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.