Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (March 2017)
34 slides from Delcath Systems's investor presentation, Mar 9, 2017
Slide 1: Delcath Investor Presentation
Exhibit 99.1 Delcath Investor Presentation (NASDAQ: DCTH) March 2017
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: Jennifer Simpson, PhD., MSN, CRNP
Jennifer Simpson, PhD., MSN, CRNP Named CEO & President of Delcath in May of 2015. Prior Pharmaceutical Roles at ImClone/Lilly/Johnson & Johnson Experience: Product development and commercialization of late stage asset across 5 indications. Field Research and clinical trial experience Led Co-Promoti
Slide 4: Delcath Systems
Delcath Systems Interventional oncology Company focused on treatment of primary/metastatic liver cancers Proprietary system delivers high-dose chemotherapy (melphalan) directly to the liver with extra-corporeal filtration to limit systemic toxicity Commercial Stage in the EU Late-stage clinical deve
Slide 5: 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, OS generally <12 months Cu
Slide 6: 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 Immunotherapy Systemic Toxicities
Slide 7: 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 as complementary therapy System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), filters most chemotherapy out of th
Slide 8: Benefits Demonstrated in Prior Phase 3 Trial
Benefits Demonstrated in Prior Phase 3 Trial Results of a Randomized Controlled Multicenter Phase 3 Trial of PHP vs. Best Available Care for Patients with Melanoma Liver Metastases – Annals of Oncology 2015 Hepatic Progression Free Survival (IRC Assessment) Overall Progression Free Survival (INV Ass
Slide 9: Global Phase III Clinical Trial
Global Phase III Clinical Trial Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma Primary Endpoint (Overall Survival) Melphalan/HDS TX every 6-8 weeks 6 Multinational, Multicenter cycles Randomized Phase 3 Trial in Secondary Endpoints (Progression Free Survival, Patients with Hepatic
Slide 10: Clinical Development Program
Clinical Development Program Tumor Type Program P2 P3 Upcoming Milestones FOCUS Trial • Interim Safety Ocular Melanoma Analysis P3 Pivotal Study in (OM) Hepatic Dominant OM • FDA 2019 Hepatocellular 201 HCC Trial • Open for Carcinoma (US Only) enrollment (HCC) • ICC Development Intrahepatic 202 HCC/
Slide 11: ICC Development Path
ICC Development Path Phase 2 ICC Cohort initiated to determine if efficacy signal present ICC Cohort: 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 d
Slide 12: Initial Commercialization
Initial Commercialization CE Marked as Class IIb Medical Device with broad indication Presence established in several major markets (~22 cancer centers) National reimbursement established in Germany for 2016 after <3 years of commercial activity European centers producing data to support reimburseme
Slide 13: Clinical Utilization
Clinical Utilization ~350 commercial procedures performed EU Physicians opting to retreat patients as familiarity/confidence grows th UK Patient received record 7 TX in Jan 2017 Established in treating centers as preferred TX for OM liver mets where reimbursement is available Broad range of tumor ty
Slide 14: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 OS results provide 736 310 (CM, confidence for new days days OM) P3 Trial GR1 (n=12), GR2 11 pts alive median Southampton - ASCO 20 2 13 2 (n=13), GR3 (n=5) 280 days, 1 CR GR4 (n=1) ongoing > 1yr 10 Stu
Slide 15: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 OS results provide 736 310 (CM, confidence for new days days OM) P3 Trial GR1 (n=12), GR2 11 pts alive median Southampton - ASCO 20 2 13 2 (n=13), GR3 (n=5) 280 days, 1 CR GR4 (n=1) ongoing > 1yr 10 Stu
Slide 16: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 OS results provide 736 310 (CM, confidence for new days days OM) P3 Trial GR1 (n=12), GR2 11 pts alive median Southampton - ASCO 20 2 13 2 (n=13), GR3 (n=5) 280 days, 1 CR GR4 (n=1) ongoing > 1yr 10 Stu
Slide 17: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 OS results provide 736 310 (CM, confidence for new days days OM) P3 Trial GR1 (n=12), GR2 11 pts alive median Southampton - ASCO 20 2 13 2 (n=13), GR3 (n=5) 280 days, 1 CR GR4 (n=1) ongoing > 1yr 10 Stu
Slide 18: Peer Reviewed Publications
Peer Reviewed Publications Hepatic Progression-free and Overall Survival After Regional Therapy to the Liver for Metastatic Melanoma – American Journal of Clinical Oncology – Accepted for Publication Chemosaturation with PercutaneousHepatic Perfusion in Patients with Unresectable Hepatic Metastases:
Slide 19: 2017 International Symposium on Regional Cancer Therapies
2017 International Symposium on Regional Cancer Therapies Percutaneous Hepatic Perfusion (PHP) for unresectable metastatic ocular melanoma to the liver: A Multi-institutional report of outcomes o New Data accepted for oral presentation o Retrospective analysis conducted by Moffitt Cancer Center/Univ
Slide 20: CIRSE 2016
CIRSE 2016 Secondary Resectabilityof Ocular Melanoma Liver Metastases (OMLM) Following Percutaneous Hepatic Perfusion (PFP) by M. Zeile, et al. Asklepios Barmbek Clinic (Hamburg, Germany) • evaluated 7 patients with unresectable ocular melanoma liver metastases treated with CHEMOSAT • ORR after 1-2
Slide 21: European Post-Chicago 2016
th 6 European Post-Chicago 2016 Chemosaturation Via Percutaneous Hepatic Perfusion – An Update on A Single Centre Experience of Treating Metastatic Uveal Melanoma Southampton University (United Kingdom) Methods – A retrospective evaluation of 27 patients treated with CHEMOSAT over 4 years; analysis
Slide 22: Multi-Billion Dollar Opportunity in Orphan Diseases
Multi-Billion Dollar Opportunity in Orphan Diseases EU & US TAM Annual Potential 1 2 Cancer Type Annual Incidence Eligible PTS Market Opportunity Fastest (Millions)3,4 Path to Ocular Melanoma ~4,700 ~ 2,000 ~$80-$200 US Market Approval Intrahepatic Cholangiocarcinoma(ICC) ~14,000 ~ 9,300 ~ $372-$930
Slide 23: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $3.7 million at September 30, 2016 Debt $35.0 million at September 30, 2016 Restricted Cash $30.3 million at September 30, 2016 1 2 Shares Outstanding 70.6 million (77.9 million fully diluted ) at March 7, 2017 1) Fully diluted includes approximately
Slide 24: Convertible Note
Convertible Note $35.0 million senior secured convertible notes issued June 2016 subject to certain equity conditions $32.2 million aggregate proceeds to fund clinical development programs, commercial activities & ongoing operations $6.0 million released; $26.2 million restricted cash remaining and
Slide 25: 2017 Value Drivers
2017 Value Drivers 2H 2016 • German ZE Reimbursement Defined • Phase2/Retrospective Data Collection Informed ICC Development Path • EU Health Authority Submissions 1H 2017 •ICC Development Path Finalized 2H 2017 • FOCUS P3 Interim Safety Analysis 25 DELCATH SYSTEMS, INC
Slide 26: Investment Highlights
Investment Highlights Attractive multi-billion dollar orphan drug business model Unique, highly differentiated solution Late-stage asset in US with active clinical development program Commercial activity in EU supports increasing procedure volumes & reimbursement appeals Imminent valuation drivers o
Slide 27: DELCATH SYSTEMS, DELCATH
© 272017 DELCATH DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.
Slide 28: Appendix
Appendix 28 DELCATH SYSTEMS, INC
Slide 29: SSO 2015
SSO 2015 Hepatic Progression Free and Overall Survival after Regional Therapy to the Liver for Metastatic Melanoma - Moffitt Cancer Center (Tampa, FL) • Methods – o Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated with Melphalan/HDS (n=10), chemoembolization (CE, n=12)
Slide 30: ASCO 2015
ASCO 2015 Single Centre Experience of Chemosaturation Percutaneous Hepatic Perfusion in the Treatment of Metastatic Uveal Melanoma - Southampton University Hospital (UK) • Methods - Analysis of 20 ocular melanoma patients who received 34 TX • Results - o Eleven patients remain alive after a median o
Slide 31: CIRSE 2015
CIRSE 2015 nd Safety and efficacy of Delcath 2 Generation filter in PHP with melphalan for unresectable hepatic metastases of colorectal cancer and uveal melanoma - Leiden University Medical Center (the Netherlands) • 15 PHP procedures performed with CHEMOSAT on 10 pts; PK blood samples @ baseline,
Slide 32: ECCO 2015
ECCO 2015 Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers - Leiden University Medical Center, Erasmus Medical Center (the Netherlands) • Methods - Investigators compared TX with IHP and PHP f
Slide 33: EADO 2015
EADO 2015 Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, Leiden University Medical Center, Erasmus Cancer Institute (the Netherlands) presented by Dr. Mark Burgmans (Leiden) • Methods - two-center Phase 2 study aims to evaluate 20 patient
Slide 34: EADO 2015
EADO 2015 Chemosaturation with Percutaneous Hepatic Perfusion of Melphalan for Hepatic Metastases from Uveal Melanoma: Multi-institutional Evaluation, poster presented by lead author Prof. Thomas Vogl, Frankfurt University Hospital • Methods - retrospective evaluation of non-resectable hepatic metas