delcath systems, inc

Delcath Systems, Inc.

Corporate Presentation(NASDAQ: DCTH)

August 2021

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 asa 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 withthe 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. 2

Delcath – A Unique Interventional Oncology Opportunity

◆ Percutaneous Hepatic Perfusion (PHP) drug – device platformo Focused chemotherapy treatment to the liver with limited systemic exposure

o >200K liver dominant cancers per year in the US and EU – difficult to treat

o >100K local / regional liver therapies per year despite inability to treat the whole liver

◆ Late-stage, de-risked programo 29% ORR (interim analysis) Phase 3 result greatly exceeds prespecified success criterion

o 1Q-2022 US NDA planned for HEPZATO KITTM in metastatic ocular melanoma (mOM)

o >1,000 PHP commercial treatments (CHEMOSATTM) in EU (stand-alone device approved

under CE mark) provide real world evidence of safety and efficacy

◆ PHP has meaningful revenue potential near term and >$1B TAM longer termo >$300M mOM TAM in US and EU – no current standard of care due to limited efficacy

o Existing proof of principal data in additional indications totaling ~100K patients per year

3

High Incidence of Liver Dominant Cancers

4See appendix for footnoted references

Partial SetLiver Dominant Cancers

US Incidence

Metastatic Ocular Melanoma (mOM)

1,530 1,2

Cholangiocarcinoma (ICC)

2,960 3,4

Liver-dominant Breast Cancer (mBC)

2,000-5,0007,8,9,10

Metastatic Neuroendocrine Tumors (mNET)

9,000 5,6

Metastatic PancreaticCancer (mPC)

24,000 7,13

Metastatic Colorectal Cancer (mCRC)

35,500 11,12

◆ Liver a common site of

metastases

Often the life-limiting organ for

cancer patients

◆ Prognosis is poor

Overall survival (OS) generally 8-

12 months

◆ Systemic therapies have

limited efficacy

Current Liver Directed Therapies and Limitations

Trans Arterial Chemo Embolization (TACE)

◆ Beads obstruct the blood flow to the

tumor and elute chemotherapy

◆ 50k – 60K treatments per year in US

Y90

◆ Radioactive beads delivered into tumor

◆ 10k – 15K treatments per year in US

◆ TACE and Y90 are effective, but tumors

recur, and retreatment often not possible

due to previous disruption of vasculature

◆ Some diseases present with multiple small

tumors, diffuse disease can not be treated

with a tumor-by-tumor modality

◆ Many tumors are not imageable – micro-

metastasis are common

◆ Liver-focused disease control: PHP system uniquely positioned to treat the entire liver as a standalone or

complementary therapy

◆ Limited systemic exposure = responses with better Quality of Life: Hepatic isolation and blood filtration

enables delivery of high concentrations of chemotherapy (melphalan) with limited systemic exposure

◆ Repeatable MINIMALLY INVASIVE procedure: Cath lab procedure which typically takes ~2-3 hours

Melphalan InfusedDirectly to Liver Via Catheter

In Hepatic Artery

Blood FilteredExiting The Liver By Proprietary

Extra-corporeal Filters

Liver IsolatedVia Double Balloon Catheter

In Inferior Vena Cava (IVC)

The PHP Solution – Liver Focused Disease Control

6

◆ Significant Unmet Need:

o Metastatic Ocular Melanoma (mOM) has high incidence (~50%) of liver metastases

o 1,200 - 1,500 cases1,2 of liver-dominant mOM diagnosed in US with median overall

survival of 6 – 9 months14,15

o Currently no standard of care and therapies have limited efficacy

◆ Lower Risk Indication with High Unmet Need:

o FDA granted Melphalan hydrochloride orphan drug designation for treatment of Ocular

Melanoma

o Efficacy data presented in multiple publications with Melphalan/HDS

◆ Targeted Call Point:

o A network of Key Opinion Leaders (KOLs) and centers specializing in mOM, allowing

for readily accessible patient population

Metastatic Ocular Melanoma (mOM)

7

2nd Global Registration Trial: Hepatic Dominant mOM

Clinical Trial For Patientswith Hepatic-Dominant Ocular

Melanoma

Trial History

◆ Initially a RCT against Best Alternative Care (BAC) – 42 patients enrolled, 32 treated in the BAC arm

◆ Patients reluctant to enroll due to BAC offering little benefit and the availability of treatment with CHEMOSAT in the EU

◆ After consultation with the FDA, trial amended to non-randomized, single-armtrial

HEPZATO

TX every 6-8 weeks

up to a maximum of

6 cycles

Primary Endpoint

(Objective Response Rate)

Secondary Endpoints

(DOR, DCR,OS, PFS)

Safety, PK, Quality of

Life

Multinational, Multicenter

Non-Randomized Trial

(N=102 Enrolled, 91

Treated)

All patients have completed treatment

8

Powered to demonstrate

superiority over checkpoint

inhibitors (lower bound of 95% CI

>8.3%)

Prespecified secondary

endpoints include exploratory

analyses against BAC

Focus Trial - Preliminary Analysis On 87% of Patients

INTERNAL-CONFIDENTIAL

* Patients who Met Criteria for Topline Analysis

Criteria: At least 2 evaluable response timepoints received prior to 12Mar2021 unless the subject had PD at the first evaluable timepoint or had

no scans acquired (and none that will be acquired in the future) after the first evaluable timepoint.

TreatedPreliminary Analysis*

Total 123 108

Melphalan/HDS Arm 91 79

Best Alternative Care (BAC) Arm 32 29

Focus Trial – Prespecified Criterion for Success Achieved

◆ A meta-analysis of checkpoint inhibitors (476 patients,16 publications) calculated

a 95% Confidence Interval for ORR of 3.6% - 8.3%

◆ Superiority requires the lower bound (95% C.I.) of the HEPZATO ITT population

to exceed 8.3%

◆ Lower bound of 20.05% >> 8.3% target - remaining 11 patients to be analyzed

will not change the result

Preliminary Intent-to-Treat Population

PHP(N=79 treated + 10 untreated)

Objective Response Rate 26 (29.2%)

95% CI [20.05, 39.81]

Secondary Analyses Possible Against BAC

INTERNAL-CONFIDENTIAL

Enrolled Treated

Best Alternative Care (BAC) Arm 42 32

Dacarbazine 1 0

Ipilimumab 7 1

Pembrolizumab 8 6

Transarterial Chemoembolization (TACE) 26 25

Strong Evidence of Superiority Versus Check Point Inhibitors and TACE

ORR and DCR Versus BAC: Compelling Improvements

PRELIMINARY DATA - SUBJECT TO CHANGE


PHP(N=89)

BAC (N=39)

Objective Response Rate 26 (29.2%) 4 (10.3%)

95% CI [20.05, 39.81] [2.87, 24.22]

p-value (Chi-square) 0.0198


PHP(N=89)

BAC (N=39)

Disease Control Rate 56 (62.92%) 11 (28.21%)

95% CI [52.03, 72.93] [15.00, 44.87]

p-value (Chi-square) 0.0003

Best Overall Response (Single Timepoint) 44% versus 17%

Best Overall Response

Preliminary Per Protocol Population

PHP(N=79)

BAC (N=29)

Complete Response (CR)6

(7.6%)0

Partial Response (PR)29

(36.7%)5

(17.2%)

Stable Disease (SD)21

(26.6%)7

(24.1%)

Progressive Disease (PD)22

(27.9%)16

(55.2%)

Not Evaluable (NE)1

(1.3%)1

(3.5%)

Note: The efficacy analysis population includes two patients without post-baseline assessments and three patients with no evaluable post-baseline

target lesion response assessments; these five patients (three PHP and two BAC) are omitted from the above graph.

Focus Trial – Progression-Free Survival Almost Triple BAC


PHP(N=79)

BAC (N=29)

Progression-Free Survival (PFS, median) 9.03 months 3.06 months

95% CI [6.24, 11.83] [2.69, 5.65]

p-value 0.0004

PFS Status

Events 50 (63.3%) 22 (75.9%)

Censored 29 (36.7%) 7 (24.1%)

Hazard Ratio Estimate 0.41

95% CI [0.246, 0.686]

p-value 0.0007

Serious TEAEs Occurring in >5% of PHP Patients

* Most commonly thrombocytopenia (14.9%), neutropenia (10.9%), and leukopenia (4.2%)† Including hemothorax, pulmonary edema, and pleural effusion‡ Including arrhythmias and cardiac arrest


CategoryFocus Trial

(n=94)

Bone Marrow Suppression* 21 (22.3%)

Respiratory and Thoracic Disorders† 6 (6.4%)

Cardiac Disorders‡ 5 (5.3%)

HEPZATO Safety - Published Studies and Real-World Evidence

◆ 4 published studies in mOM - 164 Patients

o No treatment related deaths

o Manageable toxicities

o Well-tolerated with maintenance of QoL

◆ FOCUS Trial

o 91 Patients treated for a total 356

treatments to date

o No treatment related deaths

o Toxicities consistent with published

studies

◆ >1,000 treatments in real-world clinical practice with strong safety profile

16

2013 Complete Response Letter and Resulting Improvements

CONFIDENTIAL

◆ In the first pivotal trial there were 4 deaths attributed to PHP :

o 2 due to patient related issues (1 hepatic failure and 1 gastric perforation)

o 2 due to hematological toxicities (1 sepsis and 1 neutropenic complications)

◆ A new generation filter (GEN2) was designed which is now used in all HEPZATO kits to increase filter

efficiency to a mean efficiency of 86% in the clinical setting reducing hematological toxicities

◆ Protocol amendments were put in place to exclude high risk patients

◆ The FDA has stated “the approval decision will not be based on a specific response rate (of which there

already are data), but on whether that response rate is sufficient to overcome the toxicity of the treatment.”

Adverse Event

G3/4

Hughes 2016 Karydis 2018

% n % n

Anemia 62.9% 44 29.4% 15

Neutropenia 85.7% 60 31.3% 16

Thrombocytopenia 80.0% 56 31.3% 16

Impact of Change to Gen 2 Filter

Response to 2013 Complete Response Letter (CRL)

CRL Response

◆ 4 categories of issues to address

o Medical Device Related

o Human Factors Validation

o Preclinical Tox

o Overall Benefit - Risk

18

CRL Response PDUFA Timeline

◆ Early 2022 resubmission

◆ No 60-day assessment for acceptance to file

◆ 6-month review PDUFA target

FDA required these issues be addressed to their satisfaction prior to the start of the FOCUS trial

Expect focus of review will be on the risk component of the Benefit – Risk trade-off

mOM Patient Flow and Treatment Options

>75% patients treated in

Academic centers

Non-Academic Center(less predictable referral pattern)

Treatment

Decision

Academic CenterTumor Board

(Multi-Disciplinary)

Per meta-analysis - 5.5%20

HEPZATO

HEPZATO Efficacy=32.9% 16

CHEMOSAT=27% - 72% 17

Y90/SIRT

Efficacy up to = 17%18

TACE


Immunotherapy

300 – 500

900 – 1,125

Liver-Directed

Therapy

Interventional Radiologist

Systemic Therapy

Medical Oncologist

See appendix for footnoted references

Higher

Risk 50%

1,200 – 1,500

Ideally Frequent

Screening

13-46 Months

Liver Disease

Appears

Medical Oncologist

Initial Diagnosis &

Treatment

• Enucleation or

• Radiation, PDT

Gene Expression

Burden Testing

Medical Oncologist

Lower

Risk 50%

Less Frequent

Screening

Medical Oncologist

2,400 – 3,0001,2

Patients


Tebentafusp (P3)

19

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

STAKEHOLDER PERSPECTIVE

◆ Oncologists see poor responses with systemic therapies

◆ Oncologists believe HEPZATO is a significant advance

over other liver-targeted therapies

◆ Most oncologists surveyed believe ~80% of mOM

patients with liver mets would be HEPZATO candidates

◆ Payer & hospital finance stakeholder interviews suggest

pricing expectations in the range of IO agents

(ipilimumab and nivolumab therapy per year $256k)

mOM patients that are well enough to receive Melphalan/HDS

mOM patients that are well enough to receive HEPZATO and fall within the inclusion/exclusion criteria

Oncologist perception of mOMPatients’ eligibility for HEPZATO

(n=12)

US $ TAM IMPLICATIONS

◆ HEPZATO may be positioned as a first-line

treatment in mOM due to limited efficacy of

available therapies

◆ Premium pricing feasible ($25K - $75K per

treatment)

◆ Assuming 4 treatments per patient and $50K per

treatment, TAM >$200M

HEPZATO Stakeholder Perspective and $ TAM Implications

20

Commercialization Dynamics

◆ Specialized mOM market allows focused commercial investment

o Rare disease, patients seek OM specialists found regionally at top National Cancer

Centers and Academic Centers

o ~1200/1500 of the patients (80%) will be treated in top ~20 medical centers

◆ Small but specialized interventional oncology commercial team

o Strategically placed regional sales representatives to cover 20 centers

o Experience navigating hospitals with drug/device combination products and selling to

multidisciplinary treatment teams

o Augmented with field based clinical support to ensure safe and effective treatments

o Experienced Market Access team to support customers and patients

21

European Commercialization – medac Licensing

◆ CHEMOSAT is available in ~22 centers in 3 countries with device

(CE marked) labeled for the delivery of melphalan across tumor

types – distributed by medac

◆ CHEMOSAT added to national treatment guidelines in both

Germany and Netherlands for Ocular Melanoma liver metastases

◆ Outside of Germany, most of the treatments have been self pay

given limited reimbursement

◆ National reimbursement application processes to start when full

FOCUS trial data available

◆ In April 2021, NICE (UK) upgraded CHEMOSAT’s status from

“Research” to “Special Status” which will facilitate private pay

and allow initiation of national reimbursement process

◆ While revenue modest (2019 €2.2M) due to reimbursement status,

sales allow Delcath to identify indications with strong efficacy signals

CHEMOSAT Used In 13 Tumor Types

~70%: Metastatic Ocular Melanoma (mOM)

Other Types Treated:

• Intrahepatic Cholangiocarcinoma (ICC)

• Hepatocellular Carcinoma (HCC)

• Metastatic Colorectal Cancer (mCRC)

• Metastatic Breast (mBreast)

• Pancreatic

• Metastatic Neuroendocrine Tumors

(mNET)

• Metastatic Cutaneous Melanoma

(mCM)

22

Incidence and Evidence of Possible Follow-On Indications

◆ Currently reviewing clinical and

commercial data (based on over

1,000 commercial CHEMOSAT

procedures in the EU and

multiple publications)

◆ Planning a series of medical

advisory boards

◆ 2021 Goal: Initiate trials in two

additional indications

◆ Post launch, mOM revenue should

self-fund the ongoing development

effort

23

Indication US IncidenceSupporting Data

Metastatic Ocular Melanoma(mOM)

1,530 1,2 FOCUS Data

Cholangiocarcinoma (ICC) 2,960 3,4Extensive EU experience22

Metastatic Neuroendocrine Tumors (mNET) 9,000 5,6 Phase 2 data 23

Liver-dominant Breast Cancer (mBC) 2,000-5,000 7,8,9,10 ~10 Cases in EU

Metastatic Pancreatic Cancer (mPC) 24,000 7,13 Limited

Metastatic Colorectal Cancer (mCRC) 35,500 11,12IHP efficacy well documented24

PHP Was Designed to Replace Isolated Hepatic Perfusion (IHP)

◆ IHP has documented efficacy

across multiple tumor types

including mOM, CRC, and NET

◆ Melphalan is the most commonly-

used agent

◆ But high treatment related

mortality (>5%)

◆ Not repeatable

◆ Few patients eligible

IHP Results in CRC Likely to Translate to PHP

25

Author, year N AgentResponse rate (%)

Median survival (mos.)

van Iersel et al. (2010) 99 Melphalan 47 25

Alexander et al. (2009) 120 Melphalan ± TNFα[alpha] 61 17.4

van Iersel et al. (2008) 105 Melphalan 50 24.8

van Iersel et al. (2007) 30 Melphalan 41 16.9

Alexander et al. (2005) 25 Melphalan 60 12

Rothbarth et al. (2003) 71 Melphalan 59 28.8

Alexander et al. (2002) 7 Melphalan ± TNFα[alpha] 71 19.7

Vahrmeijer et al. (2000) 24 Melphalan 29 19

Capital Structure and Share Information

1 As of June 30, 2021; includes 7.3M of Common plus 1.2M Preferred E & E-1 and 0.2M Pre-funded Warrants as converted2 As of June 30, 2021; (10-Q filing on August 10, 2021)3 As of June 30, 2021; Warrants at a $10 exercise price4 YTD Net cash used in operating activities through Q2-20215 Convertible Note; amended conversion price = $11.98 per common share equivalent and extension of maturity date to 10/20246 Used NASDAQ price information starting on June 29, 2020, through June 29, 20217 30-day average calculated between May 18, 2021, through June 29, 2021

Share Listing Current DCTH (NASDAQ)

Shares Outstanding1 8.68M

Cash and Cash Equivalents2 $19.4M *

Warrants Outstanding3 3.62M

Stock Options Granted 1.09M

2021-Q2 Cash Burn (YTD)4 $11.7M

Debt5 $2.0M *

52-week Low – High6 $8.50 - $25.18

30d Average Daily Volume7 52,460

26

* Does not include the $15M venture debt

transaction closed on Friday, August 6th

Delcath Systems, Inc. – a Unique Opportunity

Novel platform in interventional oncology

Multiple near-term catalysts (Final data and NDA filing, new indications)

Safety and efficacy supported by multiple trials and commercial usage

Initial orphan indication allows for targeted marketing effort and rapid uptake

Platform has potential utility in multiple indications

27

References1. Cancer.net Editorial Board (2020) Eye Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/eye-

cancer/statistics. Accessed 22 Jun 2020

2. Ocular Melanoma Foundation. Treatment of Metastatic Disease. In: OMF - Metastatic

Treatment. http://www.ocularmelanoma.org/metstreatment.htm. Accessed 22 Jun 2020

3. 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.

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EST2019-01).

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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

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Cancer Institute, DCCPS, Surveillance Research Program, released December 2019.

8. Adam R, Aloia T, Krissat J, Bralet MP, Paule B, Giacchetti S, Delvart V, Azoulay D, Bismuth H, Castaing D. Is liver resection

justified for patients with hepatic metastases from breast cancer? Ann Surg. 2006 Dec;244(6):897-907; discussion 907-8. doi:

10.1097/01.sla.0000246847.02058.1b. PMID: 17122615; PMCID: PMC1856635.

9. Insa A, Lluch A, Prosper F, Marugan I, Martinez-Agullo A, Garcia-Conde J. Prognostic factors predicting survival from first

recurrence in patients with metastatic breast cancer: analysis of 439 patients. Breast Cancer Res Treat. 1999 Jul;56(1):67-78. doi:

10.1023/a:1006285726561. PMID: 10517344.

10. Clark GM, Sledge GW Jr, Osborne CK, McGuire WL. Survival from first recurrence: relative importance of prognostic factors in

1,015 breast cancer patients. J Clin Oncol. 1987 Jan;5(1):55-61. doi: 10.1200/JCO.1987.5.1.55. PMID: 3806159.

11. Cancer.net Editorial Board. (2020) Colorectal Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/colorectal-

cancer/statistics. Accessed 22 Jun 2020

12. 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

28

http://www.cancer.net/cancer-types/eye-cancer/statistics



http://www.ocularmelanoma.org/metstreatment.htm

http://www.cancer.net/cancer-types/neuroendocrine-tumors/statistics



http://www.cancer.net/cancer-types/colorectal-cancer/statistics



References13. Oweira H, Petrausch U, Helbling D, Schmidt J, Mannhart M, Mehrabi A, Schöb O, Giryes A, Decker M, Abdel-

Rahman O. Prognostic value of site-specific metastases in pancreatic adenocarcinoma: A Surveillance Epidemiology

and End Results database analysis. World J Gastroenterol. 2017 Mar 14;23(10):1872-1880. doi:

10.3748/wjg.v23.i10.1872. PMID: 28348494; PMCID: PMC5352929.

14. Xu L, T, Funchain P, F, Bena J, F, Li M, Tarhini A, Berber E, Singh A, D: Uveal Melanoma Metastatic to the Liver:

Treatment Trends and Outcomes. Ocul Oncol Pathol 2019;5:323-332. doi: 10.1159/000495113

15. Lane AM, Kim IK, Gragoudas ES. Survival Rates in Patients After Treatment for Metastasis From Uveal Melanoma.

JAMA Ophthalmol. 2018 Sep 1;136(9):981-986.

16. Preliminary analysis of FOCUS trial released 3/31/21

17. Karydis I, Gangi A, Wheater MJ, et al. Percutaneous hepatic perfusion with melphalan in uveal melanoma: A safe and

effective treatment modality in an orphan disease. J Surg Oncol. 2018;117(6):1170-1178. doi:10.1002/jso.24956

18. Tulokas S, Mäenpää H, et al. Selective internal radiation therapy (SIRT) as treatment for hepatic metastases of uveal

melanoma: a Finnish nation-wide retrospective experience. Acta Oncol. 2018 Oct;57(10):1373-1380. doi:

10.1080/0284186X.2018.1465587. Epub 2018 Apr 23. PMID: 29683787.

19. Shibayama Y, Namikawa K, Sone M, et al. Efficacy and toxicity of transarterial chemoembolization therapy using

cisplatin and gelatin sponge in patients with liver metastases from uveal melanoma in an Asian population. Int J Clin

Oncol. 2017 Jun;22(3):577-584. doi: 10.1007/s10147-017-1095-0. Epub 2017 Jan 31. PMID: 28144882.

20. Meta-analysis: Data on file

21. Piperno - Neumann, et. al. AACR Annual Meeting 2021

22. Ferrucci, P.Fet al. A New Option for the Treatment of Intrahepatic Cholangiocarcinoma: Percutaneous Hepatic

Perfusion with CHEMOSAT Delivery System. Cells 2021, 10, 70. https://doi.org/10.3390/cells10010070

23. Vogel, A., Gupta, S., Zeile, M. et al. Chemosaturation Percutaneous Hepatic Perfusion: A Systematic Review. Adv

Ther 33, 2122–2138 (2016). https://doi.org/10.1007/s12325-016-0424-4

24. Reddy SK, Kesmodel SB, Alexander HR. Isolated hepatic perfusion for patients with liver metastases. Therapeutic

Advances in Medical Oncology. July 2014:180-194. doi:10.1177/1758834014529175

29

https://doi.org/10.3390/cells10010070

https://doi.org/10.1007/s12325-016-0424-4

APPENDIX

First Phase 3 RCT Results*

31CONFIDENTIAL

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

7.01.6

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

* Mix of mOM and metastatic melanoma with >90% patients diagnosed with mOM

P<.0001

PHP

Months

1.0

0.8

0.6

0.4

0.2

0.0

P<.0001

Proportion of patients surviving

5.41.6

3.8 mo

Best alternative care

0 5 10 15 20 25 30 35 40 45 50 55

Response Rates (ITT population)

Cohort hOR ORR

PHP (n = 44) 36.4% 27.3%

BAC (n = 49) 2.0% 4.1%

p value <0.001 =0.003

Recent Initial Approvals Using ORR in Single-Arm Oncology TrialsDrug and Approval Type Indication

Danyelza (naxitamab-

gqgk) - Accelerated

Relapsed or refractory neuroblastoma in bone or

marrow post response or stable disease to prior therapy

Gavreto (pralsetinib) -

AcceleratedMetastatic RET fusion-positive NSCLC

Monjuvi (tafasitamab-

cxix) - AcceleratedRelapsed or refractory diffuse large B-cell lymphoma

Tazverik (tazemetostat) -

Accelerated

Relapsed or refractory follicular lymphoma positive for

EXH2 mutation

Zepzelca (lurbinectedin) -

Accelerated

Metastatic SMLC with progression on or after platinum

chemotherapy

Tabrecta (capmatinib) -

AcceleratedMetastatic NSCLC with mutation MET exon 14 skipping

Trodelvy (sacituzumab) -

Accelerated

Metastatic triple-negative breast cancer after at least 2

prior metastatic disease therapies

Pemazyre (pemigatinib) -

Accelerated

Previously treated metastatic cholangiocarcinoma with

FGFR2 fusion

Koselugo (selumetinib) -

Accelerated

Neurofibromatosis Type 1 with inoperable plexiform

neurofibromas

Drug and Approval Type Indication

Ayvakit (avapritinib) -

Standard

Unresectable or metastatic gastrointestinal stromal

tumor with PDGFRA exon 18 mutation

Enhertu (famtrastuzmab

deruxtecan) - Accelerated

Unresectable or metastatic HER2+ breast with two or

more prior anti HER2 regimens in metastatic setting

Padcev (enfortumab vedotin)

- Accelerated

Metastatic urothelial cancer with previously received

PD-1 or PD-L1 and platinum chemotherapy

Brukinsa (zanubrutinib) -

AcceleratedMantle cell lymphoma with at least one prior therapy

Rozlytrek (entrectinib) -

StandardMetastatic NSCLC that is ROSI+

Xpovio (selinexor) -

Accelerated

Relapsed or refractory multiple myeloma with at

least 4 prior therapies

Balversa (erdafinitib) -

Accelerated

Metastatic unrothial carcinoma with susceptible FGFR

3(2) alterations

Vitrakvi (larotrectinib) -

Accelerated

Solid tumors with neurotrophic receptor tyrosine

kinase fusion

Libtayo (cemiplimab-rwlc) -

StandardMetastatic squamous cell carcinoma

Single trial 50 patients

Single trial 43 patients

Pooled subgroup analysis - 51 patients

from 3 single arm trials

Pooled subgroup analysis - 72 patients

from 2 single arm trials

Secondary Analyses Versus BAC – ITT and Per Protocol


Preliminary Analysis Per Protocol


PHP(N=79)

BAC (N=29)

PHP(N=89)

BAC (N=39)

Objective Response Rate 26 (32.9%) 4 (13.8%) 26 (29.2%) 4 (10.3%)

95% CI [22.75, 44.40] [3.89, 31.66] [20.05, 39.81] [2.87, 24.22]

p-value (Chi-square) 0.0493 0.0198

Preliminary Analysis Per Protocol


PHP(N=79)

BAC (N=29)

PHP(N=89)

BAC (N=39)

Disease Control Rate 56 (70.89%) 11 (37.93%) 56 (62.92%) 11 (28.21%)

95% CI [59.58, 80.57] [20.69, 57.74] [52.03, 72.93] [15.00, 44.87]

p-value (Chi-square) 0.002 0.0003

delcath systems, inc

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