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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 (DCTH) has secured a debt facility of up to $20 million from Avenue Venture Fund, with an initial $15 million funded at closing. This financing aims to support the upcoming NDA filing for HEPZATO™, targeting the treatment of hepatic-dominant metastatic ocular melanoma, anticipated in early 2022. CEO Gerard Michel expressed optimism regarding the partnership, which will aid in advancing Delcath's innovative cancer treatment approaches.
Delcath Systems, Inc. (Nasdaq: DCTH) announced its participation in two key conferences. The BTIG Virtual Biotechnology Conference is set for August 9, 2021, from 10:00-10:25 AM ET, featuring management-led 1x1 investor meetings. The Canaccord Genuity 41st Annual Growth Conference will follow on August 11, 2021, at 10:00 AM ET, with a webcast available at this link. Delcath specializes in treating liver cancers through its proprietary PHP system.
Delcath Systems, Inc. (Nasdaq: DCTH) will host a conference call on August 10, 2021, at 8:30 AM ET to discuss its second-quarter results for the period ending June 30, 2021. The call will be accessible via phone and online. Delcath focuses on providing innovative treatments for rare liver cancers through its proprietary PHP system, which allows high-dose chemotherapy directly to the liver, minimizing systemic side effects. In Europe, the PHP system is marketed as CHEMOSAT, while in the U.S., it is under the name HEPZATO KIT.
Delcath Systems, focused on interventional oncology for liver cancers, will present at the Access to Giving Virtual Conference on July 13, 2021, at 3 p.m. ET. CEO Gerard Michel will lead the discussion. This conference allows companies to engage with investors while supporting charitable causes. Registration is free and can be done online. Delcath’s investigational product, HEPZATO KIT, aims to deliver high-dose chemotherapy to the liver, although it is not approved by the FDA in the U.S. The system is marketed in Europe as Delcath CHEMOSAT.
Delcath Systems is set to join the Russell Microcap® Index on June 28, 2021, following the annual reconstitution. This membership will remain for one year and includes automatic inclusion in growth and value style indexes. The CEO, Gerard Michel, emphasized that this milestone enhances the company's visibility among investors. Russell indexes manage approximately $10.6 trillion in assets, being widely used by institutional investors for benchmarking. Delcath focuses on treating liver cancers using its proprietary PHP system, marketed as HEPZATO in the US and CHEMOSAT in Europe.
Delcath Systems (DCTH) reported positive preliminary results from its FOCUS Phase III trial for HEPZATO in treating liver-dominant metastatic ocular melanoma. The study achieved a significant overall response rate of 29.2%, exceeding the prespecified 8.3% threshold. Notably, 44% of patients treated with HEPZATO demonstrated a 30% or greater reduction in tumor size, compared to only 17% in the Best Alternative Care arm. The company will hold a Q&A webinar to discuss these findings further.
Delcath Systems, focused on interventional oncology, announced its management will present at the LD Micro Virtual Investor Conference on June 10, 2021, at 2:30 p.m. ET. This event will feature a live audio webcast accessible through their official link. Delcath’s investigational product, HEPZATO KIT, aims to treat primary and metastatic liver cancers by delivering high-dose chemotherapy while minimizing systemic exposure. Although not FDA-approved in the U.S., it is marketed in Europe under the CHEMOSAT name and has been CE Marked for use.
Delcath Systems (DCTH) announced management will present at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 4:00 PM (ET). The event provides a platform for showcasing Delcath's focus on treating rare primary and metastatic liver cancers using their investigational product, HEPZATO KIT, designed for high-dose chemotherapy delivery to the liver. While the HEPZATO KIT is not yet FDA-approved, it is marketed in Europe as CHEMOSAT, used in major medical centers. For more details, visit their conference page linked in the announcement.
Delcath Systems reported Q1 2021 financial results with product revenue at $0.4 million, up from $0.3 million in Q1 2020. The company posted a net loss of $6.8 million, a decline from net income of $7.9 million in the same period last year. Cash and equivalents stood at $26.7 million, significantly higher than $4.7 million a year prior. Notably, preliminary results from the FOCUS Clinical Trial show positive outcomes for HEPZATO in treating hepatic dominant ocular melanoma, with a statistically significant overall response rate exceeding the success threshold.
Delcath Systems, Inc. (DCTH) announced a conference call scheduled for May 11, 2021, to discuss its first-quarter results ending March 31, 2021. The call is set for 8:30 AM ET, and participants can join via phone or online. Delcath specializes in interventional oncology, focusing on rare liver cancers with its investigational product, HEPZATO KIT, designed for targeted chemotherapy delivery. While HEPZATO KIT is not FDA-approved in the U.S., it is CE-marked in Europe. The company has paused its ALIGN Trial for intrahepatic cholangiocarcinoma to reevaluate the trial's design.
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