DELCATH SYSTEMS, INC.

Previous wording

•our expectations and timing related to our Phase 2 clinical trial evaluating HEPZATO in combination with SOC for mCRC;

Current wording

•our expectations and timing related to our Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for liver-dominant metastatic colorectal cancer;

Previous wording

•our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners; and

Current wording

•our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners;

Previous wording

We have sufficient raw material and component constituent parts of the HEPZATO KIT to meet anticipated demand and we intend to manage supply chain risk through stockpiled inventory and contracting with multiple suppliers for critical components. As of April 30, 2025, 19 facilities have treated at least one patient with the HEPZATO KIT.

Current wording

We have sufficient raw material and component constituent parts of the HEPZATO KIT to meet anticipated demand and we intend to manage supply chain risk through stockpiled inventory and contracting with multiple suppliers for critical components.

Previous wording

Our IND application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (“SOC”) for liver-dominant metastatic colorectal cancer (“mCRC”) was cleared by the FDA in December 2024. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the second half of 2025. The trial’s primary endpoint, hepatic progression-free survival (“hPFS”), is anticipated to read out by the end of 2027, while overall survival (“OS”), a secondary endpoint, is expected in 2028. We estimate that the total addressable market (“TAM”) for liver-dominant mCRC receiving third-line treatment is between 6,000 and 10,000 patients annually in the United States. This market includes patients who present with significant liver disease burden, with liver-dominant status determined through radiological and clinical criteria. By targeting this patient population, we aim to provide a novel treatment option for those with limited therapeutic alternatives.

Current wording

Our IND application for a Phase 2 clinical trial evaluating HEPZATO in combination with SOC for liver-dominant mCRC was cleared by the FDA in December 2024. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the second half of 2025. The trial’s primary endpoint, hepatic progression-free survival (“hPFS”), is anticipated to read out by the end of 2027, while overall survival (“OS”), a secondary endpoint, is expected in 2028. We estimate that the total addressable market (“TAM”) for liver-dominant mCRC receiving third-line treatment is between 6,000 and 10,000 patients annually in the United States. This market includes patients who present with significant liver disease burden, with liver-dominant status determined through radiological and clinical criteria. By targeting this patient population, we aim to provide a novel treatment option for those with limited therapeutic alternatives.

Previous wording

The increase in total revenue for the three months ended March 31, 2025 compared to the same periods in 2024 was due to the continued commercial expansion and demand of HEPZATO in the United States and CHEMOSAT in Europe. In the first quarter of 2024 there were 4 facilities that had treated at least one patient. As of March 31, 2025, 17 facilities were treating patients.

Current wording

The increase in total revenue for the three and six months ended June 30, 2025 compared to the same periods in 2024 was due to the continued commercial expansion and demand of HEPZATO in the United States and CHEMOSAT in Europe. In the six months ended June 30, 2025, 20 facilities had treated at least one patient with HEPZATO versus 7 facilities in the six months ended June 30, 2024.

Previous wording

The change in cost of goods sold for the three months ended March 31, 2025 compared to the same periods in 2024 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, 2025 compared to the same periods in 2024 is directly related to changes in demand for product revenue.

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, 2025 compared to the same period in 2024 is due to costs associated with expanding the clinical team and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

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, 2025 compared to the same period in 2024 is due to costs associated with expanding the clinical team including the share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC and mBC. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

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, 2025 compared to the same periods in 2024, selling, general and administrative expenses increased due to continued commercial expansion activities including marketing-related expenses and additional personnel in 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, 2025 compared to the same periods in 2024, selling, general and administrative expenses increased due to continued commercial expansion activities including marketing-related expenses and additional personnel on the commercial team. In addition, the increase in personnel along with higher grant date exercise prices has increased the share-based compensation expense.

Previous wording

Interest and other income in 2025 is primarily related to the interest income associated with marketable securities and cash on hand. In 2024, this amount was offset by interest expense related to our debt instruments and the change in fair value of warrant liability. There was no interest expense for the three months ended March 31, 2025 due to all debt being paid off in 2024. There was no change in warrant valuation during the three months ended March 31, 2025 due to the exercise of all Tranche B Warrants in 2024.

Current wording

Interest and other income in 2025 is primarily related to the interest income associated with marketable securities and cash on hand. In 2024, this amount was offset by interest expense related to our debt instruments and the change in fair value of warrant liability. There was no interest expense for the three and six months ended June 30, 2025 due to all debt being paid off in 2024. There was no change in warrant valuation during the three and six months ended June 30, 2025 due to the exercise of all Tranche B Warrants in 2024.

Previous wording

At March 31, 2025, we had cash and cash equivalents totaling $12.8 million and short-term investments totaling $46.1 million, as compared to cash, cash equivalents and restricted cash totaling $32.4 million and short-term investments totaling $20.8 million at December 31, 2024. During the three months ended March 31, 2025, $2.2 million of cash was provided by operating activities compared to $9.6 million used in operating activities during the three months ended March 31, 2024, no principal payments were made during the three months ended March 31, 2025, compared to $3.1 million for principal payments during the three months ended March 31, 2024. At March 31, 2024, we had cash, cash equivalents and restricted cash totaling $11.8 million.

Current wording

At June 30, 2025, we had cash and cash equivalents totaling $34.4 million and short-term investments totaling $46.6 million, as compared to cash, cash equivalents and restricted cash totaling $32.4 million and short-term investments totaling $20.8 million at December 31, 2024. During the six months ended June 30, 2025, $9.5 million of cash was provided by operating activities compared to $14.0 million used in operating activities during the six months ended June 30, 2024, no principal payments were made during the six months ended June 30, 2025, compared to $6.1 million for principal payments during the six months ended June 30, 2024. At June 30, 2024, we had cash, cash equivalents and restricted cash totaling $14.8 million.

Previous wording

Our capital commitments over the next twelve months include (a) $5.3 million to satisfy accounts payable, accrued expenses, current lease liabilities and current medac settlement. Additional capital commitments beyond the next twelve months include (a) $1.2 million of lease liabilities and (b) $0.9 million for settlement of litigation with medac.

Current wording

Our capital commitments over the next twelve months include (a) $10.4 million to satisfy accounts payable, accrued expenses, current lease liabilities and current medac settlement. Additional capital commitments beyond the next twelve months include (a) $1.2 million of lease liabilities and (b) $0.6 million for settlement of litigation with medac.

Previous wording

In May 2020, we completed an underwritten public offering consisting of shares of common stock, Series F warrants to purchase shares of common stock and, to certain investors, in lieu of shares of common stock, pre-funded warrants to purchase shares of common stock. The Series F Warrants had an exercise price of $10.00 per share of common stock and expired on May 5, 2025, while the pre-funded warrants issued in such offering have an exercise price of $0.01, if exercised via cash payment. 238,500 Series F Warrants were exercised during the three months ended March 31, 2025 with an additional 1,377,275 Series F Warrants exercised after the quarter end and prior to their expiration.

Current wording

In May 2020, we completed an underwritten public offering consisting of shares of common stock, Series F warrants to purchase shares of common stock and, to certain investors, in lieu of shares of common stock, pre-funded warrants to purchase shares of common stock. The Series F Warrants had an exercise price of $10.00 per share of common stock and expired on May 5, 2025, while the pre-funded warrants issued in such offering have an exercise price of $0.01, if exercised via cash payment. 1,615,775 Series F Warrants were exercised during the six months ended June 30, 2025.