Robinhood shares gain on Q2 beat, as user and crypto growth accelerate
NEW YORK - Delcath Systems, Inc. (NASDAQ:DCTH), a company specializing in interventional oncology, has announced the results of an independent study published in the European Society for Medical Oncology journal of Gastrointestinal Oncology. The study, conducted by the University Hospital of Leipzig, Germany, evaluates the efficacy and safety of Delcath's CHEMOSAT Hepatic Delivery System for patients with primary or secondary liver tumors.
The retrospective study included 33 patients with unresectable intrahepatic metastases from various cancers, including uveal melanoma, cholangiocarcinoma, hepatocellular carcinoma, among others. Seven of these patients also had limited extrahepatic disease, which did not significantly impact overall survival.
Key findings revealed a high disease control rate (DCR) of 91%, with 30 patients experiencing objective tumor response or stable disease. Six patients achieved complete response in the liver after a median of five treatment cycles. Median hepatic progression-free survival (hPFS) was 52 weeks, with even longer median hPFS observed in patients with uveal melanoma and cholangiocarcinoma.
The study also highlighted the importance of repeated treatments with CHEMOSAT, akin to systemic chemotherapy, which contributed to long-term disease control and was well tolerated by patients. The safety profile was consistent with existing literature, with most adverse events being transient hematological issues managed with supportive care. There were no significant liver damages reported, even in those undergoing multiple treatments. Two patients discontinued due to adverse events, and two withdrew consent.
Dr. Vojislav Vukovic, Chief Medical Officer of Delcath, commented on the significance of the study, emphasizing the potential of CHEMOSAT as a vital tool in managing liver tumors, especially for patients with limited treatment options.
Delcath's proprietary products, including HEPZATO KIT and CHEMOSAT, are designed to administer high-dose chemotherapy directly to the liver while minimizing systemic exposure. In the U.S., HEPZATO KIT is approved for sale by the FDA for adult patients with metastatic uveal melanoma with specific criteria.
This news is based on a press release statement, and the publication of the study can be accessed through medical literature.
In other recent news, Delcath Systems has reported a significant surge in its Q2 2024 revenue, totaling $7.8 million, driven by the success of its products HEPZATO and CHEMOSAT. The company's U.S. revenue from HEPZATO stood at $6.6 million, while European revenue from CHEMOSAT was $1.2 million. Furthermore, Delcath Systems has received New Technology Add-on Payment status for HEPZATO from CMS, which is expected to significantly enhance U.S. revenue.
The company is in a robust financial position, boasting $19.9 million in cash and investments, which supports its strategic focus on clinical trials and market expansion. Delcath Systems aims to increase active treatment sites from seven to 20 by the end of 2024 and anticipates achieving $10 million in quarterly U.S. revenue by Q4 2024.
Despite some challenges, including unpredictable activation times for patients and fewer procedures performed per month than expected at some centers, the company remains optimistic about its future. Delcath Systems plans to initiate clinical studies for HEPZATO in additional indications within the next six months and aims to be cash flow positive by Q1 2025. These are the recent developments that investors should keep an eye on.
InvestingPro Insights
Delcath Systems, Inc. (NASDAQ:DCTH) has recently been in the spotlight due to promising results from an independent study regarding its CHEMOSAT Hepatic Delivery System. As the company garners attention for its innovative oncology treatments, InvestingPro data provides a deeper look into Delcath's financial health and market performance.
InvestingPro data reveals a striking 350.44% revenue growth over the last twelve months as of Q2 2024, underlining the company's expanding operational scale. This growth is further emphasized by a quarterly revenue increase of 1468.89% in Q2 2024. Despite these impressive growth figures, Delcath is trading at a Price / Book multiple of 53.5, which is considered high and may reflect market optimism about the company's future prospects.
One InvestingPro Tip highlights that Delcath's liquid assets exceed short-term obligations, which suggests a stable financial position in terms of liquidity. Another key insight from InvestingPro Tips is that four analysts have revised their earnings upwards for the upcoming period, indicating a positive sentiment among experts about the company's earnings potential. It's worth noting that Delcath is not expected to be profitable this year, but the high return over the last year and a large price uptick in the past six months reflect investor confidence.
For those interested in further analysis and additional insights, there are more InvestingPro Tips available at https://www.investing.com/pro/DCTH that can help investors make informed decisions about Delcath Systems, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.