Pluristem already knows trial results

Gali Weinreb

The question is whether the results of the gluteal muscle regeneration trial are really so interesting.

The extreme volatility in Pluristem Therapeutics Ltd.'s (Nasdaq:PSTI; TASE: PLTR) share price on the Tel Aviv Stock Exchange (TASE) today begs the question if someone knew the results. Sources inform ''Globes'' that the company already knows the results of the Phase I/II Clinical Trial of its PLacental eXpanded (PLX-PAD) for injured gluteal muscle after total hip arthroplasty, and may have had them for at least a day and that it is analyzing the data. The company will publish the results on Tuesday.

Pluristem's share price was down 13.7% by mid-afternoon on the TASE today, after falling 15%, recovering half the loss and falling again. On Friday, the share fell price 0.9% on Nasdaq to $4.43, giving a market cap of $265 million.

Pluristem's share price rose 36% in the two and half weeks until this morning, as the company conducted a unique public relations campaign to mark the publication of the study's results. On Tuesday, it will present the results to investors, analysts, and correspondents, with the participation of foreign guests. Such activity is not the habit of similar companies when they publish the results of clinical trials, and Pluristem did not act this way for previous clinical trials. Investors saw the preparations as a sign that the results will be positive.

Positive results won't shake up the share

At a recent conference, Pluristem chairman and CEO Zami Aberman said that he was optimistic about the results. He did not hesitate to say that a failure in muscle regeneration could affect all of the company's products. Investors assumed that if Aberman was pessimistic about the results, he would not have linked the things.

Despite last week's blind sale of shares by Aberman and CFO Yaky Yanay, there have no material events at Pluristem lately. Its only statement was that it obtained what it called an "important" method of use patent in Australia for its placental stem cells.

"Seeking Alpha" publishes articles by independent analyst Sharon di Stefano, who frequently writes very favorable reports about Pluristem. In her latest report, she says that the company has a better and cheaper way to produce stem cells than Australia's Mesoblast Ltd. (ASX: MSB), which has a market cap of $1.5 billion. What she failed to mention is that Mesoblast is much farther ahead in clinical trials than Pluristem.

As for Pluristem, the more important question is whether the results of the gluteal muscle regeneration trial, even if they are positive, are really so interesting. It is only an initial safety and toxicity study on 18 patients. The official objective of these studies is to show the regulators that the product is safe to use.

In such a small study, it is very hard to prove a statistically significant difference between the test group and the control group. Most companies reports "positive indications" at this stage, which may be indicative of the product's activity, or may be just a statistical artifact. The real test of products of companies like Pluristem comes in the subsequent clinical trials.

Announcing "positive indications" now should not affect Pluristem's value. An extraordinary result or total failure is another story, especially in view of Aberman's comments that a failure of the product would indicate major problems with the company's products. After all the hype, it will be interesting to hear what the company has to say tomorrow. Nonetheless, it is not certain that it will announce anything worth volatility of hundreds of millions of shekels in its market cap.

Published by Globes [online], Israel business news - - on January 20, 2014

© Copyright of Globes Publisher Itonut (1983) Ltd. 2014

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