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Forward-looking Statements 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. 1
Executive Summary Delcath aims to be the leader in targeted, safe and
highly-effective minimally-invasive treatments for patients with cancers of the liver. UNMET NEED PERCUTANEOUS HEPATIC COMPANY & LARGE MARKET CLINICAL PROGRAM LIVER CANCER PERFUSION (PHP) OPPORTUNITY Incidence US/EU PHP drug-device platform
FOCUS pivotal trial Near-term (mOM) Metastatic Ocular >200K primary and Delivers high dose >$300M TAM in US metastatic liver tumors chemotherapy to the Melanoma (mOM) and EU 1-14 per year entire liver
Primary endpoint met* Unsurpassed 1 year NDA submission 3Q 22 Limits systemic exposure survival data Current local/regional Minimally invasive, Real World Evidence treatments repeatable and well- Longer Term
(CRC, ICC, Cannot treat the whole tolerated >1k commercial Pancreatic, etc.) treatments in EU liver >>$1B TAM Targeted to visible and US: HEPZATO KIT Multiple single center Investigator
interest in accessible tumors EU: CHEMOSAT publications more than 10 other Limited in their ability to tumor types retreat ANTICIPATED FDA APPROVAL: Q1 2023 2
Liver-Dominant Cancers High incidence with poor prognosis US In In US
cid cid Inc In enc enc ciden iden e e ce o oce f f o L L o f iv iv fL er er L iv iv er Do Do er Do m m Dom in in m ant ant inan in an Canc Canc t tCanc Can er ers s cer erss* (p (p(p a art rt a(p iirt a ailla a s s rt l e e s ia tte ls s ts h h s e
o o h t w w o sw n n h) )n o) wn) Up to Many patients with liver metastases are 50,000 DELCATH OPPORTUNITY+ not amenable to surgical resection 80% 15 largely due to extensive tumor burden 40,000 30,000 Liver: Common Site of Metastases 20,000 Limited
Effective Systemic Treatments Systemic therapies - low efficacy Immuno-oncology agents - become less effective in 10,000 the presence of metastases 0 Limited Overall Survival - mOM ICC mBC mNET mPC mCRC HCC Unresectable Liver
Cancer Often the life-limiting organ 1,2 3,4 7-10 *Metastatic Ocular Melanoma (mOM) , Cholangiocarcinoma (ICC) , Liver-dominant Breast Cancer (mBC) , Metastatic Neuroendocrine 3 6,7 7,13 11,12 15 Tumors (mNET) Metastatic Pancreatic Cancer
(mPC) , Metastatic Colorectal Cancer (mCRC) , Hepatocellular carcinoma (HCC) U U. .S S. . I In nc ci id de en nc ce e
Limitations of Current Liver-Directed Therapies 17 16 Trans Arterial
Chemo Embolization (TACE) Y90 Beads obstruct blood flow to tumor and elute chemo Radioactive beads delivered into the tumor 50-60k treatments per year in US (and growing) 10-15k treatments per year in US (and growing)
Effective, but tumors Many tumors are not Diffuse disease: recur & retreatment imageable - cannot be treated limited due to micro-metastases with a tumor-by- damaged vasculature are common tumor modality 4 Majority of Treatment
Isolated Hepatic Perfusion (IHP) The pathway to developing Percutaneous
Hepatic Perfusion 15 HISTORY OF IHP Benefits st Dr. Robert Ausman publishes 1 description Temporarily isolates liver 1961 of IHP technique blood supply Delivers substantially higher Stehlin demonstrates effects of Melphalan in 1975
regional perfusion concentrations of chemotherapy (Melphalan) with limited toxicity Isolated liver perfusion in advanced metastases of 1984 colorectal cancers studied. Limitations Phase I-II study of Isolated Hepatic 1990s Perfusion using Melphalan
for patients with metastatic Ocular Melanoma. High treatment related National Cancer Institute conducts trial mortality (>5%) 1998 establishing IHP, using melphalan as a viable treatment option. Not repeatable and few patients are
eligible IHP documented efficacy across multiple 2000s tumor types including mOM, CRC, and NET 5
IHP Results in mOM Provided Rationale for PHP in mOM and Provides
Rationale for CRC and Other Tumor Types 18-22 IHP/mOM ORR 23-29 IHP/CRC ORR 80% 80% 70% 68% 70% 61% 60% 62% 62% 59% 60% 60% 50% 50% 47% 50% 41% 40% 40% 29% 30% 20% 20% 10% 0% 0% n=105 n=71 n=29 n=99 n=120 n=24 n=30* n=34 n=17 n=27 n=22 n=25*
Category 1 Category 1 IHP Studies in other disease states Primary HCC and ICC utilizing IHP (melphalan +/- TNF alpha). ORR = 67% (N=13) with a median 30 actuarial survival of 16.3 months. Unresectable GEP-NET utilizing IHP (melphalan
+/- TNF alpha). ORR = 50% (N=13) with a median 31 actuarial survival of 48 months. *Hepatic arterial infusion used adjunctively. 6 ORR % ORR %
HEPZATO Kit: Percutaneous Hepatic Perfusion (PHP) Repeatable,
safe & effective liver-focused disease control Next-Generation, Minimally-Invasive Liver-Directed Treatment Percutaneous Hepatic Perfusion (PHP) with Melphalan Hydrochloride 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. ~2-3 hr. cath-lab based procedure 7
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, Melphalan (chemo) treats micro Proprietary filters remove greater 33 enabling 12x increased dose and macro
lesions simultaneously than 85% of chemo from the body 8
History of HEPZATO Kit Development 2009 Randomized Phase III Study
Completed 2013 FDA Issues a Complete Response Letter 2021 Enrollment for FOCUS Trial Completed Q1/Q2 2023 Commercial Launch HEPZATO Kit 2006 Randomized Phase III Study Begins 2012 Gen 2 Filter CHEMOSAT Granted CE Mark 2016 EU Commercialization
Clinical Trial for Patients with Hepatic-Dominant 2022 Ocular Melanoma (FOCUS) Anticipated FDA Submission Q3 22 / Approval Q1 2023 9
mOM: Beachhead Market Opportunity No FDA-approved treatment, no current
standard of care Unmet Need Low Risk Opportunity FOCUS pivotal trial has met primary endpoints to ~6,000 cases of ocular melanoma per year in 37 12,34 support approval in mOM the US/EU 2,35 Significantly improved safety profile
over Gen 1 50% metastasize, 90% to the liver filter technology 36 Median survival up to 12 months. Real world safety and efficacy demonstrated in EU Favorable Commercial Economics High Barrier to Entry EXCLUSIVE: Granted
orphan indication Payer/hospital financial stakeholder interviews status allows for extended exclusivity suggest expected pricing to be on par with immuno-oncological agents (currently $250K - HEPZATO is a combination drug device $450k
annually) regulated by CDER - no ANDA pathway 20 US treatment centers = ~80% patients Melphalan granted orphan indication 10
Competitive Landscape for mOM Minimally Invasive - Liver Directed
Infusion - Systemic 17 16 38 29* HEPZATO TACE Y90/SIRT Mono/Combo IO Tebentafusp High Efficacy 25 36.3%** <21% <17% 5.5% Up to 9% ORR % OS at 12 months 77%*** - - - 73%**** (% surviving) Repeatable (>3x) X X
/ Preserves QoL X Q4 2022 Melanoma FDA Approved for mOM X X Applicable to most mOM X patients *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 Response Rates Hepatic Progression Free
Survival Overall Progression Free Survival (ITT population) (IRC Assessment) (INV Assessment) Proportion of patients surviving Proportion of patients surviving 1.0 3.8 1.0 PHP 5.4 mo PHP PHP BAC P- mo 0.8 Cohort Best alternative care 0.8 Best
alternative care (N=44) (N=49) Value 0.6 0.6 hOR 36.4% 2.0% <0.001 5.4 1.6 P<.0001 P<.0001 7.0 0.4 1.6 0.4 ORR 27.3% 4.1% =0.003 0.2 0.2 0.0 0.0 0 5 10 15 20 25 30 35 40 45 50 55 0 5 1 1 2 2 3 0 5 0 5 0 Months Months Hazard Ratio (95% CI) =
0.42 Hazard Ratio (95% CI) = 0.39 Crossover design confounded overall survival analysis - most subjects in BAC arm [57.1%] crossed over to PHP arm *Mix of mOM and metastatic melanoma with >90% patients diagnosed with mOM - NDA 201848
Clinical Study Report dated 15 August 2012. 12
Safety Issues and Resulting Improvements Safety Issue Improvement
Hematological toxicities led to 3 patient deaths Gen 2 Filter introduced in 2013 Gen 1 Gen 2 28 33 Adverse Event Adverse Event % Improvement Hughes 2016 Karydis 2018 Gen 1 2 G3/4 G3/4 % n % n Anemia 62.9% 44 Anemia 29.4% 15 53%
Neutropenia 85.7% 60 Neutropenia 31.3% 16 64% Thrombocytopenia 80.0% 56 Thrombocytopenia 31.3% 16 61% Inappropriate patient selection and Protocol amendments were put in place for procedural issues led to 1 patient patient
selection death and other AE's Training improved ~90% liver involvement causing tumor lysis syndrome FDA required these issues be addressed prior to the start of the FOCUS trial 13
Multinational, multicenter, single-arm trial Efficacy
Endpoints: FOCUS Trial Primary: Objective Response Rate (ORR) compared to meta-analysis of IO therapy Secondary: Duration of Response (DOR), Disease Control Rate (DCR), Overall nd Survival (OS), Progression Free Survival (PFS) 2
Registration Clinical Trial for Patients with 102 subjects enrolled, 91 completed treatments at 30 centers in the US and EU mOM 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 14 FDA will view the comparisons with the 32 patient BAC arm as supportive exploratory analyses 14
2020 -'21 Initial Approvals Using ORR in Single-Arm
Oncology Trials Two trials n=22 / 38 Single trial n=71 Single trial n=95 Single trial n=105 Single trial n=108 Single trial n=114 Single trial n=97 Danyelza (naxitamab- Gavreto (pralsetinib) Monjuvi (tafasitamab-cxix) Tazverik (tazemetostat)
Zepzelca (lurbinectedin) Tabrecta (capmatinib) Trodelvy (sacituzumab) gqgk) Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated rd Relapsed or refractory Metastatic RET NSCLC Relapsed or refractory large Lymphoma
positive for Metastatic SMLC 2nd Line mNSCLC with mutation 3 Line Metastatic triple- neuroblastoma B-cell lymphoma EXH2 mutation MET exon 14 skipping negative BC ORR Study 1 = 45% ORR na ve = 70% ORR = 39% ORR mutant = 69% ORR = 35% ORR naive =
68% ORR = 33.3% ORR Study 2 = 34% ORR exp. = 57% ORR wild-type = 34% ORR exp. = 41% Single trial n=107 Single trial n=31 Single trial n=101 Single trial N=43 Single trial n=209 Single trial n=50 Single trial n=114 Koselugo (selumetinib) Ayvakit
(avapritinib) Pemazyre (pemigatinib) Fyarro Tivdak Exkivity (mobocertinib) Jemperli (dostarlimab-gxly) (sirolimus) (tisotumab vedotin-tftv) Accelerated Standard Accelerated Standard Accelerated Accelerated Accelerated nd Neurofibromatosis Type 1
mGIST with PDGFRA exon Previously treated ICC with Malignant perivascular 2 Line cervical cancer mNSCLC with EGF exon 20 MMRD recurrent or advanced nd 18 mutation FGFR2 fusion epithelioid cell tumor insertion mutations solid tumors - 2 line
ORR = 66% ORR = 84% ORR = 36% ORR = 39% ORR = 24% ORR = 28% ORR = 41.6% Single trial n=81 Single trial n=112 Single trial n=152 Single trial n=124 Single trial n=71 Single trial n=61 for RCC* Single trial n=108 Welireg (belzutifan) Truseltiq
(infigratinib) Lumakras (sotorasib) Rybrevant (amivantamab- Jemperli (dostarlimab-gxly) Libtayo (cemiplimab-rwlc) Tepmetko (tepotinib) vmjw) Standard Accelerated Accelerated Accelerated Accelerated Accelerated Accelerated nd von Hippel-Lindau
disease 2 Line ICC with a FGF 2 KRAS G12C mutated mNSCLC with EGFR exon MMRD endometrial cancer, Metastatic BCC mNSCLC w/ met exon 14 nd +RCC, blastomas, or NET fusion mNSCLC 20 insertion mutations 2 Line. ORR meta. = 21% ORR na ve = 43% ORR =
49% ORR = 23% ORR = 36% ORR = 40% ORR = 42.3% ORR adv. = 29% ORR exp. = 43%
Focus Trial Success Criteria - Informed By FDA Interactions Critical
Single Arm Efficacy End Points* Overall Risk Benefit Assessment "Clinically Meaningful" ORR** Positive trends in exploratory BAC comparisons (ORR, DOR, DCR, PFS and OS) Trial powered to show an advantage over
immuno- oncology (IO) agents Best Alternative Enrolled Treated Upper bound at 95% Confidence Interval needed to Care (BAC) Arm N=42 N=32 exceed 8.3% 1 0 Dacarbazine "Clinically Meaningful" DOR*** 7 1 Ipilimumab
>6 months 8 6 Pembrolizumab 26 25 TACE Significantly improved safety relative to first pivotal trial * 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 16
FOCUS Trial Analysis: Prespecified Endpoint Met* ORR Advantage Coupled
With Meaningful Duration of Response DOR in the Treated Population ORR and DCR in the Treated Population Lower bound 22.55% far exceeds 8.3% upper bound prespecified threshold** 14 Month Duration of Response 26.44% >> 8.3% prespecified
threshold** Exploratory comparison versus BAC supportive 7 Complete Responses * 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%" PRELIMINARY DATA - SUBJECT TO CHANGE 17
Progression Free Survival Pre-Specified Exploratory Analyses* Kaplan
Meier Curves in Treated Populations* Exploratory comparison versus BAC supportive * 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 18
Overall Survival Pre-Specified Exploratory Analyses* Kaplan Meier
Curves in Treated Populations* Exploratory comparison versus BAC supportive ** 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 19
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. 20
Hematological Toxicities - Comparison with Previous Trials* 28 Focus
Trial Hughes 2016 Grade 3 or higher Adverse Events (n=91) (n=70) 27 (29.7%) 44 (62.9%) Anemia 24 (26.4%) 56 (80.0%) Thrombocytopenia Neutropenia 18 (19.8%) 60 (85.7%) Hematological AE's consistent with European experience * Data cut
FOCUS Trial - Safety Comparison with Previous Trials* FOCUS Trial
Pooled Analysis of Category (N=91) Prior Studies (N=121) Patients who Withdrew due to an AE or 20 (22%) 46 (38%) SAE 12 (13.2%) 27 (22.3%) Patients who Required a Dose Reduction 4.1 2.8 Average Number of Cycles Improvement in tolerability led to a