Replies to post #8847 on Pluristem Therapeutics Inc (PSTI)

[zzaatt]

Spideyboy, I admire your incredible patience and generosity
in this post (let's see if it can penetrate anyone's consciousness).

Couple of minor points:

With regards Yaky, I can't say I'm as impressed.
2. As far as I can see, no it does not appear that their bonuses were justified as yet.

Too early to tell!
If we're at 15 next year, then we can say retroactively
that their bonuses were justified. Also, it's a simple fact
that their remuneration is not out of line with
other similar companies.


Usually, any reference to mouse models is met with
mirth (you know, the "LMFAO" kind) and sneering on message boards.
Here's one (of many) articles that powerfully refute that attitude:

Humanized mouse models of clinical disease
From: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5280554/
Immunodeficient mice engrafted with functional human cells and tissues,
i.e., “humanized mice”, have become increasingly important as small pre-clinical animal models for the study of human diseases.
Since the description of immunodeficient mice bearing mutations in the IL2 receptor common gamma chain (IL2rgnull) in the early 2000’s,
investigators have been able to engraft murine recipients with
human hematopoietic stem cells that develop into functional human immune systems.
These mice can also be engrafted with human tissues such as islets, liver, skin, and most solid and hematologic cancers.
Humanized mice are permitting significant progress in studies of human infectious disease,
cancer, regenerative medicine, graft versus host disease, allergies, and immunity.
Ultimately, use of humanized mice may lead to the implementation of truly “personalized” medicine in the clinic.

Totally agree with your statement:

The science really seems astounding. The last bit of additional data that PSTI came out with last week with additional CLI murine study was quite amazing

Yes, it's true, clinical trials are still necessary (!!!!!), but isn't it nice
to have corroboration of assumptions about MOA, sort of like
seeing a road sign on the way to your destination.

[Scott999]

Hey Spidey thanks for the reply. Busy is good I hope, as I am as well. Thankfully that will allow me to buy more options as my March ones seem to be coming up faster than ever. Points well taken on all questions.

While zome might think these are invalid questions, I do not. I have always been a fan of the technology, just not management.

Hence the reason for asking about the validity of being called a phase 3 company. The data does look good on all counts, just wasn't sure about the significance of it with such small human numbers. Some good numbers regarding our IC results will put any doubt to ease.

I don't share your optimism on Zami. While yes running a company has similar traits, this complex field they are in is a little different. Connections in the upper levels of management in other big pharma companies would go a long way imo. Just the very name of his "consulting" company says it all. Rose High Tech Ltd.

Having experience would also maybe prevented the missing of targets year after year, and sometimes by years, knowing the complexities and difficulties that can arise in this field.

As for Yaki, see no point in paying him CEO type salary and bonuses. Again, the 2 of them go back a ways, and seems like a complete waste of money to me. Just 2 buddies helping each other out IMO.

And thank you for clarifying the belief that some have that CLI could be approved in 2 weeks to 90 days. Some beliebers out there may have actually believed this. From what I have read, fast track means more frequent meetings with FDA and ability to fill portions of BLA before trial is done, allowing for quicker time frame once trial is over.

Hoping we hear some of these interim results on HCT soon. The study started Feb 8th. All the primary outcome measures have a time frame of a year. So I don't know how they expect to get interim results unless they can before the year has elapsed. Could just be management's projections are exaggerated like usual.

But the estimated completion date is expected to be May 2019. Would have to think they expect all 30 to be enrolled within 5 months. Will be keeping an eye to see if any of these things are changed when they update CT site. It will be a good gauge as well to see how quickly the CLI is progressing as well imo. Even with the "new" person at Pluristem in charge that didn't "drop the ball" like they did in the IC trial like one person here says.

Your previous post on my delay of pivotal ARS trial has given me new hope that maybe this new Bill will get some sort of stock piling contract before approval. Always thoughtthat if they wanted it, they would have gotten this trial started. Your explanation seems reasonable enough for the delay. But you would still think they could announce funding for this trial, in advance of it being ready to go. Then make sure the design of this trial is correct in every way. But like always, we will just have to speculate with any info we find. And of course wait wait wait. The one thing management does best.

Again thank you for your response. A little transparency from management would go a long way. But they've been at this a long time, and don't think that will change ever. They like to keep things under wraps and only the lucky raise participants would get info that us Joe Shmo shareholders could only dream of.

[HappyBee]

Hello Spideyboy, I have been reading all your posts and have found them very informative. I feel that I have learned a lot from your expertise. Many thanks for taking the time to share your knowledge. I certainly do appreciate it.

[voova99]

Thank you for informative, deep and interesting posts, Spidey!

[EichKing]

You asked me to read your posts in their entirety, which I did and have done.
For starters your assessment of management is devoid of any objective history. I sincerely hope your comments are not based upon previous company names and their titles. If one looks into Zami's prior and current performance running companies, he's lost $200 mm with PSTI and the previous endeavors yielded poor results. History indicates they are good at making money for themselves, though as they are highly compensated. Your comment "Companies aren't wildly different when talking about top level management so top level industry experience is most important." is confusing. We are in the biotechnology industry, and neither twin has any top level industry experience....which you say is most inportant, or not? Companies ARE "wildly different" ranging from private to public, small, medium, and large, commodity to specialty, speculative to traditional. If your comment was true....splain what changed at Yahoo? Leadership and the "vision" changed along with Marketing and overall direction. IMO it is irresponsible to shareholders to imply hiring a guy who has had multiple upper level positions at various companies makes him "OK" to lead. A disregard for bio-industry expertise as secondary to basic company management as hiring criteria got us where we are. I guess he can learn it as he goes? If I was to employ your logic, then Yaky would be the better candidate based upon his degree and the fact he worked alongside Zami in his past lives. Neither get my vote.

2)Most people with a vested interest in PPS appreciation can agree the bonus situation is questionable at best

3)Completely disagree on the next dilution is "easy enough" Quite a cavalier attitude with other people's money. The next "easy enough" dilution event has a higher probability of being followed by a reverse split than it does at occurring at $5 per share. In fact, the next dilution might prove very difficult. They are out of "positive" PR, and these "phase III" approvals are make or break, that is a fact as they have no more shots on goal.

4) Shows are worthless. We have guys making over $3 mm a year wasting OUR time there (you neglect to add in that cost of compensation and missed work time) I'll break it down for you. At $3.6 mm per annum, a person makes $67,000 per week. 4 lost days per show (2 travel days and 2 show days) X 12 shows is $643,000.....that is the highest paid of a group that goes to these. Simple math, eh?

5)No we are not a phase III company. While it is true we get accelerated marketing approval, PSTI still must go through appropriate proof of concept thereafter on efficacy and safety. Would I rather have us in fast track, of course, but this in and of itself has nothing to do with the product actually delivering. PSTI is no more than a phase I company and the PPS reflects that (and dropping) When are YOU buying more at these bargain prices?

Mouse trials are nothing more than crude starting points. You indicate "I am not surprised that we have been able to see such aligned results from mouse to human data so far.", as if this means anything? Any study that moves forward that used initial trials from mice in a lab would have shown a positive result, otherwise it doesn't move forward or get discussed. Further to your "I am not surprised moment", you sight humans share 92% DNA with mice, thus making them a good indicator of success for PSTI. This is exactly the opposite of the problem with using mice, sighted by researchers. They indicate mice are not nearly close enough in DNA to humans to draw any real conclusions, amongst other problematic differences. The truth is, only late stage clinicals are decent predictors of success. One thing mouse studies are good for is predicting more cash burn and more losses.