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 members from our 1st feature back in April this season. Billions have been invested straight into countless biotechs all competing to develop a medicine or maybe treatment for severe COVID 19 situations that cause death, as well as none have been successful. Except for Cytodyn, if early indications are established in the current trial now underway.
But right after a serious jump on the business’s financial claims and SEC filings, an image emerges of company control working with a “toxic lender” to funnel seriously discounted shares to the lender regularly. An investment in Cytodyn is a purely speculative bet on my part, of course, if the expected upward price movement doesn’t manifest after results of the company’s phase 2b/3 trial for severe-to-critical COVID 19, I am going to exit the investment.
If the business’s drug does in fact reliably spend less life to come down with severe-to-critical COVID19 patients, then a groundswell of investor support could push the organization into new, higher grade relationships, which would enable for the redemption of debentures as well as elimination of reliance on fly-by-night financings like those discussed below.
Cytodyn’s sole focus is actually creating remedies used 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 obtained of Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total cost of acquisition amounts to ten dolars million and a five % net royalty on commercial sales.
The drug was acquired on its first promise as an HIV therapy, for which continued research and development by Cytodyn has shown the ability to reduce daily drug cocktails with myriad pills right into a single monthly injection, sometimes, with 0 unwanted side effects. To particular date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific staff has discovered the antibody’s impact on the CCR5 receptor has incredibly optimistic therapeutic implications for everything out of some solid tumours to NASH (Non-alcoholic steatohepatitis), the liver feature disorder which afflicts up to twelve percent of the US population, and up to twenty six % globally.
But the real emergent and likely transformational application for leronlimab, as stated at the beginning, (which is already being 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 in fatal cases of COVID infections.
Leronlimab evidently blocks the CCR5 receptor from over responding to the virus and launching the now household-word “cytokine storm”. Some proportion of individuals obviously return from the brink following 2 treatments (and in a number of cases, 1 treatment) of leronlimab, even when intubated.
The company finished 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 actually a two arm, placebo controlled, double blind, randomized, adaptive design and style multicenter study,” according to the company’s media release.
This trial period concluded on January 12 ish, of course, if the outcomes are good, this can make leronlimab a premier remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines which are now circulating are definitely lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of contamination suggest the immediate future is right now overwhelming health care systems across the world as increasingly more people call for utilization of Intensive Care Unit hospitalization.
During my 1st interview with Dr. Nader Pourhassan returned contained March of 2020, the extreme eagerness of his for the prospects of this drug’s success was apparent.
This was prior to the currently raging next trend had gathered steam, and also he was then noticing patients who were receiving leronlimab under the FDA’s Emergency Investigative New Drug exemption.
Within the time, nonetheless,, this little independent biotech without big funding and a decidedly unfortunate public listing on the naked short-sellers’ fantasy OTC marketplace was getting prepared to utilize for a listing on NASDAQ, and the deck was stacked against it.
Full Disclosure: I have 10,000 shares from an average expense of $6.23
Although the world concentrates breathlessly on the optimism for the latest vaccine to restore their social liberties, the 10-ish fraction of COVID infectees who descend into the cytokine storm driven ARDS actually have their day saved by this seemingly flexible drug. To them, a vaccine is practically useless.
This particular drug has “blockbuster potential” written all over it.
With 394 individuals enrolled inside the Phase 2b/3 trial as of December 16, and first data expected this week, a demonstrable consistency in the information will record the world’s interest in the most profound way. Short sellers may be swept aside (at least temporarily) while the business’s new share price levels qualify it for NASDAQ listing.
Cytodyn management says it has 700,000 doses prepared for sale now, with an extra 2.5 zillion purchased for each of 2021 plus 2022 in a manufacturing agreement with Samsung, based on the CEO of its.
really if leronlimab/PRO 140/Vyrologix is very great, why the stock’s been stuck in sub 1dolar1 five penny stock purgatory for so very long?
The quick remedy is “OTC”.
Besides dealing with a share price under $3, the company has not been able to meet and keep certain different quantitative prerequisites, like positive shareholders’ equity with a minimum of five dolars million.
But in the NASDAQ community, there are non-quantifiable behaviours by businesses that can cause waiting times to NASDAQ listings. Overtly advertising communications are actually among these kinds of criteria that won’t ever lead to a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn has also not been able to access capital under traditional means, because of its being mentioned on the OTC, and consequently un attractive on that foundation alone to white colored shoe firms.
Thus, they’ve been cut down to accepting shareholder hostile OID debentures with unsightly conversion terms that create a short-seller’s stormy dream.
In November, they took 28.5 million out of Streeterville Capital of that only $25 million was given to the company; $3.4 huge number of is the discount the Streeterville areas, and $100k is put aside to cover the costs. Streeterville is actually associated with Illiad Trading and Research, that is operated by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so called toxic lender”, by rival research firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the price, Cytodyn wants to pay back $7.5 million every month. In case they do not have the cash, they spend inside stock; most lately, within a sales price of $3.40 a share.
These days just imagine if you are an opportunistic low rent lender and you’ve gained an assured 2.2 million shares coming the way of yours in the first week of each month. Any price 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 may go parabolic in the event that leronlimab is deemed a remedy for ARDS; the online business model of his is limiting risk and optimize upside through discounted transformation of share.
This is the short seller’s wet dream I’m discussing. Not merely is definitely the lender enticed to go brief, but some short-trading bucket repair shop in town who could fog a mirror and read an EDGAR filing understand that every month, like clockwork, there is going to be two million+ shares hitting the bid lowered by to $3.40.
The SEC is not impressed, and on September 3, 2020, filed a complaint.
The Securities and Exchange Commission nowadays filed charges against John M. Fife of Chicago and Companies he controls for obtaining as well as selling much more than twenty one billion shares of penny stock without the need of registering as a securities dealer while using the SEC.
The SEC’s complaint, alleges this in between 2015 as well as 2020, Fife, and 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, frequently involved in the company of buying convertible paperwork at penny stock issuers, transforming these notes into shares of inventory at a major discount from the market cost, and selling the freshly issued shares into the market at a sizable profit. The SEC alleges that Fife and his businesses interested in more than 250 sports convertible transactions with approximately 135 issuers, sold greater than twenty one billion newly-issued penny stock shares into the market, and obtained more than $61 million in profits.
Streeterville Capital is not mentioned as an entity in the complaint. Which implies it was likely used by Cytodyn and Fife to stay away from detection by the SEC this same plan was being perpetrated on Cytodyn at the time of the complaint of its.
But that’s not the only reason the stock cannot observe some upward momentum.
The company has been selling stock privately at ridiculously minimal prices, to the position in which one wonders just that exactly are the blessed winners of what amounts to no cost millions of dollars?
Moreover, starting inside the month of November 2020 as well as for every one of the next five (5) calendar days thereafter, the Company is actually obliged to lower the outstanding balance of the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes are going to be credited toward the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments are not be subject to the 15 % prepayment premium.
Also detracting from the company’s shine is the propensity of management for excessively promotional communications with shareholders. During an investor webcast on January 5th, the business played a number of audio testimonials from people applying PRO 140 for HIV treatment, backed by tear jerking music, and then replete with emotional language devoid of information.
Even worse, the company’s mobile phone 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” in accordance with the automatic phone system.
That is the sort of approach that the FDA and SEC view unfavourably, and it is likely at the very least in part the reason behind their continued underdog status at both agencies.
The company has also come to be unresponsive to requests for interview, and thus using the story coming out less than only these ill advised publicity stunts, shorts are actually attracted, and huge cash investors, alienated.
But think of this specific “management discount” as the opportunity to purchase a sizable job (should someone be so inclined) found what might very well prove to be, in a situation of weeks, given that the top therapy for severe COVID19 related illness.
I expect the details in the trial now concluded for only such an indication might launch the business into a whole new valuation altitude that will allow it to overcome these shortfalls.
Average trading volume is actually steady above six million shares a day, and before the end of this week, we’ll find out exactly how efficient leronlimab/PRO 140/Vyrologix is at saving lives from the most severe of COVID nineteen. In case the results are positive, this could be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)