CytoDyn Cancels Webcast and Live Q/A Scheduled for Today | Nation/World

VANCOUVER, Wash. – (BUSINESS WIRE) – Nov. January 2022–

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotech company developing Leronlimab, a CCR5 antagonist with potential for multiple therapeutic indications, announced that it has canceled its webcast scheduled for Thursday, January 13, 2022 has an update at a later date.

About Leronlimab

The US Food and Drug Administration (FDA) has given CytoDyn Fast Track status to investigate two potential indications in which leronlimab is used to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART in HIV-infected patients, the second is in metastatic triple negative breast cancer (mTNBC). Leronlimab is a test-stage humanized IgG4 mAb that binds to CCR5, a cellular receptor important in HIV infection, tumor metastasis, and other diseases including non-alcoholic steatohepatitis (NASH). Leronlimab has been evaluated in 16 clinical studies with more than 1,200 participants and met the primary endpoints in a pivotal phase 3 study (Leronlimab combined with standard HIV treatment in patients with multiple resistance to the currently available classes of HIV drugs).

Leronlimab is a viral entry inhibitor in HIV / AIDS among several potential uses. It binds to CCR5, protecting healthy T cells from viral infection by preventing the predominant HIV (R5) subtype from entering these cells. Leronlimab has no effect on other strains of HIV (e.g. X4), but R5 is the most dominant strain of HIV. Five clinical studies have shown that leronlimab can significantly reduce or control the HIV viral load in humans. The Leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosage requirements than the daily drug therapies currently in use. Cancer research has shown that CCR5 may play a role in tumor invasion, metastasis, and control of the tumor microenvironment (e.g., 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 mouse xenograft model. For this reason, CytoDyn is conducting two clinical studies, a phase 2 study on mTNBC, which was named Fast Track by the FDA in 2019, and a second, a phase 2 basket study, which includes 22 different solid tumor cancers.

The CCR5 receptor plays a central role in modulating the transport of immune cells to foci of inflammation. After completing two clinical studies with COVID-19 patients (a phase 2 and a phase 3), CytoDyn started a phase 2 study on post-acute consequences of SARS COV-2 (PASC), also known as COVID-19 long-distance drivers. This study examined the effects of leronlimab on clinical symptoms and laboratory biomarkers to better understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term effects. Common symptoms are fatigue, cognitive impairment, trouble sleeping, and shortness of breath. CytoDyn plans to conduct clinical trials to investigate the effect of leronlimab on immunological dysregulation in other postviral syndromes, including myalgic encephalomyelitis / chronic fatigue syndrome (ME / CFS).

CytoDyn is also conducting a phase 2 clinical trial for NASH to investigate the effects of leronlimab on liver steatosis and fibrosis. Preclinical studies showed a significant reduction in NAFLD and a reduction in liver fibrosis with the use of leronlimab. There are currently no FDA approved treatments for NASH, which is a major cause of liver transplants. Approximately 30 to 40 percent of adults in the US live with NAFLD, and 3 to 12 percent of adults in the US live with NASH. No strong safety signals were identified in patients given leronlimab in multiple disease spectra, including those with HIV, COVID-19, and oncology.

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using Leronlimab, a novel humanized monoclonal antibody that targets the CCR5 receptor. CCR5 plays a critical role in HIV’s ability to invade 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 study of leronlimab in combination with standard antiretroviral therapies in HIV-infected patients who were highly experienced with limited treatment options. CytoDyn is working diligently to re-submit its Biologics License Application (“BLA”) for this HIV combination therapy since CytoDyn received a filing refusal in July 2020.In November 2021, the non-clinical and manufacturing sections of the BLA were re-submitted, all major steps in the BLA re-filing process, which is expected to be completed by the end of the first quarter of the 2022 calendar. CytoDyn also has a Phase 2b / 3 study of leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-oriented study for the indication leronlimab monotherapy. If successful, it could support approval to extend the label. Clinical results to date from two studies have shown that leronlimab can maintain suppressed viral loads in a subpopulation of R5 HIV patients who have chosen to switch from daily pill therapy to a once weekly subcutaneous dose of leronlimab. Several patients in the Phase 2b extension arm of leronlimab remained virally suppressed for nearly 7 years, and many patients in our Phase 2b / 3 study were on monotherapy for two and four years with suppressed viral load.

CytoDyn is also conducting a phase 2 clinical study with leronlimab in mTNBC, a phase 2 basket study in solid tumor carcinomas (22 different cancer indications), a phase 2 study on post-acute consequences of SARS COV-2, also known as COVID – 19 long-haul aircraft and one phase 2 clinical trial for NASH. CytoDyn has already completed a phase 2 and phase 3 study for mild to moderate or severe to severe COVID-19 patients in whom CytoDyn has not met its primary or secondary endpoints other than the secondary endpoint in critically ill subpopulation . More information is available at

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 that reflect optimism, satisfaction or disappointment about the current outlook, as well as words such as “believes”, “hopes”, “intends”, “estimates”, “expects”, “projected”, “plans”, “anticipates” and variations thereof or the use of future tenses identify forward-looking statements, but the lack of them does not mean that any statement is not forward-looking. Forward-looking statements include, in particular, statements about Leronlimab, its ability to achieve positive health outcomes, the possible outcomes of clinical trials, studies or other programs or the ability to continue such programs, the ability to obtain regulatory approvals 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) government regulations governing the effectiveness of Leronlimab in treating the humane Immunodeficiency Virus (“HIV”) patients with multiple resistance to current standard of care, COVID-19 patients, and metastatic triple-negative breast cancer (“mTNBC”), among other cancer indications, from the US Food and Drug Administration and various drug regulatory agencies in other countries; (ii) the company’s ability to raise additional capital to fund its operations; (iii) the company’s ability to meet its debts and other payment obligations; (iv) the company’s ability to enter into partnership or license agreements enter into or maintain with third parties; (v) the Company’s ability to timely identify patients for participation in its clinical trials; (vi) the timely and sufficient development by in-house resources or external consultants of the drug product analysis of data from the Company’s clinical trials as required by the FDA or other regulatory agencies in connection with the BLA re-filing or other Company regulatory filings the company; (vii) the company’s ability to obtain approval for a marketable product; (viii) the design, conduct and conduct of the Company’s clinical studies; (ix) the results of the Company’s clinical trials, including the possibility of adverse clinical trial results; (x) the market for and marketability of each approved product; (xi) the existence or development of any vaccine, drug, or other treatment that is considered by clinicians or patients to be superior to Company’s products; (xii) regulatory initiatives, regulatory compliance and regulatory approval process; (xiii) any legal proceeding, investigation or investigation into the company or its products; (xiv) general terms and conditions; (xv) changes in foreign, political and social conditions; (xvi) Actions or proposals by shareholders in relation to the company, its management or its board of directors; and (xvii) various other matters, many of which are beyond the control of the company. The company urges investors to specifically consider the various risk factors identified in its latest Form 10-K, as well as any risk factors or warnings contained in Forms 10-Qs and 8-Ks below, which are included in the Securities and Exchange Commission have been filed. 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.

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SOURCE: CytoDyn Inc.

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PUB: 01/13/2022 09:00 AM / DISC: 01/13/2022 09:02 AM


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