Remember Ernie Tremblay’s pitch about a “tiny South Texas lab” that was about to cure every disease using its revolutionary CD19 Cancer Vaccine technology, and ignite a bidding war following its fantastical release of exciting information on June 23?
Well, it’s back. Not the stock, that’s still languishing around where it was before Tremblay got his teeth into it (that pressure boosted the shares about 20% back in June, though they came back down again quite quickly once the June 23 meeting was revealed to be a non-surprise), but the teaser pitch — the ads from Money Map peddling subscriptions to Tremblay’s $1,950 Biotech Insider Alert have returned in force… only now, instead of calling it a “CD19 Cancer Vaccine” he’s calling it the “AB4 Vaccine”.
Just to double check that he is indeed still teasing the same company, I ran through a few of the hints that were dropped in the ad — here’s a taste for you:
“It’s quietly been awarded 14 patents and was initially granted ‘Priority Status’ by the FDA…
“And on June 23, 2017, it shocked the medical community.
“That’s when leading scientists from Pfizer, Sanofi, Bristol-Myers Squibb, Amgen, Gilead Sciences, Novartis, Celgene, and AbbVie all gathered in Madrid, Spain…
“And they heard the results of this small lab’s Phase II clinical trial.
“It was conducted at a Nobel Prize-winning facility. And as you are about to discover, the results were astounding.
“Then after this momentous meeting…
“The FDA made what they described in their own words to be a “historic” decision.
“In a rare 10-0 vote, they unanimously agreed that the AB4 Vaccine developed by the $195 billion pharmaceutical giant Novartis should be approved for “last-resort” use outside of clinical trials.
“Dr. Timothy Cripe, who cast one of those votes described this as the most exciting treatment he’s seen in his lifetime.
“Novartis’s approval became official on August 30, 2017.”
OK, so let’s try to be clear about some of this — the June 23 conference presentation that they gave was real, but it wasn’t revolutionary. And it didn’t shock anybody, as far as I can tell — it was just another iterative release of data for their ongoing clinical research, it seems as though the consensus is that it was fine data but not surprising news.
And the Novartis approval for its CAR-T cell therapy, Kymriah, in some patients did indeed come on August 30, and it was a historic gene therapy announcement… but it didn’t have anything to do with this “Small Texas Lab”.
OK, fine, I’ll let the cat out of the bag again — this is almost certainly still Bellicum being teased, and Bellicum’s “off switch” technology for CAR-T therapy is not currently being used by Novartis… the argument from Tremblay is that this technology is powerful because it will make aggressive gene therapy more controllable and less risky in the future, and therefore all the CAR-T (or CD19, or AB4, whatever you want to call them) “vaccine” developers will want to license Bellicum’s technology. Which will bring them big bucks.
Here’s more from the ad:
“Now that the FDA has given the AB4 Vaccine the greenlight, I expect it will likely ignite a fierce bidding war to license the tiny Texas lab’s breakthrough.
“Every major pharmaceutical firm that’s developing an AB4 Vaccine could be involved…
“Because this could be the answer that allows treatments for prostate cancer, breast cancer, lung cancer, leukemia, lymphoma… all cancer… at all stages…
“To be brought to the cancer immunotherapy market…”
And in case you’re curious, most of the other specific clues still match up…
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“Last year, this tiny lab’s total revenues were only $388,000.”
Which is true, but not particularly relevant — other than payments from deals they might make, which themselves are generally one-off events, revenue is often “zero” and is a pretty meaningless number for development-stage biotech companies.
And one more bit of info that’s new to the teaser pitch:
“All this Texas lab needs to do is work out a licensing deal with a large pharmaceutical firm t set everything in motion…
“And here’s where things get really interesting…
“This small lab has just added a very special member to its cancer-fighting dream team.
A Chief Business Officer who, according to the CEO, has been hired to ‘secure strategic partnerships.’
“In other words, his job is to lock up that licensing deal.”
So, yes, this is still a teaser pitch that’s dangling Bellicum Pharmaceuticals (BLCM) as Ernie Tremblay’s favorite idea… and if you’re curious, that announcement about their new CBO is here.
The stock had a nice surge about a week and a half ago, though that wasn’t because of either the Novartis approval or anything specific to Bellicum — it was because Gilead Sciences (GILD) offered to buy Kite Pharma (KITE) at a 30% premium price. Kite is a developer of CAR-T therapies, so all the other CAR-T stocks popped up in sympathy… as often happens when there’s a big buyout (the rumor mill then immediately starts, “who’s the next buyout target?”).
Will Bellicum get a licensing or partnership deal with a deep-pocketed pharma company someday soon? I have no idea. Their results have sounded promising, at least in press release form (I don’t understand the fancier stuff, which is why I don’t generally wade into biotech myself), but they’re also very early-stage clinical trials and this is an extremely personalized treatment. No one is going to be running a factory churning out millions of cancer vaccine pills, these are individual genetic therapy treatments that are based on both a sample of the patient’s blood and a careful construction of an individual treatment for their particular disease. Which is great, and it has led to saved lives, but it’s a lot more difficult to project or understand as a business than is, say, a pill manufacturer. Such challenges were part of the reason for Dendreon’s collapse seven years ago, so even though the comparison isn’t particularly fair (Dendreon screwed a lot of things up, it seems, it wasn’t just that their business model was challenging), it’s likely that Wall Street remembers Dendreon well and has plenty of folks nervous about the economics of “personalized” cures (Gumshoe readers might hear a faint echo, too, from the story of “one little shot to kill cancer dead” personalized cancer vaccine developer Argos Therapeutics (ARGS), teased aggressively 18 months ago by a different newsletter and further along in clinical development than Bellicum, but now down 99% or more since then).
None of that is necessarily to say that Bellicum won’t succeed — I have no idea whether or not it will work out for them. Their story hasn’t changed all that much in three months, from what I can tell, though they are shifting priorities a little bit in terms of moving from pediatric indications to finding a nice little “niche” rare indication that they can go after in the US to try to speed their time to an initial hoped-for product approval. They are still awaiting more clinical data, they would like to have some licensees or partners, and they have plenty of cash to keep them going for a while as they wait to see what the data looks like — their spending has ramped up as clinical trials have been underway, and that will probably continue, but they burned through about $25 million in cash last quarter and have another $130 million in cash on the books… so they won’t likely be under any pressure this year to raise money, at least.
From skimming through their info, including the latest quarterly press release, I don’t see any imminent catalysts on the clinical front — they have a couple Phase 1 trials ongoing at fairly slow speed (remember, this is an individualized therapy) which should have initial results in 2018 in their “high risk, high reward” programs (that’s how they describe BPX-601 and 701), and on the more advanced side of the pipeline they expect more data from their BPX-501 clinical trials sometime in the first half of next year that should lead to applying for European approval in 2019, and they’re designing grant-supported “registrational” trials in the US for a form of leukemia (that would mean Phase IIb or Phase III trials that are expected to lead to applications for FDA marketing approval).
If you want to see my prior thoughts on Bellicum after they were teased by Tremblay last time, or the reader discussion that followed, you can check that out here.
The Novartis news was positive for the sector as a whole — Bellicum’s CEO Rick Fair did note in the Q&A following their last conference call (which is worth reading if you’re interested in their strategy updates) that “we think they’ve offered a very realistic path to market for cell therapy and I think that’s positive news for the whole community including us.”
So… will Bellicum’s “safety switch” be a key technology for CAR-T therapies in the future? Will that bring them megabucks either imminently or in the years to come? I continue to have no idea… but, lucky you, the world did not change in a moment the last time this stock was teased, and it seems likely that the actual clinical work won’t be creating any shocking news in the next few months, so unless there really is a surprise licensing deal sometime soon you’ve probably got ample time to think it over before you throw your money at Bellicum.
Sound like the kind of thing you’d like to invest in? See a “bidding war” that Wall Street does not yet anticipate? Let us know with a comment below.