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 first feature returned in April this season. Billions have been invested directly into hundreds of biotechs all competing to develop a cure or perhaps treatment for severe COVID 19 instances which result in death, and also none have been successful. Except Cytodyn, if early indications are confirmed in the current trial now underway.
But after a serious plunge on the company’s fiscal statements and SEC filings, an image emerges of company control operating with a “toxic lender” to direct severely discounted shares to the lender frequently. An investment in Cytodyn is actually a strictly speculative bet on the part of mine, and if the anticipated upward price movement does not appear following results of the company’s phase 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
If the business’s drug does in fact reliably preserve lives in severe-to-critical COVID19 patients, then a groundswell of investor assistance can drive the business into new, higher grade relationships, which would permit for the redemption of debentures and elimination of reliance on fly-by-night financings for example those described below.
Cytodyn’s sole focus is actually developing therapies used on a monoclonal antibody called “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort 5 (CCR5)”. This particular engineered antibody was purchased of Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total price of acquisition amounts to ten dolars million and a 5 % net royalty on business sales.
The drug was acquired on the early promise of its as an HIV therapy, for which continued research as well as development by Cytodyn has highlighted the potential to reduce daily drug cocktails with myriad pills into a specific monthly injection, in some cases, with 0 negative effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific staff has discovered 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 function ailment that afflicts up to twelve % of the US public, and up to 26 % globally.
But the real emergent also likely transformational application for leronlimab, as stated at the start, (which is currently getting branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 which precludes the Sequential Organ Failure wearing fatal cases of COVID infections.
Leronlimab apparently prevents the CCR5 receptor from over-responding to the virus and also launching the today household word “cytokine storm”. Some proportion of people apparently return from the brink following two treatments (and in a number of cases, one treatment) of leronlimab, still when intubated.
The company finished enrollment of a phase 2b/3 trial on December fifteen to “evaluate the efficacy as well as safety of leronlimab for people with severe-to-critical COVID 19 indications is 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 outcomes are good, this can make leronlimab a premier remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines that are presently circulating are certainly lending hope for a normalization of society by mid 2021, the surging global rates of contamination mean the immediate future is today overwhelming health care systems around the world as increasingly more people call for access to Intensive Care Unit hospitalization.
During the 1st job interview of mine with Dr. Nader Pourhassan back contained March of 2020, his serious interest for the prospects of this drug’s efficacy was evident.
This was before the currently raging second trend had gathered vapor, as well as he was then noticing patients which were getting leronlimab under the FDA’s Emergency Investigative New Drug exemption.
At the time, although, this small independent biotech without any major funding along with a decidedly unfortunate public listing on the naked short-sellers’ fantasy OTC marketplace was getting ready to put on for a listing on NASDAQ, and the deck was stacked against it.
Full Disclosure: I own 10,000 shares from an average price of $6.23
Even though the planet focuses breathlessly on the optimism for a brand new vaccine to regain the social liberties of theirs, the 10 ish fraction of COVID infectees that descend into the cytokine storm-driven ARDS literally have their lives saved by this apparently versatile drug. For them, a vaccine is pretty much useless.
This particular drug has “blockbuster potential” authored all over it.
With 394 patients enrolled in the Phase 2b/3 trial as of December 16, in addition to first information expected this week, any demonstrable consistency in the data is going to record the world’s attention in essentially the most profound way. Short sellers could be swept aside (at minimum temporarily) as the business’s new share price amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses ready for sale now, with an additional 2.5 huge number of purchased for each of 2021 as well as 2022 in a manufacturing arrangement with Samsung, according to the CEO of its.
so if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub-1dolar1 5 penny stock purgatory for so long?
The fast solution is “OTC”.
Apart from faced with a share price under three dolars, the company hasn’t been equipped to meet and keep some other quantitative prerequisites, including good shareholders’ equity that is at least $5 million.
But in the NASDAQ community, one can find non-quantifiable behaviours by businesses that can cause delays to NASDAQ listings. Overtly advertising communications are among these kinds of criteria which won’t ever cause a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn has additionally not been able to access capital under traditional means, because of its being listed on the OTC, along with thus un attractive on that foundation alone to white shoe firms.
Thus, they have been lowered to accepting shareholder hostile OID debentures with ugly conversion terms that create a short-seller’s wet dream.
In November, they coppied 28.5 zillion from Streeterville Capital of that only $25 million was given to the company; $3.4 million would be the discount the Streeterville pockets, and $100k is reserved to cover the expenses. Streeterville is associated with Illiad Research and Trading, which is controlled by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so-called toxic lender”, by rival studies tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the offer, Cytodyn has got to pay back $7.5 million each month. If they don’t have the cash, they pay in stock; the majority of not long ago, within a sales price of $3.40 a share.
Now consider if you’re an opportunistic low-rent lender and you have gained an assured 2.2 million shares coming the way of yours in the 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’s not operating on the expectation that Cytodyn stock could go parabolic in the event that leronlimab is deemed a cure for ARDS; the business model of his is to limit risk and optimize upside through discounted transformation of share.
This’s the brief seller’s wet dream I am speaking about. Not merely would be the lender enticed to go short, but any short trading bucket repair shop in town who can fog a mirror and examine an EDGAR filing realize that every month, like clockwork, there is going to be two million+ shares impacting the bid down to $3.40.
The SEC isn’t impressed, additionally, on September three, 2020, filed a criticism.
The Securities and 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 inventory without any registering to be a securities dealer while using the SEC.
The SEC’s complaint, alleges this between 2015 as well as 2020, Fife, and his businesses, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co Investment, LLC, regularly interested in the company of buying convertible notes from penny stock issuers, transforming the notes into shares of stock at a large discount from the market price, and offering the newly issued shares into the market at a substantial profit. The SEC alleges which Fife as well as his companies involved in more than 250 convertible transactions with approximately 135 issuers, sold more than 21 billion newly-issued penny stock shares into the industry, and obtained more than $61 million in profits.
Streeterville Capital is not stated as an entity of the complaint. Which implies it was probably applied by Cytodyn and Fife 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 selling stock privately at ridiculously low prices, to the point where one wonders just that exactly are the blessed winners of what requires no cost millions of dollars?
Moreover, beginning in the month of November 2020 as well as for each of the following five (5) calendar months thereafter, the Company is actually obligated to reduce the excellent balance of the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes are going to be credited to the transaction of each month Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the fifteen % prepayment premium.
Also detracting from the company’s shine is the propensity of managing for excessively promotional communications with shareholders. During an investor webcast on January 5th, the business played a compilation of sound testimonials from clients using PRO 140 for HIV treatment, backed by tear-jerking music, and replete with emotional language devoid of information.
Even worse, the company’s cell 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 phone system.
That’s 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 interview, and thus using the story coming out under just these ill-advised publicity stunts, shorts are attracted, and huge cash investors, alienated.
But think of this specific “management discount” as the chance to get a sizable position (should someone be so inclined) in what might very well turn out to be, in a situation of weeks, as the best treatment for serious COVID19 related illness.
I expect the details in the trial now concluded for only such a sign may launch the organization into a whole new valuation altitude that will allow it to overcome these shortfalls.
Average trading volume is actually constant above 6 million shares one day, and before the end of this week, we’ll know precisely how efficient leronlimab/PRO 140/Vyrologix is actually for saving lives from the worst of COVID 19. If the outcomes are good, this may be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)