Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug designer, has already shipped a win for Wealthpress subscribers from our first feature returned in April this year. Billions have been invested into hundreds of biotechs all competing to make a medicine or perhaps therapy for severe COVID-19 instances that cause death, as well as none have been successful. Except for Cytodyn, when early indications are established in the current trial now underway.
But after a deep jump on the business’s fiscal statements and SEC filings, an image emerges of business management working having a “toxic lender” to direct severely discounted shares to the lender regularly. An investment in Cytodyn is actually a strictly speculative bet on the part of mine, and if the expected upward price movement does not manifest after results of the company’s period 2b/3 trial for severe-to-critical COVID-19, I will exit the investment.
If the company’s drug does in fact reliably conserve lives to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance could drive the business into new, higher-grade human relationships, which would allow for the redemption of debentures as well as elimination of reliance on fly-by-night financings such as those described below.
Cytodyn’s sole focus is actually developing remedies used on a monoclonal antibody known as “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor sort five (CCR5)”. This particular engineered antibody was acquired from Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), again in 2012.
Total expense of acquisition amounts to $10 million and a 5 % net royalty on commercial revenue.
The drug was acquired on its first promise as an HIV treatment, for which continued research and development by Cytodyn has demonstrated the potential to reduce daily drug cocktails with assortment pills into a specific monthly injection, in some cases, with zero adverse reactions. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has realized the antibody’s influence on the CCR5 receptor has extremely optimistic therapeutic implications for everything out of certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function disorder which afflicts up to twelve % of the US public, and up to twenty six % globally.
But the real emergent also potentially transformational application for leronlimab, as mentioned at the beginning, (which is now being branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 that precludes the Sequential Organ Failure wearing fatal cases of COVID infections.
Leronlimab it seems that prevents the CCR5 receptor from over-responding to the virus and launching the now household-word “cytokine storm”. Some proportion of clients obviously return from the brink after 2 treatments (and in a number of cases, 1 treatment) of leronlimab, still when intubated.
The company completed enrollment of a level 2b/3 trial on December fifteen to “evaluate the efficacy as well as safety of leronlimab for individuals with severe-to-critical COVID-19 indications is actually a two-arm, randomized, double blind, placebo controlled, adaptive style multicenter study,” according to the company’s media release.
This trial phase concluded on January 12-ish, of course, if the results are good, this will make leronlimab a high therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines which are currently spreading are certainly lending optimism for a normalization of modern society by mid-2021, the surging worldwide rates of illness suggest the immediate future is already overwhelming health care systems across the world as more and more individuals call for ability to access Intensive Care Unit hospitalization.
During the first job interview of mine with Dr. Nader Pourhassan returned contained March of 2020, the serious passion of his for the prospects of this drug’s success was evident.
It was before the currently raging next trend had gathered vapor, as well as he was then seeing patients who were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, even thought, this small independent biotech with no significant funding along with a decidedly unhappy public listing on the naked short-sellers’ fantasy OTC marketplace was getting ready to apply for a listing on NASDAQ, and the deck was stacked from it.
Full Disclosure: I have 10,000 shares at an average expense of $6.23
Even though the planet concentrates breathlessly on the optimism for a new vaccine to restore the social liberties of theirs, the 10-ish fraction of COVID infectees that descend into the cytokine storm-driven ARDS actually have their lives saved by this apparently versatile drug. To them, a vaccine is literally useless.
This drug has “blockbuster potential” written all over it.
With 394 individuals enrolled with the Phase 2b/3 trial as of December sixteen, along with first data expected this week, a demonstrable consistency in the details is going to capture the world’s focus in essentially the most profound way. Short sellers might be swept apart (at least temporarily) while the company’s new share price levels qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses ready for sale right now, with an extra 2.5 million ordered for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, according to the CEO of its.
really if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub-1dolar1 5 penny stock purgatory for so long?
The speedy remedy is “OTC”.
Besides struggling with a share price under three dolars, the company has not been able to meet and keep certain different quantitative requirements, including positive shareholders’ equity of at least five dolars million.
But in the NASDAQ community, there are non quantifiable behaviours by companies that create slow downs to NASDAQ listings. Overtly promotional communications are among such type of criteria that won’t ever result in a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn in addition has not been in a position to access capital under conventional ways, thanks to its being listed on the OTC, and therefore un-attractive on that foundation alone to white colored shoe firms.
So, they’ve been lowered to accepting shareholder-hostile OID debentures with ugly conversion terms that produce a short-seller’s stormy dream.
In November, they took 28.5 huge number of coming from Streeterville Capital of that just twenty five dolars million was paid to the company; $3.4 million will be the discount the Streeterville areas, and $100k is actually put aside to cover the bills. Streeterville is actually associated with Illiad Research and Trading, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been referred to as a “legendary so called poisonous lender”, by rival studies tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the deal, Cytodyn must pay back $7.5 million per month. If they do not possess the cash, they spend within stock; many recently, at a sales cost of $3.40 a share.
Now just think about if you are an opportunistic low-rent lender and you’ve gained a certain 2.2 million shares coming your way in the very first week of each month. Any cost above the sales expenditure is pure profit. Remember – this guy isn’t an investor; he is a lender.
He is not operating on the hope that Cytodyn stock might go parabolic in the event that leronlimab is deemed a cure for ARDS; the online business model of his is to limit risk and optimize upside through discounted conversion of share.
This is the brief seller’s wet dream I’m speaking about. Not only would be the lender enticed to go short, but any short trading bucket dealer in town who are able to fog a mirror and read an EDGAR filing realize that each month, like clockwork, there’s going to be two million+ shares striking the bid down to $3.40.
The SEC is not impressed, additionally, on September three, 2020, filed a criticism.
The Securities and Exchange Commission nowadays filed charges from John M. Fife of Companies and Chicago he controls for acquiring and promoting much more than twenty one billion shares of penny stock without registering to be a securities dealer using the SEC.
The SEC’s criticism, alleges this between 2015 as well as 2020, Fife, as well as the businesses 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, regularly engaged in the small business of buying sports convertible paperwork from penny stock issuers, converting those notes into shares of stock at a major discount from the market price, and offering the freshly issued shares into the market at a sizable profit. The SEC alleges that Fife as well as the businesses of his engaged in around 250 convertible transactions with around 135 issuers, sold more than twenty one billion newly issued penny stock shares to the market, and obtained greater than sixty one dolars million in profits.
Streeterville Capital is not mentioned as an entity in the complaint. Which suggests that it was probably used by Cytodyn and Fife to stay away from detection by the SEC that this very same scheme was getting perpetrated on Cytodyn at the time of its complaint.
But that is not the sole reason the stock can’t observe some upward momentum.
The company has been offering stock privately from ridiculously minimal prices, to the stage where by one wonders just who exactly are the blessed winners of what requires no cost millions of dollars?
Additionally, starting in the month of November 2020 and for each of the second five (five) calendar days thereafter, the Company is actually obligated to cut down the outstanding sense of balance with the Note by $7,500,000 per 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.
Also detracting from the business’s shine is the propensity of managing for endlessly promotional communications with shareholders. During an investor webcast on January 5th, the business had a compilation of audio testimonials from individuals applying PRO 140 for HIV treatment, backed by tear jerking music, and then replete with emotional language devoid of data.
Even worse, the company’s phone number at the bottom level of press releases includes an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one is a “valid extension” in accordance with the automatic phone system.
That’s the type of approach that the FDA and SEC view unfavourably, and it is likely at the very least in part the reason for the continued underdog status of theirs at both agencies.
The company also has come to be unresponsive to requests for interview, and thus using the story coming out under just these ill-advised publicity stunts, shorts are actually attracted, and big money investors, alienated.
But think of this specific “management discount” as the opportunity to purchase a sizable role (should a person be so inclined) contained what may really well prove to be, in a question of weeks, since the top therapy for severe COVID19 associated illness.
I expect the information in the trial now concluded for only such a sign can release the company into a whole new valuation altitude that will allow it to get over these shortfalls.
Average trading volume is continuous above 6 million shares a day, and before the tail end of this week, we will find out exactly how effective leronlimab/PRO 140/Vyrologix is actually at saving lives from the worst of COVID nineteen. In case the results are good, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)