What to Make of the CytoDyn Inc (OTCMKTS:CYDY) Pullback

What to Make of the CytoDyn Inc (OTCMKTS:CYDY) Pullback

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One assumes that people with significant founder equity in CytoDyn Inc (OTCMKTS:CYDY) must be consumed right now with the joy of being able to sell into this market at striking gains. Helping that tone, the company just announced the Company has met its 75 patient enrollment for its Phase 2 clinical trial entitled “Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19.”

According to the release, this Phase 2 trial evaluates clinical improvement of several symptoms over a 14-day period, including changes in multiple clinical baseline metrics after days 3, 7 and 14. The Company expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75.

CytoDyn Inc (OTCMKTS:CYDY) promulgates itself as a late-stage biotechnology company that focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection.

Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease.

CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington.

According to company materials, “CytoDyn 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. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.”

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As noted above, CYDY just announced the Company has met its 75 patient enrollment for its Phase 2 clinical trial entitled “Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19.”

Traders will note above 130% piled on for shareholders of the stock during the trailing month. Furthermore, the stock has registered increased average transaction volume recently, with the past month seeing above 100% over what the stock has registered over the longer term.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients. Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.”

At this time, carrying a capital value in the market of $3.7B, CYDY has a significant war chest ($7.1M) of cash on the books, which must be weighed relative to about $41M in total current liabilities. One should also note that debt has been growing over recent quarters. The company is pre-revenue at this point. We will update the story again soon as further details emerge. Sign-up for continuing coverage on shares of $CYDY stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!

Disclosure: we hold no position in $CYDY, either long or short, and we have not been compensated for this article.