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| 8-K - FORM 8-K - DELCATH SYSTEMS, INC. | d863028d8k.htm |
 Investor Presentation
(NASDAQ: DCTH)
February 2015
Exhibit 99.1 |
 2
DELCATH SYSTEMS, INC
Forward-looking Statements
This
presentation
contains
forward-looking
statements,
within
the
meaning
of
the
federal
securities
laws,
related
to
future
events
and
future
financial
performance
which
include
statements
about
our
expectations,
beliefs,
plans,
objectives,
intentions,
goals,
strategies,
assumptions
and
other
statements
that
are
not
historical
facts.
Forward-looking
statements
are
subject
to
known
and
unknown
risks
and
uncertainties
and
are
based
on
potentially
inaccurate
assumptions,
which
could
cause
actual
results
to
differ
materially
from
expected
results,
performance
or
achievements
expressed
or
implied
by
statements
made
herein.
Our
actual
results
could
differ
materially
from
those
anticipated
in
forward-looking
statements
for
many
reasons,
including,
but
not
limited
to,
uncertainties
relating
to:
the
timing
and
results
of
future
clinical
trials
including
without
limitation
the
OM,
HCC,
ICC,
and
mCRC
trials
in
the
Company’s
Clinical
Development
Program,
clinical
adoption,
use
and
resulting
sales,
if
any,
for
the
CHEMOSAT
system
in
Europe,
our
ability
to
obtain
reimbursement
for
the
CHEMOSAT
system
in
various
markets
including
without
limitation
Germany
and
the
United
Kingdom,
our
ability
to
successfully
commercialize
the
Melphalan/HDS
system
and
the
potential
of
the
Melphalan/HDS
system
as
a
treatment
for
patients
with
primary
and
metastatic
disease
in
the
liver,
the
Company's
ability
to
satisfy
the
requirements
of
the
FDA's
Complete
Response
Letter
relating
to
the
ocular
melanoma
indication
and
the
timing
of
the
same,
approval
of
the
Melphalan/HDS
system
by
the
US
FDA,
submission
and
acceptance
of
the
phase
3
trial
publication,
approval
of
the
current
or
future
Melphalan/HDS
system
for
delivery
and
filtration
of
melphalan
or
other
chemotherapeutic
agents
for
various
indications
in
the
US
and/or
in
foreign
markets,
actions
by
the
FDA
or
other
foreign
regulatory
agencies,
our
ability
to
successfully
enter
into
strategic
partnership
and
distribution
arrangements
in
foreign
markets
and
the
timing
and
revenue,
if
any,
of
the
same,
uncertainties
relating
to
the
timing
and
results
of
research
and
development
projects,
and
uncertainties
regarding
our
ability
to
obtain
financial
and
other
resources
for
any
clinical
trials,
research,
development,
and
commercialization
activities.
These
factors,
and
others,
are
discussed
from
time
to
time
in
our
filings
with
the
Securities
and
Exchange
Commission
including
the
section
entitled
‘‘Risk
Factors’’
in
our
most
recent
Annual
Report
on
Form
10-K
and
our
Reports
on
Form
10-Q
and
Form
8-K. |
 3
DELCATH SYSTEMS, INC
Delcath at a Glance
•
A late-stage clinical company with early commercial activity in Europe
•
CHEMOSAT is approved as a medical device (CE Mark) in Europe;
investigational new combination product in U.S. for treating cancers of
the liver
•
Focused clinical development program initially pursuing orphan
indications in metastatic ocular melanoma and primary liver cancer
•
Based in New York with European operations in Galway, Ireland
•
Traded on NASDAQ under symbol DCTH
•
More than $23 million in cash at 9/30/2014
Seeking
to
Make
a
Clinically
Meaningful
Difference
For
Cancer
Patients
With
Liver
Dominant
Disease |
 4
DELCATH SYSTEMS, INC
Investment Highlights
We
Believe
We
are
Positioned
to
Capitalize
on
Large,
Compelling
Market
Opportunity
Large
market
opportunity
-
cancers
of
the
liver
remain
a
multi-billion
dollar
unmet
medical
need
Unique,
highly
differentiated
solution
–
orphan
designations
create
barriers
to
competitive
entry
Late-stage,
asset
-
demonstrated
clinically
meaningful
efficacy
in
over
550
procedures
and
multiple
tumor
types
Compelling
emerging
data
–
demonstrated
early
success
in
multiple
tumor
types
Imminent
valuation
milestones
-
2015
value
drivers
include
publications,
reimbursement
&
clinical
data
Attractive
business
model
-
initial
orphan
focus
and
anticipated
high
gross
margins
form
basis
of
profitable
long-term
model
Experienced
management
team
-
now
aligned
with
requirements
of
clinically
driven
pharmaceutical
industry |
 5
DELCATH SYSTEMS, INC
2014-2015 Milestones
Executing on Multiple Fronts to Create Value
2014 Accomplishments
o
Phase 2 HCC trial open and first patient treated
o
100
th
patient treated in Europe (commercial and clinical)
o
Positive efficacy data from three institutions presented at ESSO
2014
o
Q3 sales increased 201% Y/Y to $217K
o
Cash burn reduced by almost 60% Y/Y through September
1H-2015
o
Submit Phase 3 metastatic melanoma publication
o
EU Registry open for enrollment
o
ICC cohort open for enrollment
o
NUB reimbursement decision in Germany —
Value 4 awarded for 2015
2H-2015
o
Interim analysis on HCC patients
o
Initiation of phase 3 ocular melanoma program |
 6
DELCATH SYSTEMS, INC
The Liver: A Life Limiting Organ
•
Cancers
of
the
liver
remain
a
major
unmet
medical
need
globally
o
Large
global
patient
population
–
approximately
1.2
million*
patients
diagnosed
annually
with
primary
or
metastatic
liver
cancer
o
The
liver
is
often
the
life
limiting
organ
for
cancer
patients
and
one
of
the
leading
causes
of
cancer
death
o
Prognosis
after
liver
involvement
is
poor
–
overall
survival
generally
less
than
12
months
•
CHEMOSAT/Melphalan/HDS
is
a
proprietary
product
uniquely
positioned
to
potentially
treat
the
entire
liver
as
a
standalone
or
complementary
therapy
* SOURCE –
2008 GLOBOCAN
Effective Liver Cancer Treatment Remains a Major Unmet Medical Need
|
 7
DELCATH SYSTEMS, INC
Existing Liver Cancer Treatments Landscape
Existing Liver Cancer Treatments Have Limitations
Treatment
Advantages
Disadvantages
Systemic
–
Non-invasive
–
Repeatable
–
Systemic toxicities
–
Limited efficacy in liver
Regional
(e.g., Isolated Hepatic Perfusion)
–
Therapeutic effect
–
Targeted
–
Invasive/limited repeatability
–
Multiple treatments are
required but not possible
Focal
(e.g. surgery, radioembolization,
chemoembolization, radio
frequency ablation)
–
Partial removal or
treatment of tumors
–
Only 10% to 20% resectable
–
Invasive and/or limited
repeatability
–
Treatment is limited by tumor
size, number of lesions and
location
–
Tumor revascularization
–
Cannot treat diffuse disease |
 8
DELCATH SYSTEMS, INC
Concentrating the Power of Chemotherapy for Disease Control in the Liver
Our Solution –
Whole Organ-Focus Disease Control
•
Our proprietary system isolates the liver circulation, delivers a
substantially higher concentration of chemotherapy (melphalan)
to the liver and filters most of the chemotherapy out of the
blood prior to returning it to the patient
•
The procedure typically takes approximately 2-3 hours to
complete and involves a team including the interventional
radiologist and perfusionist
•
We believe more than 180 treatments with improved device
and procedure in US and EU provides confidence safety can
be validated in a controlled setting |
 9
DELCATH SYSTEMS, INC
The Melphalan Hepatic Delivery System (HDS)
•
Device
designed
to
administer
high
dose
chemotherapy
to
the
liver
while
reducing
systemic
exposure
•
Marketed
as
Delcath
Hepatic
CHEMOSAT
®
Delivery
System
(device
only)
in
EU
•
Investigational
drug/device
combination
product
regulated
as
a
drug
in
the
US
Liver
Isolated
Via
Double
Balloon
Catheter
In
IVC
Melphalan
Infused
Directly
Into
Liver
Via
Catheter
In
Hepatic
Artery
Blood
Exiting
The
Liver
Filtered
By
Proprietary
Extra-corporeal
Filters
More Than 240 Patients Treated To Date |
 10
DELCATH SYSTEMS, INC
Melphalan Dosing & Background
•
Well understood, dose dependent, tumor preferential, alkylating cytotoxic agent
that demonstrates little to no hepatic toxicity
•
Dose administered directly to liver is substantially higher than
that of systemic IV
chemotherapy
Type
Dosing (mg/kg)
Multiple Myeloma (label)
0.25
Chemoembolization
0.62
Surgical Isolated Hepatic Perfusion (IHP)
1.50
Myeloablation
2.50-3.50
Chemosaturation (PHP)
3.00
An Established Drug for Liver Cancer Therapy |
 11
DELCATH SYSTEMS, INC
The Evidence for Melphalan
•
Melphalan,
an
established
chemotherapy
agent,
is
proven
active
at
high
doses
with
broad
antitumor
activity
1.
Grover
AC,
et
al.
Surgery
2004;136:1176-82
2.
Noter
SL,
et
al.
Melanoma
Res
2004;14:67-72
3.
Alexander
HR
Jr,
et
al.
Clin
Cancer
Res
2000;6:3062-70
4.
Alexander
HR
Jr,
et
al.
Clin
Cancer
Res
2003;9:6343-9
5.
Alexander
HR
Jr,
et
al.
Ann
Surg
Oncol
2009;16:1852-9
6.
Van
Iersel
LB,
et
al.
Ann
Oncol
2008;19:1127-34
7.
Van
Iersel
LB,
et
al.
Ann
Oncol
2010;21:1662-7
8.
Verhoef
C,
et
al.
Ann
Surg
Oncol
15:1367-74 |
 12
DELCATH SYSTEMS, INC
Potential Applications
Unresectable
Hepatocellular
Carcinoma (HCC)
Ocular Melanoma
(OM) Liver
Metastases
Intra-hepatic
Cholangiocarcinoma (ICC)
Colorectal Cancer Liver
Metastases (mCRC)
Multiple Opportunities Yields Potential Multi-Billion Dollar Global
Market |
 13
DELCATH SYSTEMS, INC
Total Available EU & US Market Opportunity
Effective Liver Cancer Treatment Remains a Major Unmet Medical Need
Notes:
1)
Source:
Globocan,
American
Cancer
Society
2)
Source:
LEK,
Booz/PwC,
Company
estimates
3
)
Assumes
an
average
of
two
treatments
per
patient
Cancer Type
Annual
Incidence
Eligible Pts
Revenue per
Patient
Annual Potential
Market Opportunity
(millions)
Ocular Melanoma (OM)
5,700-8,600
2,600-4,300
$40,000-$50,000
$104-$215
Cholangio Carcinoma (ICC)
11,500
6,500
$40,000-$50,000
$260-$330
Hepatocellular Carcinoma (HCC)
64,500
7,600-14,700
$40,000-$50,000
$304-$735
Colorectal (CRC)
411,000
40,000-55,000
$40,000-$50,000
$1,600-$2,750
Total EU and US
492,700-495,600
56,700-80,500
$2,268-$4,030
1
2
3 |
 14
DELCATH SYSTEMS, INC
Clinically Differentiated Results
•
Phase 1, 2 and 3 trials produced positive results in multiple histologies
•
Melanoma Liver Mets
o
Positive Phase 3 results in hepatic metastatic melanoma
o
n=93 (90% ocular melanoma, 10% cutaneous melanoma)
•
Neuroendocrine Tumor (NET) Liver Mets
o
mNET cohort in Phase 2 trial showed encouraging 42% objective response rate
(ORR) vs ~10% for approved targeted therapy
o
median overall survival of ~32 months on ITT basis
•
Hepatocellular Carcinoma (HCC)
o
Positive signal with high-dose melphalan in HCC cohort of Phase 2 trial (5/8
patients) is encouraging when approved systemic therapies have modest
efficacy and challenges with tolerability
•
Colorectal Cancer (CRC) Liver Mets
o
Data from surgical Isolated Hepatic Perfusion (IHP) with melphalan indicates
strong potential in well-defined patient population with earlier stage
CRC yielding ~50-60% median response rate and median OS of
17.4-24.8 mos Encouraging Initial Results on a Broad Range of
Histologies |
 15
DELCATH SYSTEMS, INC
Clinical Development Program Overview
•
Initiating global phase 3 trial mid-year in Ocular Melanoma
(OM) Liver Mets
•
Establish Proof of Concept in Hepatocellular Carcinoma (HCC)
and Intrahepatic Cholangiocarcinoma (ICC)
o
Commenced Global Phase 2 Program in HCC in 2014
o
Expanding Program to include ICC Cohort in EU Trial
•
Initiating EU Registry to collect efficacy and safety data in
the commercial setting
•
Supporting Investigator Initiated Trials (IITs) in HCC &
mCRC
Focused on Liver Dominant, Orphan Diseases With High Unmet Need
|
 Clinical Development Program at a Glance |
 17
DELCATH SYSTEMS, INC
Clinical Development Program –
Timeline
Legend
First Patient In
Last Patient In
Data Readout
Tumor Type
2014
2015
2016
2017
OM
(Phase 3 Pivotal Trial)
201 HCC
(US Phase 2)
202 HCC
(EU Phase 2)
Combined US, EU 31 patients
ICC Cohort
(to be added to 202 HCC;
n=11)
IITs
EU Commercial Registry |
 18
DELCATH SYSTEMS, INC
OM Rationale
•
OM
has
high
incidence
of
liver
metastases
o
Up
to
90%
of
patients
with
metastases
will
have
liver
involvement
o
Life
expectancy
of
approximately
6
months
o
5,700
-
8,600
cases
of
OM
liver
metastases
diagnosed
in
US
and
EU
annually
•
Clear
efficacy
signal
seen
in
prior
P3
trial
of
Melphalan/HDS
•
Currently
no
standard
of
care
•
Believed
to
be
fastest
pathway
to
NDA
approval
in
the
US
•
Melphalan/HDS
granted
orphan
drug
status
by
FDA
for
treatment
of
patients
with
OM
*Sources:
ACS,
SEER,
NIH,
OMF,
KOL
Interviews,
2014
3
rd
Party
Analysis
Proven Efficacy in Attractive Orphan Opportunity
5,700-8,600
Cases of Ocular
Melanoma
~50-55%
Metastasize
~90%
Show Liver Mets
~2,600 –
4,300
Eligible Patients
Limited TX Options
US/EU Market Size |
 19
DELCATH SYSTEMS, INC
Intent-to-Treat Analysis (June 2012)
5.3 mos improvement in hPFS
Hazard ratio = 0.50
(95% CI 0.31–0.80)
P=0.0029
Months
Proportion of patients surviving
Previous Ocular Melanoma Phase 3 Results
Hepatic Progression Free Survival (hPFS)
3.8 mos improvement in PFS
Hazard ratio = 0.42
(95% CI 0.27–0.64)
P<0.0001
Overall Progression Free Survival (Investigator)
Proportion of patients surviving
Intent-to-Treat Analysis (June 2012)
Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM
Patients Chemosaturation (CS-PHP)
Best alternative care (BAC)
Chemosaturation (CS-PHP)
Best alternative care (BAC)
Months |
 20
DELCATH SYSTEMS, INC
ICC Rationale
•
Significant Market Opportunity in US and EU
o
~15% of new HCC cases diagnosed annually
o
~90% of patients are not suitable for surgical resection
o
~20-30% candidates for focal interventions
o
Efficacy signals from early commercial uses in EU
•
Unmet medical need –
Delcath will pursue a melphalan orphan
drug designation from the FDA for patients with ICC
*Sources:
ACS,
SEER,
NIH,
KOL
Interviews,
2014
3
rd
Party
Analysis
Encouraging Early Commercial Activity in Disease With Limited Treatment Options
76,000
HCC Diagnosis
~90%
Unresectable
~6,500
Eligible Patients
US/EU Market Size
~15%
Of HCC
Cases
~20-30%
Focal
Interventions |
 21
DELCATH SYSTEMS, INC
HCC Rationale
•
Significant
opportunity
in
US
and
EU
o
HCC
most
common
primary
cancer
of
the
liver
o
~76,000*
cases
diagnosed
annually
•
Large
unmet
medical
need
in
first
line
therapy
o
Only
one
currently
approved
systemic
therapy
in
US,
EU,
and
certain
Asian
markets
o
~90%
of
pts
not
candidates
for
surgical
resection
o
20-30%
of
pts
candidates
for
focal
interventions
•
Melphalan/HDS
granted
orphan
drug
status
by
FDA
for
treatment
of
patients
with
unresectable
HCC
*Sources:
WHO,
KOL
Interviews,
2014
3
rd
Party
Analysis
Large, Deadly Disease in Need of Better Treatments
76,000
Cases of Primary Liver
Cancer
~80-90%
Unresectable
~20-30%
Child Pugh Class A
~7,600 –
14,700
Eligible Patients
~20-30%
Interventional
TX
US/EU Market Size
~90%
HCC |
 22
DELCATH SYSTEMS, INC
Prior FDA Experience
•
New Drug Application (NDA) submitted August 2012 seeking
indication in OM liver metastases with prior filters and
procedure
•
ODAC meeting in May 2013
o
Negative Vote
o
Complete FDA & Delcath ODAC briefing materials available at
www.delcath.com/clinical-research/clinical-bibliography/
•
Complete Response Letter (CRL) Issued September 2013
•
FDA requests include, but not limited to:
o
Well-controlled randomized trial(s) to establish the safety and
efficacy using the to-be-marketed device configuration
o
Overall survival as the primary efficacy outcome measure
o
Demonstrate clinical benefits outweigh risks
FDA Learnings Provide Beneficial Clinical Study Roadmap
|
 23
DELCATH SYSTEMS, INC
Risks Observed in Previous Clinical Program
•
Risks observed with prior product and procedure protocol
•
Integrated safety population of patients showed risks associated
with
Melphalan/HDS to include:
o
4.1% incidence of deaths due to adverse reactions
o
4% incidence of stroke
o
2%
reported
incidence
of
myocardial
infarction
in
the
setting
of
an
incomplete
cardiac
risk assessment
o
a
70%
incidence
of
grade
4
bone
marrow
suppression
with
a
median
time
of
recovery
of
greater
than
1
week
o
18% incidence of febrile neutropenia, along with the additive risk of hepatic
injury, severe hemorrhage, and gastrointestinal perforation
•
Deaths due to certain adverse reactions did not occur again during the clinical
trials following the adoption of related protocol amendments
Treating Physicians in US and EU Report Improved Safety Profile
|
 24
DELCATH SYSTEMS, INC
Safety Improvements Implemented
•
New generation filter
o
improved filter efficiency and consistency
•
Vasopressors and methylprednisolone
o
reduce cardiovascular risk
•
Prophylactic transfusions and growth factors
o
reduce risk of myelosuppression
•
Intra-arterial nitroglycerin
o
to prevent hepatic arterial spasm
•
Liver tumor burden not to exceed >50%
o
to address risk of liver failure
Decisive Measures to Seek to Improve Safety Implemented
|
 25
DELCATH SYSTEMS, INC
Positive Developments
•
Improved device and procedure since prior trials
o
>180 treatments with improved device and procedure in US and EU
o
Many issues raised at ODAC have not been reported
•
Current device/procedure permitting multiple treatment cycles
•
Recent scientific presentations at ESSO for OM from 3 centers in
US and EU
o
University Southampton reported 63% positive response (47% had a
partial response and 16% had a complete response)
o
Moffitt reported 67% positive response (partial response and one
complete response)
o
Leiden reported 80% positive response (partial response)
Patients Report Improved Quality of Life |
 26
DELCATH SYSTEMS, INC
European Commercialization
CHEMOSAT
®
Hepatic Delivery System
•
Approved
as
Class
IIb
Medical
Device;
kit
supplied
w/o
melphalan
•
Broad
indication
for
intra-hepatic
administration
of
melphalan
hydrochloride
and
subsequent
filtration
of
the
venous
blood
return
•
150
commercial
procedures
performed
in
15
leading
cancer
centers
in
the
EU
•
Reimbursement
via
Individual
Funding
Requests;
NUB
Value
4
Status
in
Germany
•
UK
Block
Grants
pending
&
private
pay
insurance |
 27
DELCATH SYSTEMS, INC
CHEMOSAT
®
Commercial Treatments in Europe
•
Multiple Tumor Types Treated Since EU Launch
Treatments/Re-treatments Increasing |
 28
DELCATH SYSTEMS, INC
Publications
Alexander,
R.,
et
al.
Current
Status
of
Percutaneous
Hepatic
Perfusion
as
Regional
Treatment
for
Patients
with
Unresectable
Hepatic
Metastases:
A
Review,
American
Oncology
and
Hematology
Review
2014:
15-23
Vogl,
et
al.
Chemosaturation
with
Percutaneous
Hepatic
Perfusions
of
Melphalan
for
Hepatic
Metastases:
Experience
from
Two
European
Centers,
Fortschr
Röntgestr
2014
•
H.
Schulze-Bergkamen
et
al.
Unresectable
Isolated
Hepatic
Metastases
from
Solid
Pseudopapillary
Neoplasm
of
the
Pancreas:
A
Case
Report
of
Chemosaturation
with
High-Dose
Melphalan,
Pancreatology
2014
Forster
M.,
et
al.
Chemosaturation
with
Percutaneous
Hepatic
Perfusion
for
Unresectable
Metastatic
Melanoma
or
Sarcoma
to
the
Liver:
A
Single
Institution
Experience.
Journal
of
Surgical
Oncology.
2013
Yamamoto
M,
Zager
J.
Isolated
Hepatic
Perfusion
for
Metastatic
Melanoma.
Journal
of
Surgical
Oncology.
2013
2014
ESSO
Congress
Presentations
Clinical Evidence and Awareness Continue to Build
A
Single
Institution
Experience
with
Percutaneous
Hepatic
Perfusion
for
Unresectable
Ocular
Melanoma
and
Sarcoma
in
the
Liver
---
Moffitt
Cancer
Center,
U.S.;
J.
Zager
Percutaneous
Hepatic
Perfusion
with
Melphalan
in
Treating
Unresectable
Liver
Metastases
from
Colorectal
Cancer
and
Uveal
(Ocular)
Melanoma
–
Leiden
University
Medical
Centre
(LUMC),
The
Netherlands;
N.
de
Leede
Initial
United
Kingdom
Experience
with
Melphalan
Percutaneous
Hepatic
Perfusion
(PHP)
For
Treatment
of
Inoperable
Ocular
Melanoma
Metastases
---
University
Hospital
Southampton,
U.K;
B.
Stedman |
 29
DELCATH SYSTEMS, INC
Cash & Capital Resources
Cash & Cash Equivalents
$23.3 million at September 30, 2014
Debt
None
ATM Program
1
$40 million available at September 30, 2014
Shares Outstanding
9.4 million (10.5 million fully diluted
3
) at
September 30, 2014
1)
Subject to market conditions and certain limitations
2)
Fully diluted includes approximate 0.2 million options and 0.9 million
warrants 2014 Operating Cash Spend (Unaudited)
Q1 A
Q2 A
Q3 A
Q4 Est.
FY Est.
Quarterly Guidance
$5-6M
$5-6M
$4-5M
$4-5M
$16.5-17.5M
Quarterly Act.
$4.5M
$4.0M
$4.0M
Focused Spending and Resources to Support Execution of Near-term Plan
|
 30
DELCATH SYSTEMS, INC
Summary
Melphalan
Hydrochloride
for
Injection
for
use
with
the
Delcath
Hepatic
Delivery
System
(Melphalan/HDS)
•
Cancers of the liver remain a large,
multi-billion dollar unmet medical
need
•
Unique, highly differentiated solution
•
Late-stage asset
•
Compelling emerging data
•
Imminent Valuation milestones
•
Attractive orphan drug business
model
•
Experienced pharmaceutical
management team executing a
data-driven plan |
 31
DELCATH SYSTEMS, INC
©
2014
DELCATH
SYSTEMS,
INC.
ALL
RIGHTS
RESERVED
Delcath
and
CHEMOSAT
are
registered
trademarks
of
Delcath
Systems,
Inc. |