Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late stage biotech drug developer, has already delivered a win for Wealthpress subscribers from our first feature returned in April this year. Billions have been invested into a huge selection of biotechs all competing to make a cure or maybe therapy for severe COVID-19 instances that trigger death, as well as none have been successful. Except Cytodyn, when early indications are verified in the current trial now underway.
But after a deep jump on the business’s monetary statements and SEC filings, an image emerges of business management working who have 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 business’s drug does in fact reliably spend less lives in danger of severe-to-critical COVID19 patients, then a groundswell of investor support could force the company into new, higher-grade human relationships, which would allow for the redemption of debentures and elimination of reliance on fly-by-night financings for instance those discussed below.
Cytodyn’s sole focus is actually creating treatments 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 engineered antibody was acquired from Progenics Pharmaceuticals as “PRO 140”, a recently acquired subsidiary of Lantheus Holdings Inc (NASDAQ:LNTH), back in 2012.
Total expense of acquisition amounts to ten dolars million plus a five % net royalty on business revenue.
The drug was acquired on the first promise of its as an HIV treatment, for which continued research as well as development by Cytodyn has highlighted the capability to reduce daily drug cocktails with assortment pills right into a specific monthly injection, in some instances, with 0 negative effects. To particular date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since then, Cytodyn’s scientific team has discovered the antibody’s effect on the CCR5 receptor has extremely positive therapeutic implications for everything from some solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function ailment which afflicts up to 12 percent of the US population, and up to twenty six % globally.
But the real emergent and potentially transformational program for leronlimab, as stated at the start, (which is already being branded as Vyrologix by Cytodyn), is for the Acute Respiratory Distress Syndrome (ARDS) due to COVID 19 that precludes the Sequential Organ Failure in fatal instances of COVID infections.
Leronlimab it seems that prevents the CCR5 receptor from over responding to the virus and launching the today household-word “cytokine storm”. Some proportion of people apparently return from the brink after 2 treatments (and in some instances, 1 treatment) of leronlimab, even when intubated.
The company completed 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 a two-arm, placebo controlled, double blind, randomized, adaptive design and style multicenter study,” based on the company’s media release.
This trial period concluded on January 12-ish, and if the results are good, this can make leronlimab a high remedy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines that are presently dispersing are surely lending hope for a normalization of modern culture by mid-2021, the surging worldwide rates of contamination suggest the immediate future is today overwhelming health care systems across the world as more and more individuals require utilization of Intensive Care Unit hospitalization.
During the 1st interview of mine with Dr. Nader Pourhassan back found March of 2020, his serious passion for the prospects of the drug’s success was apparent.
This was prior to the currently raging second trend had gathered steam, and also he was then seeing individuals that were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, however,, this small independent biotech without any significant funding along with a decidedly unfortunate public listing on the naked short-sellers’ fantasy OTC marketplace was getting prepared to put on for a listing on NASDAQ, as well as the deck was stacked against it.
Full Disclosure: I own 10,000 shares from an average price of $6.23
While the world concentrates breathlessly on the optimism for the latest vaccine to regain the community liberties of theirs, the 10 ish percentage of COVID infectees that descend into the cytokine storm driven ARDS literally have their day saved by this apparently flexible drug. For them, a vaccine is literally pointless.
This particular drug has “blockbuster potential” written all over it.
With 394 patients enrolled inside the Phase 2b/3 trial as of December sixteen, in addition to initially data expected this week, a demonstrable consistency in the details is going to record the world’s focus in essentially the most profound way. Short sellers may be swept apart (at least temporarily) while the company’s new share price amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses prepared for sale right now, with an additional 2.5 zillion purchased for each of 2021 plus 2022 in a manufacturing agreement with Samsung, according to its CEO.
really if leronlimab/PRO 140/Vyrologix is very great, how come the stock’s been trapped in sub-1dolar1 five penny stock purgatory for such a long time?
The quick solution is “OTC”.
Apart from faced with a share price under three dolars, the company has not been equipped to meet and keep certain different quantitative requirements, including good shareholders’ equity of at least five dolars million.
But in the NASDAQ community, one can find non-quantifiable behaviours by companies that cause slow downs to NASDAQ listings. Overtly promotional communications are actually among such type of criteria that will never lead to a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has additionally not been in a position to access capital under conventional ways, thanks to its being listed on the OTC, in addition to thus un attractive on that foundation alone to white shoe firms.
Thus, they have been cut down to accepting shareholder-hostile OID debentures with unsightly sales terms that create a short-seller’s wet dream.
In November, they coppied 28.5 million from Streeterville Capital of which only twenty five dolars million was given to the company; $3.4 huge number of is the discount the Streeterville pockets, and $100k is actually set aside to protect the expenses. Streeterville is associated with Illiad Trading and Research, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so-called toxic lender”, by rival studies tight 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 don’t possess the cash, they pay inside stock; many lately, within a conversion cost of $3.40 a share.
These days just imagine when you are an opportunistic low-rent lender and you have received a certain 2.2 million shares coming your way in the earliest week of every month. Any price tag above the conversion price is pure profit. Remember – this guy isn’t an investor; he’s a lender.
He’s not operating on the hope that Cytodyn stock could go parabolic if leronlimab is deemed a cure for ARDS; the online business model of his is to limit risk and optimize upside via affordable conversion of share.
This is the short seller’s wet dream I am discussing. Not merely is the lender enticed to go brief, but some short-trading pail dealer in town who are able to fog a mirror and examine an EDGAR filing know that every month, like clockwork, there’s going to be 2 million+ shares striking the bid lowered by to $3.40.
The SEC is not impressed, additionally, on September 3, 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 and selling much more than twenty one billion shares of penny inventory without registering as a securities dealer with the SEC.
The SEC’s complaint, alleges this between 2015 as well as 2020, Fife, and also the companies of his, Chicago Venture Partners, L.P., Iliad Research as well as Trading, L.P., St. George Investments LLC, Tonaquint, Inc., as well as Typenex Co Investment, LLC, frequently engaged in the company of purchasing convertible notes from penny stock issuers, converting those notes into shares of inventory at a large discount from the market cost, and selling the freshly issued shares to the marketplace at a significant profit. The SEC alleges which Fife as well as the businesses of his engaged in around 250 sports convertible transactions with around 135 issuers, sold more than 21 billion newly issued penny stock shares into the industry, and obtained greater than sixty one dolars million in earnings.
Streeterville Capital isn’t stated as an entity of the complaint. Which hints it was probably used by Cytodyn and Fife to avoid detection by the SEC that this same plan was getting perpetrated on Cytodyn within the time of the complaint of its.
But that is not the sole reason the stock can’t keep any upward momentum.
The company has been selling inventory privately from ridiculously low prices, to the point where one wonders just who exactly are the lucky winners of what requires no cost millions of dollars?
Additionally, beginning within the month of November 2020 and for each of the following 5 (5) calendar days thereafter, the Company is actually obligated to bring down the excellent sense of balance belonging to the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes within the Prior Notes will likely be acknowledged toward the payment of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the fifteen % prepayment premium.
Also detracting from the business’s gloss is actually the propensity of handling for endlessly marketing communications with shareholders. During an investor webcast on January 5th, the company had a series of audio testimonials from patients applying 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 of press releases has an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one particular is actually a “valid extension” in accordance with the automated phone system.
That’s the kind of approach that the SEC and FDA view unfavourably, and it is likely at minimum in part the reason behind the continued underdog status of theirs at both agencies.
The company also has become unresponsive to requests for interviews, and therefore while using story coming out less than only these ill-advised publicity stunts, shorts are attracted, and huge cash investors, alienated.
But think of this specific “management discount” as the chance to purchase a sizable job (should one be so inclined) found what could really well prove to be, in a matter of weeks, given that the leading treatment for severe COVID19 related illness.
I expect the data in the trial now concluded for just such a sign could release the organization into a whole new valuation altitude that will enable it to get over these shortfalls.
Average trading volume is actually steady above six million shares a day, and right before the conclusion of this week, we will find out just how efficient leronlimab/PRO 140/Vyrologix is actually 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)