BCG Live(Organon & Co.)

Five issued U.S. patents cover the combination of ImmunityBio’s IL-15 receptor agonist (NAI) with Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer treatment, with terms extending through at least 2035 Claims cover methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease, defined-dose pharmaceutical compositions matching the approved NAI + BCG intravesical regimen, and two-vial commercial kits Portfolio reinforces ImmunityBio's IL-15 receptor agonist plus BCG position as the Company executes its exclusive U.S. Tokyo-172 BCG supply agreement with Japan BCG Laboratory and continues to develop Recombinant BCG (rBCG) to enhance USA supply CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a vertically integrated commercial-stage immunotherapy company, today announced that five United States patents have been issued to ImmunityBio covering the combination of its IL-15 receptor agonist ANKTIVA ® (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for the treatment of cancer. The five patents (U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432) with terms extending through at least 2035 include compositions of combinations of ANKTIVA and BCG. Together they protect the approved ANKTIVA plus BCG product, the specific intravesical dosing regimen, the two-vial commercial kit, and methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease and bladder cancer. The issued patent portfolio establishes composition-of-matter and method-of-use protection for ImmunityBio’s IL-15 receptor agonist and BCG combination platform through the next decade and beyond. This intellectual property position supports the Company’s commercial ANKTIVA plus BCG franchise in BCG-unresponsive NMIBC and bladder cancer, its pending supplemental BLA for BCG-unresponsive papillary-only disease, and the advancing QUILT-2.005 registrational trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC carcinoma in situ . The patent portfolio also intersects with ImmunityBio’s recently announced exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172), which is supported by the positive Phase III SWOG S1602 results demonstrating non-inferiority of Tokyo-172 BCG versus TICE BCG on high-grade recurrence-free survival (HR 0.82; 95.8% CI 0.63–1.08) in 984 randomized patients with BCG-naïve high-grade NMIBC. As ImmunityBio engages with the FDA to pursue U.S. approval of Tokyo-172 BCG, the issued patent estate protects the combination of any approved BCG strain with the Company’s IL-15 receptor agonist platform. “Over the past decade, we have built an integrated immunotherapy platform grounded in the science of IL-15 and its capacity to activate NK cells, CD8+ T cells, and memory T cells without expanding suppressive regulatory T cells. These five issued patents protect that science at every layer that matters commercially: the compositions of matter, the method of treatment, the wild-type and mutant IL-15 plus BCG compositions, the intravesical dosing regimen, and the two-vial kit physicians administer. The IL-15 and BCG combination is the backbone of our bladder cancer franchise, and this patent estate protects it through at least 2035. In a similar vein, ImmunityBio has received issued patents covering the combination of ANKTIVA with checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. “This patent portfolio provides long-term protection for a cornerstone of ImmunityBio’s commercial franchise at a time when we are expanding the clinical utility of ANKTIVA plus BCG across multiple NMIBC settings, securing a second BCG supply source for the U.S. market, and generating 700% year-over-year revenue growth. The combination of durable patent protection, validated clinical data, and supply chain diversification positions ANKTIVA plus BCG as the standard of care in this disease for years to come,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. U.S. Patent No. 11,173,191 (issued November 16, 2021) covers the core method of treating cancer by administering BCG together with the IL-15N72D:IL-15RαSu/Fc complex (ALT-803/ANKTIVA), with dependent claims specific to bladder cancer, NMIBC, BCG-naïve NMIBC, and intravesical administration. This is the foundational method-of-treatment claim that reads directly on the FDA-approved use of ANKTIVA plus BCG. U.S. Patent No. 11,679,144 (issued June 20, 2023) covers the pharmaceutical composition combining BCG with a wild-type IL-15:IL-15RαSu complex, including the two-vial kit format (one vial BCG, one vial IL-15:IL-15RαSu, plus directions for use in treating cancer including bladder cancer). This broadens composition and product-form protection beyond the IL-15N72D mutant to wild-type IL-15 combinations. U.S. Patent No. 11,890,323 (issued February 6, 2024) covers the method of treating NMIBC, including BCG-naïve NMIBC, by intravesical instillation of BCG plus a wild-type IL-15:IL-15RαSu complex. This patent pairs with 11,173,191 to cover both the IL-15 mutant and wild-type forms of the combination, closing a potential design-around route. U.S. Patent No. 12,268,731 (issued April 8, 2025) covers the defined-dose composition itself: a single intravesical dose, matching the ANKTIVA plus BCG dosing regimen used in the FDA-approved label and in the QUILT-3.032 and QUILT-2.005 trials. Claims also cover the corresponding two-vial bladder cancer treatment kit. U.S. Patent No. 12,318,432 (issued June 3, 2025) covers the commercial two-vial kit itself: a first vial of BCG and a second vial of ANKTIVA (dimeric IL-15RαSu/Fc plus two IL-15N72D molecules) with instructions for treating neoplasia. This patent protects the as-supplied product configuration that physicians receive and administer. About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA ® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA ® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. Important Safety Information U.S. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (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. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com. Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio's FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements including, but are not limited to, statements regarding the expected benefits, scope, validity, enforceability, and commercial value of ImmunityBio's patent portfolio; the expected duration of patent protection for ANKTIVA® in combination with BCG through at least 2035; the potential for patent term extensions or adjustments; the commercial and competitive advantages afforded by the issued patents; the Company's ability to maintain and expand its intellectual property position around IL-15 receptor agonist and BCG combinations; expectations regarding the QUILT-2.005 registrational trial and potential supplemental BLA approval for BCG-unresponsive papillary-only disease; anticipated revenue growth and market expansion for the ANKTIVA plus BCG franchise; the successful development and U.S. regulatory approval of Tokyo-172 BCG; and the Company's ability to execute its U.S. supply agreement with Japan BCG Laboratory. These forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, known and unknown, that may cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to: challenges to the validity or enforceability of our patents in litigation or administrative proceedings; potential infringement claims by third parties; the possibility that competitors may design around our patents or develop alternative therapies; uncertainties regarding patent term extension or adjustment calculations; the risk that regulatory authorities may not approve Tokyo-172 BCG or the supplemental BLA for papillary-only disease; changes in patent laws and regulations; the outcome of ongoing and future clinical trials; market acceptance of ANKTIVA plus BCG; manufacturing and supply chain risks; and other factors discussed in ImmunityBio's filings with the U.S. Securities and Exchange Commission (SEC), including the "Risk Factors" sections of the Company's Annual Report on Form 10-K filed on February 23, 2026 and most recent Quarterly Report on Form 10-Q filed on May 7, 2026. ImmunityBio undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

On April 15, 2026, the U.S. Food and Drug Administration (FDA) approved STELARA®(ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD).1 STELARA®(ustekinumab) is the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adult and pediatric patients two years and older with moderately to severely active Crohn’s disease (CD). Nearly one million people in the U.S. live with Crohn’s disease, with up to 25% diagnosed during childhood.³ In the pediatric population, the disease is often more aggressive, increasing the risk of growth impairment and lifelong complications during critical developmental years, and approved pediatric treatment options remain limited.³⁻⁴ This approval marks the first non-TNF biologic approved for pediatric patients two years and older with moderately to severely active Crohn’s disease. The approval is based on data from the Phase 3 UNITI-Jr clinical study, a multicenter interventional study to evaluate the efficacy, safety, and pharmacokinetics of STELARA®(ustekinumab) for the treatment of pediatric CD over 52 weeks (8 weeks of induction and 44 weeks of maintenance).2 The adverse reaction profile in these pediatric subjects was similar to that reported in adult clinical trials in patients with Crohn’s disease. In the Crohn’s disease induction phase in pediatric patients treated with STELARA, the most common adverse reaction (at least 10% of pediatric patients) was upper respiratory tract infection (13%). In the Crohn’s disease maintenance phase in pediatric patients treated with STELARA, common adverse reactions (at least 10% of pediatric patients) were upper respiratory tract infection (17%), COVID-19 (17%), and headache (10%). ABOUT THE PHASE3 UNITI JR STUDY (NCT04673357) UNITI Jr is a Phase 3, multicenter open-label study evaluating the efficacy, safety, and pharmacokinetics of ustekinumab for the treatment of moderately to severely active Crohn’s disease in pediatric patients two years of age and older. ABOUT PEDIATRIC CROHN’S DISEASE Crohn’s disease (CD) is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.5 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.6 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently, no cure is available for Crohn’s disease.3 Nearly one million people in the U.S. are living with CD; up to 25% of those individuals are pediatric.3 Crohn’s disease can be more severe for the pediatric population compared to adults, further highlighting the need for additional treatment options.3,4 ABOUT STELARA®(ustekinumab) STELARA®(ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine approved in the United States to treat: adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). adults and children 6 years and older with active psoriatic arthritis. adults 18 years and older with moderately to severely active Crohn’s disease. pediatric patients 2 years of age and older with moderately to severely active Crohn’s disease. adults 18 years and older with moderately to severely active ulcerative colitis. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®. IMPORTANT SAFETY INFORMATION STELARA and Ustekinumab are prescription medicines that affect your immune system. STELARA and Ustekinumab can increase your chance of having serious side effects, including: Serious InfectionsSTELARA and Ustekinumab may lower your ability to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA or Ustekinumab, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Your healthcare provider should check you for TB before starting STELARA or Ustekinumab and watch you closely for signs and symptoms of TB during treatment with STELARA or Ustekinumab. If your healthcare provider feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA or Ustekinumab You should not start STELARA or Ustekinumab if you have any kind of infection unless your healthcare provider says it is okay. Before starting STELARA or Ustekinumab, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired are being treated for an infection or have any open cuts. get a lot of infections or have infections that keep coming back. have TB, or have been in close contact with someone with TB. fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired After starting STELARA or Ustekinumab, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA and Ustekinumab can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA or Ustekinumab may also be more likely to get these infections. CancersSTELARA and Ustekinumab may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your healthcare provider if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving either STELARA or Ustekinumab. Tell your healthcare provider if you have any new skin growths. Serious Allergic ReactionsSerious allergic reactions including death can occur. Stop using STELARA or Ustekinumab and get medical help right away if you get any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest discomfort, trouble breathing, or skin rash. Posterior Reversible Encephalopathy Syndrome (PRES)PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with STELARA, including: headache, seizures, confusion, and vision problems. Lung InflammationCases of lung inflammation have happened in some people who receive either STELARA or Ustekinumab and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA or Ustekinumab. Before you use or receive STELARA or Ustekinumab, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed above for serious infections or cancers. ever had an allergic reaction to any Ustekinumab product or any of its ingredients. Ask your healthcare provider if you are not sure. are allergic to latex. The needle cover on the prefilled syringe contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with either STELARA or Ustekinumab should avoid receiving live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should avoid receiving the BCG vaccine during the 1 year before receiving either STELARA or Ustekinumab or 1 year after you stop receiving either STELARA or Ustekinumab. have any new or changing lesions within psoriasis areas or on normal skin. are receiving or have received allergy shots, especially for serious allergic reactions. receive or have received phototherapy for your psoriasis. are pregnant or plan to become pregnant. It is not known if either STELARA or Ustekinumab can harm your unborn baby. You and your healthcare provider should decide if you will receive STELARA or Ustekinumab. are breastfeeding or plan to breastfeed. STELARA and Ustekinumab can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive STELARA or Ustekinumab. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. When prescribed STELARA or Ustekinumab: Use STELARA and Ustekinumab exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of STELARA or Ustekinumab, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments. STELARA and Ustekinumab are intended for use under the guidance and supervision of your healthcare provider. In children, it is recommended that STELARA and Ustekinumab be administered by a healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of STELARA or Ustekinumab at home, you or a caregiver should receive training on the right way to prepare and inject STELARA or Ustekinumab. Do not try to inject STELARA or Ustekinumab until you have been shown how to inject STELARA or Ustekinumab by healthcare provider. The most common side effects of STELARA and Ustekinumab include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, influenza, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA and Ustekinumab. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information. Please read the full Prescribing Information and Medication Guide for STELARA and the full Prescribing Information and Medication Guide for Ustekinumab and discuss any questions you have with your doctor. Please read the full Prescribing Information and Medication Guide for STELARA and the full Prescribing Information and Medication Guide for Ustekinumab and discuss any questions you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. cp-513655v6 Cautions Concerning Forward-Looking StatementsThis statement contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA®(ustekinumab).The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes1STELARA®Pediatrics CD FDA Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761044Orig1s020,%20125261Orig1s172ltr.pdfAccessedApril2026.2ClinicalTrials.govAbout Phase3 UNITI-Jr clinical study (NCT04673357). https://clinicaltrials.gov/study/NCT04673357 AccessedApril2026.3NationalOrganization for Rare Disorders. Pediatric Crohn’s Disease. Available at:https://rarediseases.org/rarediseases/pediatric-crohns-disease/ Accessed April 2026.4von Allmen D. (2018). Pediatric Crohn’s Disease. Clinics in Colon and Rectal Surgery, 31(2), 80–88.https://doi-org.libproxy1.nus.edu.sg/10.1055/s-0037-1609022. AccessedApril2026.5Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at:https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview Accessed April 2026.6Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at:https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes Accessed April 2026.7Mitchel EB, Rosh JR. Pediatric Management of Crohn’s Disease. Gastroenterology ClinicsofNorth America. 2022;51(2):401–424. PMID: 35595422.https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/35595422/ AccessedApril2026.