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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) has announced a conference call on August 8, 2022, at 8:30 AM Eastern Time to discuss its second-quarter results ending June 30, 2022. The company specializes in interventional oncology for liver cancer treatment. Interested participants can join by calling in or through a webcast link. Following the call, a replay will be available until August 15, 2022, using specific access codes. Delcath's proprietary systems, HEPZATO and CHEMOSAT, are designed to deliver targeted chemotherapy for liver cancers.
Delcath Systems, Inc. (Nasdaq: DCTH) announced the closing of a private placement, raising gross proceeds of approximately $5.0 million. The offering included the sale of 690,954 shares of common stock at $3.98 each and 566,751 pre-funded warrants priced at $3.97, with an exercise price of $0.01. Proceeds will be utilized for working capital and corporate purposes. The securities are not registered and cannot be offered without prior SEC registration. Delcath is focused on interventional oncology treatments for liver cancers through its proprietary systems.
Delcath Systems, Inc. (Nasdaq: DCTH) announced a securities purchase agreement for a private placement to accredited investors, aiming to raise approximately $5.0 million. The company will sell 690,954 shares of common stock at $3.98 per share or 566,761 pre-funded warrants at $3.97 each, with an exercise price of $0.01. The proceeds will support working capital and other corporate purposes. The transaction is expected to close around July 20, 2022, pending customary conditions.
Delcath Systems (Nasdaq: DCTH) announced promising initial results from the Phase 1b CHOPIN trial, where 85.7% showed Best Overall Response and a 100% Disease Control Rate in patients with advanced uveal melanoma. The median progression-free survival reached 22.4 months with all seven patients alive at follow-up. Additionally, updates on the FOCUS trial revealed consistent interim efficacy data, while a quality of life analysis presented no significant overall changes post-treatment. These results underline the potential of Delcath's percutaneous hepatic perfusion therapy as a viable option for challenging cancer cases.
Delcath Systems reported first-quarter 2022 results, highlighting a net loss of $8.2 million, up from $6.7 million year-over-year. Total revenue remained static at $0.3 million, primarily from CHEMOSAT sales in Europe. R&D expenses increased to $4.2 million, while SG&A expenses rose to $3.6 million. Notably, the company plans to file an NDA for HEPZATO in Q3 2022 following a pre-NDA meeting with the FDA. Additionally, data from a recent study showed a hepatic disease control rate of 88.9% for CHEMOSAT among uveal melanoma patients.
Delcath Systems, Inc. (Nasdaq: DCTH) announced the acceptance of a poster presentation for the FOCUS Phase 3 Trial results at the upcoming ASCO 2022 Annual Meeting in Chicago, running from June 3-7, 2022. The session will focus on the use of Percutaneous Hepatic Perfusion (PHP) with Melphalan in patients with liver metastases from ocular melanoma. The presentation, led by Dr. Jonathan Zager, is scheduled for June 6, 2022.
Delcath's PHP system is designed for targeted high-dose chemotherapy delivery to the liver, addressing unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, a leader in interventional oncology, announced a conference call to discuss its Q1 2022 financial results. The event is scheduled for May 10, 2022, at 8:30 AM ET. Participants can join by dialing in or via webcast. Delcath’s proprietary PHP system delivers high-dose chemotherapy specifically for liver cancers, including metastatic ocular melanoma, under the brand names HEPZATO in the U.S. and CHEMOSAT in Europe. This innovative approach minimizes systemic exposure while targeting cancer effectively, highlighting the company's commitment to advancing cancer treatment.
Delcath Systems, traded as DCTH, will participate in the Canaccord Genuity Horizons in Oncology Conference on April 14, 2022, at 3:00 PM ET. The event will feature a fireside chat and management will engage in virtual one-on-one meetings. Delcath focuses on treating liver cancers using its proprietary percutaneous hepatic perfusion (PHP) system, currently under development in the U.S. as HEPZATO KIT for metastatic ocular melanoma. In Europe, the PHP system is approved as CHEMOSAT to treat various liver cancers.
Delcath Systems, focused on interventional oncology, will participate in the Lytham Partners Spring 2022 Investor Conference. Key events include a presentation on April 4, 2022, at 11:00am ET, and a panel discussion on April 5, 2022, at 2:00pm ET, addressing technologies in cancer treatment. The company is known for its proprietary percutaneous hepatic perfusion system aimed at treating liver cancers, notably under the names HEPZATO in the U.S. and CHEMOSAT in Europe.
Delcath Systems reported its business highlights and financial results for Q4 and full-year 2021 on March 25, 2022. The company updated positive Phase 3 trial results for the HEPZATO Kit, confirmed a mid-year NDA resubmission to the FDA, and resumed sales of CHEMOSAT in Europe. Q4 product revenue was approximately $0.2 million, with a net loss of $5.3 million, an improvement from Q4 2020. For the year, product revenue totaled $1.3 million, while the net loss increased to $25.6 million. As of December 31, 2021, cash and equivalents totaled $27 million.
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