On November 8, 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 third quarter ended September 30, 2024 (Press release, Delcath Systems, NOV 8, 2024, View Source [SID1234648024]).
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Third Quarter and Recent Business Highlights
Total third quarter revenues of $11.2 million, up 44% from the prior quarter, including $10.0 million from HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.2 million from CHEMOSAT;
Activated four HEPZATO treatment centers in the U.S. during the third quarter and one more in October, bringing the total to twelve active centers; another center has scheduled their first treatment in November with a further 10 centers having partially or fully completed preceptorship training;
Reported that CHOPIN, an investigator-initiated study which is evaluating the effect of sequencing immunotherapy with CHEMOSAT liver directed therapy, is now fully enrolled with 76 patients;
Ended the third quarter with cash and investments of $14.0 million with quarterly cash burn of $3.6 million; and
Subsequent to September 30, 2024:
Submitted the final principal and interest payments of $2.8 million on the Rosalind note payable and as a result have no outstanding debt obligations; and
All remaining Tranche B warrants from the March 29, 2023 PIPE were exercised by the November 6, 2024 expiration date resulting in approximately $25 million in proceeds.
"We are pleased with HEPZATO’s robust market adoption in the U.S., a testament to its clinical impact and the confidence physicians are showing in its use," said Gerard Michel, Delcath’s Chief Executive Officer. "Given our strong balance sheet and consistent revenue growth, which puts us on the cusp of profitability, Delcath is in a solid position to expand our development pipeline. Based on broad interest from oncology leaders, we are advancing programs for the use of HEPZATO in liver dominant colorectal and breast cancers."
Recent Publications
Presented subgroup analyses data from the FOCUS Phase 3 trial of HEPZATO at ESMO (Free ESMO Whitepaper) 2024, demonstrating similar outcomes in overall survival, overall response rate, and progression free survival between patients with and without extrahepatic lesions or based on prior therapy. In addition, tumor responses were observed throughout the entire treatment period supporting the strategy to continue treatment until best response is achieved;
Announced multiple independent investigator-sponsored retrospective studies of HEPZATO and CHEMOSAT:
A 30-patient study published in the Annals of Surgical Oncology by researchers at Moffitt Cancer Center in Tampa, Florida. The study reported that HEPZATO used in first- or second-line therapy for metastatic uveal melanoma provided better disease control in the liver and improved progression-free survival compared to both immunotherapy and other liver-directed therapies;
A 167-patient study published in the journal Therapeutic Advances in Medical Oncology by investigators from the University of Tübingen, Germany. The study reported that first-line liver-directed therapies, including CHEMOSAT, significantly improve melanoma-specific survival in patients with liver metastases from uveal melanoma, compared to first-line systemic therapies; and
A study published in the ESMO (Free ESMO Whitepaper) journal of Gastrointestinal Oncology by researchers from the University Hospital of Leipzig reporting the results of 33 patients treated with CHEMOSAT. The study included previously treated patients with unresectable intrahepatic metastases from seven different cancer types and reported a hepatic disease control rate of 91% with six patients (18.2%) achieving complete response in the liver. Median hepatic progression-free survival was 52 weeks across all patients.
Third Quarter 2024 Results
Total revenue for the quarter ended September 30, 2024 was $11.2 million compared to $0.4 million for the same period in the prior year. Revenue includes sales of $10.0 million of HEPZATO in the U.S. and $1.2 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ended September 30, 2024, were $3.9 million compared to $4.7 million for the same period in the prior year. The change in research and development expenses is primarily due to lower costs associated with expanded access protocol 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 September 30, 2024, were $7.0 million compared to $6.2 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.
The Company submitted the final principal payment due to Avenue Venture Opportunities Fund, L.P. on August 1, 2024 for the Loan and Security Agreement entered into in August 2021. As of September 30, 2024 our cash and investments totaled $14.0 million.
Subsequent to the end of the third quarter, we submitted the final principal and interest payment of $2.8 million on the outstanding Rosalind note payable and received approximately $25 million in proceeds from the exercise of Tranche B Warrants from the previous March 29, 2023 PIPE. Currently, there are no outstanding debt obligations.