Delcath Systems (DCTH) saw its stock decline following a third-quarter report that revealed continued revenue shortfalls and setbacks in key clinical trial milestones. The biotech firm attributed the downturn to delayed regulatory feedback and lower-than-expected product sales.
- Net loss widened to $14.2 million in Q3 2024, up from $9.8 million in Q3 2023
- Revenue declined to $2.1 million, a 42% year-over-year decrease
- Operating expenses increased to $16.5 million, primarily due to clinical trial and R&D costs
- Phase 3 trial enrollment for mHAI system fell short of targets
- FDA pre-submission meeting delayed, impacting potential regulatory pathway
- Stock price dropped 28% following earnings release
Delcath Systems (DCTH) posted a net loss of $14.2 million for the third quarter of 2024, widening from a $9.8 million loss in the same period the prior year. Revenue dipped to $2.1 million, down 42% year-over-year, reflecting weak commercialization of its proprietary drug delivery platform, the Melphalan Hepatic Arterial Infusion (mHAI) system. The company cited insufficient patient enrollment in ongoing Phase 3 trials for the treatment of metastatic melanoma and liver cancer as a primary drag on progress. Regulatory delays from the U.S. Food and Drug Administration (FDA) on a pre-submission meeting for the mHAI system further hindered strategic momentum. Additionally, operating expenses rose to $16.5 million, driven by expanded clinical trial operations and increased R&D expenditures. The combined impact of declining sales and rising costs contributed to a 28% drop in share price within two trading days of the earnings release.