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FORM
Current Report
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Item 8.01 Other Events.
On December 14, 2023, CytoDyn Inc. (the “Company”) held a webcast for investors via the internet to provide an update regarding recent developments at the Company since the appointment of Jacob P. Lalezari, M.D., as the Company’s interim CEO. Information covered in the update included discussion about recent communications with the U.S. Food and Drug Administration (the “FDA”) and the status of the clinical hold imposed by the FDA and protocol submission. The webcast was recorded and will be available on the Company’s website at www.cytodyn.com through January 14, 2024. The website should not be considered part of this Form 8-K. The Company will post an update to one of the questions included under Frequently Asked Questions on its website to add information provided during the webcast, as follows:
What is the status of the clinical hold?
The Company received a letter from the FDA at the beginning of December 2023 notifying the Company that: (i) the “partial hold” implemented by the FDA in March 2022 had been lifted; and (ii) a new “full hold” had been applied as it relates to the newly proposed clinical trial protocol submitted in November 2023 alongside the Company’s complete response to the partial clinical hold.
As a whole, the Company views this as a significant step in the right direction, as the partial clinical hold that had been in place since March 2022 has been resolved. That being said, the Company now needs to resolve the FDA’s comments associated with its newly proposed clinical trial protocol which resulted in the procedural “full hold” that is currently in place. The Company believes the “full hold” will be removed after we adequately respond to the FDA’s comments and incorporate the FDA’s specific guidance as it relates to the proposed protocol.
The Company believes the proposed HIV study will allow the Company to further establish leronlimab’s mechanism of action in a cost-effective manner, and is currently working to incorporate the FDA’s feedback and submit an amended protocol as soon as practicable. The Company expects to submit a revised protocol to the FDA in January 2024.
Note Regarding Forward-Looking Statements
The information included in this report contains forward-looking statements relating to, among other things, our communications with the U.S. Food and Drug Administration, decisions by the FDA, future clinical trials, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and/or our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review the Annual Report on Form 10-K for the fiscal year ended May 31, 2023, including in the sections captioned “Forward Looking Statements” and “Item 1A. Risk Factors”, as later supplemented by our Form 10-Q for the quarter ended August 31, 2023, in the section captioned “Item 1A. Risk Factors”. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.