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 subscribers from our 1st feature back in April this year. Billions have been invested straight into hundreds of biotechs all competing to produce a medicine or therapy for serious COVID-19 instances that result in death, and also none have succeeded. Except for Cytodyn, when early indications are verified in the present trial now underway.
But right after a deep dive on the business’s financial claims as well as SEC filings, a picture emerges of company management working with a “toxic lender” to direct seriously discounted shares to the lender regularly. An investment in Cytodyn is a strictly speculative bet on my part, and when the expected upward price movement doesn’t occur after results of the company’s phase 2b/3 trial for severe-to-critical COVID 19, I will exit the investment.
In case the company’s drug does actually reliably save lifestyles in danger of severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance could drive the organization into completely new, higher grade relationships, which would allow for the redemption of elimination and debentures of reliance on fly-by-night financings for instance those described below.
Cytodyn’s sole focus is actually creating remedies based on a monoclonal antibody known as “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort five (CCR5)”. This engineered antibody was acquired from Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), again in 2012.
Total cost of acquisition amounts to $10 million and a five % net royalty on commercial sales.
The drug was acquired on the first promise of its as an HIV treatment, for which continued research and development by Cytodyn has shown the capability to reduce regular drug cocktails with myriad pills right into a specific monthly injection, sometimes, with 0 negative effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific team has discovered the antibody’s impact on the CCR5 receptor has incredibly optimistic therapeutic implications for everything from some solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function condition that afflicts up to 12 percent of the US population, and up to 26 % globally.
But the real emergent and potentially transformational application for leronlimab, as I have said at the beginning, (which is already getting branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID-19 that precludes the Sequential Organ Failure wearing fatal cases of COVID infections.
Leronlimab evidently prevents the CCR5 receptor from over-responding to the virus and launching the now household word “cytokine storm”. Some proportion of clients evidently return from the brink following 2 treatments (and in a number of instances, one 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 clients with severe-to-critical COVID 19 indications is 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 outcomes are good, this can make leronlimab a premier therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines that are now diffusing are definitely lending hope for a normalization of society by mid-2021, the surging worldwide rates of contamination mean the immediate future is today overwhelming health care systems throughout the world as more and more people require utilization of Intensive Care Unit hospitalization.
During the first interview of mine with Dr. Nader Pourhassan returned in March of 2020, the extreme passion of his for the prospects of the drug’s effectiveness was evident.
This was before the now raging second wave had gathered steam, and also he was then noticing patients that were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nonetheless,, this little independent biotech without any significant funding and a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting able to apply for a listing on NASDAQ, as well as the deck was stacked from it.
Full Disclosure: I have 10,000 shares at an average price of $6.23
While the world focuses breathlessly on the hope for a brand new vaccine to restore their social liberties, the 10-ish fraction of COVID infectees who descend into the cytokine storm driven ARDS actually have their day saved by this seemingly versatile drug. For them, a vaccine is basically pointless.
This drug has “blockbuster potential” written all over it.
With 394 clients enrolled with the Phase 2b/3 trial as of December 16, in addition to initially information expected this week, any demonstrable consistency in the data is going to record the world’s interest in essentially the most profound way. Quick sellers might be swept aside (at minimum temporarily) while the company’s brand new share price levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses all set for sale right now, with an additional 2.5 huge number of ordered for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, based on its CEO.
really if leronlimab/PRO 140/Vyrologix is so great, why the stock’s been stuck in sub-1dolar1 five penny stock purgatory for so very long?
The speedy solution is “OTC”.
Apart from struggling with a share price under $3, the company hasn’t been in a position to meet and keep some other quantitative requirements, including good shareholders’ equity with a minimum of five dolars million.
But in the NASDAQ world, one can find non-quantifiable behaviours by companies that cause waiting times to NASDAQ listings. Overtly promotional communications are among such type of criteria which won’t ever cause a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn has also not been in a position to access capital under standard means, thanks to its being mentioned on the OTC, along with consequently un attractive on that basis alone to white colored shoe firms.
Thus, they’ve been reduced to accepting shareholder hostile OID debentures with ugly sales terms that generate a short-seller’s wet dream.
In November, they borrowed 28.5 huge number of out of Streeterville Capital of which just twenty five dolars million was given to the company; $3.4 zillion will be the discount the Streeterville sections, and $100k is put aside to protect the expenses. Streeterville is related 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 poisonous lender”, by rival studies firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the deal, Cytodyn needs to pay back again $7.5 million a month. If they don’t have the cash, they spend in stock; many recently, within a conversion price of $3.40 a share.
These days just think about if you’re an opportunistic low rent lender and you have got a certain 2.2 million shares coming your way in the very first week of every month. Any price above the sales expenditure is pure profit. Remember – this guy is not an investor; he is a lender.
He’s not operating on the expectation that Cytodyn stock may go parabolic if leronlimab is deemed a cure for ARDS; his business model is to limit risk and optimize upside via affordable conversion of share.
This is the quick seller’s wet dream I am discussing. Not merely would be the lender enticed to go brief, but some short trading pail repair shop in town who could fog a mirror and read an EDGAR filing understand that each month, like clockwork, there’s going to be 2 million+ shares hitting the bid down to $3.40.
The SEC is not impressed, additionally, on September three, 2020, filed a complaint.
The Securities and Exchange Commission these days filed charges from John M. Fife of Chicago and Companies he controls for obtaining as well as marketing more than 21 billion shares of penny inventory without registering to be a securities dealer while using the SEC.
The SEC’s criticism, alleges this in between 2015 as well as 2020, Fife, as well as his businesses, Chicago Venture Partners, L.P., Iliad Research in addition to the Trading, L.P., St. George Investments LLC, Tonaquint, Inc., in addition to the Typenex Co-Investment, LLC, regularly engaged in the small business of buying sports convertible paperwork from penny stock issuers, transforming the notes into shares of stock at a big discount from the market price, and selling the freshly issued shares to the market at a significant profit. The SEC alleges that Fife and his companies interested in over 250 convertible transactions with about 135 issuers, sold more than twenty one billion newly issued penny stock shares to the market, and obtained more than sixty one dolars million in profits.
Streeterville Capital isn’t stated as an entity of the complaint. Which implies that it was likely used by Cytodyn and Fife to avoid detection by the SEC 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 keep any upward momentum.
The company has been selling stock privately from ridiculously minimal prices, to the stage where by one wonders just that exactly are the lucky winners of what amounts to no cost millions of dollars?
In addition, starting within the month of November 2020 and for each of the following 5 (5) calendar months thereafter, the Company is actually required to bring down the excellent sense of balance with the Note by $7,500,000 a 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 are not be subject to the fifteen % prepayment premium.
Additionally detracting from the business’s shine is the propensity of handling for endlessly promotional communications with shareholders. During an investor webcast on January 5th, the company played a compilation of sound testimonials from patients using PRO 140 for HIV therapy, backed by tear-jerking music, and replete with emotional language devoid of information.
Even worse, the company’s mobile phone number at the bottom of press releases includes an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is actually a “valid extension” according to the automatic system.
That is the kind of approach that the FDA and SEC view unfavourably, and is likely at least in part the reason for the continued underdog status of theirs at both agencies.
The company also has come to be unresponsive to requests for interviews, and so while using story coming out less than only these ill-advised publicity stunts, shorts are actually attracted, and big cash investors, alienated.
But think of this particular “management discount” as the ability to purchase a sizable position (should a person be so inclined) contained what could really well turn out to be, in a question of weeks, given that the top treatment for serious COVID19 related illness.
I expect the information in the trial now concluded for only such an indication can release the company into a whole new valuation altitude that will allow it to overcome these shortfalls.
Average trading volume is steady above six million shares 1 day, and before the conclusion of this week, we will learn precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the worst of COVID 19. If the results are positive, this may be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)