Full Press Release Details
Delcath Investor Presentation (NASDAQ:
DCTH) February 2017 Exhibit 99.1
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. 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: our ability to repay and comply with the obligations under our senior secured convertible notes, 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 and the impact on sales, if any, of reimbursement in these markets including ZE reimbursement in the German market, 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 remaining 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 U.S. FDA, the impact of presentations and abstracts at major medical meetings and congresses (SSO, ASCO, CIRSE, ESMO, EADO, RSNA) and future clinical results
consistent with the data presented, approval of the current or future Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. 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. 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.
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-Promotion Marketing - Brand Lead; launch team for new indication Clinician and educator with over a decade in Hematology/Oncology/Bone Marrow Transplant Ph.D. (Epidemiology UPMC), M.S. (Nursing, Rochester), B.S.
(Nursing, SUNY-Buffalo)
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 development in the US Pursuing orphan indications in metastatic ocular melanoma (OM), intrahepatic cholangiocarcinoma (ICC), and hepatocellular carcinoma (HCC) Our Mission is to Make a Clinically Meaningful Difference for Patients with
Cancers of the Liver
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 Currently available/emerging therapies limited * SOURCE - 2008 GLOBOCAN
Limitations of Current Liver Cancer
Treatments Systemic Chemotherapy Regional Therapy Surgical Resection Focal Interventions Emerging Therapy Temozolomide, carboplatin/ Paclitaxel Isolated Hepatic Perfusion Y-90, Chemo/ Radiofrequency Ablation Checkpoint Inhibitors, Immunotherapy
Systemic Toxicities Limited efficacy in liver Invasive Not Repeatable Small % of PTS are candidates Limited Efficacy in Diffuse Disease
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 the blood prior to returning it to the patient Repeatable procedure typically takes ~2-3 hours 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
Months Benefits Demonstrated in Prior
Phase 3 Trial Percutaneous Hepatic Perfusion (PHP) Overall Progression Free Survival (INV Assessment) Months 1.0 0.8 0.6 0.4 0.2 0.0 Proportion of patients surviving 5.4 1.6 3.8 mo Best alternative care (BAC) 0 5 10 15 20 25 30 35 40 45 50 55 4 PTS
alive as of Dec 2015 (OS range 6-9 years) All were recipients of melphalan 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
Proportion of patients surviving 7.0 1.6 5.2 mo Percutaneous Hepatic Perfusion (PHP) 0 5 10 15 20 25 30 Best alternative care (BAC) Hepatic Progression Free Survival (IRC Assessment) 1.0 0.8 0.6 0.4 0.2 0.0 Intent to Treat Analysis n=93 (44 PHP, 49
BAC) hPFS PFS Improvement 5.3 mos 3.8 mos Hazard Ratio .50 .42 Confidence 95%, 0.31-0.80 95%, 0.27-0.64 P Value =0.0029 <0.0001
Global Phase III Clinical Trial
Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma Melphalan/HDS TX every 6-8 weeks 6 cycles BAC Dacarbazine,TACE, ipilimumab, or pembrolizumab determined by institution SOC Primary Endpoint (Overall Survival) Secondary
Endpoints (Progression Free Survival, Objective Response Rate) Safety, Pharmacokinetics, QoL (Rigorous Analyses to Assess Risk/Benefit Profile) Multinational, Multicenter Randomized Phase 3 Trial in Patients with Hepatic Dominant Ocular Melanoma
Clinical Development Program Program
Tumor Type P2 P3 Upcoming Milestones 201 HCC Trial (US Only) 202 HCC/ICC Trial (EU Only) Open for enrollment FOCUS Trial P3 Pivotal Study in Hepatic Dominant OM Interim Safety Analysis FDA 2019 Ocular Melanoma (OM)
Hepatocellular Carcinoma (HCC) Intrahepatic Cholangiocarcinoma (ICC) Multi-Histology Prospective Commercial Registry Select IITs (EU Only) Data to Support Health Authority Submissions N/A IIT= Investigator Initiated Trial P2= Phase 2 P3= Phase 3 ICC
Development path informed by retrospective data collection
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 determined efficacy signal prior to completion of the ICC cohort Promising outcomes and observations obtained by EU investigators were presented at Delcath sponsored Medical Advisory Panel in 2016, leading to KOL agreement that
"CHEMOSAT treatment does, indeed, demonstrate an efficacy signal in ICC and is worthy of full clinical investigation" Summary of EU Investigator findings and initial research plans accepted for presentation at Cholangiocarcinoma
Foundation annual meeting Feb 1-3, 2017 Retrospective data currently embargoed pending submission for publication
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 reimbursement applications Leveraging German ZE coverage to support reimbursement applications in the UK & NL Commercial sales growing steadily; expanded reimbursement coverage in major EU countries required to expand commercial adoption
Clinical Utilization ~350 commercial
procedures performed EU Physicians opting to retreat patients as familiarity/confidence grows UK Patient received record 7th TX in Jan 2017 Established in treating centers as preferred TX for OM liver mets where reimbursement is available Broad
range of tumor types treated; EU physicians utilizing for CM, HCC, ICC, CRC, breast mets, NET mets, pancreatic, mucosal melanoma, sarcoma, and gastric mets Data from EU experience presented at multiple medical conferences since 2014
Recent Data Presentations Abstract
N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager - SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1
CR ongoing >1yr LUMC - CIRSE 10 Study analyzed filtration efficiency & TX tolerability GR3 (n=7) Filtration efficiency =93% Southampton - CIRSE 22 2 13 2 11 pts alive median 280 days; 1 CR >1yr post TX Leiden, Erasmus - ECCO/ESMO 9 8
PTS still alive, 7 w/o disease progression Decrease red/white BC count; 3 PTS rec'd blood TF TX overall well tolerated Southampton -EADO 20 1 4 11 181 days (@ cut off) Non-hemo AE's (n=3) GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) TX
can be used safely by exp team; high PFS and OS in select OM pts Leiden - EADO 20 (CRC, OM) 10 PTS remain in FU, 4 w/o progression; Max FU= GR 3,4 (n=4) TX appears safe/effective in select OM PTS Frankfurt - EADO 14 4 5 7 leukopenia, 6
thrombocytopenia, 2 neutropenia 11 of 14 PTS evaluable; TX potential demonstrated CM=Cutaneous Melanoma, OM=Ocular Melanoma, CRC=Colorectal Cancer
Recent Data Presentations Abstract
N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager - SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1
CR ongoing >1yr LUMC - CIRSE 10 Study analyzed filtration efficiency & TX tolerability GR3 (n=7) Filtration efficiency =93% Southampton - CIRSE 22 2 13 2 11 pts alive median 280 days; 1 CR >1yr post TX Leiden, Erasmus - ECCO/ESMO 9 8
PTS still alive, 7 w/o disease progression Decrease red/white BC count; 3 PTS rec'd blood TF TX overall well tolerated Southampton -EADO 20 1 4 11 181 days (@ cut off) Non-hemo AE's (n=3) GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) TX
can be used safely by exp team; high PFS and OS in select OM pts Leiden - EADO 20 (CRC, OM) 10 PTS remain in FU, 4 w/o progression; Max FU= GR 3,4 (n=4) TX appears safe/effective in select OM PTS Frankfurt - EADO 14 4 5 7 leukopenia, 6
thrombocytopenia, 2 neutropenia 11 of 14 PTS evaluable; TX potential demonstrated CM=Cutaneous Melanoma, OM=Ocular Melanoma, CRC=Colorectal Cancer
Recent Data Presentations Abstract
N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager - SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1
CR ongoing >1yr LUMC - CIRSE 10 Study analyzed filtration efficiency & TX tolerability GR3 (n=7) Filtration efficiency =93% Southampton - CIRSE 22 2 13 2 11 pts alive median 280 days; 1 CR >1yr post TX Leiden, Erasmus - ECCO/ESMO 9 8
PTS still alive, 7 w/o disease progression Decrease red/white BC count; 3 PTS rec'd blood TF TX overall well tolerated Southampton -EADO 20 1 4 11 181 days (@ cut off) Non-hemo AE's (n=3) GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) TX
can be used safely by exp team; high PFS and OS in select OM pts Leiden - EADO 20 (CRC, OM) 10 PTS remain in FU, 4 w/o progression; Max FU= GR 3,4 (n=4) TX appears safe/effective in select OM PTS Frankfurt - EADO 14 4 5 7 leukopenia, 6
thrombocytopenia, 2 neutropenia 11 of 14 PTS evaluable; TX potential demonstrated CM=Cutaneous Melanoma, OM=Ocular Melanoma, CRC=Colorectal Cancer
Recent Data Presentations Abstract
N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager - SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1
CR ongoing >1yr LUMC - CIRSE 10 Study analyzed filtration efficiency & TX tolerability GR3 (n=7) Filtration efficiency =93% Southampton - CIRSE 22 2 13 2 11 pts alive median 280 days; 1 CR >1yr post TX Leiden, Erasmus - ECCO/ESMO 9 8
PTS still alive, 7 w/o disease progression Decrease red/white BC count; 3 PTS rec'd blood TF TX overall well tolerated Southampton -EADO 20 1 4 11 181 days (@ cut off) Non-hemo AE's (n=3) GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) TX
can be used safely by exp team; high PFS and OS in select OM pts Leiden - EADO 20 (CRC, OM) 10 PTS remain in FU, 4 w/o progression; Max FU= GR 3,4 (n=4) TX appears safe/effective in select OM PTS Frankfurt - EADO 14 4 5 7 leukopenia, 6
thrombocytopenia, 2 neutropenia 11 of 14 PTS evaluable; TX potential demonstrated CM=Cutaneous Melanoma, OM=Ocular Melanoma, CRC=Colorectal Cancer
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 Percutaneous Hepatic Perfusion in Patients with
Unresectable Hepatic Metastases: Review of Outcomes, Cancer Control - Accepted for Publication Chemosaturation Percutaneous Hepatic Perfusion: A Systemic Review, Advances in Therapy - January 2017 Percutaneous Isolated Hepatic Perfusion
for the Treatment of Unresectable Liver Malignancies, Cardiovascular and Interventional Radiology - December 2015 Current Status of Percutaneous Hepatic Perfusion as Regional Treatment for Patients with Unresectable Metastases: A Review,
American Oncology and Hematology Review - 2014 Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable Metastatic Melanoma or Sarcoma to the Liver: A Single Institution Experience, Journal of Surgical Oncology - October 2013
and Isolated Hepatic Perfusion for Metastatic Melanoma, Journal of Surgical Oncology - September 2013
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 New Data accepted for oral presentation Retrospective analysis conducted by Moffitt
Cancer Center/University of South Florida (Tampa, FL) and University of Southampton (Southampton, United Kingdom) Data also accepted for presentation as a poster at the Society of Surgical Oncology (March 15-18, 2017)
CIRSE 2016 Secondary Resectability
of 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 treatments was 71.4%; PFS was 9.9 months, HPFS was 11.2 months Median survival for the study has not yet been reached, but is higher than 16.9 months. Two patients showed secondary resectability on imaging after completing two
treatments and remain alive for over 26 months following resections no adverse events of grade 3 or higher Conclusions - CHEMOSAT is safe to use in these patients; significant downsizing of OM liver metastases can be achieved; "if these
promising results were further validated it may lead to a new standard of therapy for the treatment of patients with OM liver metastases." Percutaneous Isolated Hepatic Perfusion (Chemosaturation) In Patients With Primary Or Secondary Liver
Tumours: Experience In 20 Patients, by S. Marquardt et al., of Hanover Medical School in Hanover, Germany Retrospective analysis of 20 pts with advanced disease from primary or metastatic liver cancers local response rate (stable disease or partial
response) was 80% Mean PFS was 3.2 months Investigators reported no major complications and that bone marrow suppression was common but controllable Conclusion - patients with primary or secondary liver tumors that have disease progression under
standard therapy "may profit from PHP with Melphalan," that technical execution is problem-free, and complications are manageable.
6th 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 of survival, tumor response, time to progression and treatment related adverse events; 25 patients received 43 treatments, 24 were evaluable Results - 14 patients remained alive after median 290 days 1 complete