Delcath(DCTH) - 2025 Q3 - Quarterly Results

Form 8-K Filing Information Registrant Information 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] - Principal Executive Offices: 566 Queensbury Avenue, Queensbury, NY 12804[1] Securities and Emerging Growth Status 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] Item 2.02 Results of Operations and Financial Condition Preliminary Q3 2025 Financial Results Announcement 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] - 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][5] Item 7.01 Regulation FD Disclosure Updated 2025 Full Year Revenue Guidance 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] - 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][7] Item 8.01 Other Events CHOPIN Trial Results 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 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] - 76 patients with mUM were randomized 1:1 to receive PHP alone or four cycles of ipilimumab and nivolumab with two PHP treatments[9] - 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] Progression-Free Survival (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) 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) 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) 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 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] 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 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] - Investors should not place undue reliance on these preliminary financial results[12] GAAP vs. Non-GAAP Measures 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] - 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] - 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] Forward-Looking Statements 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] - 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] - 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] Item 9.01 Financial Statements and Exhibits List of Exhibits 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 Report Signatory 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][22] - Date of signature: October 20, 2025[22]