Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug creator, has already delivered a win for Wealthpress subscribers from our first feature back in April this year. Billions have been invested straight into hundreds of biotechs all competing to develop a medicine or perhaps treatment for severe COVID 19 situations which result in death, and also none have been successful. Except for Cytodyn, if early indications are confirmed in the present trial now underway.
But after a serious dive on the business’s financial claims and SEC filings, a picture emerges of company control functioning with a “toxic lender” to funnel seriously discounted shares to the lender regularly. An investment in Cytodyn is a strictly speculative bet on the part of mine, and if the anticipated upward price movement doesn’t manifest following results in the company’s stage 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
In case the business’s drug does actually reliably preserve lifestyles in severe-to-critical COVID19 individuals, then a groundswell of investor assistance can force the organization 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 such as those discussed below.
Cytodyn’s sole focus is actually developing treatments based on a monoclonal antibody called “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor type five (CCR5)”. This engineered antibody was obtained 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 ten dolars million and a five % net royalty on business sales.
The drug was acquired on its early promise as an HIV treatment, for which continued research and development by Cytodyn has highlighted the potential to reduce daily drug cocktails with assortment pills right into a single monthly injection, in some cases, with zero adverse reactions. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific staff has realized 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 disorder which 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 stated at the beginning, (which is already getting branded as Vyrologix by Cytodyn), is designed 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 apparently prevents the CCR5 receptor from over responding to the virus as well as launching the today household-word “cytokine storm”. Some proportion of individuals apparently return from the brink after two treatments (and in a number of instances, 1 treatment) of leronlimab, still if intubated.
The company finished enrollment of a phase 2b/3 trial on December fifteen to “evaluate the efficacy and safety of leronlimab for individuals with severe-to-critical COVID 19 indications is actually a two arm, placebo controlled, double blind, randomized, adaptive design and style multicenter study,” based on the company’s press release.
This trial phase concluded on January 12 ish, of course, if the results are positive, this can make leronlimab a top treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines that are presently dispersing are definitely lending hope for a normalization of modern culture by mid-2021, the surging global rates of disease mean the immediate future is already overwhelming health care systems across the world as increasingly more individuals call for access to Intensive Care Unit hospitalization.
During the first job interview of mine with Dr. Nader Pourhassan returned contained March of 2020, his extreme passion for the prospects of this drug’s efficacy was apparent.
It was prior to the currently raging second trend had gathered steam, and also he was then seeing individuals who were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, however,, this small independent biotech without major funding along with a decidedly unfortunate public listing on the naked short-sellers’ fantasy OTC marketplace was getting ready to apply for a listing on NASDAQ, along with the deck was stacked from it.
Full Disclosure: I have 10,000 shares from an average cost of $6.23
Even though the planet focuses breathlessly on the optimism for a new vaccine to restore the community 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. To them, a vaccine is literally useless.
This drug has “blockbuster potential” written all over it.
With 394 clients enrolled with the Phase 2b/3 trial as of December sixteen, in addition to first data expected this week, a demonstrable consistency in the information is going to capture the world’s attention in pretty much the most profound way. Quick sellers could be swept apart (at the very least temporarily) while the company’s brand new share priced amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses prepared for sale right now, with an additional 2.5 huge number of ordered for each of 2021 and 2022 in a manufacturing arrangement with Samsung, according to the CEO of its.
really if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been stuck in sub 1dolar1 five penny stock purgatory for such a long time?
The quick answer is “OTC”.
Besides dealing with a share price under three dolars, the company hasn’t been in a position to meet and keep certain different quantitative requirements, including good shareholders’ equity with a minimum of five dolars million.
But in the NASDAQ community, you can find non-quantifiable behaviours by businesses that can cause delays to NASDAQ listings. Overtly promotional communications are among such type of criteria that will never result in a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn has also not been equipped to access capital under traditional ways, because of its being mentioned on the OTC, and consequently un attractive on that foundation alone to white colored shoe firms.
Thus, they’ve been reduced to accepting shareholder hostile OID debentures with ugly sales terms that create a short-seller’s stormy dream.
In November, they borrowed 28.5 million coming from Streeterville Capital of that just $25 million was given to the company; $3.4 zillion is the discount the Streeterville areas, and $100k is reserved to protect the costs. Streeterville is actually linked with Illiad Research and Trading, which is operated by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so-called toxic lender”, by rival studies tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the price, Cytodyn needs to pay back $7.5 million per month. In case they do not possess the cash, they pay inside stock; most not long ago, at a conversion cost of $3.40 a share.
These days just think about when you’re an opportunistic low-rent lender and you’ve gained a guaranteed 2.2 million shares coming your way in the earliest week of every 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 may go parabolic if leronlimab is deemed a cure for ARDS; his online business model is to limit risk and maximize upside via discounted conversion of share.
This’s the quick seller’s wet dream I’m talking about. Not merely is the lender enticed to go short, but some short-trading bucket shop in town who are able to fog a mirror and read 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 isn’t impressed, in addition, on September three, 2020, filed a criticism.
The Securities as well as Exchange Commission nowadays filed charges from John M. Fife of Companies and Chicago he controls for acquiring and promoting much more than 21 billion shares of penny stock without any registering to be a securities dealer with the SEC.
The SEC’s complaint, alleges this in between 2015 as well as 2020, Fife, as well as the businesses of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., in addition to the Typenex Co Investment, LLC, regularly involved in the business of purchasing convertible notes 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 significant profit. The SEC alleges that Fife and the businesses of his involved in over 250 convertible transactions with about 135 issuers, sold greater than twenty one billion newly-issued penny stock shares into the market, and obtained more than sixty one dolars million in profits.
Streeterville Capital isn’t mentioned as an entity of the complaint. Which hints that it was likely utilized by Fife as well as Cytodyn to avoid detection by the SEC that this very same plan was getting perpetrated on Cytodyn at the time of the complaint of its.
But that is not the only reason the stock cannot 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 fortunate winners of what requires free millions of dollars?
Furthermore, starting within the month of November 2020 as well as for every one of the following 5 (5) calendar days thereafter, the Company is actually required to lower the excellent balance belonging to the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes will likely be acknowledged to the payment of each monthly Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the 15 % prepayment premium.
Also detracting from the business’s gloss is the propensity of managing for endlessly marketing communications with shareholders. During an investor webcast on January 5th, the company had a compilation of sound testimonials from patients applying PRO 140 for HIV therapy, backed by tear jerking music, and therefore replete with mental language devoid of information.
Worse, the company’s phone number at the bottom level of press releases includes an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is a “valid extension” based on the automatic system.
That is the type of approach that the FDA and SEC view unfavourably, and it is likely at the very least in part the reason behind the continued underdog status of theirs at both agencies.
The company has also become unresponsive to requests for interview, and thus with the story coming out less than just these ill-advised publicity stunts, shorts are attracted, and huge money investors, alienated.
But think of this particular “management discount” as the ability to acquire a sizable role (should someone be so inclined) contained what might really well turn out to be, in a question of weeks, as the top therapy for severe COVID19 related illness.
I expect the data in the trial now concluded for only such a sign can launch the business into a whole new valuation altitude that will enable it to overpower these shortfalls.
Average trading volume is actually steady above six million shares a day, and before the end of this week, we’ll know exactly how efficient leronlimab/PRO 140/Vyrologix is for saving lives from the worst of COVID nineteen. If the outcomes are good, this could be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)