CytoDyn Files New Protocol with U.S. FDA for 4 Doses of Leronlimab for Critically Ill COVID-19 Patients with the Objective to Duplicate or Surpass 82% Survival Benefit with P-Value of 0.0233 Originally Achieved from Two Weeks of Treatment in CD12 Trial Wi

Trial commencement will be expedited by enrolling patients in Brazil, U.K., and Canada while immediate EUA requests are pursued in multiple countries

VANCOUVER, Washington, April 01, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that after several weeks of discussions with the U.S. Food and Drug Administration (“FDA”) and analysis of CD12 trial data, and in particular the 82% survival results over placebo after two weeks of leronlimab treatment, with statistically significant p-value of 0.0233, the Company has filed a new protocol to extend treatment to four weeks. The Company will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU. CytoDyn believes four weeks of leronlimab treatment to be sufficient to calm the cytokine storm and to have a positive effect on survival rate at 4 weeks and potentially 8 weeks.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “As recently reported, our further analysis of the CD12 trial data demonstrated a statistically significant 82% reduction in mortality at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on ordinal scale with discharge rate much better in leronlimab with p-value statistically significant. These results were achieved with just two doses of leronlimab, one dose at day 0 and a second dose at day 7. The half-life of leronlimab is 10 days and with only 2 doses, it is impressive we observed a 24% survival benefit at 28 days in critically ill COVID-19 patients, which we believe is as good or better than any reported results achieved so far with any other product for the critically ill population of COVID-19. Based on these results, we believe an increased dosage regimen will result in an equal or greater mortality benefit.”

About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (Nonalcoholic Steatohepatitis). Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).