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 first feature returned in April this season. Billions have been invested directly into a huge selection of biotechs all competing to create a medicine or perhaps treatment for severe COVID 19 situations which cause death, and none have succeeded. Except Cytodyn, when early indications are established in the present trial now underway.
But after a serious plunge on the business’s monetary statements as well as SEC filings, a picture emerges of company control operating having a “toxic lender” to direct seriously discounted shares to the lender frequently. An investment in Cytodyn is actually a strictly speculative bet on my part, and if the anticipated upward price movement doesn’t occur after results of the company’s stage 2b/3 trial for severe-to-critical COVID-19, I am going to exit the investment.
In case the company’s drug does in fact reliably save lifestyles to come down with severe-to-critical COVID19 individuals, then a groundswell of investor support may drive the business into completely new, higher grade human relationships, which would enable for the redemption of elimination as well as debentures of reliance on fly-by-night financings like those discussed below.
Cytodyn’s sole focus is developing remedies based on a monoclonal antibody known as “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor sort five (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 price of acquisition amounts to $10 million plus a 5 % net royalty on commercial revenue.
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 capability to reduce regular drug cocktails with myriad pills into a specific monthly injection, in some instances, with zero side effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has found the antibody’s influence on the CCR5 receptor has extremely positive therapeutic implications for everything out of some solid tumours to NASH (Non alcoholic steatohepatitis), the liver feature disorder that afflicts up to 12 percent of the US population, and up to twenty six % globally.
But the real emergent and potentially transformational application for leronlimab, as stated at the start, (which is currently getting branded as Vyrologix by Cytodyn), is designed for the Acute Respiratory Distress Syndrome (ARDS) brought on by COVID-19 that precludes the Sequential Organ Failure wearing fatal instances 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 patients apparently return from the brink following 2 treatments (and in some instances, 1 treatment) of leronlimab, even when intubated.
The company finished enrollment of a stage 2b/3 trial on December 15 to “evaluate the efficacy and safety of leronlimab for clients with severe-to-critical COVID-19 indications is actually a two-arm, randomized, double blind, placebo controlled, adaptive style multicenter study,” according to the company’s press release.
This trial phase concluded on January 12 ish, of course, if the outcomes are good, this will make leronlimab a top treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are currently dispersing are definitely lending hope for a normalization of modern society by mid 2021, the surging worldwide rates of illness suggest the immediate future is today overwhelming health care systems across the world as increasingly more individuals require access to 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 this drug’s success was evident.
This was prior to the now raging second wave had gathered heavy steam, and also he was then noticing patients who were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, though, this small independent biotech with no major funding along with a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting able to apply for a listing on NASDAQ, and the deck was stacked from it.
Full Disclosure: I have 10,000 shares from an average price of $6.23
Even though the planet concentrates breathlessly on the optimism for the latest vaccine to restore the social liberties of theirs, the 10 ish fraction of COVID infectees that descend into the cytokine storm-driven ARDS literally have their day saved by this seemingly versatile drug. For them, a vaccine is pretty much pointless.
This drug has “blockbuster potential” authored all over it.
With 394 patients enrolled with the Phase 2b/3 trial as of December 16, and first information expected this week, a demonstrable consistency in the information is going to record the world’s interest in probably the most profound way. Quick sellers could be swept aside (at least temporarily) as the business’s brand new share priced levels qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses prepared for sale right now, with an extra 2.5 million purchased for each of 2021 and 2022 in a manufacturing agreement with Samsung, as per the CEO of its.
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 fast answer is “OTC”.
Besides dealing with a share price under $3, the company has not been in a position to meet and maintain some other quantitative requirements, including positive shareholders’ equity with a minimum of $5 million.
But in the NASDAQ world, 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 lead to a refusal letter…nor a NASDAQ listing.
More importantly, Cytodyn in addition has not been able to access capital under conventional means, thanks to its being listed on the OTC, along with therefore un-attractive on that basis alone to white colored shoe firms.
Thus, they have been cut down to accepting shareholder-hostile OID debentures with ugly conversion terms that generate a short-seller’s damp dream.
In November, they took 28.5 million coming from Streeterville Capital of that just $25 million was given to the company; $3.4 zillion would be the discount the Streeterville pockets, and $100k is reserved to cover the bills. Streeterville is linked with Illiad Research and Trading, which is operated by John Fife of Chicago Ventures Inc. Iliad has been called a “legendary so called poisonous lender”, by rival research firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the offer, Cytodyn must pay again $7.5 million every month. If they don’t possess the cash, they pay in stock; the majority of not long ago, within a sales price of $3.40 a share.
Now just imagine when you’re an opportunistic low rent lender and you’ve received a guaranteed 2.2 million shares coming your way in the first week of each month. Any cost above the conversion cost is pure profit. Remember – this guy is not an investor; he is a lender.
He is not operating on the hope that Cytodyn stock could go parabolic in the event that leronlimab is deemed a cure for ARDS; his business model is limiting risk and optimize upside through discounted transformation of share.
This’s the short seller’s wet dream I am discussing. Not merely is the lender enticed to go short, but any short-trading bucket shop in town who are able to fog a mirror and examine an EDGAR filing understand that each month, like clockwork, there’s going to be two million+ shares impacting the bid lowered by to $3.40.
The SEC is not impressed, additionally, on September 3, 2020, filed a criticism.
The Securities in addition to the Exchange Commission nowadays filed charges against John M. Fife of Chicago and Companies he controls for acquiring and selling much more than twenty one billion shares of penny stock without registering to be a securities dealer with the SEC.
The SEC’s complaint, alleges this in between 2015 and 2020, Fife, as well as the businesses of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co-Investment, LLC, regularly interested in the business of purchasing convertible notes at penny stock issuers, converting these notes into shares of stock at a major discount from the market cost, and selling the newly issued shares to the marketplace at a sizable profit. The SEC alleges that Fife as well as his businesses interested in more than 250 convertible transactions with roughly 135 issuers, sold greater than 21 billion newly issued penny stock shares to the market, and obtained more than sixty one dolars million in earnings.
Streeterville Capital is not mentioned as an entity of the complaint. Which suggests that it was probably applied by Cytodyn as well as Fife to avoid detection by the SEC this same scheme was getting perpetrated on Cytodyn within the time of its complaint.
But that’s not the only reason the stock can’t maintain some upward momentum.
The company has been offering inventory privately at ridiculously minimal prices, to the stage in which one wonders just who exactly are the fortunate winners of what amounts to no cost millions of dollars?
Additionally, starting inside the month of November 2020 and for each of the next five (5) calendar days thereafter, the Company is actually obligated to bring down 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 likely be credited to the transaction of each monthly Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the fifteen % prepayment premium.
Also detracting from the business’s shine is actually the propensity of management for endlessly promotional communications with shareholders. During an investor webcast on January 5th, the business played a series of sound testimonials from people using PRO 140 for HIV treatment, backed by tear-jerking music, and therefore replete with emotional language devoid of data.
Worse, the company’s telephone number at the bottom level of press releases includes an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is a “valid extension” according to the automated system.
That’s the type of approach that the FDA and SEC view unfavourably, and it is likely at minimum in part the reason for the continued underdog status of theirs at both agencies.
The company also has become unresponsive to requests for interview, and therefore while using story coming out under 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 purchase a sizable job (should someone be so inclined) in what may really well turn out to be, in a situation of weeks, since the top treatment for severe COVID19 associated illness.
I expect the data in the trial now concluded for just such an indication can launch the business into a whole new valuation altitude that will enable it to overcome these shortfalls.
Average trading volume is constant above 6 million shares one day, and before the tail end of this week, we will learn precisely how effective leronlimab/PRO 140/Vyrologix is for saving lives from the worst of COVID 19. In case the outcomes are positive, this can be a significant winner.
Cytodyn Inc (OTCMKTS:CYDY)