Stem Cell Therapeutics

The May 20, 2009 AGM was a “good news” AGM

For starters, we’re getting a PR tomorrow morning with the results of the “orphaned” 7 patients that were enrolled in the Phase IIb stroke Trial that was halted. This trial was basically identical to the 12 patient Phase IIa Trial that had such great results, except that this one was a randomized double blind Trial. When it was halted, 7 patients had been enrolled … 2 treated with our hCG + EPO, and the other 5 with a placebo (basically salt water). The 2 treated patients did better than the 12 did in the Phase IIa Trial. This is good. The 5 placebo patients did less well than we had assumed that untreated patients would do. This is good for us statistically. The patient count is way way way too small to give us a free pass to an Approval, but I think that the results are great. More on this tomorrow after we get the PR.

The new “modified EPO” protocol is the just our regular protocol, but with “slightly less” EPO. Because we are now the only company allowed to proceed with EPO (at any level) so far for central nervous system disorders, the exact new protocol is not being disclosed … so that we can keep a competitive edge. Alan Moore said that they expect the new protocol to work as well as the old protocol.

We are still on hold (by Health Canada) for the Traumatic Brain Injury (TBI) Trial, but is expected that this hold will be removed too.

I asked what differences we might expect between a stroke Trial and a TBI Trial under the same protocol. Alan said that we would have to wait for the results as nobody has ever done this before. He was willing to tell us that the rat Trials for stroke (that gave us results that paralleled the human results nicely) were giving essentially the same results to the rat Trials for TBI …. And that the TBI Rats were showing full recovery in 21 days.

While we’re comparing Stroke vs TBI … it was pointed out that our only competitor for stroke is tPA (usually called a clot buster). tPA is designed to break up blockage to the blood flow in the brain, and must be administered within 3 hours of the stroke occurring, at a location set up to do it. It has the nasty side effect of brain hemorrhage. The one brand of tPA on the market was being challenged by Vipromex (spelling?) with a new product, but the Vipromex product failed. The tPA application is available to about 5% of stroke victims. For TBI, there is NO other treatment other than what we are putting into our next TBI Trial.

Q. For stroke, what happens beyond the recovery achieved in our Trials after the first 90 days?

A. We don’t know, but with the rats, they continue to improve. Longer is better.

Q. Can we have the slide show that you’re working from put on the web site?

A. Yes. Chloe will look after that.

The MS Trial will be starting this year, and is being funded by “the Canadian Stem Cell Consortium” (I think I have the name right?)

Free is good because we have about $5.5 million in the bank, and out new 128 patient Phase IIb stroke Trial will cost about $3 million.

Alan spoke of having serious partnering discussions in the last half of this year, and when discussing our portfolio of patents, mentioned the PDGF patents (that are suitable for applications with Parkinson’s disease) are apparently of interest to some other companies that could be interested in purchasing them, or rights to them. It looks like there might be some options to postpone any need for further financing.

We haven’t had much news for the last many months because it’s good to keep the promotion to a minimum when you are in negotiations with the FDA. We’re approved now, so we should be expecting to hear of more promotion (and news) in the future. If anyone here knows of any innovative ways to get the story out, let Alan know. He’s interested.

The CBC had asked us to let them know when the FDA lifted their hold, we told them a few days ago, and they showed up at the AGM with a TV camera. Nothing was said as to how or when the recorded footage would be used.

Their new member on the Science advisory team, Dalton Dietrich (spelling?) has strong ties with the US Dept of Defense, and has a strong interest in TBI.

Stroke Trial enrollment is to start early in Q3 … think July 1 or a little later. Trials will be run in Canada (2 sites?) and in India (10 sites). The Trial will be completed before the end of this year. Although double blinded, the “Data Safety Monitoring Board” is not blinded, so we have the possibility of both enrollment and safety updates as the Trial progresses.

Insiders own somewhere between 10% and 13% of SCT, and these are shares that were bought at higher prices than we’ve been able to get over the last several months.

Alan said that he was not being allowed to include the slide in his presentation any more that showed a fair share price evaluation as being over $5.00 per share. He didn’t hesitate to let us know though that everything that had justified that figure still stands (now that the Trials can start again).

There is more, but I’ll have to re-read my notes a few times to figure out what I’ve forgotten.

Sorry for the scrambled nature of this post, but I’m smiling too much to keep this post well organized.

It was a very good AGM.

rjc