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DCTH Positive Sentiment Score: 65/100

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to

Key Takeaway: Delcath Systems Inc. is poised to receive FDA approval for its HEPZATO Kit/CHEMOSAT system, targeting liver cancers with high incidence rates. The company has met the primary endpoints in pivotal trials for Metastatic Ocular Melanoma (mOM), allowing for a potential launch within the coming months. The system aims to deliver high doses of chemotherapy through a minimally invasive process, addressing significant market needs. Additionally, the company is strategically positioned to enhance treatment options for liver cancer patients.

Market Sentiment Analysis

POSITIVE FACTORS

  • Potential FDA approval for the HEPZATO Kit/CHEMOSAT system is anticipated in Q3 2023.
  • The pivotal trial for Metastatic Ocular Melanoma has met primary endpoints, indicating strong efficacy.
  • The company has a favorable commercial opportunity in a market with high unmet needs and no current standard of care.

Full Press Release Details

Corporate Presentation (NASDAQ: DCTH)
January 2023 Exhibit 99.1
The Private Securities Litigation
Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results
to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the timing and results of the Company's clinical trials, including without limitation the mOM
and ICC clinical trial programs, as well as the receipt of additional data and the performance of additional analyses with respect to the mOM clinical trial, our determination whether to continue the ICC clinical trial program or to focus on
other alternative indications, and timely monitoring and treatment of patients in the global Phase 3 mOM clinical trial and the impact of the COVID-19 pandemic on the completion of our clinical trials; the impact of the presentations at major
medical conferences and future clinical results consistent with the data presented; approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure; the impact, if any, of ZE reimbursement on potential CHEMOSAT product use and
sales in Germany; clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK; the Company's ability to
successfully commercialize the HEPZATO KIT/CHEMOSAT system and the potential of the HEPZATO KIT/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver; our ability to obtain reimbursement for the CHEMOSAT system
in various markets; approval of the current or future HEPZATO KIT/CHEMOSAT 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 foreign regulatory agencies; the Company's 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 the Company's ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others,
are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to
publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. Forward-looking Statements
Executive Summary Delcath aims to be
the leader in targeted, safe and highly-effective minimally-invasive treatments for patients with cancers of the liver. Incidence US/EU >200K primary and metastatic liver tumors per year1-14 Current local/regional treatments Cannot treat the
whole liver Targeted to visible and accessible tumors Limited in their ability to retreat UNMET NEED LIVER CANCER PHP drug-device platform Delivers high dose chemotherapy to the entire liver Limits systemic exposure Minimally invasive, repeatable
and well-tolerated US: HEPZATO KIT EU: CHEMOSAT PERCUTANEOUS HEPATIC PERFUSION (PHP) Near-term (mOM) >$500 TAM in US and EU Unsurpassed 1 year survival data Longer Term (CRC, ICC, Pancreatic, etc.) >>$1B TAM Investigator interest in more
than 10 other tumor types LARGE MARKET OPPORTUNITY FOCUS pivotal trial Metastatic Ocular Melanoma (mOM) Primary endpoint met* NDA submission 1Q 22 Real World Evidence >1k commercial treatments in EU Multiple single center publications
COMPANY & CLINICAL PROGRAM POTENTIAL FDA APPROVAL: Q3 2023
Liver-Dominant Cancers High incidence
with poor prognosis U.S. Incidence Incidence of Liver Dominant Cancers (partial set shown) Liver: Common Site of Metastases Limited Overall Survival - Unresectable Liver Cancer Often the life-limiting organ Many patients with liver metastases
are not amenable to surgical resection largely due to extensive tumor burden15 Limited Effective Systemic Treatments Systemic therapies - low efficacy Immuno-oncology agents - become less effective in the presence of metastases 80% Up to US
Incidence of Liver Dominant Cancers (partial set shown) *Metastatic Ocular Melanoma (mOM)1,2, Cholangiocarcinoma (ICC)3,4, Liver-dominant Breast Cancer (mBC)7-10, Metastatic Neuroendocrine Tumors (mNET)6,7 Metastatic Pancreatic Cancer (mPC)7,13,
Metastatic Colorectal Cancer (mCRC)11,12, Hepatocellular carcinoma (HCC)15 U.S. Incidence Incidence of Liver Dominant Cancers (partial set shown) US Incidence of Liver Dominant Cancers* (partial set shown) DELCATH OPPORTUNITY+
Majority of Treatment Limitations of
Current Liver-Directed Therapies Beads obstruct blood flow to tumor and elute chemo 50-60k treatments per year in US (and growing) Radioactive beads delivered into the tumor 10-15k treatments per year in US (and growing) Trans Arterial Chemo
Embolization (TACE)17 Y9016 Effective, but tumors recur & retreatment limited due to damaged vasculature Diffuse disease: cannot be treated with a tumor-by-tumor modality Many tumors are not imageable - micro-metastases are common
Isolated Hepatic Perfusion (IHP) The
pathway to developing Percutaneous Hepatic Perfusion Temporarily isolates liver blood supply Delivers substantially higher concentrations of chemotherapy (Melphalan) with limited toxicity High treatment related mortality (>5%) Not repeatable and
few patients are eligible 1961 Dr. Robert Ausman publishes 1st description of IHP technique 1975 Stehlin demonstrates effects of Melphalan in regional perfusion 1990s Phase I-II study of Isolated Hepatic Perfusion using Melphalan for patients with
metastatic Ocular Melanoma. Benefits Limitations Isolated liver perfusion in advanced metastases of colorectal cancers studied. National Cancer Institute conducts trial establishing IHP, using melphalan as a viable treatment option. 1998 2000s IHP
documented efficacy across multiple tumor types including mOM, CRC, and NET HISTORY OF IHP15 1984
IHP Results in mOM Provided Rationale
for PHP in mOM and Provides Rationale for CRC and Other Tumor Types ORR % ORR % IHP/mOM ORR18-22 IHP Studies in other disease states Primary HCC and ICC utilizing IHP (melphalan +/- TNF alpha). ORR = 67% (N=13) with a median actuarial survival of
16.3 months.30 Unresectable GEP-NET utilizing IHP (melphalan +/- TNF alpha). ORR = 50% (N=13) with a median actuarial survival of 48 months.31 n=99 n=120 n=105 n=71 n=24 n=34 n=17 n=27 n=22 n=29 n=25* n=30* *Hepatic arterial infusion used
HEPZATO Kit: Percutaneous
Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control ISOLATION Hepatic venous flow is isolated, enabling 12x increased dose SATURATION Melphalan (chemo) treats micro and macro lesions simultaneously FILTRATION
Proprietary filters remove greater than 85% of chemo from the body33 Blood Return Catheter Chemo Filtration Veno-veno Bypass Pump Chemo Isolation (Balloon) Catheter Chemo Delivery Catheter Liver
Randomized Phase III Study Begins 2006
Gen 2 Filter CHEMOSAT Granted CE Mark EU Commercialization 2012 Clinical Trial for Patients with Hepatic-Dominant Ocular Melanoma (FOCUS) 2016 Randomized Phase III Study Completed 2009 FDA Issues a Complete Response Letter 2013 Enrollment for FOCUS
Trial Completed 2021 History of HEPZATO Kit Development Potential FDA Submission Q1 23 / Approval Q3 2023 2023 Commercial Launch HEPZATO Kit Q3/Q4 2023
Unmet Need Low Risk Opportunity High
Barrier to Entry Favorable Commercial Economics mOM: Beachhead Market Opportunity No FDA-approved treatment, no current standard of care ~6,000 cases of ocular melanoma per year in the US/EU12,34 50% metastasize, 90% to the liver2,35 Median survival
up to 12 months.36 FOCUS pivotal trial has met primary endpoints to support approval in mOM37 Significantly improved safety profile over Gen 1 filter technology Real world safety and efficacy demonstrated in EU EXCLUSIVE: Granted orphan indication
status allows for extended exclusivity HEPZATO is a combination drug device regulated by CDER - no ANDA pathway Melphalan granted orphan indication Most commonly used systemic treatments (immuno-oncological agents) cost $250K - $1M annually 20
US treatment centers = ~80% patients
Competitive Landscape for mOM
Minimally Invasive - Liver Directed Infusion - Systemic Minimally Invasive HEPZATO TACE17 Y90/SIRT16 Mono/Combo IO38 Tebentafusp29* High Efficacy 36.3%** <21% <17% 5.5% Up to 9%25 ORR % OS at 12 months (% surviving) 77%*** -
- - 73%**** Repeatable (>3x) X / X Preserves QoL X FDA Approved for mOM Q2 2023 X X Melanoma Applicable to most mOM patients X *HLA A+ patient indication
only ** Treated Population 29-Apr-2022 data cut ***Post hoc analysis Treated Population, BAC OS 59%, HR 0.48 , 95% CI 0.22, 1.08, p-value = 0.075 based on 1-Jun-2022 data cut ****Control OS 59%, HR 0.51, 95% CI 0.37, 0.71, p-value <0.001
First Phase 3 RCT Results* Months
Overall Progression Free Survival (INV Assessment) Crossover design confounded overall survival analysis - most subjects in BAC arm [57.1%] crossed over to PHP arm Proportion of patients surviving 7.0 1.6 5.4 mo PHP 0 5 10 15 20 25 30 Best
alternative care Hepatic Progression Free Survival (IRC Assessment) 1.0 0.8 0.6 0.4 0.2 0.0 P<.0001 PHP Months 1.0 0.8 0.6 0.4 0.2 0.0 P<.0001 Proportion of patients surviving 5.4 1.6 3.8 mo Best alternative care 0 5 10 15 20 25 30 35 40 45 50
55 Response Rates (ITT population) Cohort PHP (N=44) BAC (N=49) P-Value hOR 36.4% 2.0% <0.001 ORR 27.3% 4.1% =0.003 *Mix of mOM and metastatic melanoma with >90% patients diagnosed with mOM - NDA 201848 Clinical Study Report dated 15 August
2012. Hazard Ratio (95% CI) = 0.39 Hazard Ratio (95% CI) = 0.42
Safety Issues and Resulting
Improvements Safety Issue Hematological toxicities led to 3 patient deaths Improvement Gen 2 Filter introduced in 2013 Adverse Event G3/4 Gen 1 Hughes 201628 % n Anemia 62.9% 44 Neutropenia 85.7% 60 Thrombocytopenia 80.0% 56 Adverse Event G3/4 Gen 2
Karydis 201833 % Improvement Gen 1 2 % n Anemia 29.4% 15 53% Neutropenia 31.3% 16 64% Thrombocytopenia 31.3% 16 61% Inappropriate patient selection and procedural issues led to 1 patient death and other AE's ~90%
liver involvement causing tumor lysis syndrome Protocol amendments were put in place for patient selection Training improved FDA required these issues be addressed prior to the start of the FOCUS trial
2nd Registration Clinical Trial for
Patients with mOM Multinational, multicenter, single-arm trial Efficacy Endpoints: Primary: Objective Response Rate (ORR) compared to meta-analysis of IO therapy Secondary: Duration of Response (DOR), Disease Control Rate (DCR), Overall Survival
(OS), Progression Free Survival (PFS) 102 subjects enrolled, 91 completed treatments at 23 centers in the US and EU HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles Initially a RCT against Best Alternative Care (BAC) Subsequently modified with
FDA agreement to single-arm trial FDA will view the comparisons with the 32 patient BAC arm as supportive exploratory analyses FOCUS Trial
Approvals Using ORR in Single-Arm Oncology Trials Danyelza (naxitamab-gqgk) Gavreto (pralsetinib) Monjuvi (tafasitamab-cxix) Tazverik (tazemetostat) Zepzelca (lurbinectedin) Tabrecta (capmatinib) Trodelvy (sacituzumab) Accelerated Accelerated
Accelerated Accelerated Accelerated Accelerated Accelerated Relapsed or refractory neuroblastoma ORR Study 1 = 45% ORR Study 2 = 34% Metastatic RET NSCLC ORR na ve = 70% ORR exp. = 57% Relapsed or refractory large B-cell lymphoma ORR = 39%
Lymphoma positive for EXH2 mutation ORR mutant = 69% ORR wild-type = 34% Metastatic SMLC 2nd Line ORR = 35% mNSCLC with mutation MET exon 14 skipping ORR naive = 68% ORR exp. = 41% 3rd Line Metastatic triple-negative BC ORR = 33.3% Two trials n=22 /
38 Single trial N=43 Koselugo (selumetinib) Ayvakit (avapritinib) Pemazyre (pemigatinib) Fyarro (sirolimus) Tivdak (tisotumab vedotin-tftv) Exkivity (mobocertinib) Jemperli (dostarlimab-gxly) Accelerated Standard Accelerated Standard Accelerated
Accelerated Accelerated Neurofibromatosis Type 1 ORR = 66% mGIST with PDGFRA exon 18 mutation ORR = 84% Previously treated ICC with FGFR2 fusion ORR = 36% Malignant perivascular epithelioid cell tumor ORR = 39% 2nd Line cervical cancer ORR = 24%
mNSCLC with EGF exon 20 insertion mutations ORR = 28% MMRD recurrent or advanced solid tumors - 2nd line ORR = 41.6% Single trial n=31 Single trial n=61 for RCC* Single trial n=81 Single trial n=71 Welireg (belzutifan) Truseltiq (infigratinib)
Lumakras (sotorasib) Rybrevant (amivantamab-vmjw) Jemperli (dostarlimab-gxly) Libtayo (cemiplimab-rwlc) Tepmetko (tepotinib) Standard Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated von Hippel-Lindau disease +RCC, blastomas,
or NET ORR = 49% 2nd Line ICC with a FGF 2 fusion ORR = 23% KRAS G12C mutated mNSCLC ORR = 36% mNSCLC with EGFR exon 20 insertion mutations ORR = 40% MMRD endometrial cancer, 2nd Line. ORR = 42.3% Metastatic BCC ORR meta. = 21% ORR adv.
= 29% mNSCLC w/ met exon 14 ORR na ve = 43% ORR exp. = 43% Single trial n=112 Single trial n=152 Single trial n=114 Single trial n=97 Single trial n=50 Single trial n=95 Single trial n=71 Single trial n=105 Single trial n=108 Single trial n=107
Single trial n=101 Single trial n=114 Single trial n=108 Single trial n=124 Single trial n=209
Significantly improved safety
relative to first pivotal trial Positive trends in exploratory BAC comparisons (ORR, DOR, DCR, PFS and OS) Focus Trial Success Criteria - Informed By FDA Interactions Best Alternative Care (BAC) Arm Enrolled N=42 Treated N=32 Dacarbazine 1 0
Ipilimumab 7 1 Pembrolizumab 8 6 TACE 26 25 Critical Single Arm Efficacy End Points* "Clinically Meaningful" ORR** Trial powered to show an advantage over immuno-oncology (IO) agents Upper bound at 95% Confidence Interval needed to
exceed 8.3% "Clinically Meaningful" DOR*** >6 months * Per FDA and SAP ORR is the primary endpoint and per FDA primary analysis population will be treated patient population (SAP defined ITT as primary analysis population) ** FDA did
not object to using a meta-analysis of checkpoint inhibitors "to provide support for a clinically meaningful ORR" (476 patients from 16 publications, 95% Confidence Interval for ORR of 3.6% - 8.3%) *** FDA specified that DOR would be the
critical secondary endpoint and requested that patients be followed for at least 6 months to assess durability of response Overall Risk Benefit Assessment
FOCUS Trial Analysis: Prespecified
Endpoint Met* ORR and DCR in the Treated Population Lower bound 22.55% far exceeds 8.3% upper bound prespecified threshold** PRELIMINARY DATA - SUBJECT TO CHANGE * 29-Apr-2022 data cut, data continues to mature and patients will be followed at least
through May, 2023 * * Meta-analysis of checkpoint inhibitors (476 patients,16 publications) calculated a 95% Confidence Interval for ORR of 3.6% - 8.3%" ORR Advantage Coupled With Meaningful Duration of Response 14 Month Duration of Response 7
Complete Responses 26.44% >> 8.3% prespecified threshold** Exploratory comparison versus BAC supportive DOR in the Treated Population
Progression Free Survival Kaplan
Meier Curves in Treated Populations* * 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 Pre-Specified Exploratory Analyses* Exploratory comparison versus BAC supportive
Overall Survival Kaplan Meier Curves
in Treated Populations* ** 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 Pre-Specified Exploratory Analyses* Exploratory comparison versus BAC supportive
Best Percent Change in Target Lesion
Tumor Burden PHP Patients (n=91) BAC Patients (n=32) CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable. * Best Overall Response (BOR) is based on status of target, nontarget and new lesions,
so a 30% or 100% reduction in target lesion tumor burden does not necessarily indicate BOR of PR or CR. ** Not evaluable target lesions are represented with a 0% change from baseline.
Hematological Toxicities -
Comparison with Previous Trials* Grade 3 or higher Adverse Events Focus Trial (n=91) Hughes 201628 (n=70) Anemia 27 (29.7%) 44 (62.9%) Thrombocytopenia 24 (26.4%) 56 (80.0%) Neutropenia 18 (19.8%) 60 (85.7%) Hematological AE's consistent with
European experience * Data cut 29-Apr-2022
FOCUS Trial - Safety
Comparison with Previous Trials* Category FOCUS Trial (N=91) Pooled Analysis of Prior Studies (N=121) Patients who Withdrew due to an AE or SAE 20 (22%) 46 (38%) Patients who Required a Dose Reduction 12 (13.2%) 27 (22.3%) Average Number of Cycles
4.1 2.8 Improvement in tolerability led to a larger number of treatments * Data cut on 29-Apr-2022
Substantial Clinical Improvement for
All Patients Over the Only Other FDA-Approved Therapy for mOM Treatment PT n CR PR ORR SD DCR PD PFS DOR mOS 1yr OS Hepzato Kit* TN,2L,3L 102 7.7 28.6 36.3 37.4 73.6 25.3 9.03 14 19.3 77% Kimmtrak3 TN 252 0 9 9 35 46 64 3.3 9.9 21.7 73% Hepzato Kit

Frequently Asked Questions

What is the focus of Delcath's clinical program?

Delcath focuses on developing safe, effective treatments for liver cancer.

What is the significance of the HEPZATO KIT?

The HEPZATO KIT delivers high-dose chemotherapy while minimizing systemic exposure.

What are the main challenges in liver cancer treatments?

Current therapies struggle with limited effectiveness and retreatment options due to tumor complexities.

When does FDA approval for the HEPZATO KIT expect?

FDA approval for the HEPZATO KIT is anticipated in Q3 2023.

How does the HEPZATO KIT improve treatment outcomes?

It enables repeatable, targeted delivery of chemotherapy to effectively treat liver tumors.

Last updated: Jan 3, 2023