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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) has announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™. This approval, effective from October 1, 2024, will support the adoption of this innovative liver-directed therapy under the CMS Inpatient Prospective Payment System.
The NTAP designation will help cover costs associated with HEPZATO KIT for eligible Medicare inpatients, ensuring broader access to this treatment. The HEPZATO KIT is a combination product that delivers high-dose chemotherapy directly to the liver while minimizing systemic exposure, indicated for treating adult patients with unresectable hepatic-dominant metastatic uveal melanoma.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company focusing on liver cancer treatments, has announced its participation in two upcoming investor conferences. The company will attend the BTIG Virtual Biotechnology Conference on August 6, 2024, which will be held virtually. Additionally, Delcath will present at Canaccord Genuity's 44th Annual Growth Conference on August 14, 2024, at 9:30 am Eastern Time in Boston, MA.
These conferences provide Delcath Systems with opportunities to showcase its advancements in liver cancer treatment and engage with investors. The company's participation in both virtual and in-person events demonstrates its commitment to maintaining strong investor relations and promoting its innovative oncology solutions.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced its upcoming second quarter 2024 earnings call. The call is scheduled for August 5, 2024, at 4:30 PM Eastern Time. Investors and interested parties can participate by dialing the provided toll-free or international numbers. A webcast of the call will also be available, with a replay accessible on the company's website shortly after the event concludes.
This earnings call will provide insights into Delcath's financial performance and operational updates for the quarter ended June 30, 2024. As a company focused on innovative liver cancer treatments, the call may offer valuable information on Delcath's progress in the oncology field and its market position.
Delcath Systems (Nasdaq: DCTH) reported its Q1 2024 financial results and business highlights on May 14, 2024. The company recognized $3.1 million in total revenue, a significant increase from $0.6 million in Q1 2023, driven by sales of HEPZATO KIT and CHEMOSAT. Delcath updated its U.S. center activation guidance to 20 by end of 2024, activated six new centers, and has five more preparing for activation. The company raised $7.0 million in a private placement and has cash reserves totaling $27.2 million.
Delcath appointed Martha S. Rook, Ph.D., as COO and received a permanent J-code and pass-through payment status for HEPZATO KIT from CMS effective April 1, 2024. Research and development expenses decreased to $3.7 million, while selling, general, and administrative expenses rose to $8.8 million, mainly due to commercial launch activities. The company also published pivotal Phase 3 FOCUS study results on HEPZATO KIT for treating unresectable metastatic Uveal Melanoma in the Annals of Surgical Oncology.
Delcath Systems, Inc. (Nasdaq: DCTH) will host a conference call on May 14, 2024, to discuss first quarter results. The company focuses on interventional oncology for liver cancers.
Delcath Systems, an interventional oncology company, announced positive results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma. The study showed a significantly higher Overall Response Rate of 36.3% compared to historical controls, with a Disease Control Rate of 73.6% and a Complete Response Rate of 7.7%. Secondary endpoints included Duration of Response, Progression-free Survival, and Overall Survival. The study also reported comparable safety and tolerability with no treatment-related deaths.
Delcath Systems, Inc. (Nasdaq: DCTH) granted equity awards to two individuals as inducements for employment, totaling 33,000 shares of common stock, with an exercise price of $5.20. The options vest over a 24-month period and have a ten-year term, subject to continued employment.
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