Core Points - Stellar AfricaGold Inc. has successfully closed a non-brokered private placement, raising a total of $4 million through the issuance of 22,222,222 units at a price of C$0.18 per unit [1][2] - Each unit consists of one common share and one-half of a transferable common share purchase warrant, with warrants allowing the purchase of additional shares at $0.28 for 36 months [2] - Proceeds from the offering will be used for exploration efforts at the Tichka Est Gold Project in Morocco and the Zuénoula gold property in Ivory Coast, as well as for general corporate purposes [3] Financial Details - The total gross proceeds from the offering amount to $4 million [2] - Finder's fees for the offering included $111,938.40 in cash, 557,725 units, and 64,155 non-transferable Finder's Warrants [5] - Two directors subscribed for a total of 677,545 units, generating gross proceeds of $121,958.10, classified as a related party transaction [6] Regulatory Information - All securities issued are subject to a statutory hold period of four months and one day, expiring on March 1, 2026 [4] - The securities have not been registered under the United States Securities Act of 1933 and cannot be offered or sold in the U.S. without compliance with registration requirements [7] Company Overview - Stellar AfricaGold Inc. is focused on precious metals exploration in North and West Africa, with key projects in Morocco and Côte d'Ivoire [8] - The company is listed on the TSX Venture Exchange, Tradegate Exchange, and Frankfurt Stock Exchange [9] - The head office is located in Vancouver, BC, with a representative office in Casablanca, Morocco [10]

Core Insights - Delcath Systems, Inc. (DCTH) reported quarterly earnings of $0.02 per share, matching the Zacks Consensus Estimate, and showing improvement from a loss of $0.03 per share a year ago [1] - The company achieved revenues of $20.56 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 0.41% and significantly up from $11.2 million year-over-year [2] - Delcath Systems shares have underperformed, losing about 20.9% since the beginning of the year, while the S&P 500 has gained 16.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.02 on revenues of $19.51 million, and for the current fiscal year, it is $0.13 on revenues of $83.93 million [7] - The estimate revisions trend for Delcath Systems was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Instruments industry, to which Delcath Systems belongs, is currently ranked in the top 38% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Revenue from HEPZATO sales was $19.3 million in Q3 2025, compared to $10 million in Q3 2024, while CHEMOSAT revenue was $1.3 million, up from $1.2 million in the same period last year [18] - Gross margins improved to 87% in Q3 2025 from 85% in Q3 2024 [18] - Research and development expenses increased to $8.0 million from $3.9 million year-over-year, while selling, general, and administrative expenses rose to $10.3 million from $7.0 million [18] - Net income for Q3 2025 was $0.8 million, down from $1.9 million in Q3 2024 [18] - Positive adjusted EBITDA for Q3 2025 was $5.3 million, compared to $1.0 million in Q3 2024 [18] - The company ended the quarter with approximately $89 million in cash and investments, with a quarterly positive operating cash flow of $4.8 million [19] Business Line Data and Key Metrics Changes - The average revenue per kit sold decreased by approximately 13% due to 340B pricing related to NDRA participation [5] - The total HEPZATO treatment volume in 2025 is projected to increase by nearly 150% compared to 2024 [19] Market Data and Key Metrics Changes - There was a slowdown in the pace of site activation from June to August, but the company activated four new sites in the past two months, bringing the total to 25 REMS-certified treatment sites [6][9] - The company plans to expand to 26-28 active treating centers by the end of 2025 and 40 centers by the end of 2026 [6] Company Strategy and Development Direction - The company aims to build referral networks to treatment locations, particularly as many targeted clinical sites have few metastatic uveal melanoma patients [6] - Delcath is committed to advancing research and development for HEPZATO, with ongoing trials in liver-dominant metastatic colorectal cancer and liver-dominant metastatic breast cancer [15][16] - The company is exploring additional tumor types and indications for HEPZATO, including intrahepatic cholangiocarcinoma, cutaneous metastatic melanoma, and non-small cell lung cancer [16] Management's Comments on Operating Environment and Future Outlook - Management adjusted the 2025 annual guidance to $83-$85 million due to changes in the rate of new patient starts and competitive clinical trial activity [10] - The results from the Chopin trial are expected to lessen competitive impacts as data is disseminated and physicians observe durable patient responses [10] - Management acknowledged the challenges posed by seasonality and competition for clinical trials, particularly during holiday periods [9][10] Other Important Information - The company has no outstanding debt obligations and no outstanding warrants [19] - Forecasts for 2025 gross margins are expected to be between 85%-87% [19] Q&A Session Summary Question: What are the Q4 expectations regarding competitive clinical trial activity and seasonality? - Management expects a modest amount of seasonality in Q4 and has factored in the same level of clinical trial competition seen mid-year [22] Question: How will site additions roll out into 2026? - Management anticipates that site additions will accelerate in the latter half of the year as the company expands to nine regions [26] Question: What steps are being taken to improve utilization at lower volume accounts? - The company is building referral networks and expanding the medical affairs team to address lower utilization sites [28] Question: How does the NDRA program influence profitability and revenue growth? - Management indicated that the NDRA will result in a one-time step down in revenue, but they do not anticipate a dramatic change in average revenue per kit [37] Question: What is the status of the Scandium III trial? - The Scandium III trial is recruiting slowly, and no timeline is available for when data might be reported [43]

Regulatory Approvals and Clinical Trials - The HEPZATO KIT was approved by the FDA on August 14, 2023, for liver-directed treatment of adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver[110]. - The first commercial use of the HEPZATO KIT occurred in January 2024[110]. - The CHOPIN clinical trial showed a one-year progression-free survival rate of 54.7% in the combination group versus 15.8% in the PHP group[114]. - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer (mCRC) is expected to enroll approximately 90 patients, with results anticipated by the end of 2027[119]. - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic breast cancer (mBC) is expected to enroll approximately 90 patients, with results anticipated by the end of 2028[120]. - The Phase 2 clinical trial for HEPZATO in combination with standard care for mCRC and mBC is expected to progress, with significant investments in clinical team expansion[127]. - The company expects to enroll approximately 90 patients in the Phase 2 clinical trial for liver-dominant metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC), with trials expected to take place at over 20 sites across the U.S. and Europe[119][120]. - The Phase 2 trial for HEPZATO in liver-dominant mBC is expected to read out its primary endpoint by the end of 2028[120]. Market and Patient Data - The total addressable market for liver-dominant mCRC receiving third-line treatment is estimated to be between 6,000 and 10,000 patients annually in the United States[119]. - Approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases[121]. - The number of facilities treating patients with HEPZATO increased to 22 in the nine months ended September 30, 2025, from 11 facilities in the same period of 2024[125]. Financial Performance - Total revenues for the three months ended September 30, 2025, increased to $20,563,000, up from $11,200,000 in the same period of 2024, representing an 83.5% growth[124]. - For the nine months ended September 30, 2025, total revenues reached $64,503,000, compared to $22,105,000 in 2024, marking a 192.5% increase[124]. - Gross profit for the three months ended September 30, 2025, was $17,939,000, compared to $9,560,000 in 2024, reflecting a 87.8% increase[124]. - Gross profit for the nine months ended September 30, 2025, was $55,716,000, up from $18,043,000 in 2024, indicating a significant increase in profitability[124]. - Net income for the three months ended September 30, 2025, was $830,000, compared to a net loss of $1,864,000 in the same period of 2024[124]. - Cash and cash equivalents totaled $41.8 million as of September 30, 2025, compared to $8.3 million at the same date in 2024[132]. - The company has capital commitments of $8.0 million over the next twelve months for accounts payable and accrued expenses[134]. Expenses and Investments - Research and development expenses are expected to increase due to costs associated with completing Phase 2 clinical trials[122]. - Research and development expenses rose to $7,986,000 for the three months ended September 30, 2025, up from $3,866,000 in 2024, a 106.0% increase[127]. - Selling, general and administrative expenses increased to $10,341,000 for the three months ended September 30, 2025, compared to $6,953,000 in 2024, a 48.5% rise[128]. - The company anticipates that research and development expenses will continue to rise as it completes ongoing clinical trials[122]. - Selling, general and administrative expenses increased to $10.341 million for the three months ended September 30, 2025, from $6.953 million in 2024, driven by commercial expansion activities[128]. Supply Chain and Product Management - The company has sufficient raw materials for the HEPZATO KIT to meet anticipated demand and plans to manage supply chain risks[112]. - CHEMOSAT received Medical Device Regulation certification in Europe on February 28, 2022, and the company has assumed direct responsibility for its sales and marketing in Europe[113].

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Points - Delcath Systems held a Business Update Call to discuss recent developments and future plans [2] - Key executives present included the CEO, CFO, and Chief Medical Officer, indicating a comprehensive leadership overview [2] Company Overview - The call was hosted by David Hoffman, who serves as General Counsel, Corporate Secretary, and Chief Compliance Officer [2] - A prerecorded conversation featuring Dr. Vincent T. Ma, an Assistant Professor and Medical Oncologist, was included to provide expert insights [2] Forward-Looking Statements - The company issued a safe harbor statement regarding forward-looking statements, emphasizing that expectations and assumptions are based on reasonable beliefs but are not guaranteed [3]

Company Overview - Delcath (NASDAQ: DCTH) has developed a liver-directed chemotherapy system currently used to treat liver metastatic uveal melanoma [1] - The addressable market for Delcath's treatment is currently small, but the uveal melanoma opportunity is likely sufficient to justify the company's current market capitalization [1] Investment Strategy - Narweena, an asset manager led by Richard Durant, focuses on identifying market dislocations due to poor understanding of long-term business prospects [2] - The firm aims to achieve excess risk-adjusted returns by targeting businesses with secular growth opportunities in markets with barriers to entry [2] - Narweena's research emphasizes company and industry fundamentals to uncover unique insights, with a high risk appetite and long-term investment horizon [2] Market Dynamics - An aging population with low growth and stagnating productivity is expected to create a different set of investment opportunities compared to the past [2] - Many industries may face stagnation or secular decline, which could paradoxically enhance business performance as competition decreases [2] - Conversely, some businesses may encounter rising costs and diseconomies of scale [2] - The economy is increasingly dominated by asset-light businesses, leading to a declining need for infrastructure investments over time [2] - A large pool of capital is pursuing a limited set of investment opportunities, resulting in rising asset prices and compressed risk premia [2]

Delcath Systems (NasdaqCM:DCTH) Update Summary Company Overview - **Company**: Delcath Systems - **Industry**: Oncology, specifically focusing on treatments for metastatic uveal melanoma Key Points from the Call Chopin Trial Results - The Chopin trial involved 76 patients randomized to receive either percutaneous hepatic perfusion (PHP) alone or a combination of PHP with ipilimumab and nivolumab [6][8] - **Primary Endpoint**: One-year progression-free survival (PFS) was 54.7% in the combination group versus 15.8% in the PHP group [9] - **Overall Survival**: The combination therapy showed a median overall survival of 23.1 months compared to 19.6 months for PHP alone [9] - **Response Rates**: Best overall response rates were 76.3% for the combination group versus 39.5% for PHP alone [9] - **Adverse Events**: Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%) but were manageable [9][18] Implications for Clinical Practice - The results are considered practice-changing, suggesting that the combination of ipilimumab and PHP should be offered to eligible patients [21] - There is a need for further studies to understand the immune versus cytotoxic mechanisms behind the observed efficacy [20] - The combination therapy may be particularly beneficial for patients with both hepatic and extrahepatic disease [21] Financial Results and Guidance - **Q3 2025 Preliminary Results**: Revenue of $20.5 million, gross margins of 87%, net income of $0.8 million, and positive adjusted EBITDA of $5.3 million [32] - **Cash Position**: As of September 30, 2025, the company reported $88.9 million in cash and equivalents [33] - **Revenue Guidance**: The company lowered its revenue guidance for 2025 to $83 million to $85 million due to a slowdown in new patient starts and the impact of 340B discounts [35] - **Treatment Volume Projection**: Total HEPZATO KIT treatment volume is projected to increase by approximately 150% compared to 2024 [36] Market Dynamics - There was a noted decrease in new patient starts per site, attributed to seasonality and scheduling issues [34][50] - The company is optimistic that the Chopin trial data will encourage quicker adoption of combination therapies among oncologists [39][41] - Interest from major cancer centers remains strong, with expectations to have 40 operational centers by the end of next year [33] Additional Insights - The combination therapy's efficacy may lead to a shift in treatment paradigms for other cancers with liver metastases [27][29] - The company is focused on training additional healthcare professionals to administer HEPZATO KIT to mitigate scheduling conflicts [34] - The feedback from oncologists indicates that HEPZATO KIT addresses a significant unmet need in the treatment landscape [35] Conclusion Delcath Systems is positioned to leverage the positive results from the Chopin trial to enhance its market presence and treatment adoption for metastatic uveal melanoma. The financial outlook reflects challenges but also opportunities for growth as the company navigates the complexities of patient recruitment and treatment administration.

CHOPIN Trial Results - The CHOPIN trial demonstrated that adding ipilimumab and nivolumab to PHP is effective and tolerable [9] - The combination group showed a one-year progression-free survival rate of 54.7% (95% CI: 36.8 - 69.5) compared to 15.8% (95% CI: 5.8 - 30.1) in the PHP group [6] - Median progression-free survival was 12.8 months (95% CI: 9.2 - 15.4) in the combination group versus 8.3 months (95% CI: 6.0 - 9.6) in the PHP group [6] - The hazard ratio for progression-free survival was 0.34 (0.19 - 0.60), with P<0.001 [6] - One-year overall survival was 82.8% (95% CI: 65.6 - 91.9) in the combination group and 82.2% (95% CI: 64.5 - 91.6) in the PHP group [6, 7] - Two-year overall survival was 49.6% (95% CI: 29.3 - 67.0) in the combination group and 22.1% (95% CI: 7.9 - 40.6) in the PHP group [7] - Median overall survival was 23.1 months (95% CI: 20.2 - 38.5) in the combination group and 19.6 months (95% CI: 15.2 - 21.8) in the PHP group [7] - The hazard ratio for overall survival was 0.39 (0.20 - 0.77), with P = 0.006 [7] - The best overall response rate in the combination group was 76.3% (59.4 - 88.0) [7] - Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs 40.5%, P<0.001) [7] Company Statements - Delcath Systems is focused on the treatment of primary and metastatic liver cancers [2, 14]

[Form 8-K Filing Information](index=1&type=section&id=Form%208-K%20Filing%20Information) [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides the official details of the registrant, DELCATH SYSTEMS, INC., including its state of incorporation, commission file number, and principal executive offices - Registrant: **DELCATH SYSTEMS, INC.**, incorporated in Delaware[1](index=1&type=chunk) - Principal Executive Offices: **566 Queensbury Avenue, Queensbury, NY 12804**[1](index=1&type=chunk) [Securities and Emerging Growth Status](index=1&type=section&id=Securities%20and%20Emerging%20Growth%20Status) This section identifies the company's common stock trading symbol and the exchange on which it is registered, and confirms that the registrant is not an emerging growth company Securities Registered | Title of each class | Trading symbol(s) | Name of each exchange on which registered | |---|---|---| | Common Stock, $.01 par value | DCTH | The Nasdaq Capital Market | - Registrant is **not an emerging growth company**[3](index=3&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) [Preliminary Q3 2025 Financial Results Announcement](index=2&type=section&id=Preliminary%20Q3%202025%20Financial%20Results%20Announcement) Delcath Systems, Inc. announced preliminary financial results for the quarter ended September 30, 2025, through a press release issued on October 18, 2025, which is furnished as Exhibit 99.1 - Delcath issued a press release on **October 18, 2025**, announcing preliminary financial results for the quarter ended **September 30, 2025**[4](index=4&type=chunk) - The press release (**Exhibit 99.1**) is furnished and incorporated by reference, but **not deemed 'filed'** for purposes of Section 18 of the Exchange Act[4](index=4&type=chunk)[5](index=5&type=chunk) [Item 7.01 Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) [Updated 2025 Full Year Revenue Guidance](index=2&type=section&id=Updated%202025%20Full%20Year%20Revenue%20Guidance) Delcath provided updated 2025 full-year revenue guidance in a press release on October 18, 2025, which is furnished as Exhibit 99.1 - Delcath issued a press release on **October 18, 2025**, announcing updated **2025 full year revenue guidance**[6](index=6&type=chunk) - The press release (**Exhibit 99.1**) is furnished and incorporated by reference, but **not deemed 'filed'** for purposes of Section 18 of the Exchange Act[6](index=6&type=chunk)[7](index=7&type=chunk) [Item 8.01 Other Events](index=2&type=section&id=Item%208.01%20Other%20Events) [CHOPIN Trial Results](index=2&type=section&id=CHOPIN%20Trial%20Results) Delcath announced CHOPIN Trial results, showing significantly improved progression-free survival, overall survival, and best overall response rate for combination therapy (PHP with ICI) in metastatic uveal melanoma compared to PHP alone [Trial Design and Patient Cohorts](index=2&type=section&id=Trial%20Design%20and%20Patient%20Cohorts) The CHOPIN Trial randomized 76 patients with metastatic uveal melanoma (mUM) 1:1 to receive either PHP alone or PHP combined with ipilimumab and nivolumab, with one-year progression-free survival as the primary endpoint - The CHOPIN Trial compared **CHEMOSAT® HDS** with **melphalan (PHP)** alone versus combined with **systemic immune checkpoint inhibitors (ICI) ipilimumab and nivolumab** for **metastatic uveal melanoma (mUM)**[8](index=8&type=chunk) - **76 patients** with mUM were randomized **1:1** to receive PHP alone or **four cycles** of ipilimumab and nivolumab with **two PHP treatments**[9](index=9&type=chunk) - The primary endpoint was **one-year progression-free survival**; secondary endpoints included safety, best overall response rate, overall survival, and hepatic progression-free survival[9](index=9&type=chunk) [Progression-Free Survival (PFS)](index=2&type=section&id=Progression-Free%20Survival%20(PFS)) The combination group showed significantly superior progression-free survival compared to the PHP alone group, with a higher one-year PFS percentage and longer median months Progression-Free Survival (95% CI) | Metric | Combination group | PHP group | |---|---|---| | One Year % (95% CI) | 54.7% (36.8 - 69.5) | 15.8% (5.8 - 30.1) | | Median months (95% CI) | 12.8 (9.2 - 15.4) | 8.3 (6.0 - 9.6) | | Hazard Ratio | 0.34 (0.19 - 0.60) | | | P-value | <0.001 | | [Overall Survival (OS)](index=2&type=section&id=Overall%20Survival%20(OS)) The combination group demonstrated improved overall survival, particularly at the two-year mark, with a longer median survival compared to the PHP alone group Overall Survival (95% CI) | Metric | Combination group | PHP group | |---|---|---| | One Year % (95% CI) | 82.8% (65.6 - 91.9) | 82.2% (64.5 - 91.6) | | Two Year % (95% CI) | 49.6% (29.3 - 67.0) | 22.1% (7.9 - 40.6) | | Median months (95% CI) | 23.1 (20.2 - 38.5) | 19.6 (15.2 - 21.8) | | Hazard Ratio | 0.39 (0.20 - 0.77) | | | P-value | 0.006 | | [Best Overall Response Rate (BORR)](index=3&type=section&id=Best%20Overall%20Response%20Rate%20(BORR)) The combination therapy group achieved a significantly higher best overall response rate compared to the PHP alone group Best Overall Response Rate (95% CI) | Group | Best Overall Response Rate (95% CI) | |---|---| | Combination group | 76.3 (59.4 - 88.0) | | PHP group | 39.5 (24.5 - 56.5) | | P-value | < 0.001 | [Preliminary Third Quarter Financial and Operational Results (Unaudited)](index=3&type=section&id=Preliminary%20Third%20Quarter%20Financial%20and%20Operational%20Results%20(Unaudited)) Delcath announced preliminary unaudited financial and operational results for the third quarter ended September 30, 2025, reporting a strong cash position, positive net income, adjusted EBITDA, and operating cash flow, primarily driven by HEPZATO KIT™ revenue [Key Financial Highlights](index=3&type=section&id=Key%20Financial%20Highlights) As of September 30, 2025, Delcath held approximately $88.9 million in cash and investments with no debt, and reported positive net income, adjusted EBITDA, and operating cash flow for Q3 2025 - As of **September 30, 2025**, Delcath had approximately **$88.9 million** of cash, cash equivalents and short-term investments and **no debt**[11](index=11&type=chunk) Preliminary Q3 2025 Financial Highlights | Metric | Amount | |---|---| | Total CHEMOSAT and HEPZATO KIT revenue | ~$20.5 million | | HEPZATO KIT™ revenue | $19.2 million | | CHEMOSAT® revenue | $1.3 million | | Gross margins expected | 87% | | Net income | $0.8 million | | Positive adjusted EBITDA | $5.3 million | | Positive operating cash flow | ~$4.8 million | [Nature of Preliminary Results and Disclaimers](index=3&type=section&id=Nature%20of%20Preliminary%20Results%20and%20Disclaimers) The preliminary Q3 2025 financial results are unaudited, subject to completion of quarter-end procedures, and represent management estimates, cautioning investors against undue reliance - Preliminary estimated financial results for **Q3 2025** are **unaudited**, subject to completion of quarter-end financial and accounting procedures, and may **materially differ** from actual results[12](index=12&type=chunk) - Investors should **not place undue reliance** on these preliminary financial results[12](index=12&type=chunk) [GAAP vs. Non-GAAP Measures](index=3&type=section&id=GAAP%20vs.%20Non-GAAP%20Measures) Delcath uses non-GAAP adjusted EBITDA for operational insights, noting these unaudited measures are not GAAP substitutes, and reconciliation to net loss is not provided due to estimation difficulties - Delcath's management believes **non-GAAP adjusted EBITDA** provides **additional information** useful to investors in understanding underlying performance and business trends[13](index=13&type=chunk) - Non-GAAP financial measures are **not required to be uniformly applied**, are **not audited**, and should **not be considered in isolation or as substitutes for results prepared in accordance with GAAP**[15](index=15&type=chunk) - Delcath **does not provide a reconciliation** between its forecasted Adjusted EBITDA and net loss without **unreasonable effort** due to the **unavailability of reliable estimates** for certain components[16](index=16&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section highlights that the report contains forward-looking statements, including 2025 full-year revenue guidance, which are subject to various risks and uncertainties that could cause actual results to differ materially, with Delcath disclaiming any obligation to publicly update or revise these statements - This Current Report on **Form 8-K** contains **forward-looking statements**, including statements regarding Delcath's **2025 full-year revenue guidance**, which are subject to certain **risks and uncertainties**[17](index=17&type=chunk) - Factors that may cause differences include uncertainties relating to **commercialization plans**, **supply chain management**, **FDA inspections**, **reimbursement**, and implementation of the **HEPZATO KIT Risk Evaluation and Mitigation Strategy**[17](index=17&type=chunk) - Delcath undertakes **no obligation to publicly update or revise** these forward-looking statements to reflect events or circumstances after the date they are made[17](index=17&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=4&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) [List of Exhibits](index=4&type=section&id=List%20of%20Exhibits) This section provides a list of all exhibits filed as part of this Form 8-K, including press releases related to preliminary financial results and the CHOPIN Trial results Exhibits Filed | Exhibit No. | Description | |---|---| | 99.1 | Press Release (Preliminary Financial Results), dated October 18, 2025 | | 99.2 | Press Release (CHOPIN Trial results), dated October 18, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signature](index=5&type=section&id=Signature) [Report Signatory](index=5&type=section&id=Report%20Signatory) The report was duly signed on behalf of DELCATH SYSTEMS, INC. by Gerard Michel, Chief Executive Officer, on October 20, 2025 - The report was signed by **Gerard Michel, Chief Executive Officer** of **DELCATH SYSTEMS, INC.**[21](index=21&type=chunk)[22](index=22&type=chunk) - Date of signature: **October 20, 2025**[22](index=22&type=chunk)