Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug developer, has already delivered a win for Wealthpress members from our first feature back in April this year. Billions have been invested into a huge selection of biotechs all competing to produce a cure or maybe treatment for severe COVID-19 instances that cause death, and also none have succeeded. Except for Cytodyn, if early indications are established in the present trial now underway.
But right after a serious plunge on the business’s financial claims as well as SEC filings, a picture emerges of business management working having a “toxic lender” to direct seriously discounted shares to the lender regularly. An investment in Cytodyn is a purely speculative bet on my part, of course, if the expected 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 business’s drug does actually reliably save life in danger of severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance may push the company into new, higher-grade relationships, which would enable for the redemption of debentures as well as elimination of reliance on fly-by-night financings for example those described below.
Cytodyn’s sole focus is actually developing therapies based on a monoclonal antibody called “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)”. This engineered antibody was purchased of Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), again in 2012.
Total price of acquisition amounts to $10 million plus a 5 % net royalty on commercial revenue.
The drug was acquired on its early promise as an HIV treatment, for which continued research and development by Cytodyn has highlighted the ability to reduce regular drug cocktails with myriad pills 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 team has discovered the antibody’s influence on the CCR5 receptor has incredibly optimistic therapeutic implications for everything out of certain solid tumours to NASH (Non alcoholic steatohepatitis), the liver feature disorder that afflicts up to 12 % of the US public, and up to twenty six % globally.
But the real emergent also potentially transformational application for leronlimab, as mentioned at the start, (which is already being branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 which precludes the Sequential Organ Failure in fatal situations of COVID infections.
Leronlimab it seems that blocks 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 following two treatments (and in some cases, 1 treatment) of leronlimab, still if intubated.
The company finished enrollment of a level 2b/3 trial on December fifteen to “evaluate the efficacy and safety of leronlimab for individuals with severe-to-critical COVID-19 indications is 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, and if the outcomes are good, this can make leronlimab a premier treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines which are currently circulating are definitely lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of disease mean the immediate future is today overwhelming health care systems across the world as a lot more men and women call for access to Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan returned contained March of 2020, the extreme interest of his for the prospects of the drug’s efficacy was evident.
This was prior to the currently raging second wave had gathered steam, and also he was then discovering patients who were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, nevertheless,, this little independent biotech without big 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, and the deck was stacked from it.
Full Disclosure: I posses 10,000 shares at an average expense of $6.23
Even though the planet focuses breathlessly on the hope for a new vaccine to restore the social liberties of theirs, the 10-ish percentage of COVID infectees who 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” authored all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December 16, along with initially data expected this week, any demonstrable consistency in the data will record the world’s focus in pretty much the most profound way. Short sellers could be swept apart (at least temporarily) as 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 zillion ordered for each of 2021 and 2022 in a manufacturing understanding with Samsung, according to the CEO of its.
so if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been stuck in sub 1dolar1 five penny stock purgatory for so very long?
The speedy solution is “OTC”.
Besides faced with a share price under three dolars, the company has not been able to meet and maintain certain different quantitative prerequisites, including good shareholders’ equity of at least $5 million.
But in the NASDAQ world, there are non quantifiable behaviours by organizations that cause waiting times to NASDAQ listings. Overtly advertising communications are among these kinds of criteria that will never lead to a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has additionally not been in a position to access capital under conventional means, because of its being listed on the OTC, in addition to consequently un attractive on that basis alone to white colored shoe firms.
So, they have been reduced to accepting shareholder hostile OID debentures with ugly conversion terms that create a short-seller’s wet dream.
In November, they coppied 28.5 zillion coming from Streeterville Capital of which just $25 million was paid to the company; $3.4 zillion will be the discount the Streeterville areas, and $100k is actually reserved to protect the costs. Streeterville is actually linked 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 research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the offer, Cytodyn has to pay again $7.5 million every month. If they do not have the cash, they pay inside stock; most not long ago, at a sales cost of $3.40 a share.
Now consider if you are an opportunistic low-rent lender and you’ve got a guaranteed 2.2 million shares coming your way in the earliest week of each month. Any cost above the sales price is pure profit. Remember – this guy is not an investor; he’s a lender.
He is not operating on the hope that Cytodyn stock could 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 via discounted transformation of share.
This is the quick seller’s wet dream I am discussing. Not only would be the lender enticed to go short, but some short trading container repair shop in town who could 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 is not impressed, in addition, on September 3, 2020, filed a criticism.
The Securities in addition to the Exchange Commission these days filed charges from John M. Fife of Chicago and Companies he controls for acquiring and selling more than 21 billion shares of penny inventory without any registering as a securities dealer with the SEC.
The SEC’s complaint, alleges this between 2015 and 2020, Fife, and his businesses, Chicago Venture Partners, L.P., Iliad Research in addition to the Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co Investment, LLC, frequently engaged in the company of buying convertible paperwork from penny stock issuers, converting these notes into shares of inventory at a large discount from the market cost, and selling the freshly issued shares into the marketplace at a significant profit. The SEC alleges which Fife as well as the companies of his involved in around 250 sports convertible transactions with approximately 135 issuers, sold more than 21 billion newly issued penny stock shares to the industry, and obtained more than sixty one dolars million in profits.
Streeterville Capital isn’t mentioned as an entity of the complaint. Which implies it was probably applied by Cytodyn and Fife to avoid detection by the SEC that this same plan was being perpetrated on Cytodyn within the time of the complaint of its.
But that’s not the sole reason the stock can’t maintain some upward momentum.
The company has been offering stock privately at ridiculously minimal prices, to the position in which one wonders just that exactly are the lucky winners of what requires free millions of dollars?
Furthermore, starting in the month of November 2020 as well as for every one of the second five (5) calendar days thereafter, the Company is actually obligated to lower the excellent sense of balance of the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes will likely be acknowledged toward the transaction 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 shine is the propensity of management for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company played a number of audio testimonials from clients making use of PRO 140 for HIV therapy, backed by tear-jerking music, and replete with emotional language devoid of information.
Worse, the company’s mobile phone number at the bottom of press releases has an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is a “valid extension” according to the automated phone system.
That’s the approach type that the FDA and SEC view unfavourably, and it is likely at the very least in part the reason for their continued underdog status at both agencies.
The company also has come to be unresponsive to requests for interview, and thus using the story coming out less than just these ill advised publicity stunts, shorts are actually attracted, and big money investors, alienated.
But think of this “management discount” as the chance to buy a sizable position (should someone be so inclined) contained what might really well turn out to be, in a question of weeks, since the best therapy for serious COVID19 associated illness.
I expect the information from your trial now concluded for only such a sign could release the business into a complete new valuation altitude that will permit it to overpower these shortfalls.
Average trading volume is actually steady above six million shares a day, and right before the tail end of this week, we’ll know exactly how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the most severe of COVID 19. In case the outcomes are good, this could be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)