Core Insights - ImmunityBio reported a quarterly loss of $0.1 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.2 per share a year ago [1] - The company achieved revenues of $26.43 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 0.10%, and significantly up from $1.05 million year-over-year [2] - ImmunityBio shares have declined approximately 5.9% year-to-date, contrasting with the S&P 500's gain of 7.6% [3] Earnings Outlook - The earnings outlook for ImmunityBio is mixed, with the current consensus EPS estimate at -$0.10 on revenues of $27.17 million for the upcoming quarter, and -$0.45 on revenues of $96.77 million for the current fiscal year [7] - The company's Zacks Rank is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which ImmunityBio belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, suggesting potential challenges ahead [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact ImmunityBio's stock performance [5]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its ch ...

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this "Agreement") is dated as of July 24, 2025, by and among ImmunityBio, Inc., a Delaware corporation (the "Company"), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a "Purchaser" and collectively the "Purchasers"). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an effective registration statement under the Securities Act (as defi ...

Group 1 - The article discusses the recent FDA Refusal to File (RTF) letter received by ImmunityBio (IBRX) regarding ANKTIVA's supplemental BLA for papillary-only NMIBC, which led to a negative market reaction [1] - The author emphasizes their long position in IBRX shares, indicating a belief in the company's potential despite recent setbacks [2] - The article is part of a broader investment strategy focused on innovative biotech companies developing breakthrough therapies, highlighting the author's expertise in the healthcare sector [1]

January 2025 ImmunityBio Investor Presentation Forward-Looking Statements and Intended Use This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data and results from clinical trials and potential implications therefrom, commercialization plans and timelines, including product availability and shipments, potential regulatory pathways and approval requests and submissions, FDA, UK MHRA, EU EMA and other r ...

Forward-Looking Statements and Intended Use This presentation and the accompanying verbal remarks contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data and results from clinical trials and potential implications therefrom, commercialization plans and timelines, including product availability and shipments, potential regulatory pathways and approval requests and submissions, FDA and other regulatory agency meetings, ti ...

Core Viewpoint - ImmunityBio (IBRX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - For the fiscal year ending December 2025, ImmunityBio is expected to earn -$0.43 per share, representing a 41.1% change from the previous year's reported number [8]. Analyst Sentiment and Market Position - Analysts have raised their earnings estimates for ImmunityBio, with the Zacks Consensus Estimate increasing by 46.6% over the past three months [8]. - The upgrade to Zacks Rank 2 places ImmunityBio in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

分组1 - ImmunityBio reported a quarterly loss of $0.15 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.12, but an improvement from a loss of $0.20 per share a year ago, indicating a surprise of -25% [1] - The company posted revenues of $16.52 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 5.25%, and showing a significant increase from revenues of $0.04 million in the same quarter last year [2] - ImmunityBio shares have declined approximately 19.1% since the beginning of the year, contrasting with the S&P 500's decline of -3.8% [3] 分组2 - The earnings outlook for ImmunityBio is mixed, with the current consensus EPS estimate for the coming quarter at -$0.12 on revenues of $21.11 million, and -$0.44 on revenues of $93.87 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which ImmunityBio belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Product Development and Approvals - ANKTIVA has been approved by the U.S. FDA for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with CIS, with commercial distribution beginning in May 2024[309]. - The company submitted a supplemental Biologics License Application (sBLA) for BCG-unresponsive NMIBC Papillary in March 2025 and received a Complete Response Letter (RTF) from the FDA in May 2025[310]. - ANKTIVA is being evaluated in multiple oncology indications, including lung, colorectal, prostate, and ovarian cancers, as well as glioblastoma multiforme and non-Hodgkin lymphoma[311]. - The company is exploring ANKTIVA's potential in combination with other therapies, including therapeutic monoclonal antibodies and in infectious diseases like HIV and long COVID[311]. - The proprietary platforms for product development include cytokine fusion proteins, DNA and vaccine vectors, and cell therapies, with prioritized studies across various cancer types and infectious diseases[312]. - The company aims to enhance the activity of therapeutic monoclonal antibodies across a wide range of tumor types, indicating a focus on improving treatment efficacy[311]. - ANKTIVA has shown potential to increase lymphocyte count in healthy adults, suggesting its use as a lymphopenia rescue agent[311]. - The company is committed to developing next-generation therapies and vaccines that leverage the immune system to combat cancers and infectious diseases[307]. Financial Performance - As of March 31, 2025, ImmunityBio reported an accumulated deficit of $3.5 billion, with net losses of $129.6 million and $134.1 million for the three months ended March 31, 2025, and 2024, respectively[320]. - ImmunityBio achieved net product revenue of approximately $16.5 million in Q1 2025, a 129% increase from $7.2 million in Q4 2024, with ANKTIVA unit sales volume growing 150% over Q4 2024[321]. - Product revenue increased by $16.5 million to $16.5 million for the three months ended March 31, 2025, compared to the same period in 2024, driven by sales of ANKTIVA[348]. - Total revenue for the three months ended March 31, 2025, was $16.5 million, a significant increase from $40,000 in the same period in 2024[347]. - Research and development expense decreased by $5.1 million to $48.2 million for the three months ended March 31, 2025, compared to $53.4 million in 2024[351]. - Selling, general and administrative expense decreased by $9.2 million to $32.7 million for the three months ended March 31, 2025, compared to $41.9 million in 2024[354]. - Total other expense increased by $26.5 million during the three months ended March 31, 2025, primarily due to a $42.6 million increase in the change in fair value of a related-party convertible note[355]. - Cash and cash equivalents, and marketable securities decreased to $61.6 million as of March 31, 2025, from $149.8 million as of December 31, 2024[357]. - The company reported a net loss of $129.7 million for the three months ended March 31, 2025, with adjustments for non-cash items totaling $65.8 million[368]. - The company generated $4.1 million in net cash from investing activities during the three months ended March 31, 2025, compared to a cash outflow of $35.6 million in the same period in 2024[372][373]. - The company reported a net change in cash and cash equivalents of $(82.8) million for the three months ended March 31, 2025[367]. Commercialization and Market Strategy - The company is focused on obtaining additional financing to support the commercialization of ANKTIVA and the development of other product candidates[298]. - The company emphasizes the importance of regulatory approvals and market acceptance for its product candidates to achieve its strategic goals[298]. - The company began commercial distribution of ANKTIVA in May 2024 after receiving FDA approval on April 22, 2024, marking its first approved product for commercial sale[333]. - Nearly 200 urology practices in the U.S. are registering for ImmunityBio's rBCG Expanded Access Program (EAP) to address the BCG shortage and broaden the market for ANKTIVA[321]. - The company expects selling, general and administrative expenses to increase as it commercializes its approved product and expands operations[343]. - The company expects to incur significant incremental commercialization expenses for product sales, marketing, manufacturing, and distribution as it commercializes its approved product[378]. - The company anticipates substantial additional funding will be required to support ongoing operations and commercialization efforts[379]. Financing and Obligations - ImmunityBio completed a $75 million equity financing in April 2025 to support ongoing operations[321]. - As of March 31, 2025, the company had $565.6 million available for use under its $750 million shelf registration statement filed in 2023[358]. - The company entered into a Revenue Interest Purchase Agreement (RIPA) on December 29, 2023, with a $100 million second payment received following FDA approval of ANKTIVA on April 22, 2024[360]. - Under the RIPA, the company will pay tiered revenue interest payments ranging from 4.5% to 10.0% of worldwide net sales, excluding those in China[361]. - The company has obligations to pay approximately $304.0 million in contingent consideration related to the acquisition of Altor, contingent on net sales of ANKTIVA exceeding $1.0 billion before December 31, 2026[369]. - The company has approximately $5.0 million remaining available for future exercise under the SPOA as of March 31, 2025[363]. - The company is obligated to spend an aggregate of $1.52 billion on operational expenses during the initial 10-year term of the Dunkirk Facility lease, with an additional $1.50 billion if the lease is renewed[394]. - The company is obligated to make payments to related-party affiliates and third parties under various contractual obligations, including promissory notes and revenue interest liabilities[388]. - The maximum amount payable related to contingent consideration obligations from acquisitions is $292.9 million, contingent upon achieving various milestones[394]. Regulatory and Compliance Issues - The company is working to reconcile an inconsistency with the FDA regarding the requirement for a randomized trial for ANKTIVA's sBLA submission[321]. - The company received a response to its sBLA submission for ANKTIVA plus BCG indicating that a randomized trial is required, which contradicts previous guidance from the FDA[396]. - The company has no committed source of additional capital and may need to delay or reduce research or development programs if unable to raise sufficient funds[385]. - The company’s financial condition and results of operations are based on estimates and assumptions that could materially differ from actual results[391]. - There have been no material changes to the company's financial market risks related to interest rates, foreign currency exchange rates, and stock price volatility as of the date of the quarterly report[398].

分组1 - ImmunityBio, Inc. (NASDAQ: IBRX) received a Refusal to File (RTF) letter from the FDA regarding its supplemental Biologics License Application (sBLA) for Anktiva in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer [1] - The RTF letter indicates that the FDA found issues with the submission that need to be addressed before the application can be considered [1] - This development may impact the company's stock performance and investor sentiment in the biotech sector [1]