Item 7.01 Regulation FD Disclosure. On October 28
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Posted On: 10/28/2022 5:36:18 PM
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On October 28, 2022, the Company issued a press release announcing the Company had voluntarily withdrawn the pending BLA for leronlimab as a combination therapy in persons living with HIV with resistance to highly active antiretroviral therapy (“HAART”) in the HIV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.
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On October 28, 2022, the Company issued a press release announcing the Company had voluntarily withdrawn the pending BLA for leronlimab as a combination therapy in persons living with HIV with resistance to highly active antiretroviral therapy (“HAART”) in the HIV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.
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(0)CytoDyn Inc (CYDY) Stock Research Links
Daniel Rizzo
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com