Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company specializing in treating primary and metastatic liver cancers, has announced its financial results and business highlights for the second quarter ended June 30, 2024.
Recent Business Highlights
- Revenues: For Q2 2024, Delcath reported $6.6 million in sales from HEPZATO KIT™ and $1.2 million from CHEMOSAT.
- Expansion: Three new HEPZATO KIT treating centers were activated in the US during the quarter, with an additional center added in July. This brings the total to eight active centers. Two more centers are scheduled to begin treatments in August, and four additional centers are preparing for their first commercial treatments.
- NTAP Status: On August 1, 2024, Delcath received New Technology Add-on Payment (NTAP) status from the Centers for Medicare & Medicaid Services (CMS) for HEPZATO, which provides extra payments for inpatient use, though HEPZATO is mainly used in outpatient settings.
- Research Publications: Key results from the Phase 3 FOCUS study of HEPZATO KIT for unresectable metastatic Uveal Melanoma were published in the Annals of Surgical Oncology.
- Conference Presentation: The FOCUS study’s efficacy analysis will be presented as a poster at the ESMO conference in September 2024.
- CHOPIN Trial Enrollment: Leiden University investigators have enrolled 70 out of 76 patients in the Phase 2 CHOPIN trial, which studies the sequencing of Immunotherapy with CHEMOSAT.
- Supply Agreement: Delcath amended its agreement with Synerx Pharma, LLC and Mylan Teoranta to extend the supply of melphalan hydrochloride through December 31, 2028.
- Board Appointment: Dr. Bridget Martell was appointed to Delcath’s Board of Directors effective May 23, 2024.
- Debt Repayment: The final principal payment was made to Avenue Venture Opportunities Fund, L.P. on August 1, 2024, for the Loan and Security Agreement from August 2021.
- Financial Position: Delcath ended the quarter with $19.9 million in cash and investments.
“We are thrilled with the ongoing adoption of the HEPZATO KIT and the positive feedback from physicians,” said Gerard Michel, Delcath’s CEO. “We are hopeful that HEPZATO KIT will become a vital component in treating metastatic uveal melanoma patients.”
Second Quarter 2024 Financial Results
- Total Revenue: For the quarter ending June 30, 2024, Delcath reported $7.8 million in revenue, a significant increase from $0.5 million in the same period last year. This includes $6.6 million from HEPZATO in the U.S. and $1.2 million from CHEMOSAT in Europe.
- R&D Expenses: Research and development costs were $3.4 million, down from $3.6 million the previous year. The decrease reflects lower costs from earlier NDA submissions, offset by increased medical affairs and regulatory expenses for the approved product.
- SG&A Expenses: Selling, general, and administrative expenses rose to $6.8 million from $4.8 million, mainly due to costs related to commercial launch activities, including marketing and additional personnel.
- Cash Position: As of June 30, 2024, cash, cash equivalents, and investments totaled $19.9 million.
