On August 5, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the second quarter ended June 30, 2024 (Press release, Delcath Systems, AUG 5, 2024, View Source [SID1234645337]).
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Recent Business Highlights
Recognized second quarter 2024 revenues of $6.6 million from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.2 million in CHEMOSAT sales;
Activated three HEPZATO KIT treating centers in the US during the second quarter with an additional center in July for a total of eight active treating centers. Two additional centers have completed the necessary steps and have scheduled their first treatments in August. An additional four centers are ready to conduct their first commercial treatment and are currently in the process of scheduling patients for treatment;
Received New Technology Add-on Payment status (NTAP) on August 1, 2024 for HEPZATO from the Centers for Medicare & Medicaid Services (CMS) which provides hospitals additional payments to cover the costs associated with the treatment for cases in the inpatient setting. While HEPZATO KIT is used primarily in the outpatient setting, there are instances where it is used in the inpatient setting;
Published key results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma in the journal Annals of Surgical Oncology;
Announced the acceptance of the FOCUS study efficacy analysis as a poster presentation at the upcoming ESMO (Free ESMO Whitepaper) conference to be held September 2024;
Reported that independent investigators at the Leiden University have enrolled 70 of the total 76 patients planned in the Phase 2 part of the CHOPIN trial which is evaluating the effect of sequencing Immunotherapy with CHEMOSAT liver directed therapy;
Executed an amendment with Synerx Pharma, LLC and Mylan Teoranta for Delcath’s supply of melphalan hydrochloride which extends the term of the original agreement to December 31, 2028;
Appointed Dr. Bridget Martell to the Company’s Board of Directors effective May 23, 2024;
Submitted the final principal payment due to Avenue Venture Opportunities Fund, L.P. (Avenue) on August 1, 2024 for the Loan and Security Agreement entered into in August 2021; and
Ended the quarter with cash and investments of $19.9 million
"We are excited about the continued adoption of the HEPZATO KIT and the positive feedback from physicians," said Gerard Michel, Delcath’s Chief Executive Officer. "We are optimistic that HEPZATO KIT will become a key part of the therapeutic approach for metastatic uveal melanoma patients."
Second Quarter 2024 Results
Total revenue for the quarter ended June 30, 2024 was $7.8 million compared to $0.5 million for the same period in the prior year. Revenues include sales of $6.6 million of HEPZATO in the U.S. and $1.2 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ended June 30, 2024, were $3.4 million compared to $3.6 million for the same period in the prior year. The change in research and development expenses is primarily due to lower costs associated with NDA submission incurred in previous periods offset by an increase in medical affairs and regulatory costs associated with an approved product.
Selling, general and administrative expenses for the quarter ended June 30, 2024, were $6.8 million compared to $4.8 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.
Cash, cash equivalents and investment totaled $19.9 million as of June 30, 2024.
Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.
Event Date:
Monday, August 5, 2024
Time:
4:30 PM Eastern Time
Participant Numbers
Toll Free:
1-877-407-3982
International:
1-201-493-6780
Webcast:
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A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website: View Source