ImmunityBio, Inc. (NASDAQ: IBRX)

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. The company harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of its strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via its proprietary IL-15 superagonist, ANKTIVA® (nogapendekin alfa inbakicept).

ImmunityBio generates revenue primarily through the commercial sale of ANKTIVA, its approved biologic product for the treatment of BCG-unresponsive NMIBC CIS with or without papillary tumors. The company began commercial distribution of ANKTIVA in May 2024 following FDA approval and reported net product revenue of approximately $113 million for the full year 2025. Revenue is also supported by expanded access programs and potential future approvals for additional indications, including metastatic NSCLC and other solid and liquid tumor types.

The company operates through the following segments:

• Cytokine Fusion Proteins: This segment focuses on IL-15 receptor superagonist antibody-cytokine fusion proteins, with ANKTIVA as the lead product. ANKTIVA is a first-in-class IL-15 receptor superagonist that activates NK cells, CD8+ T cells, and memory T cells without expanding immunosuppressive Tregs. The segment also includes development of multi-functional cytokine fusion proteins targeting TGF-ß, PD-L1, CD16, CD20, and comprising IL-12, IL-15, and IL-21 to enhance immune responses in the tumor microenvironment.

• DNA and Vaccine Vectors: This segment utilizes adenovirus-vectored vaccines, including hAd5 constructs, to deliver tumor-associated antigens and neoepitopes for oncology and infectious diseases. Key product candidates target PSA, Brachyury, CEA, MUC1, HPV [E6/E7], and nucleocapsid antigens. These vectors are designed to induce B and T cell memory and antibody responses, with second-generation hAd5 [E1-, E2b-, E3-] vectors overcoming pre-existing adenovirus immunity.

• NK Cell Therapies: This segment includes off-the-shelf and autologous NK-cell therapies, such as the CAR NK Platform (CD19 CAR-NK or t-haNK, PD-L1 CAR-NK or t-haNK) and the Apheresis Platform (M-ceNK). M-ceNK cells are generated from donor lymphocytes pre-activated with IL-12, IL-15 (N-803), and IL-18 to enhance antitumor activity, persistence, and immune memory. The segment also includes haNK and taNK platforms for targeted cancer cell killing.

ImmunityBio holds a differentiated position in the immunotherapy industry through its Cancer BioShield platform, which integrates cytokine fusion proteins, vaccine vectors, and cell therapies to address lymphopenia and immune evasion in cancer. ANKTIVA is the only FDA-approved IL-15 receptor superagonist as of December 31, 2025, giving the company a first-mover advantage in this therapeutic class. The company competes with established therapies such as pembrolizumab (KEYTRUDA), nivolumab (OPDIVO), and atezolizumab (TECENTRIQ) in NSCLC, and with BCG and approved agents like nadofaragene firadenovec (ADSTILADRIN) and nadofaragene firadenovec-vncg in NMIBC, but distinguishes itself through its mechanism of activating both innate and adaptive immune systems without Treg expansion.

ImmunityBio serves hospitals, urology clinics, oncology centers, and infusion centers where its products are administered for the treatment of bladder cancer, lung cancer, pancreatic cancer, glioblastoma, lymphoma, and other solid tumors. The company’s ANKTIVA therapy is used in combination with BCG or checkpoint inhibitors in adult patients with BCG-unresponsive NMIBC CIS with or without papillary tumors and metastatic NSCLC progressing after standard-of-care therapy. Specific customer names are not disclosed in the filing, but the company reports payer coverage exceeding 240 million lives in the U. S. as of December 2025, supported by a permanent J-code (J9028) from CMS effective January 1, 2025.