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): May 17, 2013 (May 16, 2013)
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-16133
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06-1245881
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(State or Other Jurisdiction
of Incorporation)
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(Commission File Number)
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(IRS Employer
Identification Number)
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566 Queensbury Avenue, Queensbury, New York 12804
(Address of principal executive offices, including zip code)
(518) 743-8892
(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 (the “Company”) presentation slides that the Company presented at the Annual Meeting of Stockholders held on May 16, 2013 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.
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Exhibit No.
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Description
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99.1
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Delcath Systems, Inc. Annual Meeting of Stockholders Presentation Slides
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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.
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DELCATH SYSTEMS, INC.
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Dated: May 17, 2013
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By:
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/s/ Peter J. Graham
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Name:
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Peter J. Graham
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Title:
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Executive Vice President,
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General Counsel
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EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
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Delcath Systems, Inc. Annual Meeting of Stockholders Presentation Slides
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Exhibit 99.1
Annual Shareholder Meeting
(NASDAQ: DCTH)
(NASDAQ: DCTH)
May 16, 2013
2 DELCATH SYSTEMS, INC
Forward-looking Statements
Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on
its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause
actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to,
uncertainties relating to: the impact of the negative advisory vote by the ODAC panel on the FDA’s decision regarding the
Company’s new drug application (NDA), timing of completion of the FDA’s review of our NDA, the extent to which the FDA may
request additional information, data, or new clinical trials and our ability to provide the same in a timely manner, additional PDUFA
goal date extensions by the FDA, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, FDA approval of the Company's
NDA for the treatment of metastatic ocular melanoma to the liver, adoption, use and resulting sales, if any, for the MelblezTM Kit in
the United States, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT Delivery System in the EEA, our ability to
successfully commercialize the Melblez/CHEMOSAT System in various markets and the potential of the system as a treatment for
patients with cancers in the liver, the timing and our ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets including Australia and key Asian markets and resulting sales, if any, from the same, patient
outcomes using the Generation 2 system, approval of the current or future system for other indications and/or for use with various
chemotherapeutic agents, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the
CHEMOSAT system in various markets, the number of cancer centers in Germany and Italy able to successfully negotiate and
receive reimbursement for the CHEMOSAT procedure and the amount of reimbursement to be provided, submission and publication
of the Phase II and III clinical trial data, the timing and results of research and development projects, the timing and results of future
clinical trials including the initiation of clinical trials in key Asian markets with the CHEMOSAT Hepatic Delivery System device for
intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin, approval of the CHEMOSAT Hepatic Delivery System to
delver and filter doxorubicin in key Asian markets and adoption, sales, if any, and patient outcomes using the same, the timing, price
and use, if any, of the committee equity financing facility with Terrapin, the timing and use, if any, of the line of credit from SVB and
our ability to access this facility, the timing and use, if any, of the At-the-Market financing program, and uncertainties regarding our
ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and
others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue
reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly
update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause
actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to,
uncertainties relating to: the impact of the negative advisory vote by the ODAC panel on the FDA’s decision regarding the
Company’s new drug application (NDA), timing of completion of the FDA’s review of our NDA, the extent to which the FDA may
request additional information, data, or new clinical trials and our ability to provide the same in a timely manner, additional PDUFA
goal date extensions by the FDA, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, FDA approval of the Company's
NDA for the treatment of metastatic ocular melanoma to the liver, adoption, use and resulting sales, if any, for the MelblezTM Kit in
the United States, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT Delivery System in the EEA, our ability to
successfully commercialize the Melblez/CHEMOSAT System in various markets and the potential of the system as a treatment for
patients with cancers in the liver, the timing and our ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets including Australia and key Asian markets and resulting sales, if any, from the same, patient
outcomes using the Generation 2 system, approval of the current or future system for other indications and/or for use with various
chemotherapeutic agents, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the
CHEMOSAT system in various markets, the number of cancer centers in Germany and Italy able to successfully negotiate and
receive reimbursement for the CHEMOSAT procedure and the amount of reimbursement to be provided, submission and publication
of the Phase II and III clinical trial data, the timing and results of research and development projects, the timing and results of future
clinical trials including the initiation of clinical trials in key Asian markets with the CHEMOSAT Hepatic Delivery System device for
intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin, approval of the CHEMOSAT Hepatic Delivery System to
delver and filter doxorubicin in key Asian markets and adoption, sales, if any, and patient outcomes using the same, the timing, price
and use, if any, of the committee equity financing facility with Terrapin, the timing and use, if any, of the line of credit from SVB and
our ability to access this facility, the timing and use, if any, of the At-the-Market financing program, and uncertainties regarding our
ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and
others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue
reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly
update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
3 DELCATH SYSTEMS, INC
US Market
• Proposed Trade Name
Melblez KitTM (Melblez (melphalan) for
Injection for use with the Delcath
Hepatic Delivery System)
Injection for use with the Delcath
Hepatic Delivery System)
• Proprietary Drug/Device Combination
Product Regulated as a drug 505(b)(2)
NDA by U.S. FDA
• Proposed initial indication for the
treatment of patients with unresectable
ocular melanoma metastatic to the liver
• Melblez Kit comprised of MelblezTM
(melphalan hydrochloride for injection)
and the Delcath Hepatic Delivery
System
Product Status
Ex US Markets
• Marketed under the trade name
CHEMOSAT® Hepatic Delivery
System
System
• Regulated as a Class IIb Medical
Device
• Indicated for the intra-hepatic of
administration of melphalan
hydrochloride and subsequent
filtration of the venous blood
return.
• CHEMOSAT Kit supplied without
melphalan
4 DELCATH SYSTEMS, INC
How the Combination Product Works
Filters
Veno-veno
Bypass Pump
Bypass Pump
3. Filters
2. Blood and melphalan
collected in IVC as they
collected in IVC as they
exit liver via hepatic
veins
veins
1. Melphalan
Administration
directly into
Hepatic Artery
blood flow
Administration
directly into
Hepatic Artery
blood flow
4. Filtered Blood returned
to systemic circulation via
jugular vein
jugular vein
5 DELCATH SYSTEMS, INC
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2001
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2002
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2003
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2004
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2005
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2006
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2007
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2008
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2009
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2010
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2011
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2012
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2013
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2014
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2015
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2016
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Clinical Program
Phase I
Unresectable
hepatic tumors
Unresectable
hepatic tumors
N=34 PHP
Phase II
Unresectable hepatic tumors
Unresectable hepatic tumors
N=56 PHP
Phase III
Melanoma
Melanoma
N=93 44 PHP, 49 BAC
OS Follow-up
EAP Program
Melanoma
EU
Retro-
Registry
EU Propsective Registry
Phase III
Hepatocellular Carcinoma
6 DELCATH SYSTEMS, INC
ODAC – U.S. NDA Still Under Review
• Oncology Drug Advisory Committee (ODAC) negative vote based on
Gen 1 Data
Gen 1 Data
• NDA filing included:
o Gen 2 filter contained in the Chemistry, Manufacturing and Control
(CMC) module as a technical change
(CMC) module as a technical change
• Waiting for FDA Clarification of what additional Gen 2 clinical data is
required
required
o Actively collecting Gen 2 Clinical Data
§ US EAP (melanoma)
§ EU Retrospective & Prospective Registries (mixed
histologies)
histologies)
• PDUFA Goal Date: September 13, 2013
• Initial indication: seeking unresectable metastatic ocular melanoma in
the liver
the liver
FDA Decision Expected in September
7 DELCATH SYSTEMS, INC
ODAC Patient Letter
8 DELCATH SYSTEMS, INC
ODAC Briefing Materials Available on Website
9 DELCATH SYSTEMS, INC
Phase 2 NCI Trial – Hepatobiliary Carcinoma Cohort
• Best hepatic tumor response by modified RECIST assessed by investigators
o Partial response (PR) 1 patient
o Stable disease (SD) 4 patients
o Progressive disease 1 patient
o Not assessed or evaluable 2 patients
• Median duration of response
o hPR (N=1) 6.42 months
o hPR/SD (N=5) 8.12 months
• Hepatic progression free survival (ITT N=8)
o Median 5.60 months
o Minimum, Maximum 2.7, 12.2 months
• Overall survival (ITT N=8)
o Median 9.12 months
o Minimum, Maximum 3.4, 20.5 months
• HCC is the most common primary cancer of the liver, with approximately 750,000* new
cases diagnosed worldwide annually
cases diagnosed worldwide annually
• Intend to initiate new Phase 3 trial in HCC in 2013
o Met with FDA and obtained feedback on trial design
Encouraging Positive Signal for Primary Liver Cancer
*Source: GLOBOCAN
10 DELCATH SYSTEMS, INC
HCC Opportunity
• Large U.S. & Global Market
• Liver centric disease, liver centric treatment
• Unmet need in 2L therapies
• Clinical Trial Design:
o Gen 2 Filter
o OS primary endpoint
o No Crossover – clear OS data
o QoL data collection
• Expect Improved Safety over P2 & P3 trials:
o P2 & P3 Protocol amendments, REMS training, and Gen 2
CHEMOSAT System are demonstrating significantly improved
safety in US EAP and EU Commercial Use
CHEMOSAT System are demonstrating significantly improved
safety in US EAP and EU Commercial Use
11 DELCATH SYSTEMS, INC
HCC – Global Market Opportunity Estimate
Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assume 2.5 treatments per patient.
2) US Assumes ASP of ~$75K USD
3) EU Assumes ASP of ~$15K USD; mix of direct/distributor pricing
4) APAC Assumes ASP of ~$5K USD; device only
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Market
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# Patients
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Potential #
Procedures |
Potential Market
($MM)1,2,3 |
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United States
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5,586
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13,964
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$ 1,047
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Europe
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7,671
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19,177
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$277
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APAC
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99,749
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249,373
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$ 1,156
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TOTAL
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113,006
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282,514
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$2,480
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Attractive U.S. & Global HCC Market Opportunity
12 DELCATH SYSTEMS, INC
US Market by Disease – Device and Drug Combination
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Liver Metastasis
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Potential Market
# Patients
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Potential Market
# Procedures
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Potential Market
($MM)1,2,3 |
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Ocular
Melanoma
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1,685
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4,213
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$ 300
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HCC (Primary)
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5,586
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13,964
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$ 1,047
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CRC
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19,861
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49,653
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$ 1,241
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NET
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8,212
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20,530
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$ 513
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Cutaneous
Melanoma
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7,023
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17,557
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$ 439
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TOTAL
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42,367
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105,917
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$ 3,540
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Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assume 2.5 treatments per patient.
2) Assume ASP of $75K for Ocular Melanoma/HCC (estimated orphan drug pricing)
3) Assume ASP of $25K in Cutaneous Melanoma, CRC, NET
13 DELCATH SYSTEMS, INC
Europe Market by Disease – Device Only
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Germany
(Direct)
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UK
(Direct)
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France
(Indirect)
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Italy
(Indirect)
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Spain
(Indirect)
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Netherlands
(Direct)
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Ireland
(Direct) |
Total
Potential (patients)
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Potential
Market ($ MM)1,2,3
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Total Potential Market #Patients
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Ocular
Melanoma |
404
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297
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295
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285
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197
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79
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19
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1,576
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$ 62
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Cutaneous
Melanoma |
1,625
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994
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753
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801
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360
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379
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73
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4,987
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$ 206
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HCC
(Primary) |
1,637
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720
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1,514
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2,597
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1,087
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82
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35
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7,671
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$277
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CRC
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9,902
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5,300
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5,475
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7,281
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4,016
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1,644
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335
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33,953
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$1,339
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NET
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1,783
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1,336
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1,353
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1,299
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974
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360
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98
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7,202
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$ 281
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TOTAL
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15,351
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8,647
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9,389
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12,263
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6,634
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2,545
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560
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55,389
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$ 2,166
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Europe Presents Significant Potential Market Opportunity
Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assumes 2.5 treatments per patient.
2) Assumes ASP of ~$15K USD.
3) Assumes mix of direct sales and distributors.
14 DELCATH SYSTEMS, INC
APAC Market by Disease
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China
(Device)
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S. Korea
(Device)
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Japan
(Device)
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Taiwan
(Device)
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Australia
(Device)
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Total
Potential (patients)
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Potential
Market ($MM)1,2
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|||||||
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Total Potential Market #Patients
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|||||||
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HCC
(Primary) |
85,780
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3,258
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8,296
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2,152
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263
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99,749
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$ 1,156
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Other
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|||||||
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CRC
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31,127
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3,245
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14,298
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1,441
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2,031
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52,143
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$ 642
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NET
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29,197
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1,048
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2,759
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500
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462
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33,966
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$ 393
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Ocular
Melanoma |
1,765
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66
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175
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31
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96
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2,134
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$ 25
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Cutaneous
Melanoma |
382
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43
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136
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246
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1,144
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1,951
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$ 23
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OTHER
TOTAL |
62,472
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4,403
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17,368
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2,218
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3,733
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90,194
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$ 1,083
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TOTAL
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148,104
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7,661
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25,665
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4,370
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3,996
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189,943
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$ 2,239
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APAC Target Markets Represent Over $2 Billion Potential Market Opportunity
Sources: LEK Consulting, GLOBOCAN, Company estimates.
1) Assume 2.5 treatments per patient.
2) Estimated ASP of ~$5K.
15 DELCATH SYSTEMS, INC
2013 Clinical Development Plan
Hepatocellular carcinoma (HCC) Trial Design:
Global Phase 3 Randomized (1:1)
CHEMOSAT/MELBLEZ Melphalan vs. best supportive
care (BSC) for patients who have failed Sorafenib (or
are intolerant due to unacceptable toxicity)
CHEMOSAT/MELBLEZ Melphalan vs. best supportive
care (BSC) for patients who have failed Sorafenib (or
are intolerant due to unacceptable toxicity)
– Primary endpoint: Overall Survival w/no crossover
– Secondary endpoints: hPFS, hORR, extra-hepatic PFS
– Exploratory analysis: QoL
• Planned, small phase 2 studies including Investigator-
initiated trials (IITs) in multiple indications: HCC, NET, CRC,
Melanoma
initiated trials (IITs) in multiple indications: HCC, NET, CRC,
Melanoma
Establish PHP/Melphalan as Standard of Care (SOC) for Disease Control in the Liver
16 DELCATH SYSTEMS, INC
Additional Clinical Data Generation
• Goals:
§ Expand US (PHP: MEL) label indications beyond the initial
indication we are seeking
indication we are seeking
§ Generate robust clinical data to support commercialization
• FDA has accepted IND Amendment that includes Gen 2 device
in US Expanded Access Program (EAP), compassionate use
(CU), and all future clinical trials
in US Expanded Access Program (EAP), compassionate use
(CU), and all future clinical trials
• Initiated US EAP with Gen 2 to treat first patient in January,
2013; 2 patients treated (1 twice), 4 additional currently
scheduled
2013; 2 patients treated (1 twice), 4 additional currently
scheduled
• Activate EU Registries to systematically collect Gen 2 data from
commercial experience
commercial experience
• Include Taiwan Partner Chi Fu in Global HCC P3 trial
Establish PHP/Melphalan as Standard of Care (SOC) for Disease Control in the Liver
17 DELCATH SYSTEMS, INC
Publications: Abstracts Accepted in 2012
• Over 20 Abstracts Accepted and Presented in 2012
Ø Moeslein F. Chemosaturation therapy - evolution, clinical
experience and applications.
experience and applications.
Ø Deneve JL. Percutaneous hepatic perfusion for unresectable
metastatic sarcoma to the liver.
metastatic sarcoma to the liver.
Ø Wood B. Isolated liver perfusion.
Ø Zager J. Chemosaturation therapy with percutaneous hepatic
perfusions of melphalan versus standard of care in patients
with hepatic metastases from melanoma: A randomized
multicenter phase 3 study.
perfusions of melphalan versus standard of care in patients
with hepatic metastases from melanoma: A randomized
multicenter phase 3 study.
Ø Ferrucci P. Chemosaturation therapy as part of patient
management: an oncologist's perspective.
management: an oncologist's perspective.
Ø Orsi F. First European center experience with chemosaturation:
an IR's perspective.
an IR's perspective.
Ø Vogl TJ. Chemosaturation therapy: an Interventional
Radiologist's perspective on where it fits now and in the future.
Radiologist's perspective on where it fits now and in the future.
Ø Ferrucci P. Chemosaturation therapy with percutaneous
hepatic perfusion (CS-PHP) for unresectable hepatic
metastases: the European Institute of Oncology (EIO)
Experience.
hepatic perfusion (CS-PHP) for unresectable hepatic
metastases: the European Institute of Oncology (EIO)
Experience.
Ø Moeslein F. Chemosaturation with percutaneous hepatic
perfusions: vasopressor, nitroglycerin, and pre-embolization
requirements
perfusions: vasopressor, nitroglycerin, and pre-embolization
requirements
Ø Moeslein F. Chemosaturation with percutaneous hepatic
perfusions (CS-PHP): Utilization of vasopressors, nitroglycerin,
and pre-embolization
perfusions (CS-PHP): Utilization of vasopressors, nitroglycerin,
and pre-embolization
Ø Moeslein F. Chemosaturation using percutaneous hepatic perfusion: pre-
embolization of GI branches in a phase 3 clinical trial.
embolization of GI branches in a phase 3 clinical trial.
Ø Alexander HR. Percutaneous hepatic perfusion (PHP or CHEMOSAT®) with
melphalan versus best alternative care in patients with hepatic
metastases from melanoma: A post-hoc analysis of PHP-randomized vs
BAC-to-PHP crossover vs BAC-only pts.
melphalan versus best alternative care in patients with hepatic
metastases from melanoma: A post-hoc analysis of PHP-randomized vs
BAC-to-PHP crossover vs BAC-only pts.
Ø Gardner ER. Pharmacokinetic analysis of Percutaneous Hepatic Perfusion
(PHP) of melphalan in patients with hepatic metastases from melanoma.
(PHP) of melphalan in patients with hepatic metastases from melanoma.
Ø Alexander HR. Hepatic perfusion (CHEMOSAT® or CS-PHP) of melphalan
vs. best alternative care in patients with hepatic metastases from
melanoma: Update of a randomized phase 3 study.
vs. best alternative care in patients with hepatic metastases from
melanoma: Update of a randomized phase 3 study.
Ø Gardner ER. Percutaneous hepatic perfusion (CHEMOSAT® or CS-PHP) of
melphalan in patients with hepatic metastases from melanoma: Phase III
pharmacokinetic analysis
melphalan in patients with hepatic metastases from melanoma: Phase III
pharmacokinetic analysis
Ø Testori A. Chemosaturation therapy with percutaneous hepatic perfusion
(CS-PHP) for unresectable hepatic metastases: the European Institute of
Oncology (EIO) Experience
(CS-PHP) for unresectable hepatic metastases: the European Institute of
Oncology (EIO) Experience
Ø Gardner ER. Pharmacokinetic Analysis of Percutaneous Hepatic Perfusion
of Melphalan in Patients with Hepatic Metastases from Melanoma
of Melphalan in Patients with Hepatic Metastases from Melanoma
Ø Orsi F. Role of regional therapies compared with advances in systemic
treatment for melanoma
treatment for melanoma
18 DELCATH SYSTEMS, INC
New Publications in 2012
• Deneve, Jeremiah L., et al. "Chemosaturation with Percutaneous Hepatic Perfusion for
Unresectable Isolated Hepatic Metastases from Sarcoma." Cardiovasc Intervent
Radiol (2012)
Unresectable Isolated Hepatic Metastases from Sarcoma." Cardiovasc Intervent
Radiol (2012)
• Leong, Stanley PL, et al. "Progression of Cutaneous Melanoma: Implications for
Treatment." Clin Exp Metastasis (2012)
Treatment." Clin Exp Metastasis (2012)
19 DELCATH SYSTEMS, INC
A Glimpse of 2013 Publications Thus Far
• Publications
o Uzgare RP, et al. Evaluation of
melphalan, oxaliplatin, and paclitaxel in
colon, liver, and gastric cancer cell lines
in a short-term exposure model of
chemosaturation therapy by
percutaneous hepatic perfusion.
Anticancer Research. 2013;33:1989-
2000.
melphalan, oxaliplatin, and paclitaxel in
colon, liver, and gastric cancer cell lines
in a short-term exposure model of
chemosaturation therapy by
percutaneous hepatic perfusion.
Anticancer Research. 2013;33:1989-
2000.
o Rofo German publication – submission
pending
pending
20 DELCATH SYSTEMS, INC
2013 Abstracts
• Abstracts presented in Q1 2013
• Other accepted abstracts to be presented
o Forster M. Percutaneous hepatic perfusion for unresectable melanoma or sarcoma to the
liver: a single institution experience.
liver: a single institution experience.
o Testori A. Chemosaturation therapy with percutaneous hepatic perfusion for
unresectable liver metastases: the European Institute of Oncology (EIO) experience.
unresectable liver metastases: the European Institute of Oncology (EIO) experience.
o Ferrucci P. Chemosaturation with percutaneous hepatic perfusions (CS-PHP) of melphalan
for hepatic metastases: a comparison between old and new-generation high-efficiency
filters. CIRSE 2013
for hepatic metastases: a comparison between old and new-generation high-efficiency
filters. CIRSE 2013
21 DELCATH SYSTEMS, INC
2013 Planned Publications
• Agarwala, et al. “Treatment of Melanoma Liver Metastases:
Impact on Overall Survival” Under Review
Impact on Overall Survival” Under Review
• Ferrucci, et al. “Experience with Generation 1 Filters vs
Generation 2 Filters” Under Review.
Generation 2 Filters” Under Review.
• Alexander, et al. “Review of Percutaneous Hepatic Perfusion
for Ocular Melanoma Liver Metastases” To be published in
American Oncology and Hematology
for Ocular Melanoma Liver Metastases” To be published in
American Oncology and Hematology
• Zager, J. “Moffitt Cancer Center Experience with PHP”,
submission pending
submission pending
• Phase III and Phase II Publications – final stages of review
22 DELCATH SYSTEMS, INC
CHEMOSAT: EU Commercial Launch Underway
• Marketing in target EU countries – Italy, Germany, France,
UK, Ireland, NL, Spain
UK, Ireland, NL, Spain
• Training completed in key centers
o Nine EU Clinical Sites activated as of March, 2013
• EU clinicians using CHEMOSAT for a broad range of liver
metastases
metastases
o Use includes: cutaneous melanoma, ocular melanoma, colorectal cancer
(CRC), gastric cancer, breast cancer, neuroendocrine tumor (NET),
hepatocellular carcinoma (HCC) and Cholangiocarcinoma
(CRC), gastric cancer, breast cancer, neuroendocrine tumor (NET),
hepatocellular carcinoma (HCC) and Cholangiocarcinoma
• EU reimbursement: work in progress
o Italy – Existing DRG for partial reimbursement identified; supplemental
reimbursement applications submitted
reimbursement applications submitted
o Germany – Value 4 NUB interim reimbursement pathway granted February 2013
o UK – Reimbursement anticipated Q2 2013
23 DELCATH SYSTEMS, INC
Active CHEMOSAT Centers in Europe
• Milan, Italy – European Institute of Oncology (IEO)
• Frankfurt, Germany – Johann Wolfgang Goethe-Universität (JWG)
• Villejuif, France – Cancer Institute Gustave Roussy (IGR)
• Bordeaux, France – Hôpital Saint-André (St Andre)
• Galway, Ireland – University Hospital Galway (UHG)
• Southampton, United Kingdom – Southampton University Hospital (SUH)
• Göttingen, Germany – University Medical Center Göttingen (UMG)
• Varese, Italy – Varese University Hospital (VUH)
• Amsterdam, The Netherlands – Netherlands Cancer Institute- Antoni van
Leeuwenhoek Hospital (NKI)
Leeuwenhoek Hospital (NKI)
24 DELCATH SYSTEMS, INC
CHEMOSAT: Multiple Tumor Types Treated in Europe
• Physicians are recognizing the potential of CHEMOSAT in various tumor types
• CHEMOSAT utilized in Germany, Italy, UK, France, Ireland, and the Netherlands
• EU Retrospective Data Collection to be initiated in Q2
• EU Prospective Registry To Be Initiated Q3
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Germany
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The
Netherlands |
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The
Netherlands |
kanker-actueel.nl
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Italy
25 DELCATH SYSTEMS, INC
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Fondazione Melanoma
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26 DELCATH SYSTEMS, INC
EU Coverage – Excerpts
27 DELCATH SYSTEMS, INC
Financial Update
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Cash & Cash Equivalents:
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$42.8 million at March 31, 2013
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ATM Program
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up to $50.0 million available
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Committed Equity Financing
Facility (CEFF) |
Up to $23.9 million as of March 31, 2013
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Working Capital Line of Credit:
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$20 million credit facility
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Debt:
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None
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Cash Utilization:
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$11.3 million in 1Q 2013
Projected quarterly cash spend:
$9-$12 million for first half of 2013
$9-$10 million for Q3 2013
$6-$8 million for Q4 2013
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Shares Outstanding:
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96.8 million (107.8 million fully diluted1,2) as of
March 31, 2013 |
1) Fully diluted includes an additional 5.6 million options and 5.4 million warrants
2) Includes 5.6 million shares issued to Terrapin Opportunity L.P. on April 1, 2013
Multiple Capital Resources Available to Execute Plan
* DELCATH SYSTEMS, INC
© 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED