Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug designer, has already shipped a win for Wealthpress subscribers from our first feature returned in April this season. Billions have been invested directly into countless biotechs all competing to develop a cure or perhaps treatment for serious COVID-19 instances that result in death, and also none have succeeded. Except Cytodyn, when 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, a picture emerges of company control operating who have a “toxic lender” to direct severely discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on my part, and if the expected upward price movement does not manifest following results in the company’s stage 2b/3 trial for severe-to-critical COVID-19, I will exit the investment.
In case the company’s drug does in fact reliably preserve lifestyles in severe-to-critical COVID19 patients, subsequently a groundswell of investor support can force the company into new, higher-grade relationships, which would allow for the redemption of elimination as well as debentures of reliance on fly-by-night financings like those described below.
Cytodyn’s sole focus is creating therapies based on a monoclonal antibody called “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort 5 (CCR5)”. This engineered antibody was purchased of Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total cost of acquisition amounts to ten dolars million plus a 5 % net royalty on business revenue.
The drug was acquired on the first promise of its as an HIV treatment, for which continued research and development by Cytodyn has highlighted the potential to reduce regular drug cocktails with assortment pills right into a single monthly injection, in some cases, with 0 adverse reactions. To particular date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team 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 feature disorder which afflicts up to twelve % of the US public, and up to twenty six % globally.
But the real emergent and likely transformational application for leronlimab, as I have said at the beginning, (which is already getting branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 that precludes the Sequential Organ Failure in fatal cases of COVID infections.
Leronlimab apparently blocks the CCR5 receptor from over-responding to the virus and launching the today household-word “cytokine storm”. Some proportion of individuals evidently return from the brink following 2 treatments (and in some cases, 1 treatment) of leronlimab, even when intubated.
The company completed enrollment of a phase 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 media release.
This trial phase concluded on January 12 ish, and if the outcomes are positive, this can make leronlimab a top therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are presently spreading are surely lending optimism for a normalization of modern culture by mid 2021, the surging global rates of contamination suggest the immediate future is today overwhelming health care systems around the world as a lot more people require ability to access Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan returned contained March of 2020, the serious interest of his for the prospects of the drug’s effectiveness was evident.
It was before the now raging second wave had gathered steam, and he was then discovering patients which were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.
At the time, however,, this little independent biotech without any significant funding along with a decidedly unhappy public listing on the naked short-sellers’ fantasy OTC marketplace was getting ready to put on for a listing on NASDAQ, as well as the deck was stacked from it.
Full Disclosure: I posses 10,000 shares at an average expense of $6.23
Even though the world concentrates breathlessly on the optimism for the latest 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 apparently flexible drug. For them, a vaccine is pretty much pointless.
This drug has “blockbuster potential” authored all over it.
With 394 clients enrolled with the Phase 2b/3 trial as of December sixteen, along with initially data expected this week, a demonstrable consistency in the information will capture the world’s interest in probably the most profound way. Short sellers might be swept aside (at minimum temporarily) as the company’s brand new share priced amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses prepared for sale now, with an additional 2.5 huge number of purchased for each of 2021 and 2022 in a manufacturing arrangement with Samsung, as per its CEO.
really if leronlimab/PRO 140/Vyrologix is very great, how come the stock’s been stuck in sub-1dolar1 five penny stock purgatory for such a long time?
The fast remedy is “OTC”.
Apart from struggling with a share price under $3, the company has not been in a position to meet and maintain some different quantitative prerequisites, including good shareholders’ equity of at least five dolars million.
But in the NASDAQ community, one can find non quantifiable behaviours by businesses that can cause slow downs to NASDAQ listings. Overtly advertising communications are actually among such criteria that won’t ever cause a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has also not been able to access capital under traditional ways, thanks to its being listed on the OTC, in addition to therefore un attractive on that basis alone to white colored shoe firms.
And so, they’ve been lowered to accepting shareholder hostile OID debentures with unsightly sales terms that generate a short-seller’s stormy dream.
In November, they coppied 28.5 zillion out of Streeterville Capital of which only twenty five dolars million was given to the company; $3.4 zillion would be the discount the Streeterville pockets, and $100k is actually set aside to protect the costs. Streeterville is linked with Illiad Trading and Research, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been referred to as a “legendary so called poisonous lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the deal, Cytodyn must pay back again $7.5 million each month. If they don’t have the cash, they spend inside stock; many not long ago, within a conversion cost of $3.40 a share.
Now just think about if you’re an opportunistic low rent lender and you’ve gained an assured 2.2 million shares coming the way of yours in the very first week of each month. Any price above the conversion price is pure profit. Remember – this guy is not an investor; he is a lender.
He’s not operating on the hope that Cytodyn stock might go parabolic if leronlimab is deemed a remedy for ARDS; his online business model is limiting risk and maximize upside through discounted conversion of share.
This is the quick seller’s wet dream I am speaking about. Not merely is the lender enticed to go brief, but some short trading bucket dealer in town who are able to fog a mirror and read an EDGAR filing know that every month, like clockwork, there’s going to be 2 million+ shares striking the bid down to $3.40.
The SEC is not impressed, additionally, on September 3, 2020, filed a criticism.
The Securities in addition to the Exchange Commission nowadays filed charges from John M. Fife of Companies and Chicago he controls for obtaining as well as marketing more than twenty one billion shares of penny stock without the need of registering to be a securities dealer with the SEC.
The SEC’s criticism, alleges that in between 2015 as well as 2020, Fife, as well as the businesses of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co-Investment, LLC, routinely involved in the company of purchasing convertible paperwork at penny stock issuers, converting these 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 as well as the companies of his engaged in around 250 sports convertible transactions with about 135 issuers, sold more than 21 billion newly-issued penny stock shares to the industry, and obtained greater than $61 million in earnings.
Streeterville Capital isn’t mentioned as an entity of the complaint. Which hints that it was likely used by Cytodyn and Fife to avoid detection by the SEC that this same plan was being perpetrated on Cytodyn within the time of the complaint of its.
But that’s not the sole reason the stock cannot preserve any upward momentum.
The company has been offering stock privately at ridiculously minimal prices, to the position where by one wonders just that exactly are the blessed winners of what requires free millions of dollars?
Additionally, starting inside the month of November 2020 as well as for every one of the following five (five) calendar days thereafter, the Company is actually obliged to cut down the outstanding sense of balance belonging to the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes are going to be credited toward the payment 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 handling for excessively promotional communications with shareholders. During an investor webcast on January 5th, the business played a number of audio testimonials from people using PRO 140 for HIV treatment, backed by tear jerking music, and replete with emotional language devoid of data.
Even worse, the company’s phone number at the bottom part of press releases includes an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one is actually a “valid extension” according to the automatic phone system.
That is the kind of approach that the FDA and SEC view unfavourably, and it 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 interview, and therefore using the story coming out less than only these ill-advised publicity stunts, shorts are actually attracted, and huge money investors, alienated.
But think of this specific “management discount” as the opportunity to buy a sizable job (should someone be so inclined) contained what could really well prove to be, in a situation of weeks, as the top therapy for severe COVID19 related illness.
I expect the data in the trial now concluded for only such a sign can release the organization into a whole new valuation altitude that will permit it to overcome these shortfalls.
Average trading volume is constant above six million shares one day, and before the tail end of this week, we’ll know precisely how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the most severe of COVID nineteen. In case the outcomes are good, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)