Clinical Trial Results - Evorpacept demonstrated a 65.0% objective response rate (ORR) in patients with retained HER2+ and CD47-high gastric cancer, compared to 26.1% for the control group[4] - The median duration of response (DOR) for evorpacept plus trastuzumab, ramucirumab, and paclitaxel was 25.5 months, significantly longer than the 8.4 months for the control group[4] - Progression-free survival (PFS) for the evorpacept combination was 18.4 months versus 7.0 months for the control, with a hazard ratio (HR) of 0.39[4] - The Phase 2 ASPEN-09-Breast Cancer trial is on track for first patient in (FPI) in Q4 2025, with interim data expected in Q3 2026[4] - The Phase 1 trial for ALX2004 is currently enrolling patients and is expected to deliver initial safety data in the first half of 2026[4] Financial Performance - Cash, cash equivalents, and investments as of September 30, 2025, were $66.5 million, sufficient to fund operations into Q1 2027[11] - Research and development (R&D) expenses for Q3 2025 were $17.4 million, a decrease of $9.0 million from the prior year[11] - General and administrative (G&A) expenses for Q3 2025 were $5.1 million, down from $6.1 million in the prior year[11] - GAAP net loss for Q3 2025 was ($22.1) million, or ($0.41) per share, compared to a net loss of ($30.7) million, or ($0.58) per share, in Q3 2024[11] - For the three months ended September 30, 2025, the total operating expenses were $22,532,000, a decrease of 30.8% compared to $32,567,000 for the same period in 2024[15] - The net loss for the three months ended September 30, 2025, was $22,144,000, which is a reduction of 27.8% from the net loss of $30,707,000 in the prior year[15] - The company reported a non-GAAP net loss of $19,551,000 for the three months ended September 30, 2025, compared to a non-GAAP net loss of $23,689,000 for the same period in 2024, reflecting a 17.9% improvement[19] - Cash, cash equivalents, and investments decreased to $66,464,000 as of September 30, 2025, down from $131,281,000 at the end of 2024, indicating a decline of 49.3%[17] - Total assets as of September 30, 2025, were $82,723,000, a decrease of 44.0% from $147,775,000 on December 31, 2024[17] - The accumulated deficit increased to $699,969,000 as of September 30, 2025, compared to $621,122,000 at the end of 2024, representing an increase of 12.6%[17] - Total stockholders' equity decreased to $44,800,000 as of September 30, 2025, down from $113,618,000 at the end of 2024, a decline of 60.6%[17] - Research and development expenses for the three months ended September 30, 2025, were $17,441,000, a decrease of 34.1% from $26,471,000 in the same period of 2024[15] - Interest income for the three months ended September 30, 2025, was $802,000, compared to $2,303,000 in the same period of 2024, reflecting a decrease of 65.2%[15] - The weighted-average shares of common stock used to compute net loss per share increased to 53,577,066 for the three months ended September 30, 2025, compared to 52,693,878 for the same period in 2024, an increase of 1.7%[15] Management Changes - Barbara Klencke, M.D., has been appointed as Chief Medical Officer, bringing over 30 years of experience in oncology drug development[4]
ALX Oncology(ALXO) - 2025 Q3 - Quarterly Results