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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Quick Take – How To Tell Cytodyn is Nothing More Than A Stock Promotion? (CYDY)

Just as we were digging into the recently filed late Friday afternoon Form 10K from everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), the company issued not one, but two, ridiculous press releases on Monday morning the 17th of August. Here is one, which will be the subject of this quick post.

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What Is Cytodyn (Not)Curing Now? A Guest Post from B4UConsent (CYDY)

[Editors Note – The following is a guest post about everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) from @B4UConsent, a real life patient with tremendous insight into drug development from both the patient and the clinical trial management perspectives. Follow her blog and on Twitter.]

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.

Quick Take – What Stupidity Is Cytodyn Finishing Up The Week With? (CYDY)

Just when we thought we could end the week without any more insanity, everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), issued a brand new, utterly ridiculous, press release (here). No doubt desperate to maintain a $4 bid price for that ever-elusive “uplisting” (Pro Tip: any company that talks about UPlisting is a scam, plain and simple. Cytodyn is currently UNlisted, it is applying for an INITIAL listing). Let’s take a look at what BS The NaDDir* is slinging this morning:

SeeksUKApproval

Interesting, seeing as though the company couldn’t even get its BLA accepted for review in the USA. Exactly what does “seeking approval” entail? Read past the headine:

VANCOUVER, Washington, Aug. 06, 2020 (GLOBE NEWSWIRE) —  CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company, announced today it will submit requests for pre-submission meetings (equivalent to pre-BLA meeting in U.S.) in the U.K. for leronlimab as an HIV treatment in combination with HAART for highly treatment experienced HIV patients (350 mg dose, self-injectable, subcutaneous ), as well as for emergency approval of leronlimab for COVID-19 patients with mild-to-moderate symptoms (Phase 2 – CD10).

In The NaDDir*’s world (*spelled thusly for a double dose of that sweet sweet stock pimpin’) seeking approval actually means merely submitting a request for a meeting!

And the subject of that meeting is quite interesting, the 350mg dose of leronlimab for HIV combination therapy. The company submitted the now infamous botched BLA for that same indication in the USA, but for the 700mg dose. After a series of miscues by Cytodyn, the FDA, as you may recall, sent the company a humiliating RTF (Refuse To File) letter, telling them to go back to the drawing board.

Any why even bother with the 350mg dose? By the company’s own admission it doesn’t work very well, with only a 70% response rate.

CYDY-Dosage

Notice anything else about that chart? When the middle dose outperforms the low and the high dose, what should that tell you?

One last tidbit, one dose is actually 2 injections. Good luck with that.

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 – How Expanded Is That Access, scAmAVEX? (AVXL)

It has been a long time, almost five years, since we last discussed Vancouver stock promoter Harvey Lalach‘s Alzheimer’s reverse-merger stinker, Anavex, but affectionately known at BuyersStrike! HQ as scAmavex Labs (AVXL).

Harvey and CEO Christopher U Missling sure know how to make hires, including a superstar CFO, and a Hall of Fame IR Staffer. They also know how to excite retail investors, teasing them with provocative press releases, like this one from last night, touting “approval” for “special access” to their Alzheimer’s snake oil:

SpecialAccessHeadline

But what does this actually mean? Has Anavex’s drug actually been approved for Alzheimer’s Diease? Can desperate patients and their families finally queue for a cure? OF COURSE NOT! Read past the headline.

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