CytoDyn Inc (OTCMKTS:CYDY) has been getting increased attention after the Company took its leronlimab to the front lines against the deadly coronavirus “COVID-19” pandemic. On March 19 CytoDyn reported that two coronavirus patients were treated with the Company’s investigational new drug, leronlimab which has no risen to a total of 4 patients. The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA).
Leronlimab is intended to serve as a therapy for patients who experience respiratory illness as a result of contracting the Coronavirus Disease 2019 (COVID-19). The treatment of these patients was not under the Company’s proposed randomized controlled Phase 2 clinical trial protocol recently submitted to the FDA. If successful CYDY could hit national news and could significantly elevate investors appetite for leronlimab chances as well.
CytoDyn Inc (OTCMKTS:CYDY) is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH.
Leronlimab has demonstrated significant potential to attack a number of diseases – The U.S. Food and Drug Administration (FDA) have granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully 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).
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On March 23 CYDY announced the third and fourth coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients. The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).
Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, “IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the ‘cytokine storm’ that leads to morbidity and mortality in these patients.”
— Proactive USA (@proactive_NA) March 23, 2020
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Currently trading at a $479 million market valuation based on 461 million OS CYDY has just $1.2 million in cash on the books and significant debt of $29.7M in total current liabilities which has been growing in recent quarters. CYDY is an exciting story developing in small caps; CytoDyn lead candidate Leronlimab has been found to have significant potential to attack a host of diseases besides just HIV. Leronlimab’s benign safety profile sets it apart from other therapies and it has been hailed as a possible wonder drug. Leronlimbab is currently being evaluated for dozens of indications besides HIV and is showing huge promise. Some investors even view using lerolimab for coronavirus as a distracition more than anything else; currently 4 patients in NYC hospitals are being treated for coronavirus with leronlimab using an emergency IND. If successful CYDY could hit national news. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.
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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.