DELCATH SYSTEMS, INC.

Previous wording

We are an interventional oncology company focused on the treatment of cancers primary or metastatic to the liver. Our lead product, the HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), a drug/device combination product (“HEPZATO” or “HEPZATO KIT”), was approved by the US Food and Drug Administration (the “FDA”) on August 14, 2023, 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. The first commercial use of the HEPZATO for the treatment of metastatic hepatic dominant uveal melanoma (“mUM”) took place in January 2024.

Current wording

We are an interventional oncology company focused on the treatment of cancers primary to or metastatic to the liver. Our lead product, the HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), a drug/device combination product (“HEPZATO” or “HEPZATO KIT”), was approved by the US Food and Drug Administration (the “FDA”) on August 14, 2023, 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. The first commercial use of the HEPZATO KIT for the treatment of metastatic hepatic dominant uveal melanoma (“mUM”) took place in January 2024.

Previous wording

On April 28, 2025, we announced our IND application clearance by the FDA for the Phase 2 clinical trial of HEPZATO in mBC. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. We expect approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 15 sites across the United States and Europe. Patient enrollment began in the third quarter of 2026. The trial’s primary endpoint, hPFS, is anticipated to read out by the end of 2028, while results for OS, a secondary endpoint, is expected in 2029.

Current wording

On April 28, 2025, we announced our IND application clearance by the FDA for the Phase 2 clinical trial of HEPZATO in mBC. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. We expect approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 15 sites across the United States and Europe. Patient enrollment began in the third quarter of 2026. The trial’s primary endpoint, hPFS, is anticipated to read out by the end of 2028, while OS results, a secondary endpoint, are expected in 2029.

Previous wording

The increase in total revenue for the three and six months ended June 30, 2026 compared to the same period in 2025 was due to the continued commercial expansion and demand of HEPZATO in the United States.

Current wording

The increase in total revenue for the three and nine months ended September 30, 2026 compared to the same period in 2025 was due to the continued commercial expansion and demand of HEPZATO in the United States.

Previous wording

Our revenue is generated from a relatively concentrated group of customers. For the six months ended June 30, 2026, two customers each accounted for more than 10% of our total product revenue, representing in the aggregate approximately 29.2% of revenue. As of June 30, 2026, our largest customer by revenue accounted for approximately 19.0% of our total accounts receivable balance of $15.9 million. Our standard payment terms are 30 to 60 days, and we have not experienced material collection losses to date. However, as our commercial business scales, the absolute dollar concentration of our receivables with a limited number of large hospital or treatment center customers increases. A payment delay, dispute, or reduction in ordering activity by one or more significant customers could adversely affect our operating cash flow in any given period. We actively monitor our receivables aging and have not applied any estimated credit loss reserves against our accounts receivable balance as of June 30, 2026.

Current wording

Our revenue is generated from a relatively concentrated group of customers. For the nine months ended September 30, 2026, two customers each accounted for more than 10% of our total product revenue, representing in the aggregate approximately 31.3% of revenue. For the nine months ended September 30, 2026, our largest customer represented 17.8% of revenue; as of September 30, 2026, that customer represented 15.9% of our total accounts receivable balance of $20.2 million. Our standard payment terms are 30 to 60 days, and we have not experienced material collection losses to date. However, as our commercial business scales, the absolute dollar concentration of our receivables with a limited number of large hospital or treatment center customers increases. A payment delay, dispute, or reduction in ordering activity by one or more significant customers could adversely affect our operating cash flow in any given period. We actively monitor our receivables aging and have not applied any estimated credit loss reserves against our accounts receivable balance as of September 30, 2026.

Previous wording

The change in cost of goods sold for the three and six months ended June 30, 2026 compared to the same period in 2025 is directly related to changes in demand for product revenue, offset by decreases in supplemental wages.

Current wording

The change in cost of goods sold for the three and nine months ended September 30, 2026 compared to the same period in 2025 is directly related to changes in demand for product revenue, offset by decreases in supplemental wages.

Previous wording

Research and development expenses are incurred for the development of HEPZATO and consist primarily of payroll and payments to contract research and development companies. The increase for the three and six months ended June 30, 2026 compared to the same period in 2025 is due to the continued costs associated with expanding the clinical team, including the base and supplemental wages related to an increase in headcount, and continuation of the Phase 2 clinical trials evaluating HEPZATO in combination with standard of care for mCRC and mBC. In addition to the Phase 2 clinical trials, we are researching initiatives to explore different indications, combinations, and potential applications of our therapies.

Current wording

Research and development expenses are incurred for the development of HEPZATO and consist primarily of payroll and payments to contract research and development companies. The increase for the three and nine months ended September 30, 2026 compared to the same period in 2025 is due to the continued costs associated with expanding the clinical team, including the base and supplemental wages related to an increase in headcount, and continuation of the Phase 2 clinical trials evaluating HEPZATO in combination with standard of care for mCRC and mBC. In addition to the Phase 2 clinical trials, we are researching initiatives to explore different indications, combinations, and potential applications of our therapies.

Previous wording

Selling, general and administrative expenses consist primarily of payroll, rent and professional services such as accounting, legal, marketing and commercial preparation services. For the three and six months ended June 30, 2026 compared to the same period in 2025, selling, general and administrative expenses increased due to continued commercial expansion activities including marketing-related travel expenses and additional personnel on the commercial team.

Current wording

Selling, general and administrative expenses consist primarily of payroll, rent and professional services such as accounting, legal, marketing and commercial preparation services. For the three and nine months ended September 30, 2026 compared to the same period in 2025, selling, general and administrative expenses increased due to continued commercial expansion activities including marketing-related travel expenses and additional personnel on the commercial team.

Previous wording

Interest and other income is primarily related to the interest income associated with marketable securities and cash on hand. There was no interest expense for the three and six months ended June 30, 2026 and 2025 due to all debt being paid off in 2024.

Current wording

Interest and other income is primarily related to the interest income associated with marketable securities and cash on hand. There was no interest expense for the three and nine months ended September 30, 2026 and 2025 due to all debt being paid off in 2024.

Previous wording

At June 30, 2026, we had cash and cash equivalents totaling $47.5 million and short-term investments totaling $48.4 million, as compared to cash and cash equivalents totaling $34.4 million and short-term investments totaling $46.6 million at June 30, 2025.

Current wording

At September 30, 2026, we had cash and cash equivalents totaling $55.5 million and short-term investments totaling $48.8 million, as compared to cash and cash equivalents totaling $41.8 million and short-term investments totaling $47.1 million at September 30, 2025.

Previous wording

Our capital commitments over the next twelve months include $13.3 million to satisfy accounts payable, accrued expenses, current lease liabilities and current portion of the medac settlement which includes $1.7 million to purchase melphalan under the Supply Agreement discussed in “Note 12 - Commitments and Contingencies”. Additional capital commitments beyond the next twelve months include (a) $2.3 million of lease liabilities and (b) $0.3 million for settlement of litigation with medac.

Current wording

Our capital commitments over the next twelve months include $13.0 million to satisfy accounts payable, accrued expenses, current lease liabilities and the current portion of the medac settlement. Additional capital commitments beyond the next twelve months include (a) $2.2 million of lease liabilities and (b) $0.3 million for settlement of litigation with medac.