Delcath(US:DCTH)2021-08-09 16:00Revenue Performance - Revenue for the three months ended June 30, 2021, was approximately $536,000, an increase of $157,000 compared to $379,000 for the same period in 2020, driven by increased CHEMOSAT unit sales[91]. - Revenue for the six months ended June 30, 2021, was approximately $924, an increase of $252 from $672 for the same period in 2020, driven by increased CHEMOSAT unit sales[98]. - Total revenue for the six months ended June 30, 2021, was approximately $924,000, an increase of 37.4% compared to $672,000 for the same period in 2020[98]. Cost of Goods Sold - Cost of goods sold for the three months ended June 30, 2021, was approximately $202,000, up from $168,000 in the prior year, primarily due to increased sales volume[92]. - Cost of goods sold for the three months ended June 30, 2021, was approximately $202,000, up from $168,000 in the prior year, reflecting increased sales volume[92]. Research and Development Expenses - Research and development expenses rose to $3,497,000 for the three months ended June 30, 2021, compared to $2,223,000 in the prior year, influenced by stock option expenses and hiring of additional employees[94]. - Research and development expenses increased to $7,204 for the six months ended June 30, 2021, from $5,197 in the prior year, partly due to stock option expenses of $1,093 and hiring five additional employees[99]. - Research and development expenses for the six months ended June 30, 2021, rose to $7,204,000 from $5,197,000 in the prior year, influenced by stock option expenses and ongoing trial costs[99]. Selling, General and Administrative Expenses - Selling, general and administrative expenses increased to $3,288,000 for the three months ended June 30, 2021, from $2,257,000 in the prior year, largely due to stock option expenses of $1,163,000[95]. - Selling, general and administrative expenses rose to $6,584 for the six months ended June 30, 2021, from $4,573 in the prior year, primarily due to stock option expenses of $2,681[100]. - Selling, general and administrative expenses for the six months ended June 30, 2021, were $6,584,000, up from $4,573,000 in the prior year, largely due to stock option expenses[100]. Net Loss - Net loss for the six months ended June 30, 2021, was $13,177, an increase of $1,041 compared to a net loss of $12,136 for the same period in 2020[102]. - Net loss for the three months ended June 30, 2021, was $6,430,000, an increase of 50.5% compared to a net loss of $4,275,000 for the same period in 2020[97]. Clinical Trials - The FOCUS Trial for HEPZATO reported an objective response rate (ORR) of 29.2% in the intent-to-treat population, significantly exceeding the predefined success criterion of 8.3%[83]. - The median progression-free survival (PFS) in the HEPZATO arm was 9.0 months, compared to 3.1 months in the Best Alternative Care (BAC) arm, indicating a statistically significant improvement[83]. - The company has paused the ALIGN Trial due to enrollment difficulties but is reviewing the potential to restart it based on market opportunities[85]. - The company experienced delays in patient recruitment and data monitoring for the FOCUS Trial due to the COVID-19 pandemic, impacting timelines for data announcements[87]. - The company intends to submit a New Drug Application (NDA) to the FDA in Q1 2022 for the treatment of metastatic ocular melanoma, contingent on the completion of the FOCUS Trial[87]. Cash Position - Cash, cash equivalents, and restricted cash totaled $19,425 at June 30, 2021, down from $28,756 at December 31, 2020, and $16,192 at June 30, 2020[103]. - Cash, cash equivalents, and restricted cash totaled $19,425,000 as of June 30, 2021, down from $28,756,000 at December 31, 2020[103]. Regulatory Status - The current CE Mark under the Medical Device Directive remains effective until April 2024, allowing the company to operate in Europe while working towards MDR certification[90]. - The company has not yet achieved MDR certification as of June 30, 2021, but the current CE Mark remains effective until April 2024[90]. Future Outlook - The company anticipates continued operating losses and emphasizes the need for additional capital to support future operations[104][105]. - The company is focused on maximizing the value of the HEPZATO platform by investigating a broad set of liver cancers to address unmet medical needs[86].