We continue to wait for The NaDDir*, and his klown krew, at everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) to actually reveal the top line results from the CD12 study of loserlimab for Severe-to-Critical Chinese Coronavirus Disease. With all of this extra time, we will continue our look back at Cytodyn’s long history of broken, empty, promises. Failing to deliver is a bit of a specialty for the klown krew.

Many readers are aware of Cytodyn’s laughable promises of using their drug as a monotherapy for HIV treatment. Why laughable? Because even if you take the company at its word (we don’t), loserlimab only blocks one strain of HIV (there are two strains). This is why the existing, approved, drug on the market, maraviroc, which does exactly what Cytodyn’s drug does, is not used for monotherapy. There are other drugs already on the market, like Trogarzo, that block both strains. And there are other drugs further ahead in development from Viiv and others, including a once-every-six-month subcutaneous treatment, from Gilead (GILD). Read more about those here.

For over four years Cytodyn has been running its Phase 3 HIV monotherapy trial, often referred to as CD03. Details can be found here. The trial started in August 2016, although the company has been eerily silent about it for a little over two years.

For quite some time, Cytodyn press releases carried a little bit of boilerplate about the trial at the bottom. Here is an example from the 2nd of Sept 2020:

Just a few weeks later, on the 20th of September, the boilerplate changed:

Sometime in mid-September 2020, the CD03 trial has been completed. Yet five months later there is still no press release announcing results, no 8k has been filed with the SEC, and the klown krew could not even update Clinicaltrials.gov records. Seems strange for a Phase 3 trial of a supposedly revolutionary treatment. The only clues we have about how the trial had been faring are from an interim look at the data. The company issued a press release in November 2018 stating:

Unlike 2020’s CROI debacle, which we looked at a few days ago, this time the poster actually was available at the conference. You can look it up here, and download the poster for yourself here. What you will find is, well, not good. The interim look at CD03 caught all of the patients in the 350mg dose group (which is actually 2 injections of 175mg each), the 525mg group (3 injections x 175mg) and only some of the 700mg dose group (yes…even more injections!). While The NaDDir* loves to mention the handful of patients that have done well on conference calls, does he ever mention the huge numbers of patients that failed on loserlimab monotherapy? See the boxes entitled Virologic Failure. Here is a hint for biotech neophytes, failure is bad:

Well even though monotherapy is singularly unimpressive, at least they have that safety record to tout, right? It is true that injection site reactions appear to be uncommon. The same cannot be said about other Adverse Events (AEs).

Anywhere from 48% to 75% of subjects experienced at least one AE. Somewhere between 3.5% and 8.4% of patients experienced a Serious Adverse Event (SAE). One might notice the Cytodyn never reveals exactly what these AEs are, nor their grade. The bulls might say, “oh, but the company says ‘None of the reported SAEs were definitely or probably related to PRO 140.’ that means it is safe.” According to whom? The company? The company’s hired gun CRO? The investigators who may have tremendous conflicts? What of the possibly related SAEs and the unlikely but possible ones?

Of course the easiest way to know the CD03 trial failed is just to look at the boilerplate of recent Cytodyn press releases, like the one from earlier this week. Notice what the company says about the CD02 trial versus the CD03 trial (and the CD10 trial for good measure). Here’s CD02:

And CD03:

And for fun, CD10:

What a difference that one little word in the boilerplate makes. The late 2019 pivot to cancer, and the 2020 pivot to Chinese Coronavirus Disease makes all the more sense. Will we ever see the real, complete, CD03 results? Will we ever see the real, complete, CD10 results? And will we ever see the real, complete CD12 results? Or will we just see the next pivot?

* 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.

We continue to wait for The NaDDir*, and his klown krew, at everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) to actually reveal the top line results from the CD12 study of loserlimab for Severe-to-Critical Chinese Coronavirus Disease. Since The NaDDir* is giving us extra time, we will continue our look back at Cytodyn’s long history of broken, empty, promises. Failing to deliver is a bit of a specialty for the klown krew.

For example, a little over a year ago, we recalled seeing a press release touting both a presentation by Jonah Sacha, PhD., and a new clinical trial in Thailand, testing loserlimab as an HIV Pre-Exposure Prophylactic (PrEP). Try as we might, however, we could not find it on the Cytodyn website, although the press release still shows up on Bloomberg, Yahoo Finance, and other sources. Here is the timestamp from Bloomberg:

Yet on the Cytodyn website there is now a gap where the Jan 27th press release used to be:

Why did it disappear? Reading on from the headline we might get some clues:

First, Jonah Sacha is not a medical doctor, his work is on animals. Any abstract by Sacha would have nothing to do with the use of loserlimab as PrEP for HIV in humans. But more importantly, outside of this press release’s claims, there is no evidence of this presentation at the CROI conference in 2020. Here are the details from the press release:

Try as we might, we could find no record at all of such a presentation on the CROI 2020 website. Not in the Abstract E-Book, not in the online search tool. Nothing. Don’t believe that? Try it for yourself here.

Somewhat amazingly, four months later, back when the company took live questions on their conference calls, The NaDDir* stumbled through a weird excuse as to why this never materialized:

Surely then, the Cytofans would argue, that was just a mistake and rest of the press release was true. The part about doing a PrEP study with loserlimab in Thailand:

You remember, the one they had been touting since at least June 2019:

Would you be surprised to learn that the Thai PrEP trial, like the CROI presentation by Sacha, never happened?

So there you have it. Just one of the press releases from 2020 that Cytodyn would rather readers forget. There are well over 100 more press releases from 2020 for us to explore together, as we await the denouement.

*Spelled thusly for a double dose of that sweet sweet stock pimpin’

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.

Another day, and we finally get a press release from The NaDDir* and his klown krew at everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY). Sadly they have yet again denied the world the top line results from the CD12 study of loserlimab for Severe-to-Critical Chinese Coronavirus Disease. Instead, seemingly to break the monotony, this morning they decided to tell Cytofans everywhere (and we count ourselves among the fans of this ever more crazy circus) to go pound sand for another two to three weeks. Yet again we wait. To call a Cytodyn press release, like the one this morning, curiously worded, is redundant at this point:

Everyone at HQ is quite surprised that The NaDDir* needs two to three more weeks to craft a new story for the suckers. At least this gives enough time for Fife to get his next monthly $7.5mm payment before the bottom falls out.

*Spelled thusly for a double dose of that sweet sweet stock pimpin’

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.

For a month The NaDDir* and his klown krew at everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), have kept the world waiting for the top line results from the CD12 study of loserlimab for Severe-to-Critical Covid-19. Keen readers already know that, regardless of the outcome, an EUA for loserlimab in the USA is virtually impossible at any time (see why here). While the world waits, the curmudgeons at BuyersStrike! HQ thought it might be fun to look back at some of the other developments Cytodyn has promised and never delivered.

It has been a little over seven weeks since Cytodyn announced what they claim to be an “Open Label Extension” would be added to the CD12 study. The hype began on Christmas Eve, 2020:

A follow-up press release was issued a few days later,on the 28th:

Leaving aside Cytodyn’s complete misunderstanding and misrepresentation of what an Open Label Extension actually is, for such a monumental achievement that warranted two press releases, there was no corresponding 8k filed with the SEC. What does that mean? Simply put, any time you see a press release but no corresponding 8k, the “big news” is actually completely immaterial.

An 8k is not the only thing missing. Even though it has been 6 weeks since the protocol amendment has been supposedly accepted by the FDA, there is no evidence of any OLE for the CD12 study on Clinicaltrials.gov. See for yourself here. The most recent updates to the CD12 trial records are from mid-November, 3 months ago!

Does the OLE exist only in Cytodyn press releases and The NaDDir’s* imagination?

*Spelled thusly for a double dose of that sweet sweet stock pimpin’

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.

For a few weeks now paid touts and retail fans were pushing a bizarre conspiracy theory about everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), and epic news to come on January 21st, 2021. Their fantasies included full approval of loserlimab for Covid-19, or an EUA for loserlimab in the USA (virtually impossible at any time, see why here), or an EUA in the Philippines (also impossible, see why here), or an “uplisting” (to use the moron-term, the correct term is “initial listing“) to NASDAQ (also virtually impossible, see why here), or getting Medicare reimbursement (A fantasy based on a monumentally flawed understanding of CMS codes. Hint: Codes that begin with “X” are for experimental treatments, not for approved products), or any of a dozen other fever dreams.

One thing that the Cytodummies likely did not expect to occur on January 21st, 2021 was the complete evisceration of their dreams of HIV riches:

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Remember when, in late July 2020, 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 2020 when this post explained why a Nasdaq listing was a virtual impossibility. Or in October 2020, when this post explained why it was still a virtual impossibility.

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