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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.
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Delcath Systems (NASDAQ: DCTH) announced an amendment to its loan agreement with Avenue Venture Opportunities Fund, allowing for an interest-only period from March 31, 2023 to September 30, 2023. This defers approximately $4.3 million in principal payments. The company may extend this period to December 31, 2023 if it secures FDA approval for the HEPZATO Kit and raises at least $10 million through equity sales. Delcath will issue 34,025 warrants to Avenue with an exercise price of $0.01. This support aims to enhance the company's cash runway ahead of its PDUFA date on August 14, 2023.
Delcath Systems, Inc. (Nasdaq: DCTH) has completed a $25 million private placement with the potential for an additional $60 million based on milestone achievements. The financing, led by Vivo Capital and supported by various investors, is intended to fund operations through the anticipated FDA PDUFA date of August 14, 2023 for its product HEPZATO. The total proceeds are expected to cover working capital and general corporate purposes, with warrants providing further potential funding. The deal enables funding for commercialization if HEPZATO receives approval.
Delcath Systems, Inc. (DCTH) announced its fourth quarter and full year 2022 results, emphasizing significant milestones, including FDA acceptance of the NDA resubmission for Hepzato Kit® with a PDUFA date of August 14, 2023. The company secured $25 million in upfront financing, with potential additional funding of up to $60 million. Product revenue increased to $0.6 million in Q4 2022, up from $0.2 million in Q4 2021. However, Delcath reported a net loss of $8.5 million in Q4 2022, increasing its annual net loss to $36.5 million. As of December 31, 2022, cash holdings decreased to $11.8 million from $26.9 million the previous year.
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.