Friday File: Biotech Insider Alert hints at “128,756% Sales Growth on June 23” From “CD19 Vaccine”

Tremblay teases that "A small Texas lab plans to announce a miraculous breakthrough that could defeat the most dangerous disease known to man." What's the story, and the stock?

By Travis Johnson, Stock Gumshoe, June 26, 2017



This Friday File article was originally released to the Irregulars on June 16, we have now opened it up for anyone to read in hopes of answering some questions that continue to roll in about the latest Biotech Insider Alert ads. The text below has not been updated or revised, though I and other readers have added updated comments to the discussion thread at the bottom.


–from 6/16/17–

Hello, Friends — I don’t have any major updates for you this week, other than the “Holy cow!” news this morning that Amazon (AMZN) is buying Whole Foods (WFM). That will be immediately accretive to earnings at Amazon (meaning their earnings per share will rise), but no one cares about Amazon earnings so I guess we’ll see what happens. Will it matter if they go from 50X 2019 earnings to 45X 2019 earnings? Probably not… and as for immediate impact, this deal, if completed today, would change Amazon’s trailing PE from 185 to 160.

This could become a brilliant way for Bezos to build out Amazon’s grocery business and further extend the Amazon brand into “bricks and mortar” retail, and probably every single Whole Foods shopper is already an Amazon prime member, so it will be an interesting merger to watch. There will almost certainly be strategic integrations at some level, even though the talk so far is about Whole Foods remaining independently managed and run by John Mackey out of Austin. And given the very small size of the deal relative to Amazon’s business, and the fact that Amazon’s paying with cash, there’s very little downside risk.

This doesn’t make me change my mind about Amazon, which I already like and own because of the still ridiculous future growth potential (even as I hold my nose a little when I think about the valuation)… but if something about this deal brings down Amazon’s share price, perhaps I’ll eventually add to that position.

That’s certainly not happening so far, Amazon and Whole Foods are both higher in early trading today (it’s a cash deal at $42 a share, just FYI, and presumably there won’t be any problem getting the deal through unless another bidder appears, which seems unlikely but not impossible).

… so there’s nothing really to add on the portfolio front this week and no updates to the Real Money Portfolio, after a few weeks of lots of buy/sell action for me… which means we’ll spend our Friday File looking into a new teaser pitch that a bunch of you have asked me about.

It’s from Ernie Tremblay, who some might remember well from a slew of disastrously unsuccessful and heavily promoted teaser ads last year like Auris Medical, Transenterix, Cempra and Aralez… though he did, to be fair, tease a few in prior years that ended up doing well (like OraSure, Nektar and Durata). He’s again selling his Biotech Insider Alert ($1,950/year), and doing so by promising great returns for the company behind the “CD19 Vaccine.”

So what’s the story? Here’s the intro:

“On June 23, 2017, a small Texas lab plans to announce a miraculous breakthrough that could defeat the most dangerous disease known to man.

“This historic event will take place in a room full of executives from the world’s largest pharmaceutical firms…

“And they will hear the official results of a clinical trial conducted at a Nobel Prize-winning facility. We have seen these results firsthand and they are stunning.”

This is a company that’s not yet really generating any revenue, so the growth numbers sound exciting:

“Last year, their sales were only $388,000.

“However, next week, after their trial results become official, we expect them to quickly ink a licensing deal…

“And it could pay them $500 million in just a single year.

“That would represent a 128,765% surge in revenue… “

So what is this little Texas company? What announcement is Tremblay talking about?

“This trial was conducted at the Nobel Prize-winning Fred Hutchinson Cancer Center and the Dana-Farber Cancer Institute.

“And 91% of the patients experienced complete remission from an advanced and aggressive form of cancer.

“Compared to existing treatments, this CD19 Vaccine breakthrough delivered a 10-fold improvement in mortality rates.

“That’s unheard of.

“And these results are set in stone. I’ve seen them firsthand.

“But this June 23 announcement will make them official.”

OK, so unless someone is doing some illegal leaking, Ernie Tremblay doesn’t know anything about this that other investors don’t also know — if he’s “seen them firsthand,” then Mr. Market knows them, too. So don’t get your hopes up too much about some exciting and fantastical announcement that’s going to shock the world — if he’s right in his assessment, then probably the shock would be if something bad or disappointing is announced…. Wall Street doesn’t cause wild swings in the stock prices of companies who do and say what’s expected, the big driver of wild jumps in stock prices is the surprise. At least in the short term, which is what newsletter pitchmen are usually selling (who wants to wait a couple years to be a millionaire, after all? Don’t we deserve 1,200% gains TOMORROW? Especially for $1,950?)

OK… so what’s the story? Here are our clues:

This June 23 announcement will be the lab…

“making the results of their Phase II clinical trial official.”

They have protected this “vaccine breakthrough” with 13 patents.

“it’s received “Priority Status” from the FDA and the European Medicines Agency (EMA).”

What else? More from Tremblay:

“This is a millionaire-making opportunity…

“And the insiders at the company know it. They’ve recently locked up 5.7 million shares.”

So… Tremblay actually uses the CD19 term to refer to all cancer immunotherapies, which have been used for many years as we attempt to find ways to awaken the immune system and help it fight off cancer cells, often by simply helping the immune system identify cancer cells. But this particular version of the CD19 Vaccine from this “south Texas lab” is apparently different, because they added a “magic” ingredient:

“In 2002, an MIT biologist was jointly awarded the Nobel Prize for discovering a magic molecule that’s present in our nerve cells.

“Its specific job is to regulate the speed at which those cells multiply.

“So this small Texas lab simply took this molecule and added it to the CD19 Vaccine formula.

“And it became:

The Patient’s T-cells
+
The Cancer antibodies
+
This Magic Molecule

“And the transformation was profound.

“Now, doctors could create customized doses of these living drugs based on a patient’s exact cancer diagnosis.”

Other little hints?

“T-cells with this lab’s discovery can multiply at a rate that’s 23 times faster than those without it.”

and…

“It took place at both the Fred Hutchinson Cancer Center and the Dana-Farber Cancer Institute.

“It involved patients who were suffering from very aggressive and advanced-stage leukemia….

“More than 91% of the trial’s participants experienced complete remission.”

So… the promise seems to be that this company will, upon the re-announcement of their Phase II results, get a lucrative deal with big pharma. One last bit from Tremblay:

“All they need is to work out a licensing deal with a large pharmaceutical firm…

“And on June 23 there’s going to be a room full of them in Madrid, Spain…

“Each with deep pockets…

“And each will have no problem cutting a deal that could transform a small lab with only $388,000 in revenue into a major player with $500 million in the bank within a single year.”

OK, so the meeting is the Congress of the European Hematology Association, which starts next week in Madrid and will indeed include three presentations by a certain little “small Texas lab” — that’s Bellicum Pharmaceuticals (BLCM), which, Thinkolator sez, must be the stock being teased here.

Bellicum is developing BPX-501 as their lead drug candidate, and all three of their presentations at that Congress will be about that drug’s clinical trials. The most prominent presentation they’re providing is part of the Presidential Symposium on June 23 at that Congress, you can see the abstract here if you’d like to try to wade through the details.

I’m sure that all of the big pharma companies will be represented at the Congress, and they are all always looking for attractive new drugs to acquire, but there’s unlikely to be a surprise beyond the results detailed in the abstract and I don’t know why they’d have to see the results at this particular meeting in person to make a definitive decision… Bellicum, it seems to me, has been releasing similar incremental data every few months at one conference or another as they continue their relatively small-scale trials in blood cancers.

So Bellicum may well be an interesting candidate for your biotech research, I don’t know one way or the other, but I’d assume that the June 23 date is at least as much for Ernie Tremblay’s benefit as for yours — newsletter ad pitches have to have a hard and critical deadline that inspires possible subscribers into action, particularly if it’s a high-priced letter and they don’t want you think about it for too long before you sign up.

Tremblay uses the term “CD19 Vaccine” to show the vast potential of cancer immunotherapy in general, though all of the examples he gives of successful tumor treatments seem to be from a variety of immunotherapy studies and trials in recent years, not necessarily specifically from Bellicum’s trials (CD19. This is pretty common in newsletter teaser pitches, using a broad trend or a big industry-wide advance to illustrate the huge potential, but then carefully sidestepping over and implying, to at least some degree, that all of that potential belongs to just your one special “secret” company.

If you want more on the basics of CD19 and CAR-T, there’s a good article here from the National Cancer Institute that even I can understand.

The company describes itself thusly:

“Bellicum Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering and developing first- and best-in-class cellular immunotherapies for hematological cancers and solid tumors, as well as orphan inherited blood diseases.

“Our product candidates are differentiated by the inclusion of powerful molecular switches designed to eliminate, reduce or activate therapeutic cells, and thereby potentially provide greater efficacy and safety compared to the current generation of cell therapies. Our approach has yielded highly encouraging results to date from our lead BPX-501 program in the haploidentical transplant setting, as children with hematological cancers and life-long genetic blood diseases were able to leave the hospital in remission or disease-free, respectively. We believe this reflects the promise of our cellular control therapies to transform standard of care—and the lives of patients and their families. We now have orphan drug designation from the US FDA and the EMA for both BPX-501 for treatment in HSCT, and for activator agent rimiducid for the treatment of GvHD….

“To date, CAR T and TCR therapies have only been shown to be broadly effective in certain blood cancers, and if they are to become a viable option in solid tumors, new approaches will be needed. We believe our proprietary cellular control CAR T and TCR immunotherapies may bring greater levels of efficacy and safety to the treatment of solid as well as hematologic tumors—addressing enormous unmet needs and a much broader market opportunity.”

That’s the big hope for all the various CD19-related (and other) cancer immunotherapies, that they can be applied to lots of different kinds of cancers — and as Tremblay notes in the ad, there have been dozens of examples of individual success… though my impression of this field, which also includes CAR-T developers like Kite Pharma (KITE) and Juno Therapeutics (JUNO) as well as lots of work being done by big Pharma (including Novartis (NVS), who might beat the little guys to market with the first drug), is that there have also been plenty of disappointments and examples of treatments that work spectacularly well in a few patients but don’t prove to be sustainable or compelling in larger cohorts.

There are lots of variations on these technologies and approaches, Bellicum’s differentiating factor appears to be their “switch” technology that lets them modulate the impact of the treatment, which presumably is designed to control or avoid the runaway side effects that have sometimes occurred during this kind of immunotherapy — I don’t know if there are other companies that are working on similar “off switch” technologies for these treatments, but I would assume that there are. Oh, and Bellicum did indeed have 13 patents to their name as of a couple days ago, at least according to these folks (they added another patent yesterday, so it’s 14 now).

Bellicum explains their technologies here, the 91% remission number used for their success rate, and the 100% response, come from some preliminary data released earlier this year — the press release is here, the actual poster presentation is here, a Seeking Alpha article that tries to explain it is here.

It all sounds quite compelling as data from these small Phase 1/2 trials is released, and it looks like folks who have some truly terrible blood cancers, particularly children, are getting great results from this personalized immunotherapy in combination with transplants… but the stock has also not done anything following the latest data releases, it has generally trended very slowly down this year.

Will that mean that Bellicum gets snapped up, or that next week is the point when investors or possible acquirers start to get excited? I have no idea. It’s a very small company, with a market cap of $360 million or so, so they wouldn’t need their technology to be of blockbuster size and a decent licensing deal or joint venture with another company could easily be significant… but they also do have plenty of cash, nearly $150 million after doing a $65 million equity raise earlier this year, so they don’t have to partner with anyone if they don’t want to, and there’s no risk of real financial duress for them.

On the flip side, I have no real way of guessing at what such a drug might be worth in the marketplace — maybe Tremblay’s right and someone will buy it or partner with them for $500 million, I have no idea, but this is not a mass-market drug, it’s a personalized and intensive immunotherapy, and those kinds of personalized drugs have been hard to assess financially… it’s a far different business than manufacturing and building a salesforce to sell a billion pills. Not that I’m particularly adept at judging the profitability of a standard medicine either, I’m afraid, which is why I generally tend to avoid the sector, particularly the research and clinical stage companies (though that is, of course, where most of the potential for blockbuster investing profits hides).

The stock has come up quite a few times on the biotech threads helmed by Dr. KSS, though as of a few months ago he was quite cautious on the CAR-T space in general.

And… anything else I add will be even less informed than what I’ve shared above, so I’ll leave you to think on this one for yourself. Sound like one you want to get excited about? Expect great things at their presentations next weekend? Or is this the next exaggeration from newsletterdom that will prove a disappointment in the near term? Let us know what you think with a comment below… thanks!

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48 Comments on "Friday File: Biotech Insider Alert hints at “128,756% Sales Growth on June 23” From “CD19 Vaccine”"

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vanderwall7
Irregular
4
vanderwall7

One of the example he used was a GBM that went into remission.
To my knowledge there has never been a cure of a GBM which is a stage four glioblastoma multiforma which is not a blood disease like a leukemia.
Most GBM patients do not survive a year or twowith chemo and radiation

schubrrw3212
Irregular
53
There has been a glioblastoma multiforma that was held in remission for 5 years, using a low-temperature water extract of Cannabis indica, the low-THC high-CBD species of cannabis that’s traditionally been used for rope manufacture (and not for making people feel “high”). Research is now underway at several labs, only one in the US, hoping to identify the active ingredient that caused the remission (if there is one). The US lab is focusing in on a terpene hydrocarbon that’s found in C. indica. Israeli researchers are focusing in on a carboxylic acid of CBD, that decomposes when heated and is… Read more »
mvssysprog
Irregular
374
mvssysprog
vanderwall7, you said there has never been a cure of a glioblastoma multiforma tumor. I’ve been following a doctor in Houston named Stanislaw Burzynski who has been working with patients with brain cancers, and other forms. He is quite controversial, with both the Texas Medical board in conjunction with the FDA trying to shut him down and take his patents. It’s an interesting story. But back to the point, rather than deal with anecdotal information, let me refer you to an NIH document: https://www.ncbi.nlm.nih.gov/pubmed/15312271 Apparently has had success in ‘curing’ GBM in the document cited above. The interesting thing for… Read more »
vonmajor
Irregular
14
vonmajor
Following the work of Dr Burzynski and have been appalled that the establishment has done everything possible to crucify him. His crime of curing, in many cases stage IV cancers, especially in children, and without the devastating tissue damage and suffering endured that is standard for chemotherapy. Note they want his patents. Own them, file them away and never allow the masses to benefit from them. There is too much money in cancer as a disease to allow the tables to be upturned. He was cleared by a jury who felt the government of ours to be acting in contempt.
Janine
Guest
0
Janine

Isnt that always the case ?

vanderwall7
Guest
0
vanderwall7

Thanks for the link. First I would have to know the pathology because brainstem lesions are rarely Grade 4 GBM but rather lesser grade 2-3 Astrocytoma.
6 times a day for 655 consecutive days at what cost. That is 3,930 infusions.
Were there any clinical trials or animal studies or was just off label human use? This patient must have had a boatload of cash.

Janine
Guest
0
Janine

That’s a tremendous amount of infusion therapy at a high cost. Won’t work, never get approved and requires more research to be more effective with less infusions.

Janine
Guest
0
Janine

Exactly ! Thank you for sharing . Isn’t everything connected to Big Pharma, FDA and CDC in these matters ? And it’s controlled by Big Government

cocobolo
Irregular
57
It never fails to amaze me how these newsletter writers are able to pull totally meaningless numbers out of a hat and make it sound as though this little company with essentially zero sales is all of a sudden going to be worth $500 million or better. I don’t see where a sales figure of $388K has a lot to do with a possible sale price of $500M. Since the company already has $150M (give or take) in the bank, bumping that to $500M doesn’t strike me as being that much. Surely their potential is far greater than that. And… Read more »
rdimand
Irregular
1
rdimand

an exciting addition to the use of Bone Marrow Transplant (BMT) techniques, but no magic bullet for cancer, etc. Does appear to make BMT more successful. BMTs are already very expensive, this is unlikely to be a $$ game changer, but still an exciting adjunct.

adadfarm
Irregular
804
adadfarm

A more exciting facilitation of BMT, in my opinion, is present in the work being done by Actinium Pharmaceuticals, $ATNM – long, Curt

Eph97
Irregular
46
Eph97

I took a small position in this company after I found out that Baker Brothers, a respectable hedge fund that invests mainly in biotech, own 10% of BLCM. Early results look promising, but you can never tell in biotech as phase 3 failures can and often happen.

freddy74
Member
7
freddy74

Same here. Plunked down 300 dollars, planning to exit ith a 20% gain if it can hit 16.50 or higher. Morbid curiousity more than anything else.

backoffice
Irregular
187

Thank you for your input Travis. His teaser for the cd19 drug was for the first 500 people who signed up for his newsletter. He also mentioned an orphan drug that may be coming close to market I’m curious what Dr.KSS thinks about this pitch.

Dr. KSS MD PhD
Author
45029

Hi—see post above.

backoffice
Irregular
187

Thank you for your insight I appreciate it. Third party payers are reluctant to pay for any new therapy these days.

manticore
Member
7
manticore

I’m sorry maybe I’m just stupid, but who are you referring to as Third party payers? The larger drug companies?

backoffice
Irregular
187

You’re not stupid, a third party payer is another term for insurance companies that most people depend upon for paying for their medication.

Dr. KSS MD PhD
Author
45029
I agree with Travis’s excellent synopsis of this situation and this company. I was formerly long $BLCM, but this one has never caught fire and frankly I wonder if CAR-T ever will. What few realize is that when invoked, CAR-T won’t be first or second-line therapy, but third and fourth line, and offered only at elite tertiary centers and there after a struggle to get third party payers to cover it. Bellicum’s stated appeal is its off-switch for CAR-T, able to swoop in and shut down CAR-T attack should the patient be in cytokine storm or be afflicted with severe… Read more »
Peter Tilton
Guest
0
Peter Tilton

Thank you, Dr. KSS, for excellent critique of this company and CAR-T

gumshoestocks
Irregular
6
gumshoestocks

Apropos of our Bringer of News, Have I told you lately, Travis, how much I appreciate your writing? Interesting. Lucid — meaning you write so that you cannot be misunderstood. A rare trait, indeed!
As to Bellicum, and other infant pharmaceutical companies, there is plenty of time for them to grow enough to prove themselves before trusting them with my own dimes.

manticore
Member
7
manticore
Agreed!! Travis does have a nice writing style to make even the incomprehensible supposed miracle cures touted by so many technology newsletter writers seem more “down to earth” and understandable. I was long another biotech (name escapes me now, looked at so many) that had a sure fire cure for blindness! My son suffers from RP since birth and is practically completely blind now at age 30. So I was more than interested (deliriously excited about the possibility of a cure) and jumped in with 2 feet around $7 a share. Watched it trend sideways for half a year before… Read more »
oceanview101
Member
1

BUY “PHM.MC or PHMMF ” INSTEAD OF BLCM( PRICE @ $11.33 WITH NEGATIVE GROSS PROFIT )
PHMMF is making money & about to be list in US market ( 10x beggar )

archives2001
Irregular
39
archives2001

Per usual, Gummy, I’d say u hit this one out of the park.

4r86p8s2
Irregular
10
4r86p8s2

Great analysis. thanks for the info.

backoffice
Irregular
187

Well one way I can look at it is I just saved $1,950.00 on the newsletter which is a positive. Thanks for the re-inforcement Travis.

yclin6
Irregular
37

I wonder why WFM closed at a price higher than $42 last Friday. Can Travis or knowledgeable irregulars tell me the reason? Thanks.

steveflick
Irregular
11
steveflick

I joined StockGumShoe yesterday, specifically to read this entry. Thank you Travis for saving me the $1950 to join Biotech Insider, and thank you Dr. KSS – I don’t think I will invest in BLCM, but perhaps put on a watch list. Also thank you Travis for informing me of the enewsletter teaser of Fitz Gerald and tobacco – and also all of the comments thereafter.

epeter61
Irregular
2
epeter61

Same here Steve but since I have been reading Travis’ stuff for years now I felt it was time to pay up also.

rvoisard
Irregular
3
rvoisard

thanks for the input, my first day as an subscriber

SoGiAm
Irregular
9630

$BLCM –
Bellicum Reports Clinical Results of BPX-501 in Pediatric Leukemias at the 22nd Congress of the European Hematology Association

Oral presentation highlights high success rate of haploidentical transplants, with low incidence of disease relapse and uncontrolled GvHD

https://globenewswire.com/news-release/2017/06/23/1028392/0/en/Bellicum-Reports-Clinical-Results-of-BPX-501-in-Pediatric-Leukemias-at-the-22nd-Congress-of-the-European-Hematology-Association.html

Janine
Guest
0
Janine

Maybe it will be released to help immonatherapy with transplants first then more research for other uses.

lamorgan101
Irregular
8

if anybody is tracking this one,,,, its down 4% already and dropping. as of 8:00 AM pst, Announcement must have been as predicted, shit

allen_6
Irregular
0
allen_6

Hello, I posted the short list of potential candidates mentioned in this discussion, but the post seems to have vanished. In any event, did any of the other firms make the presentation we were expecting?

sigmull
Irregular
77
sigmull

Dr KSS: I am not down on BLCM yet. Bought it a couple of months ago. I like that 80% of stock is held by institutions and mutual funds as well as a healthy insider ownership plus a fair amount of cash. Management has a a fairly good pedigree. Bur what I like is that FDA and EC have granted orphan drug status. As a recent buyer I do not have any fatigue yet. Presentation in Madrid last week at a Hematology symposium was reassuring. I plan to hold for now

atharali
Guest
0
atharali

Thank you Travis for sending me report on “CD19”. On your information & group discussion I bought some stock of BLCM,MBRX & JUNO. After June 23rd BLCM stock is not showing any excitement, but MBRX gone up 44% & JUNO is 10% up. Thanks for the article update.

sam_trader
Member
2
sam_trader

I’m the new gummie around trying to get used to the website’s layout. Where actually did Travis mention about MBRX and JUNO? I do not see any articles around.

Victor
Guest
0
Victor

I think the correct stock is MBRX and not BLCM

Ekaterina
Guest
0
Ekaterina

BLCM has an interesting technology but not one to get too excited about. The market figured this out already as the stock price would be equal to BLUE and KITE if it was of any unique value. Most co’s are working on an “off” switch so I doubt a buyout anytime soon.

Bernie
Guest
0
Bernie

New too buying stocks, within a few days I can see what teasing stocks is all about. People like Ernie Tremblay would be great in selling used cars by the way he verbally strokes you. Fortunately I didn’t pay the $1950. And looked it up myself. I did buy a bunch of shares but saw n read the value n sold immediately.

Jeffrey Lewis Belman
Guest
0
Jeffrey Lewis Belman

What does Ernie Tremblay think of Bellicum Phrmaceuticals now? The share price is really dropping after poor 2nd quarter results,but is there something else we should be aware of? Has Bellicum signed any new agreements with Big Pharma since the June 23 announcement?

seminole2
Irregular
12
seminole2

Yes. Bellicum Phrmaceuticals is down a whopping 38% since his recommendation, but good ole Ernie still has confidence it will turn around. I wonder if he still thinks it will bounce over 128,000%.

jcpru3
Member
0
jcpru3

Agora, Oxford, etc. are offering “deals” upwards of 2K to learn the name of the tiny Texas biotech. Does anyone believe they really know? I’ve been taken by them all before.

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