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Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
Delcath Systems (Nasdaq: DCTH) reported Q2 2024 results, with total revenue of $7.8 million, including $6.6 million from HEPZATO KIT™ sales in the US and $1.2 million from CHEMOSAT sales in Europe. The company activated three new HEPZATO KIT treating centers in Q2, bringing the total to eight active centers. Delcath received New Technology Add-on Payment status for HEPZATO from CMS, published key results from the Phase 3 FOCUS study, and announced the acceptance of the FOCUS study efficacy analysis for presentation at the upcoming ESMO conference. The company ended the quarter with $19.9 million in cash and investments.
R&D expenses were $3.4 million, down from $3.6 million in Q2 2023, while SG&A expenses increased to $6.8 million from $4.8 million, primarily due to commercial launch activities. CEO Gerard Michel expressed optimism about HEPZATO KIT's adoption and its potential as a key therapeutic approach for metastatic uveal melanoma patients.
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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