Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug designer, has already delivered a win for Wealthpress members from our 1st feature returned in April this season. Billions have been invested straight into countless biotechs all competing to produce a cure or perhaps therapy for serious COVID-19 instances that cause death, and none have been successful. Except Cytodyn, if early indications are established in the present trial now underway.
But after a serious jump on the company’s financial claims and SEC filings, a picture emerges of company management functioning having a “toxic lender” to direct severely discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on the part of mine, and if the expected upward price movement doesn’t occur following results of the company’s stage 2b/3 trial for severe-to-critical COVID-19, I will exit the investment.
In case the business’s drug does in fact reliably preserve life in danger of severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance can drive the company into new, higher grade human relationships, which would permit for the redemption of debentures as well as elimination of reliance on fly-by-night financings for instance those discussed below.
Cytodyn’s sole focus is actually creating treatments based on a monoclonal antibody called “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)”. This particular 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 and a five % net royalty on business sales.
The drug was acquired on its early promise as an HIV treatment, for which continued research as well as development by Cytodyn has demonstrated the potential to reduce regular drug cocktails with myriad pills right into a specific monthly injection, in some cases, with 0 negative effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has discovered the antibody’s impact on the CCR5 receptor has incredibly positive therapeutic implications for everything out of certain stable tumours to NASH (Non alcoholic steatohepatitis), the liver function disorder that afflicts up to 12 % of the US public, and up to twenty six % globally.
But the real emergent and potentially transformational application for leronlimab, as I have said at the start, (which is already 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 situations of COVID infections.
Leronlimab apparently prevents the CCR5 receptor from over responding to the virus and also launching the now household-word “cytokine storm”. Some proportion of clients apparently return from the brink after 2 treatments (and in a number of instances, one treatment) of leronlimab, even if intubated.
The company completed enrollment of a phase 2b/3 trial on December fifteen to “evaluate the efficacy as well as safety of leronlimab for clients 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 media release.
This trial period concluded on January 12 ish, and if the outcomes are good, this can make leronlimab a premier remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are presently diffusing are definitely lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of infection suggest the immediate future is today overwhelming health care systems throughout the world as a lot more people require ability to access Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan returned contained March of 2020, the extreme passion of his for the prospects of the drug’s effectiveness was apparent.
This was prior to the now raging second trend had gathered vapor, and also he was then discovering patients that were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.
Within the time, even thought, this little independent biotech without any major funding along with a decidedly unhappy public listing on the naked short-sellers’ fantasy OTC marketplace was getting prepared to utilize for a listing on NASDAQ, and the deck was stacked from 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 their social liberties, the 10 ish portion of COVID infectees who descend into the cytokine storm driven ARDS actually have their lives saved by this seemingly flexible drug. To them, a vaccine is basically pointless.
This drug has “blockbuster potential” written all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December 16, and first data expected this week, a demonstrable consistency in the information will capture the world’s focus in essentially the most profound way. Short sellers might be swept aside (at minimum temporarily) simply because company’s new share price levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses ready for sale right now, with an additional 2.5 huge number of ordered for each of 2021 plus 2022 in a manufacturing arrangement with Samsung, according to its CEO.
so if leronlimab/PRO 140/Vyrologix is very great, how come the stock’s been stuck in sub-1dolar1 5 penny stock purgatory for so long?
The quick 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 good shareholders’ equity that is at least $5 million.
But in the NASDAQ community, you can find non-quantifiable behaviours by companies that cause slow downs to NASDAQ listings. Overtly promotional communications are among such type of criteria that won’t ever cause a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has also not been equipped to access capital under conventional ways, because of its being mentioned on the OTC, and therefore un-attractive on that foundation alone to white colored shoe firms.
So, they’ve been cut down to accepting shareholder hostile OID debentures with unsightly sales terms that create a short-seller’s stormy dream.
In November, they coppied 28.5 zillion coming from Streeterville Capital of which just twenty five dolars million was given to the company; $3.4 huge number of will be the discount the Streeterville pockets, and $100k is actually put aside to cover the expenses. Streeterville is actually associated with Illiad Research and Trading, which is controlled 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 must pay again $7.5 million each month. In case they don’t possess the cash, they spend in stock; many recently, at a conversion price of $3.40 a share.
These days consider if you are an opportunistic low rent lender and you’ve got an assured 2.2 million shares coming the way of yours in the earliest week of every month. Any cost above the sales price is pure profit. Remember – this guy isn’t an investor; he is a lender.
He is not operating on the hope that Cytodyn stock may go parabolic if leronlimab is deemed a remedy for ARDS; his online business model is to limit risk and maximize upside through affordable conversion of share.
This’s the quick seller’s wet dream I am talking about. Not only is definitely the lender enticed to go short, but any short-trading container dealer in town who are able to fog a mirror and examine an EDGAR filing realize that every month, like clockwork, there is going to be 2 million+ shares hitting the bid down to $3.40.
The SEC isn’t impressed, and on September three, 2020, filed a complaint.
The Securities and Exchange Commission today filed charges against John M. Fife of Chicago and Companies he controls for acquiring and promoting more than 21 billion shares of penny inventory without registering to be a securities dealer while using 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 and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co-Investment, LLC, routinely engaged in the small business of buying sports convertible notes at penny stock issuers, transforming the notes into shares of inventory at a big discount from the market cost, and selling the freshly issued shares into the marketplace at a substantial profit. The SEC alleges that Fife and the companies of his engaged in more than 250 convertible transactions with about 135 issuers, sold greater than twenty one billion newly issued penny stock shares into the industry, and obtained more than $61 million in profits.
Streeterville Capital is not stated as an entity in the complaint. Which suggests it was likely used by Fife and Cytodyn to avoid detection by the SEC this same scheme was being perpetrated on Cytodyn at the time of the complaint of its.
But that’s not the only reason the stock cannot preserve some upward momentum.
The company has been selling stock privately at ridiculously minimal prices, to the stage where one wonders just that exactly are the lucky winners of what amounts to free millions of dollars?
In addition, starting inside the month of November 2020 and for each of the next 5 (five) calendar days thereafter, the Company is required to lower the excellent sense of balance with the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will be credited to the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % prepayment premium.
Also detracting from the company’s gloss is the propensity of management for excessively promotional communications with shareholders. During an investor webcast on January 5th, the company played a series of audio testimonials from individuals using PRO 140 for HIV treatment, backed by tear jerking music, and then replete with emotional language devoid of information.
Even worse, the company’s mobile phone number at the bottom part of press releases comes with an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one is actually a “valid extension” according to the automated system.
That’s the approach type that the SEC and FDA view unfavourably, and 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 interviews, and thus while using story coming out less than only these ill-advised publicity stunts, shorts are attracted, and big cash investors, alienated.
But think of this particular “management discount” as the chance to purchase a sizable job (should someone be so inclined) in what might very well turn out to be, in a matter of weeks, as the leading therapy for serious COVID19 related illness.
I expect the data from your trial now concluded for just such a sign might launch the organization into a whole new valuation altitude that will enable it to overcome these shortfalls.
Average trading volume is actually steady above 6 million shares one day, and right before the end of this week, we will know precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the most severe of COVID 19. If the outcomes are good, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)