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ImmunityBio (NASDAQ: IBRX) gains UAE nod for ANKTIVA in bladder and lung cancer

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Rhea-AI Filing Summary

ImmunityBio, Inc. reports that the Emirates Drug Establishment in the United Arab Emirates has granted Marketing Authorization for ANKTIVA across two indications: BCG-unresponsive non-muscle invasive bladder cancer (including carcinoma in situ and papillary-only disease) and metastatic non-small cell lung cancer after progression on checkpoint inhibitor–based therapy.

The bladder cancer authorization, described as the first worldwide to span the full spectrum of BCG-unresponsive disease, is supported by QUILT-3.032, where ANKTIVA plus BCG produced a 71% complete response rate in the CIS cohort (N=100) and a 12-month disease-free survival rate of 58.2% in papillary-only patients (N=80); Grade 3 treatment-related adverse events occurred in 1% of patients, with no Grade 4 or 5 events reported. The lung cancer indication is backed by QUILT-3.055, showing median overall survival of 14.6 months in checkpoint-refractory advanced NSCLC (N=79) and 16.2 months in patients achieving higher absolute lymphocyte counts. With this decision, ANKTIVA is now authorized in 34 countries, including the UAE, United States, United Kingdom, Saudi Arabia and the European Union.

Positive

  • UAE Marketing Authorization for ANKTIVA in bladder and lung cancer adds a fifth regulatory jurisdiction and expands its footprint to 34 countries, supported by registrational data showing a 71% complete response rate in CIS BCG-unresponsive NMIBC and 14.6-month median overall survival in checkpoint-refractory advanced NSCLC.

Negative

  • None.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Countries with ANKTIVA authorization 34 countries Global regulatory footprint after UAE Marketing Authorization
CIS cohort complete response rate 71% (95% CI: 61, 80) BCG-unresponsive NMIBC CIS cohort, QUILT-3.032 (N=100)
Median duration of complete response 26.6 months (95% CI: 13.0, 49.9) Responders in CIS cohort of QUILT-3.032
Papillary cohort 12-month DFS rate 58.2% (95% CI: 46.6, 68.2) Papillary-only NMIBC cohort, QUILT-3.032 (N=80)
Cystectomy-free rate at 36 months 83.1% (95% CI: 70.8, 90.5) Papillary-only NMIBC cohort, QUILT-3.032
Median overall survival in NSCLC 14.6 months (95% CI: 12.0, 19.5) Checkpoint-refractory advanced NSCLC, QUILT-3.055 (N=79)
Median OS with ALC ≥ 1,000 16.2 months (95% CI: 13.8, 22.0) NSCLC patients with mean on-treatment ALC ≥ 1,000 in QUILT-3.055
Grade 3 treatment-related adverse events 1% of patients Treatment-related safety profile in QUILT-3.032 NMIBC program
BCG-unresponsive non-muscle invasive bladder cancer medical
"The BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) authorization is the first worldwide..."
A form of bladder cancer confined to the inner lining of the bladder that has not spread into the muscle, and that has failed to respond to or has returned after standard treatment with BCG immunotherapy. It matters to investors because these patients represent a clear, often underserved market for new medicines and devices; success in this group can unlock regulatory approvals, premium pricing, and significant commercial opportunity—similar to finding a new key when the old one no longer opens an important door.
carcinoma in situ (CIS) medical
"span the full spectrum of BCG-unresponsive disease: carcinoma in situ (CIS) with or without papillary tumors..."
Carcinoma in situ (CIS) is a group of abnormal cells that look like cancer under a microscope but remain confined to the layer of tissue where they started and have not invaded nearby tissues or spread. Think of it as a small fire behind a closed window — serious because it can progress, but easier to contain than an active blaze. For investors, CIS matters because its detection, treatment options and regulatory pathways strongly influence demand for diagnostics, therapies and the commercial outlook for related medical products.
checkpoint-refractory medical
"NSCLC evidence (QUILT-3.055): in checkpoint-refractory advanced NSCLC (N=79), median overall survival was 14.6 months..."
Cancer described as "checkpoint-refractory" does not respond, or has stopped responding, to therapies that unblock the immune system’s natural brakes (so-called checkpoint inhibitor drugs). For investors, this signals a significant unmet medical need and a clear market opportunity: patients who are refractory often require different treatments or combination approaches, so successful new therapies or tests that predict or overcome resistance can change clinical outcomes and drive commercial value.
absolute lymphocyte count medical
"Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL..."
Absolute lymphocyte count is the number of a specific type of white blood cell—lymphocytes—found in a given volume of blood, often reported as cells per microliter. Think of it as the size of the body’s immune “army”; higher or lower counts signal how well the immune system can respond. For investors, this measure matters because it is used in clinical trials and safety monitoring to judge drug effects, patient risk, dosing decisions, and potential regulatory outcomes.
cystectomy-free rate medical
"in the papillary-only cohort (N=80), 12-month disease-free survival rate was 58.2%, with a cystectomy free rate at 36-months of 83%."
Kaplan-Meier analysis method medical
"DFS rate was estimated and DFS was analyzed using Kaplan-Meier analysis method."

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FAQ

What did ImmunityBio (IBRX) announce about ANKTIVA in the United Arab Emirates?
ImmunityBio announced that UAE’s Emirates Drug Establishment granted Marketing Authorization for ANKTIVA across two indications: BCG-unresponsive non-muscle invasive bladder cancer and metastatic non-small cell lung cancer after progression on checkpoint inhibitor-based therapy, expanding ANKTIVA’s regulatory footprint to 34 countries.

Which cancer indications are covered by the UAE approval for ANKTIVA from ImmunityBio (IBRX)?
The UAE authorization covers ANKTIVA 0.4 mg with BCG for BCG-unresponsive NMIBC (CIS with or without papillary tumors and papillary-only disease) and ANKTIVA 1.2 mg with immune checkpoint inhibitors for metastatic NSCLC in adults whose disease progressed after standard checkpoint inhibitor–based treatment.

What key NMIBC efficacy data supported the UAE approval of ANKTIVA for ImmunityBio (IBRX)?
In QUILT-3.032, ANKTIVA plus BCG achieved a 71% complete response rate (95% CI: 61, 80) in the CIS cohort (N=100), with 26.6-month median duration of response. In papillary-only patients (N=80), 12-month disease-free survival was 58.2% and the 36-month cystectomy-free rate was 83.1%.

What overall survival results were reported for ANKTIVA in the NSCLC study for ImmunityBio (IBRX)?
In QUILT-3.055, a Phase 2 trial in checkpoint-refractory advanced NSCLC (N=79), ANKTIVA plus a checkpoint inhibitor produced median overall survival of 14.6 months. Among patients achieving a mean on-treatment absolute lymphocyte count ≥1,000 cells/µL, median overall survival was 16.2 months.

How long is the UAE Marketing Authorization for ANKTIVA valid and how many countries now authorize it for ImmunityBio (IBRX)?
UAE Marketing Authorization for ANKTIVA was first registered in July 2026 and is valid through July 2031. With the UAE, ANKTIVA is now authorized in 34 countries, including the United States, United Kingdom, Saudi Arabia and the European Union.

What safety profile for ANKTIVA in NMIBC is highlighted in ImmunityBio (IBRX)’s disclosure?
In the QUILT-3.032 NMIBC program, most treatment-related adverse events were Grade 1 or 2. Grade 3 treatment-related events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported, supporting the tolerability profile in this setting.
FALSE000132611000013261102026-07-292026-07-29

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 29, 2026

ImmunityBio, Inc.
(Exact name of registrant as specified in its charter)

Delaware001-3750743-1979754
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
3530 John Hopkins Court
San Diego, California 92121
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (844) 696-5235

Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.0001 per shareIBRXThe Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 7.01    Regulation FD Disclosure.
On July 29, 2026, ImmunityBio, Inc. (“ImmunityBio” or the “Company”) issued a press release announcing that the Emirates Drug Establishment (“EDE”) of the United Arab Emirates (“UAE”) has granted marketing authorization for ANKTIVA® across two indications.
A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is furnished as Exhibit 99.1 hereto.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01    Financial Statements and Exhibits.
(d)Exhibits
Exhibit
Number		Description of Exhibit
  99.1**
Press release dated July 29, 2026.
  104Cover Page Interactive Data File (embedded within the Inline XBRL document).
_______________
**    Furnished herewith.


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
IMMUNITYBIO, INC.
Registrant
Date: July 30, 2026By:/s/ David C. Sachs
David C. Sachs
Chief Financial Officer

EXHIBIT 99.1
ib_earnings-releasexlogox1a.jpg
ImmunityBio Receives United Arab Emirates (UAE) Marketing
Authorization for ANKTIVA® Across BCG-Unresponsive Non-Muscle
Invasive Bladder Cancer for CIS and Papillary Disease and Metastatic
Non-Small Cell Lung Cancer
•The UAE authorization further expands ANKTIVA’s global regulatory footprint to 34 countries. The BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) authorization is the first worldwide to span the full spectrum of BCG-unresponsive disease: carcinoma in situ (CIS) with or without papillary tumors, and papillary disease alone without CIS.
•The Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) granted Marketing Authorization for two ANKTIVA presentations, the broadest approval to date for ANKTIVA including papillary disease and CIS in non-muscle invasive bladder cancer and non-small cell lung cancer in patients who failed checkpoint inhibitors and chemotherapy.
•Each approval covers a distinct indication: ANKTIVA 0.4 mg/0.4 mL (solution for intravesical instillation) in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg/0.6 mL (solution for subcutaneous injection) in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC).
•NMIBC evidence (QUILT-3.032): in the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61,80), with duration of complete response extending beyond 54 months; in the papillary-only cohort (N=80), 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a cystectomy free rate at 36-months of 83%.
•In the NSCLC indication, ANKTIVA plus a checkpoint inhibitor is authorized for adult patients with metastatic disease that progressed on or after standard of care including checkpoint failure. NSCLC evidence (QUILT-3.055): in checkpoint-refractory advanced NSCLC (N=79), median overall survival was 14.6 months (95% CI: 12.0, 19.5), with subjects of mean on-treatment ALC ≥ 1,000 achieving of median OS of 16.2 months (95% CI: 13.8, 22.0).
CULVER CITY, Calif., July 29, 2026 — ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage biotechnology company, today announced that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA® (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. With this action, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA, expanding its global footprint to 34 countries. The UAE has taken the lead in the broadest approval of ANKTIVA to date. The NMIBC authorization is the first anywhere in the world to span carcinoma in situ (CIS) and papillary disease, including patients with papillary-only tumors in the absence of CIS.
World’s First Approval Spanning the Full Spectrum of BCG-Unresponsive Disease in NMIBC
Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS.


BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option.
“For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007, we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy. This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.
Authorization in Checkpoint-Refractory Metastatic Non-Small Cell Lung Cancer
Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy.
Checkpoint inhibitor resistance represents a defined unmet need in metastatic NSCLC, with limited options and poor survival after progression. By activating the natural killer and memory T cells that checkpoint inhibitors alone do not reach, ANKTIVA is designed to restore anti-tumor immunity in this setting.
Clinical Evidence Supporting the Approvals
NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC.
CIS with or without Papillary Disease (QUILT-3.032, Cohort A): In the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61, 80) as shown in table below.
Table 2. Efficacy Results in QUILT-3.032: NMIBC CIS (Cohort A)
EndpointANKTIVA with BCG (n=100)
Complete response rate (95% CI)71% (61, 80)
Median duration of complete response (DoR), months (95% CI) (n=71)26.6 (13.0, 49.9)
   Range in monthsᵃ0.0, 54+ months
CR rate of responders at 12 and 24 months
   % (n) with CR at 12 months66% (47/71)
   % (n) with CR at 24 months42% (30/71)
+ Denotes ongoing response.
ᵃ Based on 71 patients that achieved a complete response at any time; reflects period from the time complete response was achieved.


Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months as shown in the table below.
Table 3. Efficacy Results in QUILT-3.032: Papillary NMIBC (Cohort B)
EndpointANKTIVA with BCG (n=80)
Disease-Free Survival (DFS) Rate at 12 Months (95% CI)¹58.2% (46.6, 68.2)
Median Disease-Free Survival (DFS), months (95% CI)¹25.3 (9.8, 33.5)
Cystectomy-Free Rate²
   Median Time to Cystectomy (months)Not Reached
   Rate at Month 12 (95% CI)92.2% (83.4, 96.4)
   Rate at Month 18 (95% CI)87.9% (78.0, 93.5)
   Rate at Month 24 (95% CI)87.9% (78.0, 93.5)
   Rate at Month 36 (95% CI)83.1% (70.8, 90.5)
¹ DFS defined as time from initial study drug administration until recurrence of high-grade Ta (excluding low-grade Ta) or any grade T1, persistent CIS ≥6 months, new CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death (any cause), whichever occurred first. Patients who didn’t have any evidence of disease at end of study were censored at last known date the patient was disease-free. DFS rate was estimated and DFS was analyzed using Kaplan-Meier analysis method.
² Time to cystectomy defined as time from initial study drug administration to cystectomy using Kaplan-Meier analysis method. Patients who did not have documented cystectomy during the study were censored at the last date of follow up visits. Cystectomy-free rates were estimated using Kaplan Meier analysis method.
In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported.
NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055, a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). The table below summarizes these findings.


OS Results in QUILT-3.055 – Safety Population
ANKTIVA plus
CPI All NSCLC
(N=79)
Mean On-
Treatment ALC
< 1000/µL (N=18)
Mean On-
Treatment ALC
≥ 1000/µL (N=61)
Log-rank
P-value
Hazard Ratio
(95% CI)
Number of deaths58 (73%)14 (78%)44 (72%)0.03690.52 (0.28, 0.97)
Median OSᵃ (months)14.611.816.2
95% CI for the Median OS12.0, 19.56.9, 14.113.8, 22.0
Overall survival (OS) rateᵇ at:
   Month 1261.4% (49.5, 71.4)44.1% (20.0, 65.9)66.1% (52.6, 76.6)--
   Month 2429.8% (19.8, 40.4)12.6% (2.1, 33.0)34.6% (22.7, 46.8)--
ALC, absolute lymphocyte count; CI, confidence interval; CPI, checkpoint inhibitor; NSCLC, non-small cell lung cancer; OS, overall survival.
ᵃ OS defined as time from date of first study drug administration to date of death from any cause. Participants who were alive at end of follow-up were censored at the last known date the participant was alive.
ᵇ OS rates estimated using Kaplan-Meier analysis method.
In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%).
Regulatory Details
The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive NMIBC, is registered under No. 78609-45860-260486. ANKTIVA 1.2 mg (solution for subcutaneous injection), indicated for metastatic NSCLC, is registered under No. 78609-1572-260487. ImmunityBio, Inc. is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as the local agent in the United Arab Emirates. The UAE is the fifth regulatory jurisdiction to authorize ANKTIVA, following the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the European Union, and expands the global footprint of ANKTIVA to more than 30 countries.
“With this authorization, the global regulatory footprint for ANKTIVA now includes 34 countries. Securing approvals across two distinct indications, bladder cancer and lung cancer, on the strength of the same data packages we submitted to the FDA, positions us to broaden access across the Gulf region through our partnership with Modern Pharmaceutical Company, in markets where the need for new treatment options is significant,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio.
Sources
1.Chamie K, et al. IL-15 Superagonist NAI (N-803) plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. NEJM Evidence. 2023;2(1). (CIS cohort complete response rate.)
2.QUILT-3.032 updated analyses, including the papillary-only (Ta/T1) cohort and extended duration-of-response follow-up, as presented at AUA 2025 and disclosed by ImmunityBio, Inc.
3.QUILT-3.055 Phase 2 overall survival results in checkpoint-refractory advanced NSCLC, as disclosed by ImmunityBio, Inc.


4.ClinicalTrials.gov Identifiers (QUILT-3.032) and (QUILT-3.055).
5.Emirates Drug Establishment, Product Marketing Authorization Approval certificates and approved Summaries of Product Characteristics, Registration Nos. 78609-45860-260486 (NMIBC) and 78609-1572-260487 (NSCLC), first registration 24 July 2026.
6.Immunotherapy Agent Workshop, July 12, 2007 NCI, https://sitc.sitcancer.org/news/nci_manuscript.pdf
7.Cancer Immune Evasion Through Loss of MHC Class I Antigen Presentation. Karthik Dhatchinamoorthy, et. al. https://pmc.ncbi.nlm.nih.gov/articles/PMC7986854/#s14
About ANKTIVA® (nogapendekin alfa inbakicept-pmln)
The interleukin-15 (IL-15) cytokine 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 receptor 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 independent of 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.
About ImmunityBio, Inc.
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 receptor superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a 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.
About U.S. Indication
U.S. Indication and Important Safety Information: The following U.S. Prescribing Information applies only to ANKTIVA® as approved in the United States for the treatment of adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, in combination with BCG. ANKTIVA has not been approved in the United States for the treatment of metastatic non-small cell lung cancer (NSCLC).
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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, commercial success of its products and product candidates, manufacturing capabilities, continued collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such statements include, but are not limited to, statements regarding the commercial availability and uptake of ANKTIVA in the United Arab Emirates, the scope and interpretation of the Marketing Authorizations granted by the Emirates Drug Establishment for the NMIBC and NSCLC indications, the number of jurisdictions and countries in which ANKTIVA is authorized, the timing and outcome of pending and future regulatory submissions in the United States and other jurisdictions, including for papillary disease and for lung cancer, and the clinical benefit, durability of response, overall survival benefit, and safety profile of ANKTIVA in combination with BCG and in combination with immune checkpoint inhibitors Additional risks related to international commercialization include: our reliance on our regional partner in the UAE and their ability to successfully launch and distribute ANKTIVA; the timing and outcome of pricing and reimbursement decisions by UAE health authorities; continued global BCG supply shortages that could limit combination therapy availability; manufacturing and supply chain complexities for international distribution; regulatory actions in any of the 34 countries where ANKTIVA is authorized that could affect labeling or market access; and competition from existing or new therapies in the UAE and broader Gulf region.
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. Actual results may differ materially. For a discussion of factors that could cause actual results to differ, please refer to ImmunityBio’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. ImmunityBio does not undertake any obligation to update forward-looking statements.
ImmunityBio 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

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