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Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
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.
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.