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 members from our 1st feature back in April this season. Billions have been invested directly into hundreds of biotechs all competing to develop a medicine or maybe treatment for serious COVID 19 instances which result in death, and also none have succeeded. Except Cytodyn, if early indications are verified in the current trial now underway.
But right after a deep jump on the company’s financial statements and SEC filings, a picture emerges of business control functioning with a “toxic lender” to direct seriously discounted shares to the lender regularly. An investment in Cytodyn is a strictly speculative bet on the part of mine, and when the expected upward price movement does not manifest after results of 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 conserve life in danger of severe-to-critical COVID19 individuals, then a groundswell of investor assistance can push the business into completely new, higher-grade relationships, which would permit 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 developing treatments used on a monoclonal antibody known as “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor type five (CCR5)”. This particular engineered antibody was obtained 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 ten dolars million and a five % net royalty on commercial revenue.
The drug was acquired on its early promise as an HIV treatment, for which continued development and research by Cytodyn has shown the potential to reduce daily drug cocktails with myriad pills right into a specific monthly injection, in some instances, with 0 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 from certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function ailment that afflicts up to twelve % of the US population, and up to twenty six % globally.
But the real emergent and likely transformational program for leronlimab, as mentioned at the beginning, (which is now getting branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) caused by COVID 19 that 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 launching the now household-word “cytokine storm”. Some proportion of clients apparently return from the brink following two treatments (and in a number of instances, 1 treatment) of leronlimab, still if intubated.
The company finished enrollment of a stage 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 design multicenter study,” based on the company’s media release.
This trial period concluded on January 12-ish, and if the outcomes are good, this can make leronlimab a top remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are now diffusing are certainly lending hope for a normalization of society by mid 2021, the surging global rates of disease mean the immediate future is already overwhelming health care systems around the world as increasingly more people call for access to Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan returned found March of 2020, his extreme eagerness for the prospects of the drug’s success was evident.
It was before the currently raging next trend had gathered heavy steam, and he was then seeing patients that were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, nonetheless,, this small independent biotech with no big funding and a decidedly unhappy 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 expense of $6.23
Even though the world concentrates breathlessly on the hope for a brand new vaccine to regain their community liberties, the 10-ish percentage of COVID infectees that descend into the cytokine storm driven ARDS literally have their day saved by this seemingly versatile drug. To them, a vaccine is pretty much useless.
This particular drug has “blockbuster potential” written all over it.
With 394 patients enrolled in the Phase 2b/3 trial as of December sixteen, along with initially data expected this week, any demonstrable consistency in the data is going to record the world’s focus in likely the most profound way. Quick sellers might be swept aside (at least temporarily) simply because business’s brand new share price levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses all set for sale now, with an extra 2.5 huge number of purchased for each of 2021 and 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 such a long time?
The quick solution is “OTC”.
Apart from struggling with a share price under $3, the company hasn’t been equipped to meet and keep some other quantitative prerequisites, including good shareholders’ equity with a minimum of $5 million.
But in the NASDAQ community, there are non quantifiable behaviours by businesses that create delays to NASDAQ listings. Overtly advertising communications are actually among these kinds of criteria which will never cause a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn has additionally not been in a position to access capital under standard means, thanks to its being listed on the OTC, and therefore un attractive on that foundation alone to white colored shoe firms.
And so, they have been lowered to accepting shareholder hostile OID debentures with ugly sales terms that generate a short-seller’s wet dream.
In November, they borrowed 28.5 zillion from Streeterville Capital of which just $25 million was given to the company; $3.4 huge number of is the discount the Streeterville areas, and $100k is actually set aside to cover the expenditures. Streeterville is actually associated with Illiad Research and Trading, that is managed by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so called poisonous lender”, by rival studies tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the price, Cytodyn has to pay again $7.5 million each month. If they don’t have the cash, they spend in stock; many recently, within a sales price of $3.40 a share.
Now just imagine when you’re an opportunistic low rent lender and you have gained an assured 2.2 million shares coming the way of yours in the very first week of each month. Any price tag above the sales cost is pure profit. Remember – this guy isn’t an investor; he’s a lender.
He is not operating on the expectation that Cytodyn stock could go parabolic if leronlimab is deemed a cure for ARDS; the business model of his is to limit risk and maximize upside through affordable transformation of share.
This’s the quick seller’s wet dream I’m speaking about. Not only is the lender enticed to go short, but some short-trading pail repair shop in town who are able to fog a mirror and go through an EDGAR filing understand that every month, like clockwork, there is going to be 2 million+ shares impacting the bid lowered by to $3.40.
The SEC is not impressed, additionally, on September 3, 2020, filed a criticism.
The Securities as well as Exchange Commission today filed charges against John M. Fife of Chicago and Companies he controls for obtaining as well as marketing more than twenty one billion shares of penny stock without the need of registering to be a securities dealer with the SEC.
The SEC’s complaint, alleges this between 2015 and 2020, Fife, as well as 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, regularly interested in the company of buying convertible paperwork at penny stock issuers, transforming the notes into shares of inventory at a large discount from the market price, and selling the newly issued shares to the marketplace at a substantial profit. The SEC alleges which Fife as well as the businesses of his involved in more than 250 convertible transactions with about 135 issuers, sold greater than twenty one billion newly issued penny stock shares to the industry, and obtained more than sixty one dolars million in profits.
Streeterville Capital is not stated as an entity in the complaint. Which hints it was likely utilized by Fife and Cytodyn to avoid detection by the SEC this same plan was being perpetrated on Cytodyn within the time of the complaint of its.
But that is not the only reason the stock cannot preserve any upward momentum.
The company has been selling inventory privately at ridiculously minimal prices, to the point where one wonders just who exactly are the lucky winners of what amounts to no cost millions of dollars?
In addition, starting inside the month of November 2020 and also for every one of the second five (five) calendar months thereafter, the Company is actually required to cut down the excellent harmony of the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will likely be credited toward the transaction of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the fifteen % prepayment premium.
Also detracting from the business’s shine is the propensity of management for excessively marketing communications with shareholders. During an investor webcast on January 5th, the business played a series of sound testimonials from patients using PRO 140 for HIV treatment, backed by tear-jerking music, and therefore replete with emotional language devoid of data.
Worse, the company’s phone number at the bottom part of press releases comes with an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one is actually a “valid extension” based on the automated system.
That’s the sort of approach that the FDA and SEC view unfavourably, and is likely at minimum in part the reason for the continued underdog status of theirs at both agencies.
The company has additionally become unresponsive to requests for interview, and so with 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 ability to get a sizable role (should one be so inclined) in what may really well turn out to be, in a matter of weeks, given that the top treatment for serious COVID19 related illness.
I expect the details from your trial now concluded for only such a sign could launch the organization into a whole new valuation altitude that will allow it to overcome these shortfalls.
Average trading volume is steady above 6 million shares one day, and before the end of this week, we will know precisely how efficient leronlimab/PRO 140/Vyrologix is at saving lives from the worst of COVID nineteen. In case the outcomes are positive, this could be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)