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About Delcath Systems, Inc.
Delcath Systems, Inc. (NASDAQ: DCTH) is a specialty pharmaceutical and medical device company at the forefront of interventional oncology, focusing on the treatment of primary and metastatic liver cancers. With its innovative approach to liver-directed therapies, Delcath addresses a critical unmet need in oncology, where effective and targeted treatment options for liver tumors remain limited. The company’s mission is to enhance outcomes for patients with liver-dominant cancers by combining advanced pharmaceutical and medical device technologies.
Core Technology: Melphalan/HDS
Delcath’s flagship product is the Melphalan Hydrochloride for Injection, used in conjunction with the proprietary Delcath Hepatic Delivery System (HDS). This drug-device combination is designed to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and associated side effects. The HDS isolates the liver during treatment, enabling loco-regional delivery of chemotherapy and filtration of hepatic venous blood. This innovative approach allows for higher drug concentrations in the liver, potentially improving tumor response rates while reducing systemic toxicity.
Market Applications and Regulatory Approvals
In the United States, Delcath’s product is marketed under the brand name HEPZATO KIT™, a combination drug and device approved by the FDA for the treatment of metastatic uveal melanoma (mUM) with unresectable hepatic metastases. The HEPZATO KIT allows for precise targeting of liver tumors, making it a valuable option for patients with limited systemic disease. In Europe, the device-only configuration of the HDS is marketed as the CHEMOSAT® Hepatic Delivery System for Melphalan. It is classified as a Class III medical device and is used in percutaneous hepatic perfusion procedures at leading cancer centers across the region.
Operational Strategy
Delcath’s operational strategy focuses on expanding clinical adoption, securing reimbursement, and training healthcare professionals to perform its specialized procedures. The company has steadily grown its presence in Europe, with over 250 CHEMOSAT treatments conducted at more than 20 leading cancer centers. In the U.S., Delcath is building a network of treatment centers to increase access to the HEPZATO KIT, supported by a dedicated field force and comprehensive training programs.
Competitive Positioning
Delcath operates in a niche segment of the oncology market, where its unique drug-device combination differentiates it from traditional chemotherapy and systemic therapies. Competitors may include other interventional oncology companies and liver cancer treatment providers, but Delcath’s ability to isolate the liver and deliver high-dose chemotherapy provides a distinct advantage. This approach not only enhances therapeutic efficacy but also aligns with the growing demand for precision medicine in oncology.
Challenges and Opportunities
While Delcath’s technology offers significant clinical benefits, the company faces challenges such as navigating complex regulatory frameworks, securing reimbursement, and competing in a crowded oncology market. However, its focus on a specialized therapeutic area, coupled with robust clinical data and growing adoption, positions it well for long-term success.
Conclusion
Delcath Systems, Inc. exemplifies innovation in interventional oncology with its proprietary technologies for liver-directed chemotherapy. By addressing a critical unmet need in liver cancer treatment, the company is poised to make a meaningful impact on patient outcomes while carving out a unique position in the oncology market.
Delcath Systems (NASDAQ: DCTH) announced an amendment to its loan agreement with Avenue Venture Opportunities Fund, allowing for an interest-only period from
Delcath Systems, Inc. (Nasdaq: DCTH) has completed a $25 million private placement with the potential for an additional $60 million based on milestone achievements. The financing, led by Vivo Capital and supported by various investors, is intended to fund operations through the anticipated FDA PDUFA date of August 14, 2023 for its product HEPZATO. The total proceeds are expected to cover working capital and general corporate purposes, with warrants providing further potential funding. The deal enables funding for commercialization if HEPZATO receives approval.
Delcath Systems, Inc. (DCTH) announced its fourth quarter and full year 2022 results, emphasizing significant milestones, including FDA acceptance of the NDA resubmission for Hepzato Kit® with a PDUFA date of August 14, 2023. The company secured $25 million in upfront financing, with potential additional funding of up to $60 million. Product revenue increased to $0.6 million in Q4 2022, up from $0.2 million in Q4 2021. However, Delcath reported a net loss of $8.5 million in Q4 2022, increasing its annual net loss to $36.5 million. As of December 31, 2022, cash holdings decreased to $11.8 million from $26.9 million the previous year.
Delcath Systems has secured
This capital will support the company through the anticipated PDUFA date of August 14, 2023 for HEPZATO approval and its commercialization efforts. Key investors include Vivo Capital and Logos Capital. The financing involves issuing Series F Convertible Preferred Stock and warrants, contingent on shareholder approval for conversions. Canaccord Genuity served as placement agent for this private placement.
Delcath Systems, Inc. (NASDAQ: DCTH) announced the FDA has accepted its resubmission of a new drug application for the HEPZATO™ Kit, aimed at treating unresectable hepatic-dominant metastatic ocular melanoma. This acceptance is deemed a complete class 2 response, with a PDUFA date set for August 14, 2023. The HEPZATO Kit combines melphalan and a hepatic delivery system to optimize cancer treatment while minimizing systemic exposure. The CEO expressed optimism regarding the potential approval of HEPZATO as a significant treatment option for patients. However, the drug’s efficacy has yet to be established in the U.S.
Delcath Systems (NASDAQ: DCTH) has appointed John R. Sylvester as its new Chairman, succeeding Dr. Roger Stoll, who has served since October 2015. Sylvester, a director since July 2019, brings extensive experience in interventional oncology, previously leading Curium's SPECT and International business units. Dr. Stoll will remain on the board. CEO Gerard Michel highlighted Sylvester's commercial expertise as the company prepares for the US launch of its HEPZATO Kit, which recently underwent a new drug application resubmission to the FDA for treating unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, Inc. (NASDAQ: DCTH) has resubmitted a New Drug Application (NDA) to the FDA for the HEPZATO™ Kit, aimed at treating unresectable hepatic-dominant metastatic ocular melanoma (mOM). This action addresses the issues raised in a Complete Response Letter from September 2013. A decision from the FDA is anticipated within 30 days. The NDA includes data from the FOCUS trial, showing a 36.3% overall response rate and a median overall survival of 20.53 months among treated patients. The HEPZATO Kit employs a unique delivery system designed to minimize systemic exposure to the drug while effectively targeting liver tumors.
Delcath Systems, Inc. (NASDAQ: DCTH) is set to participate in the BTIG MedTech, Digital Health, Life Sciences, & Diagnostics Tools Conference from February 14 to 16, 2023, in Snowbird, Utah. CEO Gerard Michel will hold one-on-one meetings during the event. The company specializes in treating primary and metastatic liver cancers, utilizing its percutaneous hepatic perfusion (PHP) system to deliver high-dose chemotherapy while minimizing side effects. In the U.S., the PHP system is under development as HEPZATO™ KIT for metastatic ocular melanoma, while in Europe, it's marketed as CHEMOSAT.
Delcath Systems, Inc. (DCTH) has published updated results from the Phase 1b CHOPIN Trial for treating advanced uveal melanoma with a combination of Delcath's CHEMOSAT and immune checkpoint inhibitors ipilimumab and nivolumab. The study, conducted at Leiden University Medical Center, showed a median progression-free survival (PFS) of 29.1 months, with all seven patients still alive at follow-up. The trial has demonstrated an 85.7% objective response rate and a 100% disease control rate. The ongoing Phase 2 part of the trial aims to further validate these findings with 76 additional patients enrolled.
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