Item 7.01 Regulation FD Disclosure.
On October 28, 2022, CytoDyn Inc. (the “Company”) issued a press release describing its voluntary withdrawal of its Biologics License Application (“BLA”) and plans for the future study of leronlimab in HIV-related, non-alcoholic steatohepatitis (“NASH”), and oncology indications.
The Company will host a conference call on Monday, October 31, 2022, at 5:30 a.m. Pacific Time to discuss this regulatory and clinical update. A copy of the press release is being filed as Exhibit 99.1 and incorporated in this Item by reference.
Item 8.01 Other Events.
On October 28, 2022, the Company issued a press release announcing the Company had voluntarily withdrawn the pending BLA for leronlimab as a combination therapy in persons living with HIV with resistance to highly active antiretroviral therapy (“HAART”) in the HIV multi-drug resistant population (“HIV-MDR”).
Item 9.01 Financial Statements And Exhibits.
(d) Exhibits.
99.1 Press Release, dated October 28, 2022.**
Exhibit 104 The cover page from this Current Report on Form 8-K formatted in Inline XBRL.
** Furnished, not filed.