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): January 12, 2015

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)
 
1301 Avenue of the Americas, 43rd 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 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: January 12, 2015
  
By:
/s/ Barbra Keck
  
   
Name:    
Barbra Keck
  
   
Title:
Vice President, Controller
  

 

 
 
 

 
EXHIBIT INDEX
 
Exhibit No.    
 
Description
     
99.1
  
Delcath Systems, Inc. Investor Presentation Slides




Exhibit 99.1
 
Investor Presentation
(NASDAQ: DCTH)
January 2015
 
 
 
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
Why Invest in Delcath?
• We are a late-stage clinical company with early commercial activity in
 Europe focused on cancers of the liver
• Cancers of the liver are an unmet medical need representing a multi-
 billion dollar global market
• Focused clinical development program
 o Multiple clinical trials: OM, HCC, ICC
 o Prior FDA experience provides roadmap for clinical programs
• Demonstrated efficacy
 o 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
• Safety improvements implemented
 o >180 treatments with improved device and procedure in US and EU
 provides confidence safety can be validated in controlled clinical setting
Large Market Opportunity, Demonstrated Efficacy, Near-term Value Drivers
 
 
 
4 DELCATH SYSTEMS, INC
2015 Milestones to Create Value
2014 Accomplishments
 o Phase 2 HCC trial open and first patient treated
 o 100th patient treated in Europe (commercial and clinical)
 o Positive efficacy data from three institutions presented at ESSO 2014
Q1
 o Prior phase 3 publication submitted
 o EU Registry open for enrollment
 o ICC cohort open for enrollment
 o NUB reimbursement decision in Germany by February 1, 2015
Mid-year
 o Interim analysis on HCC patients
 o Go/no-go decision on ICC program
 o Initiation of phase 3 ocular melanoma program
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
 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
 
 
 
6 DELCATH SYSTEMS, INC
Potential Applications
Unresectable
Hepatocellular
Carcinoma (HCC)
(76,000 Cases
Diagnosed in US/EU
Annually)
Ocular Melanoma
(OM) Liver
Metastases
( ~4,000 Cases
Diagnosed in US/EU
Annually)
Intra-hepatic
Cholangiocarcinoma (ICC)
(~11,500 Cases Diagnosed
in US/EU Annually)
Colorectal Cancer Liver
Metastases (mCRC)
(~65,000 Cases Diagnosed
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
• 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
 
>240 Patients Treated In Clinical Development and Initial Commercial Use
 
 
 
8 DELCATH SYSTEMS, INC
Focused Clinical Development Program
• 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
• EU Registry to collect efficacy and safety data in the
 commercial setting
• Supporting Investigator Initiated Trials (IITs) in HCC &
 mCRC
 
 
 
9 DELCATH SYSTEMS, INC
Clinical Development Program at a Glance
 
 
 
 
10 DELCATH SYSTEMS, INC
Clinical Development Program - Timeline
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
• 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
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
*Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3rd Party
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
• 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
76,000
~90%
HCC
~80-90%
Unresectable
~20-30%
Child Pugh Class A
~7,600 - 14,700
Eligible Patients
~20-30%
Interventional
TX
US/EU Market Size
*Sources: WHO, KOL Interviews, 2014 3rd Party Analysis
 
 
 
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
• Unmet medical need – Delcath will pursue a melphalan orphan
drug designation from the FDA for patients with ICC
76,000
HCC Diagnosis
~90%
Unresectable
~6,500
Eligible Patients
US/EU Market Size
~15%
Of HCC
Cases
*Sources: ACS, SEER, NIH, KOL Interviews, 2014 3rd Party Analysis
~20-30%
Focal
Interventions
 
 
 
 
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 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
• Provides roadmap for clinical studies in any tumor type
 
 
 
16 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
• Reports from treating physicians in US and EU indicate improved safety
profile with improved device and procedure refinements
 
 
 
17 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
 
 
 
18 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
• 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
 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 Benefiting from Melphalan/HDS
 
 
 
 
19 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
•   Growing Support for NUB Value 1 Status among
    German KOLs; 2015 NUB decision by February 1,
     2015
•   UK Block Grants pending & private pay insurance
 
 
 
20 DELCATH SYSTEMS, INC
CHEMOSAT® Commercial Treatments in Europe
• Multiple Tumor Types Treated Since EU Launch
Treatments/Re-treatments Increasing
 
 
 
 
21 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 market conditions and certain limitations
2) Subject to 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.
$4.5M
$4.0M
$4.0M
 
 
 
 
 
22 DELCATH SYSTEMS, INC
Summary
• Cancers of the liver are an unmet
 medical need representing a multi-billion
 dollar global market
• Demonstrated efficacy
 o Prior phase 3 trial
 o Recent presentations at ESSO
• >180 treatments with improved device
 and procedure in US and EU
• Current device/procedure permitting
 multiple treatment cycles
• Phase 2 HCC trial open for enrollment
• Value driving milestones in 2015
 o Initiate Phase 3 OM trial
 o Expand HCC trial to include ICC cohort
 o Interim data in HCC
• Experienced team to help achieve
 milestones in a cost efficient manner
Melphalan Hydrochloride for Injection for use with the
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.
 
 
 
24 DELCATH SYSTEMS, INC
APPENDIX
 
 
 
25 DELCATH SYSTEMS, INC
Previous Clinical Program
Clinical Trials
Phase 1
Phase 2
Phase 3
Follow Up
Unresectable Hepatic
Tumors
 
 
 
 
Unresectable Hepatic
Tumors (Multi-Histology)*
 
 
 
 
Melanoma Liver Metastases
 
 
 
 
 
 
 
Integrated Safety Population
N=35
N=56
N=93
(44PHP, 49 BAC)
• Previous Clinical Program demonstrated improvement in hepatic
 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
• Reports from treating physicians in US and EU indicate improved
 safety profile with improved device and procedure refinements
 
 
 
26 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
§ 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