Welcome to our dedicated page for Delcath Sys news (Ticker: DCTH), a resource for investors and traders seeking the latest updates and insights on Delcath Sys stock.
The Delcath Systems Inc (DCTH) news page on Stock Titan aggregates company announcements, clinical updates, and financial disclosures for this interventional oncology business focused on primary and metastatic liver cancers. Delcath’s communications frequently highlight developments related to its proprietary hepatic delivery technologies, HEPZATO KIT and the CHEMOSAT Hepatic Delivery System for Melphalan, which are used in percutaneous hepatic perfusion (PHP) procedures.
Investors and observers can use this news feed to follow earnings reports and financial updates, including quarterly and preliminary revenue results, product revenue from HEPZATO KIT in the United States and CHEMOSAT in Europe, gross margin commentary, and discussions of non-GAAP measures such as adjusted EBITDA. The company also issues releases on capital allocation and corporate actions, such as authorization of share repurchase programs and equity inducement grants under stock incentive plans.
A significant portion of Delcath’s news flow centers on clinical and scientific developments. Recent announcements describe subgroup analyses from the Phase 3 FOCUS study of Melphalan/Hepatic Delivery System in unresectable metastatic uveal melanoma, the Phase 2 CHOPIN trial evaluating CHEMOSAT with ipilimumab and nivolumab, real-world evidence from retrospective analyses of metastatic uveal melanoma patients, and a 10-year single-center experience with CHEMOSAT in liver-dominant disease. The company also highlights expert narrative reviews discussing PHP with melphalan using HEPZATO KIT, including patient selection, technique, and outcomes.
Additional updates include participation in investor conferences and scheduling of earnings calls, providing context for how Delcath communicates with the capital markets. For users tracking DCTH, this page offers a centralized view of regulatory, clinical, and financial news that shapes the company’s progress in liver-directed oncology therapies. Bookmark this feed to monitor new data releases, product-related publications, and ongoing disclosures from Delcath Systems Inc.
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.
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.