ImmunityBio, Inc. announced that the drug substance (DS) has been completed and successfully qualified for "fill finish" (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA (nogapendekin alfa inbakicept-pmln). Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company's own drug substance and fill-finish manufacturing plants in California and New York. The drug product will be filled at the Dunkirk, New York facility, a 400,000 square foot GMP facility in which the fill-finish equipment has been purchased and is in the process of being installed.

These infrastructure capacity plans were initiated in anticipation of the approval of ANKTIVA in combination with BCG for non-muscle invasive bladder cancer, carcinoma in situ (CIS), to ensure that ImmunityBio has sufficient drug product supply, not only for the first commercial launch of ANKTIVA but for other clinical trials and indications.