0250
No targeted drug approved
after patients progress under
Tagrisso® treatment
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MP0274: Killing HER2+ Cells by New MoA
HER2
DARPin® A
HER2
DARPin® B
HSA
DARPin®
Medical need: despite good antibody-based
HER2+ treatments, eventually patients progress
Novel mode of action: MP0274 is an allosteric
inhibitor blocking HER2- and HER3 signaling and
inducing apoptosis
No need for drug conjugation (ADC) for direct
tumor cell killing
Status: Phase 1 dose escalation in HER2 positive
tumor patients that have progressed on SOC
ongoing; Recruitment of first patient cohort
completed
MP0274
Bi-paratopic DARPin®
MP0274 locks Her2 into fully
inactive conformation
Her2
«Open»
Her2
«Locked»
Apoptosis: Tumor
cell suicide
MP0274
HSA
DARPin®
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1 0 0 1 0 1 1 0 2 1 0 3 1 0 4 1 0 5 1 0 6
0
2 0
4 0
6 0
8 0
1 0 0
New MoA may help patients who do not adequately respond to current therapies
MP0274 is a Highly Potent Tumor Cell Killer
Tumor Cell ApoptosisBT474
Tumor Cell KillingBT474
[nM]
0 100 101 102 103
100
80
60
40
20
0
(Herceptin®/Perjeta®)
MP0274
% K
illin
g
[nM]
MP0274
Ado-trastuzumab emtansine
Trastuzumab/Pertuzumab
(Kadcyla®)
100
80
60
40
20
0
100 101 102 104103 105 106
MP0274
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UNBLOCK
DIRECT
KILL
ENGAGE
Tumor Cells
Tumor Stroma
Cells
MODULATE
PRIME &
ACTIVATE
Immune CellT cells
ENGAGECytotoxic Immune Cells
UNBLOCKCheckpoint Approaches
T cells
DIRECT KILLDirect Tumor Cell Killing
Tumor cells
MODULATETumor Microenvironment Modulators
Tumor / Stromal cell interactions
PRIME & ACTIVATELocalized Immune Modulators
Antigen-presenting cells, T cells
DARPin® Strategy in Oncology
MP0274
MP0250
MP0310
pMHCs
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DARPin® Strategy in Immuno-Oncology
Tumor Stroma
Cells
Immune
Cell
4-1BB, others
CD-3
FAP
Tumor antigen
PD-1
Tumor Cells
ENGAGE
Tumor Cell
Immune
Cell
ACTIVATE
PD-1 mAB
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Our Vision to Expand the Therapeutic WindowThrough Tumor-Localized Immune Modulation
Current IO therapeutics that
activate the immune system
(agonists) throughout the
body show systemic side
effects that can limit the
effective dosing
Tumor-localized IO
therapeutics that activate
immune cells preferentially
within the tumor may both
increase efficacy and
reduce systemic toxicities
tumor
stroma
tumor cells
tumor cells
healthy cells
activated
T cell
activated
T cell
resting
T cell
MP0310
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DARPin® Toolbox: Tumor-LocalizedImmune Modulators
Tumor-localized immune modulators – overcoming the limitation of systemic side effects
OX-40 4-1BB CD40 Other Targets
Solid Tumor
TAA*TAA x 4-1BB
Tumor
Stromal
Antigen
FAP x 4-1BB
MP0310FAP x CD40
Hematologic
TAATAA x OX40 TAA x 4-1BB TAA x CD40
Immune Modulator
Lo
cali
zer
*Tumor-Associated Antigen (TAA)
MP0310
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MP0310 (FAP x 4-1BB): Activating T-cells in the Tumor
HSA, human serum albumin.
Medical need: most current 4-1BB agonists activate
T-cells and NK cells systemically and are limited by
side-effects
MoA: MP0310 uses binding to FAP – a tumor
stromal target – to cluster and activate T-cells
primarily in the tumor
Status: MP0310 is in preclinical development and
partnered with Amgen. Phase 1 to start in H2 2019
4-1BB
DARPin®
FAP
DARPin®
HSA
DARPin®Illustrative graphic
MP0310
DARPin® modules
Immune modulator Localizer Half-life extender
MP0310
+ +
+ MP0310
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Intratumoral CD8 T cells
Combined Therapy with MP0310 and TAA x CD3 Bi-Specific Results in Significant Increase of Intratumoral CD8+ T Cells
Veh
icle
TAA x
CD3
TAA x
CD3
+ M
P03
10
0
10000
20000
30000
40000
Nu
mb
er
of
hC
D8
T c
ells
pe
r 0
.2 g
tu
mo
r
***
**
FAP-Mediated Tumor
Accumulation of MP0310
HT-29-T-implanted NSG mice
Tumor growth inhibition
PBMC humanized HT-29 xenograft model
0
500
1000
1500
2000
Treatment days
Me
an
tu
mo
r v
olu
me
(m
m3)
0 3 7 10 14 16
Vehicle
TAA x CD3
TAA x CD3+ MP0310
mFAP x 4-1BBno-FAP x 4-1BB
Tumor
MP0310
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Peptide-MHCs – DARPin® approach for «un-accessible» targets
Extracellular
targets
MHC
peptide
Intracellular
targets
Most targets are in the intracellular space and not accessible with antibody-based approaches
Antibody-based approaches:
Limited success with mAbs, BiTEs, CAR-T cell, etc. to
target pMHC complexes
Soluble T cell receptor approaches:
limited by biophysical characteristics and
rather low affinity to pMHCs
DARPin®-based approaches:
Research projects to test DARPin® binders to pMHCs
in oncology and virology
Engage
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Abicipar has Potential to be First Fixed 12 Week anti-VEGF
Source: Allergan presentation, 06 Dec 2018, VA visual acuity, OCT optical coherence tomography
Medical Need: current anti-VEGFs in nAMD are mostly
dosed monthly or extended to bi-monthly, leading to high
patient burden and under-dosing in real-world settings
MoA: Abicipar is the only long-acting anti-VEGF and has
shown to be the first fixed 12-week nAMD drug, lowering
patient burden given full effectiveness in real world setting
Status: Allergan plans FDA filing in H1 2019 and launch in
2020 and plans to start DME Phase 3 in H2 2019
VA defect in nAMD
OCT in nAMD
Choroidal
Neovascularization
Abicipar
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Phase 3 Efficacy Results (SEQUOIA study, 1yr data)
Source: Allergan July, 2018 and October 2018
Primary Endpoint: STABLE VISION Abicipar
Q8 and Q12 Non-Inferior to Ranibizumab Q4
Secondary Endpoint: Change in BCVA From Baseline Abicipar
Q8 and Q12 in SEQUOIA Non-Inferior to Ranibizumab
Secondary Endpoint: Change in CRT similar across in all
groups
Abicipar
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Allergan is further optimizing the material for potential launch 2020
Primary and secondary endpoints support abicipar potential to become
the first fixed 12-week anti VEGF in nAMD
Overall safety events between abicipar and ranibizumab were comparable
– Intraocular inflammation potential was higher for Abicipar (15%) vs ranibizumab (< 1%)
–Majority of inflammation was mild to moderate and were treated with topical corticosteroids
Further optimized Abicipar material was produced and is currently being tested
in clinical trial (MAPLE) – Allergan expects results in H1 2019
Abicipar
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Leveraging our DARPin® Engine via Partners
Strategy: Broaden and accelerate our activities & cross-finance our proprietary pipeline
Partnership to leverage the DARPin®candidates in ophthalmology (no cost share)
• Total of USD 360m in potential future milestones
• Tiered royalties: Low double-digit to mid-teens
Gilead-supports research project to test if
DARPin® molecules can specifically bind to
peptide-MHC complexes
Partnership to test MP0310 in combination
with other IO drug candidates (cost share for
some clinical trials)
• USD 50mio upfront payment, USD 497mio in
clinical, regulatory and commercial milestones
• Double-digit, tiered royalties up to the high teens
Collaboration to test MP0250 combination with
Tagrisso® in EGFR-mut NSCLC
• No MP0250 rights attached
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DARPin® Engine: Source for candidates with novel therapeutic designs
Advanced and balanced DARPin® Portfolio
–Abicipar in pivotal trial with potential to be first fixed 12-week anti VEGF in nAMD
–MP0250 in P2 pioneering a new MoA in MM, P2 in NSCLC & MP0274 in P1
–Research in oncology focus areas set-up to deliver highly innovative designs of
candidates (tumor local agonists, pMHC DARPins, …)
Organizational focus on product innovation and company growth
Partnerships to accelerate development of DARPin® candidates
Well financed & on-track towards steady income with expected Abicipar launch in
2020 by AGN
Investment Case
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Accelerating Progress in 2019 and Beyond
2019 2020
Abicipar BLA filing planned (H1)
DME: P3 start
MAPLE: data of further optimized material (H1)
nAMD Launch
MP0250 Additional data: ongoing P2 MM trial
Start of P2 PI and IMiD-combo trial in MM
Interim results from P2 NSCLC trial
Interim P2 data: PI-combo trial
Interim P2 data: IMiD-combo trial
MP0274 First safety & interim efficacy data
MP0310 FIH with MP0310 (mono therapy) MP0310 combination trials
Research Advance DARPin® candidates
Establish novel therapeutic designs
CapitalFunding into H2 2020 (excl. any future proceeds related to Abicipar and partnerships)
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Tree of Evolution of DARPin® Approaches
Abicipar: Local activity,
high affinity bindingSystemic
validation
Bi-Specifics
MP0250
Incre
asin
g le
ve
l of
Inn
ova
tion &
Diffe
ren
tiatio
n
Direct Tumor
Cell Killers
MP0274
Next level of immune
cell targeting
MHC-peptides
Local
Agonists
MP0310
FAP x CD40
DARPin® Platform
Mono-Specifics
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Dr. Patrick Amstutz, CEO
Co-founder, former CBO & COO
Member of the Board of Directors
PhD in molecular biology from UZH
Dr. Andreas Harstrick, CMO, MD
30 years of experience in oncology
Developed multiple mAb oncology products
Senior positions at Merck-Serono, Imclone, Eli Lilly
Dr. Michael Stumpp, COO
Co-founder
PhD and postdoc from UZH;
research in Tokyo, London
Andreas Emmenegger, CFO
Former CFO Glycart, Finance Roles at Roche
>20 years experience as CFO of private & listed
companies and in fund raising, IPOs
Dr. Pamela Trail, CSO
>30 years of experience in directing cancer drug
discovery at leading global pharma companies
Experienced Management Team & Board of Directors
Bill Burns, Chairman Former CEO of Roche Pharmaceuticals
Former board member of Roche, Genentech,
Chugai Pharmaceuticals, Shire
Göran Ando, Vice Chairman Former Chairman, Novo Nordisk
Former CSO, Pharmacia
Gwen Fyfe Former VP, Oncology Development at
Genentech
Steven H. Holtzman President and CEO, Decibel Therapeutics
Former EVP, Biogen
William “Bill” Lee EVP Research, Gilead
Petri Vainio Managing Director, Essex Woodlands
Ventures
EX
EC
UT
IVE
MA
NA
GE
ME
NT
BO
AR
D O
F D
IRE
CT
OR
S
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(CHF million, except per share and FTE data) FY 2018 FY 2017 change
Revenues 10.4 20.0 (9.6)
Total expenses1 (47.8) (45.9) (2.0)
Operating result – EBIT (37.4) (25.8) (11.6)
Net financial result 0.4 0.4 0.0
Net result (37.0) (25.4) (11.6)
Basic net result per share (in CHF) (1.75) (1.22) (0.53)
Net cash used in operations (42.5) (40.0) (2.5)
Cash balance (incl. time deposits) as of Dec 31 99.02 141.13 (42.1)
Number of FTE’s as of Dec 31 117.7 107.8 9.9
Key Figures FY2018
1 Thereof non-cash costs of CHF 5.3mn in in FY2018 and CHF 5.0mn in FY20172 CHF 146m per January 31, 2019, including USD 50 million upfront payment collected from collaboration agreement with Amgen3 Including CHF 9.8m short-term time deposits
Note: Rounding differences may occur
40
• Total expenses of CHF 70-80 million,
of which around CHF 7 million non-cash effective costs
• Capital expenditures of ca. CHF 3 million
• No guidance on net cash flow;
timelines and potential milestones payments with partnerships not disclosed
• Guidance subject to progress and changes of pipeline
Financial Guidance for Full-Year 2019
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Shareholder Structure
VC holdings halved vs. end 2016 to 23%
Listed on SIX Swiss Exchange (SIX: MOLN)
Included in key indices: SPI, SPI Extra,
SXI Life Sciences and SXI Bio+Medtech
21,228,593 shares outstanding
Ca. CHF 405 million market cap. as of Dec. 31, 2018
No lock-up restrictions in place
Formal free float as per SIX definition: 84%
Shareholder structure as of December 31, 2018
23%*
18%*
59%
Pre-IPO investors (4 VC's)
Management, Board, Founders
Others
Highlights
* According to SIX Swiss Exchange Filings
42
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