First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated

Fifteen (15) severely ill COVID-19 patients have been treated under an EIND; 7-day results from the first four patients are available and are very promising; 7-day results for the first 10 patients will be available this week

VANCOUVER, Washington, April 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Company’s Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

In addition, the Company’s investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.

CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimab’s mechanism of action.”