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 subscribers from our 1st feature back in April this year. Billions have been invested into hundreds of biotechs all competing to make a cure or perhaps treatment for serious COVID 19 situations that cause death, as well as none have been successful. Except for Cytodyn, if early indications are confirmed in the present trial now underway.
But right after a deep plunge on the company’s fiscal statements as well as SEC filings, a picture emerges of company control functioning who have a “toxic lender” to direct seriously discounted shares to the lender regularly. An investment in Cytodyn is actually a purely speculative bet on the part of mine, and when the anticipated upward price movement doesn’t manifest after results in the company’s stage 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
If the company’s drug does in fact reliably conserve life to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance could force 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 example those discussed below.
Cytodyn’s sole focus is creating therapies used on a monoclonal antibody called “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)”. This particular engineered antibody was obtained of 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 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 demonstrated the potential to reduce daily drug cocktails with myriad pills right into a single monthly injection, in some cases, with 0 negative effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific team has found 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 function ailment that afflicts up to twelve percent of the US population, and up to 26 % globally.
But the real emergent and likely transformational application for leronlimab, as I have said at the start, (which is currently getting branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 which precludes the Sequential Organ Failure wearing fatal cases of COVID infections.
Leronlimab evidently prevents the CCR5 receptor from over responding to the virus as well as launching the now household word “cytokine storm”. Some proportion of clients apparently return from the brink following two treatments (and in some cases, 1 treatment) of leronlimab, still if intubated.
The company completed enrollment of a level 2b/3 trial on December fifteen to “evaluate the efficacy and safety of leronlimab for people with severe-to-critical COVID-19 indications is actually a two-arm, randomized, double blind, placebo controlled, adaptive style multicenter study,” based on the company’s press release.
This trial period concluded on January 12 ish, of course, if the results are good, this can make leronlimab a premier treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines which are now diffusing are certainly lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of disease suggest the immediate future is today overwhelming health care systems around the world as a lot more individuals require access to Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan returned in March of 2020, his serious enthusiasm for the prospects of the drug’s efficacy was apparent.
This was prior to the now raging second wave had gathered vapor, as well as he was then seeing patients who were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.
Within the time, nevertheless,, this little independent biotech without big funding along with a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting prepared to utilize for a listing on NASDAQ, along with the deck was stacked from it.
Full Disclosure: I posses 10,000 shares from an average cost of $6.23
Even though the world focuses breathlessly on the optimism for the latest vaccine to regain their social liberties, the 10 ish fraction of COVID infectees that descend into the cytokine storm driven ARDS actually have their day saved by this apparently versatile drug. To them, a vaccine is pretty much useless.
This particular drug has “blockbuster potential” written all over it.
With 394 individuals enrolled in the Phase 2b/3 trial as of December 16, and initially information expected this week, any demonstrable consistency in the data is going to capture the world’s attention in likely the most profound way. Short sellers might be swept apart (at minimum temporarily) while the business’s new share priced levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses all set for sale right now, with an extra 2.5 zillion ordered for each of 2021 plus 2022 in a manufacturing arrangement with Samsung, based on the CEO of its.
really if leronlimab/PRO 140/Vyrologix is so great, why the stock’s been stuck in sub-1dolar1 five penny stock purgatory for so long?
The fast solution is “OTC”.
Apart from struggling with a share price under three dolars, the company has not been equipped to meet and keep some other quantitative requirements, like positive shareholders’ equity of at least five dolars million.
But in the NASDAQ community, you can find non-quantifiable behaviours by organizations that create delays to NASDAQ listings. Overtly advertising communications are among such type of criteria that will never lead to a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn has additionally not been in a position to access capital under standard ways, because of its being listed on the OTC, and thus un attractive on that basis alone to white colored shoe firms.
And so, they have been lowered to accepting shareholder hostile OID debentures with unsightly sales terms that generate a short-seller’s damp dream.
In November, they borrowed 28.5 huge number of from Streeterville Capital of which only $25 million was given to the company; $3.4 zillion would be the discount the Streeterville pockets, and $100k is actually put aside to protect the expenditures. Streeterville is associated with Illiad Research and Trading, which 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 price, Cytodyn wants to pay back $7.5 million per month. In case they do not possess the cash, they pay inside stock; the majority of not long ago, at a conversion price of $3.40 a share.
These days just think about when you’re an opportunistic low rent lender and you have received an assured 2.2 million shares coming your way in the very first week of every month. Any price above the sales cost is pure profit. Remember – this guy isn’t an investor; he is a lender.
He is not operating on the expectation that Cytodyn stock could go parabolic in the event that leronlimab is deemed a cure for ARDS; his business model is to limit risk and maximize upside via discounted conversion of share.
This is the quick seller’s wet dream I am talking about. Not merely would be the lender enticed to go brief, but some short-trading container dealer in town who can fog a mirror and examine an EDGAR filing realize that each month, like clockwork, there’s going to be 2 million+ shares striking the bid lowered by 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 nowadays filed charges against John M. Fife of Chicago and Companies he controls for obtaining and promoting much more than twenty one billion shares of penny stock without any registering to be a securities dealer with the SEC.
The SEC’s criticism, alleges this between 2015 as well as 2020, Fife, as well as his businesses, Chicago Venture Partners, L.P., Iliad Research in addition to the Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co Investment, LLC, frequently involved in the company of buying sports convertible notes from penny stock issuers, transforming the notes into shares of stock at a major discount from the market cost, and selling the newly issued shares to the marketplace at a sizable profit. The SEC alleges which Fife and his companies interested in more than 250 sports convertible transactions with around 135 issuers, sold more than twenty one billion newly-issued penny stock shares to the market, and obtained greater than $61 million in profits.
Streeterville Capital isn’t mentioned as an entity of the complaint. Which suggests it was very likely used by Fife and Cytodyn to avoid detection by the SEC this very same scheme was being perpetrated on Cytodyn at the time of the complaint of its.
But that’s not the only reason the stock cannot keep any upward momentum.
The company has been offering stock privately from ridiculously minimal prices, to the stage where one wonders just that exactly are the fortunate winners of what amounts to free millions of dollars?
Additionally, beginning within the month of November 2020 and also for each of the following 5 (5) calendar days thereafter, the Company is actually obliged to lower the exceptional harmony of the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes will likely be credited to the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the 15 % prepayment premium.
Additionally detracting from the business’s gloss is the propensity of managing for excessively marketing communications with shareholders. During an investor webcast on January 5th, the business had a series of audio testimonials from individuals applying PRO 140 for HIV therapy, 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 has an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is a “valid extension” based on the automatic system.
That is the approach type that the FDA and SEC view unfavourably, and is likely at least in part the reason behind their continued underdog status at both agencies.
The company has additionally become unresponsive to requests for interviews, and thus while using story coming out less than merely these ill-advised publicity stunts, shorts are attracted, and huge money investors, alienated.
But think of this specific “management discount” as the ability to acquire a sizable position (should someone be so inclined) contained what might very well prove to be, in a situation of weeks, since the leading treatment for serious COVID19 associated illness.
I expect the details in the trial now concluded for just such an indication may release the business into a complete new valuation altitude that will allow it to overpower these shortfalls.
Average trading volume is continuous above 6 million shares a day, and before the tail end of this week, we will know just how effective leronlimab/PRO 140/Vyrologix is at saving lives from the most severe of COVID 19. If the results are positive, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)