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)

分组1 - Delcath Systems Inc reported a significant increase in share price, rising 14.2% to $13.66 in pre-market trading following the announcement of preliminary third quarter 2025 financial results [1] - The company's Phase 2 CHOPIN study achieved its primary endpoint, demonstrating that PHP plus immunotherapy extended median progression-free survival (PFS) to 12.8 months, compared to 8.3 months previously [1] 分组2 - Beyond Meat Inc saw a substantial gain of 76.6%, reaching $1.14 in pre-market trading after a 24% surge on the previous Friday [4] - FGI Industries Ltd experienced a 64.1% increase to $7.81 in pre-market trading [4] - Celcuity Inc surged 44.3% to $75.00 following the announcement of Phase 3 VIKTORIA-1 data [4] - Rani Therapeutics Holdings Inc's shares jumped 32.5% to $2.18 after a collaboration agreement with Chugai Pharmaceutical and an oversubscribed $60.3 million private placement [4] 分组3 - Exelixis Inc's shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer [5]

Core Insights - Delcath Systems, Inc. reported preliminary revenue results for Q3 2025, indicating a total revenue of approximately $20.5 million from its CHEMOSAT and HEPZATO KIT products [1] - The revenue breakdown shows HEPZATO KIT generated $19.2 million, while CHEMOSAT revenue was not fully disclosed [1] Financial Performance - Total revenue for CHEMOSAT and HEPZATO KIT reached around $20.5 million for the quarter ended September 30, 2025 [1] - HEPZATO KIT specifically contributed $19.2 million to the total revenue [1]

Core Insights - Delcath Systems, Inc. announced the results of the CHOPIN randomized Phase 2 clinical trial focused on treating primary and metastatic liver cancers [1] Company Summary - Delcath Systems, Inc. is an interventional oncology company [1] - The CHOPIN Trial was presented by Professor Ellen Kapiteijn from Leiden University Medical Center at the 2025 ESMO Annual Congress [1]

Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Company Overview - Delcath Systems, Inc. is a medical technology company focused on oncology, specifically developing therapies for primary and metastatic liver cancers [1] - The main product is the Hepatic Delivery System, which administers high-dose chemotherapy to the liver while minimizing systemic exposure [1] - Delcath operates in a competitive landscape with peers including Interpace Biosciences, EOM Pharmaceuticals Holdings, Aeterna Zentaris, and Rennova Health [1] Financial Performance - Delcath's Return on Invested Capital (ROIC) is 3.58%, which is lower than its Weighted Average Cost of Capital (WACC) of 7.61%, indicating insufficient returns to cover capital costs [2] - In comparison, Interpace Biosciences has a positive ROIC of 84.16% with a WACC of 9.41%, resulting in a favorable ROIC to WACC ratio of 8.94, suggesting better capital efficiency than Delcath [3] - EOM Pharmaceuticals Holdings exhibits an impressive ROIC of 1,140.12% and a WACC of 16.82%, leading to a ROIC to WACC ratio of 67.77, indicating strong capital efficiency and growth potential [4] - Aeterna Zentaris and Rennova Health both report negative ROICs, highlighting challenges in generating sufficient returns on invested capital [4]