CytoDyn Research Paper on Leronlimab Published in Frontiers in Immunology Journal

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 its research paper entitled “CCR5 receptor occupancy analysis reveals increased peripheral blood CCR5+CD4+ T cells following treatment with the anti-CCR5 antibody Leronlimab” has been accepted by Frontiers in Immunology, a leading journal in its field publishing rigorously peer-reviewed research across basic, translational and clinical immunology.

The article can be found here: http://journal.frontiersin.org/article/10.3389/fimmu.2021.794638/full? ...

Importantly, the results of the study outlined in the research paper:

1. Establish two CCR5 receptor occupancy calculation methods for longitudinal monitoring of anti-CCR5 therapeutic antibody blockade efficacy in both macaques and humans;
2. Demonstrate that CCR5+CD4+ T cell levels temporarily increase with leronlimab treatment; and
3. Facilitate future detailed investigations into the immunological impacts of CCR5 inhibition in multiple pathophysiological processes.

“We are thrilled that the Frontiers in Immunology journal has published this important paper to inform further the scientific community of these exciting developments with leronlimab,” said CytoDyn’s Chief Medical Officer, Scott A. Kelly M.D. “We will relentlessly pursue the various indications for leronlimab to realize its full therapeutic potential. Our continued work on the mechanism of action of leronlimab continues to lay the foundation for more exciting opportunities of leronlimab for patients and our shareholders.”

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.

CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options. CytoDyn is working diligently to resubmit its BLA for this HIV combination therapy since receiving a Refusal to File in July 2020. In July 2021, CytoDyn announced that it had submitted a dose justification report to the FDA, an integral step in the resubmission process for its BLA, which it expects to complete by the end of the first quarter of calendar 2022. CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label expansion approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to once-a-week subcutaneous dose of leronlimab. Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load.