At this time, there are minimal treatment options for COVID-19. VANCOUVER, Washington, July 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology … The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. VANCOUVER, Washington, July 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or ... package with The Nasdaq Stock Market to request an uplisting … Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission.

Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients). CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. Fundraising and Uplisting The Company believes it satisfies the initial listing requirements for The Nasdaq Capital Market®. In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Clinical manifestations in patients have ranged from non-existent to severe and fatal. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: “While we realize the regulatory review of our application to uplist to Nasdaq will take several weeks, we believe the Company is well positioned for success. Discussions are on all indications that include HIV, Cancer, NASH, COVID-19. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. VANCOUVER, Washington, July 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it recently filed a comprehensive listing application package with The Nasdaq Stock Market to request an uplisting of the Company’s common stock. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Big pharma in the USA indicated that it is waiting to see the readout from the COVID-19 trials before taking action. More information is at www.cytodyn.com. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

Clinical manifestations in patients have ranged from non-existent to severe and fatal. More information is at www.cytodyn.com.

CYTODYN CONTACTSInvestors: Cristina De LeonOffice: 360.980.8524, ext.

As we advance the evaluation of our drug, leronlimab, including the upcoming results of the COVID-19 trials, we believe a listing on Nasdaq will enhance shareholder value by providing our shareholders with improved liquidity and by giving us greater access to the capital markets, which will allow us to achieve our objective of bringing leronlimab to market.”. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The Company believes it satisfies the initial listing requirements for The Nasdaq Capital Market®. In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China.

The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve FDA approval of a marketable product, (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 unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. Proactive Investors Interview on October 23, Investment Community Webcast on Tuesday, October 20, CEO Appearance on FOX Business: After The Bell, Dr. Seethamraju’s Presentation at Special isirv-AVG Virtual Conference, Manuscript Accepted by Infectious Diseases Society of America.

The Company is working diligently to provide the information required by the FDA in order to resubmit its Biologics License Application for this combination therapy. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.

Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV.

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