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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 H pital Saint Andr (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 G ttingen, Germany University Medical Center G ttingen (UMG) o Varese, Italy Varese University Hospital (VUH) 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
Korea (CHEMOSAT Doxorubicin) Mexico China (CHEMOSAT Doxorubicin) Taiwan Russia India Japan Israel Utilize 3 party melphalan and doxorubicin available to physicians Combination of Strategic Partnerships and Specialty Distributors rd 54 DELCATH SYSTEMS, INC CHEMOSAT CENTERS Appendix 8 55 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 Universit t (JWG) o Kiel, Germany Universit tsklinikum Schleswig Holstein o Villejuif, France Cancer Institute Gustave Roussy (IGR) o Barcelona, Spain El Hospital Quiron o Naples, Italy Instituto Nazionale Tumori Fondazione G.
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 Doxorubicin in Asia Phase III 2L HCC trials Addressing the Large HCC Market Opportunity in China 52 DELCATH SYSTEMS, INC NON US/EU REGULATORY UPDATE Appendix 7 53 DELCATH SYSTEMS, INC International Strategy beyond EU and US Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT System in other international markets o Obtained approval for Gen 2 CHEMOSAT System with 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.
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. 49 DELCATH SYSTEMS, INC PRODUCT DEVELOPMENT PIPELINE Appendix 6 50 DELCATH SYSTEMS, INC Product Development Pipeline Orphan Drug Ocular Melanoma liver mets Proprietary drug melphalan CHEMOSAT System 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 CHEMOSAT for additional drugs CHEMOSAT 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 51 DELCATH SYSTEMS, INC CHEMOSAT 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 (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. 40 DELCATH SYSTEMS, INC HIGH DOSE MELPHALAN HISTORY AND RATIONALE Appendix 3 41 DELCATH SYSTEMS, INC The Evidence for Melphalan Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity 42 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 Chemosaturation (PHP) 3.00 An Established Drug for Liver Cancer Therapy 43 DELCATH SYSTEMS, INC Melphalan Sensitivity: In Vitro Tumor Cell Lines Study We Believe CHEMOSAT Will Be Effective On a Wide Range of Solid Tumors 44 DELCATH SYSTEMS, INC PHASE 3 TRIAL Appendix 4 45 DELCATH SYSTEMS, INC Phase III Clinical Trial Design Randomized to CS 93 patients: ocular or cutaneous melanoma Best Alternative Care (BAC) Investigator and patient decision (any and all treatments) CS/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 CS (Baseline) Post CS (22+ Months) Hepatic Response Metastatic Melanoma Fully Powered, 93 Patient, Randomized, Multi Center NCI Led Study CS = Chemosaturation (CHEMOSAT) 46 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 CS/PHP median hepatic progression free survival (hPFS) was 4 fold of control, or 5.3 months improvement o CS/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 CS/PHP o Median OS 10.6 months vs. 10.0 months for CS/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 CS/PHP had a median survival of 4.1 months o 7 CS/PHP treated and 3 BAC only patients still alive as of 6/2012 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 47 DELCATH SYSTEMS, INC PUBLISHED PHASE 1 / 2 STUDIES OF DOXORUBICIN WITH CS PHP Appendix 5 48 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.
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 25 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 26 DELCATH SYSTEMS, INC 2013 Anticipated Milestones First patient enrolled in EAP Q1 2013 Secure interim reimbursement in Germany and UK Q1 2013 Submission for publications of Phase 3 data and mNET arm of Phase 2 data in Q1 2013 Initiate EU Registry Q1 2013 First commercial sale in APLA Q2 2013 ODAC Panel Meeting May 2013 Receive NDA approval of Delcath s chemosaturation system by PDUFA date of June 15, 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 Delcath s chemosaturation system Q4 2013 First patient enrolled in Taiwan HCC pivotal trial Q4 2013 Execute strategic partnership for China A Busy Year Focused on Increased Commercial Adoption and Clinical Data 27 DELCATH SYSTEMS, INC A Compelling Investment Opportunity Commercial stage company focused on oncology CHEMOSAT provides a unique whole organ therapy for the liver CHEMOSAT system has demonstrated extension of progression free survival (PFS) Addressing large unmet market need for cancer patients who usually die of liver failure EU commercial launch underway 2013 estimated addressable market opportunity of $2.3 billion Reimbursement in additional key EU markets expected in Q1 U.S.
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.
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 chemosaturation specific CPT reimbursement code, 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 22 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 23 DELCATH SYSTEMS, INC Financial Summary 1) Fully diluted includes an additional 4.8 million options and 5.6 million warrants Multiple Capital Resources Available to Execute Plan 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 24 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.
NDA Under Review 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 Oncology Drug Advisory Committee (ODAC) panel expected May 2013 Three meetings scheduled with FDA to discuss clinical programs for planned label expansions in each of NET, HCC,CRC FDA Decision Expected in June 21 DELCATH SYSTEMS, INC U.S.
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 $2.2 B 42,367 $2.6 B 189,943 $2.2 B HCC CRC Melanoma NET $2.3B Initial Opportunity $100M Initial on label opportunity in Ocular Melanoma in US* $2.2B multi histology opportunity in EU * Assumes FDA approval for ocular melanoma metastatic to the liver CHEMOSAT Potential Multi Billion Dollar Global Market 17 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 18 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 gaining momentum o Italy Reimbursement pathway established o Germany Value 4 NUB interim reimbursement granted February 2013 o UK Reimbursement anticipated Q1 2013 Rapid Expansion of EU Clinical and Commercial Footprint Expected in 2013 19 DELCATH SYSTEMS, INC Multiple Tumor Types Treated in Europe Countries: Germany, Italy, UK, France, Ireland EU Registry To Be Initiated Q2 20 DELCATH SYSTEMS, INC U.S.
Best Alternative Care (BAC) Primary endpoint: Hepatic PFS 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 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 16 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 Market Opportunity in 2013 with Pharmaceutical Like Gross Margins Sources: LEK Consulting, GLOBOCAN, Company estimates.
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 14 DELCATH SYSTEMS, INC Additional Clinical Data Generation Goals: Expand US (CS 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 15 DELCATH SYSTEMS, INC 2013 Clinical Development Plan Planned company sponsored trials, pending discussion with the FDA Metastatic Neuroendocrine tumor (NET) with liver dominant disease o Global Phase 3 Randomized CHEMOSAT Melphalan vs.
NDA under review PDUFA date June 15, 2013 Attractive financial model, multiple capital resources available and experienced management team to execute plan 4 DELCATH SYSTEMS, INC 1. ISOLATE 2. SATURATE 3. FILTRATE The Delcath CHEMOSAT System Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy Chemosaturation Improves disease control in the liver Treats entire liver (macro and micro) Controls systemic toxicities Allows for over 100x effective dose escalation at tumor site 5 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 that are effective on a wide variety of cancers in the liver Physicians are recognizing the broad applicability of CHEMOSAT, based on early EU experience 6 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 Safety profiles consistent with pivotal US Phase 3 melanoma trial Encouraging Initial Results on a Broad Range of Histologies 7 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 Chemosaturation (CS PHP) Best alternative care (BAC) Positive Phase 3 Results Primary Endpoint hPFS CS PHP Demonstrated 4x or 5.3 months Improvement in Primary Endpoint of hPFS 8 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 Chemosaturation (CS PHP) Best alternative care (BAC) Positive Phase 3 Results Overall PFS CS PHP also Demonstrated a Highly Statistically Significant Improvement in Overall PFS 9 DELCATH SYSTEMS, INC TOTAL CS PHP vs BAC ONLY Overall Survival Exploratory Subset Analysis Overall Survival Tail For CS PHP Treated Patients 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 CS PHP incl. crossover BAC only Months 4.1 Intent to treat population 7.3 mo 10 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 11 DELCATH SYSTEMS, INC Phase 2 NCI Trial Metastatic Neuroendocrine Cohort Pre CS (Baseline) Post CS #2 (+4 Months) Post CS #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 12 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 13 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 mos 1,2 Delcath Phase 2 NCI Chemosaturation 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 Strong Rationale for Using CHEMOSAT with Melphalan to Treat mCRC 1) van Iersel LB, Gelderblom H, et al.
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 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 2013 estimated addressable market opportunity of ~$2.3 billion Expanding clinical data expected to broaden clinical use and indications On the cusp of realizing the potential: o EU commercial launch underway o Reimbursement in additional key EU markets expected in Q1 o U.S.
Factors that may cause such differences include, but are not limited to, 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 chemosaturation 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 chemosaturation system in various markets and the potential of the chemosaturation 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 chemosaturation 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 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 Hepatic CHEMOSAT Delivery System device for intra hepatic arterial delivery and extracorporeal filtration of doxorubicin, approval of the Hepatic CHEMOSAT 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.