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]

Core Viewpoint - ImmunityBio, Inc. received a Refusal to File (RTF) letter from the FDA for the supplemental biologics license application (sBLA) for ANKTIVA plus BCG in treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease, despite prior unanimous guidance from FDA leadership to submit the application [1][2][3] Group 1: FDA Interaction - The RTF letter was unexpected as the FDA's leadership had previously encouraged the company to submit the sBLA during a January 2025 meeting [2] - The company has requested an urgent meeting with the FDA to address the inconsistencies between the guidance received and the RTF letter [3][6] Group 2: Clinical Trial Data - ANKTIVA was previously approved by the FDA in 2024 for BCG-unresponsive NMIBC with papillary tumors with CIS [3] - Long-term results from the clinical trial (QUILT-3.032) showed a disease-specific overall survival rate of 99% at 12 months and 96% at 36 months for patients with papillary disease without CIS [4][5] Group 3: Market Reaction - Following the news of the RTF letter, ImmunityBio's stock (IBRX) fell by 16.50% to $2.12 in premarket trading [7]

Core Viewpoint - ImmunityBio (IBRX) is anticipated to report a year-over-year increase in earnings driven by higher revenues, with a consensus outlook suggesting a quarterly loss of $0.12 per share, reflecting a 40% improvement from the previous year, and revenues expected to reach $15.69 million, a staggering increase of 39,125% from the same quarter last year [1][3]. Earnings Expectations - The stock price may rise if the actual earnings exceed expectations in the upcoming report, while a miss could lead to a decline [2]. - The consensus EPS estimate has been revised down by 1.45% over the last 30 days, indicating a reassessment by analysts [4]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that the Most Accurate Estimate for ImmunityBio is lower than the consensus estimate, resulting in an Earnings ESP of -2.85%, suggesting a bearish outlook [10][11]. - A positive Earnings ESP is generally a strong predictor of an earnings beat, especially when combined with a favorable Zacks Rank [8]. Historical Performance - In the last reported quarter, ImmunityBio was expected to post a loss of $0.26 per share but actually reported a loss of $0.15, resulting in a positive surprise of 42.31% [12]. - Over the past four quarters, the company has beaten consensus EPS estimates twice [13]. Comparative Industry Analysis - Pacira (PCRX), another player in the biomedical and genetics industry, is expected to report earnings of $0.57 per share, reflecting an 8.1% decline year-over-year, with revenues projected at $174.96 million, a 4.7% increase [17]. - Pacira's consensus EPS estimate has remained unchanged over the last 30 days, but it has an Earnings ESP of 34.51%, indicating a strong likelihood of beating the consensus estimate [18].

Group 1 - The article discusses the investment opportunities in ImmunityBio, Inc. (NASDAQ: IBRX), highlighting previous coverage and ratings issued by the author, including a "Hold" rating since April last year [1] - The Haggerston BioHealth marketplace channel offers exclusive stock tips focused on Pharma, Biotech, and Healthcare, providing access to financial models and research [1] - The investing group is designed for both novice and experienced biotech investors, offering insights on catalysts, product sales forecasts, and integrated financial statements [1] Group 2 - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, with detailed reports on over 1,000 companies [1]

Financial Results - ImmunityBio, Inc. reported estimated net product revenue and unit sales volume for the three-month period ended March 31, 2025[4]. - The financial results are preliminary estimates and may differ materially from the actual results to be reported in the Quarterly Report on Form 10-Q[5]. - The report does not include comprehensive financial results or position as of March 31, 2025[5]. Company Information - The company is listed on The Nasdaq Global Select Market under the symbol IBRX[2]. - The company is incorporated in Delaware and has an IRS Employer Identification No. 43-1979754[1]. - The company has not indicated if it is an emerging growth company[3]. Report Details - The press release providing the business update was issued on April 15, 2025[4]. - The report was signed by David C. Sachs, Chief Financial Officer, on April 15, 2025[10]. - The report includes an Interactive Data File embedded within the Inline XBRL document[7]. - The information provided is not deemed "filed" under the Securities Exchange Act of 1934[6].

Core Points - A proposed settlement of $10.5 million has been reached for all individuals or entities who purchased ImmunityBio, Inc. securities between March 10, 2021, and May 10, 2023 [1][2] - The settlement aims to resolve allegations of material misrepresentations and omissions regarding ImmunityBio's compliance with manufacturing practices and product approval prospects [3] Settlement Details - The settlement class excludes defendants, their immediate family members, subsidiaries, affiliates, and any controlling persons or entities [2] - A hearing is scheduled for June 13, 2025, to determine the fairness and adequacy of the proposed settlement and the plan for allocating the settlement proceeds [1][3] Claims and Objections - Settlement class members must submit a Proof of Claim and Release Form by July 7, 2025, to participate in the distribution of the settlement fund [4] - Members wishing to exclude themselves from the settlement must submit a request by May 23, 2025 [5] - Settlement class members have the right to object to the settlement and related requests, with objections due by May 23, 2025 [6] Additional Information - Detailed documents regarding the settlement can be obtained online or by contacting the claims administrator [7] - The notice is dated April 7, 2025, and is issued by the United States District Court for the Southern District of California [8]

Core Insights - The article discusses ImmunityBio, Inc. (NASDAQ: IBRX) and its recent $100 million public offering, which is deemed necessary for supporting the commercialization efforts of its product Anktiva [1] Group 1: Company Overview - ImmunityBio, Inc. is focused on developing innovative therapies and pharmaceuticals, particularly in the biotech sector [1] - The company is involved in the commercialization of Anktiva, which is a key product in its portfolio [1] Group 2: Investment Perspective - The author expresses a beneficial long position in IBRX shares, indicating confidence in the company's future performance [2] - The article is part of a broader investment analysis service that includes model healthcare portfolios and market insights [1]

Core Insights - The article provides an overview of the investment landscape, emphasizing the importance of independent research and verification of information before making investment decisions [2][3]. Group 1 - The article highlights that past performance does not guarantee future results, indicating a need for caution among investors [3]. - It stresses that the opinions presented are based on probabilistic analysis rather than absolute certainty, which reflects the inherent volatility and risk in stock investments [2][3]. - The content is intended for informational purposes and should not be interpreted as personalized investment advice, underscoring the necessity for investors to assess their financial circumstances independently [2][3].