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ImmunityBio (IBRX) 2025 Earnings Call Presentation
ImmunityBioImmunityBio(US:IBRX)2025-06-25 06:49

Anktiva in Bladder Cancer - Anktiva, combined with BCG, received FDA approval in April 2024 for NMIBC CIS +/- Papillary[29, 30] - In BCG-unresponsive papillary disease, Anktiva + BCG resulted in cystectomy avoidance of 92% at 12 months and 82% at 36 months[34, 41] - The disease-specific overall survival rate at 36 months with Anktiva + BCG was 96%[34, 41] - Treatment-related Grade 3 adverse events occurred in only 3% of NMIBC CIS & papillary subjects treated with Anktiva + BCG, with no Grade 4 or 5 TRAEs[42, 43] - In BCG Naïve NMIBC, 6 out of 6 patients (100%) remained disease-free for ≥ 95 years with Anktiva + BCG[57, 58] - In evaluable patients with CIS BCG Naïve NMIBC receiving Anktiva + BCG, the complete response rate was 86% at any time, 82% at 6 months, and 63% at 12 months[63, 64] - Q1 2025 Anktiva unit sales volume grew 150% over Q4 2024 due to a permanent J-code awarded in January 2025[125] - For the three-month period ending March 31, 2025, ImmunityBio achieved estimated net product revenue of approximately $165 million, surpassing net product revenue of $72 million in the prior quarter, a 129% quarter over quarter increase[125] Lymphopenia and Anktiva's Mechanism - The presentation introduces the concept of lymphopenia (ALC <1,000 Lymphocytes per Microliter) and its negative impact on overall survival in cancer patients[136, 146, 149] - Anktiva is highlighted as a lymphocyte stimulating agent that promotes the proliferation and activation of NK, CD8+, and memory T cells[165, 179, 182] Other Pipeline and Initiatives - ImmunityBio and Serum Institute of India have an exclusive arrangement for global supply of Bacillus Calmette-Guerin (BCG) across all cancer types[72] - A randomized Phase 3 trial (ResQ201A) is underway evaluating Anktiva + Tislelizumab versus Docetaxel in 2nd line NSCLC (N=460)[258, 259] - As of January 2025, the total enrollment in the Lynch Syndrome prevention trial (NCT05419011) is 101 subjects[251]