ImmunityBio, Inc. (NASDAQ: IBRX) is a vertically-integrated biotechnology company developing next-generation therapies and vaccines to bolster the natural immune system and defeat cancers and infectious diseases. The company's range of immunotherapy and cell therapy platforms, alone and together, aim to drive and sustain an immune response with the goal of creating durable and safe protection against disease.

Financial Overview

For the full year 2023, ImmunityBio reported annual revenue of $622,000 and a net loss of $583,196,000. The company's annual operating cash flow was negative $366,757,000, and its annual free cash flow was negative $397,341,000. These financial results reflect the company's continued investment in research and development to advance its product pipeline.

In the first quarter of 2024, ImmunityBio generated revenue of $40,000, down from $360,000 in the prior-year period, primarily due to a decline in grant revenue. The company reported a net loss of $134,130,000 for the quarter, compared to a net loss of $116,583,000 in the same period of 2023. Operating cash flow was negative $106,982,000, and free cash flow was negative $142,604,000 in the first quarter of 2024.

Approved Product and Robust Pipeline

On April 22, 2024, the FDA approved ImmunityBio's product, ANKTIVA (nogapendekin alfa inbakicept-pmln), with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This approval marks a significant milestone for the company, as ANKTIVA is its first approved product.

In addition to ANKTIVA, ImmunityBio has a broad pipeline of product candidates in various stages of development, including novel therapies and vaccines based on its proprietary antibody-cytokine fusion proteins, DNA, RNA, and recombinant protein technologies, as well as cell therapies. The company's clinical focus includes bladder, lung, and colorectal cancers, as well as glioblastoma multiforme (GBM), which are among the most frequent and lethal cancer types and where there are high failure rates for existing standards of care or no available effective treatment.

Business Overview

ImmunityBio is a vertically-integrated biotechnology company with a range of proprietary platforms for the development of biologic product candidates, including antibody-cytokine fusion proteins, DNA, RNA, and recombinant protein vaccines, and cell therapies. These platforms have generated 9 novel therapeutic agents for which clinical trials are either underway or planned in solid and liquid tumors.

The company's lead biologic product, ANKTIVA, is a novel first-in-class IL-15 agonist antibody-cytokine fusion protein. ANKTIVA was approved by the FDA on April 22, 2024, for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ImmunityBio is now focused on the commercialization of ANKTIVA and the continued development of its other product candidates.

ImmunityBio's other product candidates in development include hAd5 and saRNA vaccine candidates, as well as various cell therapy product candidates, such as haNK, taNK, t-haNK, MSC, and M-ceNK. These product candidates are being evaluated for the treatment of a range of cancers, including bladder, lung, and colorectal cancers, as well as GBM.

Risks and Challenges

While ImmunityBio has made significant progress with the approval of ANKTIVA and the advancement of its pipeline, the company faces several risks and challenges. These include the ability to successfully commercialize ANKTIVA and generate meaningful revenue, the continued development and regulatory approval of its other product candidates, the ability to manufacture its products at scale, and the competition from other immunotherapy and biopharmaceutical companies.

Additionally, ImmunityBio's substantial indebtedness, including its related-party promissory notes and revenue interest liability, could adversely affect its cash flows and limit its flexibility to raise additional capital. The company will need to obtain additional financing to fund its future operations, including completing the commercialization of ANKTIVA and the development and commercialization of its other product candidates.

Liquidity

As of March 31, 2024, ImmunityBio had cash, cash equivalents, and marketable securities of $170.5 million. The company has funded its operations primarily through the issuance of related-party promissory notes and the sale of its common stock under its at-the-market (ATM) offering program and shelf registration statement.

In December 2023, ImmunityBio entered into a Revenue Interest Purchase Agreement (RIPA) with Infinity and Oberland, under which Oberland acquired certain revenue interests from the company for a gross purchase price of $200 million. Oberland may also purchase additional revenue interests from the company in exchange for a $100 million payment upon the satisfaction of certain conditions, including the FDA approval of ANKTIVA, which was received on April 22, 2024.

The company's substantial indebtedness, including its related-party promissory notes and the revenue interest liability, could adversely affect its cash flows and limit its flexibility to raise additional capital. ImmunityBio will need to obtain additional financing to fund its future operations, including completing the commercialization of ANKTIVA and the development and commercialization of its other product candidates.

Guidance and Outlook

ImmunityBio has not provided specific financial guidance for the full year 2024. However, the company has stated that it expects to begin commercial distribution of ANKTIVA as early as May 2024, following its FDA approval. The company also plans to continue the development of its other product candidates, including advancing its clinical trials and seeking regulatory approvals.

The successful commercialization of ANKTIVA and the continued advancement of ImmunityBio's pipeline will be critical to the company's future growth and profitability. Investors will be closely watching the company's ability to generate revenue from ANKTIVA and its progress in developing its other product candidates.

Conclusion

ImmunityBio is a promising biotechnology company with a diverse pipeline of novel immunotherapy and cell therapy product candidates. The recent FDA approval of ANKTIVA represents a significant milestone for the company, and the successful commercialization of this product will be a key focus going forward.

However, ImmunityBio faces several risks and challenges, including the need for additional financing, the ability to manufacture its products at scale, and competition from other companies in the immunotherapy and biopharmaceutical space. The company's substantial indebtedness could also limit its financial flexibility and ability to invest in its future growth.

Overall, ImmunityBio's combination of an approved product and a robust pipeline of promising product candidates positions the company for potential long-term success, but investors should closely monitor the company's progress in addressing its risks and challenges.