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Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): March 4, 2013

 

 

DELCATH SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-16133   06-1245881

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification Number)

810 Seventh Avenue, 35th Floor, New York, New York, 10019

(Address of principal executive offices, including zip code)

(212) 489-2100

(Registrant’s telephone number, including area code)

NONE

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01. Regulation FD Disclosure.

A copy of Delcath Systems, Inc.’s (the “Company”) updated investor presentation slides that the Company intends to use effective immediately is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.

The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

Item 9.01. Financial Statements and Exhibits.

The following exhibit is filed herewith:

 

(d) Exhibits.

 

Exhibit No.

   

Description

99.1    Delcath Systems, Inc. Investor Presentation Slides

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

   

DELCATH SYSTEMS, INC.

Dated: March 4, 2013     By:   /s/ Peter J. Graham
      Name: Peter J. Graham
      Title: Executive Vice President, General Counsel

EXHIBIT INDEX

 

Exhibit No.    Description
99.1    Delcath Systems, Inc. Investor Presentation Slides
EX-99.1
Exhibit 99.1

2
DELCATH SYSTEMS, INC
Forward-looking Statements
Private
Securities
Litigation
Reform
Act
of
1995
provides
a
safe
harbor
for
forward-looking
statements
made
by
the
Company
or
on
its
behalf.
This
presentation
contains
forward-looking
statements,
which
are
subject
to
certain
risks
and
uncertainties
that
can
cause
actual
results
to
differ
materially
from
those
described.
Factors
that
may
cause
such
differences
include,
but
are
not
limited
to,
uncertainties
relating
to:
the
outcome
of
the
ODAC
meeting,
and
the
impact,
if
any,
of
the
advisory
panel’s
recommendation
on
the
FDA’s
decision
regarding
the
Company’s
new
drug
application
(NDA),
uncertainties
relating
to:
timing
of
completion
of
the
FDA’s
review
of
our
NDA,
the
extent
to
which
the
FDA
may
request
additional
information
or
data
and
our
ability
to
provide
the
same
in
a
timely
manner,
acceptability
of
the
Phase
1,
2
and
3
clinical
trial
data
by
the
FDA,
FDA
approval
of
the
Company's
NDA
for
the
treatment
of
metastatic
ocular
melanoma
to
the
liver,
adoption,
use
and
resulting
sales,
if
any,
for
the
Delcath
Hepatic
Delivery
System
in
the
United
States,
adoption,
use
and
resulting
sales,
if
any,
for
the
Hepatic
CHEMOSAT
Delivery
System
in
the
EEA,
our
ability
to
successfully
commercialize
the
Delivery
System
in
various
markets
and
the
potential
of
the
system
as
a
treatment
for
patients
with
cancers
in
the
liver,
the
timing
and
our
ability
to
successfully
enter
into
strategic
partnership
and
distribution
arrangements
in
foreign
markets
including
Australia
and
key
Asian
markets
and
resulting
sales,
if
any,
from
the
same,
patient
outcomes
using
the
Generation
2
system,
approval
of
the
current
or
future
system
for
other
indications
and/or
for
use
with
various
chemotherapeutic
agents,
actions
by
the
FDA
or
other
foreign
regulatory
agencies,
our
ability
to
obtain
reimbursement
for
the
CHEMOSAT
system
in
various
markets,
the
number
of
cancer
centers
in
Germany
and
Italy
able
to
successfully
negotiate
and
receive
reimbursement
for
the
CHEMOSAT
procedure
and
the
amount
of
reimbursement
to
be
provided,
submission
and
publication
of
the
Phase
II
and
III
clinical
trial
data,
the
timing
and
results
of
research
and
development
projects,
the
timing
and
results
of
future
clinical
trials
including
the
initiation
of
clinical
trials
in
key
Asian
markets
with
the
CHEMOSAT
Hepatic
Delivery
System
device
for intra-
hepatic
arterial
delivery
and
extracorporeal
filtration
of
doxorubicin,
approval
of
the
CHEMOSAT
Hepatic
Delivery
System
to
delver
and
filter
doxorubicin
in
key
Asian
markets
and
adoption,
sales,
if
any,
and
patient
outcomes
using
the
same,
the
timing,
price
and
use,
if
any,
of
the
committee
equity
financing
facility
with
Terrapin,
the
timing
and
use,
if
any,
of
the
line
of
credit
from
SVB
and
our
ability
to
access
this
facility
and
uncertainties
regarding
our
ability
to
obtain
financial
and
other
resources
for
any
research,
development
and
commercialization
activities.
These
factors,
and
others,
are
discussed
from
time
to
time
in
our
filings
with
the
Securities
and
Exchange
Commission.
You
should
not
place
undue
reliance
on
these
forward-looking
statements,
which
speak
only
as
of
the
date
they
are
made.
We
undertake
no
obligation
to
publicly
update
or
revise
these
forward-looking
statements
to
reflect
events
or
circumstances
after
the
date
they
are
made.

3
DELCATH SYSTEMS, INC
Investment Considerations
Concentrating the Power of Chemotherapy
•
Commercial stage company focused on oncology
•
Proprietary CHEMOSAT
®
Hepatic Delivery System allows unique whole
organ therapy for the liver
•
CHEMOSAT system has demonstrated extension of progression free
survival
•
Addressing large unmet market need for cancer patients who usually die
of liver failure
•
Estimated initial market opportunity of ~$2.3 billion in U.S. & EU
•
Expanding clinical data expected to broaden clinical use and indications
•
On the cusp of realizing the potential:
o
EU
-
early commercial launch underway; reimbursement in key EU markets expected
in Q1/Q2
o
U.S. -
NDA under review ; ODAC May 2, PDUFA date June 15, 2013
•
Attractive
financial
model,
multiple
capital
resources
available
and
experienced
management
team
to
execute
plan

4
DELCATH SYSTEMS, INC
Our Product
US Market
Melblez
Kit 
(Melblez
(melphalan)
for
Injection
for
use
with
the
Delcath
Hepatic
Delivery
System)
Ex US Markets
CHEMOSAT
®
Hepatic Delivery
System
•
Proposed Trade Name
•
Proprietary Drug/Device Combination
Product Regulated as a drug 505(b)(2)
NDA by U.S. FDA
•
Proposed indication for the treatment of
patients with unresectable ocular
melanoma metastatic to the liver
•
Melblez
Kit
comprised
of
Melblez
TM
(melphalan
hydrochloride
for
injection)
and
the
Delcath
Hepatic
Delivery
System
•
Marketed under the trade name
•
Regulated as a Class IIb Medical
Device
•
Indicated for the intra-hepatic of
administration of melphalan
hydrochloride and subsequent
filtration of the venous blood
return.
•
CHEMOSAT Kit supplied without
melphalan
TM

5
DELCATH SYSTEMS, INC
1.
ISOLATE
2.
SATURATE
3.
FILTRATE
The Delcath Hepatic Delivery System
Minimally Invasive, Repeatable Procedure That Could Complement Systemic Therapy
•
Improves disease
control in the liver
•
Treats macro and micro
tumors
•
Controls systemic
toxicities
•
Allows for over 100x
dose escalation at
tumor site

6
DELCATH SYSTEMS, INC
Melanoma Liver Metastases
A Great Demonstration of CHEMOSAT’s Potential
•
A challenging histology
•
Notoriously insensitive to
systemic chemotherapy and
focal interventions
•
CHEMOSAT has
demonstrated ability to extend
progression free survival
Our Opportunity
•
Ability to achieve ultra-high concentrations of chemotherapy provides potential
treatment options for a wide variety of cancers in the liver

7
DELCATH SYSTEMS, INC
Clinically Differentiated Results
•
Phase 1, 2 and 3 trials with percutaneous hepatic perfusion (PHP) 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
•
Safety profiles consistent with pivotal US Phase 3 melanoma trial
Encouraging Initial Results on a Broad Range of Histologies

8
DELCATH SYSTEMS, INC
INDEPENDENT
REVIEW
COMMITTEE
(IRC)
ASSESSMENT
-
UPDATED
ANALYSIS
(4
June
2012)
Hepatic progression-free survival (IRC)
Hazard ratio = 0.50
(95% CI 0.31–0.80)
P=0.0029
0               
5                       10                     15
20
25                      30              
Months
7.0
1.7
1.0
0.8
0.6
0.4
0.2
0.0
Proportion of patients surviving
5.3 mo
Intent-to-treat population
Percutaneous Hepatic Perfusion (PHP)
Best alternative care (BAC)
Positive Phase 3 Results –
Primary Endpoint hPFS
PHP Demonstrated 4x or 5.3 months Improvement in Primary Endpoint of hPFS

9
DELCATH SYSTEMS, INC
INVESTIGATOR
ASSESSMENT
-
UPDATED
ANALYSIS
(4
June
2012)
Overall progression-free survival (investigator)
Months
5.4
1.6
1.0
0.8
0.6
0.4
0.2
0.0
Proportion of patients surviving
Hazard ratio = 0.42
(95% CI 0.27–0.64)
P<0.0001
0             5            10            15
20
25           30            35           40         
45           50           55
3.8 mo
Intent-to-treat population
Positive Phase 3 Results –
Overall PFS
PHP also Demonstrated a Highly Statistically Significant Improvement in Overall PFS
Percutaneous Hepatic Perfusion (PHP)
Best alternative care (BAC)

10
DELCATH SYSTEMS, INC
TOTAL PHP vs BAC ONLY
Proportion of subjects surviving
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
12
36
0
24
48
60
11.4
Total PHP incl. crossover
BAC only
Months
4.1
Intent-to-treat population
7.3 mo
Overall Survival –
Exploratory Subset Analysis
Overall Survival Tail For  PHP Treated Patients

11
DELCATH SYSTEMS, INC
Phase 2 Multi-Histology NCI Trial –
Summary
•
Strong efficacy signals in mNET
o
42% objective Response Rate (ORR) vs ~10%
for approved targeted therapy
o
66% patients had hepatic tumor shrinkage and
durable disease stabilization
•
Positive Signal in primary hepatic malignancies
(HCC and Cholangiocarcinoma) in 5 of 8 patients
•
Similar safety profiles across tumor types
Positive Efficacy Signals In Additional Types of Cancer

12
DELCATH SYSTEMS, INC
Phase 2 NCI Trial –
Metastatic Neuroendocrine Cohort
Pre-PHP
(Baseline)
Post-PHP #2
(+4 Months)
Post-PHP #1
(+6 Weeks)
Compelling Clinical Data in Attractive mNET Market
Phase 2 mNET Tumor Cohort  (n=24)*
Number (n)
Tumor Types
Pancreatic NET
13
Carcinoid tumor
3
Other NET
8
Response
Partial Response (PR)
10
Stable disease (SD)
6
Progressive disease
3
Not assessed or evaluable
5
Objective Response Rate
42%
Median Duration of Hepatic Response
Partial Response (n-10)
23.5 months
Partial Response/Stable Disease (n=16)
16.8 months
Hepatic Progression Free Survival (IIT n=24)
Median Hepatic PFS
16.8
Min/Max
2.1, 64.1
Overall Survival After CS
Median
31.9 months
Min/Max
2.4, 81.1
66%
disease
control

13
DELCATH SYSTEMS, INC
Phase 2 NCI Trial –
Hepatobiliary Carcinoma Cohort
•
Best hepatic tumor response by modified RECIST assessed by investigators
o
Partial response (PR)
1 patient
o
Stable disease (SD)
4 patients
o
Progressive disease
1 patient
o
Not assessed or evaluable
2 patients 
•
Median duration of response
o
hPR (N=1)
6.42 months
o
hPR/SD (N=5) 
8.12 months
•
Hepatic progression free survival (ITT N=8)
o
Median 
5.60 months
o
Minimum, Maximum 
2.7, 12.2 months
•
Overall survival (ITT N=8)
o
Median 
9.12 months
o
Minimum, Maximum 
3.4, 20.5 months
•
HCC is the most common primary cancer of the liver, with approximately 750,000* new
cases diagnosed worldwide annually
•
Intend to initiate new HCC trials with  CHEMOSAT
Encouraging Positive Signal for Primary Liver Cancer
*Source: GLOBOCAN

14
DELCATH SYSTEMS, INC
•
Substantial clinical evidence of benefit of using ultra-high dose
melphalan to treat mCRC via isolated hepatic perfusion (IHP)
procedure
o
Over 800 patients treated in 15 studies since 1998
o
Patients treated only once
o
Median response rate of ~50-60% and median OS of 17.4 –
24.8 mos1,2
•
Delcath Phase 2 NCI Trial  –
mCRC Cohort
o
Challenges enrolling at NCI due to competing FOLFOX & FOLFIRI trials
o
17
patients treated since 2004
o
Safety profile –
expected and consistent with pivotal FDA Phase III
melanoma trial
•
Intend to invest in new mCRC trials with CHEMOSAT Melphalan
1)
van Iersel LB, Gelderblom H, et al. Ann Oncol. 2008;19:1127-34
2)
Alexander, HR, Barlett DL, et al. Ann Surg Oncol, 16:1852-9, 2009
Phase 2 NCI Trial –
mCRC Cohort

15
DELCATH SYSTEMS, INC
Additional Clinical Data Generation
•
Goals:
Expand US (PHP: MEL) label indications beyond the initial
indication we are seeking
Generate robust clinical data to support commercialization
•
FDA has accepted IND Amendment to include Gen 2 device in
Expanded Access Program (EAP), compassionate use (CU),
and all future clinical trials
•
Initiated EAP to treat first patient in January, 2013
•
Activate EU Registry to systematically collect data from
commercial experience
Establish CHEMOSAT  as the Standard of Care (SOC) for Disease Control in the Liver

16
DELCATH SYSTEMS, INC
2013 Clinical Development Plan
•
Planned company sponsored trials, subject to agreement with FDA
Hepatocellular carcinoma (HCC)
o
Global Phase 3 Randomized CHEMOSAT Melphalan vs. best supportive
care
(BSC) for patients where Sorafenib is inappropriate
-
Primary endpoint: Overall Survival
Advanced
colorectal
cancer
(CRC)
with
liver
dominant
metastasis
o
Global Phase 3 Randomized CHEMOSAT Melphalan vs. best alternative care
(BAC)
-
Primary endpoint: Overall Survival
Metastatic Neuroendocrine tumor (NET) with liver dominant disease
o
Global Phase 3 Randomized CHEMOSAT Melphalan vs. Best Alternative Care
(BAC)
-
Primary endpoint: Hepatic PFS
•
Planned phase 2 studies including global Investigator-initiated trials (IITs) in multiple
indications: HCC, NET, CRC, melanoma
Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver

17
DELCATH SYSTEMS, INC
8,708
6,563
4,085
8,212
7,202
33,966
19,861
33,953
52,143
5,585
7,671
99,749
0
25,000
50,000
75,000
100,000
125,000
150,000
175,000
200,000
USA
EU
APAC
$2.3 Billion Initial Market Opportunity with Pharmaceutical-Like Gross Margins
Sources: LEK Consulting, GLOBOCAN, Company estimates.
EU: Initial target countries of Germany, UK, Italy, France, Spain, Netherlands, Ireland.
APAC: Initial target countries of China, Japan, S. Korea, Taiwan, Australia.
Assumes 2.5 treatments per patient.
Assumes EU ASP of $15K; US ASP of $25K; APAC ASP of $5K.
55,389
42,367
189,943
HCC
CRC
Melanoma
NET
$2.3B Initial Opportunity
* Assumes FDA approval for ocular
melanoma metastatic to the liver
CHEMOSAT -
Potential Multi-Billion Dollar Global Market
•
$100M Initial on-label
opportunity in Ocular
Melanoma in US*
•
$2.2B multi-histology
opportunity in EU

18
DELCATH SYSTEMS, INC
Approved  (CE Mark Device)
NDA Filing Accepted by the FDA with PDUFA goal date of June 15, 2013
Mutual Recognition of European CE Mark –
Applications Planned or
Submitted
Global Commercialization Status
Addressing A Multi-Billion Dollar Global Market

19
DELCATH SYSTEMS, INC
CHEMOSAT: EU Launch Underway
•
Marketing in target EU countries -
Italy, Germany, France,
UK, Ireland, NL, Spain
•
Training completed in key centers
o
Eight EU Clinical Sites activated in 2012
•
EU clinicians using CHEMOSAT for a broad range of liver
metastases
o
Use includes: cutaneous melanoma, ocular melanoma, colorectal cancer
(CRC), gastric cancer, breast cancer, neuroendocrine tumor (NET),
hepatocellular carcinoma (HCC) and Cholangiocarcinoma
•
EU reimbursement in progress
o
Italy –
Existing DRG for partial reimbursement identified; supplemental
reimbursement applications submitted
o
Germany –
Value 4 NUB interim reimbursement granted February 2013
o
UK –
Reimbursement anticipated Q2 2013
Expansion of EU Clinical and Commercial Footprint Expected in 2013

20
DELCATH SYSTEMS, INC
CHEMOSAT: Multiple Tumor Types Treated in Europe
•
Physicians are recognizing the potential of CHEMOSAT in various tumor types
•
CHEMOSAT utilized in Germany, Italy, UK, France, Ireland
•
EU Registry To Be Initiated Q2

21
DELCATH SYSTEMS, INC
U.S. NDA Under Review
•
Oncology Drug Advisory Committee (ODAC) panel
scheduled for May 2, 2013
•
PDUFA date: June 15, 2013
•
Initial indication: unresectable metastatic ocular melanoma
in the liver
o
Provides lowest risk pathway to FDA approval and fastest access
•
NDA filing included:
o
Comprehensive set of additional data in a new FDA compliant
CDISC database
o
Gen 2 filter as part of the Chemistry, Manufacturing and Control
(CMC) module
•
Three meetings scheduled with FDA to discuss clinical
programs for planned label expansions in each of NET,
HCC,CRC
FDA Decision Expected in June

22
DELCATH SYSTEMS, INC
U.S. Commercialization Strategy
•
Launch in Q4 2013 assuming approval on PDUFA date of June
15, 2013
•
Initial commercial focus on centers that are active in the EAP or
participated in the Phase 3 clinical trial
•
Utilize active EAP hospitals as Centers of Excellence for training
and support of new centers
•
Intend to seek specific CPT reimbursement code for the Melblez
Kit procedure, based upon value proposition relative to other
cancer therapies
•
Educate Medical Oncologists via Medical Science Liaison (MSL)
•
Direct strategy to sell to hospital based Interventional
Radiologists and Surgeons
Participating EAP Centers Provide Immediate Commercial Footprint

23
DELCATH SYSTEMS, INC
Barriers to Entry
•
Patent Protection
o
6 U.S. patents in force and 6 U.S. patent applications pending
o
9 foreign patents in force (with patent validity in 25 countries) and 14 foreign patent
applications pending
o
Primary US device patent set to expire August 2016
o
Up to 5 years of patent extension post FDA approval
•
Trade Secret Protection
o
Developed improved filter media via proprietary manufacturing processes
•
FDA Protection
o
Orphan Drug Designation granted for melphalan in the treatment of ocular
melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as
for doxorubicin in the treatment of HCC
Provides 7 years of marketing exclusivity post FDA approval
o
Additional Orphan Drug applications to be filed for other drugs and indications,
including melphalan for HCC and CRC
Multiple Levels of Protection

24
DELCATH SYSTEMS, INC
Financial Summary
Cash & Cash Equivalents:
$23.7 million at December 31, 2012 (unaudited)
ATM Program
$21.5 million remaining as of December 31, 2012
Committed Equity Financing
Facility (CEFF)
Up to $32.8 million as of December 31, 2012
Working Capital Line of Credit:
$20 million credit facility
Debt:
None
Cash Spend:
Approx. $10 million in 4Q 2012 (unaudited)
Projected 2013 quarterly cash spend $9-$12 million
Shares Outstanding:
76.8
million
(87.2
million
fully
diluted
1
)
as
of
December
31,
2012
1) Fully diluted includes an additional 4.8 million options and 5.6 million warrants
Multiple Capital Resources Available  to Execute Plan

25
DELCATH SYSTEMS, INC
Management: A Track Record of Success
Executive
Title
Prior Affiliation(s)
Years of
Experience
Eamonn Hobbs
President and CEO
AngioDynamics, E-Z-EM
32
Graham Miao, Ph.D.
EVP & CFO
D&B, Pagoda Pharma, Schering-Plough,
Pharmacia, JP Morgan
23
Krishna Kandarpa, M.D.,
Ph.D.
CSO and EVP, R&D
Harvard, MIT(HST), Cornell, UMass
33
Agustin Gago
EVP, Global Sales
AngioDynamics, E-Z-EM
31
Jennifer Simpson, Ph.D.
EVP, Global Marketing
Eli Lilly (ImClone), Johnson & Johnson
(Ortho Biotech)
23
Peter Graham, J.D.
EVP, General Counsel &
Global Human Resources
Bracco, E-Z-EM
18
David McDonald
EVP, Business Development
AngioDynamics, RBC Capital Markets
30
John Purpura
EVP, Regulatory Affairs & Quality
Assurance
E-Z-EM, Sanofi-Aventis
29
Harold Mapes
EVP, Global Operations
AngioDynamics, Mallinckrodt
27
Gloria Lee, M.D., PH.D.
EVP, Clinical  & Medical Affairs
Hoffmann-La Roche, Syndax
Pharmaceuticals, Inc.
21
Bill Appling
SVP Medical Device R&D
AngioDynamics
27
Dan Johnston, Ph.D.
VP, Pharmaceutical R&D
Pfizer, Wyeth
12

26
DELCATH SYSTEMS, INC
2012 Accomplishments
•
First patients treated with CHEMOSAT Melphalan in Europe in
January
•
Obtained CE Mark for Gen 2 CHEMOSAT Melphalan filter in
April
•
Executed contract for MSL services in EU in 1Q 2012 (Quintiles
was selected to support EU launch of CHEMOSAT)
•
Secured agreements with 14 leading cancer centers in EU
•
8 EU Clinical Sites Activated for commercial use
•
US NDA submitted in August 2012
•
US NDA accepted with PDUFA date of June 15, 2013
•
Obtained CE Mark for CHEMOSAT Doxorubicin in October
•
Interim reimbursement established in Italy in December
Considerable Achievements Built the Foundation For Commercial Success

27
DELCATH SYSTEMS, INC
2013 Anticipated Milestones                                 
First patient enrolled in EAP -
Q1 2013
Obtained NUB Value 4 interim reimbursement in Germany –
Q12013
•
Obtain interim reimbursement in UK –
Q2 2013
•
Submission for publications of Phase 3 data and mNET arm of Phase 2 data in
Q1 2013
•
Initiate EU Registry -
Q1 2013
•
ODAC Panel Meeting May 2, 2013
•
Receive NDA approval for Melblez Kit by PDUFA date of June 15, 2013
•
First commercial sale in APLA –
Q2 2013
•
Commence Company’s first investigator initiated trial (IIT) –
Q2 2013
•
First patient enrolled in Company sponsored trial (CST) to expand indications –
Q4 2013
•
US commercial launch of Melblez Kit –
Q4 2013
•
First patient enrolled in Taiwan HCC pivotal trial –
Q4 2013
•
Execute strategic partnership for China
A Busy Year Focused on US Approval, Clinical Data and Commercial
Adoption

28
DELCATH SYSTEMS, INC
A Compelling Investment Opportunity
Concentrating the Power of Chemotherapy
•
Commercial stage company focused on oncology
•
Proprietary CHEMOSAT Hepatic Delivery System  allows unique whole
organ therapy for the liver
•
CHEMOSAT system has demonstrated extension of progression free
survival
•
Addressing large unmet market need for cancer patients who usually die
of liver failure
•
Estimated initial market opportunity of ~$2.3 billion in U.S. & EU
•
Expanding clinical data expected to broaden clinical use and indications
•
On the cusp of realizing the potential:
o
EU -
early commercial launch underway; reimbursement in key EU markets expected in
Q1/Q2
o
U.S. -
NDA under review; ODAC May 2, PDUFA date June 15, 2013
•
Attractive
financial
model,
multiple
capital
resources
available
and
experienced
management
team
to
execute
plan

29
DELCATH SYSTEMS, INC
©
2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

30
DELCATH SYSTEMS, INC
Appendices

31
DELCATH SYSTEMS, INC
LIVER CANCER TREATMENT
OPTIONS
Appendix 1

32
DELCATH SYSTEMS, INC
Existing Liver Cancer Treatments Have Significant Limitations
The Problem
•
Metastatic disease to the liver, brain or lungs is often the life-
limiting location of solid tumors
o
Often life-limiting or leads to withdrawal of systemic treatments in
favor of palliative care
•
Effective treatment for patients with liver-limited or dominant
cancers remains a clinical challenge
o
Can be diffuse
o
Often not responsive to chemotherapy and radiation therapy
•
Whole organ therapy creates a new option for patients in the
management of liver dominant disease

33
DELCATH SYSTEMS, INC
Existing Liver Cancer Treatments Have Limitations
Unmet Medical Need Exists for More Effective Liver Cancer Treatments
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

34
DELCATH SYSTEMS, INC
Diffuse Hepatic Metastases from Melanoma
•
Diffuse disease in the liver is prevalent
•
Effective treatment for patients with liver-limited or dominant cancers
remains a clinical challenge
•
Whole organ therapy creates a new option for patients in the management
of liver dominant disease

35
DELCATH SYSTEMS, INC
Concentrating the Power of Chemotherapy for Disease Control in the Liver
Our Solution –
Whole Organ-Focus Disease Control
•
Our proprietary CHEMOSAT System isolates the liver
circulation, delivers an ultra-high 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 two hours to
complete and involves a team including the interventional
radiologist and perfusionist
•
CHEMOSAT (Gen 2) has demonstrated minimal systemic
toxicities and impact to blood components in initial commercial
use and may complement systemic therapy
•
CHEMOSAT has been used on approximately 200
patients to
date through clinical development and early commercial launch

36
DELCATH SYSTEMS, INC
MARKET OPPORTUNITY BY DISEASE
& TARGET COUNTRIES
Appendix 2

37
DELCATH SYSTEMS, INC
•
Europe
–
Largest
near-term
opportunity
•
CRC
–
Largest
opportunity
worldwide
•
Melanoma
–
Largest
opportunity
is
in
the
US
•
China
–
Largest
opportunity
for
HCC
Market Opportunity by Disease (patients)
Market Opportunity defined as Total Potential Market
(TPM) for Melblez Kit/CHEMOSAT
1.Primary cancer incidence
2.Adjusted for predominant disease in the liver (primary or      
metastatic cancer)
3.Adjusted for addressable patients via Melblez Kit/CHEMOSAT

38
DELCATH SYSTEMS, INC
Europe Market by Disease –
Device Only
Germany
(Direct)
UK
(Direct)
France
(Indirect)
Italy
(Indirect)
Spain
(Indirect)
Netherlands
(Direct)
Ireland
(Direct)
Total 
Potential
(patients)
Potential
Market
($ MM)
1,2,3
Total Potential Market #Patients
Ocular
Melanoma
404
297
295
285
197
79
19
1,576
$ 62
Cutaneous
Melanoma
1,625
994
753
801
360
379
73
4,987
$ 206
CRC
9,902
5,300
5,475
7,281
4,016
1,644
335
33,953
$1,339
HCC
(Primary)
1,637
720
1,514
2,597
1,087
82
35
7,671
$277
NET
1,783
1,336
1,353
1,299
974
360
98
7,202
$ 281
TOTAL
15,351
8,647
9,389
12,263
6,634
2,545
560
55,389
$ 2,166
Europe Presents Significant Potential Market Opportunity
Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assumes 2.5 treatments per patient.
2) Assumes ASP of  ~$15K USD.
3) Assumes mix of direct sales and distributors.

39
DELCATH SYSTEMS, INC
US Market by Disease –
Device and Drug Combination
Liver Metastasis
Potential Market
# Patients
Potential Market
# Procedures
Potential Market
($MM)
1,2
Ocular
Melanoma
1,685
4,213
$ 105
Cutaneous
Melanoma
7,023
17,557
$ 439
CRC
19,861
49,653
$ 1,241
HCC (Primary)
5,586
13,964
$ 349
NET
8,212
20,530
$ 513
TOTAL
42,367
105,917
$ 2,648
Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assume 2.5 treatments per patient.
2) Estimated ASP of $25K.

40
DELCATH SYSTEMS, INC
APAC Market by Disease
China
(Device)
S. Korea
(Device)
Japan
(Device)
Taiwan
(Device)
Australia
(Device)
Total 
Potential
(patients)
Potential
Market
($MM)
1,2
Total Potential Market  #Patients
HCC
(Primary)
85,780
3,258
8,296
2,152
263
99,749
$ 1,156
Other
CRC
31,127
3,245
14,298
1,441
2,031
52,143
$ 642
NET
29,197
1,048
2,759
500
462
33,966
$ 393
Ocular 
Melanoma
1,765
66
175
31
96
2,134
$ 25
Cutaneous
Melanoma
382
43
136
246
1,144
1,951
$ 23
OTHER
TOTAL
62,472
4,403
17,368
2,218
3,733
90,194
$ 1,083
TOTAL
148,104
7,661
25,665
4,370
3,996
189,943
$ 2,239
APAC Target Markets Represent Over $2 Billion Potential Market Opportunity 
Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assume 2.5 treatments per patient.
2) Estimated ASP of ~$5K.

41
DELCATH SYSTEMS, INC
HIGH-DOSE MELPHALAN
HISTORY AND RATIONALE
Appendix 3

42
DELCATH SYSTEMS, INC
The Evidence for Melphalan
Melphalan, an established chemotherapy agent, is proven active at
high doses with broad antitumor activity

43
DELCATH SYSTEMS, INC
Melphalan Dosing & Background
•
Well understood, dose dependent, tumor preferential, alkylating cytotoxic agent
that demonstrates little to no hepatic toxicity
•
Manageable systemic toxicities associated with Neutropenia and
Thrombocytopenia
•
Drug dosing 12x higher than FDA-approved dose via systemic IV chemotherapy
•
Dose delivered to tumor is over 100x 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
Percutaneous Hepatic Perfusion (PHP)
3.00
An Established Drug for Liver Cancer Therapy

45
DELCATH SYSTEMS, INC
PHASE 3 TRIAL
Appendix 4

46
DELCATH SYSTEMS, INC
Phase III Clinical Trial Design
Randomized to PHP
93 patients: ocular
or cutaneous melanoma
Best Alternative Care (BAC)
Investigator and patient decision
(any and all treatments)
PHP/Melphalan
Treat every 4 weeks x 4 rounds
(responders
can receive up to 6 rounds)
Cross-over
Primary Trial Endpoint
•
Statistically significant difference in Hepatic Progression
Free Survival (“hPFS”): p < 0.05 (IRC)
•
Over 80% of Oncologic drugs approved by FDA between
2005 –
2007 on endpoints other than overall survival
Modeled hPFS for Trial Success:
7.73 months (CS) 
vs.
4 months (BAC)
Secondary Trial Endpoints
•
Investigator hPFS
•
Hepatic objective response rate
•
Overall objective response rate
•
Overall Survival –
Diluted by Cross Over
•
SAP calls for analysis of various patient subsets
Pre-PHP (Baseline)
Post-PHP (22+ Months)
Hepatic Response –
Metastatic Melanoma
Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study
PHP = Meblez Kit/CHEMOSAT

47
DELCATH SYSTEMS, INC
Positive Phase 3 Results
•
Primary endpoint (hPFS by IRC) exceeded, p value = 0.0029, hazard ratio of 0.50
as of June, 2012
o
PHP
median
hepatic
progression
free
survival
(hPFS)
was
4-fold
of
control,
or
5.3
months
improvement
o
PHP achieved a median hPFS of 7.0
months  vs 1.7 months for BAC control
o
75% overall clinical benefit (CR + PR + SD)
•
Secondary endpoints consistent with primary endpoints
o
CS/PHP achieved a median overall PFS of 5.4 months vs. 1.6 months for BAC
o
OS –
No difference demonstrated due to heavy crossover from BAC to PHP
o
Median OS 10.6 months vs. 10.0 months for PHP and BAC respectively
•
OS exploratory analyses supportive of key observations
o
Median overall survival of 11.4 months for all patients treated with melphalan, including crossover
o
BAC patients did not cross-over to PHP had a median survival of 4.1 months
o
6 PHP-treated and 2 BAC-only patients still alive as of 2/2013
•
Gen 1 Safety profile –
consistent with currently approved labeling for melphalan
o
30-day deaths on PHP: 3/44 patients (6.8%)
1 Neutropenic Sepsis (2.3%); 1 Hepatic Failure 2.5% (95% tumor burden); 1 gastric perforation
o
30-day deaths on BAC: 3/49 patients (6.1%)
Trial Outcomes Favorable and Consistent with Special Protocol Assessment

48
DELCATH SYSTEMS, INC
PUBLISHED PHASE 1 / 2 STUDIES OF
DOXORUBICIN WITH PHP
Appendix 5

49
DELCATH SYSTEMS, INC
Phase 1 & 2 Studies of PHP-Doxorubicin For HCC
Delivered Safely in Multiple Studies with Promising Response Rates 
1) Ku Y et al. Chir Gastroenterol 2003;19:370–376.
2) Curley SA et al. Ann Surg Oncol 1994;1:389–99.
3) Ravikumar TS et al. J Clin Oncol 1994;12:2723–36.
4) Hwu WJ et al. Oncol Res 1999;11:529–37.

50
DELCATH SYSTEMS, INC
PRODUCT DEVELOPMENT PIPELINE
Appendix 6

51
DELCATH SYSTEMS, INC
Product Development Pipeline
•
Orphan Drug -
Ocular
Melanoma liver mets
•
Proprietary drug-melphalan &
Melblez Kit
•
All liver cancers –
melphalan
•
Classified as Medical Device
•
3   party melphalan
•
Gen 2 melphalan CE Mark
•
Doxorubicin system CE Mark
•
CHEMOSAT for additional drugs
•
CHEMOSAT for other organs (lung
and brain)
•
mNET, mCRC and HCC
indications
Initial Opportunity
Near Term (< 5 years)
Intermediate Term (> 5 years)
•
mCRC and HCC clinical trials
•
Proprietary drug/delivery system for
additional drugs
•
Proprietary drug/delivery system
for
other organs (lung and brain)
•
CHEMOSAT Melphalan in
Taiwan and Japan 
•
CHEMOSAT Doxorubicin in
China and South Korea
•
3   party doxorubicin
•
CHEMOSAT for additional drugs
•
CHEMOSAT for other organs (lung
and brain)
•
CHEMOSAT Melphalan in
Australia, New Zealand, and
Hong Kong
•
3   party melphalan
Development Aligned to Address Significant Market Opportunity
rd
rd
rd

52
DELCATH SYSTEMS, INC
CHEMOSAT Delivery System for Doxorubicin –
CE Mark
•
Satisfied all of the requirements to affix the CE Mark to Hepatic
CHEMOSAT Delivery System device for intra-hepatic arterial delivery
and extracorporeal filtration of doxorubicin in October, 2012
o
Provides a pathway for regulatory approval in China and S. Korea
•
Provides basis for partnership opportunities in China and S. Korea
where doxorubicin has a broad label for multiple tumor types
•
Multiple published Phase I/II studies from MD Anderson Cancer Center
and Yale with percutaneous hepatic perfusion (PHP) and Kobe
University using doxorubicin show promising response rates for HCC*
•
Plan to use CHEMOSAT Delivery System for Doxorubicin in Asia Phase
III 2L
HCC trials
Addressing the Large HCC Market Opportunity in China

53
DELCATH SYSTEMS, INC
NON US/EU
REGULATORY UPDATE
Appendix 7

54
DELCATH SYSTEMS, INC
International Strategy beyond EU and US
•
Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT
Systems in other international markets
o
Obtained approval for Gen 2 CHEMOSAT Delivery System for Melphalan in Australia
•
International regulatory submissions status:
Application submitted and expected approvals in
Hong Kong
-
2013
Singapore
-
2013
Argentina
-
2013
Brazil
-
2014
Intend to submit applications
S. Korea
(CHEMOSAT Doxorubicin)
Mexico
China
(CHEMOSAT Doxorubicin)
Taiwan
Russia
India
Japan
Israel
•
Utilize 3rd
party melphalan and doxorubicin available to physicians
Combination of Strategic Partnerships and Specialty Distributors

55
DELCATH SYSTEMS, INC
CHEMOSAT CENTERS
Appendix 8

56
DELCATH SYSTEMS, INC
CHEMOSAT Centers in Europe
•
Entered training and marketing agreements with leading cancer centers in Europe
o
Milan, Italy –
European Institute of Oncology (IEO)
o
Frankfurt, Germany –
Johann Wolfgang Goethe-Universität (JWG)
o
Kiel, Germany –
Universitätsklinikum Schleswig-Holstein
o
Villejuif, France –
Cancer Institute Gustave Roussy (IGR)
o
Barcelona, Spain –
El Hospital Quiron
o
Naples, Italy –
Instituto Nazionale Tumori Fondazione "G. Pascale"
o
Amsterdam, The Netherlands –
Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
o
Erlangen, Germany –
University Hospital of Erlangen
o
Pamplona, Spain –
Clinica Universidad de Navarra
o
Bordeaux, France –
Hôpital Saint-André
(St Andre)
o
Galway, Ireland –
University Hospital Galway (UHG)
o
Leiden, The Netherlands –
Leiden University Medical Center
o
Southampton, United Kingdom –
Southampton University Hospital (SUH)
o
Göttingen, Germany -
University Medical Center Göttingen (UMG)
o
Varese, Italy –
Varese University Hospital (VUH)
o
Heidelberg, Germany -
National Center Tumor Diseases 
•
Training completed and patients treated at IEO, JWG, IGR, St Andre, UHG, SUH, UMG, VUH
•
Liver metastases from cutaneous melanoma, ocular melanoma, gastric cancer, breast cancer,
neuroendocrine tumor (NET), hepatocellular carcinoma (HCC) and Cholangiocarcinoma