SEC Filing - Delcath Systems, Inc.

DELCATH SYSTEMS, INC.

Date: June 10, 2015

/s/ Jennifer K. Simpson

Jennifer K. Simpson

President and Chief Executive Officer

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Form 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): June 10, 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.

EXHIBIT INDEX


Exhibit No.		Description of Exhibit

99.1		Delcath Systems, Inc. Investor Presentation Slides

EX-99.1

Investor Presentation

(NASDAQ: DCTH)

Annual Shareholder Meeting

June 10, 2015

Exhibit 99.1

2DELCATH SYSTEMS, INC

Forward-looking Statements

This

presentation

contains

forward-looking

statements,

within

the

meaning

the

federal

securities

laws,

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

known

and

unknown

risks

and

uncertainties

and

are

based

potentially

inaccurate

assumptions,

which

could

cause

actual

results

differ

materially

from

expected

results,

performance

achievements

expressed

implied

statements

made

herein.

Our

actual

results

could

differ

materially

from

those

anticipated

forward-looking

statements

for

many

reasons,

including,

but

not

limited

to,

uncertainties

relating

to:

the

timing

and

results

future

clinical

trials

including

without

limitation

the

OM,

HCC,

ICC,

and

mCRC

trials

the

Company’s

Clinical

Development

Program,

clinical

adoption,

use

and

resulting

sales,

any,

for

the

CHEMOSAT

system

Europe,

our

ability

obtain

reimbursement

for

the

CHEMOSAT

system

various

markets

including

without

limitation

Germany

and

the

United

Kingdom,

our

ability

successfully

commercialize

the

Melphalan/HDS

system

and

the

potential

the

Melphalan/HDS

system

treatment

for

patients

with

primary

and

metastatic

disease

the

liver,

the

Company's

ability

satisfy

the

requirements

the

FDA's

Complete

Response

Letter

relating

the

ocular

melanoma

indication

and

the

timing

the

same,

approval

the

Melphalan/HDS

system

the

U.S.

FDA,

acceptance

the

Phase

trial

publication,

the

impact

presentations

and

abstracts

major

medical

meetings

and

congresses

(ESSO,

SSO,

ASCO,

CIRSE)

and

future

clinical

results

consistent

with

the

data

presented,

approval

the

current

future

Melphalan/HDS

system

for

delivery

and

filtration

melphalan

other

chemotherapeutic

agents

for

various

indications

the

U.S.

and/or

foreign

markets,

actions

the

FDA

other

foreign

regulatory

agencies,

our

ability

successfully

enter

into

strategic

partnership

and

distribution

arrangements

foreign

markets

and

the

timing

and

revenue,

any,

the

same,

uncertainties

relating

the

timing

and

results

research

and

development

projects,

and

uncertainties

regarding

our

ability

obtain

financial

and

other

resources

for

any

clinical

trials,

research,

development,

and

commercialization

activities.

These

factors,

and

others,

are

discussed

from

time

our

filings

with

the

Securities

and

Exchange

Commission

including

the

section

entitled

‘‘Risk

Factors’’

our

most

recent

Annual

Report

Form

10-K

and

our

Reports

Form

10-Q

and

Form

8-K.

3DELCATH 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

4DELCATH SYSTEMS, INC

Investment Highlights

Large, Compelling Market Opportunity

•

Late-stage

asset

–

approved

and

initial

commercial

activities

underway

EU;

demonstrated

clinically

meaningful

efficacy

than

600

procedures

and multiple tumor types

•

Active

clinical

program

–

initiating

global

Phase

study

ocular

melanoma; HCC/ICC Phase 2 program ongoing

•

Unique,

highly

differentiated

solution

–

orphan

designations

create

barriers to entry

•

Large

market

opportunity

–

cancers

the

liver

remain

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

clinically

driven pharmaceutical industry

5DELCATH SYSTEMS, INC

2014-2015 Milestones

2014 Accomplishments

Phase 2 HCC trial open and first patient treated

100

patient

treated

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

6DELCATH SYSTEMS, INC

The Liver: A Life-Limiting Organ

•

Cancers of the liver remain a major unmet medical need

Large

global

patient

population

–

approximately

1.2

million*

patients

diagnosed annually with primary or metastatic liver cancer

The liver is often the life-limiting organ for cancer patients and one of the

leading causes of cancer death

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

7DELCATH 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 200 treatments with improved device

and procedure in the U.S. and EU provide confidence safety

can be validated in a controlled setting

8DELCATH 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

9DELCATH SYSTEMS, INC

The Melphalan Hepatic Delivery System (HDS)

•

Device designed to administer high-dose chemotherapy to the liver while reducing

systemic exposure

•

Marketed

Delcath

Hepatic

CHEMOSAT

Delivery

System

(device

only)

•

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

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

Cancer Type

Annual

Incidence

Eligible Pts

Annual Potential

Market Opportunity Market Opportunity

(millions)

3,5

Annual Potential

(millions)

4,5

Ocular Melanoma (OM)

5,700-8,600

2,600-4,300

$104-$215

$208-$430

Cholangio

Carcinoma (ICC)

11,500

6,500

$260-$330

$520-$660

Hepatocellular

Carcinoma (HCC)

64,500

7,600-14,700

$304-$735

$608-$1,470

Colorectal (CRC)

411,000

40,000-55,000

$1,600-$2,750

$3,200-$5,500

Total EU and US

492,700-495,600

56,700-80,500

$2,268-$4,030

$4,536-$8,060

Notes:

1) Source: Globocan, American Cancer Society

2) Source: LEK, Strategy&, Company estimates

3 ) Assumes an average of two treatments per patient

4 ) Assumes an average of four treatments per patient

5 ) Assumes $20,000-$25,000 USD per treatment

12DELCATH SYSTEMS, INC

Clinically Differentiated Results

•

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

•

Melanoma Liver Mets

Positive Phase 3

results in hepatic metastatic melanoma

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

•

Neuroendocrine Tumor (NET) Liver Mets

mNET cohort in Phase 2

trial showed encouraging 42% objective response rate

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

Median overall survival of ~32 months on ITT basis

•

Hepatocellular Carcinoma (HCC)

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

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

Clinical Development Program Detail

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 Trial

HCC

(unresectable

confined to the

liver)

Protocol 201 (U.S.

only)

Safety,

efficacy

melphalan/HDS

treatment

followed

sorafenib

Evaluate

ORR (mRECIST)

Assess safety, PFS

Characterize systemic exposure of melphalan

Assess patient

QoL

Protocol 202 (EU only)

Safety,

efficacy

melphalan/HDS

treatment

w/o

sorafenib

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)

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; ~7 patients treated to date

HCC

Johannes

Wolfgang Goethe University

Hospital (Frankfurt) study; different

patient selection from 202 study; open for enrollment

EU Commercial

Registry

Commercial

Cases

Data collection on

safety, QoL

assessments

Potential efficacy signals in additional tumor types

Support reimbursement in key markets

14DELCATH SYSTEMS, INC

OM Metastases Rationale

•

OM has high incidence of liver metastases

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

Life expectancy of approximately 6 months

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

~2,600 –

4,300

Eligible Patients

Limited TX Options

U.S./EU Market Size

*Sources:

ACS,

SEER,

NIH,

OMF,

KOL

Interviews,

2014

Party

Analysis

Proven Efficacy in Attractive Orphan Opportunity

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

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

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)

Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients

4 subjects remain

alive at 5-8 years

All were recipients

of CS-PHP

16DELCATH SYSTEMS, INC

ICC Rationale

•

Significant market opportunity in U.S. and EU

~15% of new HCC cases diagnosed annually

~90% of patients are not suitable for surgical resection

~20-30% are candidates for focal interventions

Efficacy signals from early commercial uses in EU

•

Unmet medical need –

Delcath is pursuing a melphalan orphan

drug designation from the FDA for patients with ICC

*Sources:

ACS,

SEER,

NIH,

KOL

Interviews,

2014

Party

Analysis

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

17DELCATH SYSTEMS, INC

HCC Rationale

•

Significant opportunity in the U.S. and EU

HCC most common primary cancer of the liver

~76,000* cases diagnosed annually

•

Large unmet medical need in first-line therapy

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

markets

~90% of patients not candidates for surgical resection

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

U.S./EU Market Size

*Sources:

WHO,

KOL

Interviews,

2014

Party

Analysis

Large, Deadly Disease in Need of Better Treatments

18DELCATH 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

Efficacy shown with statistical significance

Negative vote due to benefit/risk analysis

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:

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

efficacy using the to-be-marketed device configuration

Overall survival as the primary efficacy outcome measure

Demonstrate clinical benefits outweigh risks

FDA Learnings Provide Beneficial Clinical Study Roadmap

19DELCATH 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:

4.1% incidence of death due to adverse reactions

4% incidence of stroke

2% reported incidence of myocardial infarction in the setting of an incomplete cardiac

risk assessment

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

of greater than 1 week

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

20DELCATH SYSTEMS, INC

Safety Improvements Implemented

•

New generation filter

Improve filter efficiency and consistency

•

Vasopressors and methylprednisolone

Reduce cardiovascular risk

•

Prophylactic transfusions and growth factors

Reduce risk of myelosuppression

•

Intra-arterial nitroglycerin

Prevent hepatic arterial spasm

•

Liver tumor burden not to exceed >50%

Address risk of liver failure

Decisive Measures to Assure Improved Safety

21DELCATH SYSTEMS, INC

Positive Developments

•

Improved device and procedure since prior trials

>200 treatments with improved device and procedure in U.S. and EU

Many issues raised at ODAC have not been reported

•

Current device/procedure permitting multiple treatment cycles

•

Recent Presentations & Abstracts at Major Medical Meetings/Congresses

ESSO 2014

SSO 2015

ASCO 2015

CIRSE 2015

•

Data consistent with observations from EU commercial experience

Patients Report Improved Quality of Life

22DELCATH SYSTEMS, INC

Recent Data Presentations -

ASCO 2015

•

Analysis of 20 patients who received 34 treatments at Southampton

University Hospital

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

response ongoing at >1 year

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

2 patients (10%) demonstrated stable disease for >3 months, 13 patients (65%)

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

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

the first procedure

•

Adverse Events

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)

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

Grade 4 complication was pulmonary edema due to fluid overload

23DELCATH SYSTEMS, INC

Recent Data Presentations -

SSO 2015

•

Moffitt Cancer Center (Tampa, FL)

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)

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

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

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

Y90 (285

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

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

significantly prolonged with Melphalan/HDS vs

CE and Y90

24DELCATH 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

•

>180 commercial procedures performed in

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

25DELCATH SYSTEMS, INC

CHEMOSAT

Commercial Treatments in Europe

Multiple Tumor Types Treated Since EU Launch

Treatments/Re-treatments Increasing

111

186

100

125

150

175

200

TREATMENTS

136

100

120

140

160

DISEASE (Commercial Treatments)

26DELCATH SYSTEMS, INC

Cash & Capital Resources

Cash & Cash Equivalents

$18.5 million at March 31, 2015

Debt

None

ATM Program

$40 million available at March 31, 2015

Shares Outstanding

12.2

million

(14.4

million

fully

diluted

)

March 31, 2015

Subject to market conditions and certain limitations

Fully diluted includes approximately 0.3 million options and 1.9 million warrants

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

27DELCATH 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 activity

•

Compelling emerging data

•

Imminent valuation milestones

•

Attractive orphan drug business

model

•

Experienced pharmaceutical

management team executing a

data-driven plan

28DELCATH SYSTEMS, INC

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