ImmunityBio (IBRX) Investor Day 2025 summary

Strategic vision and scientific platform

• Introduced the Cancer BioShield, an immunotherapy platform activating NK and T cells to treat and prevent cancer and infectious diseases, aiming to replace chemotherapy and radiation with immune-based approaches.

• Emphasized absolute lymphocyte count (ALC) as a key biomarker for survival and treatment efficacy, advocating for its routine measurement and reversal of lymphopenia as a new standard.

• Highlighted ANKTIVA (N-803/nogapendekin alfa inbakicept) as the first approved agent, acting as a lymphocyte stimulating agent and the first lymphocyte rescue agent in over 50 years, with ongoing expansion into multiple cancer types and infectious diseases.

• Outlined a multi-modal approach: in vivo activation, ex vivo cell therapy (CAR-NK, INKT, M-ceNK), and T cell-inducing adenoviral vaccines, enabling both treatment and prevention.

• Stressed the need for education and regulatory change to accelerate immune-based therapy adoption and overcome entrenched standards favoring chemotherapy and radiation.

Clinical and commercial progress

• Achieved FDA approval for ANKTIVA plus BCG in BCG-unresponsive NMIBC, with commercial launch in May 2024, rapid payer coverage, and 71% complete remission, up to 53 months duration, and high bladder preservation rates.

• Supplemental BLA for NMIBC papillary disease submitted, with global submissions in the UK and EU by late 2024, and advocacy for regulatory consistency and expanded access.

• Exclusive global supply agreement with Serum Institute of India for BCG manufacturing and FDA-authorized expanded access for recombinant BCG to address shortages.

• ANKTIVA unit sales volume grew 150% in Q1 2025 over Q4 2024, with net product revenue of $16.5 million and market access expanded to 240 million covered lives in the U.S.

• Built robust manufacturing and supply chain infrastructure, including control over BCG, diluent, and cell therapy production.

Clinical data and product efficacy

• ANKTIVA + BCG achieved a median disease-free survival of 25.3 months and 82% cystectomy avoidance at 36 months in BCG-unresponsive NMIBC papillary disease.

• In BCG-naïve NMIBC, ANKTIVA + BCG showed 100% disease-free survival at 6 years in phase 1b, and 85% complete response at 6 and 9 months in phase 3 interim analysis.

• ANKTIVA demonstrated best-in-class duration of response (47+ months ongoing) compared to pembrolizumab and nadofaragene.

• Treatment-related adverse events were mostly grade 1 or 2, with only 3% grade 3 and no grade 4/5 events across NMIBC cohorts.

• High ALC correlates with improved overall survival across multiple tumor types, including NSCLC and pancreatic cancer.