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X4 Pharmaceuticals(XFOR) - 2023 Q1 - Quarterly Report

Financial Performance - The company reported a net loss of $24.02 million for the three months ended March 31, 2023, compared to a net loss of $21.97 million for the same period in 2022, reflecting an increase in loss of $2.05 million [112]. - For the three months ended March 31, 2023, the net loss was $24.0 million, compared to a net loss of $22.0 million for the same period in 2022, representing an increase in net loss of approximately 9.1% [126]. - Net cash used in operating activities for the three months ended March 31, 2023, was $26.5 million, an increase of 31.4% from $20.2 million in the same period of 2022 [127]. - Cash and cash equivalents at the end of the period were $94.4 million, down from $123.0 million at the beginning of the period, reflecting a net decrease of $28.6 million [126]. - Net cash used in financing activities was $2.1 million for the three months ended March 31, 2023, compared to net cash provided of $5.0 million in the same period of 2022 [129]. Research and Development - Research and development expenses increased by $8.0 million to $22.06 million for the three months ended March 31, 2023, compared to $14.11 million in the prior year, primarily due to higher accrued in-license fees and third-party costs associated with clinical trials [112][114]. - The company expects ongoing increases in expenses related to clinical trials for its product candidates, which may significantly impact future funding requirements [130]. - The company is preparing a U.S. New Drug Application (NDA) for mavorixafor, expected to be submitted in early Q3 2023, following positive Phase 3 trial results for WHIM syndrome [104]. Liquidity and Capital Resources - As of March 31, 2023, the company had cash and cash equivalents of $93.4 million, with a restricted cash balance of $1.0 million, but faces potential liquidity issues beginning Q1 2024 [124][125]. - The Hercules Loan Agreement provides for a term loan of $32.5 million, with an interest-only payment period through October 1, 2024, but the company has fully borrowed this amount [123]. - The company anticipates that its cash and cash equivalents will fund operations into the second quarter of 2024, but may require additional capital to meet the minimum cash covenant of the Hercules Loan Agreement [130]. - The company acknowledges substantial doubt about its ability to continue as a going concern without raising additional capital [125]. Other Income and Expenses - Other income increased to $5.29 million for the three months ended March 31, 2023, compared to a net expense of $674,000 in the prior year, primarily due to changes in fair value of Class C warrants and increased interest income [117]. - Non-cash expenses for the three months ended March 31, 2023, included adjustments for the change in fair value of Class C warrant liability and stock-based compensation, totaling $3.1 million [127]. - The company expects selling, general and administrative expenses to grow as it continues to build out its functions in these areas [116]. Company Classification and Accounting Policies - The company is classified as a smaller reporting company (SRC), allowing it to take advantage of scaled disclosures under certain conditions [135]. - The company has not reported any material changes to its critical accounting policies during the three months ended March 31, 2023 [134].