May 2024 Letter to Shareholders

VANCOUVER, Washington, May 16, 2024 (GLOBE NEWSWIRE) --

Dear Shareholders,

I write today to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), as we approach the end of our 2024 fiscal year (May 31, 2024), and to sincerely thank you for your unwavering support.

Fiscal year 2024 was a significant year for CytoDyn, and one that I believe will be remembered as the beginning of a turnaround. The Company achieved the lifting of the FDA’s clinical hold in late February 2024 and is now working to return to the clinic. Over the past several months, the Company has made significant internal progress on key initiatives which we believe will lead to marked external developments in the form of the commencement of clinical trials, the rollout of a number of pre-clinical research initiatives, and the continued publication of leronlimab data.

Shortly after my appointment as the Company’s CEO in November 2023, I hosted an investment update at which I committed to prioritizing the following: (i) getting off clinical hold, which required the submission of a revised trial protocol to the FDA; (ii) publishing clinical data that had not yet been released; and (iii) exploring how to extend leronlimab’s platform wherever it made sense. As I reflect on my first six months as CEO, I am pleased with the progress, but our work is not yet done.

Over the next six months, we expect to commence at least one, and potentially two clinical trials. The prospective clinical trials, in order of priority, are: (i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and (ii) a Phase II study exploring leronlimab’s effects on inflammation. The Company’s priority will be the oncology trial which, if successful, will put us on track towards a commercial approval of leronlimab in that indication. The inflammation study is aimed at clarifying certain provocative observations related to leronlimab, and to help define the dose and underlying mechanism of anti-inflammatory action. It is imperative that the Company generate unassailable results in the clinic and I believe the above trials can accomplish this. Starting the oncology study and related fundraising is the top priority of the Company at this time, but our current hope is that we can initiate both studies before the end of this calendar year.