Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug developer, has already shipped a win for Wealthpress subscribers from our first feature returned in April this year. Billions have been invested straight into countless biotechs all competing to produce a medicine or perhaps treatment for serious COVID 19 situations that result in death, as well as none have succeeded. Except Cytodyn, when early indications are verified in the present trial now underway.
But after a serious plunge on the company’s financial statements and SEC filings, a picture emerges of company management working with a “toxic lender” to funnel severely discounted shares to the lender regularly. An investment in Cytodyn is actually a purely speculative bet on the part of mine, of course, if the anticipated upward price movement does not appear following results in the company’s phase 2b/3 trial for severe-to-critical COVID 19, I am going to exit the investment.
In case the business’s drug does in fact reliably preserve lifestyles to come down with severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance can push the organization into completely new, higher grade relationships, which would enable for the redemption of elimination and debentures of reliance on fly-by-night financings such as those described 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 5 (CCR5)”. This engineered antibody was purchased 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 ten dolars million and a 5 % net royalty on commercial sales.
The drug was acquired on its early promise as an HIV treatment, for which continued development and research by Cytodyn has shown the ability to reduce regular drug cocktails with myriad pills into a single monthly injection, sometimes, with zero negative effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific staff has realized the antibody’s influence on the CCR5 receptor has extremely positive therapeutic implications for everything out of certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver feature disorder that afflicts up to 12 percent of the US public, and up to twenty six % globally.
But the real emergent also potentially transformational program for leronlimab, as stated at the start, (which is now being branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) caused by COVID 19 that precludes the Sequential Organ Failure wearing fatal cases of COVID infections.
Leronlimab it seems that prevents the CCR5 receptor from over responding to the virus and also launching the now household word “cytokine storm”. Some proportion of clients obviously return from the brink following two treatments (and in some cases, 1 treatment) of leronlimab, even when intubated.
The company finished enrollment of a phase 2b/3 trial on December 15 to “evaluate the efficacy as well as safety of leronlimab for people with severe-to-critical COVID 19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design and style multicenter study,” based on the company’s media release.
This trial phase concluded on January 12-ish, of course, if the results are positive, this will make leronlimab a top treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are presently dispersing are definitely lending hope for a normalization of modern society by mid 2021, the surging global rates of contamination suggest the immediate future is today overwhelming health care systems across the world as more and more individuals call for utilization of Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan back found March of 2020, his serious enthusiasm for the prospects of this drug’s effectiveness was apparent.
This was before the currently raging next trend had gathered vapor, as well as he was then noticing patients who were getting leronlimab under the FDA’s Emergency Investigative New Drug exemption.
Within the time, even thought, this small independent biotech without any big funding along with a decidedly unhappy public listing on the naked short-sellers’ dream OTC marketplace was getting prepared to put on for a listing on NASDAQ, and the deck was stacked against it.
Full Disclosure: I own 10,000 shares at an average expense of $6.23
Although the world focuses breathlessly on the hope for a new vaccine to regain the social liberties of theirs, the 10-ish fraction of COVID infectees that descend into the cytokine storm driven ARDS actually have their day saved by this apparently versatile drug. For these people, a vaccine is practically pointless.
This drug has “blockbuster potential” authored all over it.
With 394 people enrolled with the Phase 2b/3 trial as of December sixteen, in addition to initially data expected this week, any demonstrable consistency in the information is going to record the world’s interest in the most profound way. Short sellers may be swept apart (at least temporarily) while the company’s new share priced 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 purchased for each of 2021 plus 2022 in a manufacturing agreement with Samsung, based on the CEO of its.
so if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been trapped in sub 1dolar1 5 penny stock purgatory for so very long?
The fast remedy is “OTC”.
Apart from dealing with a share price under three dolars, the company hasn’t been equipped to meet and maintain some other quantitative requirements, including good shareholders’ equity that is at least $5 million.
But in the NASDAQ community, you can find non quantifiable behaviours by companies that can cause delays to NASDAQ listings. Overtly advertising communications are among these kinds of criteria that won’t ever lead to a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn in addition has not been in a position to access capital under traditional ways, because of its being listed on the OTC, along with therefore un-attractive on that basis alone to white colored shoe firms.
Thus, they’ve been lowered to accepting shareholder hostile OID debentures with unsightly conversion terms that create a short-seller’s stormy dream.
In November, they borrowed 28.5 zillion coming from Streeterville Capital of which just twenty five dolars million was given to the company; $3.4 million is the discount the Streeterville pockets, and $100k is actually set aside to cover the expenditures. Streeterville is actually linked with Illiad Trading and Research, which is operated by John Fife of Chicago Ventures Inc. Iliad has been called a “legendary so-called poisonous lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the price, Cytodyn wants to pay back $7.5 million every month. In case they don’t possess the cash, they spend within stock; many lately, within a sales price of $3.40 a share.
Now just imagine if you are an opportunistic low rent lender and you’ve got an assured 2.2 million shares coming your way in the first week of every month. Any price tag above the conversion cost is pure profit. Remember – this guy is not an investor; he is a lender.
He’s not operating on the hope that Cytodyn stock could go parabolic if leronlimab is deemed a remedy for ARDS; his business model is limiting risk and maximize upside via affordable conversion of share.
This’s the brief seller’s wet dream I’m discussing. Not merely is the lender enticed to go short, but some short-trading container repair shop in town who can fog a mirror and go through an EDGAR filing realize that each month, like clockwork, there is going to be 2 million+ shares hitting the bid lowered by to $3.40.
The SEC is not impressed, and on September three, 2020, filed a complaint.
The Securities as well as Exchange Commission today filed charges from John M. Fife of Companies and Chicago he controls for obtaining as well as marketing more than twenty one billion shares of penny stock without the need of registering as a securities dealer with the SEC.
The SEC’s complaint, alleges this in between 2015 and 2020, Fife, as well as the companies of his, 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, routinely engaged in the small business of purchasing convertible paperwork from penny stock issuers, converting the notes into shares of stock at a major discount from the market cost, and selling the newly issued shares into the market at a significant profit. The SEC alleges which Fife as well as the businesses of his interested in around 250 convertible transactions with around 135 issuers, sold greater than 21 billion newly issued penny stock shares to the market, and obtained greater than sixty one dolars million in earnings.
Streeterville Capital isn’t stated as an entity in the complaint. Which implies it was very likely applied by Fife and Cytodyn to avoid detection by the SEC this very same scheme was getting perpetrated on Cytodyn at the time of the complaint of its.
But that is not the sole reason the stock can’t keep some upward momentum.
The company has been selling inventory privately at ridiculously minimal prices, to the point where one wonders just that exactly are the blessed winners of what requires free millions of dollars?
In addition, starting in the month of November 2020 as well as for every one of the next 5 (five) calendar months thereafter, the Company is obligated to lower the excellent harmony of 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 month Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % 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 company played a compilation of audio testimonials from patients using PRO 140 for HIV therapy, backed by tear jerking music, and then replete with mental language devoid of data.
Even worse, the company’s telephone number at the bottom 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 approach type that the SEC and FDA view unfavourably, and it 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 interview, and thus while using story coming out less than just these ill advised publicity stunts, shorts are attracted, and big cash investors, alienated.
But think of this specific “management discount” as the opportunity to get a sizable job (should one be so inclined) contained what could really well prove to be, in a situation of weeks, since the leading treatment for severe COVID19 related illness.
I expect the information from your trial now concluded for just such a sign could launch the company into a whole new valuation altitude that will enable it to overcome these shortfalls.
Average trading volume is actually steady above six million shares 1 day, and right before the tail end of this week, we’ll know precisely how effective leronlimab/PRO 140/Vyrologix is actually for saving lives from the worst of COVID nineteen. In case the outcomes are good, this may be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)