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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: Corporate Presentation (NASDAQ: DCTH) December 2021 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 su

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Corporate Presentation (NASDAQ: DCTH)
December 2021 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 year2-14,29 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) >$300M TAM in US and EU No effective standard of care 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 mid 22 Real World Evidence >1k commercial treatments in EU Multiple single center publications COMPANY
& CLINICAL PROGRAM ANTICIPATED FDA APPROVAL: Q4 2022 Metastatic Ocular Melanoma (mOM)2,3, Cholangiocarcinoma (ICC)4,5, Liver-dominant Breast Cancer (mBC)8-11, Metastatic Neuroendocrine Tumors (mNET)6,7, Metastatic Pancreatic Cancer (mPC)8,16,
Metastatic Colorectal Cancer (mCRC)12,13, Hepatocellular carcinoma (HCC)29
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 burden1 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) DELCATH OPPORTUNITY+ Metastatic Ocular Melanoma (mOM)2,3, Cholangiocarcinoma (ICC)4,5, Liver-dominant Breast Cancer (mBC)8-11, Metastatic Neuroendocrine Tumors (mNET)6,7, Metastatic Pancreatic Cancer
(mPC)8,16, Metastatic Colorectal Cancer (mCRC)12,13, Hepatocellular carcinoma (HCC)29
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) Y90 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 IHP1 1984
PHP Advances IHP Clinical Benefits
Overall Survival Progression-Free Survival Comparable OS & PFS Between Techniques30 There was no difference in overall survival (OS) or progression-free survival (PFS) between IHP and PHP for patients with uveal melanoma liver metastases, but
patients have significantly less of a risk for complications and mortality following PHP. " "
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 Anticipated FDA Submission mid 22 / Approval Q4 2022 2022 Commercial Launch HEPZATO Kit Q1 2023
HEPZATO Kit: Percutaneous
Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control The only minimally invasive cancer treatment that isolates the liver from systemic circulation, allowing for repeated delivery of high-dose chemo to the entire
liver while limiting systemic side effects. Next-Generation, Minimally-Invasive Liver-Directed Treatment Percutaneous Hepatic Perfusion (PHP) with Melphalan Hydrochloride ~2-3 hr. cath-lab based procedure
Three Steps. Targeted Treatment.
Novel, whole-organ treatment that provides targeted, high-dose liver chemo while minimizing systemic exposure. ISOLATION SATURATION FILTRATION Hepatic venous flow is isolated, enabling 12x increased dose Melphalan (chemo) treats micro and macro
lesions simultaneously Proprietary filters remove greater than 85% of chemo from the body1* *In vitro model - Data on file 1. de Leede E., et al. Cardiovascular Intervent Radiol. 2017 Aug;40(8):1196-1205.
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/EU13,17 50% metastasize, 90% to the liver3,14 Median survival
up to 12 months.15 FOCUS pivotal trial has met primary endpoints to support approval in mOM19 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 Payer/hospital financial stakeholder interviews suggest expected pricing is on par with
immuno-oncological agents ~$250k annually 20 US treatment centers = ~80% patients
Competitive Landscape for mOM
Minimally Invasive - Liver Directed Infusion - Systemic Minimally Invasive HEPZATO TACE23 Y90/SIRT21 Mono/Combo IO24 Tebentafusp22* High Efficacy 31.4% <21% <17% 5.5% Up to 9%25 ORR % OS at 12 months (% surviving) 75%** - -
- 73%*** Repeatable (>3x) X / X Preserves QoL X FDA Approved for mOM Q4 2022 X X Melanoma Pending Applicable to most mOM patients X HEPZATO is the only
highly-effective, targeted mOM treatment that enables repeat treatments while optimizing QoL *HLA A+ patient indication only **mITT, BAC OS 47%, HR 0.37 , 95% CI 0.17, 0.79, p-value 0.01 ***Control OS 59%, HR 0.51, 95% CI 0.37, 0.71, p-value
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 201620 % n Anemia 62.9% 44 Neutropenia 85.7% 60 Thrombocytopenia 80.0% 56 Adverse Event G3/4 Gen 2
Karydis 201815 % 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 OVERVIEW: Multinational, multicenter, single-arm trial Endpoints: Primary: Objective Response Rate compared to historic control Secondary: Duration of response, disease control rate, overall survival, progression free survival,
safety, PK, QoL 102 subjects enrolled, 91 completed treatments at 30 centers in the US and EU HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles FOCUS Trial
FOCUS Trial Analysis: Prespecified
Endpoint Met Primary Effectiveness Endpoint19 PHP (N=91 treated + 11 untreated) 95% CI* Objective Response Rate 31.4% [22.55-41.31] Intent to Treat: Lower bound 22.55% far exceeds 8.3% upper bound prespecified threshold. PRELIMINARY DATA - SUBJECT
TO CHANGE *A meta-analysis of checkpoint inhibitors (476 patients,16 publications) calculated a 95% Confidence Interval for ORR of 3.6% - 8.3%"
Hematological Toxicities -
Comparison with Previous Trials Grade 3 or higher Adverse Events Focus Trial (n=91) Hughes 2016 (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
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
Recent Initial Approvals Using ORR
in Single-Arm Oncology Trials Danyelza (naxitamab-gqgk) Gavreto (pralsetinib) Monjuvi (tafasitamab-cxix) Tazverik (tazemetostat) Zepzelca (lurbinectedin) Tabrecta (capmatinib) Trodelvy (sacituzumab) Pemazyre (pemigatinib) Koselugo (selumetinib)
Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated Relapsed or refractory neuroblastoma in bone or marrow post response or stable disease to prior therapy Metastatic RET fusion-positive NSCLC
Relapsed or refractory diffuse large B-cell lymphoma Relapsed or refractory follicular lymphoma positive for EXH2 mutation Metastatic SMLC with progression on or after platinum chemotherapy Metastatic NSCLC with mutation MET exon 14 skipping
Metastatic triple-negative breast cancer after at least 2 prior metastatic disease therapies Previously treated metastatic cholangiocarcinoma with FGFR2 fusion Neurofibromatosis Type 1 with inoperable plexiform neurofibromas Ayvakit (avapritinib)
Enhertu (famtrastuzmab deruxtecan) Padcev (enfortumab vedotin) Brukinsa (zanubrutinib) Rozlytrek (entrectinib) Xpovio (selinexor) Balversa (erdafinitib) Vitrakvi (larotrectinib) Libtayo (cemiplimab-rwlc) Standard Accelerated Accelerated Accelerated
Standard Accelerated Accelerated Accelerated Standard Unresectable or metastatic gastrointestinal stromal tumor with PDGFRA exon 18 mutation Unresectable or metastatic HER2+ breast with two or more prior anti HER2 regimens in metastatic setting
Metastatic urothelial cancer with previously received PD-1 or PD-L1 and platinum chemotherapy Mantle cell lymphoma with at least one prior therapy Metastatic NSCLC that is ROSI+ Relapsed or refractory multiple myeloma with at least 4 prior therapies
Metastatic unrothial carcinoma with susceptible FGFR 3(2) alterations Solid tumors with neurotrophic receptor tyrosine kinase fusion Metastatic squamous cell carcinoma Single trial n=50 Single trial N=43 Pooled subgroup analysis n=51 | 3 single arm
trials Pooled subgroup analysis n=72 | 2 single arm trials
Supportive Evidence: Comparison
Versus BAC Best Alternative Care (BAC) Arm Enrolled N=42 Treated N=32 Dacarbazine 1 0 Ipilimumab 7 1 Pembrolizumab 8 6 Transarterial Chemoembolization (TACE) 26 25 Amended Study FOCUS was initially a RCT against Best Alternative Care (BAC) Due to
enrollment challenges as a result of known limited efficacy of BAC control arm and availability of treatment with PHP (CHEMOSAT), FDA agreed to amend it to single-arm, non-RCT
FOCUS Trial - Exploratory
Analyses vs BAC Chi-square ** mITT Population - any patient who received at least one study treatment Efficacy Endpoint PHP (N=102) BAC (N=42) P-Value Objective Response Rate - Primary 32 (31.4%) 4 (9.5%) 0.0059 95% CI [22.55 - 41.31] [2.66
- 22.62] Disease Control Rate 67 (65.7%) 12 (28.6%) <0.0001 95% CI [55.63 - 74.81] [15.72 - 44.58] Intent to Treat: Efficacy Endpoint PHP (N=91) BAC (N=32) P-Value* Objective Response Rate 32 (35.2%) 4 (12.5%) 0.0154 95% CI [25.44 - 45.88]
[3.51 - 28.99] Disease Control Rate 67 (73.6%) 12 (37.5%) 0.0002 95% CI [63.35 - 82.31] [21.10 - 56.31] Modified Intent to Treat**: Statistically Significant ORR and DCR Advantage vs. BAC
FOCUS Trial - Exploratory
Analyses vs BAC ORR Advantage Coupled With Meaningful Duration of Response mITT Population PHP (N=91) BAC (N=32) Duration of Response (DOR, median) 14.00 mos. NC 95% CI [8.54 - NC] [6.93 - NC] Patients with Confirmed CR or PR 32 4 Patients with
Subsequent PD 14 (43.7%) 1 (25.0%) Censored 18 (56.3%) 3 (75.0%)
FOCUS Trial - Exploratory Analyses
vs BAC PHP Progression-Free Survival ~3X that of BAC19 Secondary Endpoint PHP (N=91)* BAC (N=32)* P-Value* Median Progression-Free Survival 9.03 mos. 3.12 mos. 0.0007 95% CI [6.34 - 11.56] [2.89 - 5.65] PFS Status Events 64 (70.3%) 25 (78.1%)
Censored 27 (29.7%) 7 (21.9%) Hazard Ratio Estimate 0.39 0.0002 95% CI [0.237 - 0.643] PRELIMINARY DATA - SUBJECT TO CHANGE * Treated patients only, per the protocol untreated patients were not followed
Focus Trial Results - 12-month
Last updated: Dec 2, 2021