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Saturday, May 28, 2022

CytoDyn Inc (OTCMKTS: CYDY) Major Reversal Brewing after Biotech Looks for Positive Outcome of Clinical Hold on HIV program

CytoDyn Inc (OTCMKTS: CYDY) is moving northbound after another test of $0.23 lows. The stock was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and we covered the stock regularly back on those exciting days. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. The stock saw further declines after the Company’s registered public accounting firm, Warren Averett, LLC resigned, released in an 8k on April 19.  

All of this has culminated in CYDY being offered at a cheap discount to prices from just a month ago and the opportunity to buy in to Cytodyn for around $0.25 per share. Most speculators trading this stock understand the risks, the Company could go bankrupt and that is certainly a possibility or it could see a significant reversal. The underlying science has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and coronavirus.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab and they are keeping busy with other things; on April 12 CYDY announced the publication of a peer-reviewed research paper entitled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” in the open-access journal PLOS Pathogens. According to the study; Leronlimab treatment reduced SHIV viral loads by 10,000-fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively. 

CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. 

In January the Company reported positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available. 

The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups. 

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CYDY

Cytodyn saw a significant drop on March 30 after the Company reported the US FDA placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. This was followed by a Company webcast the very next day. The stock saw further declines after the Company’s registered public accounting firm, Warren Averett, LLC resigned, released in an 8k on April 19 

On April 12 CYDY announced the publication of a peer-reviewed research paper entitled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” in the open-access journal PLOS Pathogens.

The study followed five HIV+ human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens. These five participants came from an extension study, consisting of patients who were virologically suppressed in a prior study of leronlimab. Of the ten patients enrolled in the extension study, four individuals experienced viral rebound and stopped leronlimab monotherapy, and one individual withdrew, leaving five long-term participants. All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for over seven years, with no evidence of viral escape. It is important to note that these five participants on leronlimab monotherapy exhibited a higher frequency (7.1%) of transient episodes of plasma viremia, termed viral blips, than those on combinational oral antiretroviral regimens (2.0%). To monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks. Leronlimab treatment reduced SHIV viral loads by 10,000 fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively.

Jonah Sacha, Ph.D., the lead study author, who is a CytoDyn scientific advisor and an Oregon Health & Science University professor, stated, “To our knowledge, these data represent the longest administration of monoclonal antibody monotherapy for HIV in people to date.” 

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Currently trading at a $186 million market valuation CYDY has 717,854,997 shares outstanding, CYDY is fully reporting OTCQB and while they are pre revenues the Company has close to $100 million in assets and about the same in debt. At current levels CYDY is worth a close look; The stock was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. Most speculators trading this stock understand the risks, the Company could go bankrupt and that is certainly a possibility or it could see a significant reversal. The underlying science has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and coronavirus.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab and they are keeping busy with other things; on April 12 CYDY announced the publication of a peer-reviewed research paper entitled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” in the open-access journal PLOS Pathogens. According to the study; Leronlimab treatment reduced SHIV viral loads by 10,000-fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively. 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.

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