Cytodyn (CYDY) Phase 2b/3 Trial Results Expected Any Day
Cytodyn Inc (OTCMKTS:CYDY), a late-stage biotech drug designer, has already delivered a win for Wealthpress members from our 1st feature returned in April this season. Billions have been invested into a huge selection of biotechs all competing to develop a cure or maybe therapy for severe COVID 19 instances which result in death, and none have been successful. Except for Cytodyn, if early indications are verified in the present trial now underway.
But after a serious jump on the business’s monetary claims and SEC filings, a picture emerges of business management functioning having a “toxic lender” to funnel severely discounted shares to the lender frequently. An investment in Cytodyn is actually a purely speculative bet on the part of mine, of course, if the anticipated upward price movement doesn’t manifest 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 company’s drug does in fact reliably save life in danger of severe-to-critical COVID19 individuals, subsequently a groundswell of investor support may force the organization into new, higher-grade relationships, which would permit for the redemption of debentures and elimination of reliance on fly-by-night financings for instance those discussed below.
Cytodyn’s sole focus is developing therapies used on a monoclonal antibody called “leronlimab”, technically called “humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)”. This engineered antibody was purchased 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 $10 million plus a five % net royalty on business sales.
The drug was acquired on the early promise of its as an HIV treatment, for which continued research as well as development by Cytodyn has demonstrated the capability to reduce regular drug cocktails with myriad pills into a specific monthly injection, sometimes, with 0 adverse reactions. 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 optimistic therapeutic implications for everything from certain solid tumours to NASH (Non-alcoholic steatohepatitis), the liver feature disorder which afflicts up to 12 percent of the US population, and up to 26 % globally.
But the real emergent and potentially transformational program for leronlimab, as I have said at the beginning, (which is now getting branded as Vyrologix by Cytodyn), is made for the Acute Respiratory Distress Syndrome (ARDS) caused by COVID 19 which precludes the Sequential Organ Failure wearing fatal situations 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 apparently 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 stage 2b/3 trial on December 15 to “evaluate the efficacy as well as safety of leronlimab for clients with severe-to-critical COVID-19 indications is actually a two arm, placebo controlled, double blind, randomized, adaptive design multicenter study,” based on the company’s press release.
This trial phase concluded on January 12 ish, and if the results are positive, this will make leronlimab a top therapy for ARDS.
Cytodyn Inc (OTCMKTS:CYDY)
Although the vaccines which are presently circulating are surely lending hope for a normalization of modern culture by mid 2021, the surging worldwide rates of illness mean the immediate future is right now overwhelming health care systems throughout the world as more and more people require ability to access Intensive Care Unit hospitalization.
During the 1st job interview of mine with Dr. Nader Pourhassan returned found March of 2020, the extreme enthusiasm of his for the prospects of the drug’s success was evident.
It was prior to the currently raging second wave had gathered vapor, and he was then seeing patients which were getting leronlimab underneath the FDA’s Emergency Investigative New Drug exemption.
Within the time, even thought, this little independent biotech with no big funding and a decidedly unfortunate public listing on the naked short-sellers’ dream OTC marketplace was getting able to put on for a listing on NASDAQ, as well as the deck was stacked from it.
Full Disclosure: I own 10,000 shares from an average cost of $6.23
Even though the world focuses breathlessly on the optimism for the latest vaccine to restore their community liberties, the 10-ish percentage of COVID infectees who descend into the cytokine storm-driven ARDS actually have their lives saved by this apparently versatile drug. To them, a vaccine is pretty much pointless.
This drug has “blockbuster potential” written all over it.
With 394 clients enrolled with the Phase 2b/3 trial as of December 16, and first information expected this week, a demonstrable consistency in the information will capture the world’s attention in probably the most profound way. Quick sellers may be swept aside (at least temporarily) while the business’s new share priced amounts qualify it for NASDAQ listing.
Cytodyn management says it’s 700,000 doses all set for sale now, with an additional 2.5 million ordered for each of 2021 and 2022 in a manufacturing arrangement with Samsung, according to its CEO.
so if leronlimab/PRO 140/Vyrologix is very great, how come the stock’s been stuck in sub 1dolar1 five penny stock purgatory for so long?
The fast answer is “OTC”.
Apart from struggling with a share price under three dolars, the company hasn’t been in a position to meet and keep some different quantitative requirements, including good shareholders’ equity of at least $5 million.
But in the NASDAQ community, one can find non-quantifiable behaviours by businesses that cause delays to NASDAQ listings. Overtly promotional communications are among such type of criteria which will never cause a refusal letter…nor a NASDAQ listing.
More to the point, Cytodyn in addition has not been able to access capital under standard ways, thanks to its being mentioned on the OTC, along with consequently un-attractive on that foundation alone to white colored shoe firms.
Thus, they have been cut down to accepting shareholder-hostile OID debentures with unsightly sales terms that create a short-seller’s stormy dream.
In November, they borrowed 28.5 zillion from Streeterville Capital of which just twenty five dolars million was paid to the company; $3.4 million is the discount the Streeterville pockets, and $100k is actually reserved to cover the bills. Streeterville is actually related with Illiad Trading and Research, that is controlled by John Fife of Chicago Ventures Inc. Iliad has been termed as a “legendary so called toxic lender”, by rival research tight Utopia Capital Research.
Cytodyn Inc (OTCMKTS:CYDY)
Under the phrases of the price, Cytodyn has to pay back again $7.5 million every month. In case they do not possess the cash, they pay inside stock; the majority of not long ago, at a sales cost of $3.40 a share.
These days just imagine when you’re an opportunistic low-rent lender and you’ve gained a certain 2.2 million shares coming your way in the very first 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’s not operating on the expectation that Cytodyn stock might go parabolic if leronlimab is deemed a cure for ARDS; his business model is to limit risk and optimize upside through affordable conversion of share.
This’s the short seller’s wet dream I am discussing. Not only is definitely the lender enticed to go short, but any short-trading container dealer in town who could fog a mirror and go through an EDGAR filing know that every month, like clockwork, there is going to be 2 million+ shares hitting the bid lowered by to $3.40.
The SEC isn’t impressed, in addition, on September three, 2020, filed a criticism.
The Securities and Exchange Commission today filed charges from John M. Fife of Chicago and Companies he controls for obtaining and marketing much more than twenty one billion shares of penny inventory without the need of registering as a securities dealer while using the SEC.
The SEC’s complaint, alleges that between 2015 and 2020, Fife, and also his businesses, Chicago Venture Partners, L.P., Iliad Research in addition to the Trading, L.P., St. George Investments LLC, Tonaquint, Inc., in addition to the Typenex Co Investment, LLC, frequently involved in the company of buying sports convertible paperwork at penny stock issuers, converting these notes into shares of stock at a big discount from the market cost, and offering the freshly issued shares to the marketplace at a significant profit. The SEC alleges that Fife and his companies interested in over 250 sports convertible transactions with approximately 135 issuers, sold greater than 21 billion newly issued penny stock shares to the market, and obtained more than $61 million in profits.
Streeterville Capital isn’t stated as an entity in the complaint. Which implies that it was likely applied by Cytodyn as well as Fife to stay away from detection by the SEC this very same plan was being perpetrated on Cytodyn at the time of its complaint.
But that is not the only reason the stock can’t keep any upward momentum.
The company has been offering inventory privately from ridiculously low prices, to the position where by one wonders just that exactly are the fortunate winners of what amounts to no cost millions of dollars?
Additionally, starting inside the month of November 2020 and for each of the following five (five) calendar days thereafter, the Company is actually obliged to bring down the outstanding harmony belonging to 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 to the transaction of each monthly Debt Reduction Amount. The Debt Reduction Amount payments aren’t be subject to the 15 % prepayment premium.
Likewise 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 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 telephone number at the bottom part of press releases has an extension for Nader Pourhassan, the CFO, and Mike Mulholland, the CEO, but neither one is a “valid extension” based on the automatic system.
That’s the type of approach that the FDA and SEC view unfavourably, and is likely at least in part the reason for the continued underdog status of theirs at both agencies.
The company also has come to be unresponsive to requests for interview, and thus while using story coming out less than merely these ill-advised publicity stunts, shorts are actually attracted, and huge money investors, alienated.
But think of this particular “management discount” as the chance to purchase a sizable role (should a person be so inclined) contained what could really well turn out to be, in a matter of weeks, given that the leading therapy for serious COVID19 associated illness.
I expect the data from your trial now concluded for just such an indication can launch the organization into a complete new valuation altitude that will allow it to overpower these shortfalls.
Average trading volume is steady above 6 million shares one day, and right before the end of this week, we’ll learn just how efficient leronlimab/PRO 140/Vyrologix is at saving lives from the worst of COVID 19. If the outcomes are good, this may be a huge winner.
Cytodyn Inc (OTCMKTS:CYDY)