Core Insights - ImmunityBio, Inc. has provided an update on the enrollment status of its randomized registrational trial for BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005, indicating that enrollment has exceeded internal expectations and is over 85% complete [1] Enrollment Status - The trial's enrollment is anticipated to reach full capacity by Q2 2026, based on the current enrollment trajectory [1] - The company expects to submit a biologics license application following the completion of the trial [1]

Core Insights - ImmunityBio, Inc. is positioned as a leader in immunotherapy, focusing on cancer and immune disorders with its flagship therapy ANKTIVA® [2] - The company reported significant commercial momentum in 2025, with a notable increase in revenue and unit sales following J-code approval [3][4] - ImmunityBio is actively expanding its clinical trials and regulatory efforts to enhance the adoption of ANKTIVA in various cancer indications [4][5][6] Group 1: Financial Performance - In Q2 2025, ImmunityBio reported revenue of $26.4 million, a 60% increase from Q1, leading to year-to-date sales of $43 million [3] - Unit sales surged by 246% due to streamlined reimbursement processes following J-code approval [3] Group 2: Product Development and Regulatory Efforts - ANKTIVA is being expanded for use in new indications, including lung cancer and lymphopenia, with ongoing trials [2][5] - The company is collaborating with the FDA after receiving a Refuse-to-File letter for its supplemental biologics license application for papillary-only NMIBC [4] - ImmunityBio is advocating for guideline updates through the National Comprehensive Cancer Network (NCCN) to strengthen ANKTIVA's clinical adoption in the U.S. [4] Group 3: Strategic Initiatives - The company launched the ResQ201A trial to evaluate N-803 with tislelizumab in second-line non-small cell lung cancer patients [5] - ImmunityBio raised $80 million in equity financing to support regulatory discussions, clinical trials, and commercial expansion [6] - The UK regulatory agency approved ANKTIVA plus BCG for BCG-unresponsive NMIBC carcinoma in situ, enhancing its market reach [3]