Full Press Release Details
Table of Contents Forward-Looking Statement 3 Investment Summary 4 Unmet
Need: Liver-Dominant Cancers 5 HEPZATO KIT 8 Metastatic Uveal Melanoma (mUM) 11 FOCUS Trial 16 HEPZATO KIT: Commercialization 20 Reimbursement & Pricing 25 Next Steps: Future Indications 30 References 39 2
Forward-Looking Statement The Private Securities Litigation Reform Act
of 1995 provides a safe harbor for forward- ability to successfully enter into any necessary purchase and sale agreements with looking statements made by the Company or on its behalf. This presentation contains users of the HEPZATO KIT; the timing
and results of the Company's clinical trials; our forward-looking statements, which are subject to certain risks and uncertainties that determination whether to continue a clinical trial program or to focus on other can cause actual results to
differ materially from those described. The words alternative indications; the impact of the COVID-19 pandemic or other pandemics on "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," the completion of our clinical trials; the impact of the presentations at major medical "plan," "potential," "predict,"
"project," "should," "target," "will," "would" and similar conferences and future clinical results consistent with the data presented; expressions are intended to identify forward-looking
statements, although not all uncertainties relating to the timing and results of research and development projects; forward-looking statements contain these identifying words. and uncertainties regarding the Company's ability to obtain
financial and other resources for any research, development, clinical trials and commercialization Factors that may cause such differences include, but are not limited to, uncertainties activities. These factors, and others, are discussed from time
to time in our filings relating to: the Company's ability to successfully commercialize the HEPZATO KIT; the with the Securities and Exchange Commission. Company's successful management of the HEPZATO KIT supply chain, including You should not
place undue reliance on these forward-looking statements, which securing adequate supply of critical components necessary to manufacture and speak only as of the date they are made. We undertake no obligation to publicly assemble the HEPZATO KIT;
successful FDA inspections of the facilities of Delcath and update or revise these forward-looking statements to reflect events or circumstances third-party suppliers/manufacturers; the Company's successful implementation and after the date they are
made. management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; our ability to obtain reimbursement for commercialized
product; the Company's 3
Delcath Investment Summary HEPZATO KIT Commercial Opportunity High
Penetration FDA approval for Ultra orphan pricing Included in NCCN Guidelines mUM* 8/14/23 Focused call points First and only FDA approved 1Q 2024 US Launch whole-liver directed therapy US mUM
TAM ~$600M Experienced Significant upside beyond Multiple 2024 Catalysts Management Team mUM Launch Expertise in commercializing Strong efficacy signals in Revenue build high value, specialty multiple other tumor
types CHOPIN enrollment completion products Unique interventional Initiate trials in other indications TheraSphere (BSX) veterans oncology asset * metastatic Uveal Melanoma (mUM) 4
HIGH UNMET NEED: Liver-Dominant Cancers 5
Liver-Dominant Cancers: High Incidence with High Unmet Medical Need * US
Incidence of Liver-Dominant Cancers Up to (partial set shown) of patients with liver metastases are not amenable to surgical resection % 50,000 80 1 largely due to extensive tumor burden Delcath Opportunity 40,000 Limited Overall Survival -
Unresectable Liver Cancer 30,000 Liver: Common Site of Metastases 20,000 o Often the life-limiting organ Limited Effective Systemic Treatments 10,000 o Systemic Therapies: low efficacy o Immuno-oncology agents become less effective
in the 0 presence of metastases mUM ICC mBC mNET mPC mCRC HCC *Metastatic Uveal Melanoma (mUM) 1 Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 6
Current Liver-Directed Therapies MAJORITY OF TREATMENT 3 SIRT (Y90)
Trans Arterial Chemo 2 Embolization (TACE) Beads obstruct blood flow to tumor and elute chemo Radioactive beads delivered into a portion of the liver 50-60k treatments and rising per year 10-15k treatments and rising
per year Limitations Many tumors not Tumors recur and Diffuse disease cannot be Neither approved for the imageable and micro- retreatment options limited treated with a tumor-by- treatment of mUM and metastases are common, due to damage to tumor
modality (TACE) and lacking substantial high neither TACE or Y90 can vasculature (TACE) and bilobar treatment is quality data set to support treat the entire liver hepatotoxicity (Y90) hepatotoxic (Y90) usage 2 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. 3 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. 7
Percutaneous Hepatic Perfusion (PHP) Effective, Safe & Repeatable
Liver-focused Disease Control 1. Isolation Hepatic venous flow is isolated, enabling >6X greater local Isolation concentration of chemo Filtration 2. Saturation Melphalan (chemo) treats micro and macro lesions simultaneously regardless of
location in the liver Saturation 3. Filtration Proprietary filters remove greater than 4 85% of chemo from the body 4 Heppt, M, et al. Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study. J
Immunotherap Cancer. 2019 Nov 13;7(1):299. 9
Indication Statement HEPZATO KIT (melphalan) for Injection/Hepatic
Delivery System HEPZATO KIT is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to
the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Indicated Patient Population Includes: o No HLA genotype restrictions o Treatment na ve and previously treated patients 10
Metastatic Uveal Melanoma (mUM) 11
mUM: Beachhead Market Opportunity ~2,000 newly diagnosed cases
of primary uveal 2 melanoma per year in the US 50% metastasize with the liver involved in >90% of 5,6 2,3 cases of metastatic disease (1,000 mUM patients) ~50% metastasize 1-year OS rate of patients with metastatic disease 1,2 to
the liver in the liver is 13% 2,7 o median survival ranging from 4 to 15 months 1 Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 2 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. 3 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. 5 Krantz BA, et al. Uveal Melanoma: Epidemiology, Etiology, and Treatment of Primary Disease. Clin Ophthalmol. 2017;11:279-289. 6 Eschelman DJ et al. Transhepatic Therapies
for Metastatic Uveal Melanoma. Semin Intervent Radiol. 2013;30(1):39-48. 7 Carvajal RD, et al. Metastatic Disease from Uveal Melanoma: Treatment Options and Future Prospects. Br J Ophthalmol. 2017;101(1):38-44. 12
mUM: Beachhead Market Opportunity 6 Most patients with mUM die
from liver failure In 50% of mUM patients, the liver is the only site of 5,6 metastasis Liver-directed treatment achieves better efficacy compared 8 to systemic therapy ~50% metastasize 55% of patients have no approved
systemic treatment 1,2 to the liver option Most patients treated with multiple lines of therapy 1 Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 2 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. 5 Krantz BA, et al. Uveal Melanoma: Epidemiology, Etiology, and
Treatment of Primary Disease. Clin Ophthalmol. 2017;11:279-289. 6 Eschelman DJ et al. Transhepatic Therapies for Metastatic Uveal Melanoma. Semin Intervent Radiol. 2013;30(1):39-48. 8 Olofsson BR, et al. Isolated Hepatic Perfusion With Melphalan for
Patients With Isolated Uveal Melanoma Liver Metastases: A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial). J Clin Oncol. 2023 Jun 1;41(16):3042-3050 13
Diffuse/Miliary Metastatic Pattern in mUM Diffuse Disease is Difficult
to Treat with Other Liver Directed Options Solitary liver lesions are often treated with surgery or ablation. True nature of the disease may only be seen upon visual confirmation. Radiographically, metastatic Uveal Melanoma
can initially present only as focal lesions. Traditional liver-directed therapy mechanism of action is not optimal if a whole liver treatment is needed. Whole organ therapy delivers medication to a specific organ then filters out the
medication to minimize systemic exposure. Actual patient sent for a liver resection based upon radiographic diagnosis* * Data on File . 14
Patient Journey MILESTONE MILESTONE Surveillance Decision Metastases
Detected Initial Screening Ophthalmologist/ Surgical Oncologist Ocular Oncologist Screening frequency Surgical Resection Initial diagnosis & treatment Treatment Decision Surveillance dependent on risk level Enucleation
Radiation Higher risk patients (50%) Photodynamic therapy are screened at a high Interventional frequency Medical Oncologist Most patients receive Radiologist Surveillance at Academic both systemic and
Lower risk patients (50%) Liver-directed therapy Center o Ophthalmology liver-directed are screened at a lower o Optometrists therapies frequency o Eye Specialist Medical Oncologist Medical Oncologist Gene expression profiling
Surveillance at Systemic Therapy may occur Nonacademic Center ~2,000 patients ~1,000 patients ~800 patients eligible Ophthalmologist Ocular Oncologist Pre-Metastatic | 3-5 years Post-Metastatic 15
U.S. Registration Trial for the Treatment of Patients with mUM
FOCUS TRIAL 9 Summary of Efficacy Results Endpoints HEPZATO KIT (N=91)
ORR, n 33 (36.3%) DOR, Median in months 14.0 DCR, n 67 (73.6%) PFS, Median in months 9.0 OS, Median in months 20.53 Full analysis with final data cut pending publication HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles
Prescribing Information includes ORR, DOR and response categories Trial powered to show an ORR advantage over a meta-analysis of Best Alternative Care o Checkpoint inhibitors, chemotherapy, other liver-directed therapy Lower bound of
FOCUS ORR (26.4%) is significantly higher than the upper bound of the meta-analysis (8.3%) 9 DOI: 10.1200/JCO.2022.40.16_suppl.9510 Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 9510-9510. 17
FOCUS TRIAL * Published mUM Prospective and Retrospective Studies
Median OS Median PFS Clinical Study/Publication Study Type Treatment N 1 year OS (months) (months) AL FOCUS Single-Arm HEPZATO 91 20.53 80% 9.03 systemic and liver- 10 Khoja et al 2019 Meta-Analysis 912 10.2 NA 3.3 directed therapies systemic and
liver- 11 Rantala et al 2019 Meta-Analysis 2,494 12.84 NA NA directed therapies 12 TN Piulats et al 2021 Single-Arm ipi plus nivo 52 12.7 NA 3.0 13 AL Heppt et al 2019 Single-Arm ipi plus (pembro or nivo) 64 16.1 NA 3.0 TN tebentafusp 252 21.7 73%
3.3 14 Nathan et al 2021 Randomized TN control 126 16 59% 2.9 TN = Treatment Na ve, AL = Any Line Ipi = ipilimUMab, nivo = nivolumab, pembro = pemUMab *Studies from 2019 or later with >50 patients 10 Khoja L, et al. Meta-analysis in
metastatic uveal melanoma to determine progression free and overall survival benchmarks: an international rare cancers initiative (IRCI) ocular melanoma study. Ann Oncol 2019 Aug 1, 30(8): 1370-1380. 11 Ranjala, E, et al. Overall survival after
treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. 2019 Dec; 29(6): 561-568 12 Piulats, J, et al. Nivolumab Plus Ipilimumab for Treatment-Na ve Metastatic Uveal Melanoma: An Open-Label,
Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402). Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 586-598. 13 Heppt, M, et al. Combined immune checkpoint blockade for metastatic uveal melanoma: a
retrospective, multi-center study. J Immunotherapy Cancer. 2019 Nov 13;7(1):299. 14 Nathan, P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med 2021; 385:1196-1206 18
FOCUS TRIAL Adverse Events Adverse Reactions (N=95) >10% ALL GRADES
(%) GRADES 3 OR 4 (%) Hypotension 13 3 Dyspnea 23 2 Abdominal Pain 39 1 Diarrhea 17 1 Musculoskeletal Pain 46 1 Hemorrhage 15 1 Nausea 57 0 Vomiting 35 0 Fatigue 65 0 Pyrexia 16 0 Groin Pain 11 0 Most hematological side effects result Cough
15 0 from melphalan Headache 19 0 Lethargy 12 0 Side effect profile similar to standard melphalan use Dizziness 11 0 Contusion 17 0 Decreased appetite 16 0 Adverse reactions are described further in the HEPZATO KIT PI. 19
FOCUS TRIAL Adverse Reactions Related to Study Treatment Occurring in
10% of Patients (N=95) ALL GRADES (%) GRADES 3 OR 4 (%) Adverse Events Thrombocytopenia* 64 55 Leukopenia* 44 34 Anemia* 61 33 Neutropenia* 35 29 International normalized ratio increased 29 8 Activated partial thromboplastin time prolonged 26
8 Aspartate aminotransferase increased 27 3 Hypocalcemia 12 3 Blood bilirubin increased 11 3 Alanine aminotransferase increased 31 2 Blood alkaline phosphatase increased 25 2 Troponin I increased 12 2 Abdominal pain upper 18 1 Dyspnea 11 1 Nausea 47
0 Fatigue 43 0 Vomiting 27 0 Contusion 16 0 Most hematological side effects result Asthenia 13 0 Back pain 13 0 from melphalan Decreased appetite 13 0 Abdominal pain 12 0 Side effect profile similar to standard Lethargy 12 0
melphalan use Groin pain 11 0 Headache 11 0 * Anemia includes anemia, febrile bone marrow aplasia, hemoglobin decreased, normochromic normocytic anemia, red blood cell count decreased. Leukopenia includes leukopenia, lymphocyte count decreased,
lymphopenia, and white Adverse reactions are described further in the HEPZATO KIT PI. blood cell count decreased. Neutropenia includes neutropenia and neutrophil count decreased. Thrombocytopenia includes thrombocytopenia and platelet count
HEPZATO KIT: Commercialization 21
Delivering an Innovative Treatment with a Well-Trained Team Treatment
with HEPZATO KIT involves training and a team approach. The team members below complete a preceptorship and proctorship as well as a risk evaluation and mitigation strategy (REMS) training. Interventional radiologist leads and performs the vascular
interventional procedure Perfusionist establishes, monitors, and controls the extracorporeal pump and veno- venous bypass circuit Anesthesiologist manages sedation, analgesia, and respiratory and cardiovascular support All REMS materials are
available at www.HEPZATOKITREMS.com or by calling the REMS Coordinating Center at 1-833-632-0457. 22
Referring Centers HEPZATO Medical Medical Specialized, Targeted Sales
Treating Center Oncologist Oncologist Teams Trained Treating Team Three Complementary Teams of Representatives: Perfusionist Interventional Radiologist Clinical Specialists Anesthesiologist Liver-Directed Therapy Representatives Medical Medical
Oncologist Medical Ocular Oncologist Oncologist Oncologist Oncology Managers Medical Medical Oncologist Oncologist Medical Oncologist 23
CENTER CITY STATE Treatment Sites FULLY TRAINED Duke University Durham
NC Interest from 20+ sites Moffitt Cancer Center Tampa Bay FL Ohio State University Columbus OH Focused on a subset of sites to ensure we University of Tennessee Memphis TN achieve our planned activation targets throughout the year PENDING
PROCTORSHIP Mayo Clinic Jacksonville Jacksonville FL Stanford University Stanford CA Thomas Jefferson University Philadelphia PA University of California, Los Angeles Los Angeles CA PENDING PRECEPTORSHIP St. John (Cedars) Los Angeles CA University
of Wisconsin Madison WI STRONG INTEREST/COMMITMENT Cleveland Clinic Cleveland OH Emory University Atlanta GA Honor Health Scottsdale AZ Massachusetts General Hospital Boston MA Memorial Sloan Kettering New York NY Piedmont Healthcare Atlanta GA
University of Miami Miami FL Fully Trained Pending Preceptorship University of Washington Fred Hutchinson Cancer Center Seattle WA Pending Proctorship Strong Interest/Commitment Status as of January 2024 24
Demonstrated Demand for FDA Approved Treatment in mUM KIMMTRAK
$42.1 million in Q3 2023 US sales ($168M annualized revenue) Captured an estimated 40% share of eligible patients within 12 months Approximately 360* patients are eligible for KIMMTRAK KIMMTRAK U.S. Quarterly Sales (USD) Only
45%* of mUM patients are eligible for treatment due to HLA restriction HEPZATO KIT: FDA Approved August 14, 2023 to Treat Patients with Liver-Dominant mUM Approximately 800 patients potentially eligible for treatment HEPZATO has no
HLA genotype restrictions KIMMTRAK Patients often receive both systemic and liver-directed treatment Only FDA approved drug for 100% of all mUM patients, with appropriate liver involvement *Due to HLA genotype restrictions
HEPZATO KIT: Reimbursement & Pricing 26
Reimbursement Medicare Patients Private Payer Patients Follow