Latest news with #ImmunityBio
Globe and Mail
3 days ago
- 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
National Post
4 days ago
- Business
- National Post
ImmunityBio Reports Q2 Earnings Release Reflecting 60% Increase in Revenue in Q2 2025, With Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-code
Article content Q2 2025 Revenue Growth with Continued Strong Sales Momentum: $26.4 million, up 60% from Q1 2025, with year-to-date sales of approximately $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, with additional $80 million equity financing closed in July 2025, with warrants which could result in an additional gross proceeds of up to approximately $96.0 million. Non-Small Cell Lung Cancer (NSCLC): ImmunityBio has launched ResQ201A, a randomized controlled trial (RCT), in the U.S., evaluating its IL-15 superagonist N-803 in combination with tislelizumab, a PD-1 CPI from BeOne Medicines in patients with second-line lung cancer who were progressing on checkpoint inhibitors (CPIs). The Company has also submitted clinical trial applications for ResQ201A in the EU and the UK, with Canada expected to be submitted in early Q3 2025, and with plans underway to submit in Asia. Lymphopenia: The Company met with the Division of Non-Malignant Hematology at the U.S. Food and Drug Administration (FDA) in June 2025 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). Lynch Syndrome: Full enrollment reached in the randomized National Cancer Institute (NCI) cancer prevention clinical trial using ANKTIVA in combination with adenovirus vaccine in 186 patients with Lynch Syndrome. UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved marketing authorization application of ANKTIVA in combination with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. Papillary NMIBC: ImmunityBio conducted a Type A meeting with the FDA in June 2025 to discuss its program targeting papillary-only non-muscle invasive bladder cancer (NMIBC) and the FDA's response to the supplemental BLA (sBLA) filing. Contrary to the advice the FDA gave the Company in January 2025 to submit the sBLA, the FDA responded with a Refuse to File (RTF) notice in May 2025 on the basis of requiring a randomized control trial (RCT) against chemotherapy. At the June 2025 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 in combination with BCG. ImmunityBio presented the newly published real-world data, which demonstrates that compared to chemotherapy, ANKTIVA in combination with BCG led to improved outcomes of progression-free survival and cystectomy avoidance at 36-months. To our knowledge, the results to date of ANKTIVA in combination with 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 sBLA 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 RCT of chemotherapy-free ANKTIVA in combination with BCG versus chemotherapy in the Papillary Alone indication. Article content In addition, 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. Article content CULVER CITY, Calif. — ImmunityBio, Inc. ( NASDAQ: IBRX), a leading immunotherapy company, today announced its financial results for the fiscal quarter and six months ended June 30, 2025. Article content 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 in combination with BCG in BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without Papillary tumors. The first half 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. Article content 'ANKTIVA continues to deliver clinical results and promising commercial potential for ImmunityBio,' said Richard Adcock, President and CEO of ImmunityBio. 'We're seeing robust demand across U.S. urology practices of all sizes, driven in part by ANKTIVA's ease of storage and administration. With commercial authorization now in place in the UK, we're actively evaluating our go-to-market strategy for this important initial global market. In parallel, our recombinant BCG (rBCG) therapeutic has been administered safely to more than 150 patients to date in the United States under the expanded access protocol, helping urologists address the ongoing BCG shortage in the U.S. The recent equity financing further strengthens our balance sheet and enables us to accelerate key studies.' Article content 'Our goal has always been to use our innovative science to attack a broad range of cancers, and we are deeply committed to this goal in order to meet the urgent needs of millions of patients,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'To that end, we've begun global expansion of key clinical trials, including those for BCG-naïve NMIBC and second-line lung cancer. In addition, we've initiated enrollment across multiple trials to validate our novel lymphopenia rescue agent in prolonging duration of survival across multiple tumor types—a critical effort to address this life-threatening immune deficiency, and is often triggered by chemotherapy, radiation, or some immunotherapies.' Article content Second-Quarter Ended June 30, 2025 Financial Summary and Comparison to Prior Year Quarter Article content Product Revenue, Net Article content Product revenue, net increased $25.4 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024. Article content Research and Development Expense Article content Research and development (R&D) expense increased $4.1 million to $55.2 million during the three months ended June 30, 2025, as compared to $51.1 million during the three months ended June 30, 2024. The increase was due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities, and higher license fees, partially offset by fewer sponsored research agreements. Article content Selling, General and Administrative Expense Article content Selling, general and administrative (SG&A) expense decreased $6.9 million to $42.3 million during the three months ended June 30, 2025, as compared to $49.2 million during the three months ended June 30, 2024. The decrease was due to lower costs related to litigation settlements and commercial consulting activities. Article content Net loss attributable to ImmunityBio common stockholders was $92.6 million during the three months ended June 30, 2025, compared to $134.6 million during the three months ended June 30, 2024. The reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, changes in the fair value of warrant liabilities and a related-party convertible note, partially offset by changes in the fair value of derivative liabilities and an increase in interest expense related to the revenue interest liability. Article content Six Months Ended June 30, 2025 Financial Summary and Comparison to Prior Year Six Months Ended Article content Product Revenue, Net Article content Product revenue, net increased $41.9 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024. Article content Research and Development Expense Article content R&D expense decreased $1.0 million to $103.5 million during the six months ended June 30, 2025, as compared to $104.5 million during the six months ended June 30, 2024. The decrease was mainly due to a reduction in outside service costs, CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in clinical trial costs and by higher manufacturing costs driven by increased production activities. Article content SG&A expense decreased $16.1 million to $75.0 million during the six months ended June 30, 2025, as compared to $91.1 million during the six months ended June 30, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities. Article content Net loss attributable to ImmunityBio common stockholders was $222.2 million during the six months ended June 30, 2025, compared to $268.7 million during the six months ended June 30, 2024. This reduction of loss was primarily driven by increased product revenue, lower R&D and SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability and lower interest and investment income. Article content About ANKTIVA Article content 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 natural killer (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. Article content 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. Article content ANKTIVA was approved by the FDA in 2024 Article content Article content and by UK MHRA in 2025 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Article content . Article content About ImmunityBio Article content 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. Article content Forward-Looking Statements Article content This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding future operating results and prospects, commercialization activities, momentum and market data, 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 timelines related to the Company's regulatory submissions and strategy, participation by urology practices in ImmunityBio's rBCG EAP, the expectation that the rBCG EAP will enable ImmunityBio to reliably bring an alternative source of BCG to patients in the U.S., the expectation that the EAP for lymphopenia 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 and clinical development plan and trial 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 CancerBioShield™ 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 Article content 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, as well as that associated with regulatory agencies outside of the U.S. such as the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and other regulatory agencies, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation programs described herein, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) whether the NCCN will review and/or approve the Company's submission described herein on the anticipated timeline or at all, (viii) risks and uncertainties regarding market access initiatives and timing, (ix) whether the FDA will permit the resubmission of the NMIBC papillary sBLA and the requirements thereof, (x) whether the FDA will ultimately approve the sBLA, or other submissions in a timely matter, or at all, of which there can be no assurance, (xi) risks and uncertainties regarding changes in personnel at the FDA and limited resources at the FDA and potential delays associated therewith, (xii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (xiii) 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, (xiv) potential delays in product availability and regulatory approvals, (xv) the risks and uncertainties associated with third-party collaborations and agreements, including that with Serum Institute of India, (xvi) ImmunityBio's ability to retain and hire key personnel, (xvii) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xviii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xix) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xx) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xxi) 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. 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. Article content Article content Article content Article content Article content Contacts Article content Investors Article content Article content Hemanth Ramaprakash, PhD, MBA Article content Article content ImmunityBio, Inc. Article content Article content +1 858-746-9289 Article content Article content Article content Media Article content Article content Sarah Singleton Article content Article content ImmunityBio, Inc. Article content Article content Article content
Yahoo
7 days ago
- Business
- Yahoo
Immunitybio (IBRX) Targets $80 Million Capital Raise for Business Operations
ImmunityBio, Inc. (NASDAQ:IBRX) is one of the penny stocks that will skyrocket. On July 25, the company confirmed it is eyeing $80 million in gross proceeds on the execution of a securities purchase agreement as part of a registered direct offering. It also plans to issue common stock and warrants for the purchase of additional shares. M. A. Arkhipov/ Once fully exercised, the warrants could yield up to $96 million in gross proceeds. Piper Sandler and Co. is acting as the placement agent of the registered direct offering. The net proceeds from the offering are expected to provide the company with much-needed working capital and support for its ongoing business operations. The direct offering comes on the company's ANKTIVA product, receiving FDA approval as an immunotherapy for non-muscle invasive bladder cancer. The flagship product is designated for FDA Breakthrough Therapy. ImmunityBio, Inc. (NASDAQ:IBRX) is a biotechnology company focused on developing next-generation immunotherapies and vaccines that harness the power of the immune system to fight cancer and infectious diseases. It seeks to create durable and safe protection against diseases by developing innovative therapies and cell therapies that bolster the natural immune response. 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: and 11 Defensive Stocks Billionaires are Buying amid US Trade Tariff Uncertainty. Disclosure: None. This article is originally published at Insider Monkey. 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
Yahoo
31-07-2025
- Business
- Yahoo
ImmunityBio, Inc. (IBRX) Gains UK Approval for ANKTIVA in Bladder Cancer
We recently compiled a list of ImmunityBio, Inc. stands eleventh on our list. ImmunityBio, Inc. (NASDAQ:IBRX) is one of the best future stocks to buy now. It is transforming cancer care through immunotherapies that activate the body's natural defenses. Its lead therapy, ANKTIVA (nogapendekin alfa inbakicept), has already been approved by the FDA for treating certain types of bladder cancer. The company is now expanding its approach with a focus on reversing lymphopenia, an immune deficiency often caused by chemotherapy, radiation, or immunotherapy. In June 2025, the FDA authorized an Expanded Access Program for ANKTIVA under the Cancer BioShield platform, making it the first approved therapy to target treatment-induced lymphopenia in patients with solid tumors who failed standard therapies. At ASCO 2025, data showed that restoring immune health with ANKTIVA, especially when paired with CAR-NK therapy, can significantly improve survival in metastatic pancreatic cancer patients. Internationally, ImmunityBio, Inc. (NASDAQ:IBRX) is gaining momentum. In July 2025, the UK approved ANKTIVA with BCG for non-muscle invasive bladder cancer (NMIBC), marking its first approval outside the U.S. Additionally, a partnership with Saudi Arabia's health system will bring the Cancer BioShield platform to the Middle East. The company is also expanding clinical trials, including a U.S.-based study testing ANKTIVA with PD-1 inhibitors in non-small cell lung cancer (NSCLC), with plans to expand globally. Meanwhile, the business is seeking broader FDA approval for ANKTIVA + BCG in bladder cancer after addressing regulatory hurdles. A laboratory technician using high tech equipment to sequence cancer genomics. By targeting immune collapse caused by cancer treatments, ImmunityBio, Inc. (NASDAQ:IBRX) is introducing a paradigm shift, fighting both cancer and immune dysfunction simultaneously. With FDA designations, strategic global alliances, and promising clinical data, the company is advancing a potentially life-extending new standard in oncology. While we acknowledge the potential of GOOGL 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
Yahoo
25-07-2025
- Business
- Yahoo
ImmunityBio, Inc. Announces Execution of $80 Million Equity Financing from Multiple Institutional Investors
CULVER CITY, Calif., July 25, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading 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 two institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $80 million before deducting placement agent fees and other offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to approximately $96 million. Piper Sandler & Co. is acting as the exclusive placement agent for the registered direct offering. The securities to be sold by the Company are offered under its automatic shelf registration statement on Form S-3 (Registration No. 333-278770). A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC's website at Electronic copies of the prospectus supplement may be obtained for free by contacting Piper Sandler & Co., 350 North 5th Street, Suite 1300, Minneapolis, MN 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924, or by email at prospectus@ Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About ImmunityBio, Inc. 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 the timing and size of the proposed offering, the potential exercise of the warrants being offered and resulting additional proceeds to the Company, the anticipated closing of the equity financing described herein and use of proceeds to be received from such financing, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that reduce or eliminate the need for standard high-dose chemotherapy. 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," "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) whether the equity financing transaction described herein will close on the timeline anticipated, if at all, (ii) those related to the regulatory submission, filing and review process and the timing thereof, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways, (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, regulatory approvals, and reimbursement decisions, (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 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. 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. View source version on Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 Media Sarah Singleton ImmunityBio +1 Sign in to access your portfolio
