Delcath Systems Announces Q2 2024 Results and Business Highlights

Delcath Systems, Inc. (Nasdaq: DCTH), a company specializing in interventional oncology with a focus on liver cancer treatments, has announced its financial results and business developments for the second quarter ending June 30, 2024.

Recent Business Developments

Delcath Systems reported revenues of $6.6 million from its HEPZATO KIT™ (melphalan/Hepatic Delivery System) and $1.2 million from CHEMOSAT sales in Q2 2024. The company has activated three new centers for HEPZATO KIT treatment in the US during the second quarter and added another in July, totaling eight active centers. Two additional centers are ready to begin treatments in August, and four more centers are in the process of scheduling patients.

On August 1, 2024, HEPZATO received New Technology Add-on Payment status (NTAP) from the Centers for Medicare & Medicaid Services (CMS), which allows hospitals to receive additional payments to cover treatment costs in inpatient settings. Despite HEPZATO KIT's primary use in outpatient settings, it occasionally sees inpatient use.

Key results from the pivotal Phase 3 FOCUS study on HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma were published in the Annals of Surgical Oncology. Additionally, the FOCUS study's efficacy analysis will be presented as a poster at the ESMO conference in September 2024.

At Leiden University, 70 out of 76 planned patients have been enrolled in the Phase 2 CHOPIN trial, which examines the sequential use of Immunotherapy with CHEMOSAT liver-directed therapy.

An amendment was executed with Synerx Pharma, LLC and Mylan Teoranta extending the supply agreement for melphalan hydrochloride to December 31, 2028. Furthermore, Dr. Bridget Martell was appointed to the Board of Directors effective May 23, 2024.

The final principal payment for the Loan and Security Agreement with Avenue Venture Opportunities Fund, L.P., entered in August 2021, was submitted on August 1, 2024. Delcath ended the quarter with $19.9 million in cash and investments.

Financial Results for the Second Quarter 2024

For the quarter ending June 30, 2024, Delcath Systems reported total revenue of $7.8 million, a significant increase from $0.5 million in the same period the previous year. This included $6.6 million from HEPZATO sales in the U.S. and $1.2 million from CHEMOSAT in Europe.

Research and development expenses were $3.4 million, a slight decrease from $3.6 million in the prior year, primarily due to diminished costs associated with NDA submissions. However, there were increased costs related to medical affairs and regulatory needs for the approved product.

Selling, general, and administrative expenses rose to $6.8 million from $4.8 million in the same period the previous year. This increase is attributed to commercial launch activities, including marketing and additional personnel in the commercial team.

Company Overview

Delcath Systems, Inc. specializes in the treatment of primary and metastatic liver cancers through its proprietary products, HEPZATO KIT™ and CHEMOSAT®. The HEPZATO KIT is a combination drug and device, regulated and approved in the United States by the FDA. It is designed to deliver high-dose chemotherapy to the liver while minimizing systemic exposure and side effects. The HEPZATO KIT is approved for treating adult patients with metastatic uveal melanoma with unresectable liver metastases.

In Europe, the CHEMOSAT device is approved as a Class III medical device used in percutaneous hepatic perfusion procedures at major medical centers to treat various liver cancers.

Gerard Michel, Delcath’s CEO, expressed optimism about the adoption of HEPZATO KIT and its potential to become a significant part of the therapeutic approach for metastatic uveal melanoma patients.

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