VANCOUVER, Wash., Jan. 11, 2022 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Leronlimab, a CCR5 antagonist with potential for multiple therapeutic indications, announced today that Nader Pourhassan, Ph.D., president and chief executive officer , Scott Kelly, MD, Chairman, Chief Medical Officer and Head of Business Development, Nitya Ray, Ph.D., Chief Operating Officer and Chief Technology Officer, and Christopher Recknor, MD, CytoDyn’s Senior Executive VP of Clinical Operations will be webcast of the investment community to discuss and provide updates on NASH data results (350 and 700 mg), cancer, COVID-19, HIV BLA, and the company’s finances on Thursday, January 13, 2022.
CytoDyn will present for 60 minutes including live questions and answers.
Interested participants are advised to register well in advance of the start of the event. This is a live stream presentation and a link will also be posted on the CytoDyn website within approximately 48 hours of the presentation.
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 implicated 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 has been working diligently to re-submit its BLA for this HIV combination therapy since CytoDyn received a refusal of submission in July 2020. In July 2021, CytoDyn announced it had submitted a dose adjustment report to the FDA, and in November 2021 re-submitted the non-clinical report and manufacturing stages of the BLA, both integral steps in the BLA re-submission process, which is expected to end by the end of the first quarter of the calendar year 2022 will be completed. CytoDyn has also completed 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 a suppressed viral load 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.
The story goes on
CytoDyn recently completed a phase 2 clinical study with leronlimab in mTNBC and a phase 2 basket study in solid tumor cancers (22 different cancer indications). A phase 2 study of post-acute sequelae of SARS COV-2, also known as COVID-19 long-distance runner, and a phase 2 clinical study for NASH are ongoing. 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 did not meet its primary or secondary endpoints, with the exception of the secondary endpoint in the critical one Study sick subpopulation. More information is available at www.cytodyn.com.
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, 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 a medical practitioner or patient to be superior to the 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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