CytoDyn announces treatment of the first patient in its pivotal phase 3COVID-19 trial in brazil for patients with severe symptoms

CytoDyn Inc. (OTCQB: CYDY) a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the treatment of the first patient in its pivotal Phase 3 COVID-19 trial in Brazil for patients with severe symptoms. An interim analysis will be conducted 28 days following the enrollment of245 patients, which is 40% of the total number of patients to be enrolled in the trial.

As previously announced, this pivotal Phase 3 trial for severe COVID-19 patients is being conducted by Academic Research Organization (“ARO”) Albert Einstein Israelite Hospital. This trial is intended to provide Brazil’s regulatory authority ANVISA (AgênciaNacional de Vigilância Sanitária) with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. The trial will be conducted in up to 35clinical sites with 612 patients who are hospitalized and in need of oxygenation support.

Nader Pourhassan, Ph.D., CytoDyn’s President and ChiefExecutive Officer, commented, “We are very encouraged enrollment for this first trial is underway and look forward to reaching our interim analysis target as soon as possible. We believe our second trial in Brazil will also initiate very soonas ANVISA has cleared the trial with a condition of more information about CMC, which will be provided to ANVISA no later than September 13. Today marks the first day of the much anticipated clinical trial in Brazil that we have been waiting for andwe are so grateful to our team who conducted the CD12 trial in U.S. that produced a wealth of information for us to be able to appropriately design and power these two studies. We also give especial thanks to the ARO team for a job well done andlook forward to many more trials to be conducted by them in Brazil with leronlimab. We also thank the BIOMM team for exceptional work to finalize this protocol with ANVISA and providing very valuable guidelines to our team.”

About Leronlimab:

The U.S. Food and Drug Administration(FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (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 binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). Leronlimab has been studied in 16 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimabcombined with HIV standard care in patients with multi-drug resistance to current available classes of HIV drugs).

Leronlimab, among various potential applications, is a viral-entry inhibitor in HIV/AIDS. It binds to CCR5,thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV. Fiveclinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies. Cancer research has shown CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control (for example, through angiogenesis). Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 97% in a murine xenograft model. As a result, CytoDyn is conducting two clinical trials, one, a Phase 2 in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second, a Phase 2, basket trial which encompasses 22 different solid tumor cancers.

The CCR5 receptor plays a central role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial evaluated the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. CytoDynplans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. Pre-clinical studies revealed a significant reduction in NAFLD and a reduction in liver fibrosis using leronlimab. There are currently no FDA approved treatments for NASH, which is a leading cause of liver transplant. About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH. There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19, and oncology.