IBRX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• •our expectations regarding the potential benefits of our Cancer BioShield platform (comprises multiple therapeutic modalities to activate immune response) and our strategy and technology;

• •our beliefs regarding the success, cost and timing of our approved product and product candidate development activities and current and future clinical trials and studies, including study design, the enrollment of patients, and the timing of data readouts related thereto;

• •our expectations regarding our ability to utilize the Phase 1/2 aNK, haNK®, taNK, and NK-CAR (t-haNK™) clinical trials data to support the development of our product candidates, including our NK-CAR (t-haNK), MSC, and M-ceNK™ product candidates;

• •our ability to successfully address any concerns the FDA may have associated with the sBLA for the BCG-unresponsive NMIBC with papillary tumors indication, and whether or not we will receive a CRL if there is a need for the initiation or design of a new RCT, which we could ultimately be required to…

• •our ability to enter into and successfully execute on clinical, regulatory and commercial arrangements internationally to accelerate the development and commercialization of ANKTIVA and our other product candidates;

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• •our ability to meet our payment obligations under the RIPA and to service the interest on our related-party promissory note and repay such note, to the extent required;

• •our expectations regarding the potential benefits of our strategy and technology;

• •details regarding our strategic vision and planned product candidate pipeline;

• •our beliefs regarding the success, cost and timing of our product candidate development activities and current and future clinical trials and studies, including study design and the enrollment of patients;

• •the timing of the development and commercialization of our other product candidates;

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• On November 20, 2024, a shareholder derivative action was filed in the Delaware Court of Chancery against the company’s Founder, Executive Chairman, Global Chief Scientific and Medical Officer and principal stockholder, Dr. Soon-Shiong, certain affiliates of Dr. Soon-Shiong, certain other members of…

• On May 2, 2025, instead of filing an opposition to defendants’ motion to dismiss, the plaintiff filed an amended complaint. This amended complaint added certain additional members of the company’s Board of Directors as defendants but did not add new claims. On July 16, 2025, the defendants filed a m…

• In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon the successful regulatory approval of a BLA by the FDA, or foreign equivalent, for ANKTIVA by December 31, 2022,…

• On December 27, 2022, Shareholder Representative Services, LLC (SRS), in its capacity as shareholder representative on behalf of former Altor BioScience Corp. shareholders, sent the company’s subsidiary NantCell a notice of claims relating to the regulatory milestone CVR. The notice of claims assert…

• After the company provided many of the requested documents, on September 29, 2023, SRS filed a demand for arbitration with JAMS, seeking to compel the company to produce additional documents identified in its October 2022 letter relating to its efforts to obtain FDA approval for ANKTIVA. The arbitra…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• On June 30, 2023, a putative securities class action complaint, captioned Salzman v. ImmunityBio, Inc. et al., No. 3:23-cv-01216-GCP-VET, was filed in the United States District Court for the Southern District of California against the company and three of its officers and/or directors, asserting vi…

• As a result of the foregoing, the company recorded legal settlement expense of $10.5 million in selling, general and administrative expense, on the condensed consolidated statement of operations during the year ended December 31, 2024 and a corresponding amount in accrued expenses and other liabilit…

• Altor BioScience, LLC, and NantCell, Inc. Matters Against Dr. Hing Wong and HCW Biologics, Inc.

• On December 23, 2022, Altor and NantCell filed an arbitration demand against Dr. Hing Wong, former CEO of Altor and NantCell. The demand asserts claims for breach of Dr. Wong’s contracts with the companies, breach of the covenant of good faith and fair dealing, conversion, fraudulent concealment, un…

• Also, on December 23, 2022 Altor and NantCell filed a complaint in the United States District Court for the Southern District of Florida against HCW, Dr. Wong’s new company. Altor’s and NantCell’s complaint asserts claims for misappropriation of trade secrets under both Florida and federal law, indu…

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• •We have formed, and may in the future form or seek, strategic alliances or enter into collaborations with third parties or additional licensing arrangements, and we may not realize the benefits of such alliances or licensing arrangements. Conflicts may arise between us and our collaborators or stra…

• •While we have one product approved by the U.S. FDA, the UK MHRA, the SFDA, and the ISAF of the Macau Special Administrative Region of the People’s Republic of China and have been granted conditional marketing authorization from the EC (EMA) for the EU, we may be unable to obtain additional U.S. or …

• To the extent that we raise additional capital through the sale of equity or equity-linked securities (including warrants), convertible debt, our shelf registration statements, or other offerings, or if any of our current debt is converted into equity or if our existing warrants are exercised, your …

• The RIPA contains affirmative and negative covenants and events of default, including covenants and restrictions that, among other things, restrict our ability to incur liens, incur additional indebtedness, make loans and investments, enter into transactions with affiliates, engage in mergers and ac…

• Our substantial amount of debt could have important consequences and could:

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• •We have formed, and may in the future form or seek, strategic alliances or enter into collaborations with third parties or additional licensing arrangements, and we may not realize the benefits of such alliances or licensing arrangements, and we may engage in disputes with such third parties, which…

• •While we have one product approved by the FDA and the MHRA, we may be unable to obtain additional U.S. or foreign regulatory approval and, as a result, may be unable to commercialize our other product candidates. We are, and will continue to be subject to ongoing extensive regulation, regulatory ob…

• We expect our expenses and net losses to increase significantly as we continue to commercialize our approved product, continue to develop and seek regulatory approvals for our other product candidates, and plan to commercialize other approved products, if any, as well as hire additional personnel, p…

• Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on sales, the timing of our clinical studies and trials, associated manufacturing needs, commercialization activities of our approved product, and any of our other product candidates, if they are approved,…

• To the extent that we raise additional capital through the sale of equity or equity-linked securities (including warrants), convertible debt, our shelf registration statements, or other offerings, or if any of our current debt is converted into equity or if our existing warrants are exercised, your …

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• On February 27, 2026, Ms. Cheryl Cohen, an independent member of our Board of Directors, adopted a written plan for the sale of up to 268,245 shares of our common stock that is intended to satisfy the affirmation defense conditions of Rule 10b5-1(c) under the Exchange Act. The plan will expire on Ja…

• On March 12, 2026, Mr. Michael Blaszyk, an independent member of our Board of Directors, adopted a written plan for the sale of up to 795,479 shares of our common stock that is intended to satisfy the affirmation defense conditions of Rule 10b5-1(c) under the Exchange Act. The plan will expire on De…

• On March 13, 2026, Ms. Christobel Selecky, an independent member of our Board of Directors, adopted a written plan for the sale of up to 388,986 shares of our common stock that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. The plan will expire on…

• Other than noted above, none of our directors or officers, as defined in Rule 16a-1(f) under the Exchange Act, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K, during the three months ended …

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• None of our directors or officers, as defined in Rule 16a-1(f) under the Exchange Act, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K, during the three months ended September 30, 2025.