Delcath(US:DCTH)2026-01-12 21:41Financial Performance - Preliminary total revenue for Q4 2025 is reported at $20.7 million, with full-year preliminary total revenue of $85.2 million[4]. - As of December 31, 2025, the company holds $91.0 million in cash and investments, with positive operating cash flow in Q4 2025[4]. - The company repurchased 629,000 shares for $6.0 million in 2025, indicating a strong financial position[4]. - The company has no outstanding debt obligations, further strengthening its financial stability[4]. - The company has a robust capital structure with a market capitalization including 34.7 million common shares and 1.8 million preferred shares as of December 31, 2025[47]. - The average daily trading volume was reported at 34 million shares, indicating strong market interest[46]. Product Development and Market Expansion - HEPZATO (drug/device) US launch for metastatic uveal melanoma (mUM) is scheduled for 1Q 2024, with a total addressable market (TAM) in the US estimated at approximately $500 million[4]. - The HEPZATO platform has received IND approval for metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC) trials, with patient enrollment expected to begin in Q3/Q4 2025 and Q1 2026 respectively[7]. - The company is focusing on a unique interventional oncology asset with strong efficacy signals across multiple tumor types, enhancing its market position[4]. - The company aims to leverage its HDS platform technology across a broad set of cancer types, indicating potential for future market expansion[4]. - The company is exploring market expansion opportunities through collaborations and partnerships in the oncology space[20]. - Future guidance indicates a strong pipeline with multiple upcoming product launches aimed at addressing unmet medical needs[20]. - The company anticipates a significant market expansion potential in the U.S. with an estimated upside of over $1 billion per year due to the incidence of primary/metastatic liver cancers[43]. - The company has received FDA IND clearance for a Phase 2 trial initiation planned for 2025, targeting a potential future opportunity of 30,000 patients[43]. - The company plans to address three line liver-dominant metastatic patient trials, enhancing its research and development pipeline[43]. Treatment Efficacy and Patient Outcomes - The company reported a 30% reduction in target lesion tumor burden, indicating significant treatment efficacy[17]. - The best overall response rate (BOR) in the pivotal trial was 200 patients, with a complete response rate of 91%[18]. - Approximately 800 patients are potentially eligible for treatment with the HEPAZATOKIT label, indicating a substantial market opportunity[20]. - The company reported a median Progression-Free Survival (PFS) of 12.8 months with a 1-year PFS rate of 54.7% compared to 8.3 months and 15.8% for the control group, respectively[41]. - The median Overall Survival (OS) was 23.1 months with a 1-year OS rate of 82.8%, while the control group had a median OS of 19.6 months and a 1-year OS rate of 82.2%[41]. - The historical benchmark for checkpoint combination therapy in metastatic uveal melanoma shows an overall response rate (ORR) of 15% and median OS of 16 months, indicating the company's treatment is performing significantly better[41]. - The company reported a median duration of response (DOR) of 14.0 months and a median overall survival (OS) of 20.5 months in its recent trials[51]. - HEPZATO may reduce immune tolerance effects in liver metastases, potentially enhancing the efficacy of immune-oncology therapies[35]. Patient Management and Treatment Accessibility - The company is focusing on expanding its patient population through targeted therapies, particularly in the liver-directed treatment segment[21]. - The initial screening and surveillance processes are being enhanced to improve patient outcomes and treatment decisions[21]. - The company aims to increase the frequency of screening among higher-risk patients, which constitutes about 50% of the patient population[21]. - The commercialization of HEPZATO KIT is set to begin with a J-Code assigned and active from April 1, 2024, and NTAP status approval expected by October 1, 2024[31]. - Delcath has engaged a hub service to assist with benefit verification and navigation for outpatient treatment[31]. - The company anticipates that the majority of patients will be treated as outpatients under Medicare guidelines[31]. Safety and Adverse Reactions - Adverse reactions related to study treatment occurred in ≥10% of patients, with thrombocytopenia at 64% and leukopenia at 44%[53]. - 55% of patients experienced grade 3 or 4 thrombocytopenia, while 34% experienced grade 3 or 4 leukopenia[53]. - Anemia was reported in 61% of patients, with 33% experiencing grade 3 or 4 anemia[53]. - Neutropenia occurred in 35% of patients, with 29% classified as grade 3 or 4[53]. - The side effect profile is similar to standard melphalan use, with most hematological side effects resulting from melphalan[53]. - Nausea and fatigue were reported in 47% and 43% of patients, respectively, with no grade 3 or 4 occurrences[53]. - The study included a total of 95 patients, indicating a significant sample size for evaluating adverse reactions[53]. - Blood bilirubin increased in 11% of patients, with 3% experiencing grade 3 or 4[53]. - Activated partial thromboplastin time was prolonged in 26% of patients, with 8% classified as grade 3 or 4[53]. - The overall safety profile suggests a need for careful monitoring of hematological parameters during treatment[53].