CytoDyn reaches an agreement with Albert Einstein Israelite

An interim analysis for critically ill people is performed when admission reaches approximately 120 patients, or 40% of the approximately 300 patients

VANCOUVER, Wash., May 5, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY)(“CytoDyn” or the “Company”), a late-stage biotechnology company developing Leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with potential for multiple therapeutic indications, today announced a partnership agreement with the Academic Research Organization ( ARO) – Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil, for two COVID-19 studies.

The COVID-19 studies in Brazil are set to provide the Brazilian regulator ANVISA with the necessary data to improve the availability of Leronlimab for thousands of Brazilians infected with COVID-19. These two phase 3 studies will be conducted at up to 45 clinical sites.

Chris Recknor, MD, CytoDyn’s Chief Operating Officer and Head of Clinical Development, commented, “We are excited to partner with one of the best hospitals in Latin America, Albert Einstein Israelite Hospital and its affiliated network of academic research organizations. This ARO has conducted several large-scale COVID studies for many pharmaceutical companies. CytoDyn uses its extensive experience to develop and conduct our CD16 and CD17 COVID-19 studies. With a total of approximately 1,500 patients for both studies, we expect that there will be sufficient performance in each study to achieve a significant p-value for our endpoints and will perform an interim analysis after 40% of critically ill patients have been enrolled. In Brazil, the P1 variant of COVID is driving a second wave worse than the initial outbreak. In April, more than 78,000 people were killed in 15 of the 26 Brazilian states from COVID and intensive care capacities. You are 90% or more full. Vyrologix is ​​variant-independent. We expect an interim analysis to be carried out between October and November this year. We look forward to accelerating these efforts for the benefit of the Brazilian people. “

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, “This agreement reflects the relentless efforts of the CytoDyn team with the Albert Einstein Israelite Hospital team. Dr. Christopher Recknor and many other CytoDyn team members did a great job getting this protocol into its final form. We also thank the Brazilian BIOMM team for giving us this opportunity. Without their participation, this would not have been possible. We believe that the critically ill population study will remove the final barrier to obtaining the EEA not only in Brazil but possibly around the world. We believe this is the most promising study in our company’s history as we have now generated vital information to give us the perfect opportunity to potentially receive the first approval of Leronlimab. We look forward to updating all of our shareholders later on on these two studies and other developments. “

About Leronlimab (PRO 140)
Leronlimab has been investigated in 11 clinical studies in more than 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).

Leronlimab is an inhibitor of viral entry in HIV / AIDS. It masks CCR5, protecting healthy T cells from viral infection by preventing the predominant HIV (R5) subtype from entering these cells. Nine 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 currently used daily drug therapies.

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 rejection letter in July 2020 and then telephoning the FDA to discuss their written guidelines on filing . CytoDyn expects to resubmit its BLA via a rolling filing from the third quarter of the 2021 calendar.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative therapies for multiple therapeutic indications with 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. 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 to specifically 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 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:
Michael Mulholland
Office: 360.980.8524, ext. 102
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