• Database lock completed for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial comparing ANKTIVA® plus BCG with BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC)
• ANKTIVA plus BCG is being evaluated as the first locally delivered, chemotherapy-free combination immunotherapy for BCG-naïve NMIBC
• Final analysis of the trial’s primary efficacy endpoint is underway, with topline results expected in November 2026
• Supplemental Biologics License Application (sBLA) submission remains on track for the fourth quarter of 2026, potentially expanding ANKTIVA’s indication to include patients with BCG-naïve NMIBC earlier in their disease course

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