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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, 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.
Delcath Systems reported first-quarter 2022 results, highlighting a net loss of $8.2 million, up from $6.7 million year-over-year. Total revenue remained static at $0.3 million, primarily from CHEMOSAT sales in Europe. R&D expenses increased to $4.2 million, while SG&A expenses rose to $3.6 million. Notably, the company plans to file an NDA for HEPZATO in Q3 2022 following a pre-NDA meeting with the FDA. Additionally, data from a recent study showed a hepatic disease control rate of 88.9% for CHEMOSAT among uveal melanoma patients.
Delcath Systems, Inc. (Nasdaq: DCTH) announced the acceptance of a poster presentation for the FOCUS Phase 3 Trial results at the upcoming ASCO 2022 Annual Meeting in Chicago, running from June 3-7, 2022. The session will focus on the use of Percutaneous Hepatic Perfusion (PHP) with Melphalan in patients with liver metastases from ocular melanoma. The presentation, led by Dr. Jonathan Zager, is scheduled for June 6, 2022.
Delcath's PHP system is designed for targeted high-dose chemotherapy delivery to the liver, addressing unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, a leader in interventional oncology, announced a conference call to discuss its Q1 2022 financial results. The event is scheduled for May 10, 2022, at 8:30 AM ET. Participants can join by dialing in or via webcast. Delcath’s proprietary PHP system delivers high-dose chemotherapy specifically for liver cancers, including metastatic ocular melanoma, under the brand names HEPZATO in the U.S. and CHEMOSAT in Europe. This innovative approach minimizes systemic exposure while targeting cancer effectively, highlighting the company's commitment to advancing cancer treatment.
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