Alx evorpacept shows 100% ORR in CD47‑high HER2+ breast cancer subset, non‑GAAP EPS, revenue beat

 

Alx Oncology’s evorpacept shows 100% ORR in CD47‑high HER2+ breast cancer subset, with Q1 2026 non‑GAAP EPS -$0.17 and revenue $0 beating estimates

• Evorpacept plus zanidatamab delivered 33% ORR in 24 heavily pretreated HER2+ patients.
• Centrally confirmed HER2+ subgroup achieved 60% ORR and 8.3‑month median PFS.
• CD47‑high (≥20%) HER2+ tumors saw 100% ORR and 22‑month median PFS.
• Findings align with ASPEN‑06 gastric data, reinforcing CD47 as predictive for evorpacept benefit.
• ASPEN‑09 Phase II enrolling post‑ENHERTU HER2+ patients; 80‑patient readout targeted mid‑2027.
• Ventana CD47 companion diagnostic in development; ASPEN‑09 will refine biomarker cutoff and prevalence.
• Management views ≥30% ORR and ~6‑month PFS in ASPEN‑09 as clinically meaningful.
• Accelerated approval from single‑arm ASPEN‑09 seen as unlikely; Phase III trial anticipated.
• ALX2004 EGFR ADC dose escalation continues; initial safety data expected in second half 2026.
• The company confirmed timelines for key evorpacept and ALX2004 clinical milestones.
• Q1 2026 GAAP net loss was $17.9 million, or $0.17 per share, and non‑GAAP EPS grew 71% YoY.
• R&D and G&A expenses were reduced in the quarter, and cash was $169.1 million, extending runway into first half 2028.
• February financing strengthened balance sheet to fund evorpacept and ALX2004 through upcoming milestones.
• Main concern: Very small data sets and biomarker/CDx complexity mean pivotal trials and regulatory path remain uncertain.
• Strong quarter, driven by compelling biomarker‑driven evorpacept efficacy data and steady advancement of both lead programs.

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