Full Press Release Details
Corporate Presentation (NASDAQ: DCTH)
September 6, 2023 1 Exhibit 99.1
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. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may,"
"plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words.Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's ability to
successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA
inspections of the facilities of Delcath and third-party suppliers/manufacturers; the Company's successful implementation and 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 ability to successfully enter into any necessary purchase and sale agreements with users of the
HEPZATO KIT; the timing and results of the Company's clinical trials, our determination whether to continue a clinical trial program or to focus on other alternative indications, and the impact of the COVID-19 pandemic or other
pandemics 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; 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. Forward-looking Statements
Executive Summary Delcath aims to be
the leader in targeted, safe and highly-effective minimally-invasive treatments for patients with cancers of the liver. HDS + Melphalan enables the Percutaneous Hepatic Perfusion (PHP) Procedure Delivers high dose chemotherapy to the entire liver
Limits systemic exposure Minimally invasive, repeatable and well-tolerated US: HEPZATO KIT (Melphalan/HDS) EU: CHEMOSAT (HDS) Incidence US/EU >200K primary and metastatic liver tumors per year1-14 Current local/regional treatments Cannot treat
the whole liver Targeted to visible and accessible tumors Limited in their ability to retreat UNMET NEED LIVER CANCER HEPATIC DELIVERY SYSTEM (HDS) Near-term (mUM)* Ultra orphan pricing dynamic >$600M TAM in US/EU Longer Term (CRC, ICC,
Pancreatic, etc.) >>$1B TAM Investigator interest in more than 10 other indications LARGE MARKET OPPORTUNITY FDA Approved 8/14/23 Metastatic Ocular Melanoma (mUM) Liver failure #1 cause of death in mUM Response rates >36% 1 Year OS**
= 80% Real World Evidence >1k commercial treatments in EU Multiple single center publications COMPANY & CLINICAL PROGRAM Launch Expected Q4 23 * mUM - metastatic Uveal Melanoma, also known as metastatic Ocular Melanoma
**Exploratory endpoint in FOCUS trial
Limitations of Current Liver-Directed
Therapies Majority of Treatment Beads obstruct blood flow to tumor and elute chemo 50-60k treatments per year in US (and growing) Radioactive beads delivered into the tumor 10-15k treatments per year in US (and growing) Trans Arterial Chemo
Embolization (TACE)1 Y902 Effective, but tumors recur & retreatment limited due to damaged vasculature Diffuse disease: cannot be treated with a tumor-by-tumor modality Many tumors are not imageable - micro-metastases are common
HEPZATO KIT : Enables
Percutaneous Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control ISOLATION Hepatic venous flow is isolated, enabling 12x increased dose SATURATION Melphalan (chemo) treats micro and macro lesions
simultaneously FILTRATION Proprietary filters remove greater than 85% of chemo from the body33 Blood Return Catheter Chemo Filtration Veno-veno Bypass Pump Chemo Isolation (Balloon) Catheter Chemo Delivery Catheter Liver
Liver-Dominant Cancers High incidence
with poor prognosis U.S. Incidence Incidence of Liver Dominant Cancers (partial set shown) Liver: Common Site of Metastases Limited Overall Survival - Unresectable Liver Cancer Often the life-limiting organ Many patients with liver metastases
are not amenable to surgical resection largely due to extensive tumor burden17 Limited Effective Systemic Treatments Systemic therapies - low efficacy Immuno-oncology agents - become less effective in the presence of metastases 80% Up to US
Incidence of Liver Dominant Cancers (partial set shown) *Metastatic Ocular Melanoma (mUM)3,4, Cholangiocarcinoma (ICC)5,6, Liver-dominant Breast Cancer (mBC)9-12, Metastatic Neuroendocrine Tumors (mNET)8,9 Metastatic Pancreatic Cancer (mPC)9,15,
Metastatic Colorectal Cancer (mCRC)13,14, Hepatocellular carcinoma (HCC)17 U.S. Incidence Incidence of Liver Dominant Cancers (partial set shown) US Incidence of Liver Dominant Cancers* (partial set shown) DELCATH OPPORTUNITY+
Low Risk Commercial Opportunity FDA
Approved 8/14/23 Commercial launch 4Q '23 Commercial team led by TheraSphere (BSX) veterans Focused commercial effort: 20 US treatment centers @ 2 patients/week = ~70% TAM Favorable US Commercial Economics Favorable US reimbursement
environment for ultra orphan outpatient MD administered drugs KIMMTRAK (tebentafusp-tebn) (approved 1Q 22 for ~45% of mUM population ) priced at an average of $790K per patient, reported $41.7M in 2Q 23 mUM: Beachhead
Market Opportunity High Unmet Need, Favorable Reimbursement Environment Unmet Need >5,000 cases of primary ocular melanoma per year in the US/EU 18 ~50% metastasize to the liver 4,19 US TAM ~800 patients, Europe ~1,200 patients Median survival up
to 12 months.20 55% of patients have no approved treatment option, most patients treated with multiple lines of therapy High Barrier to Entry Orphan indication status allows for extended exclusivity HEPZATO is a combination drug device regulated by
CDER - no traditional ANDA pathway IP around HEPZATO limits any 505(b)(2) follow-on
Patient Journey (Pre- Metastatic)
Ophthalmology Optometrists Eye specialist Milestone: Surveillance decision made Caregiver Patient Initial screening ~2,000 patients Initial diagnosis & treatment Enucleation Radiation Photodynamic therapy Ophthalmologist/ Ocular oncologist
Ophthalmologist/ Ocular oncologist Screening frequency dependent on risk level Higher risk patients (50%) are screened at a high frequency Lower risk patients (50%) are screened at a lower frequency Medical Oncologist Medical Oncologist Surveillance
at Nonacademic Center Surveillance at Academic Center Gene expression profiling may occur here Surveillance by Ophthalmologist/ Ocular Oncologist ~ 3-5 YEARS ~1,000 patients Milestone: Metastases detected
Patient Journey (Post Metastatic)
Treatment Decision Liver-directed therapy Surgical resection Surgical oncologist Interventional radiologist Medical oncologist Systemic therapy Milestone: Metastases detected ~1000 patients Most patients receive both systemic and liver-directed
therapies HEPZATO TAM: ~800 patients
Liver metastases: a significant
clinical problem in mUM Half of all patients with UM develop systemic metastases 21,22 The liver is involved in 90% of cases of metastatic disease 21,22 In 50% of mUM patients, the liver is the only site of metastasis 21,22 Most patients with mUM
die from liver failure 22 1-year OS rate of patients with metastatic disease in the liver is 13%; mOS with median survival ranging from 4 to 15 months 24,25 mUM patients have micrometastases with or without the presence of radiologically visible
metastases 23 Liver directed treatment, such as Isolated Hepatic Infusion* (IHP), achieves better efficacy (ORR, PFS, PFS) compared to systemic therapy 26 IHP is an invasive surgical technique for delivering high doses of chemotherapy to the liver;
procedure related mortality and morbidity prevented common usage. PHP is a minimally invasive, safer procedure which accomplishes the same goals as IHP and can be performed up to 6 times.
Diffuse/Miliary Metastatic Pattern
in mUM Solitary liver lesions are often treated with surgery or ablation Radiographically metastatic Uveal Melanoma can initially present only as focal lesions As is often the case, the true nature of the disease may only be seen upon visual
confirmation Traditional liver directed therapy mechanism of action is not ideal if a whole liver treatment is needed Whole organ therapy delivers medication to a specific organ or tissue through its blood supply, then filters out the medication to
minimize systemic exposure Actual patient sent for a liver resection based upon radiographic diagnosis* * Data on File Diffuse disease is difficult to treat with current options
Estimated 80%+ of mUM Patients Are
Eligible Indicated Patient Population includes Treatment na ve and previously treated patients No HLA genotype restrictions
Box Warnings Managed By REMS Risk
Evaluation and Mitigation Strategy Program = Training & Monitoring European experience has shown that the procedure can be safely conducted by Interventional Radiology team after appropriate training REMS program goals are to standardize
training, ensure consistent treatment methodology and monitor outcomes Myelosuppression is a black box warning for generic melphalan, the management of which is standard practice for oncologists
Registration Clinical Trial for
Patients with mUM Multinational, multicenter, single-arm trial Efficacy Endpoints: Primary: Objective Response Rate (ORR) compared to meta-analysis of IO therapy Secondary: Duration of Response (DOR), Disease Control Rate (DCR), Overall
Survival (OS), Progression Free Survival (PFS) 102 patients enrolled, 91 completed treatments at 23 centers in the US and EU HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles FOCUS Trial
FOCUS Trial Single Arm Trial
Efficacy Data in PI Efficacy Endpoint N (%) ORR, n (%) 33 (36.3) [95% CI] [26.44, 47.01] Median DOR, months 14 [95% CI] [8.31-17.74] DCR, n (%) 67 (73.6) [95% CI] [63.35, 82.31] 91 treated patients Trial powered to show an ORR advantage over a
meta-analysis of Best Alternative Care (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%) Prescribing
Information includes ORR, DOR and response categories Full analysis with final data cut pending publication - manuscript in process
HEPZATO Response Predicts Survival
Kaplan-Meier estimates. Log-Rank test. Analysis Supports that ORR is Clinically Meaningful Exploratory Analyses* CR (N=7) PR (N=26) SD (N=34) PD/ND (N=24) Status of OS, N (%) Events 1 (14.3) 17 (65.4) 29 (85.3) 20 (83.3) Censored 6
(85.7) 9 (34.6) 5 (14.7) 4 (16.7) Median OS (Months) NC 28.16 19.25 11.99 95% CI [26.71, NC] [23.46, 34.46] [15.90, 23.00] [8.18, 14.03] p-value <0.0001 CR=complete response, PR=partial response, SD=stable disease, PD=progressive
disease, ND=not done, BOR=best overall response Note: NC = Not calculable, due to the number of events within the stratum (n=1) Kaplan Meier Curves in Treated Populations* * 02-Dec-2022 data cut, patients followed through May, 2023
OS and PFS Trend Favorable Relative
to Historical Results Pre-Specified Exploratory Analyses* * 02-Dec-2022 data cut, patients followed through May, 2023 Secondary Endpoint N (%) Median OS, months 20.53 [95% CI] [16.79, 25.26] 1 Year OS, K-M Probability Point Estimate 0.80 [95% CI]
[0.70, 0.87] Median PFS, Months 9.03 [95% CI] [6.34, 11.56]
Published mUM Prospective and
Retrospective Studies* Clinical Study/Publication Study Type Treatment N Median OS (months) 1 year OS Median PFS (months) FOCUS Single-Arm Hepzato 91AL 20.53 80% 9.03 Khoja et al 201933 Meta-Analysis systemic and liver-directed therapies 912 10.2 NA
3.3 Rantala et al 201934 Meta-Analysis systemic and liver-directed therapies 2,494 12.84 NA NA Piulats et al 202135 Single-Arm ipi plus nivo 52TN 12.7 NA 3.0 Heppt et al 201936 Single-Arm ipi plus (pembro or nivo) 64AL 16.1 NA 3.0 Nathan et al
202137 Randomized tebentafusp 252TN 21.7 73% 3.3 control 126TN 16 59% 2.9 TN = Treatment Na ve, AL = Any Line *Studies from 2019 or later with >50 patients Ipi = ipilimUMab, nivo = nivolumab, pembro = pemUMab
Adverse Events Primarily
Hematological All Adverse Reactions N=95 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 Cough 15 0 Headache 19 0 Lethargy 12 0 Dizziness 11 0 Contusion 17 0 Decreased appetite 16 0 Most hematological side effects result from melphalan Side effect profile similar to other cytotoxics commonly Used By Oncologists
Patients Referred to
Multidisciplinary Treatment Teams Oncologists Are Generally the Decision Makers HEPZATO Treating Center Referring Centers Medical Oncologist Medical Oncologist Medical Oncologist Medical Oncologist Anesthesiologist Perfusionist Interventional
Radiologist Trained Treating Team
Training Key to Expanding Number of
Treating Sites and Capacity Multidisciplinary Teams to Be Expanded To Increase Both Training Capacity and Patient Flow Today Moffit UT Memphis Duke Expand Treatment Teams Increase # HCP Trainers & Treatment Capacity Increase # Sites Expanded
Plan To Launch at 10 Treating Sites
Leveraging EAP and Longitudinal Data to Build Referral Networks Planned Initial Hepzato Treatment Sites Active EAP sites EAP - Currently 3 Sites Provide immediate access to patients First Commercial Sites Train new medical teams to use Hepzato
after launch Leverage Longitudinal Data Partnered with data provider to access patient level longitudinal data with 3-week refresh Accurately map and quantify surveillance, referral and treatment patterns at the patient and MD level
Treating Centers - Current
Targets for Launch Institution City Status Moffitt Cancer Center Tampa, Florida EAP - Open and Enrolling Duke University Durham, North Carolina EAP - Open and Enrolling University of Tennessee Memphis, Tennessee EAP - Open and Enrolling Stanford
University Stanford, California EAP - Plans to join Ohio State University Columbus, Ohio EAP - Plans to join Mayo Clinic Hospital Jacksonville, Florida EAP - Plans to join HonorHealth Scottsdale, Arizona Confirmed interest in being a treating center
Thomas Jefferson University Philadelphia, Pennsylvania Confirmed interest in being a treating center University of Miami Miami, Florida Confirmed interest in being a treating center
Specialized, Targeted Sales Team
Two Complementary Teams of Representatives HEPZATO Treating Center Referring Centers Medical Oncologist Medical Oncologist Medical Oncologist Medical Oncologist Trained Treating Team Hospital Representative Responsibilities Manage Treating Centers
Including VAC/Formulary Support Treating Teams Facilitate REMS Compliance Generate Intra-Center Referrals Prospect and Open New Centers with Oncology Representative Oncology Representative Responsibilities Generate Inter-Center Referrals Support
Hospital Rep / Generate Intra-Center Referrals Prospect and Open New Centers with Hospital Representative Anesthesiologist Perfusionist Interventional Radiologist
Reimbursement HEPZATO will be
billed as a drug with a J-Code Medicare Patients Initially a C-Code Majority of patients will be outpatient (2 midnight rule) with the drug directly covered by Medicare Private Payer Patients Private Payers for rare disease generally follow Medicare
guidelines and we expect these patients to be treated as outpatients Prior-Authorization of patients might be needed, we are planning to contract out a hub service Centers of Excellence (Prospective Payment System (PPS) exempt and NCI designated