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 1st feature back in April this year. Billions have been invested directly into hundreds of biotechs all competing to develop a medicine or treatment for severe COVID-19 instances which trigger death, and none have succeeded. Except Cytodyn, if early indications are established in the present trial now underway.
But right after a serious dive on the business’s fiscal statements and SEC filings, an image emerges of company control operating having a “toxic lender” to funnel seriously discounted shares to the lender regularly. An investment in Cytodyn is actually a purely speculative bet on my part, and if the expected upward price movement doesn’t occur after results in the company’s period 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
In case the business’s drug does in fact reliably conserve life in danger of severe-to-critical COVID19 individuals, subsequently a groundswell of investor support can force the organization into completely new, higher-grade relationships, which would permit for the redemption of debentures and elimination of reliance on fly-by-night financings like those described below.
Cytodyn’s sole focus is actually creating therapies used on a monoclonal antibody called “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type five (CCR5)”. This engineered antibody was obtained of Progenics Pharmaceuticals as “PRO 140”, a recently-acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total expense of acquisition amounts to ten dolars million plus a five % net royalty on business revenue.
The drug was acquired on the early promise of its as an HIV treatment, for which continued development as well as research by Cytodyn has demonstrated the ability to reduce daily drug cocktails with myriad pills right into a single monthly injection, sometimes, with 0 unwanted side 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 impact on the CCR5 receptor has extremely positive therapeutic implications for everything from some stable tumours to NASH (Non-alcoholic steatohepatitis), the liver feature disorder that afflicts up to twelve % of the US population, and up to 26 % globally.
But the real emergent also likely transformational application for leronlimab, as mentioned at the beginning, (which is now getting branded as Vyrologix by Cytodyn), is designed for the Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 which precludes the Sequential Organ Failure in fatal instances of COVID infections.
Leronlimab evidently blocks the CCR5 receptor from over-responding to the virus as well as launching the now household word “cytokine storm”. Some proportion of clients apparently return from the brink after two treatments (and in some cases, one treatment) of leronlimab, even when intubated.
The company completed enrollment of a stage 2b/3 trial on December 15 to “evaluate the efficacy as well as safety of leronlimab for patients with severe-to-critical COVID 19 indications is actually a two-arm, randomized, double blind, placebo controlled, adaptive style multicenter study,” according to the company’s media release.
This trial period concluded on January 12 ish, of course, if the results are good, this can make leronlimab a top therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are currently dispersing are certainly lending hope for a normalization of modern society by mid 2021, the surging worldwide rates of illness suggest the immediate future is right now overwhelming health care systems throughout the world as increasingly more individuals call for ability to access Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan back contained March of 2020, his extreme eagerness for the prospects of the drug’s effectiveness was apparent.
This was prior to the now raging second trend had gathered steam, as well as he was then noticing individuals which were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nonetheless,, this small independent biotech without major 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 posses 10,000 shares at an average expense of $6.23
Even though the planet focuses breathlessly on the hope for a new vaccine to regain the social 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. For them, a vaccine is pretty much useless.
This particular drug has “blockbuster potential” written all over it.
With 394 people enrolled inside the Phase 2b/3 trial as of December sixteen, in addition to first data expected this week, any demonstrable consistency in the data is going to record the world’s attention in the most profound way. Quick sellers could be swept aside (at least temporarily) as the company’s brand new share price 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 ordered for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, according to the CEO of its.
so if leronlimab/PRO 140/Vyrologix is very great, how come the stock’s been stuck in sub 1dolar1 5 penny stock purgatory for such a long time?
The fast remedy is “OTC”.
Besides dealing with a share price under $3, the company hasn’t been able to meet and maintain certain different quantitative requirements, like good shareholders’ equity of at least $5 million.
But in the NASDAQ community, you can find non quantifiable behaviours by companies that create waiting times to NASDAQ listings. Overtly advertising communications are among these kinds of criteria which won’t ever lead to a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn has additionally not been in a position to access capital under conventional means, thanks to its being listed on the OTC, and thus un attractive on that foundation alone to white colored shoe firms.
So, they have been lowered to accepting shareholder-hostile OID debentures with ugly conversion terms that produce a short-seller’s wet dream.
In November, they coppied 28.5 million out of Streeterville Capital of that just twenty five dolars million was given to the company; $3.4 huge number of is the discount the Streeterville areas, and $100k is set aside to protect the expenses. Streeterville is linked with Illiad Research and Trading, which is controlled by John Fife of Chicago Ventures Inc. Iliad has been referred to as a “legendary so called toxic lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the price, Cytodyn wants to pay again $7.5 million per month. If they don’t possess the cash, they pay in stock; the majority of not long ago, at a conversion cost of $3.40 a share.
These days just think about when you’re an opportunistic low rent lender and you’ve gained a certain 2.2 million shares coming your way in the earliest week of every month. Any price tag above the sales expenditure is pure profit. Remember – this guy is not an investor; he’s a lender.
He’s not operating on the hope that Cytodyn stock may go parabolic if leronlimab is deemed a cure for ARDS; the online business model of his is to limit risk and maximize upside through affordable conversion of share.
This’s the short seller’s wet dream I’m talking about. Not merely is the lender enticed to go brief, but some short-trading bucket shop in town who can fog a mirror and examine an EDGAR filing understand that every month, like clockwork, there’s going to be 2 million+ shares impacting the bid down to $3.40.
The SEC is not impressed, and on September 3, 2020, filed a criticism.
The Securities as well as Exchange Commission today 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 to be a securities dealer with the SEC.
The SEC’s complaint, alleges this between 2015 and 2020, Fife, and also the businesses of his, Chicago Venture Partners, L.P., Iliad Research in addition to the Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co Investment, LLC, frequently involved in the small business of purchasing convertible paperwork from penny stock issuers, converting the notes into shares of stock at a big discount from the market cost, and selling the newly issued shares to the market at a substantial profit. The SEC alleges that Fife and the businesses of his engaged in around 250 convertible transactions with approximately 135 issuers, sold more than twenty one billion newly issued penny stock shares to the market, and obtained greater than $61 million in profits.
Streeterville Capital isn’t mentioned as an entity in the complaint. Which hints that it was probably applied by Fife as well as Cytodyn to stay away from detection by the SEC that this very 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 keep any upward momentum.
The company has been offering inventory privately at ridiculously low prices, to the position where by one wonders just that exactly are the fortunate winners of what requires free millions of dollars?
Additionally, starting inside the month of November 2020 and for every one of the second five (five) calendar days thereafter, the Company is actually obligated to bring down the excellent balance belonging to the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes are going to be acknowledged to the transaction of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the fifteen % prepayment premium.
Additionally detracting from the business’s gloss is actually the propensity of handling for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company had 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 information.
Worse, the company’s cell phone number at the bottom level of press releases includes an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one is a “valid extension” based on the automated system.
That is the type of approach that the FDA and SEC view unfavourably, and it is likely at least in part the reason behind their continued underdog status at both agencies.
The company has additionally turned out to be unresponsive to requests for interview, and thus using the story coming out less than merely 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 purchase a sizable position (should a person be so inclined) found what may very well prove to be, in a situation of weeks, since the top treatment for severe COVID19 related illness.
I expect the details from the trial now concluded for just such a sign might release the organization into a complete new valuation altitude that will permit it to get over these shortfalls.
Average trading volume is actually steady above 6 million shares one day, and right before the end of this week, we’ll find out precisely how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the most severe of COVID nineteen. In case the results are positive, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)