Delcath Sys Stock Price, News & Analysis

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.

Delcath Systems (DCTH) announces a positive oral presentation at the ASCO Annual Meeting regarding the FOCUS Phase III trial for HEPZATO in treating ocular melanoma liver metastases. The event will occur virtually from June 4-8, 2021, with Dr. Jonathan S. Zager presenting preliminary efficacy results. A Q&A webinar is also scheduled for June 7, 2021, at 8:30 AM ET, where CEO Gerard Michel will discuss the company's strategy and trial outcomes. HEPZATO aims to improve cancer treatment by delivering high-dose chemotherapy directly to the liver, minimizing side effects.

Delcath Systems (Nasdaq: DCTH) announced a significant update from the UK’s NICE, granting CHEMOSAT Hepatic Delivery System a Special Arrangement designation. This change allows increased reimbursement options, enabling private insurance and regional funding for treatments previously limited to research studies. The revised guidance also supports national reimbursement applications. CEO Gerard Michel expressed optimism regarding the availability of CHEMOSAT for patients with liver metastases from ocular melanoma, aligning with positive preliminary results from the FOCUS trial.

Delcath Systems (NASDAQ: DCTH) announced positive preliminary results from the Phase 3 FOCUS trial of HEPZATO KIT for treating liver-dominant metastatic ocular melanoma. A preliminary analysis showed an Overall Response Rate (ORR) of 29.2%, significantly exceeding the required 21.0% threshold for superiority over checkpoint inhibitors. This analysis covered 87% of enrolled patients and demonstrates the drug's efficacy, with a lower bound of 20.1% surpassing the 8.3% upper limit of prior studies. Delcath aims to address liver cancers with its innovative system.

Delcath Systems (NASDAQ: DCTH) announced fourth quarter 2020 results and business highlights on March 31, 2021. The company reported positive preliminary outcomes from the FOCUS Clinical Trial for Hepatic Dominant Ocular Melanoma, with an overall response rate exceeding expectations. Despite a 5% decrease in product revenue to $379K, total cash reserves rose to $28.8 million. The net loss for Q4 2020 was $7 million, a reversal from net income of $12.5 million in Q4 2019. Delcath also strengthened its executive team and completed a public offering, raising $22.2 million.

Delcath Systems (NASDAQ: DCTH) announced encouraging preliminary results from its Phase 3 FOCUS trial of HEPZATO KIT for liver dominant metastatic ocular melanoma, demonstrating an Overall Response Rate (ORR) of 29.2%, surpassing the predefined threshold of 21.0%. Key findings include a median Progression Free Survival of 9.0 months versus 3.1 months for Best Alternative Care (BAC), and a Disease Control Rate of 70.9%. The safety profile aligns with previous studies, noting no new safety signals. Full datasets are anticipated to further evaluate HEPZATO's efficacy and impact on regulatory submissions.

Delcath Systems, Inc. (DCTH) will host a conference call on March 31, 2021, at 8:00 AM Eastern Time to discuss its fourth quarter results for the period ended December 31, 2020. Participants can join by dialing in 5 to 10 minutes early. The company focuses on treating rare liver cancers using its investigational product, HEPZATO KIT, which is designed for high-dose chemotherapy delivery. While CE Marked in Europe as CHEMOSAT, it is not yet approved by the FDA for U.S. sales.

Delcath Systems (DCTH) announced its participation in two upcoming virtual investor conferences. The HC Wainwright Global Life Sciences Conference will occur on March 9, 2021, with on-demand viewing starting at 7:00 AM (ET). A webcast link is available for attendees. Additionally, Delcath will attend the 33rd Annual Roth Conference, scheduled for March 15-17, 2021, allowing for 1x1 meetings only. Delcath focuses on oncology treatments for liver cancers, with its investigational product, HEPZATO KIT, targeting high-dose chemotherapy treatment.