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 subscribers from our first feature returned in April this year. Billions have been invested straight into a huge selection of biotechs all competing to make a cure or therapy for severe COVID-19 instances that result in death, as well as none have succeeded. Except for Cytodyn, if early indications are confirmed in the current trial now underway.
But right after a serious plunge on the company’s fiscal claims and SEC filings, an image emerges of business control working having a “toxic lender” to direct severely discounted shares to the lender frequently. An investment in Cytodyn is actually a strictly speculative bet on the part of mine, and when the expected upward price movement doesn’t manifest following results in the company’s period 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 life in severe-to-critical COVID19 patients, then a groundswell of investor assistance can force the organization into new, higher grade human relationships, which would allow for the redemption of elimination as well as debentures of reliance on fly-by-night financings such as those described below.
Cytodyn’s sole focus is creating therapies used on a monoclonal antibody known as “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor type five (CCR5)”. This engineered antibody was obtained 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 business sales.
The drug was acquired on its early promise as an HIV treatment, for which continued development as well as research by Cytodyn has demonstrated the capability to reduce regular drug cocktails with assortment pills right into a single monthly injection, sometimes, with zero unintended effects. To day, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific staff has discovered the antibody’s effect on the CCR5 receptor has extremely optimistic therapeutic implications for everything from some solid tumours to NASH (Non alcoholic steatohepatitis), the liver function condition which afflicts up to twelve % of the US population, and up to twenty six % globally.
But the real emergent also potentially transformational application for leronlimab, as stated at the beginning, (which is currently getting branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) due to COVID 19 which precludes the Sequential Organ Failure wearing fatal situations of COVID infections.
Leronlimab evidently prevents the CCR5 receptor from over responding to the virus and also launching the today 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, still when intubated.
The company finished enrollment of a phase 2b/3 trial on December fifteen to “evaluate the efficacy and safety of leronlimab for clients with severe-to-critical COVID-19 indications is actually a two arm, placebo controlled, double blind, randomized, adaptive style multicenter study,” according to the company’s media release.
This trial period concluded on January 12-ish, of course, if the results are positive, this can make leronlimab a premier treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines which are presently circulating are surely lending optimism for a normalization of society by mid-2021, the surging worldwide rates of infection suggest the immediate future is today overwhelming health care systems across the world as a lot more men and women require utilization of Intensive Care Unit hospitalization.
During my first job interview with Dr. Nader Pourhassan returned in March of 2020, his extreme eagerness for the prospects of the drug’s effectiveness was apparent.
It was before the currently raging second wave had gathered heavy steam, as well as he was then noticing individuals which were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nevertheless,, 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, along with the deck was stacked against it.
Full Disclosure: I own 10,000 shares from an average cost of $6.23
Although the world concentrates breathlessly on the hope for a new vaccine to restore their social liberties, the 10-ish portion of COVID infectees that descend into the cytokine storm driven ARDS actually have their lives saved by this seemingly versatile drug. For these people, a vaccine is practically useless.
This particular drug has “blockbuster potential” authored all over it.
With 394 patients enrolled with the Phase 2b/3 trial as of December sixteen, and first data expected this week, any demonstrable consistency in the data will record the world’s focus in essentially the most profound way. Quick sellers may be swept apart (at least temporarily) as the business’s brand new share price amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses all set for sale right now, with an additional 2.5 million purchased for each of 2021 as well as 2022 in a manufacturing agreement with Samsung, as per the CEO of its.
so if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been stuck in sub 1dolar1 five penny stock purgatory for such a long time?
The fast solution is “OTC”.
Besides struggling with a share price under $3, the company hasn’t been equipped to meet and maintain some other quantitative prerequisites, including good shareholders’ equity of at least $5 million.
But in the NASDAQ community, one can find non quantifiable behaviours by companies that can cause slow downs to NASDAQ listings. Overtly advertising communications are among such criteria which won’t ever lead to a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn in addition has not been equipped to access capital under traditional means, because of its being mentioned on the OTC, along with consequently un attractive on that basis alone to white shoe firms.
And so, they’ve been lowered to accepting shareholder hostile OID debentures with unsightly conversion terms that produce a short-seller’s wet dream.
In November, they borrowed 28.5 million from Streeterville Capital of that just $25 million was paid to the company; $3.4 zillion will be the discount the Streeterville pockets, and $100k is reserved to protect the bills. Streeterville is actually related with Illiad Trading and Research, that is operated by John Fife of Chicago Ventures Inc. Iliad has been referred to as a “legendary so called poisonous lender”, by rival studies tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the offer, Cytodyn wants to pay back again $7.5 million per month. If they do not have the cash, they pay within stock; the majority of recently, at a sales price of $3.40 a share.
Now just imagine if you are an opportunistic low-rent lender and you have got an assured 2.2 million shares coming the way of yours in the earliest 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 hope that Cytodyn stock may go parabolic if leronlimab is deemed a cure for ARDS; his business model is limiting risk and maximize upside via discounted conversion of share.
This is the quick seller’s wet dream I’m talking about. Not merely is definitely the lender enticed to go brief, but some short trading pail dealer in town who are able to fog a mirror and go through an EDGAR filing understand that every month, like clockwork, there is going to be two million+ shares impacting the bid lowered by to $3.40.
The SEC isn’t impressed, in addition, on September 3, 2020, filed a complaint.
The Securities in addition to the Exchange Commission these days filed charges from John M. Fife of Chicago and Companies he controls for acquiring and selling much more than twenty one billion shares of penny inventory without any registering as a securities dealer with the SEC.
The SEC’s complaint, alleges this 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., in addition to the Typenex Co Investment, LLC, regularly engaged in the company of buying sports convertible notes at penny stock issuers, converting these notes into shares of inventory at a big discount from the market price, and offering the freshly issued shares into the marketplace at a sizable profit. The SEC alleges which Fife and his businesses involved in over 250 sports convertible transactions with around 135 issuers, sold greater than 21 billion newly-issued penny stock shares to the industry, and obtained greater than $61 million in earnings.
Streeterville Capital is not mentioned as an entity of the complaint. Which implies that it was probably applied by Fife as well as Cytodyn to avoid detection by the SEC that this same scheme was getting perpetrated on Cytodyn within the time of the complaint of its.
But that is not the sole reason the stock can’t observe some upward momentum.
The company has been offering inventory privately at ridiculously low prices, to the point in which one wonders just that exactly are the blessed winners of what amounts to free millions of dollars?
In addition, starting within the month of November 2020 and also for every one of the next five (5) calendar days thereafter, the Company is actually obliged to lower the excellent balance with the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within 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 15 % prepayment premium.
Additionally detracting from the company’s shine is actually the propensity of managing for excessively promotional communications with shareholders. During an investor webcast on January 5th, the business had a number of sound testimonials from clients applying PRO 140 for HIV treatment, backed by tear jerking music, and therefore replete with mental language devoid of data.
Even worse, the company’s cell phone number at the bottom of press releases has an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is a “valid extension” in accordance with the automatic system.
That is the type of approach that the SEC and FDA view unfavourably, and is likely at minimum in part the reason for the continued underdog status of theirs at both agencies.
The company has also come to be unresponsive to requests for interviews, and so using the story coming out under just these ill advised publicity stunts, shorts are actually attracted, and big cash investors, alienated.
But think of this particular “management discount” as the opportunity to get a sizable position (should someone be so inclined) contained what may really well prove to be, in a question of weeks, since the best therapy for severe COVID19 related illness.
I expect the information in the trial now concluded for only such an indication can launch the company into a complete new valuation altitude that will enable it to get over these shortfalls.
Average trading volume is steady above six million shares 1 day, and right before the tail end of this week, we’ll know precisely how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the most severe of COVID 19. In case the outcomes are good, this could be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)