According to the Complaint, ImmunityBio, Inc. is a clinical-stage biotechnology company that engages in developing therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases in the U.S. and Europe. The Company offers immunotherapy and cell therapy platforms, including antibody cytokine fusion protein N-803, commercially referred to as “Anktiva”. The Company uses third-party contract manufacturing organizations ("CMOs") to produce certain of its product candidates, including Anktiva.

In May 2022, ImmunityBio submitted a Biologics License Application (“BLA”) for Anktiva to the U.S. Food and Drug Administration (“FDA”). Following submission of its application, ImmunityBio consistently assured investors that “[w]e have established Good Manufacturing Practice (GMP) manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities[.]”

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) ImmunityBio conducted insufficient due diligence to discover, or else did discover and ignored, GMP deficiencies at its third-party CMOs for Anktiva; (ii) one or more of the Company’s third-party CMOs for Anktiva did in fact suffer from GMP deficiencies; (iii) the foregoing deficiencies was likely to cause the FDA to reject the Anktiva BLA in its present form; (iv) accordingly, the Company overstated the regulatory approval prospects for the Anktiva BLA; and (v)as a result, the Company’s public statements were materially false and misleading at all relevant times.

On September 27, 2023, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on November 17. Defendants filed a Motion to Dismiss the amended Complaint on January 8, 2024.

On June 20, 2024, the Court issued an Order granting in part and denying in part Defendants' Motion to Dismiss. Plaintiff was given leave to amend the Complaint.

On January 28, 2025, the parties entered into a Stipulation of Settlement. The Court granted preliminary approval of the Settlement on March 17.