Delcath Systems, Inc. reported significant financial developments in its 10-Q filing for the quarter ending September 30, 2024. The company, focused on interventional oncology, particularly targeting liver cancers, has seen a substantial increase in product revenue following the FDA approval of its lead product, the HEPZATO KIT, on August 14, 2023. For the three months ended September 30, 2024, total revenue reached $11.2 million, a dramatic rise from $434,000 in the same period of 2023. For the nine months ended September 30, 2024, revenue totaled $22.1 million, compared to $1.5 million in the prior year. The HEPZATO KIT contributed $10 million to the quarterly revenue, while CHEMOSAT added $1.2 million.

Gross profit for the third quarter of 2024 was $9.6 million, up from $301,000 in the previous year, while gross profit for the nine-month period was $18.0 million, compared to $1.1 million in 2023. Operating losses improved significantly, with a loss of $1.3 million for Q3 2024, compared to a loss of $10.6 million in Q3 2023. For the nine months, the operating loss was $15.4 million, down from $26.9 million in the prior year. Notably, the company reported a net income of $1.9 million for Q3 2024, a stark contrast to the net loss of $20.3 million in Q3 2023. However, for the nine-month period, the net loss was $23.0 million, improved from $36.5 million in 2023.

As of September 30, 2024, Delcath's total current assets decreased to $28.9 million from $37.2 million at the end of 2023, while total assets fell to $31.7 million from $38.6 million. Current liabilities increased to $21.6 million, up from $16.4 million. Stockholders' equity also declined to $8.6 million from $15.8 million at the end of 2023, with an accumulated deficit growing to $528.2 million.

The company has been proactive in its financing efforts, raising approximately $7 million through a private placement in March 2024 and generating $25 million from the exercise of warrants in November 2024. However, Delcath anticipates needing additional capital to support ongoing operations and product development, particularly if revenue expectations are not met. The company has also committed to various capital expenditures, including $6.8 million for accounts payable and $2 million for convertible note payments over the next twelve months.

Delcath's strategic focus remains on expanding the clinical applications of the HEPZATO KIT and CHEMOSAT, with plans for further studies targeting additional liver cancers expected to commence in late 2024 or early 2025.