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 members from our first feature back in April this season. Billions have been invested straight into hundreds of biotechs all competing to develop a medicine or perhaps therapy for severe COVID 19 instances that cause death, and also none have been successful. Except for Cytodyn, if early indications are verified in the present trial now underway.
But right after a serious dive on the business’s financial claims as well as SEC filings, an image emerges of business control operating who have a “toxic lender” to funnel severely discounted shares to the lender frequently. An investment in Cytodyn is a strictly speculative bet on the part of mine, of course, if the expected upward price movement does not appear after results in the company’s stage 2b/3 trial for severe-to-critical COVID 19, I am going to exit the investment.
If the company’s drug does actually reliably spend less life to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance may push the business into new, higher-grade relationships, which would allow for the redemption of elimination and debentures of reliance on fly-by-night financings like those discussed below.
Cytodyn’s sole focus is actually 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 engineered antibody was purchased 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 and a five % net royalty on business revenue.
The drug was acquired on its early promise as an HIV therapy, for which continued development and research by Cytodyn has shown the potential to reduce regular drug cocktails with assortment pills right into an individual monthly injection, in some cases, with zero side effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific staff has found the antibody’s effect on the CCR5 receptor has extremely optimistic therapeutic implications for everything from some stable tumours to NASH (Non-alcoholic steatohepatitis), the liver feature ailment that afflicts up to 12 % of the US population, and up to twenty six % globally.
But the real emergent and likely transformational application for leronlimab, as stated 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 that precludes the Sequential Organ Failure wearing fatal situations of COVID infections.
Leronlimab evidently blocks the CCR5 receptor from over-responding to the virus as well as launching the today household word “cytokine storm”. Some proportion of patients obviously return from the brink following 2 treatments (and in some cases, one treatment) of leronlimab, still if intubated.
The company completed enrollment of a stage 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 design and style multicenter study,” according to the company’s press release.
This trial phase concluded on January 12 ish, of course, if the outcomes are positive, this can make leronlimab a premier treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are currently circulating are definitely lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of contamination mean the immediate future is right now overwhelming health care systems throughout the world as increasingly more folks call for access to Intensive Care Unit hospitalization.
During the 1st job interview of mine with Dr. Nader Pourhassan returned in March of 2020, the extreme eagerness of his for the prospects of the drug’s efficacy was apparent.
It was before the now raging next trend had gathered vapor, and also he was then seeing patients who were getting leronlimab under the FDA’s Emergency Investigative New Drug exemption.
At the time, however,, this small independent biotech with no significant funding and a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting prepared to put on for a listing on NASDAQ, as well as the deck was stacked from it.
Full Disclosure: I posses 10,000 shares from an average price of $6.23
Even though the world concentrates breathlessly on the hope for a brand new vaccine to regain the community 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 versatile drug. For them, a vaccine is basically pointless.
This particular drug has “blockbuster potential” written all over it.
With 394 people enrolled in the Phase 2b/3 trial as of December 16, in addition to initially information expected this week, any demonstrable consistency in the data will record the world’s focus in pretty much the most profound way. Quick sellers may be swept apart (at the very least temporarily) simply because business’s new share price levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses ready for sale now, with an extra 2.5 zillion purchased for each of 2021 as well as 2022 in a manufacturing agreement with Samsung, based on the CEO of its.
really if leronlimab/PRO 140/Vyrologix is so great, why the stock’s been trapped in sub 1dolar1 5 penny stock purgatory for so very long?
The fast remedy is “OTC”.
Besides faced with a share price under three dolars, the company hasn’t been able to meet and maintain certain different quantitative prerequisites, like positive shareholders’ equity that is at least $5 million.
But in the NASDAQ community, one can find non quantifiable behaviours by companies that can cause delays to NASDAQ listings. Overtly promotional communications are actually among these kinds of criteria which will never cause a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has also not been equipped to access capital under standard ways, thanks to its being mentioned on the OTC, along with thus un-attractive on that foundation alone to white shoe firms.
So, they have been lowered to accepting shareholder hostile OID debentures with unsightly conversion terms that create a short-seller’s damp 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 is the discount the Streeterville sections, and $100k is put aside to cover the expenditures. Streeterville is actually associated with Illiad Research and Trading, which is managed by John Fife of Chicago Ventures Inc. Iliad has been called a “legendary so-called toxic lender”, by rival studies tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the price, Cytodyn has got to pay again $7.5 million a month. If they don’t have the cash, they pay in stock; the majority of recently, within 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 guaranteed 2.2 million shares coming the way of yours in the very first week of every month. Any price above the conversion cost is pure profit. Remember – this guy isn’t an investor; he’s a lender.
He’s not operating on the hope that Cytodyn stock may go parabolic if leronlimab is deemed a remedy for ARDS; his business model is to limit risk and optimize upside via discounted conversion of share.
This is the quick seller’s wet dream I am speaking about. Not merely is definitely the lender enticed to go brief, but any short trading container dealer in town who can fog a mirror and examine an EDGAR filing know that each month, like clockwork, there’s going to be two million+ shares hitting the bid down to $3.40.
The SEC isn’t 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 acquiring and promoting more than twenty one billion shares of penny inventory without any registering to be a securities dealer while using the SEC.
The SEC’s criticism, alleges this in between 2015 as well as 2020, Fife, and also the companies of his, Chicago Venture Partners, L.P., Iliad Research as well as Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co-Investment, LLC, frequently engaged in the small business of purchasing sports convertible paperwork at penny stock issuers, converting the notes into shares of stock at a big discount from the market price, and offering the newly issued shares to the marketplace at a sizable profit. The SEC alleges that Fife and the companies of his involved in around 250 sports convertible transactions with around 135 issuers, sold more than twenty one billion newly issued penny stock shares to the market, and obtained greater than sixty one dolars million in profits.
Streeterville Capital is not stated as an entity of the complaint. Which hints that it was likely applied by Cytodyn as well as Fife to avoid detection by the SEC that this very same scheme was being perpetrated on Cytodyn at the time of its complaint.
But that’s not the sole reason the stock can’t observe some upward momentum.
The company has been selling inventory privately at ridiculously minimal prices, to the point in which one wonders just that exactly are the fortunate winners of what amounts to free millions of dollars?
In addition, beginning in the month of November 2020 as well as for every one of the following five (five) calendar months thereafter, the Company is actually obligated to lower the exceptional sense of balance belonging to the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes are going to be acknowledged toward the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the 15 % prepayment premium.
Additionally detracting from the business’s gloss is actually the propensity of managing for endlessly marketing communications with shareholders. During an investor webcast on January 5th, the company had a number of sound testimonials from individuals applying PRO 140 for HIV therapy, backed by tear jerking music, and then replete with emotional language devoid of data.
Worse, the company’s phone number at the bottom level of press releases comes with an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one particular is a “valid extension” based on the automated phone system.
That is the sort of approach that the FDA and SEC view unfavourably, and is likely at minimum in part the reason behind the continued underdog status of theirs at both agencies.
The company also has come 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 huge cash investors, alienated.
But think of this “management discount” as the opportunity to get a sizable position (should a person be so inclined) in what might very well turn out to be, in a matter of weeks, as the leading therapy for serious COVID19 associated illness.
I expect the details from your trial now concluded for only such an indication could release the business into a whole new valuation altitude that will allow it to get over these shortfalls.
Average trading volume is continuous above six million shares a day, and before the conclusion of this week, we’ll learn precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the most severe of COVID 19. In case the results are good, this may be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)