Delcath(US:DCTH)2025-11-04 14:04Regulatory Approvals and Clinical Trials - The HEPZATO KIT was approved by the FDA on August 14, 2023, for liver-directed treatment of adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver[110]. - The first commercial use of the HEPZATO KIT occurred in January 2024[110]. - The CHOPIN clinical trial showed a one-year progression-free survival rate of 54.7% in the combination group versus 15.8% in the PHP group[114]. - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer (mCRC) is expected to enroll approximately 90 patients, with results anticipated by the end of 2027[119]. - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic breast cancer (mBC) is expected to enroll approximately 90 patients, with results anticipated by the end of 2028[120]. - The Phase 2 clinical trial for HEPZATO in combination with standard care for mCRC and mBC is expected to progress, with significant investments in clinical team expansion[127]. - The company expects to enroll approximately 90 patients in the Phase 2 clinical trial for liver-dominant metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC), with trials expected to take place at over 20 sites across the U.S. and Europe[119][120]. - The Phase 2 trial for HEPZATO in liver-dominant mBC is expected to read out its primary endpoint by the end of 2028[120]. Market and Patient Data - The total addressable market for liver-dominant mCRC receiving third-line treatment is estimated to be between 6,000 and 10,000 patients annually in the United States[119]. - Approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases[121]. - The number of facilities treating patients with HEPZATO increased to 22 in the nine months ended September 30, 2025, from 11 facilities in the same period of 2024[125]. Financial Performance - Total revenues for the three months ended September 30, 2025, increased to $20,563,000, up from $11,200,000 in the same period of 2024, representing an 83.5% growth[124]. - For the nine months ended September 30, 2025, total revenues reached $64,503,000, compared to $22,105,000 in 2024, marking a 192.5% increase[124]. - Gross profit for the three months ended September 30, 2025, was $17,939,000, compared to $9,560,000 in 2024, reflecting a 87.8% increase[124]. - Gross profit for the nine months ended September 30, 2025, was $55,716,000, up from $18,043,000 in 2024, indicating a significant increase in profitability[124]. - Net income for the three months ended September 30, 2025, was $830,000, compared to a net loss of $1,864,000 in the same period of 2024[124]. - Cash and cash equivalents totaled $41.8 million as of September 30, 2025, compared to $8.3 million at the same date in 2024[132]. - The company has capital commitments of $8.0 million over the next twelve months for accounts payable and accrued expenses[134]. Expenses and Investments - Research and development expenses are expected to increase due to costs associated with completing Phase 2 clinical trials[122]. - Research and development expenses rose to $7,986,000 for the three months ended September 30, 2025, up from $3,866,000 in 2024, a 106.0% increase[127]. - Selling, general and administrative expenses increased to $10,341,000 for the three months ended September 30, 2025, compared to $6,953,000 in 2024, a 48.5% rise[128]. - The company anticipates that research and development expenses will continue to rise as it completes ongoing clinical trials[122]. - Selling, general and administrative expenses increased to $10.341 million for the three months ended September 30, 2025, from $6.953 million in 2024, driven by commercial expansion activities[128]. Supply Chain and Product Management - The company has sufficient raw materials for the HEPZATO KIT to meet anticipated demand and plans to manage supply chain risks[112]. - CHEMOSAT received Medical Device Regulation certification in Europe on February 28, 2022, and the company has assumed direct responsibility for its sales and marketing in Europe[113].