UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): September 3, 2015
Delcath Systems, Inc.
(Exact Name of Registrant Specified in Charter)
| Delaware | 001-16133 | 06-1245881 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) | ||
| 1301 Avenue of the Americas, 43rd Floor New York, New York |
10019 | |||
| (Address of Principal Executive Offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (212) 489-2100
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01. | Regulation FD Disclosure. |
A copy of Delcath Systems, Inc.’s updated investor presentation slides that the Company intends to use effective immediately is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description of Exhibit | |
| 99.1 | Delcath Systems, Inc. Investor Presentation Slides | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||
| Date: September 3, 2015 | By: | /s/ Jennifer K. Simpson | ||||
| Jennifer K. Simpson | ||||||
| President and Chief Executive Officer | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description of Exhibit | |
| 99.1 | Delcath Systems, Inc. Investor Presentation Slides | |
 Investor
Presentation (NASDAQ: DCTH)
September 2015 Exhibit 99.1 |
 2 DELCATH SYSTEMS, INC Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future events and future financial performance which include statements about our expectations, beliefs, plans, objectives, intentions, goals, strategies, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to differ materially from expected results, performance or achievements expressed or implied by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials including without limitation the OM, HCC, ICC, and mCRC trials in the Company’s Clinical Development Program, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the Melphalan/HDS system by the U.S. FDA, acceptance of the Phase 3 trial publication, the impact of presentations and abstracts at major medical meetings and congresses (SSO, ASCO, CIRSE, ESMO, EADO, RSNA) and future clinical results consistent with the data presented, approval of the current or future Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, our ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, and uncertainties regarding our ability to obtain financial and other resources for any clinical trials, research, development, and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission including the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on Form 10-K and our Reports on Form 10-Q and Form 8-K. |
 3 DELCATH SYSTEMS, INC About Delcath Systems • A specialty pharmaceutical and medical device oncology company with a principal therapeutic focus on the treatment of primary liver cancer and other cancers that have metastasized to the liver • Proprietary system isolates the liver from circulation, delivers a substantially
higher concentration of chemotherapy (melphalan) compared with systemic
doses, and filters most of the chemotherapy out of the blood prior to returning
it to the patient
• In late-stage clinical development in the U.S. with initial commercial activities
underway in Europe • Initially pursuing orphan indications in metastatic ocular melanoma, hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) Seeking to Make a Clinically Meaningful Difference For Cancer Patients With Liver Dominant Disease |
 4 DELCATH SYSTEMS, INC Investment Highlights Large, Compelling Market Opportunity • Late-stage asset –clinically
meaningful efficacy demonstrated in >600 procedures and in multiple tumor types • Active clinical program – initiating global Phase 3 study in ocular melanoma; HCC/ICC Phase 2 program ongoing • Unique, highly differentiated solution – multiple orphan designations create barriers to entry • Early stage commercialization in EU – >200 procedures performed in EU with 2nd Generation product and protocol • Imminent valuation milestones – 2015 value drivers include publications, reimbursement and clinical data • Attractive business model –initial
orphan focus and anticipated high gross margins form basis of profitable long-term model • Experienced management team – aligned with requirements of clinically driven pharmaceutical industry |
 5 DELCATH SYSTEMS, INC 2014-2015 Milestones 2014 Accomplishments Phase 2 HCC trial open and first patient treated 100 patient treated in Europe (commercial and clinical) Positive efficacy data from three institutions presented at ESSO 2014 Product revenue increased 118% Y/Y to $1.1 million Cash burn reduced by 50% Y/Y 1H-2015 NUB reimbursement decision in Germany – Value 4 awarded for 2015 Submit Phase 3 metastatic melanoma trial results for publication EU registry open for enrollment ICC cohort open for enrollment 2H-2015 • Initiation of global Phase 3 metastatic ocular melanoma program • Interim evaluation on HCC/ICC program Executing on Multiple Fronts to Create Value th |
 6 DELCATH SYSTEMS, INC The Liver: A Life-Limiting Organ • Cancers of the liver remain a major unmet medical need o Large global patient population – approximately 1.2 million* patients diagnosed annually with primary or metastatic liver cancer o The liver is often the life-limiting organ for cancer patients and one of the
leading causes of cancer death
o Prognosis after liver involvement is poor, with overall survival generally less than 12 months • CHEMOSAT ® Melphalan/HDS is a proprietary product uniquely positioned to potentially treat the entire liver as a standalone or complementary therapy * SOURCE – 2008 GLOBOCAN Effective Liver Cancer Treatment Remains a Major Unmet Medical Need |
 7 DELCATH SYSTEMS, INC Whole Organ-Focus Disease Control Our Solution • Our proprietary system isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan) and filters most of the chemotherapy out of the blood prior to returning it to the patient • The procedure typically takes approximately 2-3 hours to complete and involves a team including the interventional radiologist, oncologist, anesthesiologist and perfusionist • We believe more than 200 treatments with improved device and procedure provide confidence safety can be validated in a controlled setting |
 8 DELCATH SYSTEMS, INC Existing Liver Cancer Treatments Landscape Existing Liver Cancer Treatments Have Limitations Treatment Advantages Disadvantages Systemic – Non-invasive – Repeatable – Systemic toxicities – Limited efficacy in liver Regional (e.g., Isolated Hepatic Perfusion) – Therapeutic effect – Targeted – Invasive/limited repeatability – Multiple treatments are required but not possible Focal (e.g., surgery, radioembolization, chemoembolization, radiofrequency ablation) – Partial removal or treatment of tumors – Only 10%-20% are resectable – Invasive and/or limited repeatability – Treatment is limited by tumor size, number of lesions and location – Tumor revascularization – Cannot treat diffuse disease |
 9 DELCATH SYSTEMS, INC The Melphalan Hepatic Delivery System (HDS) Liver Isolated Via Double Balloon Catheter In IVC Melphalan Infused Directly Into Liver Via Catheter In Hepatic Artery Blood Exiting The Liver Filtered By Proprietary Extra-corporeal Filters Improved Product & Procedure in Use Since 2012 • Device designed to administer high-dose chemotherapy to the liver while reducing
systemic exposure • Marketed as Delcath Hepatic CHEMOSAT Delivery System (device only) in EU • Investigational drug/device combination product regulated as a drug in the U.S.
® |
 10 DELCATH SYSTEMS, INC Melphalan Dosing & Background • Well-understood, dose-dependent, tumor-preferential, alkylating cytotoxic agent
that demonstrates little to no hepatic toxicity
• Dose administered directly to liver is substantially higher than that of systemic IV
chemotherapy • Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity An Established Drug for Liver Cancer Therapy Type Dosing (mg/kg) Multiple Myeloma (label) 0.25 Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion (IHP) 1.50 Myeloablation 2.50-3.50 Melphalan/HDS (PHP) 3.00 |
 11 DELCATH SYSTEMS, INC Total Available EU & U.S. Market Opportunity Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need |
 12 DELCATH SYSTEMS, INC European Commercial Activity CHEMOSAT Hepatic Delivery System • Approved as Class Ilb Medical Device; kit supplied without melphalan • Broad indication for intra-hepatic administration of melphalan hydrochloride and subsequent filtration of the venous blood return • >200 commercial procedures performed in leading cancer centers across the EU • Reimbursement via Individual Funding Requests; NUB Value 4 Status in Germany • UK private pay insurance; block grants pending • 2015 YTD EU Sales exceed 2014 on local currency basis ® |
 13 DELCATH SYSTEMS, INC Growing Body of Clinical Support for CHEMOSAT EU KOL Forum affirms benefits to liver cancer patients o 4 TX being administered; shown to be safe and well tolerated o Providing clinical benefit and good QoL o Reimbursement continues to be covered through individual funding requests Abstracts Accepted at Major Medical Meetings o ESSO 2014 o SSO 2015 o ASCO 2015 o CIRSE 2015 o EADO 2015 o ESMO 2015 o RSNA 2015 |
 14 DELCATH SYSTEMS, INC Increasing & Expanding Clinical Utilization Utilization Expanding Into Other Tumor Types Beyond Ocular Melanoma |
 15 DELCATH SYSTEMS, INC Clinically Differentiated Results • Phase 1, 2 and 3 trials produced positive results in multiple histologies • Melanoma Liver Mets o Positive Phase 3 results in hepatic metastatic melanoma o n=93 (90% ocular melanoma, 10% cutaneous melanoma) • Neuroendocrine Tumor (NET) Liver Mets o mNET cohort in Phase 2 trial showed encouraging 42% objective response rate (ORR) vs. ~10% for approved targeted therapy o Median overall survival of ~32 months on ITT basis • Hepatocellular Carcinoma (HCC) o Positive signal with high-dose melphalan in HCC cohort of Phase 2 trial (5/8 patients)
is encouraging when approved systemic therapies have modest efficacy and
challenges with tolerability
• Colorectal Cancer (CRC) Liver Mets o Data from surgical Isolated Hepatic Perfusion (IHP) with melphalan indicates strong
potential in well-defined patient population with earlier stage CRC yielding
~50-60% median response rate and median OS of 17.4-24.8
mos Encouraging Initial Results on a Broad Range of
Histologies |
 16 DELCATH SYSTEMS, INC Clinical Development Program Trials Tumor Objectives Phase 3 Pivotal Trial OM liver mets Global Phase 3 trial
to start 2H-2015 Primary endpoint: Overall Survival (OS) Believed to be
fastest pathway to NDA approval in the U.S. Phase 2
Program HCC
(unresectable
confined to the
liver) Protocol 201 (U.S. only) Safety, efficacy of Melphalan/HDS treatment followed by sorafenib Evaluate ORR (mRECIST) Assess safety, PFS Characterize systemic exposure of melphalan Assess patient QoL Protocol 202 (EU only) Safety, efficacy of Melphalan/HDS treatment w/o sorafenib in patients with unresectable liver cancer Evaluate ORR (mRECIST) Assess safety, PFS Characterize systemic exposure of melphalan Assess patient QoL ICC (unresectable confined to the liver) Added to 202 HCC trial protocol ORR of Melphalan/HDS treatment in patients with intra-hepatic cholangiocarcinoma (ICC) Other measures as specified in the 202 EU protocol Signal-seeking go/no-go decision 2H-2015 Investigator Initiated Trials mCRC University of Leiden study; 10 patients treated to date HCC Johannes Wolfgang Goethe University Hospital (Frankfurt) study; different patient selection from 202 study; open for enrollment EU Commercial Registry EU Commercial Cases Open for enrollment; data collection on safety, QoL assessments Potential efficacy signals in additional tumor types Support reimbursement in key markets |
 ~2,600
– 4,300
Eligible Patients OM Metastases Rationale • OM has high incidence of liver metastases o Up to 90% of patients with metastases will have liver involvement o Life expectancy of approximately 6 months o 5,700 - 8,600 cases of OM liver metastases diagnosed in U.S. and EU annually • Clear efficacy signal seen in prior Phase 3 trial of Melphalan/HDS • Currently no standard of care • Believed to be fastest pathway to NDA approval in the U.S. • FDA granted Melphalan/HDS orphan drug designation for treatment of OM 5,700-8,600 Cases of Ocular Melanoma ~50-55% Metastasize ~90% Show Liver Mets Limited TX Options U.S./EU Market Size *Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3 Party Analysis Proven Efficacy in Attractive Orphan Opportunity rd 17 DELCATH SYSTEMS, INC |
 18 DELCATH SYSTEMS, INC Intent-to-Treat Analysis (June 2012) 5.3 mos improvement in hPFS Hazard ratio = 0.50 (95% CI 0.31–0.80) p=0.0029 Months 7.0 1.7 1 . 0 0 . 8 0 . 6 0 . 4 0 . 2 0 . 0 Proportion of patients surviving 5.3 mo Chemosaturation (CS-PHP) Previous Ocular Melanoma Mets Phase 3 Results 0 5 10 15 20 25 30 Best alternative care (BAC) Hepatic Progression Free Survival (hPFS) Chemosaturation (CS-PHP) 3.8 mos improvement in PFS Hazard ratio = 0.42 (95% CI 0.27–0.64) p<0.0001 Overall Progression Free Survival (Investigator) Proportion of patients surviving Months 5.4 1.6 1 . 0 0 . 8 0 . 6 0 . 4 0 . 2 0 . 0 3.8 mo Intent-to-Treat Analysis (June 2012) Best alternative care (BAC) 0 5 10 15 20 25 30 35 40 45 50 55 Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients
4 subjects remain alive at 5-8 years All were recipients of CS-PHP |
 19 DELCATH SYSTEMS, INC ICC Rationale • Significant market opportunity in U.S. and EU o ~15% of new HCC cases diagnosed annually o ~90% of patients are not suitable for surgical resection o ~20-30% are candidates for focal interventions o Efficacy signals from early commercial uses in EU • Unmet medical need – FDA granted melphalan orphan drug designation for patients with ICC Encouraging Early Commercial Activity in Disease With Limited Treatment Options
76,000 HCC Diagnosis ~90% Unresectable ~6,500 Eligible Patients U.S./EU Market Size ~15% Of HCC Cases ~20-30% Focal Interventions *Sources: ACS, SEER, NIH, KOL Interviews, 2014 3 Party Analysis rd |
 20 DELCATH SYSTEMS, INC HCC Rationale • Significant opportunity in the U.S. and EU o HCC most common primary cancer of the liver o ~76,000* cases diagnosed annually • Large unmet medical need in first-line therapy o Only one approved systemic therapy in the U.S., EU and certain Asian markets o ~90% of patients not candidates for surgical resection o 20-30% of patients are candidates for focal interventions • FDA granted Melphalan/HDS orphan drug designation for treatment of unresectable HCC 76,000 Cases of Primary Liver Cancer ~90% HCC ~80-90% Unresectable ~20-30% Child Pugh Class A ~7,600 – 14,700 Eligible Patients ~20-30% Interventional TX U.S./EU Market Size Large, Deadly Disease in Need of Better Treatments *Sources: WHO, KOL Interviews, 2014 3 Party Analysis rd |
 21 DELCATH SYSTEMS, INC Prior FDA Experience • New Drug Application (NDA) submitted August 2012 seeking indication in OM liver metastases with first-generation filter and procedure • ODAC meeting in May 2013 o Efficacy shown with statistical significance o Negative vote due to benefit/risk analysis o Complete FDA & Delcath ODAC briefing materials available at www.delcath.com/clinical-research/clinical-bibliography/ • Complete Response Letter (CRL) issued September 2013 • FDA requests include, but not limited to: o Well-controlled randomized trial(s) to establish the safety and efficacy using the to-be-marketed device configuration o Overall survival as the primary efficacy outcome measure o Demonstrate clinical benefits outweigh risks FDA Learnings Provide Beneficial Clinical Study Roadmap |
 22 DELCATH SYSTEMS, INC Risks Observed in Previous Clinical Program • Risks observed with prior product and procedure protocol • Integrated safety population of patients showed risks associated with melphalan/HDS included: o 4.1% incidence of death due to adverse reactions o 4% incidence of stroke o 2% reported incidence of myocardial infarction in the setting of an incomplete cardiac
risk assessment o 70% incidence of grade 4 bone marrow suppression with a median time of recovery
of greater than 1 week
o 18% incidence of febrile neutropenia, along with the additive risk of hepatic injury,
severe hemorrhage and gastrointestinal perforation
• Deaths due to certain adverse reactions did not occur again during the clinical
trials following the adoption of related protocol amendments
Treating Physicians in U.S. and EU Report Improved Safety Profile
|
 23 DELCATH SYSTEMS, INC Safety Improvements Implemented • New generation filter o Improve filter efficiency and consistency • Vasopressors and methylprednisolone o Reduce cardiovascular risk • Prophylactic transfusions and growth factors o Reduce risk of myelosuppression • Intra-arterial nitroglycerin o Prevent hepatic arterial spasm • Liver tumor burden not to exceed >50% o Address risk of liver failure Decisive Measures to Assure Improved Safety |
 24 DELCATH SYSTEMS, INC Recent Data Presentations - ASCO 2015 • Analysis of 20 ocular melanoma patients who received 34 treatments at Southampton University Hospital o Eleven patients remain alive after a median of 280 days with one complete response ongoing at >1 year o From the diagnosis of liver metastases, 11 patients (55%) survived to one year and
3 (15%) for >2 years; no procedure related deaths were seen
o ORR 85%: 2 patients (10%) demonstrated stable disease for >3 months, 13 patients (65%) had a partial response, 2 patients (10%) demonstrated complete response o Nine deaths from disease progression occurred after a median of 264 days from the first procedure • Adverse Events o Early AEs often expected with percutaneous hepatic perfusion (PHP) were observed including coagulopathy, electrolyte disturbances and transient transaminases (elevated liver enzymes). Rare late AEs (1 patient each) included hair loss, skin rash, myelosuppression and persistent transaminases (elevated liver enzymes) o AEs seen were grade 1 (n=12), 2 (n=13), 3 (n=5) and 4 (n=1) o Grade 4 complication was pulmonary edema due to fluid overload |
 25 DELCATH SYSTEMS, INC Recent Data Presentations - SSO 2015 • Moffitt Cancer Center (Tampa, FL) o Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated
with Melphalan/HDS (n=10), chemoembolization (CE, n=12), and yttrium-90 (Y90,
n=6) o Study showed significant difference in hepatic progression free survival (HPFS) for
Melphalan/HDS (310 days), CE (80 days), Y-90 (54 days)
o Median overall survival (OS) longest for Melphalan/HDS (736 days) vs Y90 (285 days) CE (265 days), but did not reach statistical significance o Authors concluded that HPFS and progression free survival (PFS) were significantly prolonged with Melphalan/HDS vs CE and Y90 • Additional abstracts accepted for presentation at CIRSE, ESMO, EADO & RSNA in fall 2015 |
 26 DELCATH SYSTEMS, INC Cash & Capital Resources Cash & Cash Equivalents $19.1 million at July 31, 2015 Debt None ATM Program $40 million available at July 31, 2015 Shares Outstanding 21.8 million (40.7 million fully diluted ) at July 31, 2015 1) Subject to market conditions and certain limitations 2) Fully diluted includes approximately 0.8 million options and 18.1 million warrants
Focused Spending and Resources to Support Execution of Near-term Plan
2 1 |
 27 DELCATH SYSTEMS, INC In Summary • Attractive multi-billion dollar orphan drug business model • Unique, highly differentiated solution • Late-stage asset in U.S. with active clinical development program • Early commercial activity in EU with increasing sales/procedure volumes • Compelling emerging data • Imminent valuation milestones • Experienced pharmaceutical management team executing a data-driven plan |
 28 DELCATH SYSTEMS, INC © 2015 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc. |