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 1st feature back in April this year. Billions have been invested into a huge selection of biotechs all competing to produce a cure or maybe therapy for severe COVID 19 instances that result in death, and none have been successful. Except for Cytodyn, if early indications are verified in the current trial now underway.
But right after a deep plunge on the business’s monetary statements and SEC filings, an image emerges of company control working with a “toxic lender” to direct seriously discounted shares to the lender frequently. An investment in Cytodyn is actually a strictly speculative bet on the part of mine, and if the expected 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.
If the business’s drug does actually reliably spend less lifestyles to come down with severe-to-critical COVID19 patients, then a groundswell of investor assistance may force the organization into completely new, higher grade relationships, which would permit for the redemption of elimination and debentures of reliance on fly-by-night financings such as those discussed below.
Cytodyn’s sole focus is actually creating therapies used on a monoclonal antibody called “leronlimab”, technically described as “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (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 expense of acquisition amounts to ten dolars million plus a five % net royalty on commercial revenue.
The drug was acquired on its early promise as an HIV treatment, for which continued research as well as development by Cytodyn has highlighted the capability to reduce daily drug cocktails with myriad pills right into a specific monthly injection, sometimes, with 0 side 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 incredibly optimistic therapeutic implications for everything out of certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver function ailment which afflicts up to twelve % of the US public, and up to twenty six % globally.
But the real emergent and potentially transformational program for leronlimab, as I have said 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 situations of COVID infections.
Leronlimab evidently prevents the CCR5 receptor from over-responding to the virus and launching the now household word “cytokine storm”. Some proportion of clients apparently return from the brink after 2 treatments (and in some instances, 1 treatment) of leronlimab, even if intubated.
The company finished enrollment of a level 2b/3 trial on December 15 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 phase concluded on January 12-ish, and if the outcomes are good, this will make leronlimab a premier treatment for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Even though the vaccines which are currently dispersing are definitely lending hope for a normalization of modern society by mid-2021, the surging worldwide rates of infection mean the immediate future is already overwhelming health care systems throughout the world as more and more people call for utilization of Intensive Care Unit hospitalization.
During my 1st job interview with Dr. Nader Pourhassan back found March of 2020, his extreme enthusiasm for the prospects of this drug’s efficacy was apparent.
This was prior to the now raging next trend had gathered heavy steam, and also he was then discovering patients that were receiving leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
At the time, although, this small independent biotech without significant funding along with a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting ready to apply for a listing on NASDAQ, along with the deck was stacked from it.
Full Disclosure: I own 10,000 shares at an average price of $6.23
Although the planet focuses breathlessly on the optimism for a new vaccine to restore their community liberties, the 10 ish portion of COVID infectees that descend into the cytokine storm driven ARDS literally have their day saved by this apparently versatile drug. For them, a vaccine is pretty much useless.
This drug has “blockbuster potential” written all over it.
With 394 clients enrolled in the Phase 2b/3 trial as of December sixteen, and first data expected this week, a demonstrable consistency in the information is going to capture the world’s attention in probably the most profound way. Quick sellers could be swept apart (at the very 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 now, with an extra 2.5 huge number of ordered for each of 2021 and 2022 in a manufacturing arrangement with Samsung, based on the CEO of its.
really if leronlimab/PRO 140/Vyrologix is so great, how come the stock’s been stuck in sub 1dolar1 5 penny stock purgatory for so long?
The speedy answer is “OTC”.
Apart from struggling with a share price under three dolars, the company hasn’t been equipped to meet and maintain certain different quantitative prerequisites, including good shareholders’ equity with a minimum of five dolars million.
But in the NASDAQ community, you can find non quantifiable behaviours by organizations that can cause waiting times to NASDAQ listings. Overtly promotional communications are among such criteria which won’t ever lead to a refusal letter…nor a NASDAQ listing.
Most importantly, Cytodyn in addition has not been equipped to access capital under traditional means, because of its being listed on the OTC, along with consequently un attractive on that foundation alone to white shoe firms.
So, they have been cut down to accepting shareholder-hostile OID debentures with ugly sales terms that produce a short-seller’s damp dream.
In November, they borrowed 28.5 huge number of from Streeterville Capital of which only twenty five dolars million was given to the company; $3.4 huge number of will be the discount the Streeterville areas, and $100k is actually set aside to protect the expenses. Streeterville is related with Illiad Research and Trading, which is controlled by John Fife of Chicago Ventures Inc. Iliad has been known as a “legendary so called toxic lender”, by rival research firm Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the terms of the deal, Cytodyn has to pay back $7.5 million per month. In case they do not possess the cash, they spend in stock; the majority of not long ago, within a conversion cost of $3.40 a share.
These days just imagine when you’re an opportunistic low-rent lender and you have gained an assured 2.2 million shares coming the way of yours in the earliest 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 is not operating on the hope that Cytodyn stock could go parabolic in the event that leronlimab is deemed a cure for ARDS; the online business model of his is to limit risk and optimize upside via discounted transformation of share.
This’s the quick seller’s wet dream I am discussing. Not only is definitely the lender enticed to go brief, but any short trading container dealer in town who could fog a mirror and read an EDGAR filing know that every month, like clockwork, there’s going to be two million+ shares hitting the bid lowered by to $3.40.
The SEC isn’t impressed, additionally, on September three, 2020, filed a criticism.
The Securities as well as Exchange Commission these days filed charges from John M. Fife of Companies and Chicago he controls for acquiring and marketing more than twenty one billion shares of penny inventory without registering as a securities dealer with the SEC.
The SEC’s complaint, alleges that in between 2015 and 2020, Fife, and his businesses, 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, frequently involved in the business of purchasing convertible paperwork at penny stock issuers, transforming the notes into shares of stock at a major discount from the market cost, and selling the newly issued shares to the market at a sizable profit. The SEC alleges that Fife and his companies involved in around 250 sports convertible transactions with roughly 135 issuers, sold more than twenty one billion newly issued penny stock shares to the industry, and obtained more than sixty one dolars million in profits.
Streeterville Capital isn’t stated as an entity in the complaint. Which implies that it was probably applied by Cytodyn and Fife to stay away from detection by the SEC this very same plan was getting perpetrated on Cytodyn within the time of the complaint of its.
But that is not the sole reason the stock cannot observe some upward momentum.
The company has been offering inventory privately from ridiculously minimal prices, to the point where by one wonders just who exactly are the fortunate winners of what amounts to free millions of dollars?
Moreover, beginning in the month of November 2020 as well as for each of the second five (5) calendar months thereafter, the Company is obliged to reduce the outstanding sense of balance with the Note by $7,500,000 a month (the “Debt Reduction Amount”). Payments the Company makes under the Prior Notes will be credited to the payment of each month Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % prepayment premium.
Likewise detracting from the business’s shine is the propensity of management for excessively marketing communications with shareholders. During an investor webcast on January 5th, the company had a compilation of sound testimonials from clients making use of PRO 140 for HIV treatment, backed by tear-jerking music, and replete with emotional language devoid of data.
Worse, the company’s cell phone number at the bottom level of press releases comes with an extension for Mike Mulholland, the CFO, and Nader Pourhassan, the CEO, but neither one is a “valid extension” based on the automated system.
That is the sort of approach that the FDA and SEC view unfavourably, and it is likely at minimum in part the reason for the continued underdog status of theirs at both agencies.
The company has also become unresponsive to requests for interviews, and so with the story coming out under only these ill advised publicity stunts, shorts are attracted, and big money investors, alienated.
But think of this specific “management discount” as the ability to purchase a sizable job (should a person be so inclined) found what may very well prove to be, in a question of weeks, given that the best treatment for severe COVID19 associated illness.
I expect the data from the trial now concluded for only such an indication may release the organization into a whole new valuation altitude that will permit it to overcome these shortfalls.
Average trading volume is actually continuous above 6 million shares a day, and before the conclusion of this week, we’ll find out just how efficient leronlimab/PRO 140/Vyrologix is actually at saving lives from the most severe of COVID 19. If the results are good, this can be a big winner.
Cytodyn Inc (OTCMKTS:CYDY)