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): November 18, 2014
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
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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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.
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Description
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99.1
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Delcath Systems, Inc. Investor 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: November 18, 2014
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By:
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/s/ Barbra Keck
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Name:
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Barbra Keck
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Title:
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Vice President, Controller
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EXHIBIT INDEX
Exhibit No.
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Description
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99.1
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Delcath Systems, Inc. Investor Presentation Slides
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2 DELCATH SYSTEMS, INC
Forward-looking Statements
This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future
events and future financial performance which include statements about our expectations, beliefs, plans, objectives,
intentions, goals, strategies, assumptions and other statements that are not historical facts. Forward-looking statements
are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which
could cause actual results to differ materially from expected results, performance or achievements expressed or implied
by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements
for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials
including without limitation the OM, HCC, ICC, and mCRC trials in the Company’s Clinical Development Program, clinical
adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for
the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to
successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for
patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's
Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the
Melphalan/HDS system by the US FDA, approval of the current or future Melphalan/HDS system for delivery and filtration
of melphalan or other chemotherapeutic agents for various indications in the US and/or in foreign markets, actions by the
FDA or other foreign regulatory agencies, our ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and
results of research and development projects, and uncertainties regarding our ability to obtain financial and other
resources for any clinical trials, research, development, and commercialization activities. These factors, and others, are
discussed from time to time in our filings with the Securities and Exchange Commission including the section entitled
‘‘Risk Factors’’ in our most recent Annual Report on Form 10-K and our Reports on Form 10-Q and Form 8-K.
3 DELCATH SYSTEMS, INC
Why Invest in Delcath?
• We are a clinical company with early commercial activity in Europe
focused on cancers of the liver
• Cancers of the liver represent a multi-billion dollar global market and
an unmet medical need
• Broad and Informed clinical development program
o Multiple clinical trials: OM, HCC, ICC
o Prior FDA experience provides roadmap for clinical programs
• Demonstrated efficacy
o >225 clinical and commercial patients across multiple tumor types
o Efficacy and QoL benefit shown as reported by patients and physicians
o Three recent scientific presentations at ESSO meeting highlighted
efficacy and safety
• Demonstrated safety
o We believe EU commercial experience provides confidence safety can be
validated in controlled clinical setting
Large Market Opportunity, Demonstrated Efficacy, Near-term Value Drivers
4 DELCATH SYSTEMS, INC
Near-term Milestones to Create Value
Multiple milestones within next 12 months
•2014
o Phase 3 publication submitted by year-end
o ICC cohort open for enrollment by year-end
o EU Registry open for enrollment by year-end
•2015
o Interim analysis - first 11 HCC patients by mid-year
o Go/no-go decision on ICC program by mid-year
o Initiation of Phase 3 ocular melanoma program by mid-year
o NUB reimbursement decision in Germany by February 1, 2015
•Experienced team to achieve milestones
Obtaining Data in Multiple Tumor Types
6 DELCATH SYSTEMS, INC
Potential Applications
Unresectable
Hepatocellular
Carcinoma (HCC)
(76,000 Cases
Diagnosed in US/EU
Annually)
Ocular Melanoma
(OM) Liver
Metastases
( ~4,000 Cases
Diagnosed in US/EU
Annually)
Intra-hepatic
Cholangiocarcinoma (ICC)
(~11,500 Cases Diagnosed
in US/EU Annually)
Colorectal Cancer Liver
Metastases (mCRC)
(~65,000 Cases Diagnosed
in US/EU Annually)
Liver Cancers: Multi-Billion Dollar Global Market
Sources: ACS, SEER, NIH, OMF, KOL Interviews, 3rd Party Analysis
11 DELCATH SYSTEMS, INC
OM Rationale
• OM has high incidence of liver metastases
o Up to 90% of patients with metastases will have liver involvement
o Life expectancy of approximately 6 months
o ~7,500 cases of OM liver metastases diagnosed in US and EU annually
• Clear efficacy signal seen in prior P3 trial of Melphalan/HDS
• Currently no standard of care
5,700-8,600
Cases of Ocular
Melanoma
~50-55%
Metastasize
~90%
Show Liver Mets
~2,600 - 4,300
Eligible Patients
Limited TX Options
US/EU Market Size
*Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3rd Party
Analysis
12 DELCATH SYSTEMS, INC
Intent-to-Treat Analysis (June 2012)
§ 5.3 mos improvement in hPFS
§ Hazard ratio = 0.50
§ (95% CI 0.31-0.80)
§ P=0.0029
Months
7.0
1.7
1.0
1.0
0.8
0.8
0.6
0.6
0.4
0.4
0.2
0.2
0.0
0.0
Proportion of patients surviving
5.3 mo
Chemosaturation (CS-PHP)
Previous Ocular Melanoma Phase 3 Results
0
0
5
5
10
10
15
15
20
20
25
25
30
30
Best alternative care (BAC)
Hepatic Progression Free Survival (hPFS)
Chemosaturation (CS-PHP)
§ 3.8 mos improvement in PFS
§ Hazard ratio = 0.42
§ (95% CI 0.27-0.64)
§ P<0.0001
Overall Progression Free Survival (Investigator)
Proportion of patients surviving
Months
5.4
1.6
1.0
1.0
0.8
0.8
0.6
0.6
0.4
0.4
0.2
0.2
0.0
0.0
3.8 mo
Intent-to-Treat Analysis (June 2012)
Best alternative care (BAC)
0
0
5
5
10
10
15
15
20
20
25
25
30
30
35
35
40
40
45
45
50
50
55
55
13 DELCATH SYSTEMS, INC
HCC Rationale
76,000
~90%
HCC
~80-90%
Unresectable
~20-30%
Child Pugh Class A
~7,600 - 14,700
Eligible Patients
~20-30%
Interventional
TX
US/EU Market Size
*Sources: WHO, KOL Interviews, 2014 3rd Party Analysis
• Significant opportunity in US and EU
o HCC most common primary cancer of the liver
o ~76,000* cases diagnosed annually
• Large unmet medical need in first line therapy
o Only one currently approved systemic therapy in US, EU, and certain
Asian markets
o ~90% of pts not candidates for surgical resection
o 20-30% of pts candidates for focal interventions
• Melphalan/HDS granted orphan drug status by FDA for treatment of patients
with unresectable HCC
15 DELCATH SYSTEMS, INC
Prior FDA Experience Provides Roadmap for Clinical Programs
• New Drug Application (NDA) submitted August 2012 seeking
indication in OM liver metastases
• ODAC meeting in May 2013
o Negative Vote
o Complete FDA & Delcath ODAC briefing materials available at
www.delcath.com/clinical-research/clinical-bibliography/
• Complete Response Letter (CRL) Issued September 2013
• FDA requests include, but not limited to:
o Well-controlled randomized trial(s) to establish the safety and
efficacy using the to-be-marketed device configuration
o Overall survival as the primary efficacy outcome measure
o Demonstrate clinical benefits outweigh risks
• Provides roadmap for clinical studies in any tumor type
16 DELCATH SYSTEMS, INC
Risks Observed in Previous Clinical Trials
• Risks observed using product and procedure protocol from Previous Clinical
Program
• Integrated safety population of patients showed risks associated with
Melphalan/ HDS to include:
o 4.1% incidence of deaths due to adverse reactions
o 4% incidence of stroke
o 2% reported incidence of myocardial infarction in the setting of an incomplete cardiac
risk assessment
o a ≥ 70% incidence of grade 4 bone marrow suppression with a median time of
recovery of greater than 1 week
o 18% incidence of febrile neutropenia, along with the additive risk of hepatic injury,
severe hemorrhage, and gastrointestinal perforation
o Deaths due to certain adverse reactions did not occur again during the
clinical trials following the adoption of related protocol amendments
o Reports from treating physicians in US and EU indicate improved safety
profile with improved device and procedure refinements
17 DELCATH SYSTEMS, INC
Why Do We Believe?
• Improved device and procedure since prior trials
o >130 EU treatments
o >20 treatments in US Expanded Access Program and
Compassionate Use cases
o Many issues raised at ODAC have not been reported
• EU patients report improved QoL
• Current device/procedure permitting multiple treatment cycles
• Recent scientific presentations at ESSO for OM from 3 centers in
US and EU
o University Southampton reported 47% of patients had a partial
response and 16% had a complete response
o Moffitt reported 67% of patients had a partial response. In addition,
one patient was reported to have a complete response
o Leiden reported 80% of patients had a partial response
Patients Benefiting from Melphalan/HDS
21 DELCATH SYSTEMS, INC
Summary
• Cancers of the liver represent a multi-
Billion dollar global market and unmet
medical need
• Demonstrated efficacy
o Phase 3 trial
o Recent presentations at ESSO
• >150 treatments with improved device
and procedure in US and EU
• Current device/procedure permitting
multiple treatment cycles
• Intend to initiate Phase 3 OM trial 2015
• Phase 2 HCC trial open for enrollment
• ICC cohort to open for enrollment by end
2014
§ Several milestones over next 12 months
§ Experienced team to help achieve
milestones in a cost efficient manner
Melphalan Hydrochloride for Injection for use with the
Delcath Hepatic Delivery System (Melphalan/HDS)
25 DELCATH SYSTEMS, INC
Publications
§ Alexander, R., et al. Current Status of Percutaneous Hepatic Perfusion as Regional Treatment for
Patients with Unresectable Hepatic Metastases: A Review, American Oncology and Hematology
Review 2014: 15-23
§ Vogl, et al. Chemosaturation with Percutaneous Hepatic Perfusions of Melphalan for Hepatic
Metastases: Experience from Two European Centers, Fortschr Röntgestr 2014
• H. Schulze-Bergkamen et al. Unresectable Isolated Hepatic Metastases from Solid
Pseudopapillary Neoplasm of the Pancreas: A Case Report of Chemosaturation with High-Dose
Melphalan, Pancreatology 2014
§ Forster M., et al. Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable
Metastatic Melanoma or Sarcoma to the Liver: A Single Institution Experience. Journal of Surgical
Oncology. 2013
§ Yamamoto M, Zager J. Isolated Hepatic Perfusion for Metastatic Melanoma. Journal of Surgical
Oncology. 2013
2014 ESSO Congress Presentations
§ A Single Institution Experience with Percutaneous Hepatic Perfusion for Unresectable Ocular
Melanoma and Sarcoma in the Liver---Moffitt Cancer Center, U.S.; J. Zager
§ Percutaneous Hepatic Perfusion with Melphalan in Treating Unresectable Liver Metastases from
Colorectal Cancer and Uveal (Ocular) Melanoma - Leiden University Medical Centre (LUMC), The
Netherlands; N. de Leede
§ Initial United Kingdom Experience with Melphalan Percutaneous Hepatic Perfusion (PHP) For
Treatment of Inoperable Ocular Melanoma Metastases---University Hospital Southampton, U.K; B.
Stedman