Delcath Sys Stock Price, News & Analysis

Delcath Systems has secured $25 million in upfront financing, with potential additional funding of $60 million based on milestone achievements, totaling up to $85 million.

This capital will support the company through the anticipated PDUFA date of August 14, 2023 for HEPZATO approval and its commercialization efforts. Key investors include Vivo Capital and Logos Capital. The financing involves issuing Series F Convertible Preferred Stock and warrants, contingent on shareholder approval for conversions. Canaccord Genuity served as placement agent for this private placement.

Delcath Systems, Inc. (NASDAQ: DCTH) announced the FDA has accepted its resubmission of a new drug application for the HEPZATO™ Kit, aimed at treating unresectable hepatic-dominant metastatic ocular melanoma. This acceptance is deemed a complete class 2 response, with a PDUFA date set for August 14, 2023. The HEPZATO Kit combines melphalan and a hepatic delivery system to optimize cancer treatment while minimizing systemic exposure. The CEO expressed optimism regarding the potential approval of HEPZATO as a significant treatment option for patients. However, the drug’s efficacy has yet to be established in the U.S.

Delcath Systems (NASDAQ: DCTH) has appointed John R. Sylvester as its new Chairman, succeeding Dr. Roger Stoll, who has served since October 2015. Sylvester, a director since July 2019, brings extensive experience in interventional oncology, previously leading Curium's SPECT and International business units. Dr. Stoll will remain on the board. CEO Gerard Michel highlighted Sylvester's commercial expertise as the company prepares for the US launch of its HEPZATO Kit, which recently underwent a new drug application resubmission to the FDA for treating unresectable hepatic-dominant metastatic ocular melanoma.

Delcath Systems, Inc. (NASDAQ: DCTH) has resubmitted a New Drug Application (NDA) to the FDA for the HEPZATO™ Kit, aimed at treating unresectable hepatic-dominant metastatic ocular melanoma (mOM). This action addresses the issues raised in a Complete Response Letter from September 2013. A decision from the FDA is anticipated within 30 days. The NDA includes data from the FOCUS trial, showing a 36.3% overall response rate and a median overall survival of 20.53 months among treated patients. The HEPZATO Kit employs a unique delivery system designed to minimize systemic exposure to the drug while effectively targeting liver tumors.

Delcath Systems, Inc. (NASDAQ: DCTH) is set to participate in the BTIG MedTech, Digital Health, Life Sciences, & Diagnostics Tools Conference from February 14 to 16, 2023, in Snowbird, Utah. CEO Gerard Michel will hold one-on-one meetings during the event. The company specializes in treating primary and metastatic liver cancers, utilizing its percutaneous hepatic perfusion (PHP) system to deliver high-dose chemotherapy while minimizing side effects. In the U.S., the PHP system is under development as HEPZATO™ KIT for metastatic ocular melanoma, while in Europe, it's marketed as CHEMOSAT.

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.