ImmunityBio (IBRX) Investor Day 2025 summary

Strategic vision and scientific platform

• Introduced the Cancer BioShield, a paradigm-shifting immunotherapy platform focused on activating and sustaining NK and T cell responses to treat and prevent cancer and infectious diseases, emphasizing tumor-agnostic and host-centric approaches.

• Highlighted the limitations of traditional chemotherapy and radiation, advocating for immune system activation and avoidance of lymphopenia to improve survival and quality of life.

• Emphasized the importance of measuring and reversing lymphopenia as a universal prognostic factor across all cancers, with ANKTIVA (N-803) positioned as a first-in-class lymphocyte-stimulating agent (LSA) and the first lymphocyte rescue agent in over 50 years.

• Outlined a multi-modal platform: in vivo (fusion protein, adenoviral vaccines) and ex vivo (CAR-NK, INKT, memory NK cells) therapies, with ongoing automation to scale cell therapy manufacturing.

• Announced expansion into infectious disease (HIV, HPV, long COVID) and preventative trials (Lynch syndrome, colon cancer), leveraging the same immunological principles.

Clinical and commercial progress

• ANKTIVA plus BCG achieved 71% complete remission and up to 53 months duration in BCG-unresponsive non-muscle-invasive bladder cancer, with high cystectomy-free and overall survival rates.

• 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.

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

• Commercial launch accelerated after J-code approval, in-house sales force, and streamlined distribution, resulting in 129–150% quarter-over-quarter revenue growth and broadening access.

Regulatory and market expansion

• ANKTIVA (nogapendekin alfa inbakicept) received FDA approval in April 2024 for use with BCG in NMIBC, with commercial launch in May 2024 and rapid payer coverage expansion.

• Supplemental BLA for papillary bladder cancer submitted, showing similar efficacy and safety; regulatory approval pending, with advocacy for guideline consistency.

• Exclusive global supply agreement with Serum Institute of India for BCG manufacturing to support ANKTIVA combination therapy and address BCG shortages.

• FDA authorized expanded access for recombinant BCG (rBCG) in February 2025, with immediate shipments to address TICE BCG shortages in the U.S.

• European submissions underway (EMA, MHRA), with global expansion plans and robust supply chain investments ensuring product availability.