Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug developer, has already delivered a win for Wealthpress subscribers from our 1st feature returned in April this season. Billions have been invested straight into a huge selection of biotechs all competing to make a medicine or maybe therapy for serious COVID 19 situations that result in death, and also none have been successful. Except for Cytodyn, when early indications are established in the current trial now underway.
But after a deep jump on the company’s financial statements and SEC filings, an image emerges of business control working with a “toxic lender” to funnel severely discounted shares to the lender frequently. An investment in Cytodyn is a strictly speculative bet on my part, of course, if the expected upward price movement does not appear after results of the company’s phase 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
If the business’s drug does actually reliably preserve life in danger of severe-to-critical COVID19 individuals, subsequently a groundswell of investor assistance could drive the business into new, higher grade human relationships, which would allow for the redemption of debentures as well as elimination of reliance on fly-by-night financings like those described below.
Cytodyn’s sole focus is creating remedies used on a monoclonal antibody known as “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor type 5 (CCR5)”. This engineered antibody was obtained from 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 and a five % net royalty on business revenue.
The drug was acquired on its early promise as an HIV therapy, for which continued development as well as research by Cytodyn has demonstrated the potential to reduce regular drug cocktails with myriad pills into a single monthly injection, in some instances, with 0 negative effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has found the antibody’s influence on the CCR5 receptor has incredibly positive therapeutic implications for everything out of some stable tumours to NASH (Non alcoholic steatohepatitis), the liver feature condition which afflicts up to 12 percent of the US population, and up to twenty six % globally.
But the real emergent also likely transformational application for leronlimab, as mentioned at the start, (which is currently being branded as Vyrologix by Cytodyn), is designed for the Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 which precludes the Sequential Organ Failure wearing fatal situations of COVID infections.
Leronlimab apparently blocks the CCR5 receptor from over-responding to the virus and launching the now household-word “cytokine storm”. Some proportion of individuals evidently return from the brink after two treatments (and in a number of cases, 1 treatment) of leronlimab, even if intubated.
The company finished enrollment of a stage 2b/3 trial on December fifteen to “evaluate the efficacy and 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,” according to the company’s press release.
This trial period concluded on January 12-ish, and if the results are good, this can make leronlimab a premier therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines that are presently dispersing are surely lending optimism for a normalization of society by mid-2021, the surging worldwide rates of disease suggest the immediate future is already overwhelming health care systems across the world as a lot more individuals require access to Intensive Care Unit hospitalization.
During the first job interview of mine with Dr. Nader Pourhassan back contained March of 2020, the extreme eagerness of his for the prospects of the drug’s effectiveness was apparent.
This was before the currently raging second wave had gathered steam, as well as he was then seeing patients which were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.
Within the time, however,, this small independent biotech without any significant funding and a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting ready to utilize for a listing on NASDAQ, along with the deck was stacked against it.
Full Disclosure: I own 10,000 shares at an average price of $6.23
Although the planet focuses breathlessly on the optimism for the latest vaccine to regain the social liberties of theirs, the 10 ish portion of COVID infectees who descend into the cytokine storm-driven ARDS actually have their day saved by this apparently flexible drug. To them, a vaccine is literally pointless.
This particular drug has “blockbuster potential” authored all over it.
With 394 clients enrolled inside the Phase 2b/3 trial as of December sixteen, along with initially data expected this week, any demonstrable consistency in the details is going to capture the world’s attention in likely the most profound way. Short sellers may be swept apart (at least temporarily) while the business’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 extra 2.5 zillion purchased for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, as per its CEO.
really if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been trapped in sub-1dolar1 five penny stock purgatory for such a long time?
The quick remedy is “OTC”.
Apart from dealing with a share price under three dolars, the company hasn’t been in a position to meet and keep certain different quantitative prerequisites, like good shareholders’ equity with a minimum of five dolars million.
But in the NASDAQ world, one can find non quantifiable behaviours by businesses that cause delays to NASDAQ listings. Overtly promotional communications are actually among such type of criteria which will never lead to a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has also not been equipped to access capital under standard means, because of its being mentioned on the OTC, and thus un attractive on that basis alone to white shoe firms.
And so, they’ve been lowered to accepting shareholder hostile OID debentures with unsightly conversion terms that generate a short-seller’s damp 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 million would be the discount the Streeterville areas, and $100k is reserved to cover the expenses. Streeterville is linked with Illiad Trading and Research, which is controlled by John Fife of Chicago Ventures Inc. Iliad has been called a “legendary so-called poisonous lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the deal, Cytodyn has got to pay back $7.5 million per month. In case they don’t possess the cash, they pay inside stock; many lately, at a conversion price of $3.40 a share.
These days just think about if you are an opportunistic low rent lender and you’ve received a certain 2.2 million shares coming your way in the very first week of each month. Any price above the conversion expenditure is pure profit. Remember – this guy isn’t an investor; he is a lender.
He is not operating on the expectation that Cytodyn stock might go parabolic if leronlimab is deemed a cure for ARDS; his online business model is to limit risk and maximize upside via discounted conversion of share.
This is the brief seller’s wet dream I’m discussing. Not merely would be the lender enticed to go brief, but some short-trading bucket dealer in town who are able to fog a mirror and go through an EDGAR filing know that each month, like clockwork, there is going to be two million+ shares impacting the bid down to $3.40.
The SEC is not impressed, and on September three, 2020, filed a criticism.
The Securities and Exchange Commission nowadays filed charges against John M. Fife of Companies and Chicago he controls for obtaining as well as marketing much more than 21 billion shares of penny inventory without the need of registering to be a securities dealer while using the SEC.
The SEC’s criticism, alleges that in between 2015 as well as 2020, Fife, and also his businesses, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co Investment, LLC, routinely involved in the company of purchasing sports convertible paperwork from penny stock issuers, transforming the notes into shares of inventory at a large discount from the market price, and offering the freshly issued shares into the marketplace at a sizable profit. The SEC alleges which Fife and his companies engaged in over 250 sports convertible transactions with approximately 135 issuers, sold greater than twenty one billion newly-issued penny stock shares to the industry, and obtained more than sixty one dolars million in earnings.
Streeterville Capital is not mentioned as an entity of the complaint. Which suggests that it was probably used by Fife and Cytodyn to stay away from detection by the SEC that this same plan was getting perpetrated on Cytodyn at the time of its complaint.
But that’s not the only reason the stock can’t observe any upward momentum.
The company has been selling stock privately at ridiculously minimal prices, to the position where by one wonders just who exactly are the fortunate winners of what requires free millions of dollars?
In addition, starting inside the month of November 2020 and for each of the second 5 (five) calendar days thereafter, the Company is actually required to bring down the exceptional sense of balance belonging to the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will be acknowledged to the transaction of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the 15 % prepayment premium.
Also detracting from the company’s gloss is actually the propensity of managing for endlessly marketing communications with shareholders. During an investor webcast on January 5th, the business played a compilation of audio testimonials from clients applying PRO 140 for HIV therapy, backed by tear-jerking music, and replete with emotional language devoid of information.
Worse, the company’s telephone number at the bottom part of press releases has an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is actually a “valid extension” in accordance with the automatic system.
That is the approach type that the SEC and FDA view unfavourably, and is likely at least in part the reason behind the continued underdog status of theirs at both agencies.
The company has also become unresponsive to requests for interviews, and thus while using story coming out under merely 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 position (should one be so inclined) in what could really well turn out to be, in a matter of weeks, given that the best treatment for severe COVID19 associated illness.
I expect the data from the trial now concluded for only such a sign could release the organization into a whole new valuation altitude that will allow it to get over these shortfalls.
Average trading volume is continuous above six million shares one day, and right before the end of this week, we will learn exactly how efficient leronlimab/PRO 140/Vyrologix is for saving lives from the most severe of COVID nineteen. In case the outcomes are positive, this could be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)