While We Wait 5, What Other Study Results are Cytodyn Hiding? (CYDY)

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.

While We Wait 4, Which 2020 Press Release Does Cytodyn Hope You Have Forgotten? (CYDY)

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.

While We Wait 3, Why Are We Still Waiting? (CYDY)

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.

While We Wait 2, What Happened To The Chinese Deal? (CYDY)

Another day, and still we wait. For over a month The NaDDir* and his klown krew at everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), have denied the world the top line results from the CD12 study of loserlimab for Severe-to-Critical Chinese Coronavirus Disease. To while away the hours, today the curmudgeons at BuyersStrike! HQ continue our fun look back at some of the other developments Cytodyn has promised and never delivered.

A little over a year ago, on the 12th of February 2020, during the earliest stages of its pivot from HIV shitstock to a Coronacrapper, Cytodyn issued a press release (read it here) trumpeting a Letter of Intent for the joint development and licensing of loserlimab in China:

With all things Cytodyn, the reality appears to be very different than the headlines. As always, the first step in verifying anything in a corporate press release is to look for an associated 8k filing with the SEC. Remember, no 8k filing means the supposedly important news is actually completely immaterial. Immaterial is lawyer-speak for what in the real world is called utter and complete bullshit. Sure enough, CYDY never issued an 8k about this Chinese deal. You can find all of the 8k filed by the company in 2020 right here, there is nothing about any LOI with Longen China Group.

There is nothing about Longen China Group in Cytodyn’s annual report filed on Form 10K (read it here) either. Not even a further press release from the company. What about all of the Wuhan flu long-hoooolers in China that Cytodyn could be “saving” right this minute? With the exception of Cytodyn’s own press release, and articles regurgitating that same press release, multiple web searches reveal nothing else on Longen China Group and its supposed subsidiaries. Pretty much all we know about Longen, is from this bizarre blurb at the bottom of the Cytodyn press release:

And some people wonder why we lovingly call Cytodyn management the Klown Krew?

*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.

While We Wait, What Happened to the OLE? (CYDY)

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.

Quick Take: Was January 21st What The Cytodummies Expected? (CYDY)

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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Re-Up from 2018: Kalem, Kukekov and the Dodgy Reverse Merger in Eden Prairie, MN. (NMTC)

Note: This is a re-up of thoughts on NMTC originally from 2018, but just as relevant today. It appears NMTC has reawakened from its slumber. Kukekov is now at Paulson, home of many bioturd shitstocks. Past is Prologue. Pedigree Counts. 

A reverse-merger based in Eden Prairie, MN, hyping nonsense, recently came to our attention, NeuroOne Medical Technologies (NMTC). This filthy company shares many similarities to another reverse-merger turd, Biotricity (BTCY), we’ll examine that scam another time. For now, let’s look under the covers at NMTC.

There was recently (nb: in 2018) a conversion of notes at $1.80/shr, along with 100% warrant coverage at $1.80. Our guess is that we are seeing a walk-up (aka a “rig”) in front of a real promotion as those shares are being sold.

The company originally came public in 2011, as Original Source Entertainment, a Jody Walker shell. Ms. Walker has been responsible for countless scams: RNBI, ALKM, VHUB, RIHT, RJDG, PVTA, KRED, NAMG, DMHI, and AIDC just to start.

The original nominee holders were:

NMTC-OriginalNominees

In 2014, the control block was sold to a young gentleman named, Amer Samad:

NMTC-SaletoAmer2014

Amer moved the company to an address near Buffalo, NY. By April, 2017 some stock had leaked out, and Amer still held 69% control.

NMTC_ownership_april2017

In July 2017, the shell merged with a medical device company in Minnesota, NeuroOne, Inc., creating NeuroOne Medical Technologies (NMTC). Curiously Amer returned 100% of his holdings for cancellation.

NMTC-AmerCancellation

This leaves 1.573mm existing shares, and 6.292mm shares issued in the merger for a total outstanding of 7.865mm shares. One unanswered question is where did those existing shares, which would be free-trading, end up? Typically in these sorts of scams, these shares are actually secretly in the hands of the promoters/insiders. Another question is who has been paying Amer? An unnamed related party.

NMTC-WhoPaidAmer

Just who is this related party? That remains unanswered (for now) as well, but at BuyersStrike! HQ we have some ideas.

The merger into the shell was arranged by an outfit called Highline Research Advisors (HRA), which is made up a few ex-John Thomas Financial (expelled by FINRA, raided by Feds), ex-Merriman (expelled by FINRA), ex-Agincourt rejects, Theodore Kalem & Nikolay Kukekov. Their HRA shop has moved from JTF to Merriman to Agincourt and now they hang their hats at another bucket shop, Corinthian Partners.

Here’s Theodore’s CRD:

NMTC-TedKalemCRD

And Nickolay’s:

NMTC-Nikolay-CRD

The working theory here at HQ is that finding this shell was no chance occurrence for Kalem and Kukekov. Mr. Samad‘s name appears in a previous Kalem/Kukekov deal, Citius (CTXR). See the CTXR S-1 filed September 11, 2015. Given that they probably knew Amer from this prior turkey, it is highly likely that one of them, or an entity they control, was the related party funding the shell.

After the NMTC merger the new shareholder list looked something like this, from the most recent NMTC proxy, filed April 27, 2018.

NMTC-Proxy-2018Holders

Would it surprise you, dear reader, to learn that there are shenanigans afoot? Chromium 24 LLC and Lifestyle Healthcare LLC are actually undisclosed related parties. Their total ownership is over 18%. Likely tripping up all sorts of disclosure violations, just for a start. 

How are they related?

When pulling the ownership statement for Chromium 24, LLC we find a familiar family name, Kalem:

NMTC-Chromium2413d

“That’s only a coincidence,” the touts and shills might say. Perhaps, perhaps not. Let’s dig deeper, from Bloomberg:

BTCY-Chromium24Owners

And how about Lifestyle Healthcare, LLC? Let’s read Nickolay’s biography carefully:

NMTC-Lifestyle-Nikolay

Kukekov is an owner of both entities, and clearly has a close relationship with Kalem. Case closed. And this is not the only piece of garbage bioturd/medical device scam stock with these two fine gentlemen lurking behind the scenes.

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.

Quick Take: Just Where Is That Open Label Extension? (CYDY)

While we patiently wait for everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) to add up two sets of mortality numbers from their much hyped CD12 study in severe-to-critical Covid-19, and plug them into an Excel spreadsheet, let’s look into what else is going on with that study (full details here NCT04347239).

Keen readers might recall that at the end of 2020 Cytodyn issued a series of bizarre press releases. The first, the famous Christmas Eve surprise, buried the tacit admission that the earlier CD10 trial of loserlimab in mild-to-moderate Covid-19 patients was neither “impressive” nor “fantastic”, but rather so ineffective that the FDA, which already rejected Cytodyn’s attempt to get an EUA, would not even consider granting any EINDs for this population. Admitted The NaDDir*:

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Update Update: What Exchange Will Cytodyn STILL not be Listing on? (CYDY)

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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Cytodyn CONference Call Preview (CYDY)

On Wednesday, the 6th of January, everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) will be holding the latest in a long series of amusing presentations which we lovingly refer to as “CONference Calls.” This one must be particularly important as the company issued not one, but two press releases about it.

Here is the agenda from the first press release, on the left, and the second, on the right:

Notice the difference? Some important language was added in the second press release. Was it really intended as a reminder to investors or was it a CYA warning to investors?

Lets examine just a few of these agenda items:

There is one particular country that is suspiciously absent from the list in item 1, and by extension item 5, the Philippines. Odd considering how much The NaDDir* and the touts all over the internet have been hyping it. Want to know why an EUA in the Philippines was simply never in the cards for Cytodyn, contrary to all of the misleading hype? Read all about it here.

How about item 3? The potential revenue for Cytodyn from loserlimab, should it ever be approved? Contrary to The NaDDir’s* claims of billions in revenue, the real revenue opportunity for the company is far more modest. Why? Because even loserlimab’s biggest boosters recognize that everything they claim it can do another drug, Selzentry, can already do (and likely do far better for pharmacological reasons). Selzentry is approved and has been on the market for so long there is already a generic version known as maraviroc.

And for all of that supposed CCR5 blocking magic, maraviroc sells a bit over $20mm a quarter in the USA. That’s it. Not 000s of millions, and certainly not billions.

The proper pricing comparison for loserlimab is not remdesivir, but maraviroc, which costs about $1600 per month (300mg pill. 2x a day) without insurance reimbursement.

A shorter course of treatment, say 300mg x2 per day for one or two weeks, for coronavirus, would be about $400-800.

Agenda item 6, is an update on the the “Long Hauler” study. Want an update? Here you go. The study is ALREADY behind schedule. It was supposed to start on December 21, 2020. That date was missed. Now it is scheduled to start on January 21, 2021. It was supposed to be a quick study, lasting only three months, now it is expected to run until late June, a full five months.

For the Cytodummies who don’t believe that, please look it up for yourselves on Clinicaltrials.gov, be sure to click on “History of Changes.”

What about agenda item 8, Breakthrough Therapy Designation for loserlimab? This has already been explored at length in a post the 6th of October. It should set the record straight about Cytodyn’s REAL timeline with regards to applying for Breakthrough Therapy Designation with the FDA. Read it here. Hint: They already have applied, and they have already been rejected.

And then there is agenda item 9, GvHD Trial Status. That trial has been going nowhere fast for five years, and continues to go nowhere. Read all about it here.

Finally, item 11, the much talked about NASDAQ listing. Want to know why a NASDAQ listing is a virtual impossibility, based on currently available audited financials, for Cytodyn? Read all about that here and here.

Tomorrow should certainly be fun.

PS A great read on the Cytodyn CD12 trial is this Twitter thread here.

* 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.