Shares fell 4.7% after earnings despite an unchanged full-year revenue outlook, reflecting investor concern about slowing growth momentum and cautious incremental progress during the commercial launch phase.
- Q1 revenue of $26.2 million, with unchanged 2026 full-year guidance of $120 million to $135 million.
- First quarter showing positive gross margin, attributed to operational efficiencies and increased volume at the manufacturing plant.
- Early U.S. and U.K. commercial launches progressing with 73 U.S. centers active, expected to exceed 80 by year-end; over 10 centers active in the U.K. under NHS access.
- Product optimization efforts include a 13% workforce reduction aimed at improving cost structure, targeting a peak gross margin of 65-70% for the core ALL business.
- Pipeline progress continues with pediatric Phase II expansion underway and data expected near end of 2027; FDA alignment on protocol for registration.
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