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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, Inc. (DCTH) has published updated results from the Phase 1b CHOPIN Trial for treating advanced uveal melanoma with a combination of Delcath's CHEMOSAT and immune checkpoint inhibitors ipilimumab and nivolumab. The study, conducted at Leiden University Medical Center, showed a median progression-free survival (PFS) of 29.1 months, with all seven patients still alive at follow-up. The trial has demonstrated an 85.7% objective response rate and a 100% disease control rate. The ongoing Phase 2 part of the trial aims to further validate these findings with 76 additional patients enrolled.
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.