Delcath(US:DCTH)2020-11-12 13:32Financial Performance - Revenue for the three months ended September 30, 2020, was approximately $0.5 million, an increase from $0.4 million for the same period in 2019, representing a growth of 25%[130] - Revenue for the nine months ended September 30, 2020, remained stable at approximately $1.1 million, unchanged from the same period in 2019[137] - Net loss for the three months ended September 30, 2020, was $5.0 million, a decrease of $2.5 million compared to a net loss of $7.5 million for the same period in 2019[136] - Net loss for the nine months ended September 30, 2020, was $17.1 million, a decrease of $4.3 million compared to a net loss of $21.4 million for the same period in 2019[142] Expenses - Cost of goods sold for the three months ended September 30, 2020, remained stable at approximately $0.2 million, unchanged from the same period in 2019[131] - Research and development expenses increased to $3.3 million for the three months ended September 30, 2020, up from $1.8 million in the same period of 2019, reflecting resumed activities in clinical trials[132] - Selling, general and administrative expenses decreased to $2.0 million for the three months ended September 30, 2020, down from $4.0 million in the same period in 2019, primarily due to reduced personnel expenses[133] - Research and development expenses for the nine months ended September 30, 2020, rose to $8.5 million from $6.8 million in the same period of 2019[139] - Selling, general and administrative expenses for the nine months ended September 30, 2020, were $6.6 million, down from $9.2 million in the same period of 2019[140] Leadership Changes - The Company appointed Gerard Michel as CEO and John Purpura as COO, effective October 1, 2020, to strengthen its leadership team[115][116] Regulatory and Market Developments - The FDA granted conditional acceptance of the trade name HEPZATO™ KIT for the Company's melphalan hydrochloride for injection/hepatic delivery system on September 9, 2020[129] - The Company expects to submit a New Drug Application (NDA) to the FDA in the first quarter of 2022, following the conclusion of the FOCUS trial[117] - The COVID-19 pandemic has delayed clinical trial operations, affecting the timelines for the FOCUS trial and potentially impacting revenue from CHEMOSAT procedures[121] - The Company has paused work on the ALIGN trial to focus on the FOCUS trial conclusion and subsequent NDA filing[112] - The Company is evaluating the potential market opportunities for HEPZATO across various liver cancers, including ocular melanoma and intrahepatic cholangiocarcinoma[111] Financial Position - As of September 30, 2020, the company had cash, cash equivalents, and restricted cash totaling $11.1 million, compared to $15.5 million at September 30, 2019[145] - The company raised approximately $22.0 million from an underwritten public offering in May 2020 and launched an at-the-market offering of up to $10 million in August 2020[144] - The company expects that ongoing ATM Offering and existing cash resources will be sufficient to fund operations through the second quarter of 2021, but additional capital will be needed beyond that[144] Accounting Policies - The financial statements have been prepared in accordance with GAAP[149] - No material changes to critical accounting policies were reported for the nine months ended September 30, 2020[149] - Significant accounting policies impacting financial statement amounts are disclosed in Note 3 of the Annual Report[149]