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Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.
HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.
In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.
Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.
Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.
As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.
Delcath Systems (NASDAQ: DCTH) announced an amendment to its loan agreement with Avenue Venture Opportunities Fund, allowing for an interest-only period from
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
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.
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