BrainStorm Cell Therapeutics Inc (BCLI)

[mybikeisorange]

Minding,

First off, in response to your reply to my post about BCLI and CUR not being down because of the article, it sounds like you agree with me now that the selloff was due to the article. Not only BCLI and CUR, but other companies going after ALS took a hit as well on Monday.

Thanks for the post and quotes from your friend. He may have had a lot of success in the past, but with all due respect, he is incorrect and seems a bit misinformed on BCLI:

"BCLI is also taking some heat today in response to positive developments by other companies doing research on ALS. BCLI is only actively doing research on ALS although its technology may have other applications. (And there are a number of companies that are using stem cell tech to treat both Parkinson's and MS.) Anyone who is perceived to be ahead in the game will reduce speculation about BCLI being successful."

Not true. BCLI completed pre-clinical work for Parkinson's back in 2005, and should be close to completing (if they haven't already) their pre-clinical work for MS. Its potential application is the beauty of NurOwn and why I remain interested. Once they have proven safety and tolerability they'll likely not have to go through Phase I with other indications and be able start from a more pivotal trial, as it is the same treatment.

"I do not expect any catalysts to emerge for BCLI until next year when test results will be known."

What about BCLI's Phase 2a data that will be released before the end of this year? Why is that any less of a potential catalyst as Genervon's Phase 2a data release Monday? What results is your friend expecting next year?

"In medical tech its always about who gets to the goal line the quickest. If someone has a better mouse trap than the competition and it has to do with health care, people flock to the better trap until something better comes along. From an investing standpoint, the money will flow into the leaders in medical tech not the followers."

No one in their right mind will say that after a one-tailed pilot study done on 8 patients, that Genervon is the disputed leader. Just like there are dozens of headache medicines, there will be room for more than one player in this huge market of neurological degenerative diseases.

"With BCLI, they have not given any indication that their results are anywhere close to those reported today by a non-public company. The same can be said for CUR."

What kind of indication did Genervon give before the release of their Phase 2a data? We won't know until we see it published later this year, but again you can't compare one-tailed data to two-tailed data. Of course two-tailed will be lower than Genervon's because it is measuring both sides.

"[Genervon's] approach appears to be gene therapy, not stem cells"

Yes, and if Genervon can show that they have been able to get to the origin of what causes ALS, then that would be huge, as that has been the toughest nut to crack so far for anyone. They have not said that they have though.

"I will no longer touch CUR or BCLI, simply because neither have funding sources if something goes wrong."

Why is that suddenly a problem now? Funding is a problem with all early stage biotechs. If something "goes wrong" then it is not only funding that will be problem, but that is the risk you take with all early stage biotechs.

"One tailed or two, the numbers are really good, possibly the best ever seen in an ALS study."

I don't think your friend understands the significance of a one-tailed study. The power is greater in a one-tailed study compared to a two-tailed study of the same data. So of course the numbers are going to be really good. No scientist or scientific group will put much weight into efficacy results of a one-tailed data. The guidance Genervon is looking for will probably result in being asked to do a Phase 2b well-controlled trial. Here is a link to a training protocol sheet from the NIH. Note page 3:

Power is Affected by…..

• One-tailed vs. two-tailed tests
– Power is greater in one-tailed tests than in
comparable two-tailed tests

https://ippcr.nihtraining.com/handouts/2013/Johnson_SSP_11_19_13_C.pdf

While we are on the topic of the data, there are some other issues I have. The PR said that 8 patients were randomized to drug and 4 to placebo. Yet it also says that the 8 drug treated patients were compared to "historical controls" rather to the 4 placebo patients. Why even have placebo then? That is really strange. Also, they provided only aggregate data on the 8 patients and no baseline or endpoint data on the 8 of them in regard to ALSFRS-r or SVC. It makes it very difficult to interpret the data.

"That is where the money will go. If it were public my guess is the stock would have doubled at least on the news. Not only that it apparently has potential impact on Parkinson's. "

That is just a bunch of guessing. NurOwn also has potential impact on Parkinson's. That is what NurOwn was originally developed for and all of the pre-clinical data suggests it has a biological impact.

"BCLI may not have enough money to finish their current round to testing. If they do not get numbers equal to Gene's I doubt if anyone will want to fund future research."

That is also incorrect The company has guided on several occasions that they have enough cash to fully fund Phase 2 in the US to completion. Regardless I expect them to do a raise in conjunction with the publication of Phase 2a data, and I do not think they will have a problem at all.

Bottom line, and again no disrespect to your friend, but it seems like he made several conclusions based on incorrect information and unconclusive scientific data that still raises lots of questions. The fact of the matter is with Phase 2 initiated in the US, another indication about to filed for soon (another catalyst your friend forgot to mention), a very undervalued market cap, and a very high quality CEO at the helm, there is a lot to like about this company going forward. No doubt there will be bumps along the way and I am sure more competition is out there, but that is not a bad thing in my opinion.