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Who’s STILL Not Participating in CYTODYN’S Ridiculous Loserlimab Trial? (CYDY)

While we wait for everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), to finally release the much hyped, and delayed-yet-again (see last night’s press release from the Cytocrew here and an absolute howler of stock promoting stupidity here), interim results from their latest trial (sometimes called CD12) of loserlimab (sometimes called PRO140 or leronlimab) in Severe-To-Critical Covid-19, let’s catch up on what the company has been up to the last few weeks.

Since announcing that the interim enrollment milestone was reached on August 25th the company has had several arduous tasks in front of it:

First, The NaDDer* and his trusty clinical trial wizard, Kooosh Doody had to remember that August has 31 days, so they needed to check on whether the last patient was dead or alive on September 22nd. Then they needed to tally up all the mortality events. It took these geniuses eight days, but they did it, and on September 30th they announced to the world that there were, supposedly, 45 deaths in the trial.

Supposedly? Because it seems they weren’t exactly sure, that’s why that little tilde is hanging out there before the ’45’. Those complicated ordinal numbers. The rigors of higher math. After the deaths are counted, the Data Safety Monitoring Committee (DSMC) is usually the team tasked with seeing if the deaths occurred in Group A or Group B, putting those numbers into a spreadsheet (one so simple any 1st semester or AP Stats student could do it in under 5 minutes), determining if there is a statistically significant difference between the groups, making a recommendation, and finally reporting the results.

What should have taken 15 extra minutes on the 30th of September, takes an additional 20 days in Cytoworld.

While all this has been going on, of course, Cytodyn and the CD12 trial have not been standing still, or have they?

Recall that in late August two sites, Eisenhower Health in California and Yale-New Haven in Connecticut, dropped out of the CD12 trial (read more about that here). One might also recall that on August 20th Cytodyn claimed they would start enrolling patients in the UK “immediately”

On September 2nd they backtracked on that claim, but insisted that UK study could now be “officially initiated”:

Guess that wasn’t true either, because on the 30th of September the company provided this update on clinical trial enrollment in the UK:

Fast forward to today, the 16th of October, and a peek at the list of trial locations on both Clinicaltrials.gov and Cytodyn’s own website, show that the September 30th “update” was just another empty promise (polite term for bullshit) from the Cytodyn Klown Krew. There are still no UK sites for the CD12 trial. Both sources show 14 sites, and not a single one in the UK.

Even if progress in the UK has been stalled, the company surely must be chugging along in the USA, right? After all, as The NaDDer* constantly tells his loyal shareholder base “we are in pandemic!”.

How is trial enrollment going? We know from the press release cited above that on August 25th there were 195 patients enrolled. From a depressing (for Cytodyn believers) presentation given by Dr. Harish “Sad Sack” Seethamraju (available here) it was revealed that on September 4th enrollment was up to 220 patients.

Which makes the trial update from the 30th of September from above all the more curious. Why? Look again:

Why would there be no additional patients enrolled in almost a month? Want our guess?

Simple: “Pausing” a trial by stopping enrollment means never having to say it failed….the company can just pivot to the next pipe dream.

All is not lost, however, the Klown Krew has actually been hard at work. They did manage to get the shareholders to approve a huge, partially retroactive, options package for them on the 30th of September. They even filed an S-8 to register those shares later that same day (see here)! And the next day filed a flurry of Form 4s with the SEC to show where the goodies were distributed. Enrollment might be paused, the study might have failed, but The NaDDer* never stops cashing in while double-dosing the retail shareholder base with his sweet sweet stock pimping.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

*The NaDDer

Update: What Exchange Won’t Cytodyn Be Listed On This Month/Quarter/Year? (CYDY)

Remember when, in late July, everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) told investors that they expected to be listed on the NASDAQ within 5 to 6 weeks?

Perhaps you recall back in August when this post explained why a Nasdaq listing was a virtual impossibility.

This morning the company issued its latest 10Q, with updated (albeit unaudited) financials, detailing the results of the quarter ending August 2020. No matter the spin that The NaDDir* or CFO Mike Mulholland tries to deliver, the dream of a Nasdaq listing remains a ludicrous fantasy. Just another carrot to dangle in front of the deluded cultists.

And with updated financials from the company, it is time to update our BuyersStrike! prediction. Are you ready? Once again:

Cytodyn (CYDYwill not get “uplisted” to the NASDAQ. Not to the Nasdaq Capital Market, not to the Nasdaq Global Market, and certainly not to the Nasdaq Global Select Market.

Why not?

Simple math. Here are the listing standards for the Nasdaq Capital Market, the least stringent of the Nasdaq tiers:

A company seeking to list must meet all of the criteria under one of the three standards. Unfortunately for Cytodyn, it still fails to meet the requirements for all three standards. Remember that the listing criteria are based on the most recent audited financials, filed by the company in August.

The current financials, filed by the company on October 9, 2020 (available here), are unaudited. But even if we pretend that these figures are audited, Cytodyn still fails the Stockholder’s Equity test. That information is on the Balance Sheet which can be found on page 3 of the recent 10Q (Don’t know what a Balance Sheet is? Don’t know what Stockholder’s Equity is? Well then, you are PERFECT for Cytodyn, and the bucket shop brokers at Paulson probably have many more shitstocks for you). Here is the relevant section:

While Cytodyn has finally flipped over from Stockholder’s Deficit to having positive Stockholder’s Equity, unfortunately for Cytodyn longs dreaming of a listing on Nasdaq, 2.8mm < the required $4mm or $5mm.

There is no way, under these listing standards, for Cytodyn to get a listing.

“But wait,” the Cytodummies may say, “what IF we somehow met the Shareholder’s Equity requirements? After all The NaDDir keeps promising us he can fix it quickly.”

Even then the company would not qualify. Why?

And it is easy to see that if the company applied for a listing today it fails the minimum bid price requirement of $4. One need only look at the price of the stock the last two weeks, let alone 90 days.

“But but but”, cry the Cytodummies, “what about the Closing Price Alternative?” Great question. Let’s examine it,

Under this alternative test, the company needs to meet the lower closing price bar of $2 (which it does) and the Net Tangible Assets test. What’s that? Here’s a definition.

To simplify: Net Tangible Assets = Total Assets – Intangible Assets – Total Liabilities – Par Value of Pfd Stock

Where to find this information? Remember that pesky Balance Sheet? Let’s take another look:

OK, we have our Total Assets of $93,362,000 and our Intangible Assets of 12.959,000.

Our Total Liabilities of 90,594,000.

Plugging those numbers into the complex NTA formula gives us the following:

93,362,000 – 12,959,000 – 90,594,000 = -10,191,000

Ooops! Cytodyn’s Net Tangible Assets are still negative. Last time we checked here at BuyersStrike HQ! -10mm < +2mm. Which means the company cannot use the Closing Price Alternative.

Of course, the company knows all of this (and now you do too). Any spin they dish out about a potential listing is misleading hype designed to keep their shareholder base dreaming.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

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Reader Mailbag – Breakthrough Therapy Edition (CYDY)

Commenter Tom recently asked a very good question. To paraphrase, “everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) had bad news from the FDA but I can not find it on the FDA site. Can you help?” Certainly.

The answer to Tom’s question should be quite illuminating to readers unfamiliar with the FDA, clinical trials, and the drug approval process. Before we begin, it would be helpful to review the Maxims, especially Maxims 19 and 20.

Cytodyn often talks about “Breakthrough Therapy Designation” for loserlimab. Like in this press release from the 13th of January 2020:

So just what is Breakthrough Therapy Designation (BTD)? You can read all about it here. To briefly summarize, it is a stack of forms that a company fills out and sends to the FDA along with preliminary clinical evidence. The evidence must back up the company’s belief that the treatment may show a substantial improvement, on at least one clinically significant endpoint, over available therapies.

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Who Else Is Suing Cytodyn Now? (CYDY)

[Catch up on Cytodyn’s seemingly doomed quest for a NASDAQ listing here, and click here to learn more about who is participating in the much hyped CD12 trial of loserlimab.]

Back in late April, we looked at two rather interesting lawsuits filed against everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY). Both of those suits were filed by former insiders against the company and current management.

Just last week another suit was filed against Cytodyn. In this one, Florida Circuit Court of Miami Dade County Case 2020-020074-CA-01 (available here) Shift Media Lab is suing Cytodyn for failure to pay its bills.

So who is Shift Media Lab, and what were they doing for Cytodyn? There isn’t much about Shift on the interwebs. According to the complaint they were engaged to provide “services” to Cytodyn for three months at $25,000 per month.

And just what might those “services” have been? If one looks carefully at Cytodyn’s disclosure statement to OTC Markets, Shift appears in the rogues’ gallery of what can kindly be described as stock promoters.

Is there a term for disgruntled not-paid promoters?

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

The Death Tape (CYDY)

One message that bears repeating is that all cults, and all cult stocks, share the same basic characteristics. However some cults are crazier than others, more self-destructive, some cult members more obedient to their masters, more deluded, more willing to hold on to tightly held beliefs, more determined to bring down the supposed enemies of the only true saviors of the world. Learn more about cults and the amazing resilience of false belief in their members here.

Everyone’s favorite reverse-merger, pink sheet, Coronacrapper, Cytodyn (CYDY) is one such cult. Beyond the tacit admission that the company had been lying about enrolling patients in the UK, and obfuscations around their attempts to secure an EUA for loserlimab in the USA, yesterday afternoon’s Cytodyn conference call (replay here) reminded the curmudgeonly staff at BuyersStrike! HQ of one only thing: The Jonestown Death Tape. The NaDDir* was playing the part of Jim Jones, clueless retail shareholders, desperate trial patients and their families playing the part of the members of the People’s Temple.

We can envision the Netflix mini-series now:

The NaDDir*: The vat, with the green leronlimab please. Bring it here so the long-haulers can begin … beg you, don’t, don’t, fail to follow my advice, you’ll be sorry … you’ll be sorry … (unintelligible word) … that we’ll do it than that they do it.

Paid Promoters in the Background: That’s right, that’s right.

The NaDDir*: … Must trust, you have to step across … We used to sing: “this world, this world’s not our home.” Well, it sure isn’t. … We were saying, it sure wasn’t … Really doesn’t want, you’re telling me. All he’s doing is what we’ll tell him. Assure these … Can some people assure these patients of the relaxation of stepping over to the next plane? That’d set an example for others. You set 1,000 people who say, “We don’t like the way the world is ….

Shareholders: That’s right, that’s right.

The NaDDir*: … (unintelligible words) … take our life from us, we laid it down, we got tired. We didn’t commit suicide. We committed an act of revolutionary suicide protesting the conditions of an inhumane world.. …

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Just Who IS Participating in Cytodyn’s Loserlimab Coronavirus Trial? (CYDY)

Our last post (catch up on it here) discussed the August 31, 2020 updates to the ongoing Covid trial run by everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY). Together we looked at the strange disappearance of Yale and the complete absence of any trial sites in the UK. Some people complained that the curmudgeonly crew at BuyersStrike! HQ only looks at the negatives swirling around Cytodyn, and not the positives. “Why look at the sites that aren’t there, instead look at the sites that are there.” Spoiler Alert: Be careful what you wish for.

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Quick Take: Who’s Not Participating in Cytodyn’s Ridiculous Loserlimab Trial? (CYDY)

One thing that The NaDDir* didn’t address on last week’s bizarre conference call by everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), was the recruiting status of the much vaunted “CD12” study of loserlimab in severe-to-critical Covid-19 patients.

Recall that prestigious Ivy League university in Connecticut that was participating in the study (but never actually recruited a single patient?). Sure you do. Here’s the Clinicaltrials.gov record of study locations as of mid-August:

On August 31st, the company quietly deleted Yale from the trial location list (and it looks like Eisenhower Health in California dumped CYDY too).

And speaking of trial sites, remember that press release back on August 20th, where Cytodyn claimed that they received authorization to enroll UK patients, commencing immediately, into its ongoing Covid-19 trial?

Go back and review the list of trial sites as of August 31st, available here. Interesting that there are no UK sites listed. Not one. On the conference call last week, The NaDDir* did make some curious comments about UK trial enrollment:

“We received great news today. UK ethical committee approved CD12 study to be conducted in the UK. Now, the study can officially be initiated. Please also see our MHRA comments below”. They have recommended, CytoDyn to resubmit the CytoDyn CD12 COVID-19 study to the urgent public health, UPH scheme.”

Was the company lying about being approved to begin recruiting UK patients in the August 20th press release? It seems so. And exactly why did the company need to resubmit the study? Was it really because wink wink nudge nudge the UK health authorities love it so much? Or is it (much more likely given Cytodyn’s history), because the original filing was deficient in some way? Or maybe the MHRA (like the FDA with Cytodyn’s pathetic HIV BLA) just wanted a Double Dose of The NaDDir’s* sweet sweet regulatory filings?

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Very Quick Take: Guess Who Won’t Be Funding Cytodyn Again? (CYDY)

Remember the much hyped “institutional investor” that had been repeatedly financing everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY)? John M. Fife and his Iliad Research and Trading outift. Fife is the gentleman who invested $25mm for a $28.5mm face value 10% convertible note (with full ratchet) just a month ago. Catch up on that here.

Sadly, we don’t think he will be funding Cytodyn or any other crapco in the future. The case is US District Court N. IL.1:20-cv-05227.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

But Teh Science Be So Gud: Part 1 – A Brief History of Loserlimab (CYDY)

There is one talking point that almost every bioscam on the verge of collapse eventually reaches for, known at BuyersStrike! HQ as “but teh science be so gud.” We have reached that moment in the saga of everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), when criminal stock promoters, various shills, and the retail shareholder base of complete morons suddenly become “experts” in “teh science”.

So, while we wait for the next delusional ranting from The NaDDir*, and while we wait for the company to fess up that their quest for a Nasdaq listing is clearly doomed, in this series we’ll explore “teh science” behind leronlimab (hereafter known as loserlimab), and explain how it is basically completely useless.

Useless against HIV.

Useless against Cancer

And yes, even utterly useless against Covid-19.

First, we’ll look at the history of loserlimab and what it does, and doesn’t do, with regards to HIV. 

Far from being a new drug, loserlimab can trace its roots back to the late 1990s. Scientists discovered that people carrying a particular genetic mutation, known as “Delta 32” were immune to infection by one strain of HIV (known as “CCR5-Tropic” HIV). People carrying this mutation did not express the CCR5 receptor on the outside of their cells. This gave the CCR5-tropic HIV particles nowhere to latch onto in order to enter the cell. 

After this discovery scientists rushed to create treatments that would mimic this genetic mutation. In 2007 the first of them, Selzentry (also known generically as maraviroc) was approved for sale in the USA. Selzentry blocks the CCR5 receptor on the outside of cells, stopping CCR5-Tropic HIV from entering and doing their nasty business.

Selzentry is a daily pill that is taken in combination with other daily medications. Why in combination? Because as explained above blocking CCR5 only stops one form of HIV. CCR5 blocking monotherapy is a mono-mentally (sic) stupid idea in practice because it would fail to protect from the other form of HIV, known as CXCR4-Tropic. Any company, any tout, any deluded investor who believes that monotherapy to block only CCR5 would be a real breakthrough, and have any commercial potential, is either a con artist, or a mark. 

Although it happens to be the only one to successfully make it onto the market, maraviroc was not the only therapy developed back in the late 90s. There were many other attempts. One scientist who was working on such therapies was William Olson. Along with Paul Maddon and others at Progenics Pharmaceuticals (PGNX) he developed a series of murine (mouse) antibodies to block CCR5. One of them was originally known as PA14

Progenics then hired another firm, Protein Design Labs, to “humanize” the antibody. This process makes antibodies developed in other species, like mice, more tolerable (technically less “immunogenic”) in human patients. The resulting humanized antibody was christened PRO-140

PRO-140 had some interesting attributes. For one, it did not completely block CCR5 receptors. It only bound to a very small part of the CCR5 receptor, just the part necessary for one particular strain of HIV to enter the cell. PRO-140 also does not interfere with normal CCR5 receptor functions. According to Olson:

“Moreover, unlike other candidate CCR5 inhibitors, PRO 140 does not block CCR5’s natural activity

And, because this is a very important point that bears repeating, in another paper by Olson and Maddon, from 2001: 

Because PRO 140 does not induce signaling or downregulation of CCR5, its antiviral effect is probably exerted through a mechanism involving receptor blockade.

Eventually, after playing around with both IV and subcutaneous administration, and seeing the approval of more convenient oral Selzentry (remember that CCR5 blocking therapy MUST be given in combination with other medications in order to treat and block both forms of HIV), Progenics gave up on PRO-140. After putting it on the shelf, a small desperate reverse merger abomination known as Cytodyn came calling, bought it for a small sum, and renamed it leronlimab.

Hopefully, dear reader, you can now see that loserlimab is actually fairly useless against HIV, because it does not protect against both strains. At best one could say that it might protect against only one (the jury is still out, as the drug has not been approved anywhere, for this purpose). 

But, but, but, cry the Cytodummies, what about the plan to “cure” AIDS patients getting bone marrow transplants by adding loserlimab, announced two weeks ago?

StemCellCYDY

Yeah, that won’t work either. Why not? Because it will not protect from the other form of HIV. And this has been known for years

As for cancer, Covid, and the rest? Stay tuned…

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

*UpgrayeddMeme

What Exchange Won’t Cytodyn be Listed on this Week? (CYDY)

Remember back in July when everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) told investors that they expected to meet with the FDA within weeks? Well, get ready for rejection because the company revealed this morning that the FDA has basically told them to go pound sand.

Of course The NaDDir* is spinning this as a way to save time. Which in some ways it is. The FDA should not be wasting its time talking to these clowns. And speaking of rejections, which readers remember when Cytodyn (CYDY) told investors that they expected to be listed on the NASDAQ within 5 to 6 weeks?

Naturally that timetable wasn’t aggressive enough for The NaDDir*, he needed to rally the faithful. He and his trusty CFO continued:

That’s right, The NaDDir* was winding up the Cytodummies to expect a listing within three weeks. Poor Mike Mulholland tried to temper expectations just a little bit, to three to four weeks. Well here we are, the full six weeks later, and it’s time for a BuyersStrike! prediction. Are you ready? The prediction from the head curmudgeon here at HQ:

Cytodyn (CYDY) will not get “uplisted” to the NASDAQ. Not to the Nasdaq Capital Market, not to the Nasdaq Global Market, and certainly not to the Nasdaq Global Select Market.

Why not?

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