Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug creator, has already delivered a win for Wealthpress subscribers from our first feature back in April this season. Billions have been invested directly into a huge selection of biotechs all competing to develop a medicine or perhaps treatment for serious COVID-19 instances which trigger death, and none have succeeded. Except Cytodyn, when early indications are confirmed in the present trial now underway.
But after a deep dive on the business’s monetary statements as well as SEC filings, a picture emerges of company management functioning with a “toxic lender” to funnel severely discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on my part, and if the anticipated upward price movement does not manifest 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 in fact reliably preserve lives in severe-to-critical COVID19 patients, then a groundswell of investor support may push the business into completely new, higher grade human relationships, which would enable for the redemption of elimination as well as debentures of reliance on fly-by-night financings for example those discussed below.
Cytodyn’s sole focus is actually creating remedies used on a monoclonal antibody called “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor type five (CCR5)”. This particular 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 ten dolars million plus a five % net royalty on commercial sales.
The drug was acquired on the first promise of its as an HIV therapy, for which continued research as well as development by Cytodyn has shown the capability to reduce regular drug cocktails with myriad pills right into a single monthly injection, in some cases, with zero unintended effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has found the antibody’s effect on the CCR5 receptor has extremely positive therapeutic implications for everything out of some solid tumours to NASH (Non alcoholic steatohepatitis), the liver feature disorder that afflicts up to twelve percent of the US population, and up to 26 % globally.
But the real emergent also 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) caused by COVID 19 that precludes the Sequential Organ Failure wearing fatal instances of COVID infections.
Leronlimab evidently blocks the CCR5 receptor from over responding to the virus and launching the today household-word “cytokine storm”. Some proportion of people evidently return from the brink after 2 treatments (and in some cases, one treatment) of leronlimab, even when intubated.
The company completed enrollment of a level 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 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 premier remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are presently dispersing are certainly lending hope for a normalization of modern society by mid 2021, the surging global rates of disease suggest the immediate future is today overwhelming health care systems across the world as a lot more individuals require ability to access Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan returned found March of 2020, his serious enthusiasm for the prospects of the drug’s success was apparent.
It was prior to the now raging next wave had gathered steam, as well as he was then discovering patients who were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nevertheless,, this little independent biotech with no major funding along with a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting prepared to utilize for a listing on NASDAQ, along with the deck was stacked from it.
Full Disclosure: I have 10,000 shares at an average expense of $6.23
Even though the world concentrates breathlessly on the optimism for a new vaccine to regain the community liberties of theirs, the 10 ish portion of COVID infectees that descend into the cytokine storm driven ARDS actually have their lives saved by this apparently flexible drug. To them, a vaccine is practically pointless.
This drug has “blockbuster potential” authored all over it.
With 394 individuals enrolled inside the Phase 2b/3 trial as of December sixteen, in addition to first information expected this week, any demonstrable consistency in the data will record the world’s focus in essentially the most profound way. Quick sellers could be swept aside (at the very least temporarily) as the business’s brand new share price levels qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses all set for sale right now, with an additional 2.5 huge number of ordered for each of 2021 and 2022 in a manufacturing arrangement with Samsung, as per the CEO of its.
really if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub-1dolar1 5 penny stock purgatory for such a long time?
The fast answer is “OTC”.
Apart from faced with a share price under $3, the company hasn’t been able to meet and keep some other quantitative prerequisites, including positive shareholders’ equity that is at least $5 million.
But in the NASDAQ community, one can find non-quantifiable behaviours by companies that create waiting times to NASDAQ listings. Overtly advertising communications are actually among such type of criteria that won’t ever result in a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has additionally not been able to access capital under conventional means, because of its being mentioned on the OTC, in addition to thus un attractive on that basis alone to white shoe firms.
So, they have been lowered to accepting shareholder-hostile OID debentures with unsightly conversion terms that produce a short-seller’s wet dream.
In November, they coppied 28.5 million coming from Streeterville Capital of which only twenty five dolars million was given to the company; $3.4 zillion will be the discount the Streeterville sections, and $100k is put aside to cover the costs. Streeterville is linked with Illiad Research and Trading, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so-called poisonous lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the offer, Cytodyn needs to pay back again $7.5 million a month. In case they don’t possess the cash, they pay in stock; most recently, within a conversion price of $3.40 a share.
Now just think about when you are an opportunistic low rent lender and you have got a guaranteed 2.2 million shares coming your way in the very first week of each month. Any cost above the sales expenditure is pure profit. Remember – this guy isn’t an investor; he’s a lender.
He’s not operating on the expectation that Cytodyn stock may go parabolic if leronlimab is deemed a remedy for ARDS; his business model is limiting risk and optimize upside through affordable conversion of share.
This’s the brief seller’s wet dream I’m talking about. Not merely would be the lender enticed to go short, but any short trading container dealer in town who could fog a mirror and examine an EDGAR filing know that every month, like clockwork, there is going to be 2 million+ shares hitting the bid down to $3.40.
The SEC is not impressed, additionally, on September three, 2020, filed a criticism.
The Securities in addition to the Exchange Commission nowadays filed charges against John M. Fife of Chicago and Companies he controls for acquiring and marketing much more than twenty one billion shares of penny stock without registering as a securities dealer using the SEC.
The SEC’s complaint, alleges that between 2015 and 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., in addition to the Typenex Co-Investment, LLC, frequently engaged in the small business of purchasing sports convertible paperwork at penny stock issuers, converting the notes into shares of stock at a large discount from the market price, and offering the newly issued shares to the marketplace at a sizable profit. The SEC alleges that Fife as well as his companies involved in over 250 convertible transactions with approximately 135 issuers, sold more than 21 billion newly issued penny stock shares to the market, and obtained more than sixty one dolars million in profits.
Streeterville Capital is not mentioned as an entity of the complaint. Which implies that it was very likely utilized by Cytodyn and Fife to avoid detection by the SEC that this same plan was being perpetrated on Cytodyn at the time of its complaint.
But that’s not the only reason the stock can’t maintain any upward momentum.
The company has been offering inventory privately at ridiculously low prices, to the position where one wonders just who exactly are the fortunate winners of what requires no cost millions of dollars?
Additionally, starting inside the month of November 2020 and also for each of the following five (5) calendar days thereafter, the Company is actually required to lower the excellent harmony with 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 monthly 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 actually the propensity of managing for excessively marketing communications with shareholders. During an investor webcast on January 5th, the company played a number of audio testimonials from patients applying PRO 140 for HIV therapy, backed by tear-jerking music, and therefore replete with emotional language devoid of information.
Even worse, the company’s mobile phone number at the bottom part 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” in accordance with the automated phone system.
That is the approach type that the FDA and SEC view unfavourably, and is likely at least in part the reason behind the continued underdog status of theirs at both agencies.
The company also has become unresponsive to requests for interview, and therefore while using story coming out less than just these ill advised publicity stunts, shorts are actually attracted, and big money investors, alienated.
But think of this particular “management discount” as the ability to buy a sizable job (should a person be so inclined) in what could very well turn out to be, in a situation of weeks, given that the top therapy for serious COVID19 associated illness.
I expect the information from the trial now concluded for only such an indication could release the organization into a whole new valuation altitude that will enable it to overpower these shortfalls.
Average trading volume is actually continuous above six million shares one day, and before the end of this week, we will find out just how efficient leronlimab/PRO 140/Vyrologix is at saving lives from the most severe of COVID 19. If the outcomes are positive, this may be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)