Delcath(DCTH) - 2020 Q1 - Quarterly Report

Financial Performance - Product sales revenue for Q1 2020 was approximately $0.2 million, up from $0.1 million in Q1 2019, attributed to increased royalties from a licensing agreement [89]. - Net loss for Q1 2020 was $7.9 million, a slight decrease of $32,000 compared to Q1 2019, driven by a decrease in operating expenses offset by an increase in non-cash expenses [96]. - Cash, cash equivalents, and restricted cash totaled $4.7 million as of March 31, 2020, down from $10.2 million at December 31, 2019 [99]. - The company raised approximately $22.0 million in gross proceeds from a public offering of 2.2 million shares on May 5, 2020 [87]. - The company expects to fund operations through the second quarter of 2021 with existing cash and proceeds from the offering, but may need additional capital in the future [98]. Expenses - Research and development expenses decreased to $3.0 million in Q1 2020 from $3.3 million in Q1 2019, primarily due to lower enrollment in the FOCUS trial [91]. - Selling, general and administrative expenses were $2.3 million in Q1 2020, down from $2.5 million in Q1 2019, mainly due to reduced personnel expenses [92]. Clinical Trials - The FOCUS trial for Melphalan/HDS is impacted by the COVID-19 pandemic, delaying the announcement of top-line data [86]. - The FOCUS trial's top-line data announcement has been delayed due to the COVID-19 pandemic, impacting patient enrollment and monitoring [86]. Product Approval and Designation - Melphalan/HDS is approved for sale in Europe under the trade name CHEMOSAT, while it remains unapproved in the United States [81]. - The company has six orphan drug designations from the FDA for Melphalan, targeting various liver cancers [84]. - The company has received six orphan drug designations from the FDA for Melphalan, targeting unmet medical needs in liver cancer treatments [84].