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 back in April this season. Billions have been invested directly into countless biotechs all competing to produce a medicine or maybe treatment for severe COVID-19 situations that trigger death, and none have been successful. Except for Cytodyn, if early indications are established in the current trial now underway.
But right after a serious plunge on the company’s fiscal statements as well as SEC filings, an image emerges of business control working with a “toxic lender” to funnel severely discounted shares to the lender regularly. An investment in Cytodyn is a purely speculative bet on my part, of course, if the anticipated upward price movement doesn’t appear after results of the company’s phase 2b/3 trial for severe-to-critical COVID-19, I am going to exit the investment.
If the company’s drug does in fact reliably save lives in severe-to-critical COVID19 individuals, then a groundswell of investor support can drive the organization into new, higher-grade relationships, which would allow for the redemption of elimination as well as debentures of reliance on fly-by-night financings for instance those described below.
Cytodyn’s sole focus is actually developing treatments used on a monoclonal antibody known as “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort five (CCR5)”. This engineered antibody was purchased from Progenics Pharmaceuticals as “PRO 140”, a recently-acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total expense of acquisition amounts to $10 million plus a 5 % net royalty on business revenue.
The drug was acquired on its early promise as an HIV therapy, for which continued research and development by Cytodyn has highlighted the potential to reduce regular drug cocktails with assortment pills into a specific monthly injection, sometimes, with 0 side effects. To day, 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 extremely positive therapeutic implications for everything out of certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function disorder which afflicts up to twelve percent of the US population, and up to twenty six % globally.
But the real emergent also potentially transformational program for leronlimab, as stated at the start, (which is now 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 it seems that prevents the CCR5 receptor from over-responding to the virus and launching the now 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 when intubated.
The company completed enrollment of a level 2b/3 trial on December 15 to “evaluate the efficacy as well as safety of leronlimab for people 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 press release.
This trial period concluded on January 12-ish, and if the results are positive, this will make leronlimab a top treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are now circulating are certainly lending optimism for a normalization of modern society by mid 2021, the surging global rates of infection mean the immediate future is already overwhelming health care systems across the world as more and more men and women call for utilization of Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan returned contained March of 2020, his serious interest for the prospects of this drug’s success was apparent.
It was before the currently raging second wave had gathered steam, and also he was then noticing patients that were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, even thought, this little independent biotech with no significant funding along with a decidedly unhappy public listing on the naked short-sellers’ fantasy OTC marketplace was getting able to apply for a listing on NASDAQ, as well as the deck was stacked against it.
Full Disclosure: I have 10,000 shares at an average price of $6.23
Although the world focuses breathlessly on the hope for a new vaccine to restore the community liberties of theirs, the 10 ish portion of COVID infectees who descend into the cytokine storm driven ARDS actually have their lives saved by this seemingly versatile drug. For them, a vaccine is literally pointless.
This particular drug has “blockbuster potential” authored all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December sixteen, and first data expected this week, a demonstrable consistency in the data is going to capture the world’s interest in the most profound way. Quick sellers could be swept aside (at minimum temporarily) while the company’s new share priced levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses prepared for sale right now, with an additional 2.5 million purchased for each of 2021 plus 2022 in a manufacturing agreement with Samsung, according to its CEO.
so if leronlimab/PRO 140/Vyrologix is so great, why the stock’s been trapped in sub-1dolar1 five penny stock purgatory for so very long?
The quick answer is “OTC”.
Besides faced with a share price under three dolars, the company has not been equipped to meet and keep certain different quantitative requirements, including positive shareholders’ equity of at least five dolars million.
But in the NASDAQ world, there are non quantifiable behaviours by companies that can cause waiting times to NASDAQ listings. Overtly advertising communications are among such type of criteria that will never lead to a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has also 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 reduced to accepting shareholder hostile OID debentures with unsightly sales terms that produce a short-seller’s wet dream.
In November, they took 28.5 zillion coming from Streeterville Capital of which only twenty five dolars million was given to the company; $3.4 huge number of is the discount the Streeterville sections, and $100k is put aside to cover the bills. Streeterville is related 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 price, Cytodyn has to pay again $7.5 million every month. In case they do not possess the cash, they spend within stock; many recently, within a sales cost of $3.40 a share.
These days just think about when you are an opportunistic low rent lender and you have received an assured 2.2 million shares coming the way of yours in the first week of each month. Any price above the conversion price is pure profit. Remember – this guy isn’t an investor; he is a lender.
He’s not operating on the hope that Cytodyn stock might go parabolic if leronlimab is deemed a cure for ARDS; the business model of his is to limit risk and optimize upside via discounted transformation of share.
This’s the quick seller’s wet dream I am discussing. Not merely is the lender enticed to go brief, but some short trading pail dealer in town who can fog a mirror and read an EDGAR filing realize that each month, like clockwork, there’s going to be two million+ shares striking the bid lowered by to $3.40.
The SEC is not impressed, additionally, on September 3, 2020, filed a complaint.
The Securities in addition to the Exchange Commission these days filed charges against John M. Fife of Chicago and Companies he controls for acquiring as well as marketing more than twenty one billion shares of penny stock without registering as a securities dealer with the SEC.
The SEC’s complaint, alleges that in between 2015 as well as 2020, Fife, and the companies of his, Chicago Venture Partners, L.P., Iliad Research as well as Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co-Investment, LLC, frequently interested in the company of buying convertible paperwork from penny stock issuers, converting these notes into shares of stock at a big discount from the market cost, 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 approximately 135 issuers, sold greater than 21 billion newly issued penny stock shares into the industry, and obtained more than $61 million in profits.
Streeterville Capital isn’t mentioned as an entity in the complaint. Which suggests that it was likely used by Fife and Cytodyn to stay away from detection by the SEC that this very same scheme was being perpetrated on Cytodyn within the time of the complaint of its.
But that is not the only reason the stock cannot maintain any upward momentum.
The company has been offering stock privately from ridiculously low prices, to the point where one wonders just who exactly are the blessed winners of what requires no cost millions of dollars?
Furthermore, beginning inside the month of November 2020 and also for every one of the following five (five) calendar days thereafter, the Company is actually obligated to reduce the exceptional harmony of the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes will be acknowledged to the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the fifteen % prepayment premium.
Likewise detracting from the company’s shine is actually the propensity of managing for excessively marketing communications with shareholders. During an investor webcast on January 5th, the business had a number of sound testimonials from patients applying PRO 140 for HIV therapy, backed by tear-jerking music, and replete with mental language devoid of data.
Worse, the company’s telephone number at the bottom level of press releases includes an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is a “valid extension” in accordance with the automatic system.
That is the type of approach that the FDA and SEC view unfavourably, and is likely at the very least in part the reason for the continued underdog status of theirs at both agencies.
The company has additionally come to be unresponsive to requests for interviews, and therefore with the story coming out under only these ill advised publicity stunts, shorts are actually attracted, and big money investors, alienated.
But think of this specific “management discount” as the ability to buy a sizable role (should a person be so inclined) found what could very well prove to be, in a situation of weeks, since the leading treatment for serious COVID19 associated illness.
I expect the data from your trial now concluded for just such an indication could launch the company into a whole new valuation altitude that will permit it to overcome these shortfalls.
Average trading volume is steady above six million shares one day, and right before the end of this week, we’ll find out precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the most severe of COVID nineteen. In case the results are positive, this can be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)