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 10, 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: March 10, 2015	By:	/s/ Jennifer K. Simpson
	Name:	Jennifer K. Simpson
	Title:	Interim President and Chief Executive Officer

EXHIBIT INDEX

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

EX-99.1

Exhibit 99.1

Investor Presentation
(NASDAQ: DCTH)

March 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 U.S. FDA, acceptance of the Phase 3 trial publication, the impact of the presentations at
ESSO andSSOand future clinical results consistent with the data presented, approval of the current or future
Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in
the U.S. 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

About Delcath Systems

•A specialty pharmaceutical and medical device oncology company with a
principal therapeutic focus on the treatment of primary liver cancer and other
cancers that have metastasized to the liver

•Proprietary system isolates the liver from circulation, delivers a substantially
higher concentration of chemotherapy (melphalan) compared with systemic
doses, and filters most of the chemotherapy out of the blood prior to returning
it to the patient to reduce myleosuppressive side effects

•In late-stage clinical development in the U.S. with initial commercial activities
underway in Europe

•Initially pursuing orphan indications in metastatic ocular melanoma,
hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma
(ICC)

Seeking to Make a Clinically Meaningful Difference For Cancer Patients With Liver Dominant Disease

DELCATH SYSTEMS, INC

Investment Highlights

Believe We are Positioned to Capitalize on Large, Compelling Market Opportunity

•Late-stage asset –demonstrated clinically meaningful efficacy in more than
600procedures and multiple tumor types

•Active clinical program –initiating global Phase 3 study in ocular
melanoma; HCC/ICC Phase 2 program ongoing

•Unique, highly differentiated solution –orphan designations create
barriers to entry

•Large market opportunity–cancers of the liver remain a multibillion-dollar
unmet medical need; early commercial activity EU

•Imminent valuation milestones – 2015 value drivers include publications,
reimbursement and clinical data

•Attractive business model –initial orphan focus and anticipated high gross
margins form basis of profitable long-term model

•Experienced management team –aligned with requirements of clinically
driven pharmaceutical industry

5DELCATH SYSTEMS, INC

2014-2015 Milestones

2014 Accomplishments

üPhase 2 HCC trial open and first patient treated

ü100th patient treated in Europe (commercial and clinical)

üPositive efficacy data from three institutions presented at ESSO 2014

üProduct revenue increased 118% Y/Y to $1.1 million

üCash burn reduced by 50% Y/Y

1H-2015

üNUB reimbursement decision in Germany – Value 4 awarded for 2015

üSubmit Phase 3 metastatic melanoma trial results for publication

oEU registry open for enrollment

oICC cohort open for enrollment

2H-2015

oInitiation of Phase 3 metastatic ocular melanoma program

oInterim evaluation on HCC/ICC program

Executing on Multiple Fronts to Create Value

6DELCATH SYSTEMS, INC

The Liver:A Life-Limiting Organ

•Cancers of the liver remain a major unmet medical need

oLarge global patient population – approximately 1.2 million* patients
diagnosed annually with primary or metastatic liver cancer

oThe liver is often the life-limiting organ for cancer patients and one of the
leading causes of cancer death

oPrognosis after liver involvement is poor, with 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

7DELCATH 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, radiofrequency ablation)	–Partial removal or treatment of tumors	–Only 10%-20% are resectable –Invasive and/or limited repeatability –Treatment is limited by tumor size, number of lesions and location –Tumor revascularization –Cannot treat diffuse disease

8DELCATH 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
high concentration of chemotherapy (melphalan) 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 the U.S. and EU provide confidence safety
can be validated in a controlled setting

9DELCATH 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 U.S.

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 300 Patients Treated To Date

10DELCATH 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

•Melphalan, an established chemotherapy agent, is proven active at high doses
with broad antitumor activity

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

11DELCATH SYSTEMS, INC

Total Available EU & U.S. Market Opportunity

Effective Liver Cancer Treatment Remains a Major Unmet Medical Need

Notes:

1) Source: Globocan, American Cancer Society

2) Source: LEK, Strategy&, Company estimates

3) Assumes an average of two treatments per patient

Cancer Type	Annual Incidence1	Eligible Pts2	Revenue per Patient3	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

12DELCATH SYSTEMS, INC

Clinically Differentiated Results

•Phase 1, 2 and 3 trials produced positive results in multiple histologies

•Melanoma Liver Mets

oPositive Phase 3 results in hepatic metastatic melanoma

on=93 (90% ocular melanoma, 10% cutaneous melanoma)

•Neuroendocrine Tumor (NET) Liver Mets

omNET cohort in Phase 2 trial showed encouraging 42% objective response rate
(ORR) vs. ~10% for approved targeted therapy

oMedian overall survival of ~32 months on ITT basis

•Hepatocellular Carcinoma (HCC)

oPositive 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

oData 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

13DELCATH SYSTEMS, INC

Clinical Development Program Overview

•Initiating global Phase 3 trial 2H 2015 in Ocular Melanoma
(OM) Liver Mets

•Establish proof-of-concept in Hepatocellular Carcinoma
(HCC) and Intrahepatic Cholangiocarcinoma (ICC)

oCommenced global Phase 2 program in HCC in 2014

oExpanding 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 in HCC and in
mCRC

Focused on Liver Dominant, Orphan Diseases With High Unmet Need

14DELCATH SYSTEMS, INC

Clinical Development Program Detail

Trials	Tumor	Objectives
Phase 3 Pivotal Trial	OM liver mets	§Global Phase 3 trial tostart 2H-2015 §Primary endpoint: Overall Survival (OS) §Believed to be fastest pathway to NDA approval in the U.S.
Phase 2 Trial	HCC (unresectable confined to the liver)	§Protocol 201 (U.S. only) §Safety, efficacy of melphalan/HDS treatment followed by sorafenib §Evaluate ORR (mRECIST) §Assess safety, PFS §Characterize systemic exposure of melphalan §Assess patient QoL
		§Protocol 202 (EU only) §Safety, efficacy of melphalan/HDS treatment w/o sorafenib in patients with unresectable liver cancer §Evaluate ORR (mRECIST) §Assess safety, PFS §Characterize systemic exposure of melphalan §Assess patient QoL
Phase 2 Cohort	ICC (unresectable confined to the liver)	§To be added to 202 HCC trial protocol §ORR of melphalan/HDS treatment in patients with intra‑hepatic cholangiocarcinoma (ICC) §Other measures as specified in the 202 EU protocol §Signal-seeking go/no-go decision 2H - 2015
Investigator Initiated Trials	mCRC	§University of Leiden study; ~6 patients treated to date
	HCC	§Johannes Wolfgang Goethe University Hospital (Frankfurt) study; different patient selection from 202 study; open for enrollment
EU Commercial Registry	EU Commercial Cases	§Data collection on safety, QoL assessments §Potential efficacy signals in additional tumor types §Support reimbursement in key markets

15DELCATH SYSTEMS, INC

OM Metastases Rationale

•OM has high incidence of liver metastases

oUp to 90% of patients with metastases will have liver involvement

oLife expectancy of approximately 6 months

o5,700 - 8,600 cases of OM liver metastases diagnosed in U.S. and EU
annually

5,700-8,600

Cases of Ocular
Melanoma

~50-55%

Metastasize

~90%

Show Liver Mets

~2,600 - 4,300

Eligible Patients

Limited TX Options

U.S./EU Market Size

*Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3rd Party
Analysis

Proven Efficacy in Attractive Orphan Opportunity

•Clear efficacy signal seen in prior Phase 3 trial of melphalan/HDS

•Currently no standard of care

•Believed to be fastest pathway to NDA approval in the U.S.

•FDA granted melphalan/HDS orphan drug status for treatment of OM

15DELCATH 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 Mets 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

Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients

4 subjects remain
alive at 5-8 years

17DELCATH SYSTEMS, INC

ICC Rationale

•Significant market opportunity in U.S. and EU

o~15% of new HCC cases diagnosed annually

o~90% of patients are not suitable for surgical resection

o~20-30% are candidates for focal interventions

*Sources: ACS, SEER, NIH, KOL Interviews, 2014 3rd Party Analysis

Encouraging Early Commerical Activity in Disease With Limited Treatment Options

76,000

HCC Diagnosis

~90%

Unresectable

~6,500

Eligible Patients

U.S./EU Market Size

~15%

OfHCC
Cases

~20-30%

Focal
Interventions

•Unmet medical need – Delcath will pursue a melphalan orphan drug
designation from the FDA for patients with ICC

oEfficacy signals from early commercial uses in EU

18DELCATH SYSTEMS, INC

HCC Rationale

•Significant opportunity in the U.S. and EU

oHCC most common primary cancer of the liver

o~76,000* cases diagnosed annually

•Large unmet medical need in first-line therapy

76,000

Cases of Primary
Liver Cancer

~90%

HCC

~80-90%

Unresectable

~20-30%

Child Pugh Class A

~7,600 - 14,700

Eligible Patients

~20-30%

Interventional
TX

U.S./EU Market Size

*Sources: WHO, KOL Interviews, 2014 3rd Party Analysis

Large, Deadly Disease in Need of Better Treatments

oOnly one approved systemic therapy in the U.S., EU and certain Asian
markets

o~90% of patients not candidates for surgical resection

o20-30% of patients are candidates for focal interventions

•FDA granted melphalan/HDS orphan drug status for treatment of
unresectable HCC

19DELCATH SYSTEMS, INC

Prior FDA Experience

•New Drug Application (NDA) submitted August 2012 seeking
indication in OM liver metastases with first-generation filters
and procedure

•ODAC meeting in May 2013

oEfficacy shown with statistical significance

oNegative vote due to benefit/risk analysis

oComplete 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:

oWell-controlled randomized trial(s) to establish the safety and
efficacy using the to-be-marketed device configuration

oOverall survival as the primary efficacy outcome measure

oDemonstrate clinical benefits outweigh risks

FDA Learnings Provide Beneficial Clinical Study Roadmap

20DELCATH 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 included:

o4.1% incidence of death due to adverse reactions

o4% incidence of stroke

o2% reported incidence of myocardial infarction in the setting of an incomplete cardiac
risk assessment

o≥70% incidence of grade 4 bone marrow suppression with a median time of recovery
of greater than 1 week

o18% 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 U.S. and EU Report Improved Safety Profile

21DELCATH SYSTEMS, INC

Safety Improvements Implemented

•New generation filter

oImprove filter efficiency and consistency

•Vasopressors and methylprednisolone

oReduce cardiovascular risk

•Prophylactic transfusions and growth factors

oReduce risk of myelosuppression

•Intra-arterial nitroglycerin

oPrevent hepatic arterial spasm

•Liver tumor burden not to exceed >50%

oAddress risk of liver failure

Decisive Measures to Assure Improved Safety

22DELCATH SYSTEMS, INC

Positive Developments

•Improved device and procedure since prior trials

o>180 treatments with improved device and procedure in U.S. and
EU

oMany 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
U.S. and EU

oUniversity Southampton reported 63% positive response (47% had a
partial response and 16% had a complete response)

oMoffittreported 67% positive response (partial response and one
complete response)

oLeiden reported 80% positive response (partial response)

Patients Report Improved Quality of Life

23DELCATH SYSTEMS, INC

European Commercial Activity

CHEMOSAT®

Hepatic Delivery System

•Approved as Class IIb Medical Device; kit supplied
without melphalan

•Broad indication for intra-hepatic administration of
melphalan hydrochloride and subsequent filtration of
the venous blood return

•>160 commercial procedures performed in 15 leading
cancer centers across the EU

•Reimbursement via Individual Funding Requests;
NUB Value 4 Status in Germany

•UK Block Grants pending and private pay insurance

•Published data in peer-reviewed journal needed to
support reimbursement efforts in certain EU countries

24DELCATH SYSTEMS, INC

CHEMOSAT® Commercial Treatments in Europe

Multiple Tumor Types Treated Since EU Launch

Treatments/Re-treatments Increasing

25DELCATH SYSTEMS, INC

Cash & Capital Resources

Cash & Cash Equivalents	$20.5 million at December 31, 2014
Debt	None
ATM Program1	$40 million available at December 31, 2014
Shares Outstanding	12.2 million (14.5 million fully diluted3) at February 17, 2015

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 Actual	$4.5M	$4.0M	$4.0M	$3.7M	$16.2M

Focused Spending and Resources to Support Execution of Near-term Plan

26DELCATH SYSTEMS, INC

In Summary

Melphalan Hydrochloride for Injection for use with the
Delcath Hepatic Delivery System (Melphalan/HDS)

•Cancers of the liver remain a
multibillion-dollar unmet medical
need

•Unique, highly differentiated solution

•Late-stage asset in U.S., early
commercial activityEU

•Compelling emerging data

•Imminent valuation milestones

•Attractive orphan drug business
model

•Experienced pharmaceutical
management team executing a data
-driven plan

*DELCATH SYSTEMS, INC

© 2015 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.