CytoDyn research article on leronlimab published in Frontiers in Immunology Journal

VANCOUVER, Washington, November 19, 2021–(BUSINESS WIRE)–CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with potential for multiple indications Therapeutics, today announced that his research paper titled “CCR5 Receptor Occupancy Analysis Reveals Increased Peripheral Blood CCR5+CD4+ T Cells Following Treatment with Anti-CCR5 Antibody Leronlimab” has been accepted by Frontiers in Immunology, a leading journal in its field publishing rigorously peer-reviewed research in clinical, translational and immunology.

The article can be found here: http://journal.frontiersin.org/article/10.3389/fimmu.2021.794638/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=794638

It is important to note that the study results described in the research document:

  1. To establish two methods for calculating CCR5 receptor occupancy for longitudinal monitoring of the blocking efficacy of anti-CCR5 therapeutic antibodies in macaques and humans;

  2. Demonstrate that CCR5+CD4+ T cell levels increase temporarily with leronlimab treatment; and

  3. Facilitate future detailed investigations of the immunological impacts of CCR5 inhibition in multiple pathophysiological processes.

“We are delighted that the journal Frontiers in Immunology has published this important article to further inform the scientific community of these exciting developments with leronlimab,” said CytoDyn Chief Medical Officer Scott A. Kelly MD. different indications for leronlimab to realize its full therapeutic potential.Our ongoing work on leronlimab’s mechanism of action continues to lay the foundation for more exciting leronlimab opportunities 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 an essential role in the ability of HIV to penetrate and infect healthy T cells and appears to be involved in tumor metastasis and immune-mediated diseases, such as NASH.

CytoDyn successfully completed a pivotal Phase 3 trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were highly treatment-experienced individuals with limited treatment options. CytoDyn has been 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, a critical step in the resubmission process for its BLA, which it expects to complete by the end of the first quarter of calendar year 2022. CytoDyn has also completed a Phase 2b/ 3 with leronlimab used as monotherapy once a week for HIV-infected patients. CytoDyn plans to initiate a registration-led study of the leronlimab monotherapy indication. If successful, it could support a label extension endorsement. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a subpopulation of HIV R5 patients who have elected to switch from their daily pill regimen to a subcutaneous dose of leronlimab once a week. Several patients in the leronlimab Phase 2b extension arm remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigational trial spend two and approximately four years of monotherapy with a suppressed viral load.

CytoDyn recently completed a Phase 2 clinical trial with leronlimab in mTNBC and a Phase 2 basket trial in solid tumor cancers (22 different cancer indications), a Phase 2 investigational trial for post sequelae -acute cases of SARS COV-2, also known as long-haul COVID-19 and a phase 2 clinical trial for NASH are continuing. CytoDyn has already completed a Phase 2 and Phase 3 trial for mild-to-moderate and severe-to-critical COVID-19 patients, respectively, for which CytoDyn has not met its primary or secondary endpoints, except of the secondary endpoint in the critically ill subpopulation. More information at www.cytodyn.com.

Forward-looking statements

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intends”, “estimates”, “expects” , “projects”, “plans”, “anticipates” and variations thereof, or the use of the future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to provide positive health outcomes, possible results of or ability to continue clinical trials, studies, or other programs, the ability to obtain regulatory approval for commercial sales and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained or expressed in such statements due to risks and uncertainties, including: (i) regulatory determinations of the effectiveness leronlimab to treat human immunodeficiency virus (“HIV”) with multiple resistance to current standards of care, COVID-19 patients, and metastatic triple-negative breast cancer (“mTNBC”), among other indications, by the United States Food and Drug Administration and various drug regulatory agencies in other countries; (ii) the ability of the Company to raise additional capital to finance its operations; (iii) the ability of the Company to honor its debts; (iv) the Company’s ability to enter into partnership or license agreements with third parties; (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely manner; (vi) the Company’s ability to obtain marketable product approval; (vii) the design, implementation and conduct of the Company’s clinical trials; (viii) the results of the Company’s clinical trials, including the possibility of adverse clinical trial results; (ix) the market and merchantability of any Approved Product; (x) the existence or development of vaccines, drugs or other treatments that are considered by healthcare professionals or patients to be superior to the Company’s products; (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process; (xii) legal proceedings, investigations or inquiries regarding the Company or its products; (xiii) general economic and commercial conditions; (xiv) changes in foreign, political and social conditions; (xv) actions or shareholder proposals relating to the Company, its management or its board of directors; and (xvi) various other matters, many of which are beyond the Company’s control. The Company urges investors to specifically review the various risk factors identified in its most recent Form 10-K, as well as any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to reflect events or circumstances that occur after the date of this press release.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211119005420/en/

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