Exhibit 99.1
Investor Presentation
(NASDAQ: DCTH)
(NASDAQ: DCTH)
November 2014
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, 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.
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, 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
Why Invest in Delcath?
• We are a clinical company with early commercial activity in Europe
focused on cancers of the liver
focused on cancers of the liver
• Cancers of the liver represent a multi-billion dollar global market and
an unmet medical need
an unmet medical need
• Broad and Informed clinical development program
o Multiple clinical trials: OM, HCC, ICC
o Prior FDA experience provides roadmap for clinical programs
• Demonstrated efficacy
o >225 clinical and commercial patients across multiple tumor types
o Efficacy and QoL benefit shown as reported by patients and physicians
o Three recent scientific presentations at ESSO meeting highlighted
efficacy and safety
efficacy and safety
• Demonstrated safety
o We believe EU commercial experience provides confidence safety can be
validated in controlled clinical setting
validated in controlled clinical setting
Large Market Opportunity, Demonstrated Efficacy, Near-term Value Drivers
4 DELCATH SYSTEMS, INC
Near-term Milestones to Create Value
Multiple milestones within next 12 months
•2014
o Phase 3 publication submitted by year-end
o ICC cohort open for enrollment by year-end
o EU Registry open for enrollment by year-end
•2015
o Interim analysis - first 11 HCC patients by mid-year
o Go/no-go decision on ICC program by mid-year
o Initiation of Phase 3 ocular melanoma program by mid-year
o NUB reimbursement decision in Germany by February 1, 2015
•Experienced team to achieve milestones
Obtaining Data in Multiple Tumor Types
5 DELCATH SYSTEMS, INC
The Liver: A Life Limiting Organ
• Cancers of the liver remain a major unmet medical need
globally
globally
o Large global patient population - approximately 1.2 million* patients
diagnosed annually with primary or metastatic liver cancer
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
leading causes of cancer death
o Prognosis after liver involvement is poor - overall survival generally less
than 12 months
than 12 months
• CHEMOSAT is a proprietary product uniquely positioned to
potentially treat the entire liver as a standalone or
complementary therapy
potentially treat the entire liver as a standalone or
complementary therapy
* SOURCE - 2008 GLOBOCAN
6 DELCATH SYSTEMS, INC
Potential Applications
Unresectable
Hepatocellular
Carcinoma (HCC)
Hepatocellular
Carcinoma (HCC)
(76,000 Cases
Diagnosed in US/EU
Annually)
Diagnosed in US/EU
Annually)
Ocular Melanoma
(OM) Liver
Metastases
(OM) Liver
Metastases
( ~4,000 Cases
Diagnosed in US/EU
Annually)
Diagnosed in US/EU
Annually)
Intra-hepatic
Cholangiocarcinoma (ICC)
Cholangiocarcinoma (ICC)
(~11,500 Cases Diagnosed
in US/EU Annually)
in US/EU Annually)
Colorectal Cancer Liver
Metastases (mCRC)
Metastases (mCRC)
(~65,000 Cases Diagnosed
in US/EU Annually)
in US/EU Annually)
Liver Cancers: Multi-Billion Dollar Global Market
Sources: ACS, SEER, NIH, OMF, KOL Interviews, 3rd Party Analysis
7 DELCATH SYSTEMS, INC
The Melphalan Hepatic Delivery System (HDS)
• Device designed to administer high dose chemotherapy to the liver while reducing
systemic exposure
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
Catheter In IVC
Melphalan Infused Directly Into Liver
Via Catheter In Hepatic Artery
Via Catheter In Hepatic Artery
Blood Exiting The Liver Filtered By
Proprietary Extra-corporeal Filters
Proprietary Extra-corporeal Filters
>225 Patients Treated In Clinical Development and Initial Commercial Use
8 DELCATH SYSTEMS, INC
Broad and Informed Clinical Development Program
Multiple Clinical Trials
• Initiating plans for Global phase 3 trial in Ocular Melanoma
(OM) Liver Mets in 2015 for trial start mid year
(OM) Liver Mets in 2015 for trial start mid year
• Establish Proof of Concept in Hepatocellular Carcinoma (HCC)
and Intrahepatic Cholangiocarcinoma (ICC)
and Intrahepatic Cholangiocarcinoma (ICC)
o Commenced Global Phase 2 Program in HCC in 2014
o Expanding Program to include ICC Cohort in EU Trial
• EU Registry to collect efficacy and safety data in the
commercial setting
commercial setting
• Supporting Investigator Initiated Trials (IITs) in HCC &
mCRC
mCRC
Clinical Development Program at a Glance
10 DELCATH SYSTEMS, INC
Clinical Development Program - Timeline
Interim Analysis
Leiden University (mCRC n=~30)
JWG (HCC n =~10)
First Patient In
Last Patient In
Data Readout
Additional IITs as Opportunities Present
11 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 ~7,500 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
5,700-8,600
Cases of Ocular
Melanoma
Melanoma
~50-55%
Metastasize
~90%
Show Liver Mets
~2,600 - 4,300
Eligible Patients
Limited TX Options
US/EU Market Size
*Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3rd Party
Analysis
Analysis
12 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
7.0
1.7
1.0
1.0
0.8
0.8
0.6
0.6
0.4
0.4
0.2
0.2
0.0
0.0
Proportion of patients surviving
5.3 mo
Chemosaturation (CS-PHP)
Previous Ocular Melanoma Phase 3 Results
0
0
5
5
10
10
15
15
20
20
25
25
30
30
Best alternative care (BAC)
Hepatic Progression Free Survival (hPFS)
Chemosaturation (CS-PHP)
§ 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
Months
5.4
1.6
1.0
1.0
0.8
0.8
0.6
0.6
0.4
0.4
0.2
0.2
0.0
0.0
3.8 mo
Intent-to-Treat Analysis (June 2012)
Best alternative care (BAC)
0
0
5
5
10
10
15
15
20
20
25
25
30
30
35
35
40
40
45
45
50
50
55
55
13 DELCATH SYSTEMS, INC
HCC Rationale
76,000
~90%
HCC
~80-90%
Unresectable
~20-30%
Child Pugh Class A
~7,600 - 14,700
Eligible Patients
~20-30%
Interventional
TX
TX
US/EU Market Size
*Sources: WHO, KOL Interviews, 2014 3rd Party Analysis
• 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
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
with unresectable HCC
14 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
76,000
HCC Diagnosis
~90%
Focal Interventions
~6,500
Eligible Patients
US/EU Market Size
~15%
Of HCC
Cases
Cases
*Sources: ACS, SEER, NIH, KOL Interviews, 2014 3rd Party Analysis
~20-30%
Unresectable
15 DELCATH SYSTEMS, INC
Prior FDA Experience Provides Roadmap for Clinical Programs
• New Drug Application (NDA) submitted August 2012 seeking
indication in OM liver metastases
indication in OM liver metastases
• ODAC meeting in May 2013
o Negative Vote
o Complete FDA & Delcath ODAC briefing materials available at
www.delcath.com/clinical-research/clinical-bibliography/
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
efficacy using the to-be-marketed device configuration
o Overall survival as the primary efficacy outcome measure
o Demonstrate clinical benefits outweigh risks
• Provides roadmap for clinical studies in any tumor type
16 DELCATH SYSTEMS, INC
Risks Observed in Previous Clinical Trials
• Risks observed using product and procedure protocol from Previous Clinical
Program
Program
• Integrated safety population of patients showed risks associated with
Melphalan/ HDS to include:
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
risk assessment
o a ≥ 70% incidence of grade 4 bone marrow suppression with a median time of
recovery of greater than 1 week
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
severe hemorrhage, and gastrointestinal perforation
o Deaths due to certain adverse reactions did not occur again during the
clinical trials following the adoption of related protocol amendments
clinical trials following the adoption of related protocol amendments
o Reports from treating physicians in US and EU indicate improved safety
profile with improved device and procedure refinements
profile with improved device and procedure refinements
17 DELCATH SYSTEMS, INC
Why Do We Believe?
• Improved device and procedure since prior trials
o >130 EU treatments
o >20 treatments in US Expanded Access Program and
Compassionate Use cases
Compassionate Use cases
o Many issues raised at ODAC have not been reported
• EU patients report improved QoL
• Current device/procedure permitting multiple treatment cycles
• Recent scientific presentations at ESSO for OM from 3 centers in
US and EU
US and EU
o University Southampton reported 47% of patients had a partial
response and 16% had a complete response
response and 16% had a complete response
o Moffitt reported 67% of patients had a partial response. In addition,
one patient was reported to have a complete response
one patient was reported to have a complete response
o Leiden reported 80% of patients had a partial response
Patients Benefiting from Melphalan/HDS
18 DELCATH SYSTEMS, INC
European Commercialization
CHEMOSAT®
Hepatic Delivery System
• Approved as Class IIb Medical Device; kit supplied w/o
melphalan
melphalan
• Broad indication for intra-hepatic administration of
melphalan hydrochloride and subsequent filtration of the
venous blood return
melphalan hydrochloride and subsequent filtration of the
venous blood return
• >130 commercial procedures performed in 15 leading
cancer centers in the EU
cancer centers in the EU
• Reimbursement via Individual Funding Requests; NUB
Value 4 Status in Germany
Value 4 Status in Germany
• Growing Support for NUB Value 1 Status among
German KOLs; 2015 NUB decision by February 1, 2015
German KOLs; 2015 NUB decision by February 1, 2015
• UK Block Grants pending & private pay insurance
19 DELCATH SYSTEMS, INC
CHEMOSAT® Commercial Treatments in Europe
• Multiple Tumor Types Treated Since EU Launch
Treatments/Re-treatments Increasing
20 DELCATH SYSTEMS, INC
Cash & Capital Resources
|
Cash & Cash Equivalents
|
$23.3 million at September 30, 2014
|
|
Debt
|
None
|
|
ATM Program1
|
$40 million available at September 30, 2014
|
|
Working Capital Line of Credit2
|
$20 million credit facility
|
|
Shares Outstanding
|
9.4 million (10.5 million fully diluted3) at
September 30, 2014 |
1) Subject to certain limitations
2) Subject to market conditions and certain limitations
3) 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./Est.
|
$4.5M
|
$4.0M
|
$4.0M
|
|
|
21 DELCATH SYSTEMS, INC
Summary
• Cancers of the liver represent a multi-
Billion dollar global market and unmet
medical need
Billion dollar global market and unmet
medical need
• Demonstrated efficacy
o Phase 3 trial
o Recent presentations at ESSO
• >150 treatments with improved device
and procedure in US and EU
and procedure in US and EU
• Current device/procedure permitting
multiple treatment cycles
multiple treatment cycles
• Intend to initiate Phase 3 OM trial 2015
• Phase 2 HCC trial open for enrollment
• ICC cohort to open for enrollment by end
2014
2014
§ Several milestones over next 12 months
§ Experienced team to help achieve
milestones in a cost efficient manner
milestones in a cost efficient manner
Melphalan Hydrochloride for Injection for use with the
Delcath Hepatic Delivery System (Melphalan/HDS)
Delcath Hepatic Delivery System (Melphalan/HDS)
* DELCATH SYSTEMS, INC
© 2014 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED
Delcath and CHEMOSAT are Registered Trademarks of Delcath Systems, Inc.
23 DELCATH SYSTEMS, INC
APPENDIX
24 DELCATH SYSTEMS, INC
Historic Clinical Program
|
Clinical Trials
|
Phase 1
|
Phase 2
|
Phase 3
|
Follow Up
|
EU Commercial
Experience |
|
Unresectable Hepatic
Tumors |
|
|
|
|
|
|
Unresectable Hepatic
Tumors (Multi- Histology)* |
|
|
|
|
|
|
Melanoma Liver
Metastases |
|
|
|
|
|
|
|
|
Integrated Safety Population
|
|
||
|
Product Procedure
Refinements |
|
|
|
|
N= >90
|
N=35
N=56
N=93
(44PHP, 49 BAC)
• Historic Clinical Program demonstrated improvement in hepatic
progression free survival in patients with OM
progression free survival in patients with OM
• Positive efficacy signals also seen in HCC, mNET
• Protocol Amendments and Procedure Refinements introduced in
response to Adverse Events (AEs) seen on trial
response to Adverse Events (AEs) seen on trial
• Reports from treating physicians in US and EU indicate improved
safety profile with improved device and procedure refinements
safety profile with improved device and procedure refinements
25 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
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
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
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
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
Oncology. 2013
2014 ESSO Congress Presentations
§ A Single Institution Experience with Percutaneous Hepatic Perfusion for Unresectable Ocular
Melanoma and Sarcoma in the Liver---Moffitt Cancer Center, U.S.; J. Zager
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
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
Treatment of Inoperable Ocular Melanoma Metastases---University Hospital Southampton, U.K; B.
Stedman