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Delcath Systems, Inc. Corporate Presentation (NASDAQ: DCTH) August 2020
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Page 1: Delcath Systems, Inc.delcath.com/content/uploads/2020/08/DCTH-August... · Delcath: Restructured, Recapitalized, Refocused 3 Fully restructured in 2019, emerging with a clean balancesheet

Delcath Systems, Inc.

Corporate Presentation(NASDAQ: DCTH)August 2020

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Forward-looking Statements

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This presentation contains forward-looking statements, which are subject to certain risksand 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 ethicscommittee clearance of the Phase 3 OM and ICC Registration trial protocols from participating sites andthetiming 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 aremade.

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Delcath: Restructured, Recapitalized, Refocused

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Fully restructured in 2019, emerging with a clean balance sheet and capital table.

Recapitalized with $51.5 million over the last 12 months, led by healthcare focused funds, to complete the Phase 3 FOCUS trial in metastatic ocular melanoma (top-line data end-2020/early-2021) and refile a New Drug Application (NDA) with FDA (mid-2021).

Refocused on the approval and commercialization of Melphalan/HDS as a unique, high-value, interventional oncology platform, for the treatment of ultra-orphan and other orphan indications in areas of high unmet need.

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Capital Structure and Share Information

1 As of August 14, 2020, including Common, Preferred E & E1 & Pre-funded Warrants as converted2 As of June 30, 20203 Warrants at a $10 exercise price4 Net cash used in operating activities in 20195 Used NASDAQ price information starting on May 1st through August 14th6 30-day average calculated between July 14th and August 14th

Share Listing Current DCTH (NASDAQ)Shares Outstanding1 6.53mmCash and Cash Equivalents2 16.2mmWarrants Outstanding3 4.00mm2019 Cash Burn4 23.6mmDebt $2.0mm52 week Low – High5 $6.06 - $13.0830d Average Daily Volume6 63,551

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Management Team

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John Purpura - Interim Chief Executive OfficerPreviously Mr. Purpura was with Bracco Diagnostics/E-Z-EM as Vice President and then Executive Director ofInternational Regulatory affairs from 2007 to 2008, and Head of Regulatory Affairs for North America and LatinAmerica from 2008 to October 2009. Prior to E-Z-EM Mr. Purpura had an 11-year career with Sanofi-Aventiswith progressively more senior Regulatory and CMC responsibilities, ultimately serving as Associate VP forRegulatory and CMC from 2005 to 2007. Prior To Sanofi, Mr. Purpura held various quality and regulatorymanagement roles with Pharma companies from 1985 to 1995. Mr. Purpura earned a MS in Management &Policy and BS degrees in Chemistry and Biology at the State University of New York at Stony Brook.

Christine Padula – Principal Accounting OfficerMs. Padula joined the Company as the Vice President of Finance in September 2019. Previously she waswith medCPU, Inc. as the Vice President of Finance and Controller from 2015 to 2019. Ms. Padula had a 19-year career with Siemens of which 17 years were with Siemens Financial Services, Inc. ultimately serving asthe Vice President and Controller of the US division. From 1987 to 1995, she had various senior and staffaccountant roles. Ms. Padula earned her B.S. degree in Business Administration with a concentration inAccounting at Montclair State University in New Jersey. Ms. Padula holds an inactive CPA license from theState of New Jersey.

Johnny John, MD – Vice President MedicalAffairsDr. John has worked in oncology drug development and clinical trials for over 15 years. Prior to joiningDelcath he worked in Clinical Trial Operations at InVentiv Health. Among the clinical programs he worked onthere were the trials that resulted in the FDA approval of Ipilimumab. Prior to InVentiv Health, Dr. John spentover 11 years in clinical practice. He received his medical degree from Mangalore University, India and post-graduate training at the University of Illinois.

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Board of Directors

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Roger G. Stoll, Ph.D. Chairman (since December 2008)Appointed Chairman, September 2015. From 2002 to 2008, served as Chairman, CEO and President ofCortex Pharmaceuticals, Inc. (CORX). Dr. Stoll has served on eight corporate boards including; St. JudeMedical, The BOC Group (London), Questcor, Agensys, and Chelsea Therapeutics.

John R. Sylvester, Director (since July 2019)From 2005-2019, John was at BTG PLC, an international specialist healthcare company that developsand commercializes products targeting critical care, cancer and other disorders, and served as ChiefCommercial Officer from 2011 to 2019. He received his BSc (Honors) in Biochemistry and AppliedMolecular Biology at the University of Manchester in England.

Elizabeth Czerepak, Director (since February 2020)Ms. Czerepak recently served and CFO and CBO of Genevant Sciences, Inc. Experience includes CFOat other biotechnology companies, including Altimmune, Isarna Therapeutics, and Cancer Geneticswhere she played a key role in achieving Altimmune’s public listing through reverse merger and CancerGenetics’ IPO and subsequent uplisting to Nasdaq.

Steven Salamon, Director (since May 2020)Mr. Salamon holds a MBA from the Ivey Business School and an Engineering Physics degree from theUniversity of Toronto. Prior to cofounding Rosalind Advisors, Mr. Salamon worked as an equity analyst atHSBC securities and RBC Capital Markets.

Gil Aharon, Ph.D. Director (since May 2020)Dr. Aharon holds a Ph.D in Biophysics and Molecular Biology from the University of Toronto. Prior to co-founding Rosalind Advisors, Dr. Aharon worked as an equity analyst at Infinium Securities.

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Delcath Systems, Inc. - Overview◆ Interventional oncology (IO) company with multiple near-term catalysts

◆ Enrollment completed in a phase 3 registration trial in metastatic ocular melanoma◆ End-2020/early-2021 - Topline data expected◆ Mid-2021 - FDA NDA submission for indicationexpected

◆ Proprietary IO system (PHP) targets primary/metastatic liver cancers◆ A differentiated, high-value IO platform targeting high unmet need indications with

unsatisfactory standard-of-care.◆ Delivers chemotherapy directly to the liver with subsequent filtration to improve

safety◆ Minimally invasive, repeatable, predictable, manageable systemic toxicity profile, can

delay tumor progression and can potentially improve survival◆ Commercial / Clinical Status

◆ Commercial stage in the EU under the CHEMOSAT® brand◆ ~1,000 commercial procedures performed◆ Late-stage (Phase 3) clinical development in the US (Melphalan/HDS)◆ Pursuit of marketing approval for orphan indications in metastatic ocular◆ melanoma (mOM), intrahepatic cholangiocarcinoma (ICC) or others presently under

strategic assessment

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

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Interventional Oncology Companies have become a Strategic Asset

IO – the fourth pillar of oncology treatment. Interventional oncology has rapidly become an integrated specialty component of comprehensive oncology care. IO is fully accepted and demanded by knowledgeable oncologists where it has become an integral part of the treatment referral pattern.

Notable Recent Transactions in the Interventional Oncology Space

June 2018 - CDH investments acquires Sirtex

August 2019 - Boston Scientific acquires BTG

June 2019 - Varian Medical Systems acquires Endocare and Alicon

August 2019 - Varian acquires Boston Scientific’s microsphere business

February 2019 - Johnson & Johnson acquires Auris Health, Inc.

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Liver-focused disease control. CHEMOSAT® Melphalan/Hepatic Delivery System (HDS) product uniquely positioned to treat the entire liver as a standalone or a complementary therapy

Limited systemic exposure = responses with better Quality of Life. 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 thepatient

Repeatable MINIMALLY INVASIVE procedure. Typically takes ~2-3 hours.

Liver IsolatedVia Double Balloon Catheter In Inferior Vena Cava (IVC)

Melphalan InfusedDirectly to Liver Via Catheter In

Hepatic Artery

Filter BloodExiting The Liver By Proprietary

Extra-corporeal Filters

The PHP Solution – Liver Focused Disease Control

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Cancers of the Liver - A Major UnmetNeed

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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 8-12 months

Currently available/emerging therapies

Limited

* SOURCE – 2008GLOBOCAN

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Focused On Fastest Path to U.S. Market and Labelexpansion

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Clinically relevant Indications by US incidence numbersIndication Potential  

Patients  Annually

Development Status Notes

Metastatic Ocular  Melanoma (mOM)

1,530 1,2 Phase 3 FOCUS Trial Data Q4 2020

Cholangiocarcinoma  (ICC)

2,960 3,4 TBD Efficacy observed in EU  commercial  experience

Metastatic Neuroendocrine  Tumors (mNET)

9,000 5,6 TBD Phase 2b data  supports phase 3  initiation

Liver‐dominant Breast  Cancer (mBC)

27,300 7,8 TBD Observed in EU  commercial  experience

Metastatic Colorectal  Cancer (mCRC)

35,500 9,10 TBD Keen interest  among GI  oncologists in EU

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◆ Metastatic Ocular Melanoma (OM) has high incidence of liver metastaseso Up to 90% of patients with metastases will have liver involvemento ~ 1500 cases of liver-dominant mOM diagnosed in U.S. annually1,2o Life expectancy of approximately 6 months

◆ Currently no standard of care; therapies utilized include:o Immunotherapyo Chemoembolization (e.g.,Transarterial Chemoembolization, or “TACE”)o Radioembolization (e.g., Yttrium-90, or “Y-90”)

◆ FDA granted Melphalan hydrochloride orphan drug designation for treatment of Ocular Melanoma

◆ Efficacy demonstrated in multiple publications with Melphalan/HDS◆ A network of Key Opinion Leaders (KOLs) and centers specializing in mOM, allowing for

readily accessible patient population in need of a novel treatment paradigm.

Metastatic Ocular Melanoma (mOM)Rationale

* Ocular Melanoma Foundation (http://www.ocularmelanoma.org/disease.htm)

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Global Registration ClinicalTrial

Clinical Trial For Patientswith  Hepatic‐Dominant Ocular  

Melanoma

Trial Highlights◆ Ability to collect and report Overall Survival data when survival data

matures (all patients followed untildeath)◆ Non-randomized, single-armtrial◆ Prior enrollment counted to amended enrollmenttarget◆ Patients treated in prior randomized protocol continue to be treated/evaluated◆ Enrollment complete

Melphalan/HDSTX 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,

Quality of Life(Rigorous Analyses to

Assess Risk/BenefitProfile)

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 ConfidencePublication CR PR ORR SD DCR mOS

(mos)Safety

Hughes2015 (n=44)(Gen 1 Filter)

0.0% 27.3% 27.3% 52.3% 79.6% 10.6 Majority of adverse events were related tobonemarrow  suppression. Four deaths were attributed to PHP‐Mel,  three in the primary PHP‐Mel group, and one post‐ crossover to PHP‐Mel fromBAC.Old version of medical procedure and device used

Karydis2018 (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 patients showed cardiovascular  toxicity31.3% PTS showedGrade 3 or 4 neutropenia vs 85.7%in  prior P3 trial.No TX related deaths.

Artzner 2019(n=15)(Gen 2 Filter)

0.0% 60.0% 60.0% 33.3% 93.3% 27.4 Safety analysis showedGrade 3 SAEs observed in 14%of  TX (anemia, leukopenia,thrombocytopenia).Most SAEs were Grade 1/2, 5% of reported Grade3/4SAEs required intervention

Burgmans 2020(n=35)(Gen 2 Filter)

3.0% 69.0% 72.0% 13% 85% 19.1 Safety analysis showed no treatment related deaths, 14 serious AEs, no  severe bleeding complications,myocardial or cerebral infarctions observed.

Superior Results14

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FDA Approvals Based on ORR in Single-Arm Oncology Trials

Precedents SuggestingApprovability 15

Approval Endpoint Trial Design/Results

Erivedge (vismodegib) Standard(2012)

ORR 1 single‐arm trial; ORR 43%, duration 7.6months;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

Darzalex (daratumumab) Accelerated(2015)

ORR Single‐arm trial; ORR 29%

Kyprolis (carfilzomib) Accelerated(2012)

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

Velcade (bortezomib) Accelerated(2003)

ORR 2 Single‐arm trials; ORR 29.6%

Darzalex withpomalidomide

Regular‐sNDA(2017)

ORR Single‐arm trial; ORR 59.2%

Xpovio (selinexor) withdexamethasone

Accelerated(2019)

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

Pemigatinib Accelerated(2020)

ORR Single‐arm trial; ORR 36%

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*Source: Boston Health Associates  primary research n=13physicians

Melphalan/HDS is well received with hospital stakeholders

Market research confirms the high unmet need in mOM*:

• While systemic treatment of mOM patients is based off cutaneous melanoma therapies, oncologists see extremely poor responses in mOM patients treated with systemic therapies.

• Oncologists we surveyed unanimously suggested that Melphalan/HDS is a significant advancement for mOM patients, as compared to other liver-targeted therapies.

• A majority of oncologists we surveyed believe that up to 80% of their mOM patients with liver metastases would be candidates for treatment with Melphalan/HDS due to its clinical benefits and safety profile.

Oncologist perception of mOM  Patients eligibility forMelphalan/HDS  

(n=12)

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mOM patients that arewell enough to receiveMelphalan/HDS

mOM patients that arewell enough to receiveMelphalan/HDS and fallwithin the inclusion/exclusioncriteria

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Stakeholder survey suggests Melphalan/HDS potential positioning as a first-line treatment in mOM due to limited efficacy of available therapies and disease rarity*:

• Delcath has obtained an orphan drug designation for Melphalan from FDA in mOM.

• Cost of combined ipilimumab and nivolumab therapy per year for cutaneousmelanoma (with little to no efficacy in mOM) is $256k.

• Payer and hospital financial stakeholders price expectations for Melphalan/HDS are in-line with ultra-orphan pricing.

• The annual incidence of liver-dominant mOM in the US is ~1500.

• mOM US market opportunity is estimated at >$250 million annually assuming parity pricing with systemic cutaneous melanoma therapies.

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*Source: BHA primary research** Ocular Melanoma Foundation (http://www.ocularmelanoma.org/disease.htm)

Melphalan/HDS Market Opportunity

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Patient Journey

Chemosaturation

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Clinical Development of follow-on indications

Rationale for Melphalan/HDS in other indications:

• 2Q/2020 strategic refocusing pursuant to corporate restructuring.

• Currently reviewing clinical and commercial data, (based on over 1,000 commercial PHP procedures in the EU) concomitantly with medical advisory board consultation for optimal clinical path forward.

• The goal of the data review is to broaden our pipeline and add additional orphan indications in areas of high unmet need to our Melphalan/HDS Platform pipeline.

• Options include ICC, Neuroendocrine Tumors, Liver-dominant breast cancer, Colorectal cancer.

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Concentrating the Power of Chemotherapy

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European Commercialization – medac Licensing

Licensing agreement announced December 2018 Provides a partner with broad EU reach and

experience in developing markets. Chemosat is available in ~22 centers, with a

device label that permits broad use across arange of primary and metastatic liver cancers

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Allows Delcath to identify indications with strong efficacy signals:

Chemosat used to treat 13 different tumor types since launch

~25 reps in Europe

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Broad Device Indication in Europe Demonstrates Potential

Device label permits use in broad range of primary&metastatic liver cancers

13 tumor types treated since CHEMOSATlaunch Presence established in several major markets(~22

cancer centers) ~1,000 commercial proceduresperformed German Guidelines Program in Oncology added

CHEMOSAT to national treatment guidelines formetastatic melanoma

Added to Medical Oncology National Treatment Guidelines for Ocular Melanoma liver metastasesin the Netherlands

European centers producing data to supportreimbursement applications in additionalmarkets

Data from EU experience providing steady flow of supporting abstracts andpublications

Tumor Types TreatedVast Majority:

• Metastatic Ocular Melanoma (mOM)

Other Types Treated:• Hepatocellular Carcinoma

(HCC)• Intrahepatic

Cholangiocarcinoma (ICC)• Metastatic Colorectal Cancer

(mCRC)• Metastatic Breast (mBreast)• Pancreatic• Metastatic Neuroendocrine

Tumors (mNET)• Metastatic Cutaneous

Melanoma (mCM)21

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Summary

$51.5 Million raised (July 2019 – May 2020) - Cash runway to mid-2021

Near-term value inflection points:Late-stage clinical development trialcompleted enrollment in mOM

Topline data expected end-2020/early-2021

FDA NDA submission expected in mid-2021

Focused on cancers of the liver with high unmet medical need & no established Standard of Care (SOC)

Commercial experience from Europe & recent clinical data provide confidence in clinicaldevelopment path Over 1,000 commercial procedures performed

Pursuing indications representing large addressable markets

The technology platform can potentially be applied to other systems and organs in the body, as well as other chemotherapeutic agents

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References1. Cancer.net Editorial Board (2020) Eye Cancer - Statistics. In: Cancer.Net.

https://www.cancer.net/cancer-types/eye-cancer/statistics. Accessed 22 Jun 20202. Ocular Melanoma Foundation. Treatment of Metastatic Disease. In: OMF - Metastatic

Treatment. http://www.ocularmelanoma.org/metstreatment.htm. Accessed 22 Jun 20203. Patel N, Benipal B. Incidence of Cholangiocarcinoma in the USA from 2001 to 2015: A US

Cancer Statistics Analysis of 50 States. Cureus. 2019;11(1):e3962. Published 2019 Jan 25.4. United States Census Bureau. (2019) Monthly Population Estimates for the United States:

April 1, 2010 to December 1, 2020 (NA-EST2019-01).5. Cancer.net Editorial Board. (2020) Neuroendocrine Tumors - Statistics. In: Cancer.Net.

https://www.cancer.net/cancer-types/neuroendocrine-tumors/statistics. Accessed 22 Jun 2020

6. Saeed A, Buell JF, Kandil E. Surgical treatment of liver metastases in patients with neuroendocrine tumors. Ann Transl Med. 2013;1(1):6. doi:10.3978/j.issn.2305-5839.2013.01.08

7. Cancer.net Editorial Board. (2020) Breast Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/breast-cancer/statistics. Accessed 22 Jun 2020

8. Bale R, Putzer D, Schullian P. Local Treatment of Breast Cancer Liver Metastasis. Cancers (Basel). 2019;11(9):1341. Published 2019 Sep 11. doi:10.3390/cancers11091341

9. Cancer.net Editorial Board. (2020) Colorectal Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/colorectal-cancer/statistics. Accessed 22 Jun 2020

10. Ismaili N. Treatment of colorectal liver metastases. World J Surg Oncol. 2011;9:154. Published 2011 Nov 24. doi:10.1186/1477-7819-9-154

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