ImmunityBio, Inc. has recently released its 10-K report, providing detailed insights into the company's financial performance and operations. The clinical-stage biotechnology company is focused on discovering, developing, and commercializing next-generation immuno* and cellular therapies for cancer and infectious diseases in the United States and Europe. ImmunityBio's offerings include immunotherapy and cell therapy platforms, with its lead biologic commercial product candidate being Anktiva, an IL-15 superagonist antibody-cytokine fusion protein for the treatment of non-muscle invasive bladder cancer.
In ITEM 7 of the report, "MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS," ImmunityBio highlights its business strategy, focusing on its proprietary platforms that amplify both the innate and adaptive branches of the immune system. The company's goal is to generate immunogenic cell death to eliminate rogue cells from the body, whether cancerous or virally-infected. ImmunityBio's platforms have generated nine novel therapeutic agents for which clinical trials are either underway or planned in solid and liquid tumors, including bladder, lung, and colorectal cancers, as well as glioblastoma multiforme and acute myeloid leukemia.
The report also discusses the company's recent developments, including the submission of a Biologics License Application (BLA) to the FDA for Anktiva in combination with BCG for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The FDA delivered a Complete Response Letter (CRL) indicating that it could not approve the original BLA submission in its initial form and made recommendations to address the issues raised. ImmunityBio subsequently completed the resubmission of the BLA, which the FDA accepted for review with a new user fee goal date (PDUFA date) of April 23, 2024.
Furthermore, the report details the company's collaboration agreements with various entities, including the National Cancer Institute and Amyris, Inc., as well as license agreements with other organizations. ImmunityBio also entered into a Revenue Interest Purchase Agreement (RIPA) and a Stock Purchase and Option Agreement (SPOA) with Oberland, a healthcare royalty and investment company, in December 2023. Additionally, the report provides information on the Merger Agreement between NantKwest and NantCell, resulting in the combination of their businesses.
The report also addresses the accounting treatment of the Merger and the impact of the COVID-19 pandemic on ImmunityBio's business. The company acknowledges that it has incurred net losses in each year since its inception and had an accumulated deficit of $3.0 billion as of December 31, 2023. ImmunityBio also emphasizes the importance of strategic collaborations and anticipates that such partnerships will continue to be integral to its operations. Additionally, the report highlights the agreements with related parties, particularly with NantWorks, founded by ImmunityBio's Executive Chairman, Global Chief Scientific and Medical Officer, and principal stockholder.
Today the company's shares have moved 10.9% to a price of $6.02. For the full picture, make sure to review ImmunityBio's 10-K report.
