DELCATH SYSTEMS, INC.

Previous wording

•our ability to successfully commercialize CHEMOSAT, the HEPZATO KIT, and future products, if any, generate additional revenue and successfully obtain reimbursement for the products and/or the associated procedures;

Current wording

•our ability to successfully commercialize CHEMOSAT, the HEPZATO KIT, and future products, if any, generate additional revenue and successfully obtain and maintain reimbursement to healthcare professionals and treating facilities for the products and/or the associated procedures;

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, with patient enrollment expected to begin in the second 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 results for OS, a secondary endpoint, is expected in 2029.

Previous wording

The increase in total revenue for the three months ended March 31, 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 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.

Previous wording

Our revenue is generated from a relatively concentrated group of customers. For the three months ended March 31, 2026, two customers each accounted for more than 10% of our total product revenue, representing in the aggregate approximately 26.5% of revenue. As of March 31, 2026, our largest customer by revenue accounted for approximately 10.7% of our total accounts receivable balance of $14.2 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 March 31, 2026.

Current 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.

Previous wording

The change in cost of goods sold for the three months ended March 31, 2026 compared to the same period in 2025 is directly related to changes in demand for product revenue.

Current 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.

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 months ended March 31, 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 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.

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 months ended March 31, 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 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.

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 months ended March 31, 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 six months ended June 30, 2026 and 2025 due to all debt being paid off in 2024.

Previous wording

At March 31, 2026, we had cash and cash equivalents totaling $41.3 million and short-term investments totaling $48.0 million, as compared to cash and cash equivalents totaling $12.8 million and short-term investments totaling $46.1 million at March 31, 2025.

Current 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.

Previous wording

We believe that our current cash on hand, cash equivalents and investments will be sufficient to support our current operations through at least 12 months from the issuance of these condensed consolidated financial statements. Our actual future liquidity and capital requirements will depend on numerous factors, including the initiation and progress of clinical trials and research and product development programs; obtaining regulatory approvals and complying with applicable laws and regulations; the timing and effectiveness of product commercialization activities, including marketing arrangements; the timing and costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; the resolution of any disputes with third parties; and the effect of competing technological and market developments.

Current wording

We believe that our current cash on hand, cash equivalents and investments will be sufficient to support our current operations through at least 12 months from the issuance of these condensed consolidated financial statements. Our actual future liquidity and capital requirements will depend on numerous factors, including revenues recognized by us, the initiation and progress of clinical trials and research and product development programs; obtaining regulatory approvals and complying with applicable laws and regulations; the timing and effectiveness of product commercialization activities, including marketing arrangements; the timing and costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; the resolution of any disputes with third parties; and the effect of competing technological and market developments.

Previous wording

As of March 31, 2026, there have been 944,595 shares of common stock repurchased and retired under the repurchase program at an average price paid per share of $9.5077 for a total aggregate purchase price of approximately $9.0 million. We had approximately $16.0 million remaining under the share repurchase program at March 31, 2026.

Current wording

As of June 30, 2026, there have been 945,665 shares of common stock repurchased and retired under the repurchase program at an average price paid per share of $9.5085 for a total aggregate purchase price of approximately $9.0 million, which includes 628,572 shares repurchased prior to 2026 for an aggregate purchase price of approximately $6.0 million. We had approximately $16.0 million remaining under the share repurchase program at June 30, 2026.

Previous wording

Our capital commitments over the next twelve months include (a) $10.7 million to satisfy accounts payable, accrued expenses, current lease liabilities and current portion of the medac settlement and (b) $2.5 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) $0.8 million of lease liabilities and (b) $0.6 million for settlement of litigation with medac.

Current 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.

Previous wording

Our financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America. There were no material changes to our critical accounting policies as reported in our Annual Report. A description of certain accounting policies that may have a significant impact on amounts reported in the financial statements is disclosed in “Note 3 – Summary of Accounting Policies” to the notes to the consolidated financial statements contained in the Annual Report.

Current wording

Our financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America. There were no material changes to our critical accounting policies as reported in our Annual Report. A description of certain accounting policies that may have a significant impact on amounts reported in the financial statements is disclosed in “Note 3 – Summary of Accounting Policies” to the notes to the consolidated financial statements contained in our Annual Report.