RGMP Regnum Corporation (CE)

Item 8.01 Other Events

As previously reported, on January 3, 2022, Regnum Corp. (“Regnum”), CytoDyn, Inc. (“CytoDyn”), and SevenScore Pharmaceuticals, LLC, an affiliate of Regnum through common ownership, entered into an Assignment and Assumption Agreement of a Commercialization and License Agreement (the “License Agreement”) and a Supply Agreement (the “Supply Agreement”) with CytoDyn.  Through the License Agreement, Regnum has the exclusive right to commercialize pharmaceutical preparations containing leronlimab (PRO 140) (“leronlimab”) for treatment of all human immunodeficiency virus (“HIV”) indications in humans in the United States.  Leronlimab is the subject to of Biologics License Application (“BLA”) that has previously been submitted in part by CytoDyn to the U.S. Food and Drug Administration (“FDA”) with an indication to treat Multi-Drug Resistant HIV infection (“MDR HIV”).

On October 28, 2022, CytoDyn announced a voluntary withdrawal of their leronlimab BLA submission for MDR HIV.  In its announcement, CytoDyn indicated that the decision to voluntarily withdraw the BLA was based on various factors, including systemic issues related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization contracted to manage the trials, resulting in significant concerns with achieving a successful BLA approval by the FDA.

CytoDyn further announced that intends to continue studying leronlimab in other HIV-related indications, which Regnum would, if approved by the FDA, have the right to commercialize in the United States.  In addition, Regnum will continue to seek to acquire or in-license other pharmaceutical products or product candidates, although no products have been identified to date.