Delcath(DCTH) - 2022 Q2 - Quarterly Report

Revenue Performance - Delcath Systems recorded approximately $0.8 million in revenue for Q2 2022, up from $0.4 million in Q2 2021, primarily due to the transition to direct sales in Europe[74]. - For the six months ended June 30, 2022, revenue was approximately $1.2 million, compared to $0.9 million for the same period in 2021, again due to the direct sales transition in Europe[80]. Research and Development Expenses - Research and development expenses increased to $5.5 million in Q2 2022 from $3.5 million in Q2 2021, driven by costs related to the pre-NDA meeting and NDA submission preparations[76]. - Research and development expenses for the six months ended June 30, 2022, increased to $9.7 million from $7.2 million in the prior year, attributed to NDA submission preparations[82]. Selling, General and Administrative Expenses - Selling, general and administrative expenses rose to $4.1 million in Q2 2022 from $3.3 million in Q2 2021, reflecting higher costs for HEPZATO commercialization preparations[78]. - Selling, general and administrative expenses for the six months ended June 30, 2022, were $7.8 million, up from $6.6 million in the prior year, due to commercialization efforts and increased headcount[83]. Cash and Capital Commitments - As of June 30, 2022, Delcath had cash, cash equivalents, and restricted cash totaling $14.4 million, with $12.4 million used in operating activities during the first half of 2022[85]. - The company has capital commitments of $7.8 million for accounts payable and $5.0 million for loan principal payments over the next twelve months[88]. Going Concern and Capital Raising - Delcath's ability to continue as a going concern is dependent on raising additional capital through equity or debt securities[87]. Drug Application and Financing Activities - The company plans to submit a new drug application for HEPZATO to the FDA by the end of Q3 2022, following a successful pre-NDA meeting[72]. - The Company entered into a Loan and Security Agreement for a term loan of up to $20.0 million, with an interest rate that increased from 11.7% to 13.2% between June and August 2022[91]. - On July 20, 2022, Delcath closed a private placement, issuing 690,954 shares of common stock at $3.98 each and 566,751 pre-funded warrants at $3.97 each, raising approximately $5.0 million in gross proceeds[92]. Accounting and Internal Controls - There were no material changes to critical accounting estimates during the six months ended June 30, 2022, as reported in the Annual Report[93]. - The financial statements were prepared in accordance with generally accepted accounting principles, with no material changes to critical accounting policies during the six months ended June 30, 2022[94]. - The Company's management evaluated the effectiveness of disclosure controls and procedures, concluding they are functioning effectively as of June 30, 2022[96]. - There were no changes in internal control over financial reporting during the quarter ended June 30, 2022, that materially affected the internal control[97].