Group 1 - The article discusses the recent FDA Refusal to File (RTF) letter received by ImmunityBio (IBRX) regarding ANKTIVA's supplemental BLA for papillary-only NMIBC, which led to a negative market reaction [1] - The author emphasizes their long position in IBRX shares, indicating a belief in the company's potential despite recent setbacks [2] - The article is part of a broader investment strategy focused on innovative biotech companies developing breakthrough therapies, highlighting the author's expertise in the healthcare sector [1]

ANKTIVA Mechanism and Applications - ANKTIVA activates NK cells and rescues T cells, serving as a foundational cytokine for universal cancer immunotherapy across multiple tumor types[18] - ANKTIVA, combined with BCG, is approved for bladder cancer and is being investigated in lung cancer, prostate cancer, colon cancer, and hematologic malignancies[20, 22] - ANKTIVA's mechanism overcomes tumor evasion by activating NK cells and rescuing T cells[12] Clinical Trial Results and Regulatory Status - In BCG-unresponsive NMIBC-CIS, ANKTIVA demonstrated a 71% complete response rate[25] - In BCG-unresponsive papillary NMIBC, ANKTIVA showed a disease-free rate of 55.4% at 12 months, 51.1% at 18 months, and 48.3% at 24 months, with 93% cystectomy avoidance[50] - In the NMIBC BCG-naive setting, ANKTIVA + BCG resulted in 100% complete response and disease-free status for at least 9.5 years in 6 out of 6 patients[54, 55] - An interim analysis of a Phase 3 trial in NMIBC BCG-naive patients showed an 84% complete response rate with ANKTIVA + BCG compared to 52% with BCG alone[57] - A BLA submission is planned for the QUILT-3.055 study (N=83) for lung cancer checkpoint progressors[70] Market Access and Launch - ANKTIVA received J-Code 9028 effective January 2025[35] - Market access covers 240 million medical lives as of November 2024[37] Intellectual Property - ImmunityBio has over 700 issued patents worldwide covering its immunotherapy portfolio[75]

Forward-Looking Statements and Intended Use This presentation and the accompanying verbal remarks contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data and results from clinical trials and potential implications therefrom, commercialization plans and timelines, including product availability and shipments, potential regulatory pathways and approval requests and submissions, FDA and other regulatory agency meetings, ti ...