EX-99.1 2 d497990dex991.htm EX-99.1

Exhibit 99.1

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 outcome of the ODAC meeting, and the impact, if any, of the advisory panel’s recommendation on the FDA’s decision regarding the Company’s new drug application (NDA), uncertainties relating to: timing of completion of the FDA’s review of our NDA, the extent to which the FDA may request additional information or data and our ability to provide the same in a timely manner, 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 Delcath Hepatic Delivery System 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 Delivery 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 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 Investment Considerations Concentrating the Power of Chemotherapy • Commercial stage company focused on oncology • Proprietary CHEMOSAT ® Hepatic Delivery System allows unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need for cancer patients who usually die of liver failure • Estimated initial market opportunity of ~$2.3 billion in U.S. & EU • Expanding clinical data expected to broaden clinical use and indications • On the cusp of realizing the potential: o EU - early commercial launch underway; reimbursement in key EU markets expe cted in Q1/Q2 o U.S. - NDA under review ; ODAC May 2, PDUFA date June 15, 2013 • Attractive financial model, multiple capital resources available and experienced management team to execute plan

4 DELCATH SYSTEMS, INC Our Product US Market Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) Ex US Markets CHEMOSAT ® Hepatic Delivery System • Proposed Trade Name • Proprietary Drug/Device Combination Product Regulated as a drug 505(b)(2) NDA by U.S. FDA • Proposed indication for the treatment of patients with unresectable ocular melanoma metastatic to the liver • Melblez Kit comprised of Melblez TM (melphalan hydrochloride for injection) and the Delcath Hepatic Delivery System • Marketed under the trade name • 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 TM

5 DELCATH SYSTEMS, INC 1. ISOLATE 2. SATURATE 3. FILTRATE The Delcath Hepatic Delivery System Minimally Invasive, Repeatable Procedure That Could Complement Systemic Therapy • Improves disease control in the liver • Treats macro and micro tumors • Controls systemic toxicities • Allows for over 100x dose escalation at tumor site

6 DELCATH SYSTEMS, INC Melanoma Liver Metastases A Great Demonstration of CHEMOSAT’s Potential • A challenging histology • Notoriously insensitive to systemic chemotherapy and focal interventions • CHEMOSAT has demonstrated ability to extend progression free survival Our Opportunity • Ability to achieve ultra-high concentrations of chemotherapy provides potential treatment options for a wide variety of cancers in the liver

7 DELCATH SYSTEMS, INC Clinically Differentiated Results • Phase 1, 2 and 3 trials with percutaneous hepatic perfusion (PHP) 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 • Safety profiles consistent with pivotal US Phase 3 melanoma trial Encouraging Initial Results on a Broad Range of Histologies

8 DELCATH SYSTEMS, INC INDEPENDENT REVIEW COMMITTEE (IRC) ASSESSMENT - UPDATED ANALYSIS (4 June 2012) Hepatic progression-free survival (IRC) Hazard ratio = 0.50 (95% CI 0.31–0.80) P=0.0029 0 5 10 15 20 25 30 Months 7.0 1.7 1.0 0.8 0.6 0.4 0.2 0.0 Proportion of patients surviving 5.3 mo Intent-to-treat population Percutaneous Hepatic Perfusion (PHP) Best alternative care (BAC) Positive Phase 3 Results – Primary Endpoint hPFS PHP Demonstrated 4x or 5.3 months Improvement in Primary Endpoint of hPFS

9 DELCATH SYSTEMS, INC INVESTIGATOR ASSESSMENT - UPDATED ANALYSIS (4 June 2012) Overall progression-free survival (investigator) Months 5.4 1.6 1.0 0.8 0.6 0.4 0.2 0.0 Proportion of patients surviving Hazard ratio = 0.42 (95% CI 0.27–0.64) P<0.0001 0 5 10 15 20 25 30 35 40 45 50 55 3.8 mo Intent-to-treat population Positive Phase 3 Results – Overall PFS PHP also Demonstrated a Highly Statistically Significant Improvement in Overall PFS Percutaneous Hepatic Perfusion (PHP) Best alternative care (BAC)

10 DELCATH SYSTEMS, INC TOTAL PHP vs BAC ONLY Proportion of subjects surviving 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 12 36 0 24 48 60 11.4 Total PHP incl. crossover BAC only Months 4.1 Intent-to-treat population 7.3 mo Overall Survival – Exploratory Subset Analysis Overall Survival Tail For PHP Treated Patients

11 DELCATH SYSTEMS, INC Phase 2 Multi-Histology NCI Trial – Summary • Strong efficacy signals in mNET o 42% objective Response Rate (ORR) vs ~10% for approved targeted therapy o 66% patients had hepatic tumor shrinkage and durable disease stabilization • Positive Signal in primary hepatic malignancies (HCC and Cholangiocarcinoma) in 5 of 8 patients • Similar safety profiles across tumor types Positive Efficacy Signals In Additional Types of Cancer

12 DELCATH SYSTEMS, INC Phase 2 NCI Trial – Metastatic Neuroendocrine Cohort Pre-PHP (Baseline) Post-PHP #2 (+4 Months) Post-PHP #1 (+6 Weeks) Compelling Clinical Data in Attractive mNET Market Phase 2 mNET Tumor Cohort (n=24)* Number (n) Tumor Types Pancreatic NET 13 Carcinoid tumor 3 Other NET 8 Response Partial Response (PR) 10 Stable disease (SD) 6 Progressive disease 3 Not assessed or evaluable 5 Objective Response Rate 42% Median Duration of Hepatic Response Partial Response (n-10) 23.5 months Partial Response/Stable Disease (n=16) 16.8 months Hepatic Progression Free Survival (IIT n=24) Median Hepatic PFS 16.8 Min/Max 2.1, 64.1 Overall Survival After CS Median 31.9 months Min/Max 2.4, 81.1 66% disease control

13 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 • Intend to initiate new HCC trials with CHEMOSAT Encouraging Positive Signal for Primary Liver Cancer *Source: GLOBOCAN

14 DELCATH SYSTEMS, INC • Substantial clinical evidence of benefit of using ultra-high dose melphalan to treat mCRC via isolated hepatic perfusion (IHP) procedure o Over 800 patients treated in 15 studies since 1998 o Patients treated only once o Median response rate of ~50-60% and median OS of 17.4 – 24.8 mos1,2 • Delcath Phase 2 NCI Trial – mCRC Cohort o Challenges enrolling at NCI due to competing FOLFOX & FOLFIRI trials o 17 patients treated since 2004 o Safety profile – expected and consistent with pivotal FDA Phase III melanoma trial • Intend to invest in new mCRC trials with CHEMOSAT Melphalan 1) van Iersel LB, Gelderblom H, et al. Ann Oncol. 2008;19:1127-34 2) Alexander, HR, Barlett DL, et al. Ann Surg Oncol, 16:1852-9, 2009 Phase 2 NCI Trial – mCRC Cohort

15 DELCATH SYSTEMS, INC Additional Clinical Data Generation • Goals: Expand US (PHP: MEL) label indications beyond the initial indication we are seeking Generate robust clinical data to support commercialization • FDA has accepted IND Amendment to include Gen 2 device in Expanded Access Program (EAP), compassionate use (CU), and all future clinical trials • Initiated EAP to treat first patient in January, 2013 • Activate EU Registry to systematically collect data from commercial experience Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver

16 DELCATH SYSTEMS, INC 2013 Clinical Development Plan • Planned company sponsored trials, subject to agreement with FDA Hepatocellular carcinoma (HCC) o Global Phase 3 Randomized CHEMOSAT Melphalan vs. best supportive care (BSC) for patients where Sorafenib is inappropriate - Primary endpoint: Overall Survival Advanced colorectal cancer (CRC) with liver dominant metastasis o Global Phase 3 Randomized CHEMOSAT Melphalan vs. best alternative care (BAC) - Primary endpoint: Overall Survival Metastatic Neuroendocrine tumor (NET) with liver dominant disease o Global Phase 3 Randomized CHEMOSAT Melphalan vs. Best Alternative Care (BAC) - Primary endpoint: Hepatic PFS • Planned phase 2 studies including global Investigator-initiated trials (IITs) in multiple indications: HCC, NET, CRC, melanoma Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver

17 DELCATH SYSTEMS, INC 8,708 6,563 4,085 8,212 7,202 33,966 19,861 33,953 52,143 5,585 7,671 99,749 0 25,000 50,000 75,000 100,000 125,000 150,000 175,000 200,000 USA EU APAC $2.3 Billion Initial Market Opportunity with Pharmaceutical-Like Gross Margins Sources: LEK Consulting, GLOBOCAN, Company estimates. EU: Initial target countries of Germany, UK, Italy, France, Spain, Netherlands, Ireland. APAC: Initial target countries of China, Japan, S. Korea, Taiwan, Australia. Assumes 2.5 treatments per patient. Assumes EU ASP of $15K; US ASP of $25K; APAC ASP of $5K. 55,389 42,367 189,943 HCC CRC Melanoma NET $2.3B Initial Opportunity * Assumes FDA approval for ocular melanoma metastatic to the liver CHEMOSAT - Potential Multi-Billion Dollar Global Market • $100M Initial on-label opportunity in Ocular Melanoma in US* • $2.2B multi-histology opportunity in EU

18 DELCATH SYSTEMS, INC Approved (CE Mark Device) NDA Filing Accepted by the FDA with PDUFA goal date of June 15, 2013 Mutual Recognition of European CE Mark – Applications Planned or Submitted Global Commercialization Status Addressing A Multi-Billion Dollar Global Market

19 DELCATH SYSTEMS, INC CHEMOSAT: EU Launch Underway • Marketing in target EU countries - Italy, Germany, France, UK, Ireland, NL, Spain • Training completed in key centers o Eight EU Clinical Sites activated in 2012 • EU clinicians using CHEMOSAT for a broad range of liver metastases o Use includes: cutaneous melanoma, ocular melanoma, colorectal cancer (CRC), gastric cancer, breast cancer, neuroendocrine tumor (NET), hepatocellular carcinoma (HCC) and Cholangiocarcinoma • EU reimbursement in progress o Italy – Existing DRG for partial reimbursement identified; supplemental reimbursement applications submitted o Germany – Value 4 NUB interim reimbursement granted February 2013 o UK – Reimbursement anticipated Q2 2013 Expansion of EU Clinical and Commercial Footprint Expected in 2013

20 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 • EU Registry To Be Initiated Q2

21 DELCATH SYSTEMS, INC U.S. NDA Under Review • Oncology Drug Advisory Committee (ODAC) panel scheduled for May 2, 2013 • PDUFA date: June 15, 2013 • Initial indication: unresectable metastatic ocular melanoma in the liver o Provides lowest risk pathway to FDA approval and fastest access • NDA filing included: o Comprehensive set of additional data in a new FDA compliant CDISC database o Gen 2 filter as part of the Chemistry, Manufacturing and Control (CMC) module • Three meetings scheduled with FDA to discuss clinical programs for planned label expansions in each of NET, HCC,CRC FDA Decision Expected in June

22 DELCATH SYSTEMS, INC U.S. Commercialization Strategy • Launch in Q4 2013 assuming approval on PDUFA date of June 15, 2013 • Initial commercial focus on centers that are active in the EAP or participated in the Phase 3 clinical trial • Utilize active EAP hospitals as Centers of Excellence for training and support of new centers • Intend to seek specific CPT reimbursement code for the Melblez Kit procedure, based upon value proposition relative to other cancer therapies • Educate Medical Oncologists via Medical Science Liaison (MSL) • Direct strategy to sell to hospital based Interventional Radiologists and Surgeons Participating EAP Centers Provide Immediate Commercial Footprint

23 DELCATH SYSTEMS, INC Barriers to Entry • Patent Protection o 6 U.S. patents in force and 6 U.S. patent applications pending o 9 foreign patents in force (with patent validity in 25 countries) and 14 foreign patent applications pending o Primary US device patent set to expire August 2016 o Up to 5 years of patent extension post FDA approval • Trade Secret Protection o Developed improved filter media via proprietary manufacturing processes • FDA Protection o Orphan Drug Designation granted for melphalan in the treatment of ocular melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as for doxorubicin in the treatment of HCC Provides 7 years of marketing exclusivity post FDA approval o Additional Orphan Drug applications to be filed for other drugs and indications, including melphalan for HCC and CRC Multiple Levels of Protection

24 DELCATH SYSTEMS, INC Financial Summary Cash & Cash Equivalents: $23.7 million at December 31, 2012 (unaudited) ATM Program $21.5 million remaining as of December 31, 2012 Committed Equity Financing Facility (CEFF) Up to $32.8 million as of December 31, 2012 Working Capital Line of Credit: $20 million credit facility Debt: None Cash Spend: Approx. $10 million in 4Q 2012 (unaudited) Projected 2013 quarterly cash spend $9-$12 million Shares Outstanding: 76.8 million (87.2 million fully diluted 1 ) as of December 31, 2012 1) Fully diluted includes an additional 4.8 million options and 5.6 million warrants Multiple Capital Resources Available to Execute Plan

25 DELCATH SYSTEMS, INC Management: A Track Record of Success Executive Title Prior Affiliation(s) Years of Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 32 Graham Miao, Ph.D. EVP & CFO D&B, Pagoda Pharma, Schering-Plough, Pharmacia, JP Morgan 23 Krishna Kandarpa, M.D., Ph.D. CSO and EVP, R&D Harvard, MIT(HST), Cornell, UMass 33 Agustin Gago EVP, Global Sales AngioDynamics, E-Z-EM 31 Jennifer Simpson, Ph.D. EVP, Global Marketing Eli Lilly (ImClone), Johnson & Johnson (Ortho Biotech) 23 Peter Graham, J.D. EVP, General Counsel & Global Human Resources Bracco, E-Z-EM 18 David McDonald EVP, Business Development AngioDynamics, RBC Capital Markets 30 John Purpura EVP, Regulatory Affairs & Quality Assurance E-Z-EM, Sanofi-Aventis 29 Harold Mapes EVP, Global Operations AngioDynamics, Mallinckrodt 27 Gloria Lee, M.D., PH.D. EVP, Clinical & Medical Affairs Hoffmann-La Roche, Syndax Pharmaceuticals, Inc. 21 Bill Appling SVP Medical Device R&D AngioDynamics 27 Dan Johnston, Ph.D. VP, Pharmaceutical R&D Pfizer, Wyeth 12

26 DELCATH SYSTEMS, INC 2012 Accomplishments • First patients treated with CHEMOSAT Melphalan in Europe in January • Obtained CE Mark for Gen 2 CHEMOSAT Melphalan filter in April • Executed contract for MSL services in EU in 1Q 2012 (Quintiles was selected to support EU launch of CHEMOSAT) • Secured agreements with 14 leading cancer centers in EU • 8 EU Clinical Sites Activated for commercial use • US NDA submitted in August 2012 • US NDA accepted with PDUFA date of June 15, 2013 • Obtained CE Mark for CHEMOSAT Doxorubicin in October • Interim reimbursement established in Italy in December Considerable Achievements Built the Foundation For Commercial Success

27 DELCATH SYSTEMS, INC 2013 Anticipated Milestones First patient enrolled in EAP - Q1 2013 Obtained NUB Value 4 interim reimbursement in Germany – Q12013 • Obtain interim reimbursement in UK – Q2 2013 • Submission for publications of Phase 3 data and mNET arm of Phase 2 data in Q1 2013 • Initiate EU Registry - Q1 2013 • ODAC Panel Meeting May 2, 2013 • Receive NDA approval for Melblez Kit by PDUFA date of June 15, 2013 • First commercial sale in APLA – Q2 2013 • Commence Company’s first investigator initiated trial (IIT) – Q2 2013 • First patient enrolled in Company sponsored trial (CST) to expand indications – Q4 2013 • US commercial launch of Melblez Kit – Q4 2013 • First patient enrolled in Taiwan HCC pivotal trial – Q4 2013 • Execute strategic partnership for China A Busy Year Focused on US Approval, Clinical Data and Commercial Adoption

28 DELCATH SYSTEMS, INC A Compelling Investment Opportunity Concentrating the Power of Chemotherapy • Commercial stage company focused on oncology • Proprietary CHEMOSAT Hepatic Delivery System allows unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need for cancer patients who usually die of liver failure • Estimated initial market opportunity of ~$2.3 billion in U.S. & EU • Expanding clinical data expected to broaden clinical use and indications • On the cusp of realizing the potential: o EU - early commercial launch underway; reimbursement in key EU markets expected in Q1/Q2 o U.S. - NDA under review; ODAC May 2, PDUFA date June 15, 2013 • Attractive financial model, multiple capital resources available and experienced management team to execute plan

29 DELCATH SYSTEMS, INC © 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

30 DELCATH SYSTEMS, INC Appendices

31 DELCATH SYSTEMS, INC LIVER CANCER TREATMENT OPTIONS Appendix 1

32 DELCATH SYSTEMS, INC Existing Liver Cancer Treatments Have Significant Limitations The Problem • Metastatic disease to the liver, brain or lungs is often the life- limiting location of solid tumors o Often life-limiting or leads to withdrawal of systemic treatments in favor of palliative care • Effective treatment for patients with liver-limited or dominant cancers remains a clinical challenge o Can be diffuse o Often not responsive to chemotherapy and radiation therapy • Whole organ therapy creates a new option for patients in the management of liver dominant disease

33 DELCATH SYSTEMS, INC Existing Liver Cancer Treatments Have Limitations Unmet Medical Need Exists for More Effective Liver Cancer Treatments 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, radio frequency ablation) – Partial removal or treatment of tumors – Only 10% to 20% resectable – Invasive and/or limited repeatability – Treatment is limited by tumor size, number of lesions and location – Tumor revascularization – Cannot treat diffuse disease

34 DELCATH SYSTEMS, INC Diffuse Hepatic Metastases from Melanoma • Diffuse disease in the liver is prevalent • Effective treatment for patients with liver-limited or dominant cancers remains a clinical challenge • Whole organ therapy creates a new option for patients in the management of liver dominant disease

35 DELCATH SYSTEMS, INC Concentrating the Power of Chemotherapy for Disease Control in the Liver Our Solution – Whole Organ-Focus Disease Control • Our proprietary CHEMOSAT System isolates the liver circulation, delivers an ultra-high concentration of chemotherapy (melphalan) to the liver and filters most of the chemotherapy out of the blood prior to returning it to the patient • The procedure typically takes approximately two hours to complete and involves a team including the interventional radiologist and perfusionist • CHEMOSAT (Gen 2) has demonstrated minimal systemic toxicities and impact to blood components in initial commercial use and may complement systemic therapy • CHEMOSAT has been used on approximately 200 patients to date through clinical development and early commercial launch

36 DELCATH SYSTEMS, INC MARKET OPPORTUNITY BY DISEASE & TARGET COUNTRIES Appendix 2

37 DELCATH SYSTEMS, INC • Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in the US • China – Largest opportunity for HCC Market Opportunity by Disease (patients) Market Opportunity defined as Total Potential Market (TPM) for Melblez Kit/CHEMOSAT 1.Primary cancer incidence 2.Adjusted for predominant disease in the liver (primary or metastatic cancer) 3.Adjusted for addressable patients via Melblez Kit/CHEMOSAT

38 DELCATH SYSTEMS, INC Europe Market by Disease – Device Only Germany (Direct) UK (Direct) France (Indirect) Italy (Indirect) Spain (Indirect) Netherlands (Direct) Ireland (Direct) Total Potential (patients) Potential Market ($ MM) 1,2,3 Total Potential Market #Patients Ocular Melanoma 404 297 295 285 197 79 19 1,576 $ 62 Cutaneous Melanoma 1,625 994 753 801 360 379 73 4,987 $ 206 CRC 9,902 5,300 5,475 7,281 4,016 1,644 335 33,953 $1,339 HCC (Primary) 1,637 720 1,514 2,597 1,087 82 35 7,671 $277 NET 1,783 1,336 1,353 1,299 974 360 98 7,202 $ 281 TOTAL 15,351 8,647 9,389 12,263 6,634 2,545 560 55,389 $ 2,166 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.

39 DELCATH SYSTEMS, INC US Market by Disease – Device and Drug Combination Liver Metastasis Potential Market # Patients Potential Market # Procedures Potential Market ($MM) 1,2 Ocular Melanoma 1,685 4,213 $ 105 Cutaneous Melanoma 7,023 17,557 $ 439 CRC 19,861 49,653 $ 1,241 HCC (Primary) 5,586 13,964 $ 349 NET 8,212 20,530 $ 513 TOTAL 42,367 105,917 $ 2,648 Sources: LEK Consulting, GLOBOCAN, Company estimates. 1) Assume 2.5 treatments per patient. 2) Estimated ASP of $25K.

40 DELCATH SYSTEMS, INC APAC Market by Disease China (Device) S. Korea (Device) Japan (Device) Taiwan (Device) Australia (Device) Total Potential (patients) Potential Market ($MM) 1,2 Total Potential Market #Patients HCC (Primary) 85,780 3,258 8,296 2,152 263 99,749 $ 1,156 Other CRC 31,127 3,245 14,298 1,441 2,031 52,143 $ 642 NET 29,197 1,048 2,759 500 462 33,966 $ 393 Ocular Melanoma 1,765 66 175 31 96 2,134 $ 25 Cutaneous Melanoma 382 43 136 246 1,144 1,951 $ 23 OTHER TOTAL 62,472 4,403 17,368 2,218 3,733 90,194 $ 1,083 TOTAL 148,104 7,661 25,665 4,370 3,996 189,943 $ 2,239 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.

41 DELCATH SYSTEMS, INC HIGH-DOSE MELPHALAN HISTORY AND RATIONALE Appendix 3

42 DELCATH SYSTEMS, INC The Evidence for Melphalan Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity

43 DELCATH SYSTEMS, INC Melphalan Dosing & Background • Well understood, dose dependent, tumor preferential, alkylating cytotoxic agent that demonstrates little to no hepatic toxicity • Manageable systemic toxicities associated with Neutropenia and Thrombocytopenia • Drug dosing 12x higher than FDA-approved dose via systemic IV chemotherapy • Dose delivered to tumor is over 100x higher than that of systemic IV chemotherapy Type Dosing (mg/kg) Multiple Myeloma (label) 0.25 Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion (IHP) 1.50 Myeloablation 2.50-3.50 Percutaneous Hepatic Perfusion (PHP) 3.00 An Established Drug for Liver Cancer Therapy

45 DELCATH SYSTEMS, INC PHASE 3 TRIAL Appendix 4

46 DELCATH SYSTEMS, INC Phase III Clinical Trial Design Randomized to PHP 93 patients: ocular or cutaneous melanoma Best Alternative Care (BAC) Investigator and patient decision (any and all treatments) PHP/Melphalan Treat every 4 weeks x 4 rounds (responders can receive up to 6 rounds) Cross-over Primary Trial Endpoint • Statistically significant difference in Hepatic Progression Free Survival (“hPFS”): p < 0.05 (IRC) • Over 80% of Oncologic drugs approved by FDA between 2005 – 2007 on endpoints other than overall survival Modeled hPFS for Trial Success: 7.73 months (CS) vs. 4 months (BAC) Secondary Trial Endpoints • Investigator hPFS • Hepatic objective response rate • Overall objective response rate • Overall Survival – Diluted by Cross Over • SAP calls for analysis of various patient subsets Pre-PHP (Baseline) Post-PHP (22+ Months) Hepatic Response – Metastatic Melanoma Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study PHP = Meblez Kit/CHEMOSAT

47 DELCATH SYSTEMS, INC Positive Phase 3 Results • Primary endpoint (hPFS by IRC) exceeded, p value = 0.0029, hazard ratio of 0.50 as of June, 2012 o PHP median hepatic progression free survival (hPFS) was 4-fold of control, or 5.3 months improvement o PHP achieved a median hPFS of 7.0 months vs 1.7 months for BAC control o 75% overall clinical benefit (CR + PR + SD) • Secondary endpoints consistent with primary endpoints o CS/PHP achieved a median overall PFS of 5.4 months vs. 1.6 months for BAC o OS – No difference demonstrated due to heavy crossover from BAC to PHP o Median OS 10.6 months vs. 10.0 months for PHP and BAC respectively • OS exploratory analyses supportive of key observations o Median overall survival of 11.4 months for all patients treated with melphalan, including crossover o BAC patients did not cross-over to PHP had a median survival of 4.1 months o 6 PHP-treated and 2 BAC-only patients still alive as of 2/2013 • Gen 1 Safety profile – consistent with currently approved labeling for melphalan o 30-day deaths on PHP: 3/44 patients (6.8%) 1 Neutropenic Sepsis (2.3%); 1 Hepatic Failure 2.5% (95% tumor burden); 1 gastric perforation o 30-day deaths on BAC: 3/49 patients (6.1%) Trial Outcomes Favorable and Consistent with Special Protocol Assessment

48 DELCATH SYSTEMS, INC PUBLISHED PHASE 1 / 2 STUDIES OF DOXORUBICIN WITH PHP Appendix 5

49 DELCATH SYSTEMS, INC Phase 1 & 2 Studies of PHP-Doxorubicin For HCC Delivered Safely in Multiple Studies with Promising Response Rates 1) Ku Y et al. Chir Gastroenterol 2003;19:370–376. 2) Curley SA et al. Ann Surg Oncol 1994;1:389–99. 3) Ravikumar TS et al. J Clin Oncol 1994;12:2723–36. 4) Hwu WJ et al. Oncol Res 1999;11:529–37.

50 DELCATH SYSTEMS, INC PRODUCT DEVELOPMENT PIPELINE Appendix 6

51 DELCATH SYSTEMS, INC Product Development Pipeline • Orphan Drug - Ocular Melanoma liver mets • Proprietary drug-melphalan & Melblez Kit • All liver cancers – melphalan • Classified as Medical Device • 3 party melphalan • Gen 2 melphalan CE Mark • Doxorubicin system CE Mark • CHEMOSAT for additional drugs • CHEMOSAT for other organs (lung and brain) • mNET, mCRC and HCC indications Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • mCRC and HCC clinical trials • Proprietary drug/delivery system for additional drugs • Proprietary drug/delivery system for other organs (lung and brain) • CHEMOSAT Melphalan in Taiwan and Japan • CHEMOSAT Doxorubicin in China and South Korea • 3 party doxorubicin • CHEMOSAT for additional drugs • CHEMOSAT for other organs (lung and brain) • CHEMOSAT Melphalan in Australia, New Zealand, and Hong Kong • 3 party melphalan Development Aligned to Address Significant Market Opportunity rd rd rd

52 DELCATH SYSTEMS, INC CHEMOSAT Delivery System for Doxorubicin – CE Mark • Satisfied all of the requirements to affix the CE Mark to Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin in October, 2012 o Provides a pathway for regulatory approval in China and S. Korea • Provides basis for partnership opportunities in China and S. Korea where doxorubicin has a broad label for multiple tumor types • Multiple published Phase I/II studies from MD Anderson Cancer Center and Yale with percutaneous hepatic perfusion (PHP) and Kobe University using doxorubicin show promising response rates for HCC* • Plan to use CHEMOSAT Delivery System for Doxorubicin in Asia Phase III 2L HCC trials Addressing the Large HCC Market Opportunity in China

53 DELCATH SYSTEMS, INC NON US/EU REGULATORY UPDATE Appendix 7

54 DELCATH SYSTEMS, INC International Strategy beyond EU and US • Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT Systems in other international markets o Obtained approval for Gen 2 CHEMOSAT Delivery System for Melphalan in Australia • International regulatory submissions status: Application submitted and expected approvals in Hong Kong - 2013 Singapore - 2013 Argentina - 2013 Brazil - 2014 Intend to submit applications S. Korea (CHEMOSAT Doxorubicin) Mexico China (CHEMOSAT Doxorubicin) Taiwan Russia India Japan Israel • Utilize 3 rd party melphalan and doxorubicin available to physicians Combination of Strategic Partnerships and Specialty Distributors

55 DELCATH SYSTEMS, INC CHEMOSAT CENTERS Appendix 8

56 DELCATH SYSTEMS, INC CHEMOSAT Centers in Europe • Entered training and marketing agreements with leading cancer centers in Europe o Milan, Italy – European Institute of Oncology (IEO) o Frankfurt, Germany – Johann Wolfgang Goethe-Universität (JWG) o Kiel, Germany – Universitätsklinikum Schleswig-Holstein o Villejuif, France – Cancer Institute Gustave Roussy (IGR) o Barcelona, Spain – El Hospital Quiron o Naples, Italy – Instituto Nazionale Tumori Fondazione "G. Pascale" o Amsterdam, The Netherlands – Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital o Erlangen, Germany – University Hospital of Erlangen o Pamplona, Spain – Clinica Universidad de Navarra o Bordeaux, France – Hôpital Saint-André (St Andre) o Galway, Ireland – University Hospital Galway (UHG) o Leiden, The Netherlands – Leiden University Medical Center o Southampton, United Kingdom – Southampton University Hospital (SUH) o Göttingen, Germany - University Medical Center Göttingen (UMG) o Varese, Italy – Varese University Hospital (VUH) o Heidelberg, Germany - National Center Tumor Diseases • Training completed and patients treated at IEO, JWG, IGR, St Andre, UHG, SUH, UMG, VUH • Liver metastases from cutaneous melanoma, ocular melanoma, gastric cancer, breast cancer, neuroendocrine tumor (NET), hepatocellular carcinoma (HCC) and Cholangiocarcinoma