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Wednesday, October 5, 2022

CytoDyn Inc (OTCMKTS: CYDY) Under Accumulation as New President Determines Path Forward for leronlimab

CytoDyn Inc (OTCMKTS: CYDY) has been on the rise since a brief dip below $0.50 following the recent runup from $0.231 to a high of $1.26 per share. CytoDyn was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share before the Citron short attack took the wind out of the stocks sails and the long downward trend began.  The stock hit 52-week lows earlier this year 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. The drop was further exasperated when CytoDyn elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and informed investors they were in the process of reevaluating the timing of its HIV BLA resubmission. Also, 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 $0.60 per share.   

CYDY is a highly volatile stock 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 and leronlimab with zero side effects. leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor  metastasis, and immune signaling. leronlimab also has a lot of big believers including many well-respected scientists. Cytodyn recently raised $21.8 million in a stock offering and 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. Dr. Arman earned his MBA from the UCLA Anderson School of Management, and a Ph.D. in Neuroscience and an MS in Biomedical Engineering from the USC Keck School of Medicine. He completed his undergraduate work in Biopsychology at the University of California San Diego. Upon his hiring Dr. Arman stated, “I look forward to uniting our teams and individuals in the pursuit of CytoDyn’s success through a renewed focus on the entrepreneurial spirit. Leronlimab is a unique molecule with the potential to help many individuals, particularly with unmet medical needs. We will focus on enhancing shareholder value through focused execution and refining of the path forward for leronlimab.” 

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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. 

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 

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. Later on in April we reported on CYDY: CytoDyn Inc (OTCMKTS:CYDY) has seen a spectacular rise in recent months from well under $0.50 back in December to recent highs of $3.50 per share. The stock has transformed into a volume leader regularly topping $10 million in daily trading volume and surpassing $100 million in daily dollar volume several times in recent weeks. These are heady days indead for CYDY shareholders, many of whom have been around for years supporting Nadar and co. It is easy to get excited about CYDY as coronavirus continues its deadly march forward infecting just under 2 million people as of this writing and growing fast. There is no known cure for covid-19 but several treatments have emerged and CytoDyn’s wunderdrug Leronlimab is at the top of the pack with highly positive results coming back. The story is starting to get picked up by the national media which could spell doom for the significant short position that has built up in CYDY over the past few months.

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CYDY

On July 13 CYDY announced the appointment of Dr. Cyrus Arman as President effective July 9, 2022. Dr. Arman will be responsible for determining and leading the Company’s operating strategy for the future. It is anticipated that he will advance to Chief Executive Officer and be appointed to the Board of Directors within six months. Antonio Migliarese, who had been serving as interim President since late January, in addition to CFO, will resume his previous role as CFO. 

Dr. Arman brings over 15 years of industry experience. Most recently, Dr. Arman served as Chief Business Officer for Nimble Therapeutics and was responsible for negotiating and implementing transactions, alliances, licensing agreements, and corporate strategy. Dr. Arman’s prior experience was as the Vice President of Corporate Development and Strategy at NEUVOGEN, Inc., an early-stage immuno-oncology company, where he was responsible for corporate development, business operations, and corporate strategy functions. Before NEUVOGEN, he was a director in Amgen’s Corporate Strategy group, contributing to rebuilding and running Amgen’s Global Competitive Intelligence and Strategy unit. Dr. Arman began his career as a management consultant, advising clients on complex strategic projects involving multi-billion-dollar business development investments and partnerships in the Biopharma and Diagnostics sectors. Dr. Arman also previously served as an adjunct professor at the University of Southern California and has been published in various peer-reviewed journals. Dr. Arman earned his MBA from the UCLA Anderson School of Management, and a Ph.D. in Neuroscience and an MS in Biomedical Engineering from the USC Keck School of Medicine. He completed his undergraduate work in Biopsychology at the University of California San Diego. 

Tanya Urbach, Board Chair, commented, “Early in the process, Dr. Arman separated himself from the competition, diving deep into due diligence with a methodical, analytical and inspired approach. He has the intellectual capacity, experience, and character to lead CytoDyn into the future. Leveraging his unique blend of capital markets expertise, corporate governance experience, scientific knowledge and strategic thinking, Dr. Arman has the skills to competitively position the Company. The Board expects that CytoDyn will greatly and immediately benefit from Dr. Arman’s strategic ability to analyze and rank the Company’s various opportunities and potential indications, determine the clinical development path forward, and find the right partners to fund and advance the programs, thereby maximizing shareholder value. We welcome Dr. Arman and could not be more excited about his leadership of our company.” 

Cyrus Arman, Ph.D., stated, “I look forward to uniting our teams and individuals in the pursuit of CytoDyn’s success through a renewed focus on the entrepreneurial spirit. Leronlimab is a unique molecule with the potential to help many individuals, particularly with unmet medical needs. We will focus on enhancing shareholder value through focused execution and refining of the path forward for leronlimab.” 

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Currently trading at a $491 million market valuation CYDY has 812,079,586 shares outstanding with authorized now at 1.35 billion, 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 under $0.60, the underlying science has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and coronavirus with zero side effects. leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor  metastasis, and immune signaling. Now that Cytodyn has completed a stock offering and brough on new CEO Cyrus Arman, Ph.D. things could be on the up and up here. With a recent low of $0.231, a high of $0.10 CYDY at $0.58 is worth a look. 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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