X4 Pharmaceuticals(US:XFOR)2025-11-05 13:25Financial Performance - Total revenue for Q3 2025 was $1.765 million, a significant increase from $560,000 in Q3 2024, representing a growth of 215% year-over-year[14] - Product revenue for the nine months ended September 30, 2025, reached $4.252 million, compared to $1.123 million for the same period in 2024, marking an increase of 278%[14] - For the nine months ended September 30, 2025, total revenue was $32.5 million, significantly up from $1.1 million in the same period of 2024, indicating a 2,841% increase[141] - The company reported net product revenue of $1.6 million for the three months ended September 30, 2025, an increase from $0.6 million in the same period of 2024, and total net revenue of $4.3 million for the nine months ended September 30, 2025, compared to $1.1 million for the same period in 2024[82] - For the three months ended September 30, 2025, the company recognized $1.8 million in revenue from external customers, compared to $0.6 million for the same period in 2024, representing a 196% increase[140] Net Loss and Expenses - The company reported a net loss of $29.815 million for Q3 2025, compared to a net loss of $36.696 million in Q3 2024, indicating an improvement of 18%[14] - For the nine months ended September 30, 2025, the company reported a net loss of $55.3 million, compared to a net income of $2.4 million for the same period in 2024[25] - The net loss for the three months ended September 30, 2025, was $29.8 million, compared to a net loss of $36.7 million for the same period in 2024, indicating an improvement of 18.9%[14] - Direct research and development expenses for the three months ended September 30, 2025, were $10.3 million, compared to $9.7 million in the same period of 2024, showing an increase of 6.4%[141] - Research and development expenses for Q3 2025 were $17.337 million, a decrease of 10% from $19.173 million in Q3 2024[14] Cash and Liquidity - Cash and cash equivalents increased to $69.632 million as of September 30, 2025, up from $55.699 million at the end of 2024, reflecting a growth of 25%[11] - As of September 30, 2025, total cash, cash equivalents, and restricted cash amounted to $70,435 thousand, an increase from $56,475 thousand as of December 31, 2024, representing a 24.5% increase[55] - The company reported a net cash used in operating activities of $70,091,000 for the nine months ended September 30, 2025, compared to $97,906,000 for the same period in 2024[25] - The company believes its current cash and cash equivalents will be sufficient to fund operations for at least the next 12 months[40] - As of September 30, 2025, the company had $122.2 million in cash, cash equivalents, and short-term marketable securities, with an accumulated deficit of $570.6 million[37] Assets and Liabilities - Total assets as of September 30, 2025, were $163.555 million, an increase of 12% from $146.447 million at the end of 2024[11] - Total liabilities decreased to $101.936 million as of September 30, 2025, down from $124.298 million at the end of 2024, representing a reduction of 18%[11] - The company’s accumulated deficit increased to $570.629 million as of September 30, 2025, compared to $515.355 million at the end of 2024[11] - The total stockholders' equity rose to $61.6 million as of September 30, 2025, compared to $22.1 million as of December 31, 2024, representing a substantial increase of 178.3%[11] Stock and Shareholder Information - The weighted average shares outstanding for basic net loss per share increased to 43,272,773 in Q3 2025, compared to 6,695,509 in Q3 2024[14] - The company executed a 1-for-30 reverse stock split on April 28, 2025, affecting all common stock share amounts retroactively[8] - The company excluded 15,633 potential shares of common stock from the computation of diluted net loss per share for the three months ended September 30, 2025, due to their anti-dilutive effect[70] - The company’s weighted average shares of common stock outstanding for the three months ended September 30, 2025, were 43,272,773 for both basic and diluted calculations[67] Clinical Development and Regulatory Status - The company is progressing in its pivotal Phase 3 clinical trial (the "4WARD" trial) for mavorixafor, with full enrollment expected in Q3 2026[28] - The FDA has granted Fast Track designation to mavorixafor for the treatment of chronic neutropenia, a rare blood condition[28] - The company has one commercially approved product, XOLREMDI® (mavorixafor), for patients with WHIM syndrome[28] Strategic Restructuring - The company implemented a strategic restructuring in Q1 2025, resulting in a 30% reduction of its workforce, incurring charges of approximately $2.3 million for severance and related costs[74] - An additional strategic restructuring was announced on September 17, 2025, leading to a further workforce reduction of approximately 50%, with expenses of about $4.9 million for severance and related costs[75] Agreements and Contracts - The Company has entered into a license and supply agreement with Norgine Pharma UK Limited, which includes multiple performance obligations and various payment structures[46] - The company entered into a License and Supply Agreement with Norgine on January 13, 2025, receiving a one-time upfront payment of €28.5 million and a regulatory milestone payment of €0.5 million, with potential future payments totaling up to €225.6 million[79][80] Marketable Securities and Investments - The Company’s available-for-sale debt marketable securities as of September 30, 2025, had a fair value of $52.6 million[59] - The company incurred an unrealized loss on marketable securities of $10,000 for the three months ended June 30, 2025[25] Other Financial Metrics - The company recorded a change in fair value of warrant liability of $(12.8) million for the nine months ended September 30, 2025[25] - The fair value of the embedded derivative liability related to the Hercules Loan Agreement was estimated at $10 thousand as of September 30, 2025[60][62] - The Class C Warrant liability decreased from $13,755 thousand as of December 31, 2024, to $959 thousand as of September 30, 2025, reflecting a significant change in fair value[60][63]