NASDAQ false 0000872912 0000872912 2023-09-06 2023-09-06

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 6, 2023

 

 

DELCATH SYSTEMS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-16133   06-1245881

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1633 Broadway, Suite 22C,

New York, New York 10019

(Address of principal executive offices)

(212) 489-2100

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.01 par value   DCTH   The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 7.01.

Regulation FD Disclosure.

On September 6, 2023, Delcath Systems, Inc. (the “Company”) released an updated corporate presentation on the “Events & Presentations” section of the Company’s website at https://delcath.com/investors/events-presentations/. A copy of the corporate presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be deemed incorporated by reference in any registration statement or other filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

No.

   Description
99.1    Corporate Presentation.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    DELCATH SYSTEMS, INC.
Date: September 6, 2023     By:  

/s/ Gerard Michel

    Name:   Gerard Michel
    Title:   Chief Executive Officer

Slide 1

Corporate Presentation (NASDAQ: DCTH) September 6, 2023 1 Exhibit 99.1


Slide 2

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


Slide 3

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


Slide 4

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


Slide 5

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


Slide 6

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+


Slide 7

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


Slide 8

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


Slide 9

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


Slide 10

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.


Slide 11

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


Slide 12

Estimated 80%+ of mUM Patients Are Eligible Indicated Patient Population includes Treatment naïve and previously treated patients No HLA genotype restrictions


Slide 13

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


Slide 14

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


Slide 15

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


Slide 16

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


Slide 17

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]


Slide 18

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 Naïve, AL = Any Line *Studies from 2019 or later with >50 patients Ipi = ipilimUMab, nivo = nivolumab, pembro = pemUMab


Slide 19

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


Slide 20

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


Slide 21

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 Treatment Capacity


Slide 22

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


Slide 23

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


Slide 24

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


Slide 25

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 Cancer Centers) have the leverage to negotiate favorable rates and reimbursement terms (our target sites are all either PPS exempt or NCI Cancer Centers)


Slide 26

PHP Is ALREADY Part of Current NCCN Guidelines for mUM Regional Isolation Perfusion Methods include isolated hepatic infusion (IHP), percutaneous hepatic perfusion (PHP), HAI, and embolization techniques. PHP is a simpler, less invasive alternative to IHP that can be repeated. It uses a double-balloon catheter inserted into the inferior vena cava to isolate hepatic venous blood that is then filtered extracorporeally.


Slide 27

Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with C Code Drug ASP+6% (CMS) Likely similar for commercial payers “Physician” payment Actually goes to hospital but still matters to MD Highly variable based on coding – we do not “map” to any existing code Using existing codes is advised and should provide the hospital adequate payment Healthcare Facility Fee Highly variable based on coding – we do not “map” to any existing code Using existing codes is advised and should provide the hospital adequate payment CPT Code mapping complete – while important, it will not have a meaningful impact on drug pricing decision


Slide 28

HEPZATO Pricing Consistent with Other Approved Therapy At First Assessment (first time to discontinue treatment because of progression) Drug Dose Cost* Treatments # Total cost Kimmtrak $19,289 24 $462,936 Hepzato $182,500 2 $365,000 Mean Hepzato treatment vs. mean treatment duration of Kimmtrak (per pivotal trials) Drug Dose Cost Mean Treatments # Total cost Kimmtrak $19,289 41 $790,849 Hepzato $182,500 4.1 $748,250 *Dose Cost ASP calculated using 7/2023 CMS payment allowance limit Maximum Hepzato treatment vs. Annual treatment duration of Kimmtrak Drug Dose Cost Max / Annual Treatments # Total cost Kimmtrak $19,289 52 $1,003,028 Hepzato $182,500 6 $1,095,000


Slide 29

Rapid Uptake for FDA Approved Treatment in mUM Demonstrated demand for FDA approved treatments for mUM KIMMTRAK - $41.7 million in Q2 2023 US sales ($167M annualized revenue) Only 45% of mUM patients are eligible for treatment with KIMMTRAK (unique MOA) KIMMTRAK captured an estimated 40% share of eligible patients within12 months HEPZATO KIT approved August 14, 2023 to treat patients with liver dominant mUM mUM patients with liver involvement of <50% are eligible for treatment with HEPZATO HEPZATO would require <20% of eligible patients to achieve similar 4 quarter growth* HEPZATO has no HLA genotype restrictions and will be the only FDA approved drug for 55% of all mUM patients, as well as for KIMMTRAK failure patients HEPZATO KIT is well positioned to capture a similar share of its TAM HEPZATO is more of a complement than a competitor to KIMMTRAK for patients eligible for KIMMTRAK HEPZATO EAP patients have included: 1st line stand alone treatment, 1st line treatment for those intending to receive KIMMTRAK, as 2nd line treatment, and as a 3rd line palliative treatment NCCN Guidelines currently state  “regional isolation perfusion of the liver” as a recommended treatment “If disease is confined to the liver, regional therapies…should be considered.  Since tebentafusp-tebn response rates are low, symptomatic patients may be better palliated by liver-directed treatment first….”  NCCN Guidelines Melanoma Uveal V1.2023 *Assuming a $150,000 per kit cost and 4 kits per patient


Slide 30

Clinical Rationale for Broad Development Effort PHP treats the entire liver and is not dependent on tumor location or number of lesions Liver mets are often life limiting and reduce I/O efficacy Converting unresectable liver metastases into resectable Promising ORR, DCR and PFS signals seen across multiple tumor types with CHEMOSAT in Europe and in earlier studies with IHP HEPZATO is the only liver directed treatment which can repeatedly treat the whole liver Early data supports that combination with I/O agents is safe and effective Potential for significant improvement in survival


Slide 31

Strong Correlation of IHP and PHP Efficacy in mUM Patients IHP, or Intrahepatic Perfusion, 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. Meta-analysis of 8 mUM clinical studies 27 Endpoint IHP (%) PHP (%) mOS 17.1 17.3 mPFS 7.2 9.6 hPFS 10 9.5 Complications 39.1 23.8 Mortality 5.5 1.8 IHP in mCRC Van Iersel 28 ORR 50% mPFS 7.4 months mOS 24.8 months Magge 29 ORR 82% 1-year OS rate 91% 2-year OS rate 72% Rothbart 30 ORR 59% mTTP 7.7 months mOS 28.8 months Bartlett 31 ORR 76% DOR 8.5 months mOS 16 months IHP activity in CRC and NET IHP in mNET Grover32 ORR 50% DOR 15 months mhPFS 7 months mOS 48 months


Slide 32

Chemosat Has Been Used Across Multiple Tumor Types CE Marked - available in ~23 centers in 4 countries Delcath resumed direct sales on 3/1/22 ~1,400 commercial Chemosat kits shipped to the EU CHEMOSAT Used In 13 Tumor Types ~70%: Metastatic Ocular Melanoma (mUM) 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) Strong interest to fuel additional indications driven by HCP’s Results from over 20 retrospective and prospective trials published by independent investigators NICE (UK) upgraded status from “Research” to “Special Status” German reimbursement based on annual hospital special request (“ZE” process) Broader usage pending FOCUS trial publication to support reimbursement


Slide 33

Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy


Slide 34

CHOPIN: Phase mUM 1b/2 randomized study of PHP vs PHP+IO N=7 in Phase 1b portion of the trial38  RP2D: IPI 1mg/kg and NIVO 3mg/kg. Well tolerated, no DLTs or deaths. 1CR, 6 PR and 1 PD (85.7% ORR, 100% DCR) – meta-analysis of prior IO trials has shown ORR<<10% As of 11/15/22 the median follow-up was 29.1 months, the median PFS was 29.1 months, and the median duration of response was 27.1 months. All patients are still alive. 3 of 4 patients who subsequently experienced PD continued with treatment in the form of repeated Melphalan Chemosat treatments Ongoing randomized Phase 2 (control is Chemosat) has recruited 50% of N=76 patients and will provide an interim analysis at N=40 patients Inclusion Ipilimumab + nivolumab c1: 1+1mg/kg c2: 1+3mg/kg melphalan liver chemo-saturation Ipilimumab + nivolumab c1: 1+1mg/kg c2: 1+3mg/kg Ipilimumab + nivolumab c1: 1+1mg/kg c2: 1+3mg/kg melphalan liver chemo-saturation Ipilimumab + nivolumab c1: 1+1mg/kg c2: 1+3mg/kg


Slide 35

FOCUS Trial Phase 2 Data ~10 EU Cases40 Limited, but High Unmet Need Limited, but High Unmet Need Extensive EU Experience39 IHP Efficacy Well Documented41 Market Expansion: Significant Investigator Interest Liver Dominant Patients By Cancer Type* U.S. Incidence U.S. Incidence Combination Therapy – IO Agents US TAM >$1B Per Year *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


Slide 36

Multi-Disciplinary, Experienced Leadership Team BOARD OF DIRECTORS John R. Sylvester Chairman Dr. Roger G. Stoll, Ph.D. Director Elizabeth Czerepak Director Steven Salamon Director Dr. Gil Aharon, Ph.D. Director Gerard Michel CEO GERARD MICHEL Chief Executive Officer 30+ yrs. pharma/medtech experience C-suite roles at Vericel Corp, Biodel, & NPS M.S. Microbiology, B.S. Biology & Geology from the Univ. of Rochester School of Medicine M.B.A. Simon School of Business & Leadership JOHN PURPURA Chief Operating Officer Past VP and Exec Director roles of Reg. Affairs for Bracco Diagnostics Held senior roles Sanofi-Aventis, Bolar Pharma, Luitpold Pharma & Eon Labs M.S. Mgmnt. & Policy and B.S. Chemistry and Biology at the State University of NY at Stony Brook Vojislav Vukovic, MD PhD Chief Medical Officer Oncology dev. exec, global clinical expertise Former CMO at Aileron, Taiho, Synta MD, Univ. of Sarajevo | MSc, PhD, Univ. of Toronto Published, AACR, ASCO, ASH, ESMO member KEVIN MUIR General Manager, Interventional Oncology 20+ yrs. of medtech/bioTx sales & marketing experience. Held senior leadership roles at BTG, ClearFlow, Aragon Surgical, Kensey Nash Corporation, and Kyphon. Field Artillery officer in the U.S. Army B.S. in Management Systems Engineering at the U.S. Military Academy at West Point SANDRA PENNELL SVP, Finance 20+ years' biotech financial oversight experience Manages global financial affairs, U.S. GAAP compliance Led finance at Invivyd, VP at Vericel Corp MSc, Accountancy, Univ. of Illinois


Slide 37

Capital Structure and Share Information Share Listing - Current DCTH (NASDAQ) Shares Outstanding a 20.3M Cash and Cash Equivalents b $14.6M Cash from 3Q Warrant Exercisesc $35.0M Warrants Outstanding d 15.56M Stock Options Granted 2.9M 2023 Q2 Cash Burn e $9.6M Debt f $9.8M 52 week Low – High g $2.34 - $7.99 30d Average Daily Volume h 2,207,716 As of June 30, 2023; includes 15.3M of Common plus 1.1M Preferred E & E-1, 2.9M of Preferred F-2 & 1.0M Pre-funded Warrants as converted As of June 30, 2023; (10-Q filing on August 9, 2023)  7.78M Tranche A warrants exercised 21 days after receipt of FDA approval for HEPZATO; As of June 30, 2023; 3.6M warrants at a $10 exercise  price, 7.78M Tranche A warrants for an aggregate exercise price $35 million exercisable until the earlier of 3/31/2026 or 21 days receipt of FDA approval for HEPZATO (now all exercised); and 4.17M  Tranche B warrants for an aggregate exercise price $25 million exercisable until the earlier of 3/31/2026 or 21 days following recording at least $10 million in quarterly U.S. revenue. Q2 Net cash used in operating activities (increase from Q1 2023 due to pay down of accrued liabilities) Includes $5.0M of notes convertible at $11.98 per common share equivalent,  Used NASDAQ closing price information starting on September 4, 2022 – September 5, 2023 30-day average calculated between on August 5, 2023 – September 5, 2023


Slide 38

4Q launch in mUM Multiple 2023/2024 catalysts (Launch, CHOPIN data, Revenue Build) Delcath: Investment Summary Potential high value follow-on indications and strategic interest creates significant upside KIMMTRAK proving out significant commercial opportunity (~$167M run rate) with 45% of the HEPZATO TAM High penetration likely due to NCCN guidelines including PHP and equivalent OS as KIMMTRAK in more advance patient population Management team experienced in commercializing high value, specialty products


Slide 39

THANK YOU


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References 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. 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. Cancer.net Editorial Board (2020) Eye Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/eye-cancer/statistics. Accessed 22 Jun 2020. Ocular Melanoma Foundation. Treatment of Metastatic Disease. In: OMF – Metastatic Treatment. http://www.ocularmelanoma.org/metstreatment.htm. Accessed 22 Jun 2020. 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. United States Census Bureau. (2019) Monthly Population Estimates for the United States: April 1, 2010 to December 1, 2020 (NA-EST2019-01). Cancer.net Editorial Board. (2020) Neuroendocrine Tumors - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/neuroendocrine-tumors/statistics. Accessed 22 Jun 2020. 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. Surveillance, Epidemiology, and End Results (SEER) Program Populations (1969-2018) (www.seer.cancer.gov/popdata), National Cancer Institute, DCCPS, Surveillance Research Program, released December 2019. 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. 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. 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. Cancer.net Editorial Board. (2020) Colorectal Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/colorectal-cancer/statistics. Accessed 22 Jun 2020. 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. 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.


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References Key Statistics About Liver Cancer. American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, Ga. 2021. Key Statistics About Liver Cancer. American Cancer Society. Facts and Figures 2021. American Cancer Society. Atlanta, GA 2021. Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 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. 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. 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 Krantz BA, et al. Uveal Melanoma: Epidemiology, Etiology, and Treatment of Primary Disease. Clin Ophthalmol. 2017;11:279-289 Eschelman DJ et al. Transhepatic Therapies for Metastatic Uveal Melanoma. Semin Intervent Radiol. 2013;30(1):39-48. Gill VT et al. Multiorgan Involvement of Dormant Uveal Melanoma Micrometastases in Postmortem Tissue From Patients Without Coexisting Macrometastases. Am J Clin Pathol. 2023 Aug 1;160(2):164-174. Lane AM, et al. Survival Rates in Patients After Treatment for Metastasis From Uveal Melanoma. JAMA Ophthalmol. 2018 Sep 1;136(9):981-986. Carvajal RD, et al. Metastatic Disease from Uveal Melanoma: Treatment Options and Future Prospects. Br J Ophthalmol. 2017;101(1):38-44. 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. Bethlehem MS et al. Meta-Analysis of Isolated Hepatic Perfusion and Percutaneous Hepatic Perfusion as a Treatment for Uveal Melanoma Liver Metastases. Cancers (Basel). 2021 Sep 21;13(18):4726. van Iersel LB et al. Isolated hepatic melphalan perfusion of colorectal liver metastases: outcome and prognostic factors in 154 patients Ann Oncol. 2008;19:1127–34.  Magge D et al. A Phase I Trial of Isolated Hepatic Perfusion (IHP) Using 5-FU and Oxaliplatin in Patients with Unresectable Isolated Liver Metastases from Colorectal Cancer. Ann Surg Oncol. 2013 Jul;20(7):2180-7. Rothbarth J et al. Isolated hepatic perfusion with high-dose melphalan for the treatment of uveal melanoma metastases confined to the liver. Br J Surg. 2003;90:1391–7. Bartlett DL et al. Isolated hepatic perfusion for unresectable hepatic metastases from colorectal cancer. Surgery. 2001 Feb;129(2):176-87 Grover A et al. Isolated Hepatic Perfusion with 200 mg Melphalan for Advanced Noncolorectal Liver Metastases. Surgery. (2005). 136. 1176-82. 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.


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References 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 Piulats, J, et al. Nivolumab Plus Ipilimumab for Treatment-Naïve 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. 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. Nathan, P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med 2021; 385:1196-1206 Tong TML et al. Combining Melphalan Percutaneous Hepatic Perfusion with Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma: First Safety and Efficacy Data from the Phase Ib Part of the Chopin Trial. Cardiovasc Intervent Radiol. 2023 Mar;46(3):350-359. Rothbarth J, Pijl ME, Vahrmeijer AL, et al. Isolated hepatic perfusion with high-dose melphalan for the treatment of colorectal metastasis confined to the liver. Br J Surg. 2003;90:1391–7. Vahrmeijer AL, van Dierendonck JH, Keizer HJ, et al. Increased local cytostatic drug exposure by isolated hepatic perfusion: a phase I clinical and pharmacologic evaluation of treatment with high dose melphalan in patients with colorectal cancer confined to the liver. Br J Cancer. 2000;82:1539–46. Alexander HR Jr, Libutti SK, Pingpank JF, Bartlett DL, Helsabeck C, Beresneva T. Isolated hepatic perfusion for the treatment of patients with colorectal cancer liver metastases after irinotecan-based therapy. Ann Surg Oncol. 2005;12:138–44.

v3.23.2
Document and Entity Information
Sep. 06, 2023
Cover [Abstract]  
Security Exchange Name NASDAQ
Amendment Flag false
Entity Central Index Key 0000872912
Document Type 8-K
Document Period End Date Sep. 06, 2023
Entity Registrant Name DELCATH SYSTEMS, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-16133
Entity Tax Identification Number 06-1245881
Entity Address, Address Line One 1633 Broadway
Entity Address, Address Line Two Suite 22C
Entity Address, City or Town New York
Entity Address, State or Province NY
Entity Address, Postal Zip Code 10019
City Area Code (212)
Local Phone Number 489-2100
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Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.01 par value
Trading Symbol DCTH
Entity Emerging Growth Company false

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