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 members from our first feature returned in April this season. Billions have been invested into countless biotechs all competing to develop a cure or therapy for severe COVID-19 instances that cause death, and none have been successful. Except Cytodyn, when early indications are verified in the current trial now underway.
But after a deep dive on the company’s fiscal statements as well as SEC filings, an image emerges of company control operating who have a “toxic lender” to direct severely discounted shares to the lender regularly. An investment in Cytodyn is a strictly speculative bet on the part of mine, of course, if the anticipated upward price movement does not occur after results in the company’s phase 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
If the company’s drug does in fact reliably spend less lifestyles in danger of severe-to-critical COVID19 individuals, subsequently a groundswell of investor assistance could drive the organization into completely new, higher grade relationships, which would allow for the redemption of debentures as well as elimination of reliance on fly-by-night financings for instance those discussed below.
Cytodyn’s sole focus is actually developing treatments based on a monoclonal antibody called “leronlimab”, technically called “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), back in 2012.
Total cost of acquisition amounts to ten dolars million plus a 5 % net royalty on commercial sales.
The drug was acquired on its early promise as an HIV therapy, for which continued development as well as research by Cytodyn has highlighted the ability to reduce daily drug cocktails with assortment pills into an individual monthly injection, in some instances, with 0 negative effects. To particular date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific team has discovered the antibody’s impact on the CCR5 receptor has incredibly positive therapeutic implications for everything out of certain stable tumours to NASH (Non alcoholic steatohepatitis), the liver function condition that afflicts up to 12 percent of the US population, and up to twenty six % globally.
But the real emergent and potentially transformational program 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) brought on by COVID 19 which precludes the Sequential Organ Failure in fatal cases of COVID infections.
Leronlimab evidently blocks the CCR5 receptor from over-responding to the virus and also launching the today household-word “cytokine storm”. Some proportion of people obviously return from the brink following two treatments (and in a number of instances, 1 treatment) of leronlimab, still if intubated.
The company completed 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 a two arm, placebo controlled, double blind, randomized, adaptive design and style multicenter study,” according to the company’s press release.
This trial phase concluded on January 12 ish, and if the results are positive, this will make leronlimab a premier remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines which are presently circulating are definitely lending hope for a normalization of society by mid 2021, the surging worldwide rates of contamination mean the immediate future is right now overwhelming health care systems throughout the world as more and more folks require ability to access Intensive Care Unit hospitalization.
During my first interview with Dr. Nader Pourhassan back in March of 2020, the extreme interest of his for the prospects of this drug’s effectiveness was apparent.
It was before the currently raging second trend had gathered vapor, and also he was then noticing individuals who were getting 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 ready to utilize for a listing on NASDAQ, as well as the deck was stacked against it.
Full Disclosure: I posses 10,000 shares from an average price of $6.23
Although the planet focuses breathlessly on the hope for the latest vaccine to regain the social liberties of theirs, the 10-ish fraction of COVID infectees who descend into the cytokine storm driven ARDS actually have their day saved by this apparently flexible drug. For them, a vaccine is literally pointless.
This drug has “blockbuster potential” authored all over it.
With 394 patients enrolled with the Phase 2b/3 trial as of December sixteen, in addition to initially information expected this week, a demonstrable consistency in the data is going to capture the world’s attention in essentially the most profound way. Short sellers might be swept aside (at the very least temporarily) simply because business’s brand new share priced amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses all set for sale right now, with an additional 2.5 million ordered for each of 2021 and 2022 in a manufacturing agreement with Samsung, based on 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 so very long?
The fast solution is “OTC”.
Apart from dealing with a share price under three dolars, the company has not been equipped to meet and maintain some other quantitative prerequisites, including positive shareholders’ equity with a minimum of five dolars million.
But in the NASDAQ community, you can find non quantifiable behaviours by businesses that create delays to NASDAQ listings. Overtly promotional communications are actually among such type of criteria that won’t ever cause a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn has also not been in a position to access capital under standard ways, thanks to its being listed on the OTC, in addition to consequently un attractive on that basis alone to white shoe firms.
Thus, they have been cut down to accepting shareholder-hostile OID debentures with ugly sales terms that produce a short-seller’s wet dream.
In November, they coppied 28.5 huge number of coming from Streeterville Capital of that just twenty five dolars million was paid to the company; $3.4 huge number of is the discount the Streeterville pockets, and $100k is set aside to protect the expenses. Streeterville is linked with Illiad Trading and Research, that is managed 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 phrases of the deal, Cytodyn must pay again $7.5 million per month. In case they don’t have the cash, they spend in stock; the majority of lately, within a sales price of $3.40 a share.
Now consider when you are an opportunistic low rent lender and you’ve gained a certain 2.2 million shares coming your way in the first week of every month. Any price tag above the sales price is pure profit. Remember – this guy is not an investor; he is a lender.
He is not operating on the hope that Cytodyn stock could go parabolic in the event that leronlimab is deemed a cure for ARDS; his online business model is limiting risk and optimize upside via discounted conversion of share.
This’s the short seller’s wet dream I’m discussing. Not only is the lender enticed to go short, but any short-trading bucket dealer in town who are able to fog a mirror and go through an EDGAR filing understand that each month, like clockwork, there is going to be two million+ shares striking the bid down to $3.40.
The SEC is not impressed, and on September three, 2020, filed a criticism.
The Securities as well as Exchange Commission today filed charges from John M. Fife of Chicago and Companies he controls for obtaining and selling more than 21 billion shares of penny inventory without registering to be a securities dealer while using the SEC.
The SEC’s complaint, alleges that between 2015 and 2020, Fife, as well as the companies of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co Investment, LLC, frequently involved in the small business of buying sports convertible paperwork from penny stock issuers, transforming these notes into shares of stock at a large discount from the market price, and selling the newly issued shares into the marketplace at a substantial profit. The SEC alleges that Fife and the businesses of his engaged in over 250 convertible transactions with approximately 135 issuers, sold greater than twenty one billion newly issued penny stock shares into the market, and obtained greater than sixty one dolars million in earnings.
Streeterville Capital is not mentioned as an entity in the complaint. Which hints that it was probably used by Fife as well as Cytodyn to avoid detection by the SEC this very same plan was getting perpetrated on Cytodyn within the time of the complaint of its.
But that is not the sole reason the stock can’t preserve any upward momentum.
The company has been selling inventory privately from ridiculously minimal prices, to the position in which one wonders just who exactly are the lucky winners of what requires free millions of dollars?
In addition, starting in the month of November 2020 as well as for each of the following 5 (5) calendar days thereafter, the Company is obligated to cut down the excellent harmony of the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes are going to be credited to the transaction of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the fifteen % prepayment premium.
Likewise detracting from the company’s shine is the propensity of handling for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company had a compilation of sound testimonials from clients making use of PRO 140 for HIV therapy, backed by tear-jerking music, and therefore replete with mental language devoid of data.
Worse, the company’s mobile phone number at the bottom part of press releases includes an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is actually a “valid extension” according to the automatic system.
That is the approach type that the SEC and FDA view unfavourably, and is likely at least in part the reason behind the continued underdog status of theirs at both agencies.
The company has also turned out to be unresponsive to requests for interviews, and thus using the story coming out under just these ill-advised publicity stunts, shorts are attracted, and big money investors, alienated.
But think of this particular “management discount” as the chance to acquire a sizable position (should one be so inclined) in what might very well turn out to be, in a question of weeks, given that the top therapy for severe COVID19 associated illness.
I expect the information from your trial now concluded for only such a sign might launch the company into a complete new valuation altitude that will permit it to overpower these shortfalls.
Average trading volume is continuous above six million shares a day, and before the conclusion of this week, we will learn just how efficient leronlimab/PRO 140/Vyrologix is at saving lives from the worst of COVID 19. If the outcomes are good, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)