Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug designer, has already shipped a win for Wealthpress members from our first feature returned in April this season. Billions have been invested into a huge selection of biotechs all competing to produce a cure or maybe therapy for serious COVID 19 instances which trigger death, as well as none have been successful. Except for Cytodyn, when early indications are verified in the current trial now underway.
But right after a serious jump on the company’s monetary claims as well as SEC filings, a picture emerges of business control working who have a “toxic lender” to direct seriously discounted shares to the lender regularly. An investment in Cytodyn is a strictly speculative bet on my part, and when the expected upward price movement doesn’t occur after results in the company’s stage 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 preserve lives in severe-to-critical COVID19 patients, subsequently a groundswell of investor assistance may force the company into new, higher grade relationships, which would enable for the redemption of debentures and elimination of reliance on fly-by-night financings such as those discussed below.
Cytodyn’s sole focus is developing treatments used on a monoclonal antibody called “leronlimab”, technically referred to as “humanized IgG4, monoclonal antibody (mAb) to the C C chemokine receptor sort 5 (CCR5)”. This particular engineered antibody was acquired 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 $10 million and a 5 % net royalty on commercial revenue.
The drug was acquired on its first promise as an HIV treatment, for which continued development and research by Cytodyn has demonstrated the ability to reduce regular drug cocktails with assortment pills right into an individual monthly injection, sometimes, with zero unintended effects. To date, the FDA has denied Cytodyn’s Biologics License Application (BLA)
Since that time, Cytodyn’s scientific staff has realized the antibody’s influence on the CCR5 receptor has incredibly optimistic therapeutic implications for everything out of certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function condition that afflicts up to 12 % of the US public, and up to 26 % globally.
But the real emergent and potentially transformational program for leronlimab, as stated at the start, (which is now 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 cases of COVID infections.
Leronlimab it seems that blocks the CCR5 receptor from over responding to the virus and launching the today household-word “cytokine storm”. Some proportion of clients obviously return from the brink after 2 treatments (and in a number of instances, 1 treatment) of leronlimab, still when intubated.
The company completed enrollment of a level 2b/3 trial on December fifteen to “evaluate the efficacy as well as safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two arm, randomized, double blind, placebo controlled, adaptive design 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 will make leronlimab a premier therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
While the vaccines that are currently spreading are surely lending optimism for a normalization of society by mid-2021, the surging worldwide rates of contamination suggest the immediate future is already overwhelming health care systems around the world as more and more men and women require access to Intensive Care Unit hospitalization.
During my first interview with Dr. Nader Pourhassan back in March of 2020, his serious enthusiasm for the prospects of this drug’s efficacy was apparent.
It was prior to the currently raging next trend had gathered vapor, as well as he was then seeing patients that were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, nevertheless,, this little independent biotech without major funding along with a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting prepared to utilize for a listing on NASDAQ, as well as the deck was stacked against it.
Full Disclosure: I have 10,000 shares from an average expense of $6.23
Even though the planet concentrates breathlessly on the hope for a brand new vaccine to regain the social liberties of theirs, the 10-ish portion of COVID infectees who descend into the cytokine storm-driven ARDS literally have their day saved by this seemingly versatile drug. For them, a vaccine is practically useless.
This particular drug has “blockbuster potential” authored all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December sixteen, in addition to first information expected this week, a demonstrable consistency in the information is going to record the world’s attention in likely the most profound way. Quick sellers could be swept apart (at the very least temporarily) as the company’s brand new share price amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses ready for sale right now, with an extra 2.5 zillion ordered for each of 2021 as well as 2022 in a manufacturing understanding with Samsung, as per its CEO.
really if leronlimab/PRO 140/Vyrologix is very great, how come the stock’s been trapped in sub-1dolar1 5 penny stock purgatory for such a long time?
The quick answer is “OTC”.
Apart from struggling with a share price under $3, the company has not been able to meet and maintain certain other quantitative prerequisites, including good shareholders’ equity that is at least $5 million.
But in the NASDAQ community, there are non-quantifiable behaviours by organizations that create slow downs to NASDAQ listings. Overtly advertising communications are among such type of criteria that will never result in a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn has additionally not been equipped to access capital under standard ways, thanks to its being listed on the OTC, in addition to therefore un-attractive on that foundation alone to white colored shoe firms.
So, they have been reduced to accepting shareholder hostile OID debentures with ugly sales terms that generate a short-seller’s wet dream.
In November, they borrowed 28.5 million from Streeterville Capital of which just $25 million was given to the company; $3.4 zillion will be the discount the Streeterville areas, and $100k is actually set aside to protect the expenditures. Streeterville is actually related with Illiad Research and Trading, that is operated by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so-called poisonous lender”, by rival research firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the deal, Cytodyn wants to pay back $7.5 million every month. If they do not have the cash, they pay within stock; most not long ago, at a sales price of $3.40 a share.
Now just think about when you’re an opportunistic low rent lender and you have got a guaranteed 2.2 million shares coming the way of yours in the earliest week of every month. Any price tag above the sales expenditure is pure profit. Remember – this guy isn’t an investor; he’s a lender.
He’s not operating on the hope that Cytodyn stock might go parabolic in the event that leronlimab is deemed a remedy for ARDS; the business model of his is limiting risk and optimize upside via discounted conversion of share.
This’s the quick seller’s wet dream I am talking about. Not only is the lender enticed to go short, but some short-trading container shop 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 2 million+ shares striking the bid down to $3.40.
The SEC isn’t impressed, in addition, on September three, 2020, filed a criticism.
The Securities as well as Exchange Commission nowadays filed charges against John M. Fife of Chicago and Companies he controls for obtaining as well as marketing more than 21 billion shares of penny inventory without the need of registering to be a securities dealer with the SEC.
The SEC’s complaint, alleges that in between 2015 as well as 2020, Fife, and also the companies of his, Chicago Venture Partners, L.P., Iliad Research and Trading, L.P., St. George Investments LLC, Tonaquint, Inc., and Typenex Co Investment, LLC, regularly engaged in the company of purchasing sports convertible notes from penny stock issuers, transforming those notes into shares of stock at a major discount from the market price, and offering the freshly issued shares to the market at a sizable profit. The SEC alleges which Fife as well as his businesses engaged in over 250 convertible transactions with around 135 issuers, sold greater than twenty one billion newly issued penny stock shares to the market, and obtained more than $61 million in earnings.
Streeterville Capital is not mentioned as an entity of the complaint. Which suggests it was very likely used by Cytodyn as well as Fife to stay away from detection by the SEC this same plan was being perpetrated on Cytodyn at the time of its complaint.
But that is not the sole reason the stock cannot observe some upward momentum.
The company has been selling stock privately from ridiculously minimal prices, to the position where one wonders just who exactly are the fortunate winners of what requires no cost millions of dollars?
Furthermore, starting in the month of November 2020 and for each of the next 5 (five) calendar days thereafter, the Company is obliged to reduce the exceptional harmony of the Note by $7,500,000 per month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes are going to be credited toward 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 business’s shine is actually the propensity of management for excessively marketing communications with shareholders. During an investor webcast on January 5th, the company played a series of sound testimonials from individuals using PRO 140 for HIV treatment, backed by tear jerking music, and replete with mental language devoid of data.
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 is actually a “valid extension” in accordance with the automatic phone system.
That is the approach type that the SEC and FDA view unfavourably, and is likely at least in part the reason behind their continued underdog status at both agencies.
The company has also become unresponsive to requests for interview, and thus with the story coming out under only these ill-advised publicity stunts, shorts are actually attracted, and big cash investors, alienated.
But think of this “management discount” as the chance to acquire a sizable position (should someone be so inclined) found what may really well prove to be, in a question of weeks, as the top treatment for serious COVID19 related illness.
I expect the data from the trial now concluded for just such a sign can release the company into a whole new valuation altitude that will enable it to get over these shortfalls.
Average trading volume is actually steady above 6 million shares a day, and right before the tail end of this week, we’ll find out exactly how effective leronlimab/PRO 140/Vyrologix is at saving lives from the most severe of COVID nineteen. In case the outcomes are good, this could be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)