Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug designer, has already shipped a win for Wealthpress subscribers from our 1st feature returned in April this season. Billions have been invested into hundreds of biotechs all competing to make a cure or maybe treatment for serious COVID-19 situations which cause death, as well as none have succeeded. Except Cytodyn, when early indications are verified in the current trial now underway.
But right after a deep jump on the company’s financial claims and SEC filings, a picture emerges of business control functioning having a “toxic lender” to funnel seriously discounted shares to the lender regularly. An investment in Cytodyn is a strictly speculative bet on my part, and when the anticipated upward price movement doesn’t appear following results of 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 in fact reliably conserve lives in danger of severe-to-critical COVID19 patients, subsequently a groundswell of investor support could push the business into new, higher grade human relationships, which would enable for the redemption of elimination and debentures 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 referred to as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor sort 5 (CCR5)”. This engineered antibody was obtained of Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total price of acquisition amounts to $10 million and a five % net royalty on commercial sales.
The drug was acquired on its first promise as an HIV treatment, for which continued research and development by Cytodyn has demonstrated the capability to reduce regular drug cocktails with assortment pills right into a single monthly injection, in some cases, with zero unwanted side effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific team has realized the antibody’s impact on the CCR5 receptor has incredibly positive therapeutic implications for everything from some solid tumours to NASH (Non alcoholic steatohepatitis), the liver feature ailment which afflicts up to twelve % of the US population, and up to twenty six % globally.
But the real emergent and potentially transformational application for leronlimab, as mentioned at the beginning, (which is currently being branded as Vyrologix by Cytodyn), is designed for the Acute Respiratory Distress Syndrome (ARDS) due to COVID 19 that 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 and launching the now household-word “cytokine storm”. Some proportion of patients apparently return from the brink following two treatments (and in some cases, one treatment) of leronlimab, even 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 people with severe-to-critical COVID-19 indications is a two arm, placebo controlled, double blind, randomized, adaptive style multicenter study,” based on the company’s press release.
This trial phase concluded on January 12-ish, and if the outcomes are good, this will make leronlimab a premier therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are currently diffusing are surely lending optimism for a normalization of modern culture by mid-2021, the surging global rates of contamination suggest the immediate future is today overwhelming health care systems around the world as more and more men and women require access to Intensive Care Unit hospitalization.
During the first interview of mine with Dr. Nader Pourhassan back contained March of 2020, the extreme interest of his for the prospects of the drug’s effectiveness was apparent.
It was before the currently raging next trend had gathered heavy steam, and also he was then discovering individuals that were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nevertheless,, this small independent biotech without any significant funding and a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting able to utilize for a listing on NASDAQ, along with the deck was stacked from it.
Full Disclosure: I have 10,000 shares at an average expense of $6.23
Even though the world concentrates breathlessly on the hope for the latest vaccine to regain the community liberties of theirs, the 10 ish fraction of COVID infectees that descend into the cytokine storm driven ARDS actually have their lives saved by this apparently versatile drug. To them, a vaccine is pretty much pointless.
This drug has “blockbuster potential” authored all over it.
With 394 patients enrolled in the Phase 2b/3 trial as of December sixteen, and initially information expected this week, any demonstrable consistency in the data will capture the world’s interest in the most profound way. Short sellers could be swept apart (at least temporarily) as the business’s new share priced levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses prepared for sale now, with an extra 2.5 zillion ordered for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, according to the CEO of its.
so if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub-1dolar1 five penny stock purgatory for such a long time?
The speedy remedy is “OTC”.
Besides struggling with a share price under $3, the company hasn’t been able to meet and keep certain different quantitative prerequisites, like good shareholders’ equity that is at least five dolars million.
But in the NASDAQ community, there are non quantifiable behaviours by organizations that create slow downs to NASDAQ listings. Overtly promotional communications are actually among such type of criteria which won’t ever lead to 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 listed on the OTC, in addition to consequently un-attractive on that basis alone to white shoe firms.
Thus, they’ve been reduced to accepting shareholder-hostile OID debentures with unsightly sales terms that generate a short-seller’s stormy dream.
In November, they coppied 28.5 huge number of coming from Streeterville Capital of that only $25 million was given to the company; $3.4 zillion is the discount the Streeterville areas, and $100k is actually put aside to cover the bills. Streeterville is actually linked with Illiad Research and Trading, which is controlled by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so-called toxic lender”, by rival research firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the price, Cytodyn must pay back $7.5 million every month. If they do not have the cash, they spend within stock; the majority of recently, at a conversion price of $3.40 a share.
Now just think about if you are an opportunistic low rent lender and you have received a guaranteed 2.2 million shares coming the way of yours in the earliest week of each month. Any cost above the conversion cost is pure profit. Remember – this guy is not an investor; he’s a lender.
He is 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 to limit risk and optimize upside through affordable conversion of share.
This is the brief seller’s wet dream I am speaking about. Not merely is definitely the lender enticed to go short, but some short-trading container dealer in town who could fog a mirror and read an EDGAR filing realize that each month, like clockwork, there is going to be 2 million+ shares impacting the bid down to $3.40.
The SEC is not impressed, additionally, on September 3, 2020, filed a criticism.
The Securities in addition to the Exchange Commission these days filed charges against John M. Fife of Companies and Chicago he controls for acquiring as well as selling more than 21 billion shares of penny stock without registering as a securities dealer with the SEC.
The SEC’s complaint, alleges that in between 2015 as well as 2020, Fife, as well as his companies, Chicago Venture Partners, L.P., Iliad Research in addition to the Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co-Investment, LLC, regularly engaged in the company of purchasing convertible paperwork from penny stock issuers, converting these notes into shares of inventory at a big discount from the market price, and offering the newly issued shares into the market at a substantial profit. The SEC alleges which Fife and his companies interested in over 250 convertible transactions with about 135 issuers, sold greater than 21 billion newly issued penny stock shares into the industry, and obtained more than sixty one dolars million in earnings.
Streeterville Capital isn’t stated as an entity in the complaint. Which hints that it was very likely applied by Fife and Cytodyn to avoid detection by the SEC this very same plan was being perpetrated on Cytodyn at the time of its complaint.
But that is not the only reason the stock cannot preserve some upward momentum.
The company has been selling inventory privately at ridiculously low prices, to the point where by one wonders just who exactly are the lucky winners of what requires free millions of dollars?
Furthermore, beginning within the month of November 2020 and also for every one of the following five (5) calendar months thereafter, the Company is actually obliged to cut down the exceptional balance of the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will be acknowledged toward the transaction of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the fifteen % prepayment premium.
Additionally detracting from the company’s gloss is the propensity of managing for endlessly promotional communications with shareholders. During an investor webcast on January 5th, the business played a compilation of sound testimonials from people making use of PRO 140 for HIV treatment, backed by tear-jerking music, and replete with emotional language devoid of information.
Worse, the company’s telephone 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 system.
That’s the approach type that the SEC and FDA view unfavourably, and it is likely at the very least in part the reason behind the continued underdog status of theirs at both agencies.
The company has additionally come to be unresponsive to requests for interviews, and so with the story coming out under only these ill advised publicity stunts, shorts are attracted, and big cash investors, alienated.
But think of this particular “management discount” as the ability to buy a sizable role (should a person be so inclined) in what may really well turn out to be, in a question of weeks, as the top treatment for serious COVID19 associated illness.
I expect the data from your trial now concluded for just such an indication can launch the organization into a complete new valuation altitude that will permit it to get over these shortfalls.
Average trading volume is continuous above six million shares a day, and right before the conclusion of this week, we’ll know just how effective leronlimab/PRO 140/Vyrologix is for saving lives from the most severe of COVID nineteen. In case the results are positive, this may be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)