Latest news with #ANKTIVA
Business Wire
12 hours ago
- Health
- Business Wire
ImmunityBio Announces Phase 2 Study of ANKTIVA ® in Patients with Long COVID
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the opening of a new Phase 2 study to assess the BioShield™ platform, anchored by ANKTIVA ® (nogapendekin alfa inbakicept-pmln), in patients with long COVID. An estimated one in five Americans with a previous COVID-19 infection has long COVID, which is comprised of a broad range of symptoms that can substantially impact a patient's quality of life. Long COVID remains a significant public health challenge with no currently available established therapies. The new study, called COVID-4.019-Long, further expands the company's clinical research efforts to assess ANKTIVA's potential beyond cancer or cancer-related diseases. Currently, ANKTIVA is being evaluated alone and with other agents in multiple studies for different forms of bladder cancer, non-small cell lung cancer, glioblastoma, non-Hodgkin lymphoma, Lynch syndrome, ovarian cancer and Human Papillomavirus (HPV) associated tumors. ANKTIVA is also being studied in Human Immunodeficiency Virus (HIV) and lymphopenia. The primary objective of the exploratory, single-arm study (NCT0712372 7) is to evaluate the safety of ANKTIVA, injected under the skin (subcutaneously), in participants with long COVID. The secondary objective is to assess the effect of ANKTIVA on absolute lymphocyte count. Exploratory objectives include evaluation of ANKTIVA's ability to improve post-COVID natural killer (NK) cell and CD8+ T cell counts, and assessment of the immunological function of NK cells and CD8+ T cells. 'We are excited to study ANKTIVA for the treatment of long COVID, a substantial public health concern,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'Early in the pandemic, the common assumption was SARS-CoV-2 would prove to be a transient infection, as is the case with coronaviruses in general. But we now know viral nucleic acid and proteins can be in the gut mucosa months after infection. As such, an antiviral strategy looks insufficient to treat or cure long COVID. Based on clinical insights to date, we believe ANKTIVA may be a new therapeutic option for this chronic and potentially disabling condition by enhancing immune function, facilitating viral clearance, and addressing underlying contributions to long COVID.' The study, which is being conducted by ImmunityBio and aims to recruit up to 40 participants who meet the long COVID criteria, as established by the World Health Organization (WHO), is now accepting patients for initial screening to determine study eligibility. The safety and tolerability of ANKTIVA for long COVID is also being assessed in a separate Phase 2 study conducted at the University of California – San Francisco. Both studies are supported by ImmunityBio. To learn more, visit ANKTIVA is currently approved by the U.S. Food and Drug Administration with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. About Long COVID Long COVID is a serious illness that can cause chronic health conditions requiring comprehensive care. It may also lead to disability. 2 Long COVID impacts approximately 1 in 5 Americans adults who had a previous COVID-19 infection. 1 It can include a wide range of ongoing symptoms and conditions that can last weeks, months, or even years after COVID-19 illness. 1 Some of the common among the more than 200 identified symptoms include fatigue, brain fog, coughing, shortness of breath, heart palpitations and change in smell or taste. 3 Anyone who had a SARS-CoV-2 infection, the virus that causes COVID-19, can experience Long COVID, including children. 1 Long COVID remains a significant public health challenge with no currently available established treatments. 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. A key component in the company's BioShield platform, 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 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 Prescribing Information for ANKTIVA ® at References: Robertson MM, Qasmieh SA, Kulkarni SG, et al. The Epidemiology of Long Coronavirus Disease in US Adults. Clin Infect Dis. May 3 2023;76(9):1636-1645. U.S. Centers for Disease Control and Prevention. Long COVID Basics. July 2025. Available at U.S. Centers for Disease Control and Prevention. Long COVID Signs and Symptoms. July 2025. Available at About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies 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 NK 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 (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 potential implications to be drawn from preliminary clinical study results, clinical trial enrollment, timing, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's CancerBioShield™ platform, the potential health conditions associated with Long COVID, potential patient populations and implications thereof, 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 alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, 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 have 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 participation and enrollment and potential results from the clinical trial described herein, (ii) whether clinical trials will result in registrational pathways, (iii) whether clinical trial data will be accepted by regulatory agencies, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) 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, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio's ability to retain and hire key personnel, (viii) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) 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 August 5, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at 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.
Yahoo
2 days ago
- Business
- Yahoo
ImmunityBio (IBRX) Reports 60% Revenue Growth as ANKTIVA Adoption Accelerates
We recently published . ImmunityBio, Inc. (NASDAQ:IBRX) is one of the best healthcare stocks. ImmunityBio, Inc. (NASDAQ:IBRX) is among the best healthcare stocks. It is a clinical-stage biotech company developing advanced immunotherapies and vaccines targeting cancers and infectious diseases by activating immune cells such as natural killer and T cells. A key recent milestone is the FDA-approved immunotherapy drug ANKTIVA for bladder cancer, specifically for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). ANKTIVA, designated a Breakthrough Therapy, is expanding its clinical use, notably with the Michael E. DeBakey VA Medical Center in Houston becoming one of the first VA hospitals to administer the treatment to veterans, a population at higher bladder cancer risk. In Q2 2025, ImmunityBio, Inc. (NASDAQ:IBRX) reported a 60% revenue growth quarter-over-quarter, reaching $26.4 million and a year-to-date total of approximately $43 million. This growth is driven by increased commercial momentum post-approval and supported by an $80 million capital raise in July 2025 to fuel ongoing development and expansion. ImmunityBio, Inc. (NASDAQ:IBRX) is transitioning from a clinical-stage biotech to a commercial-stage company with ANKTIVA's expanding adoption, including recent UK regulatory approval for ANKTIVA plus BCG. The drug addresses an underserved cancer indication with the potential to reduce invasive treatments like cystectomy, backed by clinical data showing durable bladder preservation up to 36 months in responders. While we acknowledge the potential of IBRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
11-08-2025
- Health
- Business Wire
ImmunityBio Announces Houston's Michael E. DeBakey VA Medical Center Is Among the First VA Hospitals to Administer ANKTIVA ® to Bladder Cancer Patients
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the Michael E. DeBakey Department of Veterans Affairs (VA) Medical Center in Houston recently became the first VA hospital in the Houston region and one of the first in the U.S. to provide treatment with ANKTIVA ® (nogapendekin alfa inbakicept-pmln) to a veteran with bladder cancer. ANKTIVA, the first of its kind immune-boosting, lymphocyte stimulating agent, is approved by the U.S. Food and Drug Administration (FDA) in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). A 2024 study found military exposure to carcinogenic agents was associated with a higher risk for bladder cancer among veterans, making this treatment especially vital for those at the VA. Nationally recognized urologic oncologists at the Houston VA, Dr. Jeffrey Jones and Dr. Jennifer Taylor, were instrumental in bringing this novel treatment to veterans. They are strong advocates for advancing care for those battling bladder cancer. In addition, Dr. Jones, who is also affiliated with Baylor College of Medicine, led efforts to enroll the facility in ImmunityBio's Expanded Access Program (EAP) for rBCG. 'We are honored to see ANKTIVA reaching our nation's veterans,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'Drs. Jones' and Taylor's leadership and commitment to innovation are exactly what's needed to expand access to transformative treatments like ANKTIVA across the VA system. This milestone at DeBakey underscores the real-world impact of our mission.' About ANKTIVA 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 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15Rα, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA, which confers stability and longer half-life than recombinant or native IL-15, mimics the natural biological properties of the membrane-bound IL-15Rα, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo. ANKTIVA was approved by the FDA in 2024 for use in the United States with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors. For more information, visit (Founder's Vision) and About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies 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 NK 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 (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 clinical trial data and potential results and implications to be drawn therefrom, treatment of patients at VA Medical Centers and in certain geographic locations and potential implications 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 alone or in combination with other therapeutic agents 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 and for potential applications beyond oncology, 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 the FDA regulatory submission, filing and review process and the timing thereof, (ii) risks and uncertainties regarding commercial launch execution, success and timing and market access initatives, (iii) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (iv) whether clinical trials will result in registrational pathways and the risks, (v) whether clinical trial data will be accepted by regulatory agencies, (vi) 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, (vii) potential delays in product availability and regulatory approvals, (viii) ImmunityBio's ability to retain and hire key personnel, (ix) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) 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 August 5, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof.
Globe and Mail
06-08-2025
- Business
- Globe and Mail
IBRX Sales Soar 2,540%
Key Points Revenue (GAAP) soared to $26.4 million in Q2 2025, beating GAAP revenue estimates by 14.0%. Net loss per share (GAAP) improved to ($0.10), ahead of expectations. ANKTIVA sales and international launches fueled top-line growth, but heavy net losses and cash burn remain. These 10 stocks could mint the next wave of millionaires › ImmunityBio (NASDAQ:IBRX), a commercial-stage biotechnology company, released its second-quarter results on August 5, 2025. The main headline: revenue (GAAP) jumped to $26.4 million, soundly beating analyst GAAP revenue estimates of $23.15 million, as commercial sales of the immunotherapy ANKTIVA accelerated. Net loss per share (GAAP) narrowed to ($0.10), better than the projected ($0.11 GAAP EPS) and improving sharply from ($0.20) GAAP per share a year earlier. Overall, the quarter showed surging product revenue and reduced losses, even as the company maintained significant levels of R&D spending and faced regulatory hurdles. Metric Q2 2025 Q2 2025 Estimate Q2 2024 Y/Y Change EPS (GAAP) $(0.10) $(0.11) $(0.20) 50.0% Revenue $26.4 million $23.15 million $1.0 million 2,540.0% Research & Development Expense $52.4 million N/A N/A Selling, General & Administrative Expense N/A $48.6 million N/A Net Loss Attributable to Common Stockholders $(92.6 million) $(134.6 million) -31.2% Cash, Cash Equivalents & Marketable Securities $153.7 million $149.8 million* 2.6% Source: Analyst estimates for the quarter provided by FactSet. ImmunityBio's Business and Recent Focus ImmunityBio is an immunotherapy company developing treatments that stimulate a patient's own immune system to fight cancer and other diseases. Its pipeline combines biologic drugs, vaccine vectors, and cell therapies. The lead product is ANKTIVA, an antibody-cytokine fusion protein designed to amplify the immune system's attack against tumors. Recently, the company has focused on ramping up commercial sales of ANKTIVA for bladder cancer and expanding into global markets. At the same time, it continues to invest in a diverse pipeline, partnering with industry peers and scaling up its in-house manufacturing facilities. Key success factors include gaining further regulatory approvals, maintaining robust ANKTIVA sales growth, and advancing other product candidates into late-stage trials. Quarter in Review: Financial and Operational Performance Revenue (GAAP) saw a massive jump of 60% compared to Q1 2025, mainly due to rising sales of ANKTIVA for bladder cancer. The product brought in robust demand across U.S. urology practices of all sizes. GAAP revenue soared from just $1.0 million in Q2 2024. ANKTIVA unit sales surged 246% in the first half of 2025 over the second half of 2024, after the assignment of a J-code, which allows for easier reimbursement by insurers. International momentum was also notable, with the UK Medicines and Healthcare products Regulatory Agency (MHRA) approving marketing for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). However, regulatory speed bumps persisted. In the U.S, the Food and Drug Administration (FDA) issued a "Refuse to File" letter on the supplemental application for ANKTIVA in papillary-only NMIBC. ImmunityBio will need to conduct a new randomized controlled trial, which will involve added time and cost. The company also applied to the National Comprehensive Cancer Network (NCCN) for a guideline expansion to include papillary-only disease in BCG-unresponsive NMIBC, with a decision due in August 2025. On the pipeline front, ImmunityBio pushed forward with new product development. It launched a pivotal randomized trial called ResQ201A for non-small cell lung cancer (NSCLC). This combines N-803, its proprietary cytokine fusion protein, with tislelizumab, a PD-1 checkpoint inhibitor medicine from BeOne Medicines, aiming for use as second-line therapy. The company also reached full trial enrollment in a National Cancer Institute study of ANKTIVA plus adenovirus vaccine for patients with Lynch syndrome, a hereditary cancer risk syndrome. Expansion of clinical trials into Europe and Asia is in process, and the FDA indicated support for the company's lymphopenia program, which focuses on restoring immune cell counts in cancer patients. Strategic collaborations continued playing a role. ImmunityBio deepened its work with BeOne Medicines and kept leveraging the Serum Institute of India's expertise for manufacturing a recombinant BCG treatment, used to address shortages for bladder cancer therapies in the U.S. More than 150 patients received this treatment under expanded access protocols. Manufacturing expansions to support growing ANKTIVA production remained a focus, reflecting higher manufacturing and distribution outlays as well as license fees. Looking Ahead: Guidance and Watch List Management did not provide explicit forward guidance for the next quarter or for fiscal 2025. In comments, the leadership highlighted priorities around expanding ANKTIVA's reach in the U.S. and UK, progressing regulatory filings, and advancing several new pipeline trials. Management also pointed to a recent $80 million equity raise in July 2025, plus potential new warrant proceeds that could extend its cash runway. These include additional regulatory decisions, ongoing cash burn and fundraising needs, the continued pace of domestic ANKTIVA sales, and the company's ability to deliver on large late-stage trial commitments for new indications. Heavy net losses and a substantial cash burn mean financial discipline will be key as ImmunityBio navigates commercialization and pipeline growth. ImmunityBio does not currently pay a dividend. Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted. Where to invest $1,000 right now When our analyst team has a stock tip, it can pay to listen. After all, Stock Advisor's total average return is 1,039%* — a market-crushing outperformance compared to 181% for the S&P 500. They just revealed what they believe are the 10 best stocks for investors to buy right now, available when you join Stock Advisor. *Stock Advisor returns as of August 4, 2025
Business Wire
25-07-2025
- Business
- Business Wire
ImmunityBio Reports 60% Increase in Revenue in Q2 2025, with Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-Code with Regulatory Updates
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) Q2 2025 Revenue Growth with Continued Strong Sales Momentum: $26.4 million, up 60% from Q1 2025, with year-to-date sales of ~$43 million. ANKTIVA ® Unit Growth Since J-Code: 246% unit sales volume growth in 1H 2025 compared to 2H 2024. Cash Position: $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025. NSCLC: Initiated randomized clinical trial (RCT) ResQ201A with N-803 + tislelizumab in 2 nd line lung cancer; US sites initiated, submitted clinical trial applications in EU, UK; Canada and Asia filings planned. Lymphopenia: FDA supportive of new data; reaffirmed RMAT/EAP; collaborative discussion outlining regulatory endpoints, trial design and registrational pathways to full approval for the treatment of lymphopenia with randomized trial design in progress. Full Enrollment Reached in the Randomized NCI Cancer Prevention Clinical Trial Using ANKTIVA + Adenovirus Vaccine in 186 Patients with Lynch Syndrome. United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorization application of ANKTIVA approved. Papillary NMIBC: Discussion with FDA regarding filing status of supplemental BLA. ImmunityBio performing ongoing evaluation of next steps to address the Refuse to File decision by the FDA, following June Type A meeting with the Agency. New updated data on Papillary disease provided to the FDA and discussions with Agency to continue. Separately, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease. Financial Overview In the second quarter of 2025, ImmunityBio reported $26.4 million in revenue, representing a 60% increase from $16.5 million in the first quarter of 2025. This growth reflects continued commercial traction of ANKTIVA + BCG in BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without Papillary tumors. The 1H 2025 sales of $42.9 million represents a 246% increase in unit volume during the first two quarters of 2025 since the J-code approval versus the last two quarters of 2024. The Company ended the quarter with $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025. Non-Muscle Invasive Bladder Cancer (Papillary NMIBC) ImmunityBio conducted a Type A meeting with the FDA in June to discuss its program targeting papillary-only NMIBC and the Agency's response to the supplemental BLA filing. Contrary to the advice the FDA gave the Company in January 2025 to submit the supplemental BLA, the FDA responded with a Refuse-to-File (RTF) notice in May on the basis of requiring a randomized controlled trial (RCT) against chemotherapy. At the June meeting, ImmunityBio provided new data regarding the updated results since the initial BLA filing of papillary only data as well as real-world data of chemotherapy just published in this indication. In the papillary only NMIBC new data based on 26 of the 100 subjects in Cohort A and 80 subjects in Cohort B (Papillary Alone) of our QUILT-3.032 trial, demonstrated long-term (36-month) progression free survival and bladder sparing with ANKTIVA + BCG. ImmunityBio presented the newly published real-world data which demonstrates that compared to chemotherapy, ANKTIVA + BCG led to improved outcomes of progression free survival and cystectomy avoidance at 36-months. To our knowledge, the results to date of ANKTIVA + BCG represent the longest duration of follow-up with the longest duration of bladder sparing in these subjects. The Company indicated at the meeting that it would seek a new meeting request with this new data and withdraw the prior supplemental BLA filing; however, the Company is re-evaluating this approach in consultation with its regulatory counsel and may seek to amend the initial filing with the new data rather than withdrawing it, with a commitment to initiate a randomized controlled trial of chemotherapy free ANKTIVA + BCG versus chemotherapy in the papillary alone indication. Separately, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease, in addition to the currently recognized CIS with or without papillary disease. The NCCN is expected to review the submission at its August 2025 meeting. Non-Small Cell Lung Cancer (NSCLC) ImmunityBio has launched ResQ201A, a randomized controlled trial, in the United States, evaluating its IL-15 superagonist N-803 in combination with tislelizumab, a PD-1 checkpoint inhibitor from BeOne Medicines in patients with 2 nd line lung cancer who were progressing on checkpoint inhibitors. The Company has also submitted clinical trial applications for ResQ201A in the European Union and the United Kingdom, with Canada expected to be submitted in early Q3 2025, and with plans underway to submit in Asia. Lymphopenia The Company also met with the Division of Non-Malignant Hematology at the FDA in June to present updated data from its lymphopenia program. The Division was supportive of the findings including the underlying science of stimulating lymphocytes with ANKTIVA and expressed a desire to support an efficient path to approval, noting that additional time will be required to finalize the appropriate development plan. Expanded Access Program (EAP) authorization has been activated for the indication for all solid tumors in patients who have failed first-line treatment on chemotherapy, radiotherapy or immunotherapy and exhibit low Absolute Lymphocyte Counts (ALC < 1,000/μL). Disclaimer Regarding Financial Overview The information and amounts presented above, including under the caption 'Financial Overview,' reflects the Company's preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its financial results or position as of June 30, 2025. Any actual amount that the Company reports in its Quarterly Report on Form 10-Q for the period ended June 30, 2025 will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the period ended June 30, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the Company's condensed consolidated financial statements for the quarter when they are completed and publicly disclosed. About ANKTIVA 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 drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo. ANKTIVA was approved by the FDA in 2024 and by UK MHRA in 2025 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies 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 (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 discussions and meetings with the U.S. FDA, including with respect to the previously reported RTF letter received by the Company and potential implications thereof, potential next steps, decisions and timeline related to the Company's regulatory submissions and strategy, financial results anticipated to be reported in future SEC filings, clinical trial data and potential results and implications to be drawn therefrom, the expectation that the EAP described herein will enable patients to have access to ANKTIVA for the indication described, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, clinical trial and expanded access program enrollment, timing, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield TM platform, anticipated review timeline for the Company's NCCN guidelines submission in NMIBC papillary only and potential implications 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 alone or in combination with other therapeutic agents 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 and for potential applications beyond oncology, 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 have 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 the FDA regulatory submission, filing and review process and the timing thereof, (ii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iii) risks and uncertainties regarding commercial launch execution, success and timing, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (v) whether clinical trials will result in registrational pathways and the risks, (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, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio's ability to retain and hire key personnel, (x) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, (xiv) whether the NCCN will review and/or approve the Company's submission described herein on the anticipated timeline or at all, 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 ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.
