ImmunityBio, Inc. Annual Report: A Comprehensive Investor Review

This annual review offers investors a detailed look into ImmunityBio, Inc.'s performance and strategic direction, providing key insights.

Executive Summary

ImmunityBio, a clinical-stage biotechnology company, saw significant revenue growth in 2025, primarily driven by the initial commercialization of its first approved product. While sales surged, the company continues to operate at a substantial net loss, requiring ongoing capital raises through equity offerings. Key financial metrics highlight rapid expansion alongside considerable cash burn, underscoring the critical importance of clinical pipeline progress and regulatory milestones.

Business Overview

ImmunityBio, Inc. is a clinical-stage biotechnology company developing a broad pipeline of cell and gene therapies for cancer and infectious diseases. Its core NANT Cancer Vaccine platform aims to activate both the innate and adaptive immune systems. ANKTIVA® (N-803), its first commercial product, received regulatory approval for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), marking its shift to a commercial-stage entity. ImmunityBio leverages its proprietary platforms to develop, advance, and commercialize novel immunotherapies, either independently or through strategic collaborations.

Financial Performance: Rapid Revenue Growth Amidst Operating Losses

ImmunityBio experienced a transformative 2025, marked by the commercial launch of its first product and subsequent revenue acceleration.

• Product Sales: Product revenue saw a dramatic increase, growing from $0 in 2023 to $10 million in 2024, and reaching an impressive $100 million in 2025. This demonstrates successful market entry and initial adoption of ANKTIVA® (N-803) for BCG-unresponsive NMIBC carcinoma in situ (CIS).
• Other Revenue Streams:
  • Collaborative Agreements: Revenue from partnerships, such as those with A3M IPC and AAHI, grew steadily from $1 million in 2023 to $3 million in 2024, and further to $5 million in 2025, reflecting successful use of external expertise and resources.
  • Other Income: Miscellaneous income also increased from $0.5 million in 2023 to $1 million in 2024, and $2 million in 2025.
• Total Revenue: Total revenue surged from just $0.5 million in 2023 to $11 million in 2024, and a substantial $102 million in 2025.
• Operating Expenses & Profitability: Despite this revenue growth, the company reported significant operating expenses, including substantial research and development (R&D) costs and selling, general, and administrative (SG&A) expenses. As a result, ImmunityBio continued to incur substantial net losses in 2025. These losses are consistent with its stage of development as a biotech company heavily investing in its pipeline and commercial infrastructure. This reflects the high costs associated with clinical trials, regulatory processes, and commercialization efforts.

Management's Discussion and Analysis (MD&A) Highlights

• Results of Operations: ANKTIVA®'s successful commercial launch primarily drove the significant increase in total revenue in 2025. Consistent, though smaller, increases in collaborative and other income further supported this growth. Despite rising revenue, the company continued to incur substantial net losses due to significant investments in R&D for its pipeline, as well as increased SG&A expenses necessary to support commercialization efforts and expand its operational infrastructure. Management highlights that these losses are typical for a biotechnology company at this stage, balancing commercialization with ongoing pipeline development.
• Liquidity and Capital Resources: In 2025, the company's financial strategy focused on securing capital for operations, clinical trials, and commercial expansion. This was achieved through a combination of at-the-market (ATM) offerings and private placements, strengthening its cash position but also significantly diluting shareholders. Management closely monitors its cash burn and liquidity, indicating a continued need for capital raises to support future growth and achieve profitability. The company manages its existing debt, including convertible notes, with an awareness of potential future dilution upon conversion.

Financial Health: Capital Raises and Debt Management

ImmunityBio actively raised capital to fund its growth and operations, impacting its balance sheet and shareholder structure.

• Capital Raising Activities:
  • At-The-Market (ATM) Offerings: Its ATM program generated $50 million in 2025, up from $25 million in 2024 and $10 million in 2023.
  • Private Placements: Significant funds were also secured through private placements, bringing in $100 million in 2025, compared to $50 million in 2024 and $20 million in 2023.
  • Dilution: These capital raises primarily involved issuing new shares of common stock, significantly diluting existing shareholders. This increase in outstanding shares impacts earnings per share and ownership percentage.
• Debt Profile:
  • Convertible Notes: As of year-end 2025, the company had approximately $50.5 million in convertible notes payable to an affiliated entity. These notes typically have specific interest rates and maturity dates, and can convert into common stock under certain conditions, potentially causing further dilution.
  • Promissory Note: A $30 million promissory note from 2023 has since been managed or converted.
• Accrued Expenses: Accrued rebates and other fees increased from $2 million in 2024 to $5 million in 2025, a common occurrence with growing sales, representing liabilities for future product-related payments.
• Cash Burn: The company experienced substantial cash burn from operations in 2025, reflecting its investment phase. This requires continued vigilance regarding its liquidity and future financing needs.
• Investments: The company increased its holdings in US Treasury Securities to $20 million in 2025 from $15 million in 2024, indicating some strategic cash management. Investment in "in-process research and development" remained at $10 million at year-end 2025, representing capitalized costs for ongoing R&D projects not yet commercially viable.

Key Risk Factors

Investors should be aware of several critical risks inherent to ImmunityBio's business model:

• Customer Concentration: Four customers generated 90% of total sales revenue in 2025, with one customer (Customer A) alone accounting for 40%. This high concentration poses a substantial risk; losing or reducing orders from any of these key customers could materially impact revenue and financial performance.
• Regulatory Approval & Clinical Trial Success: As a biotech company, ImmunityBio's success heavily depends on successfully completing clinical trials and gaining regulatory approvals for its pipeline candidates. Failure in any trial phase or inability to secure regulatory approval for new indications or products would severely impact future growth.
• Liquidity & Capital Needs: The company's ongoing net losses and cash burn indicate a continued reliance on external financing. There is no guarantee that sufficient capital will be available on favorable terms, which could impede R&D, commercialization, or even raise going concern issues.
• Competition: The oncology and immunology markets are highly competitive. ImmunityBio faces competition from established pharmaceutical companies and other biotech firms with significant resources, approved products, and extensive pipelines.
• Product Commercialization & Market Acceptance: While ANKTIVA® has launched, its long-term commercial success depends on market adoption, physician prescribing, and reimbursement policies.
• Intellectual Property: The company's future depends on its ability to protect its intellectual property through patents and other means. Challenges to its patents could negatively impact its competitive position.

Competitive Position

ImmunityBio operates in highly competitive and rapidly evolving oncology and immunology markets. Its primary competition comes from established pharmaceutical companies and other biotechnology firms developing or commercializing therapies for similar indications, particularly in bladder cancer and other oncology areas. Key competitive factors include therapy efficacy, safety, and tolerability; the speed of clinical development and regulatory approval; market access and reimbursement; manufacturing capabilities; and intellectual property protection. ImmunityBio's competitive advantages stem from its unique NANT Cancer Vaccine platform and proprietary cell and gene therapy approaches, which aim to offer differentiated mechanisms of action. The company seeks to distinguish itself through the potential for improved patient outcomes, novel treatment approaches, and a broad pipeline addressing multiple disease areas. Specific competitors in the NMIBC market include companies with existing approved therapies or those developing new treatments for BCG-unresponsive disease. For its broader pipeline, competition exists across various cancer types and infectious diseases from companies using diverse therapeutic modalities.

Future Outlook: Pipeline Development and Market Expansion

ImmunityBio's strategy centers on leveraging its NANT Cancer Vaccine platform, commercializing ANKTIVA®, and advancing its broader pipeline.

• Pipeline Focus: The company continues to invest $10 million in "in-process research and development" at year-end 2025. This investment supports its diverse pipeline, including candidates for various cancers and infectious diseases, using its unique cell and gene therapy approaches.
• Commercialization of ANKTIVA®: The near-term primary focus is the successful commercialization and market penetration of ANKTIVA® for NMIBC. This involves expanding sales infrastructure, securing favorable reimbursement, and educating healthcare providers.
• Collaborations: Growth in collaborative revenue highlights a strategy of partnering to accelerate development, expand reach, or share expertise. These collaborations are crucial for diversifying revenue and advancing complex research.
• Future Milestones: Investors should monitor upcoming clinical trial readouts, potential regulatory submissions for new indications or products, and progress in expanding ANKTIVA®'s commercial footprint. The company's ability to transition from a single-product commercial entity to one with multiple approved therapies will be key to its long-term success.