ImmunityBio (IBRX) Investor Presentation summary

Mechanism of action and clinical innovation

• ANKTIVA activates NK, CD4+, and CD8+ T cells, overcoming tumor evasion and converting cold tumors to hot, enabling durable immune responses across multiple tumor types.

• Functions as a foundational cytokine for universal cancer immunotherapy, with combinations including BCG, checkpoint inhibitors, adenoviral vaccines, Rituxan, and CAR-T/CAR-NK.

• Demonstrates efficacy in both BCG-unresponsive and BCG-naïve non-muscle invasive bladder cancer (NMIBC), with durable complete responses and prolonged cystectomy avoidance.

• Shows activity in checkpoint inhibitor-refractory lung cancer, with median overall survival of 14.1 months in NSCLC patients progressing after CPI therapy.

Regulatory milestones and market access

• ANKTIVA received FDA approval in April 2024, with launch in May 2024 and broad payer coverage by November 2024.

• EU EMA and UK MHRA filings completed in Q4 2024, with launches and approvals targeted for 2025.

• Supplemental BLA for papillary NMIBC planned for 2025, following positive interim and registration trial results.

• Collaboration with Serum Institute of India secures global BCG supply for combination therapies.

Safety, administration, and workflow

• Safety profile of ANKTIVA plus BCG is comparable to BCG alone, with low rates of grade 3/4 adverse events and no systemic absorption.

• No changes required in urology order or BCG administration workflow; product offers one-day delivery and 36-month shelf life.