• Moderna for cancer immunotherapy.
• An aspiring Genentech, pioneering next-generation cancer treatments.
• An early-stage Amgen, building a pipeline of advanced immunotherapies.

• Anktiva (N-803): A novel IL-15 superagonist cytokine developed as a potential immunotherapy for various cancers, most notably for BCG-unresponsive non-muscle invasive bladder cancer.
• hAd5 T-Cell COVID-19 Vaccine Platform: A proprietary adenovirus-based platform designed to induce a broad T-cell immune response against infectious diseases, including COVID-19.

ImmunityBio (IBRX) primarily sells its products to other companies and institutions (business-to-business or B2B), rather than directly to individuals.

With the recent FDA approval of its flagship drug, ANKTIVA (N-803), for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in April 2024, ImmunityBio's major customers for its commercialized product are now healthcare providers in the United States. ImmunityBio plans to commercialize ANKTIVA primarily through its own sales force, targeting institutions that treat this specific patient population.

These customer categories include:

• Hospitals: Large medical institutions that administer specialized treatments for various conditions, including cancer.
• Cancer Treatment Centers: Specialized facilities focused on oncology care, where patients receive advanced cancer therapies.
• Urology Clinics: Medical practices specializing in diseases of the urinary tract and male reproductive organs, including bladder cancer.

Prior to commercialization, ImmunityBio's revenue primarily came from license and collaboration agreements and supply agreements. Its 2023 Annual Report (10-K) noted that revenue from a single customer represented 60% of its total revenue for that year; however, the name of this customer was not disclosed in public filings, and this revenue stream largely predates the commercial launch of ANKTIVA.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman, Global Chief Scientific and Medical Officer

Dr. Patrick Soon-Shiong is a transplant surgeon, medical researcher, and entrepreneur. He founded two global pharmaceutical companies, American Pharmaceutical Partners and Abraxis BioScience. He sold American Pharmaceutical Partners to Fresenius for approximately $4.6 billion in 2008, and Abraxis BioScience to Celgene for approximately $3.8 billion in 2010. Dr. Soon-Shiong also serves as Chairman and Chief Executive Officer of NantWorks, an ecosystem of companies. He founded VivoRx Inc. in 1991, which led to the establishment of APP Pharmaceuticals.

Richard Adcock, Chief Executive Officer and President

Richard Adcock has served as CEO of ImmunityBio since October 2020 and was appointed President and a Board member in March 2021. Prior to ImmunityBio, he held pivotal roles including CEO of Verity Health System and Executive Vice President and Chief Innovation Officer for Sanford Health. Earlier in his career, he was co-owner and Vice President of Research & Development at Micro Medical Systems, a company that was acquired by General Electric, where he subsequently served as Global Engineering Director.

David Sachs, Chief Financial Officer

David Sachs joined ImmunityBio as Chief Financial Officer in July 2019. He brings over two decades of operating, development, and investing experience, with a background in finance, private equity, venture capital, and investment banking. Previously, he served as CFO for several NantWorks subsidiaries, including NantHealth and Integrity Healthcare, LLC. He also held roles as a principal and executive at NantCapital, serving as a member of its investment committee. Prior to his roles with NantWorks, Mr. Sachs was an investment banker for Bank of America Merrill Lynch and held senior operating roles at Abraxis BioScience and Celgene.

Dr. Barry Simon, Chief Corporate Affairs Officer and Director

Dr. Barry Simon has served as Chief Corporate Affairs Officer and a Director of ImmunityBio since March 2021. He previously served as President and Chief Administrative Officer of Nantkwest, Inc. since 2015 and as its President and CEO from 2007 to 2015. Dr. Simon has broad experience in public and private settings, including leading product and portfolio divestitures and acquisitions, strategic licensing, and numerous commercial product launches.

Dr. Leonard S. Sender, Chief Operating Officer

Dr. Leonard Sender joined ImmunityBio as Chief Operating Officer in March 2020. Prior to this, he served as Senior Vice President of Medical Affairs at NantKwest. Dr. Sender is an accomplished transplant surgeon and has held roles such as Medical Director of the Hyundai Cancer Institute at Children's Hospital in Orange County, California, and Medical Director of Clinical Oncology at the University of California's Chao Family Comprehensive Cancer Center. He is also recognized as a pioneer in the treatment of cancer in adolescents and young adults.

The key risks to ImmunityBio's business (IBRX) are:

1. Financial Sustainability: ImmunityBio faces significant financial challenges, including ongoing operating losses, a high cash burn rate, and substantial debt. The company has a poor financial strength rating and its management has cited substantial doubt about its ability to continue as a going concern without additional funding. It relies heavily on equity offerings for financing, leading to potential shareholder dilution.
2. Regulatory and Clinical Development Risks: As a biotechnology company, ImmunityBio is exposed to the inherent uncertainties and lengthy processes of drug development and regulatory approval. While its lead product, ANKTIVA, has received approvals (e.g., FDA, conditional EMA recommendation), these approvals often require ongoing data submission and post-marketing scrutiny, and the EMA recommendation for ANKTIVA was based on a single-arm trial. There are also risks associated with potential conflicts of interest due to financial relationships with related-party clinical sites. Delays or failures in obtaining further regulatory approvals for current or pipeline candidates, or issues with manufacturing, could materially harm the business.
3. Commercialization and Market Competition: Despite ANKTIVA's approval and initial revenue generation, its revenue growth is described as modest for a high-value biologic, and the company still generates minimal overall revenue from product sales. ImmunityBio operates in a highly competitive landscape for non-muscle invasive bladder cancer (NMIBC) treatments, with emerging therapies potentially threatening ANKTIVA's market share. Challenges in sales, marketing, distribution, and securing reimbursement coverage for combination therapies, which depend on the availability and cost of other agents, also pose significant risks to its ability to successfully commercialize its products.

The primary clear emerging threat for ImmunityBio (IBRX) is the successful market entry and increasing adoption of competing novel therapies for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Specifically, Ferring Pharmaceuticals' gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg) received FDA approval in December 2022 for the same indication that ImmunityBio's leading candidate, Anktiva (N-803), is targeting. As Anktiva has faced repeated manufacturing-related delays in its Biologics License Application (BLA) review, ADSTILADRIN has been able to establish itself in the market and capture market share.

This provides a significant first-mover advantage to ADSTILADRIN and could lead to it becoming an entrenched standard of care, making it considerably more challenging for Anktiva to penetrate the market effectively and gain physician adoption once it eventually receives approval.

ImmunityBio (IBRX) is a biotechnology company focused on developing immunotherapies for various cancers and infectious diseases. Their main product, ANKTIVA, and other pipeline candidates target several significant addressable markets.

Main Products and Addressable Markets:

• ANKTIVA for BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma In Situ (CIS): ANKTIVA (nogapendekin alfa inbakicept) is FDA-approved for adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
  • The U.S. market for NMIBC was estimated at $1.7 billion in 2023 and is expected to grow.
  • The global bladder cancer market size reached $3.9 billion in 2023 and is projected to reach $5.4 billion by 2034.
  • The market gap for the Bacillus Calmette-Guérin (BCG) shortage, which ImmunityBio's recombinant BCG (rBCG) program aims to address, is a $1 billion market.
• ANKTIVA for Non-Small Cell Lung Cancer (NSCLC): ImmunityBio has initiated a global, randomized Phase 3 study (ResQ201A) evaluating ANKTIVA in combination with TEVIMBRA® (BeOne) and docetaxel for patients with checkpoint inhibitor-resistant NSCLC.
  • The global non-small cell lung cancer therapeutics market size was approximately $19.85 billion in 2023 and is projected to reach around $66.20 billion by 2033.
  • The U.S. non-small cell lung cancer therapeutics market was valued at $4.97 billion in 2023 and is projected to reach $16.82 billion by 2033.
• ANKTIVA and CAR-NK for Metastatic Pancreatic Cancer: ImmunityBio has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for ANKTIVA and CAR-NK (PD-L1 t-haNK) for the treatment of multiply relapsed locally advanced or metastatic pancreatic cancer.
  • The 7 major market (7MM) for pancreatic cancer reached approximately $2.39 billion in 2024 and is expected to reach $9.03 billion by 2035.
• ANKTIVA for Lymphopenia: ANKTIVA has RMAT designation for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy.
  • This is described as a potentially large market, with the potential to generate hundreds of millions in annual revenue, particularly as a supportive therapy for many cancer patients.
• CAR-NK cell therapy for Non-Hodgkin Lymphoma (NHL): Early results from the QUILT.106 trial showed promising complete responses in patients with late-stage Waldenstrom macroglobulinemia, a type of NHL, using its CD19 CAR-NK natural killer cell therapy.
• ANKTIVA and PD-L1 CAR-NK for Glioblastoma (GBM): Early results in recurrent glioblastoma patients treated with ANKTIVA plus the Optune Gio® device in combination with PD-L1 CAR-NK showed 100% disease control. ImmunityBio is initiating a randomized registration trial for second-line GBM patients.

For Non-Hodgkin Lymphoma and Glioblastoma, specific addressable market sizes were not identified in the provided search results.

ImmunityBio (IBRX) anticipates several key drivers to fuel its revenue growth over the next two to three years, primarily centered on the expanding applications and market reach of its leading immunotherapy, ANKTIVA (N-803), and its broader Cancer BioShield platform.

1. Increased Commercial Adoption and Market Penetration of ANKTIVA for BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma In Situ (CIS): ANKTIVA, approved by the FDA in April 2024 and commercially available since May 2024, is currently ImmunityBio's primary revenue generator. The company has reported substantial growth, with Q3 2025 product revenue increasing by 434% compared to Q3 2024, and year-to-date 2025 unit sales volume growing by 467% over fiscal year 2024. The issuance of a permanent J-code effective January 1, 2025, has made ANKTIVA widely accessible through commercial and government insurance programs, including Medicare. Its recognition as a preferred drug by a major medication contracting organization covering approximately 80 million lives further indicates growing adoption in both leading research centers and community urology clinics.

2. Expansion of ANKTIVA into New Geographical Markets (United Kingdom and European Union): ImmunityBio is actively pursuing international market expansion for ANKTIVA. A Marketing Authorization Application (MAA) for ANKTIVA in the United Kingdom was submitted to the MHRA in November 2024 and subsequently approved by August 2025. The company also intends to submit an MAA to the European Medicines Agency (EMA) in Q4 2024, aiming to cover 30 European countries. These approvals would open significant new revenue streams for ANKTIVA beyond the U.S. market.

3. Potential Approval and Commercialization of ANKTIVA for Papillary NMIBC: Beyond carcinoma in situ, ImmunityBio is working to expand ANKTIVA's indication to include papillary-only NMIBC. Updated clinical trial data (QUILT-3.032) have shown durable 36-month progression-free survival and bladder-sparing benefits for ANKTIVA plus BCG in this patient population. Although the FDA previously issued a Refuse to File decision for this specific indication, discussions with the agency are ongoing, and ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to broaden guidelines to include papillary-only disease.

4. Advancement and Potential Approval of ANKTIVA in Non-Small Cell Lung Cancer (NSCLC): ImmunityBio has initiated ResQ201A, a global, randomized Phase 3 study investigating ANKTIVA in combination with TEVIMBRA and docetaxel for patients with checkpoint inhibitor-resistant NSCLC. Clinical trial applications for this program have been submitted in the EU and UK, with plans for submissions in Canada and Asia. Positive overall survival results from earlier studies for second and third-line NSCLC patients who had progressed after checkpoint inhibitor therapy reinforce the potential for ANKTIVA in this large oncology market.

5. Development and Commercialization of the Cancer BioShield Platform for Lymphopenia: ImmunityBio's Cancer BioShield platform, which includes ANKTIVA, aims to restore immune competence by reversing lymphopenia (low lymphocyte counts), a common issue in cancer patients. The FDA has shown support for new data from their lymphopenia program, reconfirming a Regenerative Medicine Advanced Therapy (RMAT) designation and an Expanded Access Program (EAP) authorization for solid tumors in patients with low absolute lymphocyte counts. An efficient path to full approval for this indication could significantly broaden ANKTIVA's utility across various cancer types and contribute substantially to future revenue.

Share Issuance

• In March 2021, ImmunityBio completed a reverse merger with NantKwest in a stock-for-stock transaction, forming the current public company listed as IBRX.
• In December 2024, ImmunityBio issued 33,333,334 shares of common stock through an underwritten public offering at $3.00 per share, generating approximately $100 million in gross proceeds.
• In July 2025, the company executed a registered direct offering to two institutional investors, issuing 29,629,632 common shares and warrants for an equal number of shares, resulting in approximately $80 million in gross proceeds.

Inbound Investments

• ImmunityBio received approximately $80 million in gross proceeds from an equity financing with two institutional investors in July 2025.
• An underwritten public offering in December 2024 generated approximately $100 million in gross proceeds for the company.
• In July 2023, ImmunityBio secured approximately $40 million in gross proceeds through a registered direct offering, with the potential for an additional $48 million from warrant exercises.

Capital Expenditures

• ImmunityBio reported capital expenditures of $13 million in 2021, $78 million in 2022, and $31 million in 2023.
• Capital expenditures for 2024 were approximately $6.89 million.
• These expenditures primarily focus on supporting research and development, clinical trials, and the maintenance and expansion of large-scale cGMP manufacturing facilities, especially with the commercial launch of Anktiva.