Delcath Systems Q3 2024 Results and Highlights

Delcath Systems, Inc., a company specializing in interventional oncology, recently announced their financial results and key business milestones for the third quarter ending September 30, 2024. The company, known for their focus on treating primary and metastatic liver cancers, reported significant progress in both financial performance and operational achievements during this period.

For the third quarter of 2024, Delcath Systems reported total revenues of $11.2 million, representing a substantial 44% increase from the previous quarter. This revenue included $10.0 million from sales of the HEPZATO KIT™ (melphalan/Hepatic Delivery System) and $1.2 million from the CHEMOSAT® system. Additionally, Delcath activated four new HEPZATO treatment centers in the United States during the third quarter, followed by an additional center in October, bringing the total to twelve active centers. Another center is scheduled to begin treatments in November, with ten more centers having completed or partially completed the necessary preceptorship training.

One of the significant updates includes the full enrollment of the CHOPIN study, an investigator-initiated research project evaluating the sequencing of immunotherapy with CHEMOSAT liver-directed therapy, which now includes 76 patients. At the end of the third quarter, Delcath had $14.0 million in cash and investments with a quarterly cash burn rate of $3.6 million.

Following the third quarter, Delcath made the final principal and interest payments of $2.8 million on the Rosalind note payable, leaving the company with no outstanding debt obligations. Moreover, the exercise of all remaining Tranche B warrants from the March 2023 PIPE resulted in approximately $25 million in proceeds.

Gerard Michel, CEO of Delcath, expressed satisfaction with the strong market adoption of HEPZATO in the U.S., crediting it to the clinical impact and growing physician confidence. Michel noted that the company’s financial stability and consistent revenue growth have positioned Delcath to expand its development pipeline, particularly for liver-dominant colorectal and breast cancers based on the interest from oncology leaders.

In terms of recent academic contributions, the company presented subgroup analyses data from the FOCUS Phase 3 trial of HEPZATO at the ESMO 2024 conference. The results demonstrated comparable outcomes in terms of overall survival, response rates, and progression-free survival between patients with and without extrahepatic lesions, as well as those based on prior therapy. Tumor responses were observed throughout the treatment period, supporting ongoing treatment strategies until the best response is achieved.

Additionally, several independent investigator-sponsored retrospective studies of HEPZATO and CHEMOSAT were announced. These studies included a 30-patient study at Moffitt Cancer Center in Florida, which indicated improved disease control and progression-free survival in metastatic uveal melanoma with HEPZATO compared to other liver-directed therapies. Another study involving 167 patients from the University of Tübingen in Germany reported that first-line liver-directed therapies significantly improved melanoma-specific survival in patients with liver metastases from uveal melanoma. A third study from the University Hospital of Leipzig, published in the ESMO journal of Gastrointestinal Oncology, reviewed the treatment of 33 patients with unresectable intrahepatic metastases from various cancer types and observed a hepatic disease control rate of 91%, with a median hepatic progression-free survival of 52 weeks.

Financially, Delcath's third quarter results showed a marked improvement, with total revenues reaching $11.2 million compared to $0.4 million in the same period the previous year. This included $10.0 million from U.S. HEPZATO sales and $1.2 million from European CHEMOSAT sales. Research and development expenses decreased to $3.9 million from the previous year's $4.7 million, mainly due to lower costs associated with expanded access protocol, while medical affairs and regulatory costs saw an increase. Selling, general, and administrative expenses rose to $7.0 million from $6.2 million due to commercial launch activities and an increase in personnel.

Delcath Systems successfully made the final principal payment to Avenue Venture Opportunities Fund for a loan agreement from August 2021. As of the end of September 2024, the company had $14.0 million in cash and investments. Post-quarter, the company also settled the final principal and interest payment on the Rosalind note payable and received approximately $25 million from the exercise of Tranche B warrants, leaving Delcath with no outstanding debt obligations.