Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.

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Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.
Delcath Systems

                  Corporate Presentation
                            (OTCQB: DCTH)
                            December 2019
Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.
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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Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.
Management Team

Jennifer Simpson, PhD., M.S.N., C.R.N.P. -
President & Chief Executive Officer
    ♦   Vice President, Global Marketing, Oncology Brand Lead at
        ImClone Systems, Inc/Eli Lilly
    ♦   Product Director, Oncology Therapeutics Marketing at Ortho
        Biotech
    ♦   Earlier in her career Dr. Simpson spent over a decade as a
        hematology/oncology-nurse practitioner and educator
    ♦   Dr. Simpson earned a Ph.D. in Epidemiology from the
        University of Pittsburgh, an M.S. in Nursing from the University
        of Rochester, and a B.S. in Nursing from the State University
        of New York at Buffalo
Barbra C. Keck, Chief Financial Officer
    ♦   Deloitte & Touche, LLP
    ♦   Earlier in her career, Ms. Keck spent several years in
        executive roles in the non-profit sector
    ♦   Ms. Keck earned her M.B.A. in Accountancy from Baruch
        College and Bachelor of Music in Music Education from the
        University of Dayton
John Purpura, Executive Vice President - Global
Head of Operations

    ♦ Vice President and then Executive Director of International
        Regulatory 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 regulatory
        management roles with Pharma companies from 1985 to
        1995. He earned a MS in Management & Policy and BS
        degrees in Chemistry and Biology at the State University of
        New York at Stony Brook

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Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.
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)
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     Our Mission is to Make a Clinically Meaningful Difference for Patients with Cancers of the Liver
Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.
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    Melphalan Infused Directly Into Liver   Blood Exiting The Liver Filtered By
              Catheter In IVC               Via Catheter In Hepatic Artery       Proprietary Extra-corporeal Filters

                                                                                                                 5
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

                                                                                         6
Focused On Fastest Path To U.S. Market

                                          EU & US Total Addressable Market
                                                                                                   Annual Potential
                                                 Annual                                                Market
                  Cancer Type                                             Eligible PTS2
                                               Incidence1                                            Opportunity
                                                                                                     (Millions)3,4
                  Ocular Melanoma                   ~4,700                      ~2,000                         ~$200
  Orphan
Indications          Intrahepatic
                                                   ~14,000                     ~11,000                         ~$825
               Cholangiocarcinoma (ICC)
                   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

              Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need                                       7
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

                                                                             8
Global Registrational Clinical Trial

 Clinical Trial For Patients with
   Hepatic-Dominant Ocular
            Melanoma
                                                                                   Primary Endpoint
                                                                               (Objective Response Rate)

            Multinational, Multicenter
                                                                                      Secondary
                Non-Randomized                      Melphalan/HDS                     Endpoints
              Registration Trial in                TX every 6-8 weeks ≤ 6       (Duration of Response,
                                                           cycles                Disease Control Rate,
             Patients with Hepatic                                            Overall Survival, Progression
                Dominant Ocular                                                       Free Survival)
                   Melanoma                                                         Safety,
                            (N=~80)                                            Pharmacokinetics,
                                                                                     QoL
                                                                                 (Rigorous Analyses to
                                                                               Assess Risk/Benefit Profile)
  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
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Melphalan/HDS Response Comparison - Reasons for Confidence
   Publication             CR        PR         ORR     SD      DCR     mOS                           Safety
                                                                        (mos)

                                                                                Majority of adverse events were related to bone marrow
   Hughes 2015
                                                                                suppression. Four deaths were attributed to PHP-Mel,
   (n=44)                 0.0%      27.3%       27.3%   52.3%   79.6%   10.6    three in the primary PHP-Mel group, and one post-
   (Gen 1 Filter)                                                               crossover to PHP-Mel from BAC.

                                                                                37.5% had Grade 3 or 4 non-hematologic toxicity
   Karydis 2018                                                                 N=9 (17.6%) of PTS showed cardiovascular toxicity
   (n=51)                 3.9%      43.1%       47.0%   37.2%   84.3%   15.3    31.3% PTS showed Grade 3 or 4 neutropenia vs 85.7% in
   (Gen 2 Filter)                                                               prior P3 trial
                                                                                No TX related deaths

   Burgmans                                                                     Safety analysis showed 14 serious AEs, no deaths, no
   2018* (n=35)           3.1%      71.0%       74.1%   12.5%   86.6%   20.3    severe bleeding complications, myocardial or cerebral
   (Gen 2 Filter)                                                               infarctions observed

                                                                                Safety analysis showed Grade 3 SAEs observed in 14% of
   Artzner 2019
                                                                                TX (anemia, leukopenia, thrombocytopenia)
   (n=15)                 0.0%      60.0%       60.0%   33.3%   93.3%   27.4    Most SAEs were Grade 1/2, 5% of reported Grade 3/4
   (Gen 2 Filter)                                                               SAEs required intervention

* Oral Presentation – ECIO, Not yet published
                                                         Superior Results                                                     10
ORR trials in oncology

                            Approval                      Endpoint   Trial Design/Results

  Erivedge (vismodegib)     Standard                      ORR        1 single-arm trial; ORR 43%, duration 7.6 months;
                            (2012)                                   metastatic ORR 30%, duration 7.6 months

  Istodax (romidepsin)      Standard                      ORR        2 single-arm trials; ORR 34% duration 454 days,
                            (2009)                                   ORR 35% duration 336 days

  Libtayo (cemiplimab)      Standard                      ORR        2 single-arm trials; ORR 47% from pooled results
                            (2018)
  Odomzo (sonidegib)        Standard                      ORR        1 P2 randomized trial; ORR 58%
                            (2015)
  Mvasi (bevacizumab-       Standard                      ORR        1 randomized trial; ORR 39%
  awwb)                     (2017)

  Darzalex (daratumumab)    Accelerated                   ORR        Single-arm trial; ORR 29%
                            (2015)
  Kyprolis (carfilzomib)    Accelerated                   ORR        Single-arm trial; ORR 23% duration 7.8 months
                            (2012)
  Velcade (bortezomib)      Accelerated                   ORR        2 Single-arm trials; ORR 29.6%
                            (2003)
  Darzalex with             Regular-sNDA                  ORR        Single-arm trial; ORR 59.2%
  pomalidomide              (2017)
  Xpovio (selinexor) with   Accelerated                   ORR        Single-arm trial; ; ORR 25.3%
  dexamethasone             (2019)                                   duration 3.8 months
  Pemigatinib               Topline data released – NDA   ORR        Single-arm trial; ORR 36%
                            submission planned shortly
                                                                                                                        11
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

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                       Promising response rates in the salvage setting
The ALIGN Trial - Global Pivotal Trial in ICC

 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

                                                                                              Primary Endpoint
                                                                Melphalan/HDS                    (Overall Survival)
                                                             TX every 6-8 weeks ≤ 6 cycles

 Screening Phase               GEM/CIS
                             Induction Phase      R 1:1
                                (4 cycles)
      (N=295)                                                                                      Secondary
                                                                     GEM/CIS                       Endpoints
                                                                     Re-Induction                (Progression Free
                                                                                                 Survival, Objective
                                                                                               Response Rate, Safety)

       ♦    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

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Building Shareholder Value Through Clinical Development

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

                                                    Amended
                                                    Protocol
                           Focus Trial
                       Pivotal Registration       FPI Amended
                             Study in                  Trial
   Ocular Melanoma      Hepatic Dominant         Safety Analysis
         (OM)                  OM                   (DSMB)

                       ** Fastest path to US           LPI
                         market approval          Top Line Data
                                                 FDA Submission

                            ALIGN Trial          Enrollment Open
      Intrahepatic     P3 Pivotal Trial in ICC
  Cholangiocarcinoma
          (ICC)         ** Strong signal in        First PTS TX
                        commercial setting

                                                                                                        Completed
                                                                                                          14
Broad Device Indication in Europe Demonstrates Potential

                                     Device label permits use in broad range of primary &
         Tumor Types Treated          metastatic liver cancers
                                     13 tumor types treated since CHEMOSAT launch
  Vast Majority:
                                     Presence established in several major markets (~22
                   OM Mets            cancer centers)
                                     ~750 commercial procedures performed
  Other Types Treated:
                                     German Guidelines Program in Oncology added
                    HCC               CHEMOSAT to national treatment guidelines for
                     ICC              metastatic melanoma
                    CRC              Added to Medical Oncology National Treatment
                                      Guidelines for Ocular Melanoma liver metastases in
                    Breast            the Netherlands
               Pancreatic            European centers producing data to support
                    mNET              reimbursement applications in additional markets
               Cutaneous             Data from EU experience providing steady flow of
                                      supporting abstracts and publications

                                                                                 15
European Commercialization – medac Licensing

   Licensing agreement announced December 2018       Extensive network throughout Europe
   €6 million in upfront and milestone payments      Allows Delcath to focus on Clinical
   Fixed transfer price and royalty payments          Development Program
   Agreement includes EU member states plus
    United Kingdom, Norway, Switzerland,
    Liechtenstein

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2019 Private Placements

   $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

                                                                      17
Capitalization

                                                           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

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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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