Everyone loves a good “this’ll cure Alzheimer’s!” story… both because we all know someone who has been touched by this awful disease, and because we know that a cure for Alzheimer’s would likely be a multi-billion-dollar drug. So the pundits tease early-stage hopefuls quite often, they fail almost all the time, and we keep hoping and coming back for more.
This time it’s Ray Blanco, again, teasing another potential Alzheimer’s Disease drug in ads for Ray Blanco’s Catalyst Trader ($1,995/yr “on sale” from $5,000, no refunds). And sadly, it’s one of those “this alert is so urgent, we couldn’t provide a transcript” video “presentations”… so I had to sit through the whole damn thing. If you’ve ever questioned how much I love you, dear readers, question no more.
I say “again” because we’ve heard similar tales spun by Blanco (and others) before — the ones that come to mind are Anavez (AVXL), which Blanco started teasing in 2015 or so with a prediction that the CEO would soon make an announcement that changes the face of modern medicine and ProMIS Neurosciences, which he expected to similarly have a miracle announcement about three years ago. Which serves, at least, to give us a little perspective — Anavex had a big surge early this year after nearly a decade of overpromising and disappointment, so it has just now gotten back to its 2015 highs, and the ProMIS share price is still below where it was three years ago.
And, of course, lots of folks have teased big fella Biogen (BIIB) for its aducanumab, which has been the most recent big hope in Alzheimer’s Disease, is likely to generate some huge headlines in the next week or so as the FDA has to finally decide whether or not they’ll approve the drug.
So what’s the target this time? Let’s see what clues he drops in the presentation — these are the quotes and notes I took on the fly, so I may have a small error here and there… here’s how the ad started:
“Based on new research from Harvard University, Columbia University, and the Kaiser Permanente Division of Research…
“Patent Application No. 057784:
“The Most Important Medical Breakthrough of the Century?
“This Revolutionary Patent Could Soon Unlock Life-Changing Wealth For Early Movers… Beginning As Soon As May 31, 2021”
In case you’re frustrated and about to tune out because of that date, have no fear: If there was going to be some big imminent news from the company, it did not come on May 31. Or June 1, so far. (And I may be speaking out of turn here, but I wouldn’t hold my breath about June 2).
What other verbiage can we feed to the Thinkolator?
“The treatment one small pharmaceutical company is developing could spark a revolution”
“Changing the way we think about Alzheimer’s’ altogether”
Other clues? Blanco says he spoke to the CEO of this “small biotech” in an “exclusive call,” so it’s a company that needs to be promotional — which is pretty much everyone in “small biotech” world.
The stock trades under $10 a share.
What does the drug do? Blanco says there’s a new line of thinking (from those name-dropped research labs and others) about how “plaque magnets” might be the real problem in Alzheimer’s Disease, not the amyloid beta plaque itself — that’s because higher levels of that “plaque magnet” causes the plaque to develop faster, and if we can lower the level of the magnets then not as much of the plaque will attach itself and start to clog up the system (OK, some of that’s my words.)
And he says that “Word of the studies has spread all over the media,” including these quotes:
“‘[Plaque magnet] levels linked to ALzheimer’s brain plaques’ CBS News
‘Popular [plaque magnet] meds may protect against Alzheimer’s’ Washington Post“
Neither of those is particularly new — they’re generally about the link between cholesterol and Alzheimer’s Disease, that CBS quote came from this article and the Post one originates here. Neither one is about this specific company teased, of course, but it gives you an idea of the theory they’re following.
Blanco also says that a Cornell study in mice found that using “donut shaped” rings of sugar molecules could trap plaque magnets, getting them away from the brain and letting the body expel them. So the general idea is, “did a company figure out if this will work in humans?”
Ray Blanco’s answer, as I hear it, seems to be that he’s never been as sure of anything else in his entire life… if you’re not trying to sell something, I’d say we’re still at “maybe.”
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And that “maybe” starts with one person… apparently an Alzheimer’s patient got permission to take this new treatment after all others had failed, and “they’ve seen the rapid progression of Alzheimer’s grind to a screeching halt… In fact, over 18 months, not only has her memory remained stable but she’s actually starting to see improvement in several areas.”
So naturally, the company behind this wants to move the drug along — Blanco says that “they’ve already filed the patent application, and they’re awaiting results of a landmark study nearly five years in the making”
Which is what he’s talking about with that “coming soon” (or now, “yesterday”) date:
“Could all begin on May 31st, when I expect this company to make a major announcement about their clinical trials”
And he thinks we might see 5X, 10X or 15X gains in the next 12 months as the news continues to flow.
What other details get dropped as hints? These are the specifics of the clinical trial, which apparently had 12 participants:
Study start date: March 20, 2017
Primary completion: February 28, 2021
Estimated study completion May 31, 2021
And we get some other clues as well… the company had $903,376 in revenue last year… he drops a couple patent numbers on us… and he says it has a market cap of $46 million.
That patent? Here’s the description:
“methods for the prevention or treatment of Alzheimer’s Disease in a human patient are disclosed comprising administering a hydroxypropyl-beta-cyclodextrin”
And Blanco also says that “it’s also testing, in Phase 2 clinical trials right now, for a rare condition referred to as “childhood Alzheimer’s.”
So yes, that’s enough hinting — Thinkolator sez this os Cyclo Therapeutics (CYTH), which is indeed a ludicrously tiny company, with a market cap of about $50 million. And yes, it trades for less than $10, today it’s right around $8.50.
And no, they are not going to announced any clinical trial results in Alzheimer’s anytime soon — though that trial which is just wrapping up now, the “childhood Alzheimer’s” (Niemann-Pick Disease) Phase 1/2 trial is indeed the clinical trial that Blanco is hinting at, and it has already released top-line results. They’ve already gotten permission to begin enrolling the Phase 3 trial in that rare disease, which means that any potential update from the final conclusion of the first trial (which may or may not have happened yet — these things are not all that predictable to the day), will probably not mean much.
At least not for Alzheimer’s Disease — the indications for general safety and tolerability are already there in the first group, though that does presumably help support Cyclo’s plan to bypass Phase 1 for Alzheimer’s Disease and jump straight to a Phase 2 trial (the FDA has apparently supported them in this plan, but they have not yet filed the IND and expect to start that trial in the second half of 2021… so sometime between next month and December). This is welcome news, as is any progress in finding out whether a new drug might work, but it’s not super new — A couple years ago they were talking up the possibility of starting a Phase 1 trial in Alzheimer’s, building on the promising results from their single “expanded use” patient, but for whatever reason that got pushed back a couple years but also might be able to skip a step and start with Phase 2. Which tends to be the phase were investors get most excited about Alzheimer’s Disease drugs (Over the past decade in Alzheimer’s Disease, Phase 1 almost never means much, it’s often in only a handful of people… Phase 2 gets folks excited about efficacy… then in Phase 3, where AD drugs go to die, we either find that the efficacy wasn’t there once the group got big enough to find a meaningful average, or some scary side effects emerge).
I confess to having a substantial amount of skepticism about this one… after all, it hasn’t really been used yet. There have been many drugs that seem to have a meaningful impact on Alzheimer’s Disease in a few people but don’t pan out for a larger clinical trial. I’ll stay hopeful as a human being, but as an investor I’d keep this in the “extreme risk” category — yes, if it works out well and their Phase 2 trial shows some promise in Alzheimer’s the shares will probably shoot higher, I just wouldn’t count on the probability of that being super high.
I’m definitely no expert, to be clear, and I don’t really know what will happen. If you want to check through on some of the clues yourself, the press release about their patent filing a few years ago is here,
And the latest update is their first quarter report, in which they confirm that they are “advancing Alzheimer’s Disease Phase 2 asset towards investigational new drug application (IND) filing anticipated in H2 2021” and share this quote from CEO N. Scott Fine:
“Our team continues to build momentum across multiple fronts and is focused on successfully achieving the multiple value-driving milestones we have ahead of us this year. The positive topline results from our Phase 1/2 study in NPC that we reported in March bolsters our confidence as we progress into the next stage of drug development, our pivotal Phase 3 study, which remains on track to commence enrollment and dosing imminently. Coupled with the key appointments of proven industry leaders to our executive team, we are poised to execute on the milestones ahead, achieve success, and make a positive impact on families and patient communities where there remains significant unmet need.”
And yes, in a further match, this drug has been tested on exactly one Alzheimer’s Disease patient so far… a compassionate use “expanded access” agreement that started in 2018 and is just about three years in at this point — the annual update from June 2019 on that patient is here.
So… is this the kind of microcap biotech you’d like to speculate on? I know next to nothing else about them, they do have a little bit of revenue (yes, the $904K is a match for last year), but that’s mostly from selling cyclodextrins for diagnostic and formulary purposes. I don’t know if Cyclo’s cyclodextrine’s are unique or have a meaningful share of that market, or if their particular Trappsol Cyclo formulation is going to be a breakthrough. Hopefully their clinical trial will go well later this year, but I’ll watch from the sidelines — if you’ve got thoughts on this one, or on other Alzheimer’s hopefuls, please shout ’em out with a comment below… and thanks for reading.