Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to European Medicines Agency (EMA) in December 2024 and anticipated acceptance of application in 2025 Marketing authorization application for BCG Unresponsive NMIBC CIS submitted to United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024 and... Read More

BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG in partnership with Serum Institute of India: Anticipated submission for market access as an alternative source in Q1 2025 Second- and third-line non-small cell lung cancer (NSCLC) progressing on checkpoint inhibitors (QUILT-3.055):... Read More

CULVER CITY, Calif.--( BUSINESS WIRE )-- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code assigned by the Centers for Medicare & Medicaid Services (CMS) for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) became effective January 1, 2025. The U.S. Food and Drug Administration (FDA) approved ANKTIVA with Bacillus... Read More

CULVER CITY, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common... Read More

CULVER CITY, Calif. / Dec 11, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common... Read More

CULVER CITY, Calif. / Dec 10, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In addition, ImmunityBio expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in... Read More

FREMONT, Calif. , Nov. 21, 2024 /PRNewswire/ -- ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated biotechnology company, and nCartes, Inc., a transformational cloud software platform provider, announced a collaboration agreement aimed at automating and streamlining the data fulfillment process for clinical trials. The goal of the collaboration is to make this essential process easier, faster, and less expensive for... Read More

High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024 Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM CULVER CITY, Calif. / Nov 19, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ:... Read More

CULVER CITY, Calif. / Nov 12, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX) today announced its financial results for the third-quarter ended September 30, 2024. ANKTIVA ® received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025. ANKTIVA (FDA-approved and commercially available in the U.S. since May 2024) is now widely accessible to patients through commercial and government insurance... Read More

Company’s first clinical trial studying CAR-NK (CD19 t-haNK) cellular therapy in liquid tumors First natural killer cell-based cellular therapy study conducted in the continent of Africa Complete enrollment currently expected in Q1 2025 CULVER CITY, Calif. / Oct 24, 2024 / Business Wire / Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), announced today that the first patients have been dosed in an initial trial... Read More

CULVER CITY, Calif. / Oct 21, 2024 / Business Wire / Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), announced today that company executives will be participating in the Jefferies London Healthcare Conference, which is taking place November 19-21 at the Waldorf Hilton London. Details of the presentation can be found below. Jefferies London Healthcare Conference Date: Tuesday, November 19, 2024 Time: 2:30 PM GT... Read More

Phase 2 data presented at the World Conference on Lung Cancer showing a prolonged median overall survival of over 14 months in 2 nd and 3 rd line NSCLC cancer patients who progressed on checkpoint inhibitors such as KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab) ANKTIVA plus KEYTRUDA or OPDIVO rescued T cell activity in these patients who progressed on the same checkpoint inhibitor with overall survival of 57% at 12 months... Read More

ANKTIVA ® reaches U.S. commercial and Medicare insurance coverage milestone within three months of FDA approval Global expansion of commercial and clinical bladder cancer programs Filing process initiated with European Medicines Agency (EMA) for regulatory approval of ANKTIVA in European Union countries Global filing for BCG naïve trial initiated (QUILT-2.005) in India ANKTIVA Non-Small Cell Lung Cancer (NSCLC) FDA meeting... Read More

The QUILT 502 trial is testing ImmunityBio’s N-803 (ANKTIVA®) in combination with the AdHER2DC investigational vaccine for endometrial cancer, a gynecological cancer with lower survival rates and limited effective post-second-line treatment. The AdHER2DC vaccine targets the HER2 protein, which is elevated in 30% of endometrial cancer. ANKTIVA, recently approved for BCG-unresponsive non-muscle invasive bladder cancer... Read More

Multiple patients treated across the U.S. with ANKTIVA less than eight weeks after FDA approval of first-in-class cytokine immunotherapy for BCG unresponsive non-muscle invasive bladder cancer ANKTIVA launch initiates the next era of immunotherapy beyond checkpoint inhibitors that is based on cytokines and natural killer (NK) cells ANKTIVA’s novel mechanism of action activates the body’s immune system of natural killer and... Read More

CULVER CITY, Calif. / Jun 07, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX) announced today that its 2024 Annual Meeting of Stockholders will be held on Tuesday, June 11, 2024 at 9:30 a.m. Pacific Time. The Annual Meeting will be held in a virtual-only format and there will not be a physical location for the Annual Meeting. Stockholders of record at the close of business on April 17, 2024 are entitled to vote at... Read More

Three-part podcast interview features The mechanism of action of ANKTIVA® activating NK cells, Killer T cells, and Memory T cells The clinical findings of a durable complete response and implications for nonmuscle invasive bladder cancer patients with the launch of ANKTIVA Addressing the shortage of BCG and collaboration with Serum Institute of India CULVER CITY, Calif. / May 17, 2024 / Business Wire / ImmunityBio, Inc. (... Read More

ANKTIVA ® Drug Substance completed and released with two-year storage stability data sufficient for 170,000 doses of ANKTIVA product ImmunityBio’s 400,000 square foot GMP fill-finish facility in Dunkirk, New York on track to be completed in 12-18 months with capacity to produce a million vials annually Coupled with a recent... Read More

Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle invasive bladder cancer (NMIBC) Serum Institute of India (SII) will manufacture both standard BCG (“sBCG”) and next-generation recombinant BCG (“iBCG”), creating a long-term solution to chronic BCG supply shortage issues Standard BCG (sBCG) from the Serum Institute is... Read More

Dr. Sam S. Chang, Professor of Urology at Vanderbilt Cancer Program, to host the program “A Deep Dive with Patrick Soon-Shiong: Next-Generation Immunotherapy for NMBIC” Discussion about the basis for ANKTIVA’s Breakthrough Therapy designation and the novel mechanism of how the IL-15 superagonist achieves durable complete responses in BCG unresponsive NMIBC CULVER CITY, Calif. / Apr 30, 2024 / Business Wire / The Executive... Read More

Designated an FDA Breakthrough Therapy, the novel immunotherapy ANKTIVA activates the body’s natural killer (NK) and killer T-cell immune system to attack tumor cells Therapy stimulates memory T cells, leading to long duration of complete response exceeding 47 months and ongoing to date, with a median duration of response yet... Read More

CULVER CITY, Calif. / Mar 06, 2024 / Business Wire / ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the recent publication of preclinical data in the online issue of Science , First Release indicating that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without... Read More

All participants in the Phase 1 pilot study experienced a marked decrease in the burden of infection, and the procedures were found to be safe and well tolerated N-803 is being studied in three other HIV cure-related clinical trials CULVER CITY, Calif. / Mar 05, 2024 / Business Wire / ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with... Read More

The first 20 participants have been enrolled in an important national, multicenter trial to test whether ImmunityBio’s Nant Cancer Vaccine (NCV) comprising a tri-valent Adenovirus (Tri-Ad5) in combination with the company’s IL-15 superagonist N-803 could potentially prevent colon and other cancers in individuals with Lynch syndrome. With enrollment of the first two open-label phases of the trial completed, the study will now... Read More

Patient Reported Outcomes (PROs) based on a May 16, 2022 data cutoff in the QUILT 3.032 trial indicate stability of physical function and global health in patients who completed PRO questionnaires and reached month 24 on-study Overall, participants with complete responses (CRs) to combination therapy with the novel interleukin-15 (IL-15) superagonist N-803 and bacillus Calmette-Guerin (BCG) reported better physical function... Read More

Up to $300 million non-dilutive capital exchanged for royalty payments on future ImmunityBio immunotherapy product revenue with up to a $20 million equity investment Royalty financing includes $200 million funded at closing, and $100 million to be funded contingent upon FDA approval of the Company’s BLA for Anktiva® in combination with BCG for NMIBC with PDUFA date of April 23, 2024 Equity investment includes $10 million... Read More

CULVER CITY, Calif. / Nov 16, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced today that the company will be participating in the 35 th Annual Piper Sandler Healthcare Conference, which is taking place in New York City, November 28-30, 2023. Details of the presentation can be found below. Piper Sandler Healthcare Conference Date Thursday, November 30, 2023 Time:... Read More

Findings from NCI-led study suggest that Memory Cytokine-Enriched Natural Killer cells (M-ceNK) may provide benefit to patients with small cell lung cancer and patients with other types of neuroendocrine tumors M-ceNK may provide an additional line of therapy in other cases of immunologically cold tumors lacking MHC expression after a checkpoint blockade therapy The first-in-class M-ceNK cells use the patient’s own NK cells,... Read More

BLA for N-803 plus BCG in high-risk non-muscle-invasive bladder cancer (NMIBC) was resubmitted to the Agency on October 23, 2023 A new PDUFA date of April 23, 2024 has been communicated by the Agency CULVER CITY, Calif. / Oct 26, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review... Read More

Provides updated data on prolonged duration of complete response in BCG-Unresponsive and BCG-Naïve NMIBC patients Following the Type A Meeting with the FDA, ImmunityBio has completed the BLA resubmission addressing the issues in the Complete Response Letter. As part of this resubmission, ImmunityBio provided an update on the Duration of Complete Response (CR) in BCG-unresponsive NMIBC patients with CIS ± Ta/T1 disease... Read More

Financing improves the company’s balance sheet and provides $200 million of capital, as follows: Exchange of $270 million of debt held by Nant Entities into ImmunityBio equity resulting in deleveraging of the Company’s balance sheet $200 million of a new 3-year term debt financing from Nant Capital convertible at a 50 percent premium to provide capital sufficient to support the Company’s ongoing operations and... Read More

Veteran manufacturing and supply chain expert to oversee global manufacturing and QA CULVER CITY, Calif. / Aug 03, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it has named Enrique Diloné, Ph.D., to the newly created role of Chief Technology Officer. With more than three decades of pharmaceutical manufacturing expertise, Dr. Diloné will assume... Read More

CULVER CITY, Calif. / Jul 20, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of... Read More

CULVER CITY, Calif. / Jul 10, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced findings from a Phase 1 study showing that allogeneic cytokine-induced memory-like (CIML) natural killer (NK) cells used in combination with ImmunityBio’s IL-15 superagonist N-803 may induce tumor regression associated with persistent CIML NK cell expansion in advanced head-and-neck... Read More

CULVER CITY, Calif. / May 22, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong, M.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 7, 2023, at 10:00 am Eastern Time (ET) at the Marriott Marquis, New York. An... Read More

The Phase 2b cancer vaccine trial will study a multiple vaccination approach called ‘Tri-Ad5’ that uses three ImmunityBio vaccines in combination with the company’s IL-15 superagonist N-803, to potentially reduce the risk of developing colorectal and other cancers in patients with hereditary Lynch syndrome. An estimated 1 in every 300 people may be carriers of a mutation in a gene associated with Lynch syndrome 1 . People... Read More

CULVER CITY, Calif. / Apr 24, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that Executive Chairman and Global Chief Scientific and Medical Officer Patrick Soon-Shiong, M.D., has been invited to deliver the 2023 David Packard Award Lecture at the Uniformed Services University of the Health Sciences (USU). The university extended Dr. Soon-Shiong the invitation... Read More

CULVER CITY, Calif. / Feb 16, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced Dr. Karim Chamie, Associate Professor of Urology at UCLA, will be presenting “Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15R⍺Fc superagonist N-803 plus BCG” at the ASCO Genitourinary Cancers Symposium... Read More

CULVER CITY, Calif. / Feb 15, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of... Read More

Positive findings in third line and greater metastatic pancreatic cancer patients (N=83) with doubled median overall survival (OS) versus historical OS Median overall survival of 5.8 months and 61% of patients (51/83) exhibited disease control All treatments in an outpatient setting of combination immunotherapy and off-the-shelf NK cell infusion Productive discussions with the U.S. Food and Drug Administration (FDA) and... Read More

Financing transactions include approximately $50 million of equity financing from a single institutional investor, $50 million of debt financing from Nant Capital, LLC, and conversion of approximately $56.6 million of debt held by NantWorks LLC into ImmunityBio equity. Additional equity financing from the investor also includes up to $60 million of additional proceeds through a warrant exercisable over a two-year period.... Read More