Blood Samples at Day 0, 3 and 7 for Severely Ill COVID-19 Patients Clearly Indicate Leronlimab Has Significantly Reduced the Cytokine Storm in All (7) Patients and All Patients Demonstrated Immunological Benefit at Both Day 3 and Day 7

VANCOUVER, Washington, April 09, 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 results of immunological metrics from blood samples of seven severely ill COVID-19 patients after seven days of treatment with leronlimab.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, stated, “The Day-7 results from these patients demonstrates even more dramatic immune restoration especially in the CD8 T-lymphocyte population, the major immune cell responsible for eliminating virally infected cells. In addition, there is a further dramatic reduction in the critical cytokine storm cytokines IL-6, TNF-alpha. Collectively, these results are correlating with patients’ recovery. Some patients have been removed from ventilators, including one patient who was taken off of a heart/lung bypass machine. Critically ill patients are experiencing the benefit of extubating within 7 days of treatment with leronlimab.”

Following recent clearance by the U.S. Food and Drug Administration (FDA), the Company is enrolling patients in two clinical trials, a Phase 2 trial for mild-to-moderate COVID-19 patients, and a Phase 2b/3 trial for severe and critically ill COVID-19 patients. The Phase 2b/3 clinical trial is for 390 patients, double blinded with 2:1 ratio (active 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 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased that leronlimab appears to facilitate an immunological restoration in these patients and we are sharing our data with the FDA in order to hopefully accelerate the access of our drug to many more patients in need. With more than 20 EINDs approved by the FDA, we are receiving an overwhelming number of EIND requests from all over the country.”

About Coronavirus Disease 2019
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.