ImmunityBio, Saudi Arabia's Ministry of Investment, KFSHRC, and KAIMRC Sign Strategic Memorandum of Understanding to Launch Cancer BioShield™ Platform in the Middle East

ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced the signing of a strategic Memorandum of Understanding (MOU) with the Ministry of Investment of Saudi Arabia (MISA), King Faisal Specialist Hospital & Research Centre (KFSHRC), and King Abdullah International Medical Research Center (KAIMRC). This multi-party collaboration will introduce the FDA-approved Cancer BioShield platform to Saudi Arabia and the broader Middle East, paving the way for a new era of immune-restorative therapies for cancer patients.

The announcement was made during the Saudi-U.S. Investment Forum 2025 in Riyadh, held alongside the state visit of U.S. President Donald Trump. The forum convened senior government officials, Fortune 500 executives, and global innovators to strengthen strategic ties and accelerate investments in sectors such as biotechnology, healthcare, clean energy, and AI.

The BioShield platform, powered by Anktiva® (nogapendekin alfa inbakicept)—the world's first FDA-approved IL-15 superagonist to proliferate NK and T cells (lymphocytes)—represents a paradigm shift in cancer care. Unlike conventional treatments including chemotherapy and radiation that kill and suppress natural killer immune cells and thus paradoxically catalyze further spread, the BioShield protects and activates the immune system's natural killer cells and T cells to restore immune function and prolong life. For the first time in medicine, physicians can address the long-overlooked impact of lymphopenia (loss of NK and T cells), induced by current standards of care of chemotherapy, radiation, or by the cancer itself. The BioShield is the first therapy in history to specifically address the protection and restoration of lymphocytes, represented by NK, CD8, and CD4 T cells—the most important cells in the body needed to fight cancer and infection. Treating lymphopenia is an answer to premature death from life threatening diseases such as cancer and sepsis and, potentially, to aging and longevity in health.

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

"We are honored to work with KAIMRC, KFSHRC, and MISA to bring this transformative technology to the region. The BioShield platform changes the way we think about treating cancer—not by destroying the immune system but by restoring and activating it. The root cause of early mortality is the collapse of the immune system—lymphopenia is the disease, and cancer is a symptom. Together, by considering this a paradigm change, we can build a regional center of excellence for next-generation immunotherapies in which we activate the body's natural defenses."

His Excellency Khalid A. AlFalih, Minister of Investment, Saudi Arabia, commented:

"This partnership reflects the Kingdom's commitment to positioning itself as a global hub in the biotechnology sector in advanced therapeutics. Through this collaboration, we will localize cutting-edge technologies, build biomanufacturing capabilities, and enhance our national biotechnology infrastructure and human capabilities in alignment with the objectives of the National Biotech Strategy."

This MOU will enable active engagement between the parties and includes provisions to establish Middle East subsidiaries, conduct clinical trials, and transfer scientific expertise. ImmunityBio will collaborate closely with Saudi regulatory authorities and train healthcare professionals in advanced cell therapy protocols, supporting national objectives in biotechnology leadership.

His Excellency Dr. Bandar Al Knawy, CEO of the Ministry of National Guard Health Affairs and Chairman of KAIMRC, added:

"This partnership underscores our unwavering commitment to innovation in patient-centered care. With the adoption of CAR-NK and advancements in nanotechnology, we are not only enhancing the immune system during cancer treatment but also redefining the possibilities in healthcare. Through strategic partnerships, we aim to transform lives and elevate health outcomes throughout the MENA region."

His Excellency Dr. Majid AlFayyadh, CEO of KFSHRC, concluded:

"This partnership is aligned with our mission to deliver cutting-edge care and translate scientific innovation into life-saving treatment for our patients."

Together, the partners will assess integration of the BioShield platform across clinical ecosystems and jointly establish a training and research hub to serve as a regional nucleus for immune-restorative therapies.

About the Cancer BioShield™

The BioShield platform, powered by Anktiva® (nogapendekin alfa inbakicept)—the world's first FDA-approved IL-15 superagonist—represents a paradigm shift in cancer care. Unlike conventional treatments including chemotherapy and radiation that suppress immune cells, BioShield preserves and activates the immune system's natural killer cells and T cells to restore immune function and improve outcomes. It addresses the long-overlooked impact of lymphopenia, induced by current standards of care of chemotherapy, radiation, or by the cancer itself. The BioShield is the first therapy in history to specifically address the restoration of the lymphocytes, represented by NK, CD8 and CD4 T cells.

ANKTIVA was approved by the FDA in 2024 for use in the United States with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder's Vision) and Anktiva.com.

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. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its 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. For more information, visit ImmunityBio.com (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the objectives and elements of the MOU and proposed partnerships, and expectations regarding the MOU and proposed partnerships described herein, and potential results and initiatives therefrom, anticipated collaboration with Saudi regulatory authorities and related matters, proposed strategic collaboration and partnerships set forth in the MOU, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, and ImmunityBio's approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as "anticipates," "believes," "continues," "goal," "could," "estimates," "scheduled," "expects," "intends," "may," "plans," "potential," "predicts," "indicate," "projects," "is," "seeks," "should," "will," "strategy," and variations of such words or similar expressions.

Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding whether the objectives and initiatives of the strategic collaboration set forth in the MOU described herein will ultimately be implemented and realized, as the MOU is non-binding and does not create any legal or financial obligations of the parties, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties regarding potential expansion of business operations in ex-US jurisdictions including Saudi Arabia and the broader Middle East, (iv) additionally whether the FDA will accept our regulatory submissions for use of ANKTIVA and other product candidates in indications beyond our approval label indication for filing and review, and whether the FDA will ultimately approve such regulatory submissions, expanded access protocols or other submissions in a timely manner, or at all, of which there can be no assurance, (v) whether the RMAT designation received and previously reported by the Company will lead to an accelerated review or approval, of which there can be no assurance,(vi) whether clinical trial data will be accepted by regulatory agencies, (vii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (ix) potential delays in product availability and regulatory approvals, (x) ImmunityBio's ability to retain and hire key personnel, (xi) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

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ImmunityBio Contacts:

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ImmunityBio, Inc.

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