UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report: March 9, 2017
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-16133 | 06-1245881 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
1633 Broadway, Suite 22C, New York, New York 10019
(Address of principal executive offices, including zip code)
(212) 489-2100
(Registrant’s telephone number, including area code)
NONE
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure |
Delcath Systems, Inc. (the “Company”) is furnishing this Current Report on Form 8-K in connection with the disclosure of information contained in an investor presentation (the “Presentation”) to be used by the Company at various meetings. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K or other means. A copy of the Presentation is furnished herewith as Exhibit 99.1 and is incorporated into this Item 7.01 by reference.
The information furnished in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any registration statement filed pursuant to the Securities Act of 1933, as amended, except as may be expressly set forth by specific reference in such filing.
The Company expressly disclaims any obligation to update or revise any of the information contained in the Presentation.
The Presentation is available on the Company’s investor relations website located at delcath.com/investors, although the Company reserves the right to discontinue that availability at any time.
| Item 8.01. | Other Events. |
As of the close of business on March 7, 2017, there were 70.6 million shares of the Company’s common stock outstanding.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit 99.1 | Investor Presentation dated March, 2017. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||||
| Dated: March 9, 2017 | By: | /s/ Jennifer K. Simpson, Ph.D. | ||||||
| Name: | Jennifer K. Simpson, Ph.D. | |||||||
| Title: | President and Chief Executive Officer | |||||||
EXHIBIT INDEX
| Exhibit 99.1 | Investor Presentation dated March, 2017. |
 Delcath Investor Presentation (NASDAQ: DCTH) March 2017 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. 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. |
 3 DELCATH SYSTEMS, INC 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) |
 4 DELCATH SYSTEMS, INC 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 |
 5 DELCATH SYSTEMS, INC 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 |
 6 DELCATH SYSTEMS, INC 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 |
 7 DELCATH SYSTEMS, INC 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 |
 8 DELCATH SYSTEMS, INC Months Benefits Demonstrated in Prior Phase 3 Trial Percutaneous Hepatic Perfusion (PHP) Overall Progression Free Survival (INV Assessment) 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) Improvement Hazard Ratio Confidence P Value hPFS 5.3 mos .50 95%, 0.31-0.80 =0.0029 PFS 3.8 mos .42 95%, 0.27-0.64 <0.0001 Months |
 9 DELCATH SYSTEMS, INC Global Phase III Clinical Trial Multinational, Multicenter Randomized Phase 3 Trial in 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) R 1:1 Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma (N=240) |
 10 DELCATH SYSTEMS, INC 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 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 Ocular Melanoma (OM) |
 11 DELCATH SYSTEMS, INC 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 |
 12 DELCATH SYSTEMS, INC 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 |
 13 DELCATH SYSTEMS, INC Clinical Utilization ~350 commercial procedures performed EU Physicians opting to retreat patients as familiarity/confidence grows UK Patient received record 7 th 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 CM=Cutaneous Melanoma, OM=Ocular Melanoma,
CRC=Colorectal Cancer OS results provide
confidence for new P3 Trial 30 (CM, OM) Abstract Efficacy Notes Toxicity/AEs N= OS CR PR SD HPFS 736 days 310 days Zager – SSO 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 10 22 9 20 14 20 (CRC, OM) LUMC - CIRSE Southampton - CIRSE Leiden, Erasmus – ECCO/ESMO Southampton - EADO Leiden - EADO Frankfurt - EADO Study analyzed filtration efficiency & TX tolerability 2 13 2 1 4 11 4 5 8 PTS still alive, 7 w/o disease progression 10 PTS remain in FU, 4 w/o progression; Max FU= GR3 (n=7) Decrease red/white BC count; 3 PTS rec’d blood TF GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) GR 3,4 (n=4) Non-hemo AE’s (n=3) 7 leukopenia, 6 thrombocytopenia, 2 neutropenia Filtration efficiency =93% 11 pts alive median 280 days; 1 CR > 1yr post TX 11 of 14 PTS evaluable; TX potential demonstrated TX can be used safely by exp team; high PFS and OS in select OM pts TX appears safe/effective in select OM PTS TX overall well tolerated 14 DELCATH SYSTEMS, INC 181 days (@ cut off) |
 Recent
Data Presentations CM=Cutaneous Melanoma, OM=Ocular Melanoma,
CRC=Colorectal Cancer OS results provide
confidence for new P3 Trial 30 (CM, OM) Abstract Efficacy Notes Toxicity/AEs N= OS CR PR SD HPFS 736 days 310 days Zager – SSO 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 10 22 9 20 14 20 (CRC, OM) LUMC - CIRSE Southampton - CIRSE Leiden, Erasmus – ECCO/ESMO Southampton - EADO Leiden - EADO Frankfurt - EADO Study analyzed filtration efficiency & TX tolerability 2 13 2 1 4 11 4 5 8 PTS still alive, 7 w/o disease progression 10 PTS remain in FU, 4 w/o progression; Max FU= GR3 (n=7) Decrease red/white BC count; 3 PTS rec’d blood TF GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) GR 3,4 (n=4) Non-hemo AE’s (n=3) 7 leukopenia, 6 thrombocytopenia, 2 neutropenia Filtration efficiency =93% 11 pts alive median 280 days; 1 CR > 1yr post TX 11 of 14 PTS evaluable; TX potential demonstrated TX can be used safely by exp team; high PFS and OS in select OM pts TX appears safe/effective in select OM PTS TX overall well tolerated 15 DELCATH SYSTEMS, INC 181 days (@ cut off) |
 Recent
Data Presentations CM=Cutaneous Melanoma, OM=Ocular Melanoma,
CRC=Colorectal Cancer OS results provide
confidence for new P3 Trial 30 (CM, OM) Abstract Efficacy Notes Toxicity/AEs N= OS CR PR SD HPFS 736 days 310 days Zager – SSO 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 10 22 9 20 14 20 (CRC, OM) LUMC - CIRSE Southampton - CIRSE Leiden, Erasmus – ECCO/ESMO Southampton - EADO Leiden - EADO Frankfurt - EADO Study analyzed filtration efficiency & TX tolerability 2 13 2 1 4 11 4 5 8 PTS still alive, 7 w/o disease progression 10 PTS remain in FU, 4 w/o progression; Max FU= GR3 (n=7) Decrease red/white BC count; 3 PTS rec’d blood TF GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) GR 3,4 (n=4) Non-hemo AE’s (n=3) 7 leukopenia, 6 thrombocytopenia, 2 neutropenia Filtration efficiency =93% 11 pts alive median 280 days; 1 CR > 1yr post TX 11 of 14 PTS evaluable; TX potential demonstrated TX can be used safely by exp team; high PFS and OS in select OM pts TX appears safe/effective in select OM PTS TX overall well tolerated 181 days (@ cut off) 16 DELCATH SYSTEMS, INC |
 Recent
Data Presentations CM=Cutaneous Melanoma, OM=Ocular Melanoma,
CRC=Colorectal Cancer OS results provide
confidence for new P3 Trial 30 (CM, OM) Abstract Efficacy Notes Toxicity/AEs N= OS CR PR SD HPFS 736 days 310 days Zager – SSO 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 10 22 9 20 14 20 (CRC, OM) LUMC - CIRSE Southampton - CIRSE Leiden, Erasmus – ECCO/ESMO Southampton - EADO Leiden - EADO Frankfurt - EADO Study analyzed filtration efficiency & TX tolerability 2 13 2 1 4 11 4 5 8 PTS still alive, 7 w/o disease progression 10 PTS remain in FU, 4 w/o progression; Max FU= GR3 (n=7) Decrease red/white BC count; 3 PTS rec’d blood TF GR2 (89%), GR3 (n=4), GR2-4 neutropenia (n=4) GR 3,4 (n=4) Non-hemo AE’s (n=3) 7 leukopenia, 6 thrombocytopenia, 2 neutropenia Filtration efficiency =93% 11 pts alive median 280 days; 1 CR > 1yr post TX 11 of 14 PTS evaluable; TX potential demonstrated TX can be used safely by exp team; high PFS and OS in select OM pts TX appears safe/effective in select OM PTS TX overall well tolerated 17 DELCATH SYSTEMS, INC 181 days (@ cut off) |
 18 DELCATH SYSTEMS, INC 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 |
 19 DELCATH SYSTEMS, INC 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/University of South Florida
(Tampa, FL) and University of Southampton (Southampton, United Kingdom)
o Data also accepted for presentation as a poster at the Society of Surgical Oncology (March 15-
18, 2017) |
 20 DELCATH SYSTEMS, INC 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. |
 21 DELCATH SYSTEMS, INC 6 th 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 o 1 complete response (4%), 5 partial responses (21%), 12(50%) stable disease >90 days
o Progression free survival for patients who had progressed was 181 days at the time of data cut
off o 11/17 patients alive >1 year following their first treatment with projected OS of 511
o 11 deaths from disease progression occurred median 264 days following first treatment; no
treatment related deaths
Adverse Events (AEs) - treatment overall was well tolerated o Non-hematological AEs were rare (6) o Most common adverse events was transient, mild grade 2 transaminitis (64%) and thrombocytopenia (88%); grade 3 anemia seen in 36% of patients, grade 2-4 neutropenia was seen in 24% patients Conclusion – PHP achieves “unprecedented progression free and overall survival,” and can be
used safely by an experienced multidisciplinary team to administer liver directed
therapy in select UM patients. |
 22 DELCATH SYSTEMS, INC Multi-Billion Dollar Opportunity in Orphan Diseases EU & US TAM Cancer Type Annual Incidence 1 Eligible PTS 2 Annual Potential Market Opportunity (Millions) 3,4 Ocular Melanoma 4,700 2,000 $80-$200 Intrahepatic Cholangiocarcinoma (ICC) 14,000 9,300 $372-$930 Hepatocellular Carcinoma (HCC) 64,500 7,600-14,700 ~$304-$1,470 Colorectal (CRC) 411,000 40,000-55,000 $1,600-$5,500 Total EU & U.S. 492,700-495,600 56,700-80,500 $2,236--$8,100 Notes: 1) Globocan, American Cancer Society 2) LEK, Strategy&, Company Estimates 3) Assumes 2-4TX/patient 4) Assumes ~$20,000-$25,000 USD/TX Fastest Path to US Market Approval ~ ~ ~ ~ ~ ~ ~ ~ |
 23 DELCATH SYSTEMS, INC 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 Shares Outstanding 70.6 million (77.9 million fully diluted 1 ) 2 at March 7, 2017 1) Fully diluted includes approximately 0.1 million options, 0.1 million unvested restricted shares and 7.2 million warrants
2) Amortization of Convertible Note will cause delay in accurate calculation of market capitalization
Focused Spending and Resources to Support Execution of Near-term Plan
|
 24 DELCATH SYSTEMS, INC 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 scheduled to be released quarterly throughout 2017 Repayment using common shares began in December 2016; amortization is scheduled to continue through December 2017 Repayment in $2.5 million installments to the holders Anticipate repayment via shares at 15% discount to the lower of: 1. Average of three lowest VWAPS from prior 20 trading days, or 2. VWAP of the common stock on the trading day immediately preceding the installment date |
 25 DELCATH SYSTEMS, INC 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 |
 26 DELCATH SYSTEMS, INC 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 FOCUS P3 Interim Safety Analysis o ICC Indication Development Plan Finalized |
 27 DELCATH SYSTEMS, INC © 2017 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc. |
 28 DELCATH SYSTEMS, INC Appendix |
 29 DELCATH SYSTEMS, INC 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), and yttrium-90 (Y90,
n=6) • Results - o Study showed significant difference in hepatic progression free survival (HPFS) for
Melphalan/HDS (310 days), CE (80 days), Y90 (54 days)
o Median overall survival (OS) longest for Melphalan/HDS (736 days) vs Y90 (285 days) CE (265 days), but did not reach statistical significance • Conclusion -
Authors concluded that HPFS and progression free survival (PFS) were
significantly prolonged with Melphalan/HDS vs CE and Y90
|
 30 DELCATH SYSTEMS, INC 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 of 280 days with one complete response ongoing
at >1 year o From the diagnosis of liver metastases, 11 patients (55%) survived to one year and 3 (15%) for
>2 years; no procedure related deaths were seen
o ORR 85%: 2 patients (10%) demonstrated stable disease for >3 months, 13 patients (65%)
had a partial response, 2 patients (10%) demonstrated complete response
o Nine deaths from disease progression occurred after a median of 264 days from the first
procedure • Adverse Events - o Early AEs often expected with percutaneous hepatic perfusion (PHP) were observed including
coagulopathy, electrolyte disturbances and transient transaminases (elevated liver
enzymes).
Rare late AEs (1 patient each) included hair loss, skin rash, myelosuppression and
persistent transaminases (elevated liver enzymes)
o AEs seen were grade 1 (n=12), 2 (n=13), 3 (n=5) and 4 (n=1) o Grade 4 complication was pulmonary edema due to fluid overload • Conclusion - results show that PHP (CHEMOSAT) can be used safely to control hepatic metastases in selected UM patients with a high rate of hepatic progression free and excellent overall
survival |
 31 DELCATH SYSTEMS, INC CIRSE 2015 Safety and efficacy of Delcath 2 nd 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, set
intervals • PHP performed with melphalan dose of 3mg/kg; 1st blood sample filtration efficiency = 93% • Grade 3 complications (mostly leukocytopenia, thrombocytopenia) in 7 pts; febrile neutropenia
(w/bacterial pharyngitis) in 1 pts (not seen following introduction of growth factors)
• Conclusion - 2 nd Generation filter efficiency very high; PHP associated with no mortality and acceptable morbidity Lessons and Early Results from the Largest Single Center Experience in Europe of Treating
Ocular Melanoma Liver Metastases with Chemosaturation via Percutaneous Hepatic Perfusion - Southampton University (United Kingdom) • Retrospective analysis of 22 pts; 20 received TX w/PHP • 11 pts alive after median 280 days; one complete response > 1yr post TX • 9 deaths from disease progress after median 264 days post TX • Complete response in liver in 2 pts (10%), 13 pts (65%) had partial liver response, 2 pts (10%)
had stable disease > 3mos
• Conclusion - PHP effective palliative TX in bleak disease with an acceptable side-effect
profile |
 32 DELCATH SYSTEMS, INC 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 for ocular melanoma liver metastases • Results - o IHP cohort (n=30) treated between 1999 and 2009 PFS was 6 mos Disease recurrence mainly in the liver OS was 10 mos (vs 6 mos historic avg for IHP) o PHP cohort (n=9); PTS received 15 PHP TX since Feb 2014 Max follow up period was 14 mos 8 PTS still alive, 7 without disease progression Decrease in red/white blood cell count observed following TX; 3 PTS received blood transfusion TX overall was well tolerated • Conclusion - PHP appears to be effective/safe procedure in select patients with unresectable liver metastases from CRC or OM and can be repeated ECCO 2015 |
 33 DELCATH SYSTEMS, INC 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 patients with uveal, or ocular
melanoma treated
with percutaneous hepatic perfusion (PHP) performed with CHEMOSAT; data from the first 11 patients with a maximum follow up period of 16 months were presented o Primary endpoints are response rate (RECIST criteria) following two treatments at 6 week
interviews, percentage of patients with stable disease
o Secondary endpoints are safety, overall survival, hepatic progression free survival, quality of
life • Results -18 treatments performed on 11 patients, maximum follow up currently 16 months
o 10 patients remain in follow up, 4 without progression of disease • Adverse Events - grade 3 or 4 toxicity observed in 4 patients, managed with blood transfusion or
platelet infusion • Conclusion - CHEMOSAT appears to be effective and safe procedure in select patients with unresectable liver metastases of uveal melanoma and can be repeated |
 34 DELCATH SYSTEMS, INC 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 metastases from uveal melanoma treated with CHEMOSAT o 14 patients treated 2012-2014; patients received 1-3 treatments o 11 PTS evaluated by RECIST criteria; survival time analysis performed, complications
registered • Results - 4 (36%) partial response, 5 (46%) stable disease, 2 (18%) progressive disease o Survival time ranged from 1. 5 months to 23 months (median OS 6.5 months) o Time to progression for two patients who progressed was 6.2 months in one patient; the other
died 1.6 months after evaluation
• Adverse Events – treatment well tolerated by all 14 patients o 7 leukopenia, 6 thrombocytopenia, 2 neutropenia • Conclusion - CHEMOSAT has been manifested as a potential treatment for patient with non- resectable hepatic metastases of uveal melanoma |