It shouldn’t pass unnoticed that CytoDyn Inc (OTCMKTS:CYDY) just announced that it provided its Top-line Report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care.
According to the release, the Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial.
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 that it provided its Top-line Report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care.
The stock has suffered a bit of late, with shares of CYDY taking a hit in recent action, down about -30% over the past week. In addition, the name has seen interest climb, with an increase in recent trading volume of 6% over what the stock has registered over the longer term.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “As we recently reported, we are working diligently with several governmental agencies throughout the world to provide leronlimab to patients suffering from COVID-19. We believe the statistically significant results for NEWS2 is critical to identifying those patients who are at risk of progressing to a more serious condition. Importantly, in addition to the statistically significant efficacy findings, the safety results from this study were very notable with less SAEs and AEs identified in the leronlimab arm, as compared to placebo. Double-blinded clinical trials that are randomized 2:1, like our study, are very challenging to reach significant results as we demonstrated in a small population of a tough COVID-19 population in which to show efficacy and safety. We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August.”
Now commanding a market cap of $1.74B, 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. As more color becomes clear on the name, we will review the situation and update our take. 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.