CytoDyn extends the first of three main sections of HIV BLA. a

The second part of three large parts of BLA (CMC part) will be submitted shortly

Clinical section (last part for completing the BLA) is expected to be submitted in the first quarter of 2022

VANCOUVER, Wash., Nov. 16, 2021 (GLOBE NEWSWIRE) – 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, announced today that it has initiated the re-filing of its Biologics License Application (“BLA”) for HIV as part of an ongoing review under US Food and Drug Administration (“FDA”) guidelines.

Nader Pourhassan, Dr. Due to the work of our management and regulatory advisory team, we believe that the problems of the application have been successfully resolved, which allows us to move the process forward. The re-filing will include non-clinical and CMC sections in November, followed by the clinical section filing in the first quarter of 2022. In the meantime, we’re excited to announce that patients who participated in the pivotal Phase 3 CD02 study the continuation of Leronlimab, in an extension arm of our CD02 study, now sometimes reach 4 years with suppressed viral load. Therefore, CytoDyn may file an application for extended access to leronlimab for a fee for MDR-HIV patients who may urgently need leronlimab as early as next week. CytoDyn eventually selected a new BLA team to replace its previous contract research organization. While this was a difficult decision, it was in the best interests of the company due to the need for revisions in many areas of the BLA. We’d like to thank our partners who have worked over the past year to get us to where we are today. This is an exciting step for CytoDyn and we look forward to sharing further positive developments. “

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 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 is working hard to re-submit its BLA for this HIV combination therapy since CytoDyn received a BLA filing refusal in July 2020, which is expected to be completed in the first quarter of calendar year 2022. 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 suppressed viral loads in a subpopulation of R5 HIV patients who have chosen to switch from their daily pill regimen 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 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 effects of SARS COV-2, also known as COVID-19 long-haul flights, 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.

Forward-Looking Statements

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and phrases that reflect optimism, satisfaction or disappointment about current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projected,” “planet”, “anticipates” and Variations 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 marketplace for actual commercial sale. The company’s forward-looking statements are not guarantees of performance, and actual results may vary due to risks and uncertainties including: (i) governmental requirements regarding the effectiveness of Leronlimab in the treatment of human immunodeficiency virus (“HIV”) patients with multiple resistance to current Standard of Care, COVID-19 Patients, and Metastatic Triple Negative Breast Cancer (“mTNBC”), including 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 business; (iii) the company’s ability to meet its liabilities; (iv) the Company’s ability to enter into partnership or license agreements with third parties; (v) the Company’s ability to timely identify patients for participation in its clinical trials; (vi) the company’s ability to obtain approval for a marketable product; (vii) the design, conduct and conduct of the Company’s clinical studies; (viii) the results of the Company’s clinical trials, including the possibility of adverse clinical trial results; (ix) the market for and marketability of each approved product; (x) 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; (xi) regulatory initiatives, regulatory compliance and regulatory approval process; (xii) legal proceedings, investigations or inquiries relating to the company or its products; (xiii) general terms and conditions; (xiv) changes in foreign, political and social conditions; (xv) actions or proposals by shareholders in relation to the company, its management or its board of directors; and (xvi) 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 any subsequent Form 10-Q or Form 8-K submitted to the has been 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.

CONTACTS

Investors:
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Office: 360.980.8524
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Mike Verrechia / Bill Dooley, 800-662-5200
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Melissa Carlson, 833-814-9456
Alliance advisor
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Media:
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Sloane & Company
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