Yesterday after the market close, everybody’s favorite pink sheet reverse-merger zombie crapcompany, Cytodyn (CYDY), filed an S-3 with the SEC (read it here) to register nearly 209mm shares of stock for sale by outside investors. The NaDDiR* might be gone, but most of his klown krew remains, and so does the Cytoklowning. In this particular case, it is possible that the company is disqualified from registering stock on a Form S-3.

Obviously, this is something for the Corporate Finance division at the SEC to determine, but lets look at the rules.

Form S-3 is a simpler form allowing companies to register stock for resale by investors. In order to use a Form S-3 (as opposed to the more complicated, and stringent, Form S-1), a company must meet a particular set of criteria available on the SEC website (here). The relevant section for our purposes is I.A.3.(b), which says:

(more…)

Last week,  everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), began issuing a barrage of press releases (read about one here) culminating in one of their now-famous CONference calls, which you can watch here. In these calls, The NaDDiR* and his klown krew mumble incoherently, throw around tons of buzz words, and generally try to keep the suckers happy as the stock promotion lurches from one pivot to another.

On December 9, 2021, one of the Cytodyn press releases trumpeted the filing of an Expanded Access Protocol request by the company with the FDA, to allow for the use of loserlimab in HIV patients. Read it here. Expanded Access allows companies to offer unapproved drugs to patients outside of a clinical trial. Said the company:

Just five days later, on the December 14th CONference call, The NaDDiR* let this slip:

Ooops. A problem with the protocol. Did NaDDiR actually admit they “didn’t do a good job” with the submission? What could be the problem? The FDA accepts ~99% of EA submissions, so what are the reasons why the FDA would reject a submission for Expanded Access? That’s easy. The list is here:

If the curmudgeons at BuyersStrike! HQ had to guess, the FDA probably determined that either under part 2, Cytodyn was not actually pursuing marketing approval with appropriate diligence (ie the BLA submission was a pathetic joke) or part 3, there is not sufficient clinical evidence of effectiveness. Cytodyn only reports the results of one tiny Phase 3 study in HIV, and has offered no confirmatory evidence.

Just more of the endless Cytoklowning from the Klown Krew.

* Spelled Thusly For A Double Dose of That 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.

Starting yesterday, December 8th, everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), has issued a flurry of press releases. As always, it is important to read anything The NaDDiR* and his Klown Krew put out very carefully. Not just for what is said, but for what is unsaid.

One of the December 9th press releases, entitled “CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population” has a classic NaDDiRism:

Of course, this is misleading because the FDA does not APPROVE trials. The FDA only ACCEPTS or REJECTS trial protocols. Legitimate companies that are not trying to hype their prospects to gullible investors use the proper language. Scams and cons, on the other hand?

But that is just routine Cytobullshit. The really interesting bit is this, where they excerpt some communications with the FDA, but fail to provide context:

For months now Cytodyn has been trying to restart the EIND/Expanded Access loserlimab for Covid program, or as we call it here at BuyersStrike! HQ, the perpetual anecdote machine. Naturally, Cytodyn has failed. It appears that back in August and again in November the company asked the agency to accept an Expanded Access program. Expanded Access allows patients to try an unapproved therapy outside of a clinical trial. The FDA has clearly said “no, you have to do a proper trial.”

While this is a flat out rejection, will the company and its shills try to pitch this as some sort of support from the FDA, instead of just a boilerplate rejection letter? After all, didn’t the FDA say the trial “appears feasible“, that has to be good, right?

Actually no, one of the criteria for the FDA to allow Expanded Access to a drug outside of a clinical trial, is that a clinical trial must not be feasible. By stating that running a trial is feasible, the agency is actually telling Cytodyn why their request for Expanded Access was denied.

While this is a flat out rejection, will the company and its shills try to pitch this as some sort of support from the FDA, instead of just a boilerplate rejection letter?

When the FDA gives CYDY lemons, of course The NaDDiR* will try to make lemonade!

* Spelled Thusly For A Double Dose of That 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.

If you are anything like the curmudgeonly crew at BuyersStrike! HQ you probably try to keep a list, mental or otherwise, of all of the ridiculous claims made by everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY). Oftentimes these exaggerated plans deal with very specific countries which seem to flit in and out of press releases with little rhyme or reason.

One of those countries, as you might remember from the Spring of 2021, is Canada. Don’t recall The NaDDiR* hyping up Canada as a potential EUA and even as a revenue source for loserlimab? Of course you do. Here’s a mention from an early March, 2021 webcast:

Not only will CYDY file for an Interim Order, the Canadian equivalent of an Emergency Use Authoriziation, but The NaDDiR* went as far as to suggest they might charge for loserlimab. This was quickly followed up in a conference call later in March:

So, as of March 23, 2021, the company has submitted a timeline to Health Canada, to start the Interim Order process. The NaDDir* gives an update about two weeks later:

Here he claims that on the 15th of April they will submit the necessary paperwork for the Interim Order, and again suggests they might be able to sell product in Canada.

On the 19th of April, Cytodyn announces that it has submitted part, and only part, of the Interim Order application. In a press release the company stated that the remaining sections would be submitted in the very near future:

Two or so weeks later, on another webcast, The NaDDiR* claims the submission could be finished by June, with a decision in July. Now he isn’t so sure they can sell loserlimab, but he promises to ask:

And since then, nothing but crickets from Cytodyn and its Klown Krew about getting an IO, let alone selling product, in Canada?

Dear readers, do you wonder why?

Surprising nobody with an IQ to the right of the median, the request for the Interim Order with Health Canada expired after six months because Cytodyn never completed the application for loserlimab! No actual complete submission was ever made. Sound familiar?

So what did the company actually submit to Health Canada?

See it all for yourself right here. The company knew at least by June 15, 2021 that they would not get an Interim Order from Health Canada, and that the clinical data to support any application would not actually be available until the very end of this year. Did The NaDDiR* ever tell you?

Or did he just pivot to the next country? Brazil? India? Philippines?

* Spelled Thusly For A Double Dose of That 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.

Late yesterday, the 26th of October, one-time-NaDDiR*-favorite, Amarex, filed its response to the lawsuit (Case 8:21-cv-02533-PJM, see here.) initiated by everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY).

Inside the filings are some bombshell documents that The NaDDiR* and his Klown Krew surely never wanted you to see. They most certainly did not want CYDY longs to read any of these before tomorrow’s vote to grant the company an additional 200mm authorized shares, along with insane compensation for insiders.

For a start, how about this insane April 14, 2020, email from the the NaDDiR* to Amarex’s Kush Dhody, in which The NaDDiR, obsessed with the stock price and message board criticism, instructs his Krew to knowingly file an incomplete BLA:

And sure enough the something resembling a BLA was filed, and the company proudly (and falsely) announced that the completed BLA was submitted on the 27th of April:

As we all know, this was a lie. Just over one week later the company backtracked, but hid the disclosure in the boilerplate at the bottom of a press release. Finally, on May 11, they fessed up:

Surprising nobody, except the deluded retail longs who comprise the CYDY shareholder base, the FDA issued a Refusal To File (RTF) letter. For almost a year, The NaDDiR* has, himself, refused to divulge the contents of the letter. Originally The NaDDiR* claimed the issue was just the syringes. If that was true, why is the RTF letter 20 pages long? But today you can read it for yourself. Some choice tidbits:

Ooops. Did the company even file the BLA under the proper pathway? Last time anyone at BuyersStrike! HQ checked, biologics aren’t approved under 505(b)(1) or (2).

Sterility testing? We don’t need no testing because loserlimab “saveZ teH livEz” (at least according to the shills and morons who believe), plus sterility testing takes money away from stock promotion:

Did The NaDDiR* write the “Prescribing Information” section himself?

There is so much more to see in this letter, but don’t take our word for it. Read it for yourself.

* Spelled Thusly For A Double Dose of That 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.

[Editors Note – The following is a guest post that originally appeared almost a year ago. It is about everyone’s favorite reverse-merger pink sheet Coronacrapper-turning-Cancercon, Cytodyn (CYDY) from @B4UConsent, a real life patient with tremendous insight into drug development from both the patient and the clinical trial management perspectives. Given this morning’s nonsensical press release from Cytodyn, it is timely to re-up her thoughts.]

BuyersStrike has generously invited me – patient, investor, blogger at B4UConsent – back to do a guest post on CytoDyn’s TNBC delusions. Happy to help!

Today we sink from the height of scientific rigor and strategic foresight we witnessed with Roche’s IMpassion program to the sewage ditch that is CytoDyn’s attempt to take on – wait for it – triple-negative breast cancer (TNBC). TNBC is, for the uninitiated, the rarest breast cancer subtype, exhibiting no hormone receptors nor overexpressing the HER2 protein, which make patients ineligible for anti-hormonal agents or HER2-targeted agents. Further, this tends to be an aggressive subtype that occurs in younger patients, and it’s associated with the poorest outcomes.

Historically, while TNBC patients have had few treatment options beyond chemo, there have been advances, particularly with immunotherapy. Roche received an accelerated approval for the combination of atezolizumab plus the chemo drug Abraxane, to be used in the first line. Sacituzumab govitecan, from Immunomedics (IMMU) more recently received accelerated approval in third line. Atezo/Abraxane is the standout here, and I have my reservations about sac gov, but there’s no disputing that these accelerated approvals were hard-won on PFS (progression free survival) data. Roche and Immunomedics are now just left to sweat out the wait on those OS (overall survival) numbers.

In contrast, CytoDyn got rid of a fake tumor engrafted on a mouse that one time.

And since in the fever dreams of its retail fanbase, and delusional (at best) management team, leronlimab has already “cured” COVID and HIV, with GvHD and NASH (and MS and Alzheimers, and on and on and on) on deck, why not throw TNBC in the mix? It’s not like it’s hard to design, recruit and run a cancer trial. CytoDyn is generously “keep[ing] the FDA current” on their miracle outcomes, which seem largely limited to meaningless, outdated lab markers (CTCs, really?) and not the more meaningful outcomes we in cancer are all familiar with, things like, “Tumor in lung got 31% smaller.” I’m sure our friends at the Agency are eagerly anticipating these updates and sending them straight to voicemail.

The most telling press release about the garbage this company is peddling is from January 13.

They reference two patients, one of whom is apparently enrolled in the company’s phase 1b/2 study which enrolls previously untreated metastatic breast cancer patients. You can tell a patient to drink more water in the first-line setting and get at least a modest response, which is why it should be a GCP violation to enroll subjects first-line for completely unproven drugs. You get one shot at first-line, one chance to maximize response and the duration of response. We know response rates get lower with each line of treatment.

In this case, the company felt compelled to announce that their first TNBC subject had a reduction in circulating tumor cells (CTCs). This is a) not an endpoint and b) not clinically relevant. No one does CTC tests, and they were never adopted widely because they were useless. They were never sensitive enough; you could be a walking tumor and have a CTC of 0. Plenty of metastatic patients have CTCs of 0, and a CTC result higher than 5 would signal full-on death watch. A more modern and useful marker would be ctDNA, which are small fragments of tumor that are used in the liquid biopsy tests we have from Guardant and Foundation Medicine.

Guess what else? “This patient’s data also demonstrated tumor shrinkage of >20% after just a few weeks of treatment.” Greater than 20%, that sounds good, right? It’s actually not. It means the disease has remained stable. In cancer, we use one guideline to interpret tumor size and response on scans: it’s called RECIST 1.1, and the rules are very clear. As a former medical writer on oncology trials, I can recite them in my sleep: a complete disappearance of disease is a Complete Response, or CR; reduction in disease >25% is a partial response, or PR; change in tumor measurement <25% but not increasing in size by more than 25% is defined as stable disease, which is NOT considered a response; and increase in tumor measurements by >25% is progressive disease, or PD.

So by the accepted laws of oncology, this patient is an SD. The CTCs are meaningless.

And what of the second patient?

She was not enrolled in a trial. She received treatment under an “emergency IND protocol” and is described as having “HER2+ metastatic, stage 4, MBC” and “showed no sign of new metastatic spots in the liver, lung and brain during the treatment with leronlimab.” Yeah, no new lesions is always nice, but what about the lesions she had at baseline? Subsequent press releases also suggest that this patient was receiving other treatment concurrently, so how could we attribute anything positive to the leronlimab?

This nonsense concludes with, “This strong data confirms the power of leronlimab as a CCR5 inhibitor for patients living with mTNBC, and is clearly replicating early animal study results that demonstrated 98% elimination of metastases.” (Emphasis mine.)

What’s that, now? That little mouse had what would probably be classed as a CR. These two patients didn’t even respond.

But why stop at TNBC when the data are so compelling? That’s a tiny little sliver of the cancer population. Aren’t there a lot more cancers to cure and patients, shareholders and innocent bystanders to manipulate?

That brings us to the basket trial, open to all solid tumors, which seems to have just started enrolling a few days ago. “All solid tumors” will apparently be represented in a 30-subject phase 2 at one site, something called “Quest Clinical Research” in San Francisco. Just the name evokes the echelons of scientific development, no?

Let’s review the primary endpoints for this “trial” together, shall we?

1. Number, frequency, and severity of adverse events (AEs)
2. Incidence of abnormal laboratory tests results
3. Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline to subsequent scheduled visits

Are 1 and 2 not the same? And … what is 3 supposed to demonstrate? That is not an endpoint for approval in oncology. The enrollment criteria specify an ECOG status of 0-1 (that’s fully active to slightly less active; by 2, patients are getting pretty debilitated). So we’re looking at a phase 2 with no PFS endpoint. This study is exposed as even more of a sham by a line in the study description section:

Subjects participating in this study will be allowed to receive/continue standard-of-care chemotherapy or radotherapy [sic] as per the dosing schedule included on the package insert.

Let me get this straight. Subjects have the option of staying on therapies that are already working and just adding an experimental agent. What exactly is being tested here? Who would enroll in something like this, and why would anyone let them? Are they trying to design a “study” that can’t fail by deliberately rejecting the efficacy and enrollment standards by which a whole industry abides?

Though we don’t have answers, we do have a lesson: stay away from this bioturd. At least the mouse made it out.

Thanks again to BuyersStrike for having me.

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.