CytoDyn appoints Dr. Christopher Recknor as Chief Operating Officer. Other OTC: CYDY

Dr. Recknor will continue to oversee the company’s long-range COVID-19 and Phase 2 NASH studies

VANCOUVER, Wash., March 16, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY)(“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix ™ (leronlimab-PRO 140), a CCR5 antagonist with potential for multiple therapeutic indications, today announced the appointment of Dr. Christopher P. Recknor known for the leadership position of Chief Operating Officer. In his role as COO, Dr. Recknor assist the senior management team in defining and executing the overall business strategy and priorities for clinical development and the necessary timelines.

Dr. Recknor joined CytoDyn in August 2020 as Vice President Clinical Development. Before joining CytoDyn, Dr. Recknor has served as principal investigator in over 100 clinical trials for numerous global pharmaceutical companies including Amgen, AstraZeneca, Eli Lilly, Glaxo SmithKline, Merck, Novartis and Pfizer. He has a deep background in clinical research with over 40 published research studies and has authored several research abstracts. Dr. Recknor holds a BA from Furman University and an MD from Medical University in South Carolina. He graduated from Medical University in South Carolina with a degree in internal medicine. He is a former diplomat on the American Board of Internal Medicine.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are delighted to have Dr. Recknor join our leadership team. Dr. Recknor has demonstrated exemplary clinical trial management skills coupled with a keen business acumen Dr. Recknor has extensive clinical operations experience and will be effective in accelerating the evaluation of multiple indications in our pipeline. “

About Leronlimab (PRO 140)
The FDA has given CytoDyn fast-track designation for two possible indications of leronlimab in critical diseases. The first indication is combination therapy with HAART in HIV-infected patients and the second in metastatic triple negative breast cancer. Leronlimab is a humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastasis, and other diseases including NASH. Leronlimab has completed 11 clinical studies in over 1,200 people and met its primary endpoints in a key phase 3 study (Leronlimab combined with standard antiretroviral therapies in HIV-infected patients with treatment experience).

In the context of HIV / AIDS, leronlimab is an inhibitor of viral entry. It masks CCR5, protecting healthy T cells from viral infection by preventing the predominant HIV (R5) subtype from entering these cells. Leronlimab has been the subject of nine clinical studies, each of which showed that leronlimab can significantly reduce or control the HIV viral load in humans. The Leronlimab antibody appears to be a powerful antiviral agent that potentially results in fewer side effects and less frequent dosage requirements compared to the daily drug therapies currently in use.

Research has shown that CCR5 may play a role in tumor invasion, metastasis, and control of the tumor microenvironment in the development of cancer. Increased CCR5 expression is an indicator of disease status in several cancers. 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 98% in a murine xenograft model. CytoDyn is therefore conducting a phase 1b / 2 clinical trial in humans in metastatic triple negative breast cancer and was recognized as a Fast Track by the FDA in May 2019.

The CCR5 receptor appears to play a central role in modulating the trade in immune cells at foci of inflammation. It can be critical in the development of acute graft versus host disease (GvHD) and other inflammatory diseases. Clinical studies by others also support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical effects of acute GvHD without significantly affecting transplanted bone marrow stem cell transplantation. CytoDyn conducted a phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on transplanted cells is critical for the development of acute GvHD. Blocking the recognition of specific immune signal molecules by the CCR5 receptor is a viable approach to attenuating acute GvHD. The FDA granted Leronlimab the orphan drug designation for the prevention of GvHD. Due to the shortage of patients during the COVID-19 pandemic, the company suspended its phase 2 study for acute GvHD.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative therapies for multiple therapeutic indications based on Leronlimab, a novel humanized monoclonal antibody against the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T cells. The CCR5 receptor also appears to be involved in tumor metastasis and immune-mediated diseases such as GvHD and NASH.

CytoDyn has successfully completed a phase 3 registration study with leronlimab in combination with standard antiretroviral therapies in HIV-infected patients with treatment experience. CytoDyn has worked diligently to resubmit its Biologics License Application (“BLA”) for this combination HIV therapy since receiving a denial of filing in July 2020 and then telephoning the FDA to review their written guidelines on filing to discuss. CytoDyn expects to refine its BLA in the first half of the calendar year 2021.

CytoDyn has completed a phase 3 study of leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-driven study for the leronlimab monotherapy indication. If successful, a label extension could be supported. Previous clinical results from several studies have shown that leronlimab can significantly reduce the viral load in people infected with HIV. No severe drug site injection reactions were reported in approximately 800 patients treated with leronlimab, and no drug-related SAEs were reported in patients treated with 700 mg leronlimab. In addition, a phase 2b clinical study showed that monotherapy with leronlimab can prevent the escape of viruses in HIV-infected patients. Some patients receiving leronlimab monotherapy have been virally suppressed for more than six years.

CytoDyn is also conducting a phase 1b / 2 clinical study with leronlimab in metastatic triple negative breast cancer. 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 expressions that reflect optimism, satisfaction or disappointment about the current outlook, 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 any statement is not forward-looking. Forward-looking statements include, in particular, statements about Leronlimab, its ability to achieve positive health outcomes, the potential outcomes of clinical trials, studies or other programs or the ability to continue such programs, the ability to obtain regulatory approval for commercial sale, and the market for actual commercial sales. The company’s forward-looking statements are not intended to be a guarantee of performance, and actual results could differ materially from those contained in or contained in these statements due to risks and uncertainties, including: (i) the Company’s liquidity, (ii) the 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 partnerships or licensing agreements with third parties, (v) the company’s ability to identify patients who wish to enroll in clinical trials in a timely manner, (vi) the company’s ability to obtain regulatory approval for a marketable product, (vii) the company’s design, conduct and conduct of clinical trials, (viii) the results d he clinical trials of the Company’s studies, including the possibility of adverse clinical trial results, (ix) the market for and marketability of approved products, (x) the existence or development of vaccines, drugs or other treatments used by medical professionals or patients other than the Company’s products are considered superior, (xi) regulatory initiatives, regulatory compliance and approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political and social conditions, and (xiv) various other matters of many of which are beyond the control of the company. The Company urges investors, in particular, to consider the various risk factors listed on their most recent Form 10-K, as well as any risk factors or warnings contained in a subsequent Form 10-Q or Form 8-K attached to 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:
Michael Mulholland
Office: 360.980.8524, ext. 102
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