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 members from our 1st feature returned in April this season. Billions have been invested into hundreds of biotechs all competing to create a cure or therapy for severe COVID-19 situations which cause death, and also none have been successful. Except for Cytodyn, when early indications are verified in the current trial now underway.
But after a serious plunge on the company’s monetary statements and SEC filings, a picture emerges of company control working who have a “toxic lender” to direct seriously discounted shares to the lender frequently. An investment in Cytodyn is a purely speculative bet on the part of mine, of course, if the expected upward price movement doesn’t manifest following results of the company’s period 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
If the company’s drug does in fact reliably save lifestyles to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor support can force the business into new, higher grade relationships, which would allow for the redemption of elimination as well as debentures of reliance on fly-by-night financings such as those discussed below.
Cytodyn’s sole focus is creating remedies used on a monoclonal antibody called “leronlimab”, technically referred to 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 revenue.
The drug was acquired on the early promise of its as an HIV treatment, for which continued research as well as development by Cytodyn has highlighted the capability to reduce daily drug cocktails with myriad pills right into a single monthly injection, sometimes, with 0 unintended effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific team has found the antibody’s effect on the CCR5 receptor has extremely optimistic therapeutic implications for everything out of some stable tumours to NASH (Non-alcoholic steatohepatitis), the liver feature ailment that afflicts up to 12 % of the US public, and up to twenty six % globally.
But the real emergent and likely transformational program for leronlimab, as I have said at the beginning, (which is currently getting branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID-19 which precludes the Sequential Organ Failure in fatal situations of COVID infections.
Leronlimab it seems that blocks the CCR5 receptor from over-responding to the virus as well as launching the today household-word “cytokine storm”. Some proportion of people apparently return from the brink after two treatments (and in a number of cases, 1 treatment) of leronlimab, even if 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 people with severe-to-critical COVID 19 indications is actually a two-arm, placebo controlled, double blind, randomized, adaptive design multicenter study,” according to the company’s press release.
This trial phase concluded on January 12-ish, and if the results are positive, this can make leronlimab a top treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are now diffusing are certainly lending optimism for a normalization of society by mid 2021, the surging worldwide rates of infection mean the immediate future is right now overwhelming health care systems around the world as increasingly more people call for utilization of Intensive Care Unit hospitalization.
During the first interview of mine with Dr. Nader Pourhassan returned found March of 2020, the extreme passion of his for the prospects of this drug’s effectiveness was apparent.
This was before the now raging second trend had gathered steam, as well as he was then noticing patients that were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, however,, this little independent biotech without big funding along with a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting ready to put on for a listing on NASDAQ, along with the deck was stacked against it.
Full Disclosure: I have 10,000 shares at an average cost of $6.23
While the planet concentrates breathlessly on the hope for the latest vaccine to restore the social liberties of theirs, the 10-ish percentage of COVID infectees who descend into the cytokine storm-driven ARDS actually have their day saved by this seemingly flexible drug. For these people, a vaccine is pretty much pointless.
This particular drug has “blockbuster potential” written all over it.
With 394 clients enrolled with the Phase 2b/3 trial as of December 16, and first information expected this week, any demonstrable consistency in the information will record the world’s interest in the most profound way. Quick sellers might be swept aside (at least temporarily) simply because business’s new share priced amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses ready for sale right now, with an additional 2.5 million ordered for each of 2021 plus 2022 in a manufacturing understanding with Samsung, according to the CEO of its.
really if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been trapped in sub 1dolar1 5 penny stock purgatory for so long?
The fast solution is “OTC”.
Apart from dealing with a share price under three dolars, the company has not been equipped to meet and keep some other quantitative prerequisites, including positive shareholders’ equity that is at least five dolars million.
But in the NASDAQ world, there are non-quantifiable behaviours by companies that create slow downs to NASDAQ listings. Overtly promotional communications are actually among these kinds of criteria that won’t ever cause a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn in addition has not been equipped to access capital under conventional means, thanks to its being listed on the OTC, and consequently un-attractive on that foundation alone to white shoe firms.
Thus, they have been reduced to accepting shareholder hostile OID debentures with unsightly conversion terms that generate a short-seller’s damp dream.
In November, they borrowed 28.5 zillion out of Streeterville Capital of that only $25 million was paid to the company; $3.4 huge number of would be the discount the Streeterville sections, and $100k is put aside to cover the bills. Streeterville is linked with Illiad Research and Trading, that is operated by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so called poisonous lender”, by rival studies firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the deal, Cytodyn has to pay again $7.5 million per month. If they don’t possess the cash, they spend inside stock; most lately, within a conversion cost of $3.40 a share.
These days just think about when you are an opportunistic low-rent lender and you’ve gained a certain 2.2 million shares coming the way of yours in the very first week of every month. Any cost above the sales cost is pure profit. Remember – this guy is not an investor; he is a lender.
He’s not operating on the hope that Cytodyn stock may go parabolic in the event that leronlimab is deemed a cure for ARDS; his business model is limiting risk and maximize upside via affordable transformation of share.
This is the short seller’s wet dream I am talking about. Not only is the lender enticed to go short, but some short-trading bucket dealer in town who could fog a mirror and examine an EDGAR filing understand that each month, like clockwork, there’s going to be 2 million+ shares hitting the bid lowered by to $3.40.
The SEC isn’t impressed, additionally, on September 3, 2020, filed a complaint.
The Securities and Exchange Commission nowadays filed charges from John M. Fife of Companies and Chicago he controls for obtaining as well as selling much more than twenty one billion shares of penny inventory without any registering to be a securities dealer while using the SEC.
The SEC’s complaint, alleges that between 2015 and 2020, Fife, and the companies of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co-Investment, LLC, routinely engaged in the company of buying sports convertible notes from penny stock issuers, transforming these notes into shares of inventory at a major discount from the market price, and offering the newly issued shares into the market at a significant profit. The SEC alleges that Fife and his businesses interested in over 250 sports convertible transactions with about 135 issuers, sold more than twenty one billion newly issued penny stock shares to the market, and obtained greater than $61 million in earnings.
Streeterville Capital is not mentioned as an entity of the complaint. Which implies that it was likely utilized by Cytodyn and Fife to stay away from detection by the SEC this same plan was getting perpetrated on Cytodyn at the time of the complaint of its.
But that’s not the only reason the stock cannot observe some upward momentum.
The company has been selling inventory privately from ridiculously low prices, to the stage where by one wonders just who exactly are the blessed winners of what amounts to no cost millions of dollars?
Furthermore, beginning inside the month of November 2020 as well as for every one of the second five (five) calendar days thereafter, the Company is obligated to cut 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 will be acknowledged to the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the fifteen % prepayment premium.
Likewise detracting from the business’s gloss is actually the propensity of management for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company played a series of sound testimonials from people applying PRO 140 for HIV treatment, backed by tear jerking music, and replete with mental language devoid of information.
Worse, the company’s telephone number at the bottom of press releases has an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one 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 least in part the reason behind the continued underdog status of theirs at both agencies.
The company has additionally turned out to be unresponsive to requests for interview, and so with the story coming out under merely these ill advised publicity stunts, shorts are attracted, and big money investors, alienated.
But think of this specific “management discount” as the opportunity to buy a sizable role (should someone be so inclined) contained what might really well turn out to be, in a situation of weeks, given that the best treatment for serious COVID19 related illness.
I expect the information from the trial now concluded for only such a sign can release the company into a complete new valuation altitude that will allow it to overpower these shortfalls.
Average trading volume is steady above six million shares one day, and before the end of this week, we will know precisely how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the most severe of COVID nineteen. If the outcomes are positive, this can be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)