ImmunityBio Completes Database Lock For Cohort A Of QUILT-2.005, Randomized, Controlled, Registrational Trial Evaluating ANKTIVA In Combination With BCG Versus BCG Alone In Patients With BCG-Naïve NMIBC

• 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

ImmunityBio, Inc. (NASDAQ:IBRX), an immunotherapy company, today announced completion of the database lock for Cohort A of QUILT-2.005 (NCT02138734), its randomized, controlled, registrational trial evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve NMIBC. The chemotherapy-free combination is delivered directly into the bladder.

The database lock follows the completion of the data review, verification, and reconciliation of all 366 randomized patients, allowing the final efficacy analysis to proceed. The trial is designed to determine whether adding ANKTIVA to standard BCG therapy improves CR rates compared with BCG alone.

An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated statistically significant longer duration of complete response with ANKTIVA plus BCG compared to BCG alone. With the database lock complete for all patients enrolled, the final analysis is now underway and will assess the trial’s primary endpoint and key secondary endpoints, including the duration of response, in accordance with the prespecified statistical analysis plan.

ImmunityBio anticipates reporting topline results in November 2026 and remains on track to submit an sBLA to the FDA in the fourth quarter of 2026 for ANKTIVA plus BCG in patients with BCG-naïve NMIBC.

Cohort A completed enrollment in February 2026, with 366 patients randomized to receive ANKTIVA plus BCG versus BCG alone. In March 2026, following a protocol-specified interim review of the data from 183 evaluable patients, the Independent Data Monitoring Committee (IDMC) determined that the enrolled population provided sufficient statistical power to detect the prespecified clinically meaningful difference between treatment arms, with no additional enrollment required.