CytoDyn Receives Positive Response From FDA in Reg

CytoDyn Receives Positive Response From FDA in Regard to its Phase 3, Registrational Trial in COVID-19 Critically Ill Population

FDA also allows integrated or meta-analysis of the previous trial results in CD20 final analysis

CD20 is allowed to have four dosages of leronlimab in the first four weeks via IV infusion

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has received a positive response from the U.S. Food and Drug Administration (“FDA”) to conduct a Phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for Invasive Mechanical Ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).

The submission of this protocol was previously announced on December 9th. Patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered via IV infusion weekly over a four-week treatment period (dosage on days 0, 7, 14, and 21).

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “As COVID-19 cases continue to surge in the U.S., we are grateful for the opportunity to move forward with the Phase 3 trial of leronlimab as a treatment option for critically ill COVID-19 patients. There continues to be an immense need for therapeutic options to support this population, and we are optimistic that Phase 3 will show promising results. In previous trials we had issues with our CRO that we now have overcome, and are very excited that the FDA in their recent communication with CytoDyn have stated, ‘As there are now several completed, ongoing, or planned randomized trials of PRO140 (leronlimab) that include severe or critical hospitalized COVID-19 patients, any integrated or meta-analysis would be strengthened if you prespecified analysis details and submitted these for review before results of ongoing or planned trials are Unblinded.’ Since the beginning of the current pandemic, leronlimab has received about 100 eINDs approved for leronlimab by the FDA for use in critically ill COVID-19 patients in the U.S., as a result of these FDA approved eINDs and strong results from most of them, physicians have published four papers in peer review journals. Meanwhile leronlimab was also used in Philippines, under compassionate Special Permit for a fee by over 240 patients with very high rate of success. All these accomplishments along with our current trials in Brazil, we are very hopeful that we will be part of the solution to the current pandemic in U.S. and abroad especially in the critically ill population. We look forward to working with the FDA to expand the access to leronlimab as the fight against COVID-19 continues.”