Delcath Systems, Inc. (NASDAQ: DCTH) observed an upward trajectory in its stock value during the extended trading session on Tuesday. The after-hours market saw a 6.22% surge, elevating Delcath stock to $2.39. This positive movement partially offset the earlier 24.50% decline, settling the regular session at $2.25. The surge was instigated by the release of the company’s quarterly results and a comprehensive business update.
Delcath presented key business highlights and financial outcomes for the third quarter concluding on September 30, 2023. Regarding business developments, DCTH emphasized the receipt of approval from the US Food and Drug Administration (FDA) for the HEPZATO KIT (melphalan)/Hepatic Delivery System.
This recognition positions the kit as an endorsed liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) featuring unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease.
Furthermore, Delcath successfully raised approximately $35 million by exercising all Tranche A warrants issued as part of the previously announced March 29, 2023, financing. An additional $25 million is available upon reaching $10 million in quarterly revenue.
DCTH also highlighted an independent investigative publication, presenting a retrospective comparative study of the CHEMOSAT Hepatic Delivery System. The study, focusing on Melphalan percutaneous hepatic perfusion (PHP) and Selective Internal Radiation Therapy (SIRT), revealed a statistically significant difference in median overall survival—301 days for SIRT and 516 days for PHP.
Additionally, Delcath shared that independent investigators at Leiden University have recruited 55 out of the planned 76 patients in the CHOPIN trial. This trial assesses the impact of combining CHEMOSAT and immune checkpoint inhibitors in treating metastatic uveal melanoma, with full enrollment expected by mid-2024.
Anticipating a January launch of the HEPZATO KIT, Delcath has been diligently building its commercial team and collaborating with potential treatment centers. The company received positive feedback from the medical oncologist community and is confident that, by the end of 2024, at least 15 centers will actively treat metastatic uveal melanoma patients with the HEPZATO KIT.
