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 subscribers from our 1st feature returned in April this year. Billions have been invested into a huge selection of biotechs all competing to produce a medicine or maybe therapy for serious COVID 19 instances that trigger death, and none have succeeded. Except for Cytodyn, when early indications are verified in the present trial now underway.
But after a serious plunge on the company’s financial claims as well as SEC filings, a picture emerges of business control operating who have a “toxic lender” to funnel severely discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on the part of mine, and when the anticipated upward price movement doesn’t appear following results of the company’s phase 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
If the company’s drug does actually reliably preserve life to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance may push the organization into new, higher grade human relationships, which would permit for the redemption of elimination as well as debentures of reliance on fly-by-night financings like those discussed below.
Cytodyn’s sole focus is developing remedies used on a monoclonal antibody known as “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor type 5 (CCR5)”. This particular engineered antibody was acquired 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 commercial sales.
The drug was acquired on its first promise as an HIV therapy, for which continued development and research by Cytodyn has demonstrated the ability to reduce regular drug cocktails with assortment pills into a single monthly injection, sometimes, with 0 side effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific team has realized the antibody’s influence on the CCR5 receptor has extremely optimistic therapeutic implications for everything from some stable tumours to NASH (Non alcoholic steatohepatitis), the liver function condition 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 I have said at the start, (which is now being branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) due to COVID 19 that precludes the Sequential Organ Failure in fatal cases of COVID infections.
Leronlimab it seems that prevents the CCR5 receptor from over-responding to the virus as well as launching the now household word “cytokine storm”. Some proportion of clients obviously return from the brink after two treatments (and in some 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 as well as safety of leronlimab for individuals with severe-to-critical COVID 19 indications is actually a two arm, randomized, double blind, placebo controlled, adaptive design and style multicenter study,” according to the company’s press release.
This trial period concluded on January 12 ish, and if the outcomes are good, this will make leronlimab a top remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines which are now circulating are surely lending hope for a normalization of modern culture by mid 2021, the surging global rates of infection suggest the immediate future is today overwhelming health care systems throughout the world as more and more folks require access to Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan returned contained March of 2020, his extreme eagerness for the prospects of this drug’s efficacy was evident.
This was prior to the now raging next trend had gathered vapor, and he was then discovering individuals who were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, even thought, this small independent biotech without any big funding along with a decidedly unfortunate public listing on the naked short-sellers’ fantasy OTC marketplace was getting prepared 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 cost of $6.23
Although the planet concentrates breathlessly on the optimism for a brand new vaccine to restore the social liberties of theirs, the 10-ish portion of COVID infectees that descend into the cytokine storm driven ARDS literally have their lives saved by this apparently flexible drug. For these people, a vaccine is basically useless.
This particular drug has “blockbuster potential” authored all over it.
With 394 individuals enrolled inside 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 capture the world’s focus in probably the most profound way. Short sellers could be swept apart (at least temporarily) while the business’s new share price levels qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses prepared for sale right now, with an extra 2.5 million ordered for each of 2021 and 2022 in a manufacturing agreement with Samsung, based on its CEO.
so if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been stuck in sub-1dolar1 5 penny stock purgatory for so long?
The speedy answer is “OTC”.
Besides struggling with a share price under $3, the company has not been able to meet and maintain some other quantitative requirements, including good shareholders’ equity that is at least $5 million.
But in the NASDAQ world, one can find non quantifiable behaviours by organizations that cause waiting times to NASDAQ listings. Overtly promotional communications are actually among such type of criteria which won’t ever cause a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn in addition has not been in a position to access capital under traditional means, thanks to its being listed on the OTC, and thus un-attractive on that basis alone to white colored shoe firms.
And so, they’ve been reduced to accepting shareholder hostile OID debentures with unsightly sales terms that create a short-seller’s stormy dream.
In November, they took 28.5 huge number of from Streeterville Capital of which only twenty five dolars million was given to the company; $3.4 huge number of will be the discount the Streeterville areas, and $100k is put aside to protect the expenses. Streeterville is associated with Illiad Research and Trading, that is operated 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 terms of the deal, Cytodyn wants to pay back $7.5 million each month. In case they do not have the cash, they pay within stock; many recently, at a conversion cost of $3.40 a share.
Now just think about when you’re an opportunistic low-rent lender and you have gained a guaranteed 2.2 million shares coming your way in the very first week of every month. Any price above the conversion cost is pure profit. Remember – this guy is not an investor; he’s a lender.
He’s not operating on the hope that Cytodyn stock could go parabolic if leronlimab is deemed a cure for ARDS; the business model of his is limiting risk and maximize upside via discounted transformation of share.
This’s the brief seller’s wet dream I am speaking about. Not only is definitely the lender enticed to go short, but some short-trading bucket shop in town who can fog a mirror and go through an EDGAR filing understand that every month, like clockwork, there is going to be two million+ shares striking the bid lowered by to $3.40.
The SEC isn’t impressed, additionally, on September three, 2020, filed a criticism.
The Securities and Exchange Commission nowadays filed charges from John M. Fife of Companies and Chicago he controls for obtaining as well as selling more than 21 billion shares of penny stock without any registering as a securities dealer using the SEC.
The SEC’s complaint, alleges that between 2015 and 2020, Fife, as well as 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, frequently interested in the small business of buying sports convertible paperwork from penny stock issuers, converting the notes into shares of inventory at a major discount from the market price, and selling the newly issued shares into the market at a substantial profit. The SEC alleges which Fife and his businesses engaged in over 250 convertible transactions with about 135 issuers, sold more than twenty one billion newly issued penny stock shares to the market, and obtained more than sixty one dolars million in earnings.
Streeterville Capital isn’t mentioned as an entity in the complaint. Which implies that it was very likely used by Fife as well as Cytodyn to stay away from detection by the SEC that this very same scheme was being perpetrated on Cytodyn at the time of its complaint.
But that is not the sole reason the stock can’t preserve any upward momentum.
The company has been selling inventory privately from ridiculously low prices, to the stage in which one wonders just who exactly are the blessed winners of what requires no cost millions of dollars?
Moreover, starting inside the month of November 2020 and for each of the next five (5) calendar days thereafter, the Company is actually required to reduce the excellent harmony with the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes are going to be credited toward the transaction of each month Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % prepayment premium.
Additionally detracting from the company’s shine is the propensity of managing for excessively marketing communications with shareholders. During an investor webcast on January 5th, the business played a compilation of audio testimonials from people making use of PRO 140 for HIV therapy, backed by tear-jerking music, and replete with emotional language devoid of data.
Even worse, the company’s cell phone number at the bottom level of press releases has an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is actually a “valid extension” based on the automatic system.
That’s the sort 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 additionally become unresponsive to requests for interviews, and therefore using the story coming out less than merely these ill-advised publicity stunts, shorts are attracted, and huge money investors, alienated.
But think of this particular “management discount” as the ability to purchase a sizable role (should someone be so inclined) found what could really well prove to be, in a situation of weeks, given that the leading therapy for severe COVID19 related illness.
I expect the data from the trial now concluded for only such a sign might release the business into a whole new valuation altitude that will enable it to get over these shortfalls.
Average trading volume is actually continuous above 6 million shares 1 day, and right before the tail end of this week, we will know precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the worst of COVID 19. In case the outcomes are positive, this could be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)