Cytodyn Inc (CYDY)

[Jaylimab]

In July of 2021...Dr. Recknor announced on a conference call that the dosage escalation of the MTNBC trial has completed and 700mg was established as safe. Today's abstract also appears that 700 mg is effective.

10 patients were part of the phase 1B part of the trial and the remaining 18 were either compassionate use (16) or basket trial patients (2).

With phase 1B completed and 700mg established as the recommended dosage, the trial can advance to the phase 2 portion as below:

Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]

The Abstract indicated that we have results from the phase 1B / 2 trial but it appears that we have not done the phase 2 portion of this trial as of yet.

This is very confusing.

The study itself has a primary completion date of July 15, 2022 and a study completion date of September 16, 2022.

How can this be if we did not do phase 2 yet?

It requires 30 patients and I don't believe that we can include the compassionate use patients or basket trial patients. I think we can only include the 10 patients that were part of the phase 1B.

Am I right on this or can someone explain to me how we have results via an abstract about a study that still needs the phase 2 portion completed before we can say we have results?

Furthermore, is Cytodyn still dosing the survivors or did this stop at the end of 2021?