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 1st feature back in April this season. Billions have been invested straight into hundreds of biotechs all competing to develop a cure or treatment for serious COVID-19 situations which trigger death, as well as none have been successful. Except for Cytodyn, if early indications are confirmed in the present trial now underway.
But after a serious jump on the business’s financial statements as well as SEC filings, an image emerges of company management working with a “toxic lender” to direct severely discounted shares to the lender frequently. An investment in Cytodyn is a purely speculative bet on the part of mine, and if the expected upward price movement does not occur after results in the company’s stage 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
In case the company’s drug does actually reliably save lifestyles in danger of severe-to-critical COVID19 individuals, then a groundswell of investor assistance can force the company into new, higher-grade relationships, which would permit for the redemption of debentures as well as elimination of reliance on fly-by-night financings like those described below.
Cytodyn’s sole focus is actually developing remedies based on a monoclonal antibody known as “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor sort five (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 cost of acquisition amounts to $10 million and a five % net royalty on business 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 assortment pills into a specific monthly injection, in some instances, with zero unwanted side effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has found the antibody’s effect on the CCR5 receptor has incredibly optimistic therapeutic implications for everything out of some stable tumours to NASH (Non-alcoholic steatohepatitis), the liver feature condition which afflicts up to 12 % of the US population, and up to twenty six % globally.
But the real emergent and likely transformational application for leronlimab, as stated at the beginning, (which is currently being branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID 19 that precludes the Sequential Organ Failure in fatal situations 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 apparently return from the brink after 2 treatments (and in some instances, one treatment) of leronlimab, even when intubated.
The company completed enrollment of a phase 2b/3 trial on December fifteen to “evaluate the efficacy as well as safety of leronlimab for clients with severe-to-critical COVID-19 indications is actually a two-arm, placebo controlled, double blind, randomized, adaptive design and style multicenter study,” according to the company’s media release.
This trial phase concluded on January 12-ish, of course, if the outcomes are positive, this can make leronlimab a premier treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines which are currently spreading are surely lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of contamination suggest the immediate future is already overwhelming health care systems across the world as increasingly more men and women call for access to Intensive Care Unit hospitalization.
During my 1st interview with Dr. Nader Pourhassan returned contained March of 2020, the serious passion of his for the prospects of this drug’s success was evident.
This was prior to the currently raging second trend had gathered vapor, as well as he was then discovering patients which were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nonetheless,, this little independent biotech with no significant funding and a decidedly unhappy public listing on the naked short-sellers’ fantasy OTC marketplace was getting prepared to put on for a listing on NASDAQ, along with the deck was stacked against it.
Full Disclosure: I have 10,000 shares at an average price of $6.23
Although the planet concentrates breathlessly on the optimism for a new vaccine to restore their community liberties, the 10 ish fraction of COVID infectees that descend into the cytokine storm driven ARDS literally have their lives saved by this seemingly versatile drug. For them, a vaccine is practically pointless.
This drug has “blockbuster potential” authored all over it.
With 394 people enrolled inside the Phase 2b/3 trial as of December sixteen, and first data expected this week, any demonstrable consistency in the information is going to record the world’s interest in likely the most profound way. Quick sellers may be swept aside (at the very least temporarily) while the company’s 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 understanding with Samsung, based on the CEO of its.
so if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been trapped in sub-1dolar1 five penny stock purgatory for such a long time?
The quick remedy is “OTC”.
Apart from dealing with a share price under $3, the company hasn’t been in a position to meet and keep certain other quantitative prerequisites, including good shareholders’ equity of at least $5 million.
But in the NASDAQ world, one can find non-quantifiable behaviours by companies that cause delays to NASDAQ listings. Overtly promotional communications are actually among such criteria that won’t ever result in a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn in addition has not been equipped to access capital under standard means, because of its being mentioned on the OTC, and consequently un-attractive on that basis alone to white shoe firms.
So, they’ve been cut down to accepting shareholder hostile OID debentures with unsightly conversion terms that produce a short-seller’s stormy dream.
In November, they coppied 28.5 million 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 pockets, and $100k is reserved to cover the expenditures. Streeterville is associated with Illiad Research and Trading, which is operated 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 phrases of the deal, Cytodyn must pay again $7.5 million each month. In case they don’t have the cash, they spend in stock; many not long ago, within a sales cost of $3.40 a share.
Now just imagine when you are an opportunistic low rent lender and you’ve got an assured 2.2 million shares coming your way in the earliest week of each month. Any cost above the conversion cost is pure profit. Remember – this guy is not an investor; he is a lender.
He’s not operating on the expectation that Cytodyn stock may go parabolic in the event that leronlimab is deemed a cure for ARDS; his online business model is to limit risk and maximize upside via affordable conversion of share.
This’s the brief seller’s wet dream I am speaking about. Not only is the lender enticed to go brief, but some short-trading container shop in town who can fog a mirror and go through an EDGAR filing understand that every month, like clockwork, there’s going to be two million+ shares hitting the bid lowered by to $3.40.
The SEC isn’t impressed, and on September three, 2020, filed a complaint.
The Securities as well as Exchange Commission these days filed charges from John M. Fife of Chicago and Companies he controls for acquiring as well as marketing more than twenty one billion shares of penny stock without registering to be a securities dealer with the SEC.
The SEC’s criticism, alleges this between 2015 and 2020, Fife, and his companies, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co Investment, LLC, routinely interested in the business of purchasing sports convertible notes at penny stock issuers, transforming the notes into shares of inventory at a major discount from the market price, and offering the freshly issued shares to the market at a sizable profit. The SEC alleges that Fife as well as his companies engaged in around 250 convertible transactions with about 135 issuers, sold greater than 21 billion newly-issued penny stock shares to the industry, and obtained more than sixty one dolars million in profits.
Streeterville Capital is not mentioned as an entity in the complaint. Which hints it was probably applied by Cytodyn as well as Fife to avoid detection by the SEC that this very same scheme was getting perpetrated on Cytodyn within the time of the complaint of its.
But that is not the only reason the stock can’t keep some upward momentum.
The company has been selling stock privately from ridiculously low prices, to the position where by one wonders just that exactly are the lucky winners of what amounts to no cost millions of dollars?
In addition, starting within the month of November 2020 and also for each of the second five (5) calendar days thereafter, the Company is obliged to lower the exceptional sense of balance belonging to the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes are going to be acknowledged toward the transaction 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 actually the propensity of managing for endlessly promotional communications with shareholders. During an investor webcast on January 5th, the business had a compilation of sound testimonials from patients applying PRO 140 for HIV therapy, backed by tear jerking music, and then replete with emotional language devoid of data.
Worse, the company’s phone number at the bottom part of press releases has an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one is actually a “valid extension” based on the automatic system.
That’s the type of approach that the FDA and SEC view unfavourably, and is likely at the very 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 interview, and therefore 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 particular “management discount” as the ability to purchase a sizable job (should someone be so inclined) found what may really well turn out to be, in a question of weeks, since the leading therapy for serious COVID19 associated illness.
I expect the data from your trial now concluded for only such a sign could launch the business into a complete new valuation altitude that will allow it to get over these shortfalls.
Average trading volume is continuous above 6 million shares 1 day, and right before the tail end of this week, we will find out precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the worst of COVID nineteen. In case the results are positive, this may be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)