8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): September 3, 2015

Delcath Systems, Inc.

(Exact Name of Registrant Specified in Charter)

Delaware	001-16133	06-1245881
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)
1301 Avenue of the Americas, 43rd Floor New York, New York		10019
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (212) 489-2100

Not Applicable

(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:

¨ 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.

(d) Exhibits.

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

SIGNATURE

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.
Date: September 3, 2015	By:	/s/ Jennifer K. Simpson
		Jennifer K. Simpson
		President and Chief Executive Officer

EXHIBIT INDEX

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

EX-99.1

Investor Presentation

(NASDAQ: DCTH)

September 2015

Exhibit 99.1

2

DELCATH SYSTEMS, INC

Forward-looking Statements

This

presentation

contains

forward-looking

statements,

within

the

meaning

of

the

federal

securities

laws,

related

to

future

events

and

future

financial

performance

which

include

statements

about

our

expectations,

beliefs,

plans,

objectives,

intentions,

goals,

strategies,

assumptions

and

other

statements

that

are

not

historical

facts.

Forward-looking

statements

are

subject

to

known

and

unknown

risks

and

uncertainties

and

are

based

on

potentially

inaccurate

assumptions,

which

could

cause

actual

results

to

differ

materially

from

expected

results,

performance

or

achievements

expressed

or

implied

by

statements

made

herein.

Our

actual

results

could

differ

materially

from

those

anticipated

in

forward-looking

statements

for

many

reasons,

including,

but

not

limited

to,

uncertainties

relating

to:

the

timing

and

results

of

future

clinical

trials

including

without

limitation

the

OM,

HCC,

ICC,

and

mCRC

trials

in

the

Company’s

Clinical

Development

Program,

clinical

adoption,

use

and

resulting

sales,

if

any,

for

the

CHEMOSAT

system

in

Europe,

our

ability

to

obtain

reimbursement

for

the

CHEMOSAT

system

in

various

markets

including

without

limitation

Germany

and

the

United

Kingdom,

our

ability

to

successfully

commercialize

the

Melphalan/HDS

system

and

the

potential

of

the

Melphalan/HDS

system

as

a

treatment

for

patients

with

primary

and

metastatic

disease

in

the

liver,

the

Company's

ability

to

satisfy

the

requirements

of

the

FDA's

Complete

Response

Letter

relating

to

the

ocular

melanoma

indication

and

the

timing

of

the

same,

approval

of

the

Melphalan/HDS

system

by

the

U.S.

FDA,

acceptance

of

the

Phase

3

trial

publication,

the

impact

of

presentations

and

abstracts

at

major

medical

meetings

and

congresses

(SSO,

ASCO,

CIRSE,

ESMO,

EADO,

RSNA)

and

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

•

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

4

DELCATH SYSTEMS, INC

Investment Highlights

Large, Compelling Market Opportunity

•

Late-stage

asset

–clinically

meaningful

efficacy

demonstrated

in

>600

procedures and in multiple tumor types

•

Active

clinical

program

–

initiating

global

Phase

3

study

in

ocular

melanoma; HCC/ICC Phase 2 program ongoing 

•

Unique,

highly

differentiated

solution

–

multiple

orphan

designations

create barriers to entry

•

Early

stage

commercialization

in

EU

–

>200

procedures

performed

in

EU with 2nd Generation product and protocol

•

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

5

DELCATH SYSTEMS, INC

2014-2015 Milestones

2014 Accomplishments

Phase 2 HCC trial open and first patient treated

100

patient treated in Europe (commercial and clinical)

Positive efficacy data from three institutions presented at ESSO 2014

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

Cash burn reduced by 50% Y/Y

1H-2015

NUB reimbursement decision in Germany –

Value 4 awarded for 2015

Submit Phase 3 metastatic melanoma trial results for publication

EU registry open for enrollment

ICC cohort open for enrollment

2H-2015

•

Initiation of global Phase 3 metastatic ocular melanoma program

•

Interim evaluation on HCC/ICC program

Executing on Multiple Fronts to Create Value

th

6

DELCATH SYSTEMS, INC

The Liver:  A Life-Limiting Organ

•

Cancers of the liver remain a major unmet medical need

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, 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

7

DELCATH SYSTEMS, INC

Whole Organ-Focus Disease Control

Our Solution

•

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, oncologist, anesthesiologist and perfusionist

•

We believe more than 200 treatments with improved device

and procedure provide confidence safety can be validated in a

controlled setting

8

DELCATH SYSTEMS, INC

Existing Liver Cancer Treatments Landscape

Existing Liver Cancer Treatments Have Limitations

Treatment

Advantages

Disadvantages

Systemic

–

Non-invasive

–

Repeatable

–

Systemic toxicities

–

Limited efficacy in liver

Regional

(e.g., Isolated Hepatic Perfusion)

–

Therapeutic effect

–

Targeted

–

Invasive/limited repeatability

–

Multiple treatments are

required but not possible

Focal

(e.g., surgery, radioembolization,

chemoembolization,

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

9

DELCATH SYSTEMS, INC

The Melphalan Hepatic Delivery System (HDS)

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

Improved Product & Procedure in Use Since 2012

•

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.

®

10

DELCATH SYSTEMS, INC

Melphalan Dosing & Background

•

Well-understood, dose-dependent, tumor-preferential, alkylating cytotoxic agent

that demonstrates little to no hepatic toxicity

•

Dose administered directly to liver is substantially higher than that of systemic IV

chemotherapy

•

Melphalan, an established chemotherapy agent, is proven active at high doses

with broad antitumor activity

An Established Drug for Liver Cancer Therapy

Type

Dosing (mg/kg)

Multiple Myeloma (label)

0.25

Chemoembolization

0.62

Surgical Isolated Hepatic Perfusion (IHP)

1.50

Myeloablation

2.50-3.50

Melphalan/HDS (PHP)

3.00

11

DELCATH SYSTEMS, INC

Total Available EU & U.S. Market Opportunity

Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need

12

DELCATH SYSTEMS, INC

European Commercial Activity

CHEMOSAT

Hepatic Delivery System

•

Approved as Class Ilb

Medical Device; kit

supplied without melphalan

•

Broad indication for intra-hepatic

administration of melphalan hydrochloride and

subsequent filtration of the venous blood

return

•

>200 commercial procedures performed in

leading cancer centers across the EU

•

Reimbursement via Individual Funding

Requests; NUB Value 4 Status in Germany 

•

UK private pay insurance; block grants

pending

•

2015 YTD EU Sales exceed 2014 on local

currency basis

®

13

DELCATH SYSTEMS, INC

Growing Body of Clinical Support for CHEMOSAT

EU KOL Forum affirms benefits to liver

cancer patients

o

4 TX being administered; shown to be

safe and well tolerated

o

Providing clinical benefit and good QoL

o

Reimbursement continues to be

covered through individual funding

requests

Abstracts Accepted at Major Medical

Meetings

o

ESSO 2014

o

SSO 2015

o

ASCO 2015

o

CIRSE 2015

o

EADO 2015

o

ESMO 2015

o

RSNA 2015

14

DELCATH SYSTEMS, INC

Increasing & Expanding Clinical Utilization

Utilization Expanding Into Other Tumor Types Beyond Ocular Melanoma

15

DELCATH SYSTEMS, INC

Clinically Differentiated Results

•

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

•

Melanoma Liver Mets

o

Positive Phase 3 results in hepatic metastatic melanoma

o

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

•

Neuroendocrine Tumor (NET) Liver Mets

o

mNET cohort in Phase 2 trial showed encouraging 42% objective response rate

(ORR) vs. ~10% for approved targeted therapy

o

Median overall survival of ~32 months on ITT basis

•

Hepatocellular Carcinoma (HCC)

o

Positive signal with high-dose melphalan in HCC cohort of Phase 2 trial (5/8 patients)

is encouraging when approved systemic therapies have modest efficacy and

challenges with tolerability

•

Colorectal Cancer (CRC) Liver Mets

o

Data from surgical Isolated Hepatic Perfusion (IHP) with melphalan indicates strong

potential in well-defined patient population with earlier stage CRC yielding ~50-60%

median response rate and median OS of 17.4-24.8 mos

Encouraging Initial Results on a Broad Range of Histologies

16

DELCATH SYSTEMS, INC

Clinical Development Program

Trials

Tumor

Objectives

Phase 3 Pivotal Trial

OM liver mets

Global Phase 3 trial to

start

2H-2015

Primary endpoint: Overall

Survival (OS)

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

Phase 2 Program

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

ICC

(unresectable

confined to the

liver)

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; 10 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

Open

for

enrollment;

data

collection

on

safety,

QoL

assessments

Potential efficacy signals in additional tumor types

Support reimbursement in key markets

~2,600 –

4,300

Eligible Patients

OM Metastases Rationale

•

OM has high incidence of liver metastases

o

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

o

Life expectancy of approximately 6 months

o

5,700 -

8,600 cases of OM liver metastases diagnosed in U.S. and EU

annually

•

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 designation for treatment of OM

5,700-8,600

Cases of Ocular

Melanoma

~50-55%

Metastasize

~90%

Show Liver Mets

Limited TX Options

U.S./EU Market Size

*Sources:

ACS,

SEER,

NIH,

OMF,

KOL

Interviews,

2014 3 

Party

Analysis

Proven Efficacy in Attractive Orphan Opportunity

rd

17

DELCATH SYSTEMS, INC

18

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

0

.

8

0

.

6

0

.

4

0

.

2

0

.

0

Proportion of patients surviving

5.3 mo

Chemosaturation

(CS-PHP)

Previous Ocular Melanoma Mets Phase 3 Results

0

5

10

15

20

25

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

0

.

8

0

.

6

0

.

4

0

.

2

0

.

0

3.8 mo

Intent-to-Treat Analysis (June 2012)

Best alternative care (BAC)

0

5

10

15

20

25

30

35

40

45

50

55

Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients

4 subjects remain

alive at 5-8 years

All were recipients

of CS-PHP

19

DELCATH 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

o

Efficacy signals from early commercial uses in EU

•

Unmet medical need –

FDA granted melphalan orphan drug

designation for patients with ICC

Encouraging Early Commercial Activity in Disease With Limited Treatment Options

76,000

HCC Diagnosis

~90%

Unresectable

~6,500

Eligible Patients

U.S./EU Market Size

~15%

Of  HCC

Cases

~20-30%

Focal

Interventions

*Sources:

ACS,

SEER,

NIH,

KOL

Interviews,

2014

3  

Party

Analysis

rd

20

DELCATH SYSTEMS, INC

HCC Rationale

•

Significant opportunity in the U.S. 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 approved systemic therapy in the U.S., EU and certain Asian

markets

o

~90% of patients not candidates for surgical resection

o

20-30% of patients are candidates for focal interventions

•

FDA granted Melphalan/HDS orphan drug designation for treatment of

unresectable

HCC

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

Large, Deadly Disease in Need of Better Treatments

*Sources:

WHO,

KOL

Interviews,

2014 3

Party

Analysis

rd

21

DELCATH SYSTEMS, INC

Prior FDA Experience

•

New Drug Application (NDA) submitted August 2012 seeking

indication in OM liver metastases with first-generation filter and

procedure

•

ODAC meeting in May 2013

o

Efficacy shown with statistical significance

o

Negative vote due to benefit/risk analysis

o

Complete FDA & Delcath ODAC briefing materials available at

www.delcath.com/clinical-research/clinical-bibliography/

•

Complete Response Letter (CRL) issued September 2013

•

FDA requests include, but not limited to:

o

Well-controlled randomized trial(s) to establish the safety and

efficacy using the to-be-marketed device configuration

o

Overall survival as the primary efficacy outcome measure

o

Demonstrate clinical benefits outweigh risks

FDA Learnings

Provide Beneficial Clinical Study Roadmap

22

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 included:

o

4.1% incidence of death 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

70% incidence of grade 4 bone marrow suppression with a median time of recovery

of greater than 1 week

o

18% incidence of febrile neutropenia, along with the additive risk of hepatic injury,

severe hemorrhage and gastrointestinal perforation

•

Deaths due to certain adverse reactions did not occur again during the clinical

trials following the adoption of related protocol amendments

Treating Physicians in U.S. and EU Report Improved Safety Profile

23

DELCATH SYSTEMS, INC

Safety Improvements Implemented

•

New generation filter

o

Improve 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

Prevent hepatic arterial spasm

•

Liver tumor burden not to exceed >50%

o

Address risk of liver failure

Decisive Measures to Assure Improved Safety

24

DELCATH SYSTEMS, INC

Recent Data Presentations -

ASCO 2015

•

Analysis of 20 ocular melanoma patients who received 34 treatments at

Southampton University Hospital

o

Eleven patients remain alive after a median of 280 days with one complete

response ongoing at >1 year

o

From the diagnosis of liver metastases, 11 patients (55%) survived to one year and

3 (15%) for >2 years; no procedure related deaths were seen

o

ORR 85%: 2 patients (10%) demonstrated stable disease for >3 months, 13

patients (65%) had a partial response, 2 patients (10%) demonstrated complete

response

o

Nine deaths from disease progression occurred after a median of 264 days from

the first procedure

•

Adverse Events

o

Early AEs often expected with percutaneous hepatic perfusion (PHP) were

observed including coagulopathy, electrolyte disturbances and transient

transaminases (elevated liver enzymes).

Rare late AEs (1 patient each) included

hair loss, skin rash, myelosuppression

and persistent transaminases (elevated liver

enzymes)

o

AEs seen were grade 1 (n=12), 2 (n=13), 3 (n=5) and 4 (n=1)

o

Grade 4 complication was pulmonary edema due to fluid overload

25

DELCATH SYSTEMS, INC

Recent Data Presentations -

SSO 2015

•

Moffitt Cancer Center (Tampa, FL)

o

Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated

with Melphalan/HDS (n=10), chemoembolization (CE, n=12), and yttrium-90 (Y90,

n=6)

o

Study showed significant difference in hepatic progression free survival (HPFS) for

Melphalan/HDS (310 days), CE (80 days), Y-90 (54 days)

o

Median overall survival (OS) longest for Melphalan/HDS (736 days) vs Y90 (285

days) CE (265 days), but did not reach statistical significance

o

Authors concluded that HPFS and progression free survival (PFS) were

significantly prolonged with Melphalan/HDS vs CE and Y90

•

Additional abstracts accepted for presentation at CIRSE, ESMO, EADO &

RSNA in fall 2015

26

DELCATH SYSTEMS, INC

Cash & Capital Resources

Cash & Cash Equivalents

$19.1 million at July 31, 2015

Debt

None

ATM

Program

$40 million available at July 31, 2015

Shares Outstanding

21.8

million

(40.7

million

fully

diluted )

at

July

31,

2015

1)

Subject to market conditions and certain limitations

2)

Fully diluted includes approximately 0.8 million options and 18.1 million warrants

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

2

1

27

DELCATH SYSTEMS, INC

In Summary

•

Attractive multi-billion dollar orphan

drug business model

•

Unique, highly differentiated solution

•

Late-stage asset in U.S. with active

clinical development program

•

Early commercial activity in EU with

increasing sales/procedure volumes

•

Compelling emerging data

•

Imminent valuation milestones

•

Experienced pharmaceutical

management team executing a

data-driven plan

28

DELCATH SYSTEMS, INC

© 2015 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

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