South San Francisco, Calif. — November 7, 2025 — Leads & Copy — ALX Oncology Holdings Inc. (Nasdaq: ALXO) has shared its financial results for the third quarter ended September 30, 2025, alongside a corporate update. The clinical-stage biotechnology firm is focused on creating novel therapies to combat cancer and improve patient longevity.
Jason Lettmann, Chief Executive Officer at ALX Oncology, announced that data from the ASPEN-06 trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. The findings demonstrated compelling benefits across all measured outcomes for patients with high CD47-expressing HER2-positive gastric cancer treated with evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel.
Lettmann added that these results are guiding the company’s clinical development strategy for breast cancer. The company will enroll patients with HER2-positive tumors previously treated with ENHERTU®, and responses will be evaluated based on CD47-expression levels in the Phase 2 ASPEN-09-Breast Cancer trial. He is also enthusiastic about the progress of the ALX2004 clinical program, where the second dose cohort is enrolling at 2mg/kg after the first dose cohort cleared at 1mg/kg. The company plans to provide initial safety data from this program in the first half of next year and remains optimistic about ALX2004’s potential success in treating EGFR+ tumors, based on promising preclinical findings.
Peter Schmid, FRCP, M.D., Ph.D., Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre at Queen Mary University of London, noted that the evorpacept gastric cancer data is interesting for two reasons. First, there was a significant level of improvement across all efficacy measures among HER2-positive gastric cancer patients with CD47-high expression. Second, he is eager to evaluate this approach for patients with HER2+ breast cancer in the ASPEN-09 trial, which combines evorpacept and chemotherapy with trastuzumab, the same HER2-targeted antibody used in the gastric cancer study. Schmid hopes the combination will offer meaningful clinical benefit to patients with HER2-positive breast cancer who have previously received ENHERTU®, a patient population in need of new targeted therapies.
Key highlights from ALX Oncology’s Q3 2025 report include:
In a pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer, CD47 overexpression was identified as a key predictive biomarker for response and durable benefit in patients with retained HER2 expression. The data will be highlighted at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 8th.
In patients with retained HER2+ and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (TRP) had a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP, while patients with HER2+ and CD47-low gastric cancer (n=47), evorpacept + TRP had a 37.5% ORR compared to 26.1% ORR for TRP.
The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP in these patients. Evorpacept + TRP had a median DOR of 25.5 months versus 8.4 months median DOR for TRP, while patients with HER2+ and CD47-low gastric cancer, had a median DOR of 11.2 months for evorpacept + TRP compared to 12 months for TRP.
Treatment with evorpacept + TRP resulted in a progression free survival (PFS) of 18.4 months versus 7.0 months for TRP, hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in an overall survival (OS) of 17 months versus 9.9 months for TRP, HR of 0.63.
Enrollment began in August 2025 in the Phase 1 clinical trial for ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors and has cleared the first dose level. Detailed results from the Phase 2 clinical trials for ASPEN-03 and ASPEN-04, which evaluated evorpacept treatment plus KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, or pembrolizumab in combination with chemotherapy, respectively, for the treatment of recurrent, unresectable or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were presented at ESMO in October 2025. The trials did not meet their primary endpoints.
The Company appointed Board Member Barbara Klencke, M.D., as interim Chief Medical Officer.
Upcoming clinical milestones include ASPEN-09-Breast Cancer, which remains on track for FPI in Q4 2025 with interim data expected in Q3 2026, and ALX2004, for which Phase 1 trial enrollment began in August 2025 with initial safety data anticipated in 1H 2026.
The company’s cash, cash equivalents and investments as of September 30, 2025, were $66.5 million, which is believed to be sufficient to fund planned operations into Q1 2027.
R&D expenses for the three months ended September 30, 2025, were $17.4 million compared to $26.5 million for the prior-year period or a decrease of $9.0 million. G&A expenses for the three months ended September 30, 2025, were $5.1 million compared to $6.1 million for the prior year period or a decrease of $1.0 million.
GAAP net loss was ($22.1) million for the three months ended September 30, 2025, or ($0.41) per basic and diluted share, as compared to a GAAP net loss of ($30.7) million for the three months ended September 30, 2024, or ($0.58) per basic and diluted share.
Non-GAAP net loss was ($19.6) million for the three months ended September 30, 2025, as compared to a non-GAAP net loss of ($23.7) million for the three months ended September 30, 2024.
Elhan Webb, CFA, IR Consultant, ewebb@alxoncology.com
Audra Friis, Sam Brown Healthcare Communications, audrafriis@sambrown.com, (917) 519-9577
Source: ALX Oncology
