The Company’s inventory as of November 30, 2020 and May 31, 2020 was $99.1 million and $19.1 million, respectively. Inventory as of November 30, 2020 consisted of raw materials purchased for future commercial production and work-in-progress inventory related to the substantially completed commercial production of of leronlimab to support the Company’s expected approval of the product as a combination therapy for HIV patients in the United States. consists of bulk drug substance, which is the manufactured drug stored in bulk storage, and drug product, which is the manufactured drug in unlabeled vials. Bulk drug substance and drug product comprised approximately $41.1 million and $29.7 million, respectively, of inventory.

The Company believes that material uncertainties related to the ultimate regulatory approval of leronlimab for commercial sale have been significantly reduced based on positive data from the Phase 3 clinical trial results, and information gathered from meetings with the FDA for the BLA. The last two portions of the BLA (clinical and manufacturing) were submitted with the FDA in April 2020 and the BLA submission was completed on May 11, 2020. In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA filing requesting additional information. In August and September 2020, the FDA provided written responses to the Company’s questions and met telephonically with Company key personnel and its clinical research organization concerning its recent BLA for this HIV combination therapy to expedite the resubmission of its BLA filing for this indication. The Company is working diligently to resubmit the BLA, which it expects to file in the first half of calendar year 2021.