CytoDyn Inc (OTCMKTS:CYDY) Runs on New Wave

CytoDyn Inc (OTCMKTS:CYDY) Runs on New Wave

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It should be noted that CytoDyn Inc (OTCMKTS:CYDY) announced initiation of the Company’s Phase 2 clinical trial for the treatment of non-alcoholic steatohepatitis (NASH). 

According to the release, the Phase 2 trial is designed to test whether leronlimab may control the devastating liver fibrosis associated with NASH. As previously reported, the Company’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to nonalcoholic steatohepatitis (NASH). These data, along with previous findings showing that leronlimab inhibits liver fibrosis, suggests the potential of leronlimab to control both the early and late stages of NASH.

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 initiation of the Company’s Phase 2 clinical trial for the treatment of non-alcoholic steatohepatitis (NASH). 

We’ve witnessed more than 130% piled on for shareholders of the company during the trailing month. Moreover, the company has benefitted from a jump in recent trading volume to the tune of exceeding 100% above its longer-run average levels.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are excited to continue to advance the evaluation of leronlimab for a potential therapeutic benefit for NASH, a disease with an increasing prevalence in the U.S.  Our strategic plan to execute a multi-pathway approach to exploring all potential benefits of leronlimab has led to cancer, COVID-19 and now potentially NASH, along with other immunologic indications.”

At this time, carrying a capital value in the market of $3.2M, CYDY has a significant war chest ($7.1M) of cash on the books, which stands against 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.