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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, focused on interventional oncology for liver cancers, will present at the Access to Giving Virtual Conference on July 13, 2021, at 3 p.m. ET. CEO Gerard Michel will lead the discussion. This conference allows companies to engage with investors while supporting charitable causes. Registration is free and can be done online. Delcath’s investigational product, HEPZATO KIT, aims to deliver high-dose chemotherapy to the liver, although it is not approved by the FDA in the U.S. The system is marketed in Europe as Delcath CHEMOSAT.
Delcath Systems is set to join the Russell Microcap® Index on June 28, 2021, following the annual reconstitution. This membership will remain for one year and includes automatic inclusion in growth and value style indexes. The CEO, Gerard Michel, emphasized that this milestone enhances the company's visibility among investors. Russell indexes manage approximately $10.6 trillion in assets, being widely used by institutional investors for benchmarking. Delcath focuses on treating liver cancers using its proprietary PHP system, marketed as HEPZATO in the US and CHEMOSAT in Europe.
Delcath Systems (DCTH) reported positive preliminary results from its FOCUS Phase III trial for HEPZATO in treating liver-dominant metastatic ocular melanoma. The study achieved a significant overall response rate of 29.2%, exceeding the prespecified 8.3% threshold. Notably, 44% of patients treated with HEPZATO demonstrated a 30% or greater reduction in tumor size, compared to only 17% in the Best Alternative Care arm. The company will hold a Q&A webinar to discuss these findings further.
Delcath Systems, focused on interventional oncology, announced its management will present at the LD Micro Virtual Investor Conference on June 10, 2021, at 2:30 p.m. ET. This event will feature a live audio webcast accessible through their official link. Delcath’s investigational product, HEPZATO KIT, aims to treat primary and metastatic liver cancers by delivering high-dose chemotherapy while minimizing systemic exposure. Although not FDA-approved in the U.S., it is marketed in Europe under the CHEMOSAT name and has been CE Marked for use.
Delcath Systems (DCTH) announced management will present at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 4:00 PM (ET). The event provides a platform for showcasing Delcath's focus on treating rare primary and metastatic liver cancers using their investigational product, HEPZATO KIT, designed for high-dose chemotherapy delivery to the liver. While the HEPZATO KIT is not yet FDA-approved, it is marketed in Europe as CHEMOSAT, used in major medical centers. For more details, visit their conference page linked in the announcement.
Delcath Systems reported Q1 2021 financial results with product revenue at $0.4 million, up from $0.3 million in Q1 2020. The company posted a net loss of $6.8 million, a decline from net income of $7.9 million in the same period last year. Cash and equivalents stood at $26.7 million, significantly higher than $4.7 million a year prior. Notably, preliminary results from the FOCUS Clinical Trial show positive outcomes for HEPZATO in treating hepatic dominant ocular melanoma, with a statistically significant overall response rate exceeding the success threshold.
Delcath Systems, Inc. (DCTH) announced a conference call scheduled for May 11, 2021, to discuss its first-quarter results ending March 31, 2021. The call is set for 8:30 AM ET, and participants can join via phone or online. Delcath specializes in interventional oncology, focusing on rare liver cancers with its investigational product, HEPZATO KIT, designed for targeted chemotherapy delivery. While HEPZATO KIT is not FDA-approved in the U.S., it is CE-marked in Europe. The company has paused its ALIGN Trial for intrahepatic cholangiocarcinoma to reevaluate the trial's design.
Delcath Systems (DCTH) announces a positive oral presentation at the ASCO Annual Meeting regarding the FOCUS Phase III trial for HEPZATO in treating ocular melanoma liver metastases. The event will occur virtually from June 4-8, 2021, with Dr. Jonathan S. Zager presenting preliminary efficacy results. A Q&A webinar is also scheduled for June 7, 2021, at 8:30 AM ET, where CEO Gerard Michel will discuss the company's strategy and trial outcomes. HEPZATO aims to improve cancer treatment by delivering high-dose chemotherapy directly to the liver, minimizing side effects.
Delcath Systems (Nasdaq: DCTH) announced a significant update from the UK’s NICE, granting CHEMOSAT Hepatic Delivery System a Special Arrangement designation. This change allows increased reimbursement options, enabling private insurance and regional funding for treatments previously limited to research studies. The revised guidance also supports national reimbursement applications. CEO Gerard Michel expressed optimism regarding the availability of CHEMOSAT for patients with liver metastases from ocular melanoma, aligning with positive preliminary results from the FOCUS trial.
Delcath Systems (NASDAQ: DCTH) announced positive preliminary results from the Phase 3 FOCUS trial of HEPZATO KIT for treating liver-dominant metastatic ocular melanoma. A preliminary analysis showed an Overall Response Rate (ORR) of 29.2%, significantly exceeding the required 21.0% threshold for superiority over checkpoint inhibitors. This analysis covered 87% of enrolled patients and demonstrates the drug's efficacy, with a lower bound of 20.1% surpassing the 8.3% upper limit of prior studies. Delcath aims to address liver cancers with its innovative system.
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