Core Insights - ALX Oncology will not pursue a U.S. registrational path for evorpacept in gastric cancer due to FDA feedback indicating that the accelerated approval pathway is not feasible based on ASPEN-06 data, as the standard-of-care has evolved to ENHERTU® [1][11] - The company has extended its cash runway into Q4 2026, allowing for continued development of its clinical programs [2][4] - Data milestones are expected across three clinical programs in 2026, focusing on evorpacept in combination with anti-cancer antibodies and the new ADC candidate ALX2004 [4][9] Financial Performance - For Q1 2025, ALX Oncology reported a GAAP net loss of $30.8 million, or $0.58 per share, compared to a net loss of $35.6 million, or $0.71 per share, in Q1 2024 [12][17] - Research and Development (R&D) expenses decreased to $23.9 million from $31.7 million year-over-year, primarily due to reduced clinical trial material manufacturing [12][16] - General and Administrative (G&A) expenses increased to $7.9 million from $6.0 million, attributed to higher personnel-related costs [12][16] Clinical Development Updates - The company is set to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025, focusing on evorpacept in combination with HERCEPTIN® and ERBITUX® respectively [6][11] - ALX2004, a novel EGFR-targeted ADC, received IND clearance from the FDA and is expected to begin clinical trials in mid-2025 [7][11] - Encouraging results were reported from a Phase 1 trial of evorpacept in combination with RITUXAN® and lenalidomide for B-cell non-Hodgkin lymphoma, showing a complete response rate of 83% [8][11] Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $107.0 million, sufficient to fund operations into Q4 2026 [12][19] - The total assets were reported at $120.9 million, with total liabilities of $32.6 million and an accumulated deficit of $651.9 million [19]
ALX Oncology Reports First Quarter 2025 Financial Results and Provides Corporate Update