Latest news with #IBRX
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
Yahoo
23-07-2025
- Business
- Yahoo
ImmunityBio's (IBRX) ANKTIVA Gets Approved by UK's Medicines and Healthcare Regulatory Agency
ImmunityBio, Inc. (NASDAQ:IBRX) is one of the . On July 8, ImmunityBio, Inc. (NASDAQ:IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency has approved ANKTIVA with Bacillus Calmette-Guérin for treating certain bladder cancer patients. This is significant as it marks the first approval for the company outside of the United States of America. Moreover, the drug is a first-in-class IL-15 agonist, which works by activating and multiplying immune cells, specifically NK cells and T cells that help the body fight cancer. A technician analyzing natural killer cells, as part of an immune system study and research into therapeutical agents. In addition, clinical studies have shown strong results as some patients maintained a complete response for over 47 months at the last review. ImmunityBio, Inc. (NASDAQ:IBRX) is a biopharmaceutical company that develops therapies and vaccines that boost the immune system to fight cancer and infectious diseases. 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: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. 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
24-06-2025
- Business
- Yahoo
ImmunityBio (IBRX) Attains FDA's Expanded Access Authorization for its Cancer BioShield Platform Anchored by ANKTIVA
ImmunityBio Inc. (NASDAQ:IBRX) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. On June 2, ImmunityBio Inc. (NASDAQ:IBRX) announced that it attained Expanded Access authorization from the U.S. Food and Drug Administration, FDA, for its Cancer BioShield platform, anchored by ANKTIVA, to treat lymphopenia, a life-threatening immune deficiency induced by radiotherapy, chemotherapy, and immunotherapy. A technician analyzing natural killer cells, as part of an immune system study and research into therapeutical agents. The Expanded Access covers all patients with solid tumors who failed first-line treatment on radiotherapy, immunotherapy, or chemotherapy, and exhibit low Absolute Lymphocyte Counts (ALC <1,000/μL). On June 4, H.C. Wainwright analyst Andres Y. Maldonado maintained a Buy rating on ImmunityBio Inc. (NASDAQ:IBRX) and set a price target of $8.00, highlighting the company's innovative approach to the treatment of lymphopenia. He supported the optimistic outlook with ImmunityBio Inc.'s (NASDAQ:IBRX) Cancer BioShield platform, including ANKTIVA and PD-L1 t-haNK CAR-NK cells, citing that it attained notable regulatory milestones, such as an Expanded Access authorization from the FDA and RMAT designation. These milestones reflect the potential of the company's therapies in complicated cancer cases. ImmunityBio, Inc. (NASDAQ:IBRX) is a clinical-stage immunotherapy company that develops next-generation therapies to treat cancer and infectious diseases. Its immunotherapy platform activates the adaptive and innate immune systems to create long-term immunological memory. 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. Sign in to access your portfolio
Yahoo
03-06-2025
- Business
- Yahoo
ImmunityBio receives FDA Expanded Access authorization for Cancer BioShield
ImmunityBio (IBRX) announced that the U.S. Food and Drug Administration, FDA, has granted Expanded Access authorization for the use of its Cancer BioShield platform, anchored by ANKTIVA, to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on IBRX: Disclaimer & DisclosureReport an Issue ImmunityBio to launch Cancer BioShield in the Middle East Piper upgrades ImmunityBio on Anktiva expansion opportunities ImmunityBio upgraded to Overweight from Neutral at Piper Sandler Short Report: Bears not fearing rebound in Rocket, Avis Budget shares ImmunityBio Sees Revenue Surge Amid Strong Sales Momentum
Yahoo
23-05-2025
- Business
- Yahoo
Piper Sandler Upgrades ImmunityBio (IBRX) to Overweight, Lifts PT
On May 20, Piper Sandler analyst Ed Tenthoff upgraded ImmunityBio Inc. (NASDAQ:IBRX) stock from Neutral to Overweight, raising the price target from $4.25 to $5.00. In a research note, the analyst told investors that the rating is based on the development of the company's ANKTIVA, t-haNK & M-ceNK cell therapies, and DNA vaccines, which combat cancer by supporting the immune system. ANKTIVA, for non-muscle invasive bladder cancer, is attaining a strong position in the market, with a 2025 sales forecast of $83.5 million. A technician analyzing natural killer cells, as part of an immune system study and research into therapeutical agents. The rating came after ImmunityBio Inc. (NASDAQ:IBRX) reported strong fiscal Q1 2025 results on May 12, with the net product revenue reaching approximately $16.5 million. This translates to a 129% growth over $7.2 million in fiscal Q4 2024. ANKTIVA unit sales volume in the quarter also underwent a notable 150% rise over fiscal Q4 2024, with monthly volume in March growing 69% compared to February. Although the FDA's Refusal to File (RTF) letter for ANKTIVA in BCG unresponsive papillary NMIBC was a setback, Piper Sandler sees opportunity for ImmunityBio Inc. (NASDAQ:IBRX) as it is initiating the Phase III QUILT-2.005 trial in BCG naive NMIBC and expects to announce data in the coming year. While we acknowledge the potential of IBRX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than IBRX and that has 100x upside potential, check out our report about the . READ NEXT: and . Disclosure: None. Sign in to access your portfolio
