Delcath Systems ( NASDAQ: DCTH ), a medical device maker focused on liver cancers, dropped ~6% in the morning hours Tuesday, even after the company's Q3 2022 revenue exceeded the consensus.
Delcath ( DCTH ) reported $906K in revenue for the quarter, indicating ~74% YoY growth thanks to sales of its CHEMOSAT Hepatic Delivery System in Europe.
However, the company's net loss widened by ~19% YoY to $8.5M, driven by a ~34% YoY rise in R&D expenses that stood at $4.0M as the company prepared to submit a marketing application for the liver chemotherapy device Hepzato Kit to the FDA by the year-end.
"We continue to make progress toward the resubmission of the Hepzato Kit NDA by the end of this year, and assuming a six-month review, we consequently would expect a PDUFA date by the end of June 2023," Chief Executive Gerard Michel.
Highlighting the interest in Hepzato, Michel noted that the company has so far opened three sites in its Expanded Access Program (EAP) with plans to add four more locations.
However, Delcath's ( DCTH ) cash and equivalents at the end of the quarter fell to $9.8M from $22.8M at the 2021 year-end.
Delcath ( DCTH ) shares have underperformed the broader market this year with a ~65% decline YTD, as indicated in this graph.
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Delcath Systems slips despite Q3 beat