Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug creator, has already delivered a win for Wealthpress members from our 1st feature returned in April this season. Billions have been invested straight into hundreds of biotechs all competing to create a cure or treatment for severe COVID-19 instances which trigger death, as well as none have succeeded. Except for Cytodyn, when early indications are confirmed in the current trial now underway.
But right after a deep jump on the business’s financial claims as well as SEC filings, an image emerges of company management working with a “toxic lender” to direct seriously discounted shares to the lender regularly. An investment in Cytodyn is actually a strictly speculative bet on the part of mine, and when the anticipated upward price movement does not appear following results in the company’s phase 2b/3 trial for severe-to-critical COVID-19, I will exit the investment.
In case the company’s drug does actually reliably spend less lifestyles in severe-to-critical COVID19 individuals, subsequently a groundswell of investor assistance can drive the business into new, higher grade human relationships, which would enable for the redemption of elimination as well as debentures of reliance on fly-by-night financings for example those discussed below.
Cytodyn’s sole focus is actually creating therapies based on a monoclonal antibody called “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort five (CCR5)”. This engineered antibody was obtained 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 and a 5 % net royalty on business revenue.
The drug was acquired on the first promise of its as an HIV treatment, for which continued development and research by Cytodyn has highlighted the capability to reduce daily drug cocktails with assortment pills into an individual monthly injection, in some cases, with 0 unintended effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific staff has realized the antibody’s influence on the CCR5 receptor has extremely optimistic therapeutic implications for everything from certain stable tumours to NASH (Non-alcoholic steatohepatitis), the liver function condition which afflicts up to twelve percent of the US public, and up to twenty six % globally.
But the real emergent and potentially transformational program for leronlimab, as mentioned at the start, (which is already being branded as Vyrologix by Cytodyn), is designed for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID 19 that precludes the Sequential Organ Failure in fatal cases of COVID infections.
Leronlimab it seems that prevents the CCR5 receptor from over-responding to the virus as well as launching the today household word “cytokine storm”. Some proportion of individuals evidently return from the brink following two treatments (and in some instances, 1 treatment) of leronlimab, even when intubated.
The company completed enrollment of a level 2b/3 trial on December fifteen to “evaluate the efficacy and safety of leronlimab for clients with severe-to-critical COVID-19 indications is actually a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study,” according to the company’s media release.
This trial phase concluded on January 12-ish, and if the results are good, this can make leronlimab a high treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are presently dispersing are certainly lending hope for a normalization of society by mid-2021, the surging global rates of disease mean the immediate future is today overwhelming health care systems across the world as more and more folks require ability to access Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan back contained March of 2020, the serious eagerness of his for the prospects of this drug’s efficacy was evident.
This was before the now raging next trend had gathered steam, and also he was then noticing individuals who were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, though, this small independent biotech without any significant funding and a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting ready to apply for a listing on NASDAQ, along with the deck was stacked against it.
Full Disclosure: I posses 10,000 shares at an average expense of $6.23
While the world focuses breathlessly on the hope for the latest vaccine to restore their community liberties, the 10 ish percentage of COVID infectees that descend into the cytokine storm-driven ARDS actually have their lives saved by this apparently versatile drug. For these people, a vaccine is pretty much useless.
This particular drug has “blockbuster potential” written all over it.
With 394 clients enrolled with the Phase 2b/3 trial as of December 16, in addition to initially information expected this week, any demonstrable consistency in the information will record the world’s focus in pretty much the most profound way. Quick sellers may be swept aside (at least temporarily) as the business’s brand new share price amounts qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses prepared for sale right now, with an additional 2.5 zillion ordered for each of 2021 plus 2022 in a manufacturing agreement with Samsung, according to the CEO of its.
really if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been trapped in sub-1dolar1 five penny stock purgatory for so long?
The fast solution is “OTC”.
Besides faced with a share price under three dolars, the company hasn’t been in a position to meet and maintain certain different quantitative prerequisites, including good shareholders’ equity with a minimum of $5 million.
But in the NASDAQ world, one can find non quantifiable behaviours by companies that cause slow downs to NASDAQ listings. Overtly promotional communications are among such criteria that will never lead to a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn in addition has not been in a position to access capital under traditional ways, thanks to its being mentioned on the OTC, along with therefore un attractive on that foundation alone to white shoe firms.
So, they’ve been reduced to accepting shareholder-hostile OID debentures with ugly conversion terms that generate a short-seller’s stormy dream.
In November, they took 28.5 zillion out of Streeterville Capital of which only $25 million was given to the company; $3.4 million will be the discount the Streeterville areas, and $100k is actually put aside to cover the expenditures. Streeterville is associated with Illiad Research and Trading, which is managed by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so called poisonous lender”, by rival studies firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the offer, Cytodyn must pay back $7.5 million every month. If they do not have the cash, they spend in stock; most lately, at a conversion price of $3.40 a share.
Now consider when you’re an opportunistic low rent lender and you have received a certain 2.2 million shares coming your way in the very first week of each month. Any price above the sales cost is pure profit. Remember – this guy is not an investor; he’s a lender.
He is not operating on the expectation that Cytodyn stock could go parabolic in the event that leronlimab is deemed a cure for ARDS; the online business model of his is limiting risk and optimize upside via affordable transformation of share.
This’s the short seller’s wet dream I’m speaking about. Not merely would be the lender enticed to go short, but any short trading pail shop in town who can fog a mirror and read an EDGAR filing understand that every month, like clockwork, there is going to be two million+ shares striking the bid down to $3.40.
The SEC isn’t impressed, additionally, on September 3, 2020, filed a criticism.
The Securities and Exchange Commission these days filed charges against John M. Fife of Companies and Chicago he controls for obtaining and promoting more than 21 billion shares of penny inventory without the need of registering as a securities dealer with the SEC.
The SEC’s complaint, alleges that between 2015 as well as 2020, Fife, and the companies of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co Investment, LLC, routinely involved in the business of purchasing sports convertible notes from penny stock issuers, converting these notes into shares of inventory at a major discount from the market cost, and selling the newly issued shares to the marketplace at a sizable profit. The SEC alleges that Fife and the companies of his engaged in over 250 sports convertible transactions with around 135 issuers, sold greater than twenty one billion newly issued penny stock shares to the industry, and obtained more than $61 million in profits.
Streeterville Capital is not stated as an entity in the complaint. Which suggests that it was probably utilized by Cytodyn as well as Fife to avoid detection by the SEC this very same scheme was being perpetrated on Cytodyn at the time of the complaint of its.
But that is not the only reason the stock can’t preserve some upward momentum.
The company has been offering stock privately at ridiculously minimal prices, to the stage where one wonders just that exactly are the blessed winners of what amounts to free millions of dollars?
In addition, starting within the month of November 2020 as well as for every one of the second 5 (5) calendar days thereafter, the Company is required to cut down the exceptional harmony belonging to the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes will likely be credited to the transaction of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % prepayment premium.
Also detracting from the business’s shine is the propensity of management for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company played a compilation of audio testimonials from individuals using PRO 140 for HIV treatment, backed by tear jerking music, and replete with mental language devoid of information.
Even worse, the company’s telephone number at the bottom level of press releases comes with an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is actually a “valid extension” based on the automatic phone system.
That is the approach type that the FDA and SEC view unfavourably, and it is likely at least in part the reason for their continued underdog status at both agencies.
The company has additionally turned out to be unresponsive to requests for interviews, and therefore while using story coming out under only these ill advised publicity stunts, shorts are attracted, and big money investors, alienated.
But think of this specific “management discount” as the ability to purchase a sizable job (should someone be so inclined) in what may really well prove to be, in a question of weeks, as the top treatment for severe COVID19 related illness.
I expect the data from your trial now concluded for just such an indication can release the company into a whole new valuation altitude that will permit it to overcome these shortfalls.
Average trading volume is actually steady above six million shares 1 day, and before the end of this week, we’ll find out just how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the worst of COVID 19. If the results are positive, this could be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)