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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, Inc. (Nasdaq: DCTH) announced an upcoming Investor Update Meeting on December 2, 2021, focusing on its investigational drug/device combination product, HEPZATO KIT. The meeting will feature discussions on the FOCUS trial results and the clinical experience with CHEMOSAT, detailing unmet needs in treating liver cancers. A panel of leading physicians will present key topics including PHP quality of life and future clinical development plans. This event underscores Delcath's commitment to innovative solutions for liver cancer treatment.
Delcath Systems (Nasdaq: DCTH) reported its Q3 2021 results, highlighting key developments including a $20 million debt facility and FDA approval for an expanded access protocol for HEPZATO™ Kit. Product revenue increased to $522,000, up from $466,000 year-over-year. However, the company faced a net loss of $7.1 million compared to $5.0 million in Q3 2020. Operating expenses rose to $7.0 million, influenced by stock option expenses. Cash reserves improved to $29 million from $11.1 million a year prior. Delcath plans to file its HEPZATO NDA mid-2022 and hosted an investor update on December 2.
Delcath Systems, a company specializing in interventional oncology, announced its participation in the Canaccord Virtual MedTech, Diagnostics, and Digital Health & Services Forum on November 18, 2021. The event will consist of one-on-one meetings only. Delcath focuses on treating rare liver cancers using its proprietary percutaneous hepatic perfusion (PHP) system, marketed in the U.S. as HEPZATO KIT and in Europe as CHEMOSAT. This innovative system administers high-dose chemotherapy directly to the liver while minimizing systemic side effects.
Delcath Systems (DCTH) will host an Investor Update on December 2, 2021, from 10 AM to 1 PM ET, focusing on its Hepzato Kit and its applications in treating liver cancers. Physicians will present updated data from the Focus trial and discuss the potential of Hepzato in treating hepatic-dominant metastatic ocular melanoma, colorectal cancer, and intrahepatic cholangiocarcinoma. The event will be accessible via a live webcast, with the archive available afterward on the company's website.
Delcath Systems (DCTH) announced a conference call on November 9, 2021, at 8:30 AM ET to discuss its Q3 2021 results ending September 30, 2021. The company specializes in interventional oncology, focusing on liver cancers through its proprietary percutaneous hepatic perfusion (PHP) system. In the U.S., it markets the system as HEPZATO KIT, while in Europe, it operates as CHEMOSAT Hepatic Delivery System. Interested parties can join the call via toll-free or international numbers, or stream it online.
Delcath Systems, Inc. (DCTH), a leader in interventional oncology, will present at three key healthcare conferences in September 2021. The H.C. Wainwright 23rd Annual Global Investment Conference runs from September 13-15, featuring on-demand presentations starting September 13 at 7:00 AM (ET). Next is the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 20-23, with a presentation on September 21 at 12:25 PM (ET). Lastly, the Cantor Fitzgerald Healthcare Conference will occur September 27-30, with a presentation on September 29 at 4:40 PM (ET).
Delcath Systems, Inc. (DCTH) reported its Q2 2021 financial results, showing product revenue of approximately $536K, up from $379K year-over-year. Despite this growth, the company incurred a net loss of $6.4M compared to a net income of $4.3M in Q2 2020. Key highlights include positive results from the FOCUS Phase III trial of HEPZATO™ KIT, with a 29.2% overall response rate in treated patients. Additionally, Delcath's CHEMOSAT® received updated guidance from the UK's National Institute for Health and Care Excellence, enhancing treatment funding prospects.
Delcath Systems (DCTH) has secured a debt facility of up to $20 million from Avenue Venture Fund, with an initial $15 million funded at closing. This financing aims to support the upcoming NDA filing for HEPZATO™, targeting the treatment of hepatic-dominant metastatic ocular melanoma, anticipated in early 2022. CEO Gerard Michel expressed optimism regarding the partnership, which will aid in advancing Delcath's innovative cancer treatment approaches.
Delcath Systems, Inc. (Nasdaq: DCTH) announced its participation in two key conferences. The BTIG Virtual Biotechnology Conference is set for August 9, 2021, from 10:00-10:25 AM ET, featuring management-led 1x1 investor meetings. The Canaccord Genuity 41st Annual Growth Conference will follow on August 11, 2021, at 10:00 AM ET, with a webcast available at this link. Delcath specializes in treating liver cancers through its proprietary PHP system.
Delcath Systems, Inc. (Nasdaq: DCTH) will host a conference call on August 10, 2021, at 8:30 AM ET to discuss its second-quarter results for the period ending June 30, 2021. The call will be accessible via phone and online. Delcath focuses on providing innovative treatments for rare liver cancers through its proprietary PHP system, which allows high-dose chemotherapy directly to the liver, minimizing systemic side effects. In Europe, the PHP system is marketed as CHEMOSAT, while in the U.S., it is under the name HEPZATO KIT.
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