Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug designer, has already delivered a win for Wealthpress subscribers from our first feature back in April this year. Billions have been invested into countless biotechs all competing to make a medicine or therapy for serious COVID-19 instances which cause death, and also none have been successful. Except for Cytodyn, when early indications are verified in the present trial now underway.
But after a serious jump on the company’s financial claims as well as SEC filings, a picture emerges of company management operating having a “toxic lender” to funnel severely discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on the part of mine, of course, if the expected upward price movement doesn’t manifest following results of the company’s stage 2b/3 trial for severe-to-critical COVID 19, I am going to exit the investment.
In case the company’s drug does in fact reliably save lifestyles in danger of severe-to-critical COVID19 patients, subsequently a groundswell of investor support may push the business into new, higher grade human relationships, which would allow for the redemption of elimination as well as debentures of reliance on fly-by-night financings like those discussed below.
Cytodyn’s sole focus is actually creating treatments used on a monoclonal antibody called “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort 5 (CCR5)”. This particular engineered antibody was purchased 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 plus a 5 % net royalty on commercial revenue.
The drug was acquired on the first promise of its as an HIV therapy, for which continued development and research by Cytodyn has shown the potential to reduce daily drug cocktails with myriad pills into a specific monthly injection, sometimes, with zero side effects. To particular date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has realized the antibody’s impact on the CCR5 receptor has extremely optimistic therapeutic implications for everything out of some stable tumours to NASH (Non alcoholic steatohepatitis), the liver feature condition which afflicts up to twelve percent of the US population, and up to twenty six % globally.
But the real emergent also potentially transformational program 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 that precludes the Sequential Organ Failure in fatal instances 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 evidently return from the brink after two treatments (and in some cases, 1 treatment) of leronlimab, still when intubated.
The company finished 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, placebo controlled, double blind, randomized, adaptive style multicenter study,” according to the company’s media release.
This trial period concluded on January 12 ish, and if the outcomes are good, this will make leronlimab a top treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines which are currently dispersing are certainly lending hope for a normalization of modern society by mid 2021, the surging global rates of contamination mean the immediate future is already overwhelming health care systems across the world as increasingly more folks require ability to access Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan returned found March of 2020, the serious passion of his for the prospects of the drug’s efficacy was apparent.
This was before the currently raging second trend had gathered heavy steam, and he was then noticing patients that were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.
At the time, nonetheless,, this little independent biotech with no big funding along with a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting able to apply for a listing on NASDAQ, along with the deck was stacked against it.
Full Disclosure: I own 10,000 shares from an average cost of $6.23
While the world concentrates breathlessly on the optimism for a brand new vaccine to restore their social liberties, the 10-ish portion of COVID infectees who descend into the cytokine storm driven ARDS literally have their day saved by this apparently flexible drug. To them, a vaccine is basically useless.
This drug has “blockbuster potential” authored all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December sixteen, in addition to initially information expected this week, any demonstrable consistency in the information is going to record the world’s interest in essentially the most profound way. Quick sellers might be swept apart (at least temporarily) while the business’s new share priced amounts qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses all set for sale right now, with an additional 2.5 million ordered for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, based on the CEO of its.
so if leronlimab/PRO 140/Vyrologix is so great, why the stock’s been stuck in sub-1dolar1 5 penny stock purgatory for so long?
The fast remedy is “OTC”.
Besides faced with a share price under three dolars, the company has not been in a position to meet and maintain some other quantitative requirements, including good shareholders’ equity that is at least $5 million.
But in the NASDAQ world, you can find non-quantifiable behaviours by organizations that cause delays to NASDAQ listings. Overtly promotional communications are among such criteria which will never cause a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn has also not been able to access capital under traditional means, thanks to its being listed on the OTC, in addition to therefore un attractive on that basis alone to white shoe firms.
So, they’ve been lowered to accepting shareholder-hostile OID debentures with unsightly sales terms that generate a short-seller’s wet dream.
In November, they took 28.5 huge number of out of Streeterville Capital of that just twenty five dolars million was paid to the company; $3.4 huge number of will be the discount the Streeterville areas, and $100k is actually reserved to protect the costs. Streeterville is linked with Illiad Research and Trading, which is managed by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so called toxic lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the offer, Cytodyn must pay back $7.5 million a month. If they don’t have the cash, they spend within stock; most not long ago, at a sales price of $3.40 a share.
Now just think about when you’re an opportunistic low rent lender and you have received a certain 2.2 million shares coming your way in the first week of each month. Any price tag above the conversion expenditure is pure profit. Remember – this guy is not an investor; he is a lender.
He’s not operating on the hope that Cytodyn stock may go parabolic if leronlimab is deemed a cure for ARDS; his online business model is limiting risk and optimize upside through affordable conversion of share.
This is the quick seller’s wet dream I am talking about. Not only would be the lender enticed to go brief, but any short trading container dealer in town who are able to fog a mirror and read an EDGAR filing understand that each month, like clockwork, there’s going to be two million+ shares impacting the bid down to $3.40.
The SEC is not impressed, additionally, 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 as well as selling more than twenty one billion shares of penny inventory without the need of registering to be a securities dealer using the SEC.
The SEC’s criticism, alleges this in between 2015 as well as 2020, Fife, and also his businesses, Chicago Venture Partners, L.P., Iliad Research as well as Trading, L.P., St. George Investments LLC, Tonaquint, Inc., in addition to the Typenex Co-Investment, LLC, frequently interested in the company of purchasing convertible notes at penny stock issuers, converting those notes into shares of stock at a major discount from the market price, and offering the newly issued shares to the market at a sizable profit. The SEC alleges that Fife as well as his businesses involved in more than 250 convertible transactions with roughly 135 issuers, sold greater than twenty one billion newly issued penny stock shares into the industry, and obtained greater than $61 million in earnings.
Streeterville Capital isn’t mentioned as an entity in the complaint. Which hints it was probably utilized by Cytodyn and Fife to stay away from detection by the SEC that this same scheme was being perpetrated on Cytodyn at the time of its complaint.
But that is not the only reason the stock can’t keep some upward momentum.
The company has been offering stock privately at ridiculously low prices, to the stage where one wonders just who exactly are the lucky winners of what amounts to no cost millions of dollars?
In addition, beginning in the month of November 2020 as well as for each of the next 5 (5) calendar days thereafter, the Company is actually obliged to reduce the excellent sense of balance with the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will likely be credited to the payment of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % prepayment premium.
Additionally detracting from the business’s shine is the propensity of management for endlessly promotional communications with shareholders. During an investor webcast on January 5th, the business had a number of audio testimonials from people making use of PRO 140 for HIV therapy, backed by tear jerking music, and therefore replete with emotional language devoid of data.
Even worse, the company’s mobile phone number at the bottom level of press releases has an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is actually a “valid extension” according to the automated phone system.
That is the kind of approach that the SEC and FDA view unfavourably, and it is likely at the very least in part the reason behind their continued underdog status at both agencies.
The company also has become unresponsive to requests for interview, and thus while using story coming out under merely these ill advised publicity stunts, shorts are attracted, and huge cash investors, alienated.
But think of this specific “management discount” as the chance to purchase a sizable job (should a person be so inclined) found what could really well prove to be, in a situation of weeks, since the leading treatment for severe COVID19 related illness.
I expect the information from your trial now concluded for just such an indication can launch the business into a whole new valuation altitude that will enable it to overcome these shortfalls.
Average trading volume is actually continuous above six million shares a day, and right before the conclusion of this week, we will learn just how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the most severe of COVID nineteen. In case the results are good, this can be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)