Slide 1: Investor Presentation April 2015
Exhibit 99.1 Investor (NASDAQ: April 2015 Presentation DCTH)
Slide 2: Forward-looking Statements
Forward-looking This intentions, could statements Program, Kingdom, the impact for timing development, Annual 2DELCATH various requirements presentation cause and of Report clinical the our goals, for revenue, indications actual SYSTEMS, presentations and ability many onof Statements strategies, ado
Slide 3: About Delcath Systems, Inc.
About A Proprietary the In Initially Seeking 3DELCATH specialty late-stage patient Delcath pursuing to Make pharmaceutical system clinical SYSTEMS, Systems aorphan Clinically isolates development indications INC the and Meaningful liver medical in from the in metastatic device U.S. circulation, Diff
Slide 4: Investment Highlights
Investment Late-stage Active Unique, barriers Large Imminent Attractive Experienced 4DELCATH market clinical to highly valuation business entry asset Highlights management SYSTEMS, opportunity program differentiated – approved model milestones – INC initiating –team – cancers and initial solution ––
Slide 5: Executing on Multiple Fronts to Create Value
2014-2015 2014 Phase 100th Positive NUB 1H-2015 o 2H-2015 Executing 5DELCATH Initiation Accomplishments reimbursement patient 2 HCC efficacy on Milestones ofSYSTEMS, treated Multiple trial global data open in Phase decision from Fronts Europe and INC three 3first metastatic to in(commercial Create G
Slide 6: The Cancers of the Liver: A Major Unmet Medical Need
The Cancers o CHEMOSAT® Effective * 6DELCATH The Large Prognosis SOURCE Liver: liver global ofLiver A the is–after SYSTEMS, Life-Limiting often 2008 liver patient Cancer Melphalan/HDS liver the GLOBOCAN remain population involvement life-limiting Treatment INC Organ a major is–Remains aapproximately
Slide 7: Existing Liver Cancer Treatment Landscape
Treatment Systemic Focal (e.g., – Existing 7DELCATH Tumor Repeatable Invasive/limited Multiple Only Invasive Cannot Isolated surgery, repeatability 10%-20% Liver revascularization treat –Advantages and/or treatments Non-invasive SYSTEMS, –Hepatic radioembolization, diffuse Cancer Limited limited are
Slide 8: Our Solution: Concentrating the Power of Chemotherapy
Ourbelieve The We Concentrating 8DELCATH procedure Solution: proprietary more SYSTEMS, Whole the typically system than Power Organ-Focus 200 isolates takes of INC treatments Chemotherapy approximately the Disease liver with circulation, improved for Control 2-3 Disease hours delivers device to Contr
Slide 9: The Melphalan Hepatic Delivery System
The Melphalan Liver Catheter Device regulated More 9DELCATH Than Isolated designed In as300 IVC aSYSTEMS, drug Via Hepatic Patients Via toDouble in administer Catheter theDelivery Treated INC U.S. Balloon Inhigh-dose Hepatic To System Melphalan Date Artery chemotherapy (HDS)Infused Proprietary Direc
Slide 10: Melphalan Background
Melphalan Type Multiple Chemoembolization Surgical Myeloablation Chemosaturation Well-understood, Dose An 10DELCATH Established Dosing administered Isolated Myeloma Dosing (mg/kg) SYSTEMS, 2.50-3.50 Drug Hepatic (PHP) dose-dependent, &directly (label) 0.62 for Background 3.00 Liver Perfusion 0.25 IN
Slide 11: Annual Cancer Market Opportunity
3 Annual Cancer Ocular (millions) Cholangio Hepatocellular Colorectal Total 1) Notes: 2) Source: Available EUMelanoma Type Revenue Effective 11DELCATH )and Assumes Globocan, LEK, (CRC) Carcinoma Incidence1 US Liver Carcinoma EU Strategy&, per 492,700-495,600 411,000 (OM) &an Annual SYSTEMS, CancerAm
Slide 12: Clinically Differentiated Data from Phase 2 and 3 Trials
Clinically Phase Neuroendocrine Hepatocellular Colorectal o Encouraging 12DELCATH mNET Positive Data1,from 2cohort Differentiated Phase signal and Cancer surgical Initial SYSTEMS, 3Carcinoma in Tumor trials 3with (CRC) Phase results Results Isolated high-dose produced (NET) Results 2Liver in(HCC) IN
Slide 13: Clinical Development Program Overview
Clinical Establish o Initiating Supporting Focused 13DELCATH Commenced Development on global EU proof-of-concept Investigator Liver registry SYSTEMS, global Phase Dominant, to Phase Program 3Initiated collect trial INC in2Orphan 2H Hepatocellular program efficacy Overview Trials 2015Diseases in inan
Slide 14: Clinical Trials Detail
Clinical Global Believed Protocol Safety, unresectable Evaluate Characterize Assess ICC (unresectable Phase confined liver) Signal-seeking Investigator Trials patient HCC Data EU Registry Commercial To collection Assess Safety, Other Tumor Johannes 3selection 2Phase safety, patient efficacy be Trial
Slide 15: Ocular Melanoma Liver Metastases Rationale
OM has annually Currently Believed FDA U.S./EU 5,700-8,600 Cases Melanoma Proven *Sources: 15DELCATH Metastases granted ofEfficacy high Market Ocular Clear tono ACS, Metastasize be~50-55% standard melphalan/HDS incidence SYSTEMS, fastest efficacy Rationale SEER, mited in Size Attractive pathway of ~
Slide 16: Previously Demonstrated Clinically Meaningful Benefit in OM
1.0 Previous Hepatic Proportion 0.8 0 0.0 0.2 0.4 1.7 7.0 0.6 Overall Months Proportion 3.8 1.0 5 10 0.8 0 0.0 0.2 0.4 1.6 5.4 0.6 5.3 5 10atCI 15 15Progression Ocular 5.3 of Best Best Intent-to-Treat Months alive 5-8 mos 20 mo patients Melanoma Chemosaturation Free surviving alternative Progression
Slide 17: ICC Rationale
ICC Rationale Significant commercial Unmet U.S./EU 76,000 ~90% HCC Unresectable Cases Encouraging *Sources: 17DELCATH Diagnosis Interventions ~6,500 medical ~15% Market ACS, market uses Early Eligible ~20-30% SYSTEMS, need Of SEER, Size inopportunity Commercial HCC EU –Patients Delcath NIH, Focal IN
Slide 18: HCC Rationale
HCC granted Significant Large FDA interventions U.S./EU 76,000 Cases Large, TX Cancer *Sources: 18DELCATH Rationale unmet of Deadly 90% Market Primary WHO, opportunity ~80-90% medical melphalan/HDS SYSTEMS, Disease Size KOL Liver need ~20-30% in Interviews, HCC inNeed the INC in Unresectable first-l
Slide 19: Prior FDA Experience and Complete Response Letter
Prior New to Complete www.delcath.com/clinical-research/clinical-bibliography/ as FDA 19DELCATH benefit/risk theDrug Learnings FDA primary Response Application Experience SYSTEMS, analysis efficacy Provide Letter o(NDA) outcome Beneficial Complete INC (CRL) submitted measure issued Clinical FDA & Se
Slide 20: Integrated Safety Risks from Previous Clinical Program
Risks Integrated o with Deaths Treating 20DELCATH 4.1% aobserved Observed median due incidence Physicians safety to certain SYSTEMS, time with inpopulation ofPrevious of in death prior adverse recovery U.S.product due INC and Clinical ofreactions to patients of EU adverse greater and Report Program
Slide 21: Safety Measures and Improvements
Safety New Vasopressors Prophylactic Intra-arterial Liver o Decisive 21DELCATH Address Improve Reduce Prevent generation tumor Improvements Measures cardiovascular risk hepatic risk filter burden nitroglycerin transfusions and of SYSTEMS, ofefficiency filter myelosuppression liver methylprednisolone
Slide 22: Recent Developments and Improved Outcomes
Positive Improved Current Recent o free Authors Patients 22DELCATH >200 Retrospective survival scientific treatments device/procedure Report concluded Developments device (HPFS) SYSTEMS, Improved analysis presentation and with that for procedure improved HPFS of Melphalan/HDS permitting Quality INC
Slide 23: European CHEMOSAT Commercial Activity
European CHEMOSAT® Approved Broad >170 Reimbursement UK Published 23DELCATH Block commercial indication Commercial data as Grants Class SYSTEMS, inHepatic via for peer-reviewed pending procedures IIb Individual intra-hepatic Medical Activity Delivery and INC performed Funding private Device; journal
Slide 24: CHEMOSAT Multiple Treatments/Re-treatments
CHEMOSAT® Multiple Treatments/Re-treatments 24DELCATHTumor SYSTEMS, Commercial Types Treated Increasing INC Treatments Since EUin Launch Europe
Slide 25: Cash Resources and Spending Guidance
Cash Debt ATM Shares March Subject Fully 2014 Q1 Quarterly Focused 25DELCATH A None Operating & Q2 Program1 diluted 31, Outstanding to Capital Cash Spending AActual Guidance market 2015 Q3includes Equivalents SYSTEMS, AResources Cash $40 $4.5M Q4 conditions and 12.2 $million ASpend 5-6M approximate
Slide 26: In Summary
In Summary Melphalan Cancers Unique, Late-stage Compelling Imminent Attractive Experienced 26DELCATHhighly ofvaluation orphan asset Hydrochloride the emerging pharmaceutical SYSTEMS, liver differentiated indrug U.S., remain milestones data business early for INC amanagement multibillion-dollar solut
Slide 27: Concentrating the Power of Chemotherapy
Concentrating © Delcath 2015 DELCATH and CHEMOSAT the Power SYSTEMS, ofare Chemotherapy registered INC. ALL trademarks RIGHTS TM of RESERVED Delcath Systems, Inc.