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): April 13, 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: April 13, 2015 | By: | /s/ Jennifer K. Simpson | ||||
| Jennifer K. Simpson | ||||||
| Interim President and Chief Executive Officer | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description of Exhibit | |
| 99.1 | Delcath Systems, Inc. Investor Presentation Slides | |
Exhibit 99.1
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Investor Presentation
(NASDAQ: DCTH)
April 2015
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Forward-looking Statements
This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future events and future financial performance which include statements about our expectations, beliefs, plans, objectives, intentions, goals, strategies, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to differ materially from expected results, performance or achievements expressed or implied by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials including without limitation the OM, HCC, ICC, and mCRC trials in the Company’s Clinical Development Program, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for patients with primary and metastatic disease in the liver, the Company’s ability to satisfy the requirements of the FDA’s Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the Melphalan/HDS system by the U.S. FDA, acceptance of the Phase 3 trial publication, the impact of the presentations at ESSO and SSO 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.
2DELCATH SYSTEMS, INC
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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
3DELCATH SYSTEMS, INC
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Investment Highlights
Late-stage asset – approved and initial commercial activities underway in EU; demonstrated clinically meaningful efficacy in more than 600 procedures and multiple tumor types
Active clinical program – initiating global Phase 3 study in ocular melanoma; HCC/ICC Phase 2 program ongoing
Unique, highly differentiated solution – orphan designations create
barriers to entry
Large market opportunity – cancers of the liver remain a multibillion-dollar unmet medical need; early commercial activity EU
Imminent valuation milestones – 2015 value drivers include publications, reimbursement and clinical data
Attractive business model – initial orphan focus and anticipated high gross margins form basis of profitable long-term model
Experienced management team – aligned with requirements of clinically driven pharmaceutical industry Believe We are Positioned to Capitalize on Large, Compelling Market Opportunity
4DELCATH SYSTEMS, INC
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2014-2015 Milestones
2014 Accomplishments
Phase 2 HCC trial open and first patient treated
100th 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 o ICC cohort open for enrollment
2H-2015
o Initiation of global Phase 3 metastatic ocular melanoma program o Interim evaluation on HCC/ICC program
Executing on Multiple Fronts to Create Value
5DELCATH SYSTEMS, INC
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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
Effective Liver Cancer Treatment Remains a Major Unmet Medical Need
* SOURCE – 2008 GLOBOCAN
6DELCATH SYSTEMS, INC
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Existing Liver Cancer Treatments Landscape
Treatment Advantages Disadvantages
Systemic – Non-invasive – Systemic toxicities
– Repeatable – Limited efficacy in liver
– Invasive/limited repeatability Regional – Therapeutic effect
– Multiple treatments are
(e.g., Isolated Hepatic Perfusion) – Targeted required but not possible
– Only 10%-20% are resectable
– Invasive and/or limited
Focal repeatability
(e.g., surgery, radioembolization, – Partial removal or – Treatment is limited by tumor chemoembolization, treatment of tumors size, number of lesions and radiofrequency ablation) location
– Tumor revascularization
– Cannot treat diffuse disease
Existing Liver Cancer Treatments Have Limitations
7DELCATH SYSTEMS, INC
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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
Concentrating the Power of Chemotherapy for Disease Control in the Liver
8DELCATH SYSTEMS, INC
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The Melphalan Hepatic Delivery System (HDS)
Liver Isolated Via Double Balloon Melphalan Infused Directly Into Liver Blood Exiting The Liver Filtered By
Catheter In IVC Via Catheter In Hepatic Artery Proprietary Extra-corporeal Filters
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.
More Than 300 Patients Treated To Date
9DELCATH SYSTEMS, INC
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Melphalan Dosing & Background
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
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
10DELCATH SYSTEMS, INC
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Total Available EU & U.S. Market Opportunity
Annual Revenue per Annual Potential
Cancer Type Incidence1 Eligible Pts2 Patient3 Market Opportunity
(millions)
Ocular Melanoma (OM) 5,700-8,600 2,600-4,300 $40,000-$50,000 $104-$215
Cholangio Carcinoma (ICC) 11,500 6,500 $40,000-$50,000 $260-$330
Hepatocellular Carcinoma (HCC) 64,500 7,600-14,700 $40,000-$50,000 $304-$735
Colorectal (CRC) 411,000 40,000-55,000 $40,000-$50,000 $1,600-$2,750
Total EU and US 492,700-495,600 56,700-80,500 $2,268-$4,030
Notes:
1) Source: Globocan, American Cancer Society
2) Source: LEK, Strategy&, Company estimates
| 3 |
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) Assumes an average of tw o treatments per patient |
Effective Liver Cancer Treatment Remains a Major Unmet Medical Need
11DELCATH SYSTEMS, INC
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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
12DELCATH SYSTEMS, INC
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Clinical Development Program Overview
Initiating global Phase 3 trial 2H 2015 in Ocular Melanoma (OM) Liver Mets
Establish proof-of-concept in Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC)
o Commenced global Phase 2 program in HCC in 2014 o Expanding program to include ICC cohort in EU trial
Initiating EU registry to collect efficacy and safety data in the commercial setting
Supporting Investigator Initiated Trials in HCC and in mCRC
Focused on Liver Dominant, Orphan Diseases With High Unmet Need
13DELCATH SYSTEMS, INC
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Clinical Development Program Detail
Trials Tumor Objectives
Global Phase 3 trial to start 2H-2015
Phase 3 Pivotal Trial OM liver mets Primary endpoint: Overall Survival (OS)
Believed to be fastest pathway to NDA approval in the U.S.
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
HCC Assess patient QoL
(unresectable
Phase 2 Trial confined to the Protocol 202 (EU only)
liver) 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 To be added to 202 HCC trial protocol
(unresectable ORR of melphalan/HDS treatment in patients with intra-hepatic
Phase 2 Cohort
confined to the cholangiocarcinoma (ICC)
liver) Other measures as specified in the 202 EU protocol
Signal-seeking go/no-go decision 2H—2015
Investigator Initiated mCRC University of Leiden study; ~6 patients treated to date
Trials Johannes Wolfgang Goethe University Hospital (Frankfurt) study; different
HCC
patient selection from 202 study; open for enrollment
Data collection on safety, QoL assessments
EU Commercial EU Commercial Potential efficacy signals in additional tumor types
Registry Cases Support reimbursement in key markets
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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
U.S./EU Market Size
5,700-8,600 ~50-55% ~90% ~2,600 – 4,300
Cases of Ocular mited TX Options
Melanoma Metastasize how Liver Mets Eligible Patients
Proven Efficacy in Attractive Orphan Opportunity
*Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3rd Party
15DELCATH SYSTEMS, INC Analysis
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Previous Ocular Melanoma Mets Phase 3 Results
Hepatic Progression Free Survival (hPFS)
Proportion of patients surviving
| 1.0 |
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5.3 mo Chemosaturation (CS-PHP) |
| 0.8 |
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Best alternative care (BAC) |
0.6
7.0
1.7
0.4
0.2
0.0
0 5 10 15 20 25 30
Months
Overall Progression Free Survival (Investigator)
Proportion of patients surviving
1.0
| 3.8 |
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mo Chemosaturation (CS-PHP) |
| 0.8 |
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Best alternative care (BAC) |
0.6
5.4
1.6
0.4
0.2
0.0
0 5 10 15 20 25 30 35 40 45 50 55
Months
Intent-to-Treat Analysis (June 2012) 4 subjects remain Intent-to-Treat Analysis (June 2012)
alive at 5-8 years
| 5.3 |
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mos improvement in hPFS 3.8 mos improvement in PFS |
Hazard ratio = 0.50 Hazard ratio = 0.42
(95% CI 0.31–0.80) (95% CI 0.27–0.64)
| p=0.0029 |
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p<0.0001 |
Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients
16DELCATH SYSTEMS, INC
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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 – Delcath will pursue a melphalan orphan drug designation from the FDA for patients with ICC
U.S./EU Market Size
76,000 ~15% ~20-30%
~90% ~6,500
HCC Diagnosis Of HCC Focal
Unresectable Eligible Patients
Cases Interventions
Encouraging Early Commercial Activity in Disease With Limited Treatment Options
*Sources: ACS, SEER, NIH, KOL Interviews, 2014 3rd Party Analysis
17DELCATH SYSTEMS, INC
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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
U.S./EU Market Size
76,000 90% ~80-90% ~20-30% ~20-30% ~7,600 – 14,700
Cases of Primary Liver HCC Unresectable Interventional ld Pugh Class A Eligible Patients
Cancer
TX
Large, Deadly Disease in Need of Better Treatments
*Sources: WHO, KOL Interviews, 2014 3rd Party Analysis
18DELCATH SYSTEMS, INC
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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 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
19DELCATH SYSTEMS, INC
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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
20DELCATH SYSTEMS, INC
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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
21DELCATH SYSTEMS, INC
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Positive Developments
Improved device and procedure since prior trials
o >200 treatments with improved device and procedure in U.S. and EU o Many issues raised at ODAC have not been reported
Current device/procedure permitting multiple treatment cycles
Recent scientific presentation at SSO 2015 from 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
Patients Report Improved Quality of Life
22DELCATH SYSTEMS, INC
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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
>170 commercial procedures performed in 15 leading cancer centers across the EU
Reimbursement via Individual Funding Requests; NUB Value 4 Status in Germany
UK Block Grants pending and private pay insurance
Published data in peer-reviewed journal needed to support reimbursement efforts in certain EU countries
23DELCATH SYSTEMS, INC
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CHEMOSAT® Commercial Treatments in Europe
Multiple Tumor Types Treated Since EU Launch
Treatments/Re-treatments Increasing
24DELCATH SYSTEMS, INC
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Cash & Capital Resources
Cash & Cash Equivalents $20.5 million at December 31, 2014
Debt None
ATM Program1 $40 million available at December 31, 2014
Shares Outstanding 12.2 million (14.4 million fully diluted2) at
March 31, 2015
Subject to market conditions and certain limitations
Fully diluted includes approximate 0.3 million options and 1.9 million warrants
2014 Operating Cash Spend (Unaudited)
Q1 A Q2 A Q3 A Q4 A FY A
Quarterly Guidance $ 5-6M $ 5-6M $ 4-5M $ 4-5M $16.5-17.5M
Quarterly Actual $4.5M $4.0M $4.0M $3.7M $16.2M
Focused Spending and Resources to Support Execution of Near-term Plan
25DELCATH SYSTEMS, INC
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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 EU
Compelling emerging data
Imminent valuation milestones
Attractive orphan drug business model
Experienced pharmaceutical management team executing a data-driven plan
26DELCATH SYSTEMS, INC
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Concentrating the Power of Chemotherapy TM
© 2015 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED
Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.