Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (February 2019)
24 slides from Delcath Systems's investor presentation, February 2019
Slide 1: Delcath Investor Presentation
Delcath Investor Presentation (OTCQB: DCTH) February 2019 DELCATH SYSTEMS, INC 1
Slide 2: Forward-looking Statements
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, a
Slide 3: Management Team
Management Team ◆ Jennifer Simpson, PhD., M.S.N., C.R.N.P. - President & Chief Executive Officer Named President and CEO of Delcath in May of 2015. Dr. Simpson previously served as Interim President and Chief Executive Officer of Delcath and as Interim Co-President and Co-Chief Executive Officer. Sh
Slide 4: Delcath Systems
Delcath Systems ◆ Interventional oncology company focused on treatment of primary/metastatic liver cancers ◆ Proprietary percutaneous hepatic perfusion (PHP) system delivers high-dose chemotherapy (melphalan) directly to the liver with extra-corporeal filtration to minimize systemic toxicity ◆ Comme
Slide 5: Our Solution – Liver Focused Disease Control
Our Solution – Liver Focused Disease Control ◆ CHEMOSAT® Melphalan/HDS product uniquely positioned to treat the entire liver as a standalone or a complementary therapy ◆ System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), and filters most chemotherapy ou
Slide 6: Cancers of the Liver - A Major Unmet Medical Need
Cancers of the Liver - A Major Unmet Medical Need ◆ Large global patient population of ~1.2 million* patients diagnosed annually with primary or metastatic liver cancer ◆ Liver a common site of metastases and often the life-limiting organ for cancer patients ◆ Prognosis is poor, overall survival (OS
Slide 7: Limitations of Current Liver Cancer Treatments
Limitations of Current Liver Cancer Treatments Systemic Regional Surgical Focal Emerging Chemotherapy Therapy Resection Interventions Therapy Temozolomide, Isolated Y-90, Chemo/ Checkpoint carboplatin, Hepatic Radiofrequency Inhibitors, Paclitaxel, Perfusion Ablation/TACE Immunotherapy Dacarbazine (
Slide 8: Building Shareholder Value Through Clinical Development
Building Shareholder Value Through Clinical Development Tumor Type Program Notes Milestones ✓ FPI Amended Trial • Fastest Path to U.S. ✓ Interim Safety FOCUS Trial Market Approval Ocular Melanoma Analysis Aug 2018 P3 Pivotal Study in • Amended Protocol (OM) • Rollout of amended Hepatic Dominant OM J
Slide 9: Amended Global Phase III Clinical Trial
Amended Global Phase III Clinical Trial Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma Primary Endpoint (Objective Response Rate) Multinational, Multicenter Non-Randomized Melphalan/HDS Secondary Endpoints (Duration of Response, Disease Registration Trial in Patients TX every 6-8
Slide 10: Recent Data Provides Confidence: Overall Survival Signal
Recent Data Provides Confidence: Overall Survival Signal Hepatic Progression-free and Overall Survival After Regional Therapy to the Liver for Metastatic Melanoma, Moffitt Cancer Center (AJCO) ♦ Analysis of 3 non-randomized approaches for treatment of 30 patients with liver metastases primarily resu
Slide 11: Recent Data Provides Confidence: Limits of Immunotherapy in OM
Recent Data Provides Confidence: Limits of Immunotherapy in OM PD-L1 Expression In Tumor Metastasis Is Different Between Uveal Melanoma And Cutaneous Melanoma – A. Javed, D. Arguello, et al (Thomas Jefferson University, Caris Life Sciences) Immunotherapy, Nov 2017 ♦ PD-L1 expression on melanoma cell
Slide 12: Recent Data Provides Confidence: Largest Dataset Outside Clinical Trial
Recent Data Provides Confidence: Largest Dataset Outside Clinical Trial Percutaneous Hepatic Perfusion (PHP) for unresectable metastatic ocular melanoma to the liver: A Multi-institutional report of outcomes – Moffitt Cancer Center, University Hospital Southampton (Journal Surgical Oncology – Jan 20
Slide 13: Recent Data Provides Confidence: Prospective Data Presented at CIRSE
Recent Data Provides Confidence: Prospective Data Presented at CIRSE Percutaneous Hepatic Perfusion in Patients with Unresectable Liver Metastases from Ocular Melanoma using Delcath Systems’ Second Generation (GEN 2) Hemofiltration System: A Prospective Phase 2 Study - Leiden University Medical Cent
Slide 14: ICC Development Path
ICC Development Path ◆ Phase 2 ICC Cohort initiated to determine efficacy signal ◆ Patient treatment and data collection continuing; interim data to be released upon maturity ◆ Concurrently a multi-center retrospective data collection by EU investigators was conducted in 2015 and determined efficacy
Slide 15: Multi-Center ICC Outcomes Data Published in European Radiology
Multi-Center ICC Outcomes Data Published in European Radiology Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic Cholangiocarcinoma: European Multicentre Study on Safety, Short Term Effects and Survival, European Radiology 2018, Marquardt, et al ♦ Study ev
Slide 16: The ALIGN Trial - Global Pivotal Trial in ICC
The ALIGN Trial - Global Pivotal Trial in ICC A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarci
Slide 17: Focused On Fastest Path To U.S. Market
Focused On Fastest Path To U.S. Market EU & US Total Addressable Market Annual Potential Market Cancer Type Annual Incidence1 Eligible PTS2 Opportunity (Millions)3,4 Ocular Melanoma ~4,700 ~2,000 ~$80-$200 Orphan Indications Intrahepatic Cholangiocarcinoma ~14,000 ~9,300 ~$372-$930 (ICC) Colorectal
Slide 18: Broad Device Indication in Europe Demonstrates Potential
Broad Device Indication in Europe Demonstrates Potential ◆ Device label permits use in broad range of primary & Tumor Types Treated metastatic liver cancers ◆ 13 tumor types treated since CHEMOSAT launch ◆ Presence established in several major markets (~22 cancer centers) ◆ ~600 commercial procedure
Slide 19: European Commercialization – medac Licensing
European Commercialization – medac Licensing ◆ Licensing agreement announced December 2018 ◆ Extensive network throughout Europe ◆ €6 million in upfront and milestone payments ◆ Allows Delcath to focus on Clinical ◆ Fixed transfer price and royalty payments Development Program ◆ Agreement includes E
Slide 20: Recent Financing Activity
Recent Financing Activity ◆ Sold $5.0 million of common stock and warrants in Feb 2018 for net proceeds of approx. $4.6 million ◆ Issued $9.4 million in convertible notes and warrants between June – September 2018 for net cash proceeds of approx. $6.3 million ◆ $50.0 million rights offering & backst
Slide 21: Cash & Capital Resources
Cash & Capital Resources Cash $8.9 million at September 30, 2018 11.2 million (76.0 million fully diluted1) at January 18, Shares Outstanding 2019 Debt $4.5 million at November 30, 2018 1) Fully diluted includes approximately 64.8 million warrants DELCATH SYSTEMS, INC 21 21
Slide 22: 2018 Milestones
2018 Milestones ◆ medac Licensing Agreement ◆ Dose first patient in Phase 3 ICC clinical trial ◆ Data publication from ICC retrospective analysis ◆ Phase 3 OM Trial Amendment ◆ Presentations at major meetings (ECIO, SSO, CIRSE) DELCATH SYSTEMS, INC 22
Slide 23: Summary
Summary ◆ Late-stage clinical development with OM registration trial expected to complete accrual in June 2019 ◆ Focused on cancers of the liver with high unmet medical need & no established SOC ◆ Commercial experience from Europe & recent clinical data provide confidence in clinical development pat
Slide 24: Delcath Systems trademark notice
DELCATH SYSTEMS, INC 24 © 2019 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED 24 Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.
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