Delcath(US:DCTH)2025-05-08 13:25Financial Performance - Total revenues for the three months ended March 31, 2025, increased to $19.784 million, compared to $3.139 million in the same period of 2024, reflecting a significant growth due to the commercial expansion of HEPZATO and CHEMOSAT[115] - Gross profit for the three months ended March 31, 2025, was $16.939 million, compared to $2.236 million in the same period of 2024, showcasing improved profitability[115] - The company reported a net income of $1.069 million for the three months ended March 31, 2025, compared to a net loss of $11.111 million in the same period of 2024[115] - During the three months ended March 31, 2025, $2.2 million of cash was provided by operating activities, compared to $9.6 million used in the same period in 2024[121] Research and Development - Research and development expenses rose to $5.007 million for the three months ended March 31, 2025, up from $3.700 million in 2024, primarily due to costs associated with expanding the clinical team and initiating a Phase 2 clinical trial[118] - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer is expected to enroll approximately 90 patients, with patient enrollment anticipated to begin in the second half of 2025[110] - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer is expected to enroll approximately 90 patients, with results anticipated by the end of 2027[110] - The company expects research and development expenses to increase in the foreseeable future due to ongoing clinical trials and related activities[113] Market and Product Expansion - The number of facilities treating patients with HEPZATO increased from 4 in Q1 2024 to 17 by March 31, 2025, indicating a strong demand for the product[116] - The total addressable market for liver-dominant metastatic colorectal cancer receiving third-line treatment is estimated to be between 6,000 and 10,000 patients annually in the United States[110] - HEPZATO received FDA approval on August 14, 2023, for the treatment of adult patients with uveal melanoma with unresectable hepatic metastases[103] - The overall response rate (ORR) in the Phase 3 FOCUS Trial for HEPZATO was reported at 36.35%, significantly higher than the historical control group's ORR of 5.5%[107] Expenses and Financial Position - Selling, general and administrative expenses increased to $11.290 million in Q1 2025 from $8.814 million in Q1 2024, driven by marketing-related expenses and additional personnel[119] - Research and development expenses increased due to costs associated with expanding the clinical team and initiating the Phase 2 clinical trial for HEPZATO[118] - As of March 31, 2025, the company had cash and cash equivalents totaling $12.8 million and short-term investments of $46.1 million, compared to $32.4 million and $20.8 million respectively at December 31, 2024[121] - The company believes current cash and investments will support operations for at least 12 months from the issuance of the financial statements[122] - Capital commitments over the next twelve months include $5.3 million for accounts payable, accrued expenses, and current lease liabilities[123] Securities and Registrations - The company has filed a universal shelf registration statement allowing for the potential offering of up to $150 million in various securities[124] - A universal shelf registration statement was filed on June 28, 2024, allowing the company to offer up to $150 million in various securities[124] - 238,500 Series F Warrants were exercised during the three months ended March 31, 2025, with an additional 1,377,275 exercised after the quarter[125] Accounting and Estimates - There were no material changes to critical accounting estimates or policies as reported in the Annual Report[126][127]