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Thursday, August 11, 2022

CytoDyn Inc (OTCMKTS: CYDY) Breaking Out Northbound as Biotech Hires New President, Raises $21.8 million & Sets Shareholders Meeting for August 31

CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the United States. CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and Microcapdaily covered the stock regularly back in those exciting times. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA hold. Further, CytoDyn 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. CYDY saw further declines after the Company’s CEO and registered public accounting firm, Warren Averett LLC, both resigned. All of this has culminated in CYDY being offered at a cheap discount to prices from just a few months ago and the opportunity to buy in to Cytodyn for under $0.50 per share.  

CYDY has been busy in recent weeks completing a stock offering during which the Company was able to raise $21.8 million. They also signed on a new President; Cyrus Arman, Ph.D. who previously held positions with a number of biotech’s most recently serving as Chief Business Officer of Nimble Therapeutics, Inc., a company focused on engineering peptides. Also on August 31, there is a special meeting of stockholders to vote on a proposal to amend the total number of authorized shares of common stock from 1,000,000,000 shares to 1,350,000,000 shares. CYDY is a stock trading under $0.50 that ran to $10 per share in 2020 with a similar share structure. The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV.  Considering how fast and far CYDY has dropped the bounce potential here is significant and CYDY could make rapid gains in a very shorty time period.  

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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. 

CytoDyn believes in the future of precision medicine… more specificity, less side effects. The Company’s target, the CCR5 receptor, has been implicated in multiple disease processes from HIV, GvHD, NASH, stroke recovery, multiple sclerosis, COVID-19, NAFLD/NASH, to metastatic cancer. Leronlimab, our CCR5 antagonist, is a once-a-week, subcutaneous injection. One molecule with multiple opportunities. Welcome to the future of target specific, precision medicine. Welcome to CytoDyn, a biotechnology company focused on developing innovative treatments for multiple therapeutic indications. The Company’s lead candidate leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is an experimental monoclonal antibody for HIV treatment. 

Microcapdaily first covered CYDY on February 1, 2020 when the stock was $1.50 as it was on its way to $10 per share in summer 2020 reporting at the time: “CYDY is an exciting company in small caps developing a promising drug in the billion-dollar HIV market. Just last week CYDY announced an $87.5 million licensing deal for commercializing Leronlimab to treat HIV. The stock is in full beast mode currently among the top most traded stocks in small caps. CYDY Is still pre revenue and high risk with a very exciting week.” 

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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.

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Currently trading at a $336 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. Now trading for well under $0.50, 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 the stock could make rapid gains in a very shorty time period. CYDY has been busy in recent weeks completing a stock offering during which the Company was able to raise $21.8 million. They also signed on a new President; Cyrus Arman, Ph.D. who previously held positions with a number of biotech’s most recently serving as Chief Business Officer of Nimble Therapeutics, Inc., a company focused on engineering peptides. Also on August 31, there is a special meeting of stockholders to vote on a proposal to amend the total number of authorized shares of common stock from 1,000,000,000 shares to 1,350,000,000 shares. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily.

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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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