ALX Oncology Reports Q4 Earnings with Promising Clinical Updates

ALX Oncology (NASDAQ:ALXO) has provided a comprehensive update during its fourth-quarter earnings call, highlighting significant progress in its clinical programs, particularly with the CD47 blocker evorpacept and the EGFR-targeted antibody-drug conjugate ALX2004. The company also shared its financial position and outlined strategic timelines for upcoming clinical developments.

Chief Executive Officer Jason Lettmann emphasized that the priority for ALX Oncology remains the execution of its clinical strategies, designating 2025 as a pivotal year for accumulating extensive clinical data on evorpacept. The company announced that Dr. Barbara Klencke, who had been serving as interim Chief Medical Officer since September 2025, will transition into the role permanently. Klencke brings valuable experience from her previous positions at Sierra Oncology, Onyx, and Genentech.

Clinical Advancements and Biomarker Insights

ALX Oncology is increasingly confident in the role of CD47 as a predictive biomarker for responses to evorpacept in patients with HER2-positive cancers. To date, the company has treated over 750 patients with evorpacept. Klencke discussed data from a randomized phase 2 study of HER2-positive gastric cancer, presented at the Society for Immunotherapy of Cancer (SITC) in November 2025. This study focused on patients whose tumors overexpressed both HER2 and CD47, providing strong support for the potential of CD47 as a predictive biomarker.

The company is also evaluating evorpacept in combination with zanidatamab in a phase 1/2 study targeting HER2-positive metastatic breast cancer patients. Results from this trial were first shared at the San Antonio Breast Cancer Symposium in December 2024. Among nine patients with confirmed HER2 expression, the response rate was notably high at 56%, with responses lasting between 5.5 and nearly 26 months. The median progression-free survival (PFS) was recorded at 7.4 months. Klencke noted that the analysis of CD47 biomarkers was completed in January 2026, indicating that responders were mainly those with CD47 overexpression. Full results are expected to be unveiled at the upcoming ESMO Breast Cancer Conference in the second quarter of 2026.

ALX Oncology also provided updates on its phase 2 ASPEN-09-Breast study, which is exploring the combination of evorpacept with trastuzumab and chemotherapy in patients who have progressed on ENHERTU. The study will expand from 80 to 120 patients to ensure a robust analysis of CD47 overexpression and its impact on treatment outcomes. Management confirmed that results from the initial 80 patients are now anticipated in mid-2027, aimed at delivering more comprehensive and meaningful data.

Progress on ALX2004 and Financial Position

ALX2004, the company’s EGFR-targeted antibody-drug conjugate, is also making headway. Klencke discussed the challenges of developing EGFR ADCs, particularly due to their narrow therapeutic window. The ADC has shown broad antitumor activity in preclinical studies without causing significant EGFR-related skin toxicity or interstitial lung disease in non-human primate studies. Currently, the company has successfully cleared the first two dose cohorts and is enrolling patients in the third cohort at 4 mg/kg. There were no dose-limiting toxicities observed at the lower dose levels, and ALX Oncology aims to provide safety data from the ongoing phase 1 trial by the second half of 2026.

In terms of financing, CFO Harish Shantharam reported that ALX ended the fourth quarter of 2025 with $48.3 million in cash, equivalents, and investments prior to a significant financing round in February 2026. The company successfully raised $150 million in this round, netting approximately $140.4 million after underwriting fees and expenses. This financial boost is expected to sustain ALX’s operations through the first half of 2028.

For the quarter ending December 31, 2025, ALX reported a GAAP net loss of $22.8 million, or $0.42 per share. This figure is an improvement over the previous year’s loss of $29.2 million, or $0.55 per share, primarily due to reduced stock-based compensation and lower personnel-related costs.

ALX Oncology’s upcoming milestones include presentations of biomarker results at the ESMO Breast Cancer Conference in May 2026, updates on ALX2004’s dose escalation safety by late 2026, and top-line data from the ASPEN-09-Breast study by mid-2027.

Based in Redwood City, California, ALX Oncology focuses on developing innovative immuno-oncology therapies aimed at enhancing patient outcomes for various cancers. The lead candidate, evorpacept, is designed to improve macrophage-mediated phagocytosis of cancer cells through its unique mechanism of action.