Alx Oncology Holdings Stock Earnings Reports

ALX reported strong Q1 2026 execution and data that materially de-risks its lead program, evorpacept (Evo). An exploratory analysis of a Phase Ib/II combo of evorpacept + zanidatamab in heavily pretreated HER2-positive metastatic breast cancer (median ~5 prior HER2 lines; all had prior T-DXd) showed: overall confirmed objective response rate (ORR) 33% (24 patients), ORR 60% in 10 centrally confirmed HER2-positive patients, and ORR 100% in the 5 patients who were both centrally HER2-positive and CD47-high (retrospective cutoff ≥20%). Responders exhibited durable benefit (median duration of response ~20 months) and a large PFS separation by CD47 status (median PFS ~22 months for CD47-high vs ~3.4 months for CD47-low, small n). These findings replicate and align with prior ASPEN-06 gastric cancer data (higher responses and long DOR/PFS in CD47-high patients), supporting CD47 as a predictive biomarker and a targeted development strategy. The randomized ASPEN-09 (single-arm design for now with up to 120 patients; interim topline ~80 patients mid-2027) is enrolling post-ENHERTU HER2-positive patients and will prospectively evaluate response rates by CD47 expression to optimize a diagnostic cut point. ALX2004 (novel EGFR-targeted ADC) continues dose escalation and is on track for an initial safety readout in H2 2026. Company strengthened its balance sheet with a February financing and added Jeff Knight as Chief Development & COO. Management reiterated a development path aiming for registrational readiness by end of next year, noted the potential market opportunity (estimated ~20,000 CD47-high HER2-positive patients across major markets, $2–4B), and emphasized the differentiated safety profile of evorpacept (designed without an active Fc to limit on-target hematologic toxicity). Key risks: current biomarker findings are from small cohorts and require confirmation in ASPEN-09 and later randomized trials; accelerated approval is possible but not management’s base case (they expect a Phase III registrational trial unless data are extraordinary).