IBRX Shareholder/Stockholder Letter Transcript:
Annual Report
2025
Letter to Our Stockholders
Dear Fellow Stockholders,
This past year and the early part of 2026 have been transformational for ImmunityBio. We achieved commercial
scale, secured multiple international approvals, and validated our vision of Immunotherapy 2.0 with clinical results
that continue to exceed expectations. We are proud to share these achievements with you.
From Approval to Commercial Success
When ANKTIVA received FDA approval in April 2024, we set an ambitious goal to demonstrate that our first-in-class
IL-15 immunotherapy could become a new standard-of-care for non-muscle invasive bladder cancer patients with
CIS with or without papillary disease (NMIBC). The results speak for themselves. Full-year 2025 net product revenue
reached approximately $113 million, a 700% increase over the prior year. Unit sales grew 750%. Today, commercial
and governmental insurance programs covering more than 240 million lives provide access to ANKTIVA.
The implementation of our permanent J-code (J9028) in January 2025 simplified reimbursement and accelerated
adoption. But the true driver of our commercial success has been clinical outcomes. NMIBC CIS patients are
achieving durable complete responses measured in years, not months. ANKTIVA is changing the treatment
paradigm.
Global Expansion
Our regulatory momentum continued this period. In NMIBC, the UK s MHRA approved ANKTIVA in July 2025, and in
February 2026 the EC issued a conditional marketing authorization covering the EU as well as Iceland,
Liechtenstein, and Norway. A significant milestone, however, came from the SFDA, which granted accelerated
approval for ANKTIVA in metastatic non-small cell lung cancer in combination with checkpoint inhibitors for adult
patients whose disease has progressed after standard therapy. This is the first regulatory approval for this indication
anywhere in the world.
We view this lung cancer approval as validation of the core thesis behind our QUILT clinical trials: that ANKTIVA
restores immune competence. In checkpoint-refractory patients who had exhausted standard options, ANKTIVA
rescued lymphocyte populations and extended median overall survival to 21 months in patients who achieved higher
immune competence, nearly three times historical outcomes.
Advancing the Science
The scientific rationale underlying our approach has never been stronger. Every cancer patient receives a complete
blood count, yet the absolute lymphocyte count, a powerful predictor of outcomes, has been largely overlooked by
oncology. Standard treatments including chemotherapy, radiation, and even some immunotherapies deplete the very
immune cells needed to fight cancer. ANKTIVA is designed to help address this fundamental problem. Our RMAT
designation for the reversal of lymphopenia in pancreatic cancer, our FDA Expanded Access authorization for solid
tumors, and our Phase 3 NSCLC trial all advance a single hypothesis: restore the immune system, and patients
survive longer.
Our off-the-shelf CAR-NK cell therapy platform reached another milestone this year with durable complete responses
in Waldenstr m lymphoma. It is the first chemotherapy-free, lymphodepletion-free CAR cell therapy to demonstrate
100% disease control in this population, and it is administered entirely in the outpatient setting.
Helping Solve the BCG Shortage
For 14 years, a BCG shortage has left tens of thousands of bladder cancer patients without adequate treatment.
Through our partnership with Serum Institute of India, we secured FDA authorization for an Expanded Access
Program providing recombinant BCG to urologists nationwide. Shipments began in the first quarter of 2025. We
continue to work with the FDA on pathways to make BCG permanently available.
Looking Ahead
As we enter 2026, our pipeline continues to advance toward registration across multiple indications. Our BCG-na ve
trial has fully enrolled with interim results showing statistically significant improvements. Our glioblastoma registration
trial is underway. Our Phase 3 NSCLC trial with BeiGene is enrolling patients. We remain committed to our mission:
activating the patient s natural immune defenses to achieve durable, lasting responses against cancer and infectious
diseases. We call this Immunotherapy 2.0, and the results are validating our vision. Thank you for your continued
support and confidence in ImmunityBio.
Sincerely,
Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer
Richard Adcock, President and Chief Executive Officer
April 2026
4/29/2026 Letter Continued (Full PDF)