Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug developer, has already shipped a win for Wealthpress subscribers from our first feature back in April this season. Billions have been invested directly into hundreds of biotechs all competing to create a medicine or maybe therapy for severe COVID-19 situations that trigger death, and none have been successful. Except Cytodyn, if early indications are verified in the current trial now underway.
But after a serious jump on the company’s monetary claims as well as SEC filings, a picture emerges of company management operating who have a “toxic lender” to direct severely discounted shares to the lender regularly. An investment in Cytodyn is actually a purely speculative bet on my part, and when the expected upward price movement doesn’t occur after results in the company’s period 2b/3 trial for severe-to-critical COVID-19, I will exit the investment.
In case the business’s drug does actually reliably preserve lives in danger of severe-to-critical COVID19 individuals, then a groundswell of investor assistance could drive the business into new, higher grade human relationships, which would enable for the redemption of debentures as well as elimination of reliance on fly-by-night financings for instance those described below.
Cytodyn’s sole focus is developing remedies used on a monoclonal antibody known as “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort five (CCR5)”. This particular engineered antibody was obtained from Progenics Pharmaceuticals as “PRO 140”, a recently-acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total price of acquisition amounts to ten dolars million and a five % net royalty on commercial sales.
The drug was acquired on its first promise as an HIV treatment, for which continued development and research by Cytodyn has shown the capability to reduce daily drug cocktails with myriad pills into a specific monthly injection, in some cases, with zero side effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific staff has found the antibody’s effect on the CCR5 receptor has extremely positive therapeutic implications for everything out of some solid tumours to NASH (Non alcoholic steatohepatitis), the liver feature condition which afflicts up to twelve percent of the US public, and up to 26 % globally.
But the real emergent also likely transformational program for leronlimab, as I have said at the beginning, (which is now being branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID-19 that precludes the Sequential Organ Failure wearing fatal instances of COVID infections.
Leronlimab apparently prevents the CCR5 receptor from over responding to the virus and also launching the now household word “cytokine storm”. Some proportion of individuals apparently return from the brink after two treatments (and in a number of cases, 1 treatment) of leronlimab, even if intubated.
The company completed enrollment of a phase 2b/3 trial on December fifteen to “evaluate the efficacy and safety of leronlimab for clients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design and style multicenter study,” according to the company’s press release.
This trial period concluded on January 12 ish, and if the outcomes are good, this can make leronlimab a high treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are now spreading are definitely lending optimism for a normalization of modern society by mid-2021, the surging global rates of contamination suggest the immediate future is today overwhelming health care systems throughout the world as a lot more people call for access to Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan back in March of 2020, the serious passion of his for the prospects of this drug’s success was apparent.
It was prior to the currently raging second wave had gathered steam, and also he was then discovering individuals that were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nevertheless,, this small independent biotech with no significant funding and a decidedly unfortunate public listing on the naked short-sellers’ fantasy OTC marketplace was getting able to put on for a listing on NASDAQ, and the deck was stacked from it.
Full Disclosure: I posses 10,000 shares at an average price of $6.23
Although the planet concentrates breathlessly on the hope for a new vaccine to restore their social liberties, the 10-ish percentage of COVID infectees that descend into the cytokine storm-driven ARDS literally have their day saved by this apparently versatile drug. For these people, a vaccine is literally useless.
This particular drug has “blockbuster potential” written all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December 16, along with first information expected this week, a demonstrable consistency in the details will capture the world’s interest in pretty much the most profound way. Quick sellers may be swept aside (at the very least temporarily) while the business’s brand new share price levels qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses all set for sale now, with an extra 2.5 huge number of ordered for each of 2021 as well as 2022 in a manufacturing arrangement with Samsung, based on its CEO.
so if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub-1dolar1 five penny stock purgatory for such a long time?
The quick remedy is “OTC”.
Besides struggling with a share price under three dolars, the company has not been able to meet and maintain some different quantitative prerequisites, like positive shareholders’ equity that is at least $5 million.
But in the NASDAQ community, you can find non-quantifiable behaviours by businesses that can cause delays to NASDAQ listings. Overtly promotional communications are among these kinds of criteria which will never cause a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has additionally not been equipped to access capital under standard ways, because of its being mentioned on the OTC, along with consequently un attractive on that foundation alone to white colored shoe firms.
And so, they have been reduced to accepting shareholder hostile OID debentures with unsightly conversion terms that generate a short-seller’s stormy dream.
In November, they took 28.5 zillion from Streeterville Capital of which just twenty five dolars million was paid to the company; $3.4 zillion is the discount the Streeterville pockets, and $100k is actually put aside to cover the expenditures. Streeterville is actually associated with Illiad Research and Trading, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so-called poisonous lender”, by rival studies firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the price, Cytodyn has to pay back $7.5 million every month. If they do not possess the cash, they pay within stock; the majority of recently, within a sales cost of $3.40 a share.
Now just think about when you’re an opportunistic low-rent lender and you have received a guaranteed 2.2 million shares coming the way of yours in the very first week of each month. Any price tag above the sales 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 could go parabolic in the event that leronlimab is deemed a remedy for ARDS; his business model is limiting risk and optimize upside through discounted conversion of share.
This’s the quick seller’s wet dream I’m speaking about. Not merely is the lender enticed to go brief, but any short trading bucket dealer in town who can fog a mirror and go through an EDGAR filing realize that every month, like clockwork, there’s going to be two million+ shares striking the bid down to $3.40.
The SEC isn’t impressed, additionally, on September three, 2020, filed a complaint.
The Securities in addition to the Exchange Commission nowadays filed charges against John M. Fife of Companies and Chicago he controls for obtaining and marketing much more than 21 billion shares of penny stock without any registering as a securities dealer with the SEC.
The SEC’s criticism, alleges this in between 2015 as well as 2020, Fife, as well as his companies, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co-Investment, LLC, frequently involved in the small business of buying sports convertible paperwork at penny stock issuers, converting the notes into shares of inventory at a major discount from the market price, and selling the newly issued shares to the market at a substantial profit. The SEC alleges which Fife as well as his businesses engaged in over 250 convertible transactions with approximately 135 issuers, sold greater than 21 billion newly-issued penny stock shares into the industry, and obtained more than sixty one dolars million in profits.
Streeterville Capital isn’t mentioned as an entity in the complaint. Which suggests that it was probably used by Cytodyn as well as Fife to avoid detection by the SEC this same plan 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 any upward momentum.
The company has been selling stock privately at ridiculously low prices, to the position where by one wonders just who exactly are the blessed winners of what amounts to no cost millions of dollars?
Additionally, beginning within the month of November 2020 as well as for every one of the next 5 (5) calendar days thereafter, the Company is obliged to cut down the outstanding balance with the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will likely be acknowledged to the payment of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the fifteen % prepayment premium.
Also detracting from the business’s gloss is the propensity of handling for excessively marketing communications with shareholders. During an investor webcast on January 5th, the company had a series of audio testimonials from clients making use of PRO 140 for HIV treatment, backed by tear jerking music, and then replete with emotional language devoid of information.
Worse, the company’s cell phone number at the bottom part of press releases includes an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is a “valid extension” according to the automatic system.
That’s the kind of approach 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 also has become unresponsive to requests for interviews, and so using the story coming out less than merely these ill advised publicity stunts, shorts are actually attracted, and big cash investors, alienated.
But think of this “management discount” as the ability to buy a sizable role (should a person be so inclined) in what might very well turn out to be, in a matter of weeks, as the top therapy for serious COVID19 associated illness.
I expect the data from the trial now concluded for just such a sign may release the business into a complete new valuation altitude that will allow it to get over these shortfalls.
Average trading volume is actually constant above 6 million shares one day, and right before the conclusion of this week, we’ll find out just how effective leronlimab/PRO 140/Vyrologix is for saving lives from the worst of COVID nineteen. If the outcomes are positive, this could be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)