Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug developer, has already delivered a win for Wealthpress members

Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day

Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug creator, has already shipped a win for Wealthpress subscribers from our first feature back in April this year. Billions have been invested straight into hundreds of biotechs all competing to produce a cure or therapy for severe COVID 19 situations which cause death, and also none have succeeded. Except for Cytodyn, if early indications are established in the present trial now underway.

But after a deep jump on the company’s financial statements as well as SEC filings, an image emerges of company control functioning having a “toxic lender” to funnel severely discounted shares to the lender regularly. An investment in Cytodyn is actually a strictly speculative bet on my part, and if the expected upward price movement does not appear after results in the company’s stage 2b/3 trial for severe-to-critical COVID-19, I am going to exit the investment.

In case the business’s drug does in fact reliably preserve lives in severe-to-critical COVID19 patients, then a groundswell of investor assistance can force the organization into completely new, higher grade human relationships, which would enable for the redemption of elimination and debentures of reliance on fly-by-night financings for instance those discussed below.

Cytodyn’s sole focus is developing remedies used on a monoclonal antibody called “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)”. This particular engineered antibody was purchased of Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.

Total cost of acquisition amounts to $10 million plus a 5 % net royalty on business sales.

The drug was acquired on the first promise of its as an HIV therapy, for which continued research as well as development by Cytodyn has shown the ability to reduce regular drug cocktails with assortment pills right into a single monthly injection, sometimes, with zero negative effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)

Since that time, Cytodyn’s scientific staff has discovered the antibody’s impact on the CCR5 receptor has incredibly optimistic therapeutic implications for everything out of some stable tumours to NASH (Non alcoholic steatohepatitis), the liver function disorder that afflicts up to 12 percent of the US public, and up to 26 % globally.

But the real emergent also likely transformational application for leronlimab, as I have said at the beginning, (which is already getting branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 which precludes the Sequential Organ Failure wearing fatal situations of COVID infections.

Leronlimab it seems that prevents the CCR5 receptor from over-responding to the virus and also launching the now household-word “cytokine storm”. Some proportion of people obviously return from the brink following 2 treatments (and in some instances, one treatment) of leronlimab, even if intubated.

The company completed enrollment of a stage 2b/3 trial on December 15 to “evaluate the efficacy as well as safety of leronlimab for patients with severe-to-critical COVID 19 indications is actually a two arm, placebo controlled, double blind, randomized, adaptive style multicenter study,” based on the company’s press release.

This trial period concluded on January 12 ish, and if the outcomes are good, this can make leronlimab a top remedy for ARDS.

Cytodyn Inc (OTCMKTS:CYDY)

Although the vaccines that are presently circulating are surely lending optimism for a normalization of modern society by mid-2021, the surging global rates of infection mean the immediate future is right now overwhelming health care systems across the world as more and more individuals call for access to Intensive Care Unit hospitalization.

During my 1st interview with Dr. Nader Pourhassan returned contained March of 2020, the serious eagerness of his for the prospects of the drug’s success was evident.

It was prior to the currently raging second trend had gathered heavy steam, and he was then seeing patients which were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.

Within the time, although, this little independent biotech without any significant funding and a decidedly unhappy public listing on the naked short-sellers’ fantasy OTC marketplace was getting prepared to put on for a listing on NASDAQ, as well as the deck was stacked against it.

Full Disclosure: I posses 10,000 shares from an average expense of $6.23

Although the planet focuses breathlessly on the optimism for a new vaccine to restore their community liberties, the 10 ish percentage of COVID infectees who descend into the cytokine storm-driven ARDS actually have their lives saved by this apparently versatile drug. For them, a vaccine is pretty much pointless.

This particular drug has “blockbuster potential” written all over it.

With 394 patients enrolled inside the Phase 2b/3 trial as of December sixteen, and first data expected this week, any demonstrable consistency in the data is going to record the world’s focus in likely the most profound way. Quick sellers may be swept apart (at minimum temporarily) as the company’s new share priced levels qualify it for NASDAQ listing.

Cytodyn management says it’s 700,000 doses prepared for sale right now, with an extra 2.5 million ordered for each of 2021 as well as 2022 in a manufacturing agreement with Samsung, as per its CEO.

The Downside

so if leronlimab/PRO 140/Vyrologix is so great, why the stock’s been trapped in sub 1dolar1 five penny stock purgatory for so long?

The speedy remedy is “OTC”.

Apart from struggling with a share price under $3, the company has not been able to meet and keep certain other quantitative prerequisites, including good shareholders’ equity with a minimum of five dolars million.

But in the NASDAQ world, you can find non quantifiable behaviours by companies that can cause waiting times to NASDAQ listings. Overtly promotional communications are actually among these kinds of criteria which will never cause a refusal letter…nor a NASDAQ listing.

More importantly, Cytodyn in addition has not been able to access capital under standard ways, thanks to its being listed on the OTC, along with therefore un-attractive on that basis alone to white colored shoe firms.

And so, they have been lowered to accepting shareholder-hostile OID debentures with unsightly sales terms that produce a short-seller’s wet dream.

In November, they borrowed 28.5 zillion out of Streeterville Capital of that just $25 million was given to the company; $3.4 zillion will be the discount the Streeterville pockets, and $100k is actually reserved to protect the bills. Streeterville is linked with Illiad Research and Trading, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been called a “legendary so-called toxic lender”, by rival studies tight Utopia Capital Research.

Cytodyn Inc (OTCMKTS:CYDY)

Under the phrases of the price, Cytodyn has got to pay back again $7.5 million a month. If they do not have the cash, they pay in stock; many lately, at a sales price of $3.40 a share.

These days consider if you’re an opportunistic low rent lender and you have gained a guaranteed 2.2 million shares coming your way in the earliest week of each month. Any price tag above the conversion price is pure profit. Remember – this guy is not an investor; he’s a lender.

He’s not operating on the expectation that Cytodyn stock may go parabolic if leronlimab is deemed a cure for ARDS; his business model is to limit risk and maximize upside through discounted conversion of share.

This’s the short seller’s wet dream I am discussing. Not merely would be the lender enticed to go short, but any short trading bucket shop in town who can fog a mirror and go through an EDGAR filing understand that each month, like clockwork, there is going to be 2 million+ shares hitting the bid down to $3.40.

The SEC isn’t impressed, and on September three, 2020, filed a criticism.

The Securities in addition to the Exchange Commission nowadays filed charges from John M. Fife of Companies and Chicago he controls for obtaining and selling much more than twenty one billion shares of penny stock without any registering as a securities dealer using the SEC.

The SEC’s complaint, alleges this between 2015 and 2020, Fife, as well as his companies, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., in addition to the Typenex Co-Investment, LLC, frequently engaged in the small business of purchasing convertible notes from penny stock issuers, converting these notes into shares of stock at a large discount from the market cost, and offering the newly issued shares to the market at a significant profit. The SEC alleges which Fife and the companies of his involved in over 250 convertible transactions with about 135 issuers, sold more than 21 billion newly-issued penny stock shares into the industry, and obtained more than $61 million in earnings.

Streeterville Capital is not mentioned as an entity of the complaint. Which implies that it was likely used by Cytodyn as well as Fife to avoid detection by the SEC that this very same scheme was getting perpetrated on Cytodyn at the time of its complaint.

But that’s not the sole reason the stock can’t maintain any upward momentum.

The company has been selling inventory privately at ridiculously low prices, to the point in which one wonders just who exactly are the blessed winners of what requires free millions of dollars?

To wit:

In addition, starting inside the month of November 2020 and for every one of the next five (five) calendar months thereafter, the Company is actually obligated to cut down the outstanding harmony belonging to the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes are going to be credited toward the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the fifteen % prepayment premium.

Likewise detracting from the company’s gloss is the propensity of managing for endlessly marketing communications with shareholders. During an investor webcast on January 5th, the company played a number of sound testimonials from individuals applying PRO 140 for HIV therapy, backed by tear jerking music, and replete with mental language devoid of information.

Even worse, the company’s phone number at the bottom part of press releases has an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one is a “valid extension” based on the automated phone system.

That’s the sort of approach that the FDA and SEC view unfavourably, and it is likely at the very least in part the reason behind the continued underdog status of theirs at both agencies.

The company also has become unresponsive to requests for interview, and so while using story coming out less than just these ill-advised publicity stunts, shorts are actually attracted, and huge cash investors, alienated.

But think of this particular “management discount” as the opportunity to acquire a sizable position (should someone be so inclined) in what could really well turn out to be, in a question of weeks, as the leading therapy for serious COVID19 associated illness.

I expect the details in the trial now concluded for just such an indication can release the business into a complete new valuation altitude that will allow it to get over these shortfalls.

Average trading volume is constant above 6 million shares one day, and before the conclusion of this week, we will learn just how efficient leronlimab/PRO 140/Vyrologix is at saving lives from the worst of COVID nineteen. If the outcomes are good, this can be a significant winner.

Cytodyn Inc (OTCMKTS:CYDY)