Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug creator, has already shipped a win for Wealthpress members from our first feature returned in April this season. Billions have been invested straight into countless biotechs all competing to create a cure or perhaps therapy for serious COVID 19 situations that cause death, as well as none have succeeded. Except Cytodyn, when early indications are confirmed in the current trial now underway.
But right after a deep plunge on the company’s financial statements as well as SEC filings, an image emerges of business control operating who have a “toxic lender” to funnel seriously discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on the part of mine, and if the expected upward price movement does not manifest following results of the company’s stage 2b/3 trial for severe-to-critical COVID 19, I am going to exit the investment.
If the business’s drug does in fact reliably save lifestyles to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor support may drive the organization into new, higher-grade human relationships, which would permit for the redemption of elimination and debentures of reliance on fly-by-night financings such as those discussed below.
Cytodyn’s sole focus is actually creating remedies used on a monoclonal antibody called “leronlimab”, technically described 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 $10 million and a 5 % net royalty on business revenue.
The drug was acquired on the first promise of its as an HIV therapy, for which continued research and development by Cytodyn has highlighted the capability to reduce daily drug cocktails with assortment pills right into an individual monthly injection, sometimes, with 0 negative effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific staff has realized the antibody’s influence on the CCR5 receptor has incredibly optimistic therapeutic implications for everything from certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver feature condition that afflicts up to 12 percent of the US public, and up to 26 % globally.
But the real emergent and potentially transformational application for leronlimab, as stated at the beginning, (which is now being branded as Vyrologix by Cytodyn), is designed for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID 19 which precludes the Sequential Organ Failure in fatal instances of COVID infections.
Leronlimab evidently prevents the CCR5 receptor from over-responding to the virus and launching the now household-word “cytokine storm”. Some proportion of clients evidently return from the brink after two treatments (and in a number of instances, 1 treatment) of leronlimab, even when intubated.
The company finished enrollment of a stage 2b/3 trial on December fifteen to “evaluate the efficacy as well as safety of leronlimab for individuals with severe-to-critical COVID-19 indications is actually a two arm, placebo controlled, double blind, randomized, adaptive style multicenter study,” based on the company’s media 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)
Even though the vaccines which are presently circulating are certainly lending hope for a normalization of society by mid 2021, the surging worldwide rates of contamination mean the immediate future is already overwhelming health care systems across the world as more and more people require ability to access Intensive Care Unit hospitalization.
During my first interview with Dr. Nader Pourhassan back found March of 2020, the serious eagerness of his for the prospects of this drug’s success was apparent.
This was prior to the currently raging next wave had gathered heavy steam, as well as he was then discovering patients who were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, however,, this little independent biotech with no big funding and a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting able to utilize for a listing on NASDAQ, and the deck was stacked against it.
Full Disclosure: I posses 10,000 shares from an average cost of $6.23
While the planet concentrates breathlessly on the optimism for a new vaccine to regain their community liberties, the 10 ish portion of COVID infectees who descend into the cytokine storm driven ARDS actually have their day saved by this apparently versatile drug. For these people, a vaccine is literally pointless.
This drug has “blockbuster potential” authored all over it.
With 394 patients enrolled in the Phase 2b/3 trial as of December 16, and first data expected this week, a demonstrable consistency in the details will record the world’s interest in pretty much the most profound way. Short sellers may be swept apart (at minimum temporarily) as the business’s brand new share price amounts qualify it for NASDAQ listing.
Cytodyn management says it has 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 agreement with Samsung, based on the CEO of its.
really if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub-1dolar1 five penny stock purgatory for so very long?
The fast solution is “OTC”.
Besides dealing with a share price under $3, the company has not been equipped to meet and keep some other quantitative prerequisites, including good shareholders’ equity with a minimum of $5 million.
But in the NASDAQ world, you can find non quantifiable behaviours by businesses that cause slow downs to NASDAQ listings. Overtly promotional communications are among such type of criteria that will never lead to a refusal letter…nor a NASDAQ listing.
Most importantly, 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 foundation alone to white shoe firms.
Thus, they have been cut down to accepting shareholder-hostile OID debentures with unsightly sales terms that create a short-seller’s wet dream.
In November, they took 28.5 huge number of from Streeterville Capital of which only $25 million was given to the company; $3.4 zillion is the discount the Streeterville areas, and $100k is actually put aside to cover the expenditures. Streeterville is actually associated with Illiad Trading and Research, which is operated by John Fife of Chicago Ventures Inc. Iliad has been called a “legendary so-called poisonous lender”, by rival studies firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the deal, Cytodyn wants to pay again $7.5 million a month. If they do not possess the cash, they pay within stock; most recently, at a conversion price of $3.40 a share.
These days just imagine when you’re an opportunistic low-rent lender and you have got an assured 2.2 million shares coming your way in the earliest week of each month. Any price tag above the conversion expenditure is pure profit. Remember – this guy isn’t an investor; he is a lender.
He’s not operating on the expectation that Cytodyn stock might go parabolic in the event that leronlimab is deemed a cure for ARDS; the online business model of his is limiting risk and optimize upside via affordable conversion of share.
This is the brief seller’s wet dream I am discussing. Not only is definitely the lender enticed to go brief, but any short trading container shop in town who can fog a mirror and examine an EDGAR filing know that every month, like clockwork, there is going to be two million+ shares hitting the bid lowered by to $3.40.
The SEC isn’t impressed, additionally, on September 3, 2020, filed a criticism.
The Securities and Exchange Commission nowadays filed charges from John M. Fife of Chicago and Companies he controls for obtaining as well as marketing much more than 21 billion shares of penny inventory without any registering as a securities dealer with the SEC.
The SEC’s complaint, alleges this in between 2015 as well as 2020, Fife, and also his companies, Chicago Venture Partners, L.P., Iliad Research as well as Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co Investment, LLC, regularly interested in the business of buying convertible notes from penny stock issuers, converting those notes into shares of inventory at a big discount from the market price, and offering the freshly issued shares into the market at a sizable profit. The SEC alleges that Fife as well as the companies of his involved in around 250 convertible transactions with around 135 issuers, sold greater than 21 billion newly-issued penny stock shares to the market, and obtained greater than $61 million in earnings.
Streeterville Capital isn’t stated as an entity of the complaint. Which suggests that it was probably applied by Fife as well as Cytodyn to avoid detection by the SEC that this very same scheme was being perpetrated on Cytodyn within the time of its complaint.
But that’s not the sole reason the stock can’t preserve any upward momentum.
The company has been offering stock privately from ridiculously low prices, to the stage where one wonders just that exactly are the blessed winners of what requires free millions of dollars?
Furthermore, starting in the month of November 2020 and for every one of the next five (five) calendar months thereafter, the Company is actually required to bring down the outstanding harmony belonging to the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will be credited to the payment of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the fifteen % prepayment premium.
Also detracting from the company’s gloss is actually the propensity of managing for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company had a compilation of sound testimonials from individuals using PRO 140 for HIV therapy, backed by tear jerking music, and replete with emotional language devoid of data.
Even worse, the company’s mobile phone number at the bottom of press releases comes with an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is a “valid extension” based on the automatic phone system.
That’s the approach type that the SEC and FDA view unfavourably, and it is likely at least in part the reason for the continued underdog status of theirs at both agencies.
The company also has come to be unresponsive to requests for interview, and therefore while using story coming out under merely these ill advised publicity stunts, shorts are actually attracted, and huge cash investors, alienated.
But think of this specific “management discount” as the ability to acquire a sizable job (should a person be so inclined) found what could very well prove to be, in a question of weeks, since the top therapy for serious COVID19 associated illness.
I expect the information from your trial now concluded for just such a sign might launch the company into a whole new valuation altitude that will permit it to overcome these shortfalls.
Average trading volume is continuous above 6 million shares 1 day, and right before the conclusion of this week, we will learn exactly how efficient leronlimab/PRO 140/Vyrologix is actually for saving lives from the worst of COVID nineteen. If the results are positive, this can be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)