CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab - Seite 2

Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung Transplantation Program, commented, “The CD12 trial results are very promising and leronlimab may be the only safe medication to help critically ill patients.”

Scott A. Kelly, M.D., Chairman and Chief Medical Officer, noted, “We believe this further supports CCR5 as a therapeutic target for immunomodulation and the importance of the disruption of the CCL5-CCR5 axis via leronlimab-mediated CCR5 blockade of pro-inflammatory leukocytes and reversal of the cytokine storm in critical COVID-19 patients.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “Today, there are no approved drugs to effectively address the unmet medical need for critically ill COVID-19 patients. Our CD12 study demonstrates leronlimab is particularly effective in treating this patient population. We believe these results are the best results ever achieved for this population in a Phase 3 clinical trial. A recently approved IL-6 blocker used to treat severe to critical hospitalized COVID-19 patients requiring mechanical ventilation, reduced mortality by 2% compared to the placebo group. In contrast, leronlimab demonstrated a reduction of 24% in mortality compared to the SoC treated group, which is 12 times better in reducing all-cause mortality for critically ill COVID-19 patients. The Company is very excited about these results and is concurrently working with regulators here and abroad to expedite leronlimab’s approval to treat COVID-19.”

About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).