Announcement • May 27
Delcath Systems Publishes Two Investigator-Initiated Trials-In-Progress Abstracts At 2026 ASCO Annual Meeting Delcath Systems, Inc. announced the publication of two investigator-initiated trials-in-progress abstracts on May 21, 2026. These abstracts will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The abstracts highlight ongoing clinical investigations evaluating the use of Delcath’s percutaneous hepatic perfusion (PHP) with melphalan using the HEPZATO KIT Hepatic Delivery System (HDS) in metastatic melanoma involving the liver. One abstract, titled 'Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma,' describes an investigator-initiated Phase 2 trial evaluating sequential treatment with HEPZATO followed by tebentafusp in patients with metastatic uveal melanoma (mUM) who are HLA-A*02:01 positive and have isolated or liver-dominant metastases. The study is designed to assess progression-free survival and additional measures including safety, objective response, overall survival, and biomarker analyses. The study opened for enrollment in November 2025. A second abstract, titled 'Phase 1b/2 trial of melphalan-percutaneous hepatic perfusion (PHP) therapy and nivolumab/relatlimab in patients with metastatic melanoma and liver metastasis,' outlines a single-center Phase 1b/2 study evaluating HEPZATO in combination with nivolumab/relatlimab as a first-line treatment approach for patients with metastatic non-uveal melanoma involving the liver. The trial is intended to assess safety, tolerability, and preliminary efficacy, with secondary objectives including disease control rate, progression-free survival, overall survival, duration of response, and tumor reduction. The study opened for enrollment in January 2026. The abstract on sequential PHP followed by tebentafusp in mUM (Abstract TPS9605) and the abstract on PHP plus nivolumab/relatlimab in metastatic melanoma with liver metastasis (Abstract TPS9600) will be presented as posters at the 2026 ASCO Annual Meeting. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Announcement • May 10
Delcath Systems, Inc. Announces Presentation Of New Data On Percutaneous Hepatic Perfusion With Melphalan In Liver-Dominant Metastatic Breast Cancer Delcath Systems, Inc. announced that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT Hepatic Delivery System was presented at the ESMO Breast Cancer Congress 2026. Independent investigators at three European centers retrospectively identified 15 patients with liver-dominant metastatic breast cancer treated with M-PHP (CHEMOSAT) at three European centers. The analysis evaluated feasibility, safety, and tumor response per RECIST v1.1. Fifteen patients were treated between September 2015 and May 2024 after a median of 4 prior systemic therapy lines (range 1–6). Patients received a median of 1 M-PHP cycle (range 1–7), typically followed by ICU admission of 1–2 days. 67% of patients required blood transfusions (primarily packed red blood cells). Intra-/peri-procedural adverse events occurred in 60% of patients (primarily hematologic or hemodynamic). Grade 3–4 post-procedure adverse events occurred in 80% of patients, predominantly bone marrow suppression with neutropenic-related infections; events typically onset early (median 1 day) and resolved in a median of 7 days. Hepatic partial response was observed in 9 of 15 treated patients (60%); 3 patients were not evaluable for response. Median overall survival from first M-PHP was 6.0 months (95% CI, 2.9–NR; range 0.1–76.5); 33% (5/15) of patients were alive at last follow-up. Median follow-up was 55.6 months (95% CI, 53.7–NR). HEPZATO KIT is currently being evaluated in a randomized Phase 2 trial in metastatic breast cancer patients with liver dominant disease (PHP-MBC-202; ClinicalTrials.gov identifier NCT06875128). HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Reported Earnings • May 07
First quarter 2026 earnings released: US$0.03 loss per share (vs US$0.031 profit in 1Q 2025) First quarter 2026 results: US$0.03 loss per share (down from US$0.031 profit in 1Q 2025). Revenue: US$25.0m (up 26% from 1Q 2025). Net loss: US$1.07m (down 200% from profit in 1Q 2025). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 8.0% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 91% per year but the company’s share price has only increased by 23% per year, which means it is significantly lagging earnings growth. Announcement • Apr 07
Delcath Systems, Inc. Announces Inclusion of Chemosat Hepatic Delivery System for Melphalan as A Recommended Liver-Directed Regional Therapy Option in the Esmo–Euracan Clinical Practice Guidelines for Uveal Melanoma Delcath Systems, Inc. announced that its proprietary CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026). M-PHP is also recognized in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT™ (also referred to as melphalan/HDS), is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma (mUM). M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT. The ESMO-EURACAN guideline recognizes M-PHP under regional treatments for patients with liver-dominant mUM. Two Phase 3 trials of M-PHP (NCT02678572 and NCT00324727) are cited as key supporting data, demonstrating improved hepatic and overall progression-free survival, and overall response rates compared with best alternative care. The guideline also assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 to M-PHP in the supplementary materials, for patients with unresectable hepatic metastases affecting. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Announcement • Apr 03
Delcath Systems, Inc., Annual General Meeting, May 13, 2026 Delcath Systems, Inc., Annual General Meeting, May 13, 2026. Recent Insider Transactions • Mar 06
CEO & Director recently bought US$100k worth of stock On the 2nd of March, Gerard Michel bought around 11k shares on-market at roughly US$8.96 per share. This transaction amounted to 3.4% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Gerard has been a buyer over the last 12 months, purchasing a net total of US$198k worth in shares. Major Estimate Revision • Mar 05
Consensus EPS estimates have been downgraded. The consensus outlook for earnings per share (EPS) in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$110.6m to US$103.0m. Now expected to report a loss of US$0.65 per share instead of US$0.095 per share profit previously forecast. Medical Equipment industry in the US expected to see average net income growth of 15% next year. Consensus price target down from US$22.33 to US$21.33. Share price fell 9.6% to US$9.23 over the past week. Announcement • Mar 03
Delcath Systems Announces Publication of Chopin Clinical Trial Results in the Lancet Oncology Delcath Systems, Inc. announced the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology. The publication, titled “Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial” is published in The Lancet Oncology and presents detailed analyses from the trial, building on the positive topline results previously presented at the European Society for Medical Oncology (ESMO) Congress in October 2025. The CHOPIN trial randomized 76 patients with metastatic uveal melanoma (mUM; n=38 per arm) to percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT® Hepatic Delivery System (HDS) alone or in combination with ipilimumab plus nivolumab. In both arms patients received two PHP treatments (weeks 1 and 7). In the combination arm patients also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, with no maintenance therapy. Key results (intention-to-treat population): · Primary endpoint – 1-year progression-free survival (PFS): 54.7% vs 15.8% (adjusted HR 0.34 [95% CI 0.19–0.60]; p=0.0002), Median PFS: 12.8 months vs 8.3 months · Overall Survival (OS): Median 23.1 months vs 19.6 months (HR 0.39 [95% CI 0.20–0.77]; p=0.0065) 2-year OS: 49.6% vs 22.1% · Objective Response Rate (ORR): 76.3% vs 39.5% Complete response (CR) rate: 13% vs 3% Safety Grade 3 or higher treatment-related adverse events occurred significantly more frequently in the combination arm (82%) than in the PHP-alone arm (41%); p=0.0006. The rate in the combination arm was similar to that reported in the FOCUS trial (81%). The most common grade 3/4 events were thrombocytopenia (34% vs 14%), leukopenia (26% vs 14%), ?-glutamyl transferase increase (18% vs 8%), and anemia (13% vs 3%). Most events were self-limiting or manageable with standard supportive care; no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm. Overall, the authors conclude that the combination of PHP with ipilimumab and nivolumab offers a promising new approach for patients with metastatic uveal melanoma. Delcath Systems, Inc. proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Reported Earnings • Feb 27
Full year 2025 earnings released: EPS: US$0.075 (vs US$0.93 loss in FY 2024) Full year 2025 results: EPS: US$0.075 (up from US$0.93 loss in FY 2024). Revenue: US$85.2m (up 129% from FY 2024). Net income: US$2.70m (up US$29.1m from FY 2024). Profit margin: 3.2% (up from net loss in FY 2024). The move to profitability was driven by higher revenue. Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 81% per year but the company’s share price has only increased by 23% per year, which means it is significantly lagging earnings growth. Major Estimate Revision • Jan 13
Consensus EPS estimates increase by 30% The consensus outlook for fiscal year 2025 has been updated. 2025 EPS estimate increased from US$0.055 to US$0.072. Revenue forecast steady at US$84.8m. Net income forecast to grow 608% next year vs 17% growth forecast for Medical Equipment industry in the US. Consensus price target broadly unchanged at US$22.33. Share price was steady at US$10.42 over the past week. Announcement • Jan 09
Delcath Systems, Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year 2025 Delcath Systems, Inc. provided earnings guidance for the fourth quarter and full year 2025. For the quarter, HEPZATO KIT™revenue expected to be approximately $19.0 million and CHEMOSAT revenue expected to be approximately $1.7 million.
For the year, company HEPZATO KIT™revenue expected to be approximately $78.8 million and CHEMOSAT revenue expected to be approximately $6.4 million. Announcement • Jan 01
Delcath Systems, Inc. Announces Publication of Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma Delcath Systems, Inc. announced the publication of results from subgroup analyses of the phase 3 FOCUS study. The publication, titled "Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" was published in the Journal of Cancer Research and Clinical Oncology. The analysis assessed efficacy and safety in subgroups of patients treated with Delcath's HEPZATO KIT, a drug/device combination for liver-directed treatment of mUM patients. The HEPZATO K IT is currently the only liver-directed treatment to be approved by the FDA for patients with unresectable mUM. The article provides clinically relevant subgroup analyses of key efficacy endpoints, including overall response rate (ORR), progression-free survival (PFS) and overall survival (OS), and safety categories. Prespecified subgroups included age (ORR: significantly higher ORR for patients with tumor burden below the median (51.1% vs. 22.2%, p=0.008). No significant differences for other subgroups. PFS: significantly longer median PFS for patients with tumor burden below The median (11.3 vs. 5.8 months, p=0.007). OS: significantly longer median OS for patients with smaller extent of tumor liver involvement (22.4 vs 16.8 months, p= 0.032), tumor burden below the median (26.7 vs 15.4 months, p=0.008) and low/normal LDH (23.4 vs 15.3 months, p=0.019). Of the 33 patients achieving an objective response (CR or PR), 57.6% (19 patients) responded within the first or second treatment cycle, while one-third (33.3%; 11 patients) of responses were observed in Cycles 4-6, highlighting the importance of continued treatment up to the maximum of 6 cycles to optimize tumor response. The overall safety profile was similar across subgroups, with no evidence of cumulative toxicity with successive treatment cycles. The incidence of serious adverse events and Grade 3/4 adverse events was consistent with the overall study population, and no treatment-related deaths occurred. The FOCUS study utilized HEPZATO Kit (HEPZATO (melphalan) for Injection/Hepatic Delivery System), and results from the FOCUS study lead to the approval of HEPZATO by the U.S. Food and Drug Administration (FDA). Announcement • Dec 04
Delcath Systems, Inc. Announces Publication of 10-Year Single-Center Experience with Percutaneous Hepatic Perfusion in Liver-Dominant Metastatic Uveal Melanoma Delcath Systems, Inc. announced the publication of a retrospective study by leading interventional radiologists and oncologists from Asklepios Hospital Barmbek in Hamburg, Germany. The study, titled "Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience," was published in the journal Cancers and reports outcomes from 38 consecutive patients with liver-dominant metastatic uveal melanoma (mUM) who underwent 99 procedures using Delcath's CHEMOSAT®? Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). The article highlights the procedure's safety and efficacy, demonstrating a median overall survival (OS) of 29.1 months from the first PHP treatment, with improved outcomes associated with additional treatment cycles. The retrospective study synthesizes data from consecutive patients treated between April 2014 and March 2024, demonstrating safety and efficacy of CHEMOSAT in a real-world setting. Key highlights include: Median OS of 29.1 months (95% CI: 18.4-38.9 months) from the first PHP treatment, With 1-, 2-, and 3-year OS rates of 79.5%, 53.2%, and 28.5%, respectively; Numerically improved median OS with 3 PHP cycles (29.8 months) versus 2 cycles (21.4 months; p=0.058), with each additional cycle associated with a ~40% reduction in risk of death (HR=0.414); No treatment-related deaths, with procedure-related adverse events graded 2 occurring in 10.5% of patients; Patient population with ECOG-PS 0-1, 70% liver involvement, and limited extrahepatic disease, reflecting appropriate selection for PHP; Support for institutional experience and volume as factors in optimizing outcomes, providing a reference for novel mUM management strategies. Announcement • Nov 21
Delcath Systems, Inc. (NasdaqCM:DCTH) announces an Equity Buyback for $25 million worth of its shares. Delcath Systems, Inc. (NasdaqCM:DCTH) announces a share repurchase program. Under the program, the company will repurchase up to $25 million worth of its common shares. Recent Insider Transactions • Nov 14
CEO & Director recently bought US$98k worth of stock On the 11th of November, Gerard Michel bought around 12k shares on-market at roughly US$8.53 per share. This transaction amounted to 3.6% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Gerard's only on-market trade for the last 12 months. Reported Earnings • Nov 04
Third quarter 2025 earnings released: EPS: US$0.023 (vs US$0.065 in 3Q 2024) Third quarter 2025 results: EPS: US$0.023 (down from US$0.065 in 3Q 2024). Revenue: US$20.6m (up 84% from 3Q 2024). Net income: US$830.0k (down 56% from 3Q 2024). Profit margin: 4.0% (down from 17% in 3Q 2024). The decrease in margin was driven by higher expenses. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 68% per year but the company’s share price has only increased by 48% per year, which means it is significantly lagging earnings growth. Major Estimate Revision • Oct 21
Consensus revenue estimates fall by 11% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$94.6m to US$84.4m. EPS estimate fell from US$0.06 to US$0.02 per share. Net income forecast to grow 371% next year vs 16% growth forecast for Medical Equipment industry in the US. Consensus price target broadly unchanged at US$24.17. Share price was steady at US$11.42 over the past week. Announcement • Sep 23
Delcath Systems, Inc. Announces Investigator-Initiated Chopin Phase 2 Trial Presentation At Esmo 2025 Congress Delcath Systems, Inc. announced the acceptance of an oral presentation on results from the investigator-initiated CHOPIN randomized Phase 2 trial at the 2025 European Society for Medical Oncology (ESMO) Annual Congress. Principal Investigator Ellen Kapiteijn, MD, from Leiden University Medical Center's Department of Medical Oncology, will present data evaluating the safety, tolerability, and efficacy of sequencing systemic ipilimumab and nivolumab with Delcath's CHEMOSAT®? Hepatic Delivery System for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma. Principal Investigator Ellen Kapite Netherlands, will present data evaluate the safety, tolerability, and efficacy of sequencing systemicipilimumab and Nivolumab with DelCath's CHEMOSAT Hepatic Delivery System for per cutaneous hepatic perfusion with Melphalan in patients with metastatics uveal melanoma. The poster will be available at <URL> when the ESMO embargo is released on October 18, 2025. Announcement • Aug 20
Delcath Systems, Inc. Announces First Patient Dosed in Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Colorectal Cancer Delcath Systems, Inc. announced that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO™ in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC). 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 be conducted at more than 20 sites across the United States and Europe. Results from the trial’s primary endpoint, hepatic progression-free survival (hPFS), are anticipated by mid-2028, while overall survival (OS), a secondary endpoint, is expected in late 2028. The company estimates that the total addressable market 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, determined through radiological and clinical criteria. Delcath aims to provide a novel treatment option for this patient population with limited therapeutic alternatives. Reported Earnings • Aug 06
Second quarter 2025 earnings released Second quarter 2025 results: Net income: (up US$13.7m from 2Q 2024). Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has only increased by 35% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • Aug 06 The 6 analysts covering Delcath Systems previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of US$86.3k in 2025. Earnings growth of 47% is required to achieve expected profit on schedule.
Announcement • Aug 06
Delcath Systems, Inc. Updates Earnings Guidance for the Fiscal Year 2025 Delcath Systems, Inc. updated earnings guidance for the fiscal year 2025 . For the year, company expected Total CHEMOSAT and HEPZATO KIT revenue of $93 to $96 million, an increase of more than 150% over 2024 . Recent Insider Transactions Derivative • Jun 15
Chief Medical Officer exercised options to buy US$644k worth of stock. On the 12th of June, Vojislav Vukovic exercised options to buy 42k shares at a strike price of around US$4.78, costing a total of US$201k. This transaction amounted to 33% of their direct individual holding at the time of the trade. Since March 2025, Vojislav has owned 126.88k shares directly. Company insiders have collectively bought US$301k more than they sold, via options and on-market transactions, in the last 12 months. Price Target Changed • May 23
Price target increased by 7.0% to US$24.08 Up from US$22.50, the current price target is an average from 6 analysts. New target price is 49% above last closing price of US$16.11. Stock is up 107% over the past year. The company is forecast to post earnings per share of US$0.023 next year compared to a net loss per share of US$0.93 last year. Announcement • May 22
Delcath Systems, Inc. Provides Earnings Guidance for the Fiscal Year 2025 Delcath Systems, Inc. provided earnings guidance for the fiscal year 2025 . For the year, company expected Total CHEMOSAT and HEPZATO KIT revenue of $94 to $98 million, an increase of more than 150% over 2024 . Breakeven Date Change • May 12
Forecast breakeven date moved forward to 2026 The 6 analysts covering Delcath Systems previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of US$26.7m in 2026. Average annual earnings growth of 63% is required to achieve expected profit on schedule. Reported Earnings • May 09
First quarter 2025 earnings: EPS and revenues exceed analyst expectations First quarter 2025 results: EPS: US$0.031 (up from US$0.45 loss in 1Q 2024). Revenue: US$19.8m (up US$16.6m from 1Q 2024). Net income: US$1.07m (up US$12.2m from 1Q 2024). Profit margin: 5.4% (up from net loss in 1Q 2024). The move to profitability was driven by higher revenue. Revenue exceeded analyst estimates by 2.9%. Earnings per share (EPS) also surpassed analyst estimates by 100%. Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 41% per year whereas the company’s share price has increased by 45% per year. Breakeven Date Change • May 08
Forecast breakeven date moved forward to 2025 The 6 analysts covering Delcath Systems previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of US$9.28m in 2025. Earnings growth of 48% is required to achieve expected profit on schedule. Announcement • Apr 28
Delcath Systems Announces Fda Clearance of Ind Application for Phase 2 Clinical Trial of Hepzato in Liver-Dominant Metastatic Breast Cancer Delcath Systems, Inc. announced that the U.S. Food and Drug Administration has completed its 30-day review of the Company's Investigational New Drug application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for liver-dominant metastatic breast cancer. With the FDA's review complete, Delcath is now cleared to initiate patient enrollment in the U.S. 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. 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 fourth quarter of 2025. Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. By focusing on this demographic, Delcath intends to offer a novel therapeutic option to those patients with limited treatment alternatives. Announcement • Apr 10
Delcath Systems Announces Publication of Comparative Analysis from Randomized Portion of FOCUS Study in Metastatic Uveal Melanoma Delcath Systems, Inc. announced the publication of a comparative analysis from the randomized cohort of the Company's Phase 3 FOCUS study in Annals of Surgical Oncology. The study, titled "An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma," indicates that treatment with the Melphalan/Hepatics Delivery System (Melphalan/HDS) shows a trend toward favorable clinical outcomes compared to best alternative care (BAC), which included the physician's choice of dacarbazine, transarterialchemoembolization (TACE), ipilimumab or pembrolizumab in patients with unresectable metastatic uveal melanoma (mUM) with liver involvement. The FOCUS study was initially designed and conducted as a randomized controlled trial but was amended to a single-arm design. As a result, comparative efficacy analyses were designated as exploratory. A total of 85 patients were enrolled during the randomized portion of the trial, with 72 receiving study treatment (40 Melphalan/HDS; 32 BAC). All efficacy endpoints of the trial demonstrated substantial and consistent improvements in patients treated with Melphalan/HDS over BAC, including: Median progression-free survival in patients treated with MelphAL/HDS was 9.1 months, nearly three times longer than the 3.3 months observed in patients treated with BAC; Median overall survival was 18.5 months for Melphalan/HDS compared to 14.5 months with BAC; Objective response rate was 27.5% with Melphalan/Hep System, nearly three times higher than 9.4% with BAC; Disease control rate was 80.0% with Melphalan/HEPZATO KIT, substantially higher than the 46.9% observed with BAC; Median hepatic progression-free survival was 11.4 months for Melphalan/HDS – more than three times longer than the 3.3 months for BAC. The safety profile of patients treated with Melphalan/HDS was consistent with prior reports and primarily hematologic in nature. No treatment-related deaths were observed. Announcement • Apr 03
Delcath Systems, Inc., Annual General Meeting, May 15, 2025 Delcath Systems, Inc., Annual General Meeting, May 15, 2025. Announcement • Mar 08
Delcath Systems, Inc. Appoints Michael Brunner as Senior Vice President of Interventional Oncology Delcath Systems, Inc. appointed Michael Brunner, M.D., as the Senior Vice President of Interventional Oncology to further Delcath’s research and development efforts. Dr. Brunner is the former President of the Society of Interventional Radiology with over 25 years of experience in academia and biotech leadership. Reported Earnings • Mar 06
Full year 2024 earnings: EPS misses analyst expectations Full year 2024 results: US$0.93 loss per share (improved from US$2.94 loss in FY 2023). Revenue: US$37.2m (up US$35.1m from FY 2023). Net loss: US$26.4m (loss narrowed 45% from FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 16%. Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 30% per year whereas the company’s share price has increased by 27% per year. Announcement • Jan 16
Delcath Systems, Inc. Provides Unaudited Preliminary Earning Guidance for the Fourth Quarter and Full-Year 2024 Delcath Systems, Inc. provided unaudited preliminary earning guidance for the Fourth Quarter and Full-Year 2024. For the fourth quarter, the company expects revenue to be approximately $15.1 million.
For the full year, the company expects revenue to be approximately $37.2 million. New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 45% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Minor Risk Less than 1 year of cash runway based on current free cash flow (-US$26m). Announcement • Jan 13
Delcath Systems, Inc. to Report Q4, 2024 Results on Mar 06, 2025 Delcath Systems, Inc. announced that they will report Q4, 2024 results on Mar 06, 2025 Recent Insider Transactions Derivative • Dec 29
Independent Director exercised options to buy US$3.0m worth of stock. On the 24th of December, Steven Salamon exercised options to buy 250k shares at a strike price of around US$10.00, costing a total of US$2.5m. This transaction amounted to 9.0% of their direct individual holding at the time of the trade. Since March 2024, Steven has owned 82.20k shares directly. Company insiders have collectively bought US$2.6m more than they sold, via options and on-market transactions, in the last 12 months. Announcement • Dec 02
Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Colorectal Cancer Delcath Systems, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic colorectal cancer (mCRC). With the FDA's review complete, Delcath is now authorized to initiate patient enrollment. 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. The company estimates 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, Delcath aims to provide a novel treatment option for those with limited therapeutic alternatives. Major Estimate Revision • Nov 15
Consensus estimates of losses per share improve by 35% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$33.7m to US$34.5m. EPS estimate increased from -US$1.31 per share to -US$0.845 per share. Medical Equipment industry in the US expected to see average net income growth of 20% next year. Consensus price target of US$21.33 unchanged from last update. Share price fell 16% to US$9.23 over the past week. Breakeven Date Change • Nov 10 The 5 analysts covering Delcath Systems previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of US$38.1m in 2026. Average annual earnings growth of 70% is required to achieve expected profit on schedule.
Reported Earnings • Nov 10
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: EPS: US$0.065 (up from US$1.14 loss in 3Q 2023). Revenue: US$11.2m (up US$10.8m from 3Q 2023). Net income: US$1.86m (up US$22.2m from 3Q 2023). Profit margin: 17% (up from net loss in 3Q 2023). The move to profitability was primarily driven by higher revenue. Revenue exceeded analyst estimates by 7.1%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has only increased by 1% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • Nov 08
Forecast breakeven date moved forward to 2025 The 6 analysts covering Delcath Systems previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 23% to 2024. The company is expected to make a profit of US$2.24m in 2025. Average annual earnings growth of 69% is required to achieve expected profit on schedule. Recent Insider Transactions Derivative • Oct 24
CEO & Director exercised options to buy US$177k worth of stock. On the 22nd of October, Gerard Michel exercised options to buy 17k shares at a strike price of around US$6.00, costing a total of US$100k. This transaction amounted to 5.5% of their direct individual holding at the time of the trade. Since December 2023, Gerard's direct individual holding has increased from 262.35k shares to 302.67k. Company insiders have collectively bought US$641k more than they sold, via options and on-market transactions, in the last 12 months. Breakeven Date Change • Sep 27
Forecast breakeven date moved forward to 2025 The 6 analysts covering Delcath Systems previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 21% to 2024. The company is expected to make a profit of US$1.80m in 2025. Average annual earnings growth of 71% is required to achieve expected profit on schedule. Major Estimate Revision • Aug 28
Consensus EPS estimates fall by 14% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$1.17 to -US$1.34 per share. Revenue forecast of US$32.8m unchanged since last update. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target of US$21.33 unchanged from last update. Share price rose 34% to US$10.64 over the past week. Major Estimate Revision • Aug 12
Consensus revenue estimates increase by 13% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$29.1m to US$32.8m. Forecast losses expected to reduce from -US$1.25 to -US$1.17 per share. Medical Equipment industry in the US expected to see average net income growth of 17% next year. Consensus price target up from US$20.67 to US$21.33. Share price fell 6.5% to US$7.78 over the past week. Reported Earnings • Aug 06
Second quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2024 results: US$0.48 loss per share. Revenue: US$7.77m (up US$7.27m from 2Q 2023). Net loss: US$13.7m (loss widened 91% from 2Q 2023). Revenue exceeded analyst estimates by 43%. Earnings per share (EPS) missed analyst estimates by 36%. Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Announcement • Jul 09
Delcath Systems Regains Compliance with the Audit Committee Composition Requirements On July 8, 2024, Delcath Systems, Inc. (the Company") received a letter from The Nasdaq Stock Market LLC (Nasdaq") informing the Company that it had regained compliance with the audit committee composition requirements as set in Nasdaq Listing Rule 5605 for continued listing on The Nasdaq Capital Market. As previously disclosed, on May 29, 2024, the Company was notified by Nasdaq that it was not in compliance with Nasdaq Listing Rule 5605 because its Audit Committee was not comprised of at least three independent directors" (as defined in Nasdaq Listing Rule 5605(a)(2)). The Company was given until the Company's next annual meeting of stockholders or May 23, 2025 to regain compliance. To regain compliance, the Company was required to identify and select a member of the board of directors of the Company (the Board") who qualifies as independent" and would meet the audit committee criteria set in Nasdaq Listing Rule 5605. This requirement was met on July 2, 2024, when the Board appointed Dr. Bridget Martell as a member of the Audit Committee of the Board. Announcement • May 29
Delcath Systems, Inc. Appoints Bridget Martell to Board of Directors Delcath Systems, Inc. announce the appointment of Dr. Bridget Martell to the Company’s Board of Directors effective May 23, 2024. Dr. Martell is currently an independent director at the publicly traded companies Aligos Therapeutics and Achieve Life Sciences. She was a director of POINT Biopharma Global, Inc. (Nasdaq: PNT), a cancer treatment biotechnology company, from June 2023 until its acquisition by Eli Lilly and Company in December 2023 and Ayala Pharmaceuticals, another oncology focused company whose assets were sold to Immunome in March of 2024. She recently joined Two Bear Capital as a Biotechnology Operating Partner. Prior to this she was the founder and managing partner of BAM Consultants, a biotechnology focused consulting practice and during that tenure has served in a full time capacity as a C-suite executive including as President and Chief Executive Officer of Artizan Biosciences, Inc., a privately held biotechnology company, and as a Chief Medical Officer for various early-stage and mid-stage private and public biotechnology companies. Dr. Martell holds a B.S. in microbiology from Cornell University, an M.A. in Molecular Immunology from Boston University and an M.D. from Chicago Medical School. She completed her internship and residency in internal medicine and was an internal medicine chief resident and RWJ Faculty Clinical Scholar at Yale University. Dr. Martell is board certified in both Internal and Addiction Medicine. Dr. Martell was a Teaching Attending and Clinical Associate Professor at Yale from 2005 to 2020 and has continued her engagement at Yale as an Entrepreneur In Residence at Yale Ventures since 2017. New Risk • May 19
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$31m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$31m free cash flow). Shareholders have been substantially diluted in the past year (162% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Revenue is less than US$5m (US$4.6m revenue). Reported Earnings • May 16
First quarter 2024 earnings: EPS in line with analyst expectations despite revenue beat First quarter 2024 results: US$0.45 loss per share. Revenue: US$3.14m (up 426% from 1Q 2023). Net loss: US$11.1m (loss widened 24% from 1Q 2023). Revenue exceeded analyst estimates by 42%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Major Estimate Revision • May 15
Consensus revenue estimates increase by 11% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$25.9m to US$28.7m. EPS estimate unchanged from -US$1.23 at last update. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target of US$21.20 unchanged from last update. Share price rose 30% to US$7.19 over the past week. Price Target Changed • May 14
Price target increased by 8.1% to US$20.80 Up from US$19.25, the current price target is an average from 5 analysts. New target price is 194% above last closing price of US$7.07. Stock is up 14% over the past year. The company is forecast to post a net loss per share of US$1.28 next year compared to a net loss per share of US$2.94 last year. Announcement • May 09
Delcath Systems, Inc. to Report Q1, 2024 Results on May 14, 2024 Delcath Systems, Inc. announced that they will report Q1, 2024 results on May 14, 2024 Announcement • May 08
Delcath Systems, Inc Announces Publication of Results from Pivotal FOCUS Study in Metastatic Uveal Melanoma Patients treated with HEPZATO KIT Delcath Systems, Inc. announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT (melphalan/Hepatic Delivery System) in patients with unresectable metastatic Uveal Melanoma (mUM) on May 5, 2024 in the journal Annals of Surgical Oncology. The Food and Drug Administration (FDA) approved HEPZATO KIT on August 14, 2023 based on the results from the pivotal FOCUS study. A total of 91 patients with unresectable mUM were treated with HEPZATO KIT at 23 treatment centers in the US and Europe. Preliminary results from the FOCUS study were presented at the American Society of Clinical Oncology Annual Meeting in 2022. The FOCUS study was designed to provide a robust evaluation of efficacy and safety of HEPZATO KIT treatment, and enrolled a heterogeneous mUM patient population, including treatment-naïve and pretreated patients, patients with and without extrahepatic disease and patients with a range of baseline tumor burden. The primary efficacy endpoint of the FOCUS study was Overall Response Rate (ORR), which was 36.3%, including 7.7% of patients with Complete Response (CR), as determined by an Independent Review Committee. 37.4% of patients had Stable Disease (SD). ORR achieved in the FOCUS study was compared to a Meta-analysis of historic data, encompassing 16 published clinical studies with a total of 476 mUM patients treated with contemporary immunotherapy drugs. ORR of 36.3% in the FOCUS study was statistically significantly better than the pooled ORR estimate (a weighted mean of the observed ORR) of 5.5% in the historical control group. Secondary efficacy endpoints included Duration of Response (DOR), median Progression-free Survival (mPFS) and median Overall Survival (mOS), which were 14, 9 and 20.5 months, respectively. Safety and tolerability of HEPZATO KIT treatment reported in the FOCUS study was comparable with published clinical experience with Chemosat in Europe. Median number of administered HEPZATO KIT treatment cycles in the FOCUS study was 4. The most common serious treatment-emergent adverse events (SAE) were thrombocytopenia (15.8%) and neutropenia (10.5%), managed with standard supportive care and resolved with no ongoing complications. No treatment-related deaths were observed. Announcement • Apr 13
Delcath Systems, Inc., Annual General Meeting, May 23, 2024 Delcath Systems, Inc., Annual General Meeting, May 23, 2024, at 10:00 US Eastern Standard Time. Agenda: to elect Steven Salamon as a Class III director for a term expiring at the 2027 annual meeting of the Company’s stockholders and until their successors are elected and qualified; to approve an amendment of the Company’s 2020 Omnibus Equity Incentive Plan to increase by 2,000,000 the number of shares of common stock, $0.01 par value per share (“Common Stock”) available thereunder; to ratify the selection, by the Audit Committee of Board of Directors, of Marcum LLP as the independent registered public accounting firm of the Company for the fiscal year ending December 31, 2024; to approve, on a non-binding advisory basis, the compensation of named executive officers as disclosed in the accompanying proxy statement (“Proxy Statement”); and to transact such other business as may properly come before the Annual Meeting or any adjournments thereof. Breakeven Date Change • Mar 26
Forecast breakeven date pushed back to 2026 The 4 analysts covering Delcath Systems previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 88% per year to 2025. The company is expected to make a profit of US$56.0m in 2026. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Announcement • Mar 19
Delcath Systems, Inc. Appoints Martha S. Rook as Chief Operating Officer Delcath Systems, Inc. announced the appointment of Martha S. Rook as its new Chief Operating Officer (COO). Martha S. Rook, Ph.D., is an experienced industry leader who brings more than 25 years of academic and industry experience in molecular biology, diagnostics development, biologics process development and biologics manufacturing. She joins Delcath from insitro where she served as a Chief Technical Operations Officer and was responsible for core research services, facilities and laboratory operations, quality and project and portfolio management. Prior to insitro, she was with Sigilon Therapeutics, where she served as Chief Technical Operations Officer and was responsible for the analytics, manufacturing, supply chain and quality organizations producing a biologic-device combination product. Martha's experience also includes 13 years at MilliporeSigma, where she held a variety of roles, ultimately serving as vice president and head of the Gene Editing & Novel Modalities Business and led a team developing and providing tools and services for cell and gene therapies from discovery to manufacturing. Martha received her Ph.D. in biochemistry from MIT and holds a B.S. in chemistry from Texas A&M University. She pursued postdoctoral studies in neuroscience as a Lefler Fellow at Harvard Medical School'sCenter for Neurologic Diseases. Announcement • Feb 23
Delcath Systems, Inc. Announces Healthcare Setting Locator for HEPZATO™ KIT (melphalan/Hepatic Delivery System) Delcath Systems, Inc. announced that the company has launched a Healthcare Setting Locator (Locator) on the hepzatokit.com website. Potential patients, caregivers, and healthcare providers may use the Locator to identify healthcare settings, offering treatment with the HEPZATO KIT. Sites included on the Locator are accepting inquiries from patients or their physicians seeking potential treatment with HEPZATO KIT. These sites either have or expect to have completed all training and internal approvals necessary to treat a patient subsequent to the normal screening for eligibility. The HEPZATO KIT is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Announcement • Feb 17
Delcath Systems, Inc. Announces Executive Changes On February 12, 2024, John Purpura notified Delcath Systems, Inc. (the “Company”) of his intent to retire as the Company’s Chief Operating Officer. The Company is engaged in active discussions to appoint a new Chief Operating Officer with a preferred candidate identified. Mr. Purpura will remain with the Company until such time as his successor is named and has agreed to consult with the Company after he leaves. Additionally, on February 9, 2024, Roger Stoll notified the Company of his intent to retire from the board of directors of the Company (the “Board”) and not stand for re-election at the Company’s 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”). Mr. Stoll has served the Board for over fourteen years and, after the recent FDA approval and commercial launch of Delcath’s first product, Mr. Stoll decided that this was an appropriate time to retire from the Board. Mr. Stoll’s retirement will become effective at the conclusion of the 2024 Annual Meeting. Mr. Stoll’s decision to retire and not stand for re-election was not the result of a disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Announcement • Jan 31
Delcath Systems Receives Permanent J-Code (J9248) for HEPZATO™ (melphalan/Hepatic Delivery System) Effective April 1, 2024 Delcath Systems, Inc. announced that the Centers for Medicare & Medicaid Services ("CMS") has established a permanent and product-specific J-code (J9248) for HEPZATO. The J-code will become effective on April 1, 2024. J-codes are a form of Healthcare Common Procedure Coding System Level II identifiers used by payors to streamline the billing of Medicare Part B drugs. In its summary of Delcath's application for the J-code, CMS stated that "xistng melphalan hydrochloride is FDA approved at 0.25 mg/kg via intravenous infusion for patients with multiple myeloma and is not substitutable for the melphalan hydrochloride in the HEPZATO KIT which is approved at 3.0 mg/kg via intraarterial delivery for patients with metastatic ocular melanoma. The HEPZATO KIT is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. 
