IBRX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-04

• •our ability to successfully commercialize ANKTIVA globally in current and future approved indications (including NMIBC and NSCLC), and to obtain incremental regulatory approvals for new indications (including BCG-unresponsive NMIBC with CIS, with or without papillary tumors, BCG-unresponsive NMIBC …

• •our expectations regarding the operation and effectiveness of our approved product and product candidates and related benefits, potential future uses and applications of our approved product and product candidates, including potential use in cancer vaccines and across multiple tumor types, and the …

• •our ability to forecast operating results, including estimates regarding our future revenue and operating expenses, and make period-to-period comparisons predictive of future performance, including due to the impact of fluctuations in warrant, derivative, and fair value accounting measurement value…

• •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; the timing or likelihood of regulatory filings or oth…

• Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• •our ability to successfully commercialize ANKTIVA globally in NMIBC, NSCLC or other indications or any future approved products in the U.S. or internationally;

• •our ability to obtain incremental approvals for ANKTIVA for new indications, including, without limitation, in BCG-unresponsive NMIBC with CIS, with papillary tumors and NSCLC from the FDA or clearances or approvals from international regulatory agencies for the treatment of patients with NMIBC, NS…

• •potential future uses and applications of ANKTIVA, including as a lymphopenia rescue agent in solid tumors or other indications, and use in cancer vaccines and across multiple tumor types;

• •our ability to develop next-generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases;

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

Text added vs the prior filing · source: 10-Q · 2026-08-04

• 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…

• Altor shareholders for additional merger consideration in the amount of the $2.00 per share milestone payment under the regulatory CVR milestone. The notice stated that any such claim would be based on NantCell’s alleged failure to use commercially reasonable efforts to secure FDA approval of ANKTIV…

Text removed vs the prior filing · source: 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…

• 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…

Text added vs the prior filing · source: 10-Q · 2026-08-04

• •While we currently have one product approved, we may be unable to obtain additional U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our other product candidates.

• •require us to dedicate a substantial portion of our cash and cash equivalents to make interest and principal payments on our debt and revenue interest liability payments, reducing the availability of our cash and cash equivalents, and cash flow from operations to fund future capital expenditures, w…

• In connection with our RDO transactions in the years ended December 31, 2023 and December 31, 2025, we entered into warrant agreements with certain institutional investors that allow such investors to purchase up to an aggregate total of 87,296,311 shares of our common stock, with exercise prices ra…

• After a series of productive meetings, a December 2025 Type B meeting with senior FDA officials was held. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations, and perspectives on the interpretation of the company’s data. BCG-unrespons…

• In May 2026, we announced that the FDA had accepted for review the sBLA for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027. There can be no assurance that the FDA…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• •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 …

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

• •require us to dedicate a substantial portion of our cash and cash equivalents to make interest and principal payments on our debt and revenue interest liability payments, reducing the availability of our cash and cash equivalents and cash flow from operations to fund future capital expenditures, wo…

• In connection with our RDO transactions in the years ended December 31, 2023 and December 31, 2025, we entered into warrant agreements with certain institutional investors that allow such investors to purchase up to an aggregate total of 87,296,311 shares of our common stock, with exercise prices ra…

• After a series of productive meetings, a December 2025 Type B meeting with senior FDA officials was held. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations, and perspectives on the interpretation of the company’s data. BCG-unrespons…

Text added vs the prior filing · source: 10-Q · 2026-08-04

• 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 June 30, 2026.

Text removed vs the prior filing · source: 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 …