– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

– Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women –

– The V012 dialysis access study found that women who received Humacyte's ATEV experienced an average of three more months without a dialysis catheter than women who received AV fistula, the current standard of care –