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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 the granting of an equity award as an inducement for employment to an individual. The award consists of 12,500 shares of common stock outside its 2020 Stock Incentive Plan, with an exercise price equal to the closing stock price on the grant date. A third of the options will vest after one year, with the remainder vesting monthly over two years. This action complies with NASDAQ Listing Rule 5635(c)(4). Delcath specializes in interventional oncology for liver cancers, notably using the PHP system for treating unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, Inc. (Nasdaq: DCTH) has successfully closed a private placement, raising approximately $6.2 million. The placement involved issuing 1,448,889 shares of common stock at $2.90 per share, and 692,042 pre-funded warrants at $2.89, with an exercise price of $0.01. Proceeds will be used for working capital and corporate purposes. The securities sold are unregistered and Delcath plans to file for registration with the SEC. The company is focused on treating liver cancers via its proprietary PHP system, known as HEPZATO in the U.S. and CHEMOSAT in Europe.
Delcath Systems, Inc. (Nasdaq: DCTH) has announced a private placement transaction, raising approximately $6.2 million. The company will issue 1,448,889 shares of common stock at $2.90 per share, or 692,042 pre-funded warrants at $2.89 each. The proceeds will support working capital and other corporate needs. The issuance is not registered under the Securities Act and is subject to customary closing conditions. Delcath specializes in treating liver cancers with its proprietary PHP system, marketed as HEPZATO in the U.S. and CHEMOSAT in Europe.
Delcath Systems announces findings from a study showing that CHEMOSAT is a promising treatment for patients with advanced cholangiocarcinoma (CCA). Conducted on 17 patients, the study revealed a 25% overall response rate and a 75% disease control rate after 42 PHP procedures. The median survival post-treatment was 9.9 months, significantly longer than traditional options. While treatment presented minor and manageable side effects, the results affirm PHP’s potential in extending life for inoperable cases, making it a valuable palliative option.
Delcath Systems (Nasdaq: DCTH) announced the granting of equity awards as an inducement for employment to two individuals. A total of 40,000 shares of common stock were issued, with an exercise price based on the closing stock price on the grant date. The vesting schedule includes one-third of the options vesting on the first anniversary, followed by equal monthly installments over 24 months. These awards comply with NASDAQ Listing Rule 5635(c)(4) and were made per the company's amended stock incentive plan.
Delcath Systems, Inc. (DCTH) reported its third-quarter results on November 8, 2022, showing a total revenue of approximately $0.9 million, up from $0.5 million year-over-year, attributed to direct sales of CHEMOSAT in Europe. R&D expenses rose to $4.0 million from $3.0 million, driven by NDA filing preparations. The net loss increased to $8.5 million, or $0.92 per share, compared to $7.1 million, or $0.94 per share, in the previous year. The company raised $5 million through private placement, strengthening its balance sheet amidst ongoing developments for the Hepzato Kit NDA resubmission by year-end.
Delcath Systems, Inc. (Nasdaq: DCTH), specializing in interventional oncology, will host a conference call on November 8, 2022, at 8:30 AM ET to discuss its third quarter results for the period ending September 30, 2022. The conference will explore the company's proprietary percutaneous hepatic perfusion (PHP) system, designed for administering high-dose chemotherapy to liver cancers. Participants can dial in or join via a webcast link provided in the announcement. A replay will be available until November 15, 2022.
Delcath Systems, an interventional oncology firm focusing on liver cancer treatments, will participate in the H.C. Wainwright 24th Annual Global Investor Conference on September 12, 2022, at 8:30 AM ET. CEO Gerard Michel will present, and a webcast will be available for viewing. The company’s proprietary system, HEPZATO, is designed to administer high-dose chemotherapy for patients with unresectable hepatic-dominant metastatic ocular melanoma in the U.S. The system is also marketed as CHEMOSAT in Europe. One-on-one meetings for investors can be scheduled through Lytham Partners.
Delcath Systems, Inc. (DCTH) reported its Q2 2022 financial results, highlighting a revenue increase to $0.8 million from $0.5 million year-over-year, attributed to direct product sales in Europe. The net loss expanded to $9.7 million, up from $6.4 million in Q2 2021. R&D expenses rose to $5.5 million, driven by NDA preparations. The company raised $5 million through a private placement aimed at funding working capital. Delcath plans to resubmit the NDA for the Hepzato Kit in Q3 2022, with a PDUFA date anticipated in early 2023.
Delcath Systems has announced a retrospective study revealing a 59.4% objective response rate and 89.1% disease control rate in metastatic uveal melanoma patients treated with the CHEMOSAT system. The study, conducted in Europe from 2014 to 2019, included 101 patients. Results indicate that complete, partial, or stable disease correlates with improved survival, with a median overall survival of 20 months. Notably, the study supports the efficacy of PHP in managing liver-dominant metastatic cancers.
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