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Here are 1-3 brief analogies to describe Delcath Systems:

• It's like a specialized oncology company, similar to a dedicated division of AstraZeneca or Merck, but Delcath focuses exclusively on liver cancers with a unique regional drug delivery system.
• Think of it as a niche biotech firm like Sarepta Therapeutics (which focuses on specific rare diseases), but Delcath develops and commercializes targeted therapies for liver cancers.
• Imagine an oncology innovator like a focused version of Genentech (known for cancer breakthroughs), but Delcath specializes in treating liver cancers using a unique device for direct drug delivery.

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• CHEMOSAT Hepatic Delivery System (Delcath System): A medical device system designed for targeted delivery of high-dose chemotherapy directly to the liver for the treatment of liver-dominant cancers, such as unresectable hepatic metastases from ocular melanoma.

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Delcath Systems (symbol: DCTH) primarily sells its Hepzato Kit, a specialized medical device and drug combination for treating liver cancers, to other companies within the healthcare sector.

Based on the company's most recent public filings, specifically its 10-K report for the fiscal year ended December 31, 2023, Delcath Systems has not disclosed any single customer that accounted for 10% or more of its total revenue for either the fiscal year 2022 or 2023. This indicates that, according to standard SEC reporting thresholds, Delcath Systems does not currently have "major customers" that are individually named in its financial disclosures.

Instead, Delcath's customer base consists of various healthcare institutions that perform complex oncology procedures. These typically fall into the following categories:

• Comprehensive Cancer Centers: Institutions dedicated to advanced cancer diagnosis, treatment, and research.
• Academic Medical Centers: University-affiliated hospitals and healthcare systems that often specialize in complex procedures and research.
• Specialized Treatment Facilities: Community hospitals and other medical centers that possess the necessary interventional radiology and oncology capabilities to perform the Percutaneous Hepatic Perfusion (PHP) procedure using the Hepzato Kit.

In Europe, Delcath also utilizes distributors to reach these types of medical facilities.

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• Evonik Industries AG (FWB: EVK)

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Gerard Michel, Chief Executive Officer

Mr. Michel has over 30 years of experience in the pharmaceutical and medical technology industries across multiple functional areas. Prior to joining Delcath Systems in October 2020, he served as Chief Financial Officer of Vericel Corp. since June 2014, where he was instrumental in integrating a transformative acquisition and shifting the company's business model to a fully integrated, profitable commercial entity. He also held CFO and Vice President of Corporate Development roles at Biodel Inc. from 2007 to 2014 and NPS Pharmaceuticals Inc. from 2002 to 2007. Earlier in his career, Mr. Michel was a Principal at Booz Allen Hamilton Inc. and held various commercial positions at Lederle Labs and Wyeth Labs.

Sandra Pennell, Chief Financial Officer

Ms. Pennell brings over 20 years of experience in diverse financial areas, including comprehensive oversight of finance and accounting functions, with expertise in SEC reporting, equity raises, financial planning and analysis (FP&A), and treasury management.

Martha S. Rook, PhD, Chief Operating Officer

Dr. Rook serves as the Chief Operating Officer of Delcath Systems.

Vojislav "Vojo" Vukovic, MD, MSc, PhD, Chief Medical Officer

Dr. Vukovic's experience encompasses early- to late-stage clinical development projects across various anticancer modalities and tumor types, as well as global medical affairs programs for several commercial oncology drugs. He previously served as Senior Vice President and Chief Medical Officer at Aileron Therapeutics, Taiho Oncology Inc., and Synta Pharmaceuticals Inc.

Kevin Muir, General Manager Interventional Oncology

Mr. Muir has over 20 years of sales and marketing experience in the biotherapeutics and medical technology industries. Before joining Delcath, he was Director of U.S. Sales for the Interventional Oncology business unit at BTG, where he significantly contributed to the success of TheraSphere™. He also held sales leadership positions at ClearFlow Inc., Aragon Surgical, Kensey Nash Corporation, Kyphon, and Genzyme Biosurgery. Mr. Muir served as a Field Artillery officer in the U.S. Army prior to his industry career.

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Delcath Systems (DCTH) faces several key risks to its business, primarily centered around market adoption, product safety, and financial liquidity.

1. Commercialization and Market Adoption Challenges: Delcath Systems is experiencing pricing pressure and slower than anticipated hospital onboarding, which is affecting the company's addressable market size and overall revenue growth. Difficulties in activating new clinical sites and complexities in workflow are also hindering sales growth and operational efficiency. Recent weakness in performance has been attributed to Medicaid National Drug Rebate Agreement (NDRA) discounts and seasonal impacts on patient starts. The company's ability to successfully implement its commercialization plans, manage its supply chain, and secure adequate reimbursement for its HEPZATO KIT are ongoing challenges.
2. Product Safety Profile and Restricted Access: The HEPZATO KIT carries a Boxed Warning due to the risk of severe peri-procedural complications, including hemorrhage, hepatocellular injury, thromboembolic events, and myelosuppression. Consequently, the product is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), which adds complexity to its commercialization and limits its use to specific patient populations and healthcare settings.
3. Liquidity and Funding for Future Expansion: Delcath Systems has reported a negative free cash flow, which could present liquidity risks if not adequately addressed. While the company aims for expansion into larger indications like breast and colorectal cancer, results from these clinical trials are not expected until 2028–2030, requiring significant ongoing investment. Margin pressures from discounted pricing and increased research and development (R&D) spending could also outpace revenue growth, potentially leading to financial stagnation if not managed effectively.

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Delcath Systems' main product, the HEPZATO KIT™ (melphalan hydrochloride for injection/hepatic delivery system), is known as CHEMOSAT® Hepatic Delivery System for Melphalan in Europe. This drug/device combination is designed to deliver high-dose chemotherapy directly to the liver while limiting systemic exposure.

Addressable Markets:

Uveal Melanoma Metastatic to the Liver (mUM):

• United States: The annual addressable market for HEPZATO KIT for adult patients with uveal melanoma metastatic to the liver is estimated to be approximately $500 million, based on around 800 eligible patients per year. Other estimates suggest the market could be slightly under $1.1 billion annually.
• Europe: For CHEMOSAT, the addressable market for uveal melanoma metastatic to the liver is estimated to be about $1.1 billion annually, accounting for potential reimbursement adjustments, with approximately 1,200 eligible patients each year.
• Combined U.S. and Europe: One estimate for this combined market is approximately $600 million per year. Another combined estimate suggests a total addressable market of $2.2 billion.

Potential Future Indications (if approved):

• Intrahepatic Cholangiocarcinoma (ICC): Approximately 2,000 patients annually in the United States, United Kingdom, and the EU could be candidates for treatment with HEPZATO KIT or CHEMOSAT.
• Broader Liver Metastases (including metastatic colorectal cancer, metastatic breast cancer, etc.): The estimated total potentially addressable market for liver cancer (primary and metastatic) in the United States is approximately 200,000 patients per year. The estimated total addressable market in the United States for mUM, ICC, hepatocellular carcinoma (HCC), breast cancer, neuroendocrine, pancreatic, and colorectal liver metastases is well over $1.0 billion. The global liver metastases treatment market was valued at USD 1.63 billion in 2023 and is projected to reach USD 2.66 billion by 2030.

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• Expansion of Treatment Centers and Sales Force: Delcath Systems is actively expanding its network of REMS-certified treatment sites in the U.S., with plans to increase from 25 to 40 by the end of 2026. This expansion is supported by an enlarged U.S. sales force, which grew from four to six regions in 2025 and is projected to expand further to nine regions by the second quarter of 2026, aiming to strengthen referral networks and site activation.
• Increased Adoption and Volume of HEPZATO KIT: The company projects a substantial increase in HEPZATO KIT treatment volume, with a forecast of nearly 150% growth in 2025 compared to 2024. This growth is a continuation of strong sales performance observed in 2025, where HEPZATO KIT revenue saw significant increases year-over-year.
• Geographic and Indication Expansion for HEPZATO: While HEPZATO KIT sales are primarily driven by the U.S. market, the company is exploring new clinical trials for its hepatic delivery system platform in other liver-dominant metastatic cancers, including colorectal and breast cancer. The initiation of a global Phase 2 trial for liver-dominant metastatic colorectal cancer and ongoing trials are expected to provide interim data by 2027, potentially expanding the addressable market for HEPZATO.
• Continued Performance of CHEMOSAT in Europe: Delcath Systems continues to generate revenue from CHEMOSAT sales in Europe, which complements its U.S. operations.

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Share Issuance

• Delcath Systems completed a public offering in November 2020, resulting in net proceeds of $32.4 million from the sale of 9,775,000 shares of common stock.
• In December 2020, the company completed an upsized public offering of 1,679,031 shares of common stock, including the full exercise of the underwriters' option to purchase additional shares, with gross proceeds of approximately $22.2 million.
• The exercise of 1.62 million Series F warrants, initially issued in 2020, generated $16.2 million in funding for the company in 2025.

Inbound Investments

• In March 2023, Delcath Systems announced a financing agreement for up to $85 million, which included $25 million in upfront funding and up to $60 million contingent upon achieving certain milestones. This financing was led by Vivo Capital.
• During the first quarter of 2024, Delcath raised $7.0 million through a private placement transaction with accredited investors, including existing investors, senior executives, and board members.

Capital Expenditures

• Proceeds from public offerings in 2020 were allocated towards general corporate purposes, including regulatory approvals, commercialization of products, clinical trials, and capital expenditures.
• Capital has been focused on funding the FOCUS Clinical Trial for Hepatic Dominant Ocular Melanoma, preparing federal regulatory applications for the HEPZATO KIT, and preparing for its commercial launch.
• More recently, capital is being directed towards expanding the clinical team and initiating Phase 2 clinical trials for HEPZATO in combination with standard of care for metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC), with an Investigational New Drug (IND) application for mCRC cleared by the FDA in December 2024.