Delcath Systems

Corporate Presentation(OTCQB: DCTH)

December 2019

Forward-looking Statements

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 OM and ICC clinical trial programs, timely enrollment and treatment of patients in the global Phase 3 OM and ICC Registration trials, IRB or ethics committee clearance of the Phase 3 OM and ICC Registration trial protocols from participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical conferences and future clinical results consistent with the data presented, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/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 Melphalan HDS/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 other foreign regulatory agencies, the impact of the Company’s exclusive licensing agreement with medac on commercial adoption in Europe and resulting revenue, if any, the Company’s ability to successfully enter into other strategic partnerships 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.

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Management Team

Jennifer Simpson, PhD., M.S.N., C.R.N.P. -President & Chief Executive Officer

♦ Vice President, Global Marketing, Oncology Brand Lead atImClone Systems, Inc/Eli Lilly

♦ Product Director, Oncology Therapeutics Marketing at OrthoBiotech

♦ Earlier in her career Dr. Simpson spent over a decade as ahematology/oncology-nurse practitioner and educator

♦ Dr. Simpson earned a Ph.D. in Epidemiology from theUniversity of Pittsburgh, an M.S. in Nursing from the Universityof Rochester, and a B.S. in Nursing from the State Universityof New York at Buffalo

Barbra C. Keck, Chief Financial Officer♦ Deloitte & Touche, LLP

♦ Earlier in her career, Ms. Keck spent several years inexecutive roles in the non-profit sector

♦ Ms. Keck earned her M.B.A. in Accountancy from BaruchCollege and Bachelor of Music in Music Education from theUniversity of Dayton

John Purpura, Executive Vice President - Global Head of Operations

♦ Vice President and then Executive Director of InternationalRegulatory Affairs with Bracco/ E-Z-EM

♦ Associate Vice President for Regulatory and CMC with Sanofi-Aventis

♦ Prior to Sanofi, Mr. Purpura held various quality and regulatorymanagement roles with Pharma companies from 1985 to1995. He earned a MS in Management & Policy and BSdegrees in Chemistry and Biology at the State University ofNew York at Stony Brook

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Delcath Systems

♦ Interventional oncology (IO) company with multiple near term catalysts

♦ 2H 2019 - FOCUS trial expected to complete enrollment; Publication from Prospective Phase 2 Study

♦ 1H 2020 - Topline data expected to be complete

♦ 2H 2020 - FDA NDA submission for indication expected

♦ “IO is the Fourth pillar of Oncology treatment” - ASCO

♦ Competitors include Boston Scientific (BTG), Sirtex

♦ Proprietary IO system (PHP) treats primary/metastatic liver cancers

♦ Delivers chemotherapy directly to the liver

♦ Minimally invasive, repeatable, predictable, manageable systemic toxicity profile, can delay tumor progression and could potentially improve survival

♦ Commercial / Clinical Status

♦ Commercial stage in the EU under the CHEMOSAT® brand

♦ ~750 commercial procedures performed

♦ Late-stage (Phase 3) clinical development in the US (Melphalan/HDS)

♦ Pursuit of orphan indications in metastatic ocular melanoma (mOM) and intrahepatic cholangiocarcinoma (ICC)

Our Mission is to Make a Clinically Meaningful Difference for Patients with Cancers of the Liver4

Our Solution – Liver Focused Disease Control

♦ CHEMOSAT® Melphalan/HDS product uniquely positioned to treat the entire liver as a standalone or a complementary therapy

♦ System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), and 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

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Cancers of the Liver - A Major Unmet Need Need

Large global patient population

~1.2 million* patients diagnosed annually with primary or metastatic liver cancer

Liver a common site of metastases

Often the life-limiting organ for cancer patients

Prognosis is poor

Overall survival (OS) generally < 12 months

Currently available/emerging therapies

Limited

* SOURCE – 2008 GLOBOCAN

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Focused On Fastest Path To U.S. Market

EU & US Total Addressable Market

Cancer TypeAnnual

Incidence1 Eligible PTS2

Annual Potential Market

Opportunity (Millions)3,4

Ocular Melanoma ~4,700 ~2,000 ~$200

Intrahepatic Cholangiocarcinoma (ICC)

~14,000 ~11,000 ~$825

Colorectal (CRC) ~411,000 ~47,500 ~$3,563

Total EU & U.S. ~429,700 ~60,500 ~$4,588

Notes:

1) Globocan, American Cancer Society

2) LEK, Strategy&, Company Estimates

3) Assumes 4 TX/patient for OM and 3TX/patient for ICC, CRC

4) Utilizes current reimbursed amount in Europe ~$25,000 USD/TX

Orphan

Indications

Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need

Metastatic Ocular Melanoma (mOM) Rationale

♦ OM has high incidence of liver metastases

o ~4,700 cases of OM diagnosed in U.S. and EU annually

o Up to 90% of patients with metastases will have liver involvement

o Life expectancy of approximately 6 months

♦ Currently no standard of care; therapies utilized include:

o Immunotherapy

o TACE

o Y-90

♦ Believed to be fastest pathway to NDA approval in the U.S

♦ FDA granted Melphalan hydrochloride orphan drug designation for treatment of OM

♦ Clear efficacy signal seen in multiple publications with Melphalan/HDS

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Global Registrational Clinical Trial

Clinical Trial For Patients with Hepatic-Dominant Ocular

Melanoma

Amendment Highlights♦ Ability to collect and report Overall Survival data when survival data

matures (all patients followed until death)

♦ Non-randomized, single-arm trial

♦ Prior enrollment counted to amended enrollment target

♦ PTS treated in prior randomized protocol continue to be treated/evaluated

♦ Anticipate completing enrollment in 2H 2019

Melphalan/HDS TX every 6-8 weeks ≤ 6

cycles

Primary Endpoint(Objective Response Rate)

Secondary

Endpoints(Duration of Response,

Disease Control Rate,

Overall Survival, Progression

Free Survival)

Safety,

Pharmacokinetics,

QoL(Rigorous Analyses to

Assess Risk/Benefit Profile)

Multinational, Multicenter

Non-Randomized

Registration Trial in

Patients with Hepatic

Dominant Ocular

Melanoma(N=~80)

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Melphalan/HDS Response Comparison - Reasons for Confidence

Publication CR PR ORR SD DCR mOS(mos)

Safety

Hughes 2015

(n=44)

(Gen 1 Filter)

0.0% 27.3% 27.3% 52.3% 79.6% 10.6

Majority of adverse events were related to bone marrow suppression. Four deaths were attributed to PHP-Mel, three in the primary PHP-Mel group, and one post-crossover to PHP-Mel from BAC.

Karydis 2018

(n=51)

(Gen 2 Filter)

3.9% 43.1% 47.0% 37.2% 84.3% 15.3

37.5% had Grade 3 or 4 non-hematologic toxicity N=9 (17.6%) of PTS showed cardiovascular toxicity31.3% PTS showed Grade 3 or 4 neutropenia vs 85.7% in prior P3 trialNo TX related deaths

Burgmans

2018* (n=35)

(Gen 2 Filter)

3.1% 71.0% 74.1% 12.5% 86.6% 20.3Safety analysis showed 14 serious AEs, no deaths, no severe bleeding complications, myocardial or cerebral infarctions observed

Artzner 2019

(n=15)

(Gen 2 Filter)

0.0% 60.0% 60.0% 33.3% 93.3% 27.4

Safety analysis showed Grade 3 SAEs observed in 14% of TX (anemia, leukopenia, thrombocytopenia)Most SAEs were Grade 1/2, 5% of reported Grade 3/4 SAEs required intervention

* Oral Presentation – ECIO, Not yet publishedSuperior Results 10

ORR trials in oncology

Approval Endpoint Trial Design/Results

Erivedge (vismodegib) Standard(2012)

ORR 1 single-arm trial; ORR 43%, duration 7.6 months; metastatic ORR 30%, duration 7.6 months

Istodax (romidepsin) Standard(2009)

ORR 2 single-arm trials; ORR 34% duration 454 days, ORR 35% duration 336 days

Libtayo (cemiplimab) Standard(2018)

ORR 2 single-arm trials; ORR 47% from pooled results

Odomzo (sonidegib) Standard(2015)

ORR 1 P2 randomized trial; ORR 58%

Mvasi (bevacizumab-awwb)

Standard(2017)

ORR 1 randomized trial; ORR 39%

Darzalex (daratumumab) Accelerated(2015)

ORR Single-arm trial; ORR 29%

Kyprolis (carfilzomib) Accelerated(2012)

ORR Single-arm trial; ORR 23% duration 7.8 months

Velcade (bortezomib) Accelerated(2003)

ORR 2 Single-arm trials; ORR 29.6%

Darzalex with pomalidomide

Regular-sNDA(2017)

ORR Single-arm trial; ORR 59.2%

Xpovio (selinexor) with dexamethasone

Accelerated(2019)

ORR Single-arm trial; ; ORR 25.3%duration 3.8 months

Pemigatinib Topline data released – NDA submission planned shortly

ORR Single-arm trial; ORR 36%

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Multi-Center ICC Outcomes Data Published in European Radiology

Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic Cholangiocarcinoma: European Multicentre Study on Safety, Short Term Effects and Survival, European Radiology 2018, Marquardt, et al

♦ Study evaluated 15 PTS with ICC selected for PHP TX after failing prior therapies; PTS TX at nine hospitals in Europe between 2012 and 2016

♦ TX outcomes assessed by imaging every three mos following PHP TX

♦ Results after the first PHP TX:

♦ CR: 1 (7%) - CR patient not retreated and is still alive

♦ PR: 2 (13%)

♦ SD: 8 (53%)

♦ Disease Control rate (CR+PR+SD) was 73%

♦ Median OS was 26.9 months from initial diagnosis and 7.6 months from first PHP TX

♦ One-year OS from first PHP TX was 40%, Median PFS was 122 days, and median hepatic hPFS was 131 days

♦ Results after the second PHP TX – 5 patients with SD received 2nd PHP treatment

♦ PR:1 (20%)

♦ SD: 3 (60%)♦ PD: 1 (20%)

♦ Side-effects were potentially under-reported but were considered by the investigators to be tolerable and comparable to other systemic and local therapies

♦ Practitioners observed no Grade 3/4 AEs during the PHP procedure; significant hematological toxicity was observed post-procedure in the form of anemia and thrombocytopenia 5-7 days after the PHP TX

♦ Investigators concluded that PHP Therapy provides “promising response rates in patients with ICC,” and that side-effects were tolerable and comparable to other treatment strategies

Promising response rates in the salvage setting 12

The ALIGN Trial - Global Pivotal Trial in ICC

♦ Continuing to support enrollment in existing network of enrolling centers

♦ Utilizing efficient allocation of resources to advance this trial in conjunction with OM

Registration Trial

A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of

Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus

Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma

Screening Phase

(N=295)

Melphalan/HDS TX every 6-8 weeks ≤ 6 cycles

GEM/CISRe-Induction

Primary Endpoint(Overall Survival)

Secondary Endpoints

(Progression Free Survival, Objective

Response Rate, Safety)

R 1:1

GEM/CISInduction Phase

(4 cycles)

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Tumor Type Program Tasks 2018 1H 2019 2H 2019 1H 2020 2H 2020

Ocular Melanoma(OM)

Focus Trial Pivotal Registration

Study in Hepatic Dominant

OM

** Fastest path to US market approval

Amended Protocol

FPI AmendedTrial

Safety Analysis (DSMB)

LPI

Top Line Data

FDA Submission

Intrahepatic Cholangiocarcinoma

(ICC)

ALIGN TrialP3 Pivotal Trial in ICC

** Strong signal in commercial setting

Enrollment Open

First PTS TX

Building Shareholder Value Through Clinical Development

Completed14

Broad Device Indication in Europe Demonstrates Potential

Device label permits use in broad range of primary &

metastatic liver cancers

13 tumor types treated since CHEMOSAT launch

Presence established in several major markets (~22

cancer centers)

~750 commercial procedures performed

German Guidelines Program in Oncology added

CHEMOSAT to national treatment guidelines for

metastatic melanoma

Added to Medical Oncology National Treatment

Guidelines for Ocular Melanoma liver metastases in

the Netherlands

European centers producing data to support

reimbursement applications in additional markets

Data from EU experience providing steady flow of

supporting abstracts and publications

Tumor Types Treated

Vast Majority:

OM Mets

Other Types Treated:

HCC

ICC

CRC

Breast

Pancreatic

mNET

Cutaneous

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European Commercialization – medac Licensing

Licensing agreement announced December 2018

€6 million in upfront and milestone payments

Fixed transfer price and royalty payments

Agreement includes EU member states plus

United Kingdom, Norway, Switzerland,

Liechtenstein

Extensive network throughout Europe

Allows Delcath to focus on Clinical

Development Program

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2019 Private Placements

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$29.5 Million raised (July 2019 - August 2019)

♦ $12.0 million in debt equitized in addition to cash proceeds

♦ Cash runway beyond top line data

♦ Clean capitalization table

♦ Foundation for a possible path to National Exchange listing

Positioned for success through multiple value inflection points

♦ Full enrollment 2H 2019

♦ Top line data 1H 2020

♦ NDA filing Q4 2020

Capitalization

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Authorized Issued and Outstanding

Preferred Shares 10,000,000 41,716

Common Shares 1,000,000,000 24,388,054

Shares reserved for conversion of Preferred Stock: 695,263,245

Warrants and Options:

Feb 2015 Warrants ($0.01; exp 2/2020) 9

July 2015 Warrants ($0.01; exp 7/2020) 9

Oct 2016 Warrants ($0.01; exp 10/2021) 11

2019 Warrants ($0.06; exp XX/202X) 701,373,492

Options 1,150,000

Total shares reserved for warrants and options: 702,523,521

Shares reserved for conversion of convertible notes: 44,444,444

Total shares issued and reserved: 1,466,619,264

Summary

Ocular Melanoma (OM)

Late-stage clinical development trial expected to complete accrual in 2H 2019

Topline data expected to complete in 1H 2020

FDA NDA submission for indication expected in 2H 2020

Focused on cancers of the liver with high unmet medical need & no established SOC

Commercial experience from Europe & recent clinical data provide confidence in clinical

development path

~750 commercial procedures performed

Pursuing indications representing ~$1 billion opportunity in the U.S. & Europe with additional

potential in Latin America

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