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Leronlimab update fails to lift CytoDyn, shares down

September 17, 2020

CytoDyn (OTCQB:CYDY -16.4%) is down on average volume on the heels of its conference call updating its activities related to leronlimab. Key points:

COVID-19: Both the FDA and UK’s MHRA both want to see interim data from the results from the Phase 2 study, CD12, in severe/critical patients before deciding on emergency use authorization/fast track of leronlimab.

Data from 60 mild-to-moderate patients in the Phase 2 study, CD10, shared with MHRA on September 9. May be a candidate for early access program. MHRA wants these data, along with results from other ongoing studies, to be submitted for review. Compilation in process. Site selection for UK study in process.

Working with FDA on protocol for a Phase 3 study assessing four weekly injections in moderately ill COVID-19 patients. Some of these will be considered “long-haulers,” those who have been infected with SARS-CoV-2 but have never fully recovered. Leronlimab may be effective in these patients considering its ability to cross the blood-brain barrier.

Company believes the quickest path to approval is moderately ill patients including long-haulers.

Planned U.S. marketing application in treatment-resistant HIV-1 to be based on 700 mg dose. The Phase 3 study (CD02) was conducted with 350 mg dose, however. A different Phase 3 (CD03) assessed three doses of leronlimab alone (350 mg, 525 mg and 700 mg) in virally suppressed CCR5-tropic HIV-1 patients. Company says the agency has agreed that the 700 mg dose is the one that it will approve but wants to see data from an ongoing monotherapy study to demonstrate efficacy. All patients in this dose arm in CD03 have completed treatment so management believes it has the necessary data to support a BLA filing.

NASH: Phase 2 trial poised to start. Most sites selected. Dosing should commence in mid-to-late November.

Uplisting plan: Nasdaq notified the company that it expects to complete its review of its application for uplisting to the Capital Market tier next week. A $4 share price is a key criterion. If a $3 price comes into play, another threshold, then a net tangible asset test will be involved. Positive equity of $4M – 5M required at time of uplisting. A major investment bank is poised to raise additional capital if necessary. Confident that it can address the “going concern” issue.

Management seeking shareholder sign-off on 25M-share increase in equity incentive plan.

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