On this page of StockholderLetter.com we present the latest annual shareholder letter from ImmunityBio, Inc. — ticker symbol IBRX. Reading current and past IBRX letters to shareholders can bring important insights into the investment thesis.
Annual Report 2023
About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. We are applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. Our platforms and their associated product candidates are designed to attack cancer and infectious pathogens by activating and proliferating natural killer cells, and stimulating CD8+ killer memory T cells in an orchestrated manner. The goal of this potentially best-in-class approach is to generate immunogenic cell death thereby eliminating rogue cells from the body whether they are cancerous or virally-infected. Our ultimate goal is to overcome the limitations of current treatments, such as checkpoint inhibitors, and/or reduce the need for standard highdose chemotherapy in cancer by employing this coordinated approach to establish immunological memory that confers long-term benefit for the patient. Our proprietary platforms for the development of biologic product candidates include: (i) antibody-cytokine fusion proteins, (ii) DNA, RNA, and recombinant protein vaccines, and (iii) cell therapies. As of April 2024, our platforms have generated 9 first-in-human therapeutic agents that are currently being or planned to be studied in 24 clinical trials across 12 indications in liquid and solid tumors, including bladder, lung and colorectal cancers, and GBM. These indications are among the most frequent and lethal cancer types for which there are high failure rates for existing standards of care or, in some cases, no available effective treatment. We are constantly monitoring and prioritizing clinical development based upon the availability of our resources and the efficacy and market developments of our competitors products and product candidates, among other factors. Our lead biologic product Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) is a novel first-in-class agonist antibody-cytokine fusion protein. On April 22, 2024, the FDA approved Anktiva plus Bacillus Calmette-Gu rin (BCG) for the treatment of adult patients with BCGunresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Based on Anktiva s unique mechanism of action, we believe it could potentially lead to the evolution of immunotherapy beyond T cells. We have adopted a strategic position to be vertically-integrated and develop our products according to the FDA s Good Manufacturing Practice standards for large-scale manufacturing, even during Phase II clinical trial development. Biological upstream and downstream manufacturing capabilities, with its attendant know-how and regulatory compliance for approval, have long lead times. We have adopted an approach for preparedness to provide our vaccine, immunotherapy, and cell therapy products at a global scale. As such, we have established our own plants and have access to facilities on a global basis. We believe our plan to selectively use third-party contract manufacturing organizations for certain of our assets at various stages, coupled with internal development, will give us assurance that any products will have backup manufacturing options.
 • shareholder letter icon 4/29/2024 Letter Continued (Full PDF)
 • stockholder letter icon 4/28/2023 IBRX Stockholder Letter
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IBRX Shareholder/Stockholder Letter Transcript:

Annual Report

2023


About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation
therapies and vaccines that bolster the natural immune system to defeat cancers and infectious
diseases. The company   s range of immunotherapy and cell therapy platforms, alone and
together, act to drive and sustain an immune response with the goal of creating durable and
safe protection against disease. We are applying our science and platforms to treating cancers,
including the development of potential cancer vaccines, as well as developing immunotherapies
and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose
chemotherapy. These platforms and their associated product candidates are designed to be
more effective, accessible, and easily administered than current standards of care in oncology
and infectious diseases.
Our platforms and their associated product candidates are designed to attack cancer and
infectious pathogens by activating and proliferating natural killer cells, and stimulating
CD8+ killer memory T cells in an orchestrated manner. The goal of this potentially best-in-class
approach is to generate immunogenic cell death thereby eliminating rogue cells from the body
whether they are cancerous or virally-infected. Our ultimate goal is to overcome the limitations
of current treatments, such as checkpoint inhibitors, and/or reduce the need for standard highdose chemotherapy in cancer by employing this coordinated approach to establish
   immunological memory    that confers long-term benefit for the patient.
Our proprietary platforms for the development of biologic product candidates include:
(i) antibody-cytokine fusion proteins, (ii) DNA, RNA, and recombinant protein vaccines, and
(iii) cell therapies. As of April 2024, our platforms have generated 9 first-in-human therapeutic
agents that are currently being or planned to be studied in 24 clinical trials across 12 indications
in liquid and solid tumors, including bladder, lung and colorectal cancers, and GBM. These
indications are among the most frequent and lethal cancer types for which there are high failure
rates for existing standards of care or, in some cases, no available effective treatment. We are
constantly monitoring and prioritizing clinical development based upon the availability of our
resources and the efficacy and market developments of our competitors    products and product
candidates, among other factors.
Our lead biologic product Anktiva   (N-803, or nogapendekin alfa inbakicept-pmln) is a novel
first-in-class agonist antibody-cytokine fusion protein. On April 22, 2024, the FDA approved
Anktiva plus Bacillus Calmette-Gu  rin (BCG) for the treatment of adult patients with BCGunresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or
without papillary tumors. Based on Anktiva   s unique mechanism of action, we believe it could
potentially lead to the evolution of immunotherapy beyond T cells.
We have adopted a strategic position to be vertically-integrated and develop our products
according to the FDA   s Good Manufacturing Practice standards for large-scale manufacturing,
even during Phase II clinical trial development. Biological upstream and downstream
manufacturing capabilities, with its attendant know-how and regulatory compliance for approval,
have long lead times. We have adopted an approach for preparedness to provide our vaccine,
immunotherapy, and cell therapy products at a global scale. As such, we have established our
own plants and have access to facilities on a global basis. We believe our plan to selectively
use third-party contract manufacturing organizations for certain of our assets at various stages,
coupled with internal development, will give us assurance that any products will have backup
manufacturing options.




shareholder letter icon 4/29/2024 Letter Continued (Full PDF)
 

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