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FY Est. Quarterly Guidance $5 6M $5 6M $4 5M $4 5M $16.5 17.5M Quarterly Act. $4.5M $4.0M $4.0M Focused Spending and Resources to Support Execution of Near term Plan 30 DELCATH SYSTEMS, INC Summary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) Cancers of the liver remain a large, multi billion dollar unmet medical need Unique, highly differentiated solution Late stage asset Compelling emerging data Imminent Valuation milestones Attractive orphan drug business model Experienced pharmaceutical management team executing a data driven plan 31 DELCATH SYSTEMS, INC 2014 DELCATH SYSTEMS, INC.
Stedman 29 DELCATH SYSTEMS, INC Cash Capital Resources Cash Cash Equivalents $23.3 million at September 30, 2014 Debt None ATM Program 1 $40 million available at September 30, 2014 Shares Outstanding 9.4 million (10.5 million fully diluted 3 ) at September 30, 2014 1) Subject to market conditions and certain limitations 2) Fully diluted includes approximate 0.2 million options and 0.9 million warrants 2014 Operating Cash Spend (Unaudited) Q1 A Q2 A Q3 A Q4 Est.
Zager Percutaneous Hepatic Perfusion with Melphalan in Treating Unresectable Liver Metastases from Colorectal Cancer and Uveal (Ocular) Melanoma Leiden University Medical Centre (LUMC), The Netherlands; N. de Leede Initial United Kingdom Experience with Melphalan Percutaneous Hepatic Perfusion (PHP) For Treatment of Inoperable Ocular Melanoma Metastases University Hospital Southampton, U.K; B.
Journal of Surgical Oncology . 2013 Yamamoto M, Zager J. Isolated Hepatic Perfusion for Metastatic Melanoma. Journal of Surgical Oncology. 2013 2014 ESSO Congress Presentations Clinical Evidence and Awareness Continue to Build A Single Institution Experience with Percutaneous Hepatic Perfusion for Unresectable Ocular Melanoma and Sarcoma in the Liver Moffitt Cancer Center, U.S.; J.
Schulze Bergkamen et al. Unresectable Isolated Hepatic Metastases from Solid Pseudopapillary Neoplasm of the Pancreas: A Case Report of Chemosaturation with High Dose Melphalan, Pancreatology 2014 Forster M., et al. Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable Metastatic Melanoma or Sarcoma to the Liver: A Single Institution Experience.
Current Status of Percutaneous Hepatic Perfusion as Regional Treatment for Patients with Unresectable Hepatic Metastases: A Review, American Oncology and Hematology Review 2014: 15 23 Vogl, et al. Chemosaturation with Percutaneous Hepatic Perfusions of Melphalan for Hepatic Metastases: Experience from Two European Centers , Fortschr R ntgestr 2014 H.
Verhoef C, et al. Ann Surg Oncol 15:1367 74 12 DELCATH SYSTEMS, INC Potential Applications Unresectable Hepatocellular Carcinoma (HCC) Ocular Melanoma (OM) Liver Metastases Intra hepatic Cholangiocarcinoma (ICC) Colorectal Cancer Liver Metastases (mCRC) Multiple Opportunities Yields Potential Multi Billion Dollar Global Market 13 DELCATH SYSTEMS, INC Total Available EU US Market Opportunity Effective Liver Cancer Treatment Remains a Major Unmet Medical Need Notes: 1) Source: Globocan, American Cancer Society 2) Source: LEK, Booz/PwC, Company estimates 3 ) Assumes an average of two treatments per patient Cancer Type Annual Incidence Eligible Pts Revenue per Patient Annual Potential 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 1 2 3 14 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 15 DELCATH SYSTEMS, INC Clinical Development Program Overview Initiating global phase 3 trial mid year 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 (IITs) in HCC mCRC Focused on Liver Dominant, Orphan Diseases With High Unmet Need Clinical Development Program at a Glance 17 DELCATH SYSTEMS, INC Clinical Development Program Timeline Legend First Patient In Last Patient In Data Readout Tumor Type 2014 2015 2016 2017 OM (Phase 3 Pivotal Trial) 201 HCC (US Phase 2) 202 HCC (EU Phase 2) Combined US, EU 31 patients ICC Cohort (to be added to 202 HCC; n=11) IITs EU Commercial Registry 18 DELCATH SYSTEMS, INC OM Rationale OM has high incidence of liver metastases o Up to 90% of patients with metastases will have liver involvement o Life expectancy of approximately 6 months o 5,700 8,600 cases of OM liver metastases diagnosed in US and EU annually Clear efficacy signal seen in prior P3 trial of Melphalan/HDS Currently no standard of care Believed to be fastest pathway to NDA approval in the US Melphalan/HDS granted orphan drug status by FDA for treatment of patients with OM *Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3 rd Party Analysis Proven Efficacy in Attractive Orphan Opportunity 5,700 8,600 Cases of Ocular Melanoma ~50 55% Metastasize ~90% Show Liver Mets ~2,600 4,300 Eligible Patients Limited TX Options US/EU Market Size 19 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 Proportion of patients surviving Previous Ocular Melanoma Phase 3 Results Hepatic Progression Free Survival (hPFS) 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 Intent to Treat Analysis (June 2012) Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients Chemosaturation (CS PHP) Best alternative care (BAC) Chemosaturation (CS PHP) Best alternative care (BAC) Months 20 DELCATH SYSTEMS, INC ICC Rationale Significant Market Opportunity in US and EU o ~15% of new HCC cases diagnosed annually o ~90% of patients are not suitable for surgical resection o ~20 30% 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 Sources: ACS, SEER, NIH, KOL Interviews, 2014 3 rd Party Analysis Encouraging Early Commercial Activity in Disease With Limited Treatment Options 76,000 HCC Diagnosis ~90% Unresectable ~6,500 Eligible Patients US/EU Market Size ~15% Of HCC Cases ~20 30% Focal Interventions 21 DELCATH SYSTEMS, INC HCC Rationale Significant opportunity in US and EU o HCC most common primary cancer of the liver o ~76,000 cases diagnosed annually Large unmet medical need in first line therapy o Only one currently approved systemic therapy in US, EU, and certain Asian markets o ~90% of pts not candidates for surgical resection o 20 30% of pts candidates for focal interventions Melphalan/HDS granted orphan drug status by FDA for treatment of patients with unresectable HCC *Sources: WHO, KOL Interviews, 2014 3 rd Party Analysis Large, Deadly Disease in Need of Better Treatments 76,000 Cases of Primary Liver Cancer ~80 90% Unresectable ~20 30% Child Pugh Class A ~7,600 14,700 Eligible Patients ~20 30% Interventional TX US/EU Market Size ~90% HCC 22 DELCATH SYSTEMS, INC Prior FDA Experience New Drug Application (NDA) submitted August 2012 seeking indication in OM liver metastases with prior filters and procedure ODAC meeting in May 2013 o Negative Vote o Complete FDA Delcath ODAC briefing materials available at www.delcath.com/clinical research/clinical bibliography/ Complete Response Letter (CRL) Issued September 2013 FDA requests include, but not limited to: o Well controlled randomized trial(s) to establish the safety and efficacy using the to be marketed device configuration o Overall survival as the primary efficacy outcome measure o Demonstrate clinical benefits outweigh risks FDA Learnings Provide Beneficial Clinical Study Roadmap 23 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 to include: o 4.1% incidence of deaths due to adverse reactions o 4% incidence of stroke o 2% reported incidence of myocardial infarction in the setting of an incomplete cardiac risk assessment o a 70% incidence of grade 4 bone marrow suppression with a median time of recovery of greater than 1 week o 18% incidence of febrile neutropenia, along with the additive risk of hepatic injury, severe hemorrhage, and gastrointestinal perforation Deaths due to certain adverse reactions did not occur again during the clinical trials following the adoption of related protocol amendments Treating Physicians in US and EU Report Improved Safety Profile 24 DELCATH SYSTEMS, INC Safety Improvements Implemented New generation filter o improved 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 to prevent hepatic arterial spasm Liver tumor burden not to exceed 50% o to address risk of liver failure Decisive Measures to Seek to Improve Safety Implemented 25 DELCATH SYSTEMS, INC Positive Developments Improved device and procedure since prior trials o 180 treatments with improved device and procedure in US and EU o Many issues raised at ODAC have not been reported Current device/procedure permitting multiple treatment cycles Recent scientific presentations at ESSO for OM from 3 centers in US and EU o University Southampton reported 63% positive response (47% had a partial response and 16% had a complete response) o Moffitt reported 67% positive response (partial response and one complete response) o Leiden reported 80% positive response (partial response) Patients Report Improved Quality of Life 26 DELCATH SYSTEMS, INC European Commercialization CHEMOSAT Hepatic Delivery System Approved as Class IIb Medical Device; kit supplied w/o melphalan Broad indication for intra hepatic administration of melphalan hydrochloride and subsequent filtration of the venous blood return 150 commercial procedures performed in 15 leading cancer centers in the EU Reimbursement via Individual Funding Requests; NUB Value 4 Status in Germany UK Block Grants pending private pay insurance 27 DELCATH SYSTEMS, INC CHEMOSAT Commercial Treatments in Europe Multiple Tumor Types Treated Since EU Launch Treatments/Re treatments Increasing 28 DELCATH SYSTEMS, INC Publications Alexander, R., et al.
Grover AC, et al. Surgery 2004;136:1176 82 2. Noter SL, et al. Melanoma Res 2004;14:67 72 3. Alexander HR Jr, et al. Clin Cancer Res 2000;6:3062 70 4. Alexander HR Jr, et al. Clin Cancer Res 2003;9:6343 9 5. Alexander HR Jr, et al. Ann Surg Oncol 2009;16:1852 9 6. Van Iersel LB, et al. Ann Oncol 2008;19:1127 34 7. Van Iersel LB, et al. Ann Oncol 2010;21:1662 7 8.
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 Delcath at a Glance A late stage clinical company with early commercial activity in Europe CHEMOSAT is approved as a medical device (CE Mark) in Europe; investigational new combination product in U.S. for treating cancers of the liver Focused clinical development program initially pursuing orphan indications in metastatic ocular melanoma and primary liver cancer Based in New York with European operations in Galway, Ireland Traded on NASDAQ under symbol DCTH More than $23 million in cash at 9/30/2014 Seeking to Make a Clinically Meaningful Difference For Cancer Patients With Liver Dominant Disease 4 DELCATH SYSTEMS, INC Investment Highlights We Believe We are Positioned to Capitalize on Large, Compelling Market Opportunity Large market opportunity cancers of the liver remain a multi billion dollar unmet medical need Unique, highly differentiated solution orphan designations create barriers to competitive entry Late stage, asset demonstrated clinically meaningful efficacy in over 550 procedures and multiple tumor types Compelling emerging data demonstrated early success in multiple tumor types Imminent valuation milestones 2015 value drivers include publications, reimbursement clinical data Attractive business model initial orphan focus and anticipated high gross margins form basis of profitable long term model Experienced management team now aligned with requirements of clinically driven pharmaceutical industry 5 DELCATH SYSTEMS, INC 2014 2015 Milestones Executing on Multiple Fronts to Create Value 2014 Accomplishments o Phase 2 HCC trial open and first patient treated o 100 th patient treated in Europe (commercial and clinical) o Positive efficacy data from three institutions presented at ESSO 2014 o Q3 sales increased 201% Y/Y to $217K o Cash burn reduced by almost 60% Y/Y through September 1H 2015 o Submit Phase 3 metastatic melanoma publication o EU Registry open for enrollment o ICC cohort open for enrollment o NUB reimbursement decision in Germany Value 4 awarded for 2015 2H 2015 o Interim analysis on HCC patients o Initiation of phase 3 ocular melanoma program 6 DELCATH SYSTEMS, INC The Liver: A Life Limiting Organ Cancers of the liver remain a major unmet medical need globally 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 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 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, 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 8 DELCATH SYSTEMS, INC Concentrating the Power of Chemotherapy for Disease Control in the Liver Our Solution Whole Organ Focus Disease Control Our proprietary system isolates the liver circulation, delivers a substantially higher 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 2 3 hours to complete and involves a team including the interventional radiologist and perfusionist We believe more than 180 treatments with improved device and procedure in US and EU provides confidence safety can be validated in a controlled setting 9 DELCATH SYSTEMS, INC The Melphalan Hepatic Delivery System (HDS) 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 US 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 More Than 240 Patients Treated To Date 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 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 11 DELCATH SYSTEMS, INC The Evidence for Melphalan Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity 1.
Forward looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to differ materially from expected results, performance or achievements expressed or implied by statements made herein. Our actual results could differ materially from those anticipated in forward looking statements for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials including without limitation the OM, HCC, ICC, and mCRC trials in the Company s Clinical Development Program, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the Melphalan/HDS system by the US FDA, submission and acceptance of the phase 3 trial publication, approval of the current or future Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the US and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, our ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, and uncertainties regarding our ability to obtain financial and other resources for any clinical trials, research, development, and commercialization activities.
Investor Presentation (NASDAQ: DCTH) February 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.