StemCell Therapy

The following is an excerpt from the June 29, 2010 Breakthrough Technology Alert, published by Agora Financial. Agora Financial is a fully independent publisher and has no financial connections to companies listed below. Breakthrough Technology Alert’s editor is industry expert Patrick Cox. Patrick is renowned for his innovative forecasts and keeping readers “ahead of the story”.



For more information about Patrick Cox and Breakthrough Technology Alert please visit http://www.agorafinancial.com

Q&A with ISCO



International Stem Cell Corp. (OTCBB: ISCO) has also been the target of rumor campaigns. ISCO, incidentally, recently announced further positive IP news. Specifically, Advanced Cell Technology, Inc. (ACT) was just issued U.S. Patent Number 7736896 covering a method for producing retinal pigment epithelial cells. ISCO, however, had previously acquired rights to this technology from ACT, so the award solidifies their position in stem cell eye therapies.

ISCO's corneal research also got an unexpected boost last week, though it's not clear how many people know it yet. A stem cell breakthrough from Italy made quite a few headlines. The article that provoked the coverage was in the June 23 online version of The New England Journal of Medicine (NEJM). Specifically, it featured clinical research from professor Graziella Pellegrini et al. titled "Limbal Stem-Cell Therapy and Long-Term Corneal Regeneration." A helpful video by ABC News can be viewed here.



The coverage of the journal article is, however, incomplete. So let me put it in perspective.

The procedure made use of the well-established practice of extracting and cultivating limbal stem cells. Each of the patients, in effect, had stem cells removed from at least one eye. Once the adult stem cells were multiplied in the lab, they were applied to the cornea. There, they regenerated the corneal epithelium (the outermost thin layer of the cornea), restoring sight.

This is wonderful proof of the power of stem cells, but it doesn't represent a breakthrough in terms of basic science or investment possibilities. This is because the cost of extracting these surviving stem cells is very high. So is multiplying and reattaching them. The only reason the experiments were even allowed to proceed is that all the cell materials come from the subjects of the procedures. They would not have been allowed if, for example, scientists wanted to use the stem cells from one patient to treat another patient. Nor is it clear to what extent, if any, a company can patent these procedures.

On the other hand, the Italian procedures were most successful when they were combined with the implantation of replacement corneal structures. Those replacement corneas cannot be regenerated from limbal stem cells. In fact, they came from cadavers.

ISCO, however, is now able to grow them in the lab to produce cheaper, safer corneas. ISCO is involved in discussions with various companies to commercialize those parthenogenic corneal structures.

For most patients, who have enough of their own stem cells to regenerate the corneal epithelium, ISCO's corneas are all that are required to recover sight. Eventually, in fact, I suspect that ISCO will also have off-the-shelf limbal stem cells that will regenerate the corneal epithelial too. These cells would be from each of ISCO's cell bank lines. Now being established, it will include 50-100 cell lines that immune match most of the world's population. No other company has this ability to provide inexpensive stem cells for the masses.

Now allow me to debunk some of the rumors currently being spread about ISCO. Normally, as you know, I don't like to dignify these attacks, but I do make exceptions when it's important. I'm doing this, by the way, in a question-and-answer format that board chairman Ken Aldrich was kind enough to answer. The questions deal with some of the unfounded rumors circulating. If these don't concern you, feel free to skip them. Q1. Did ISCO close its financing?



A1. Yes, they did a $10 million financing, and then used $2.5 million as part of a balance sheet cleanup that removed approximately $15 million of 10% preferred stock and still left them with an additional $7.5 million in cash on the balance sheet, in addition to whatever cash was already there.

Q2. Doesn't Socius hold a lot of preferred stock that will be a future burden to ISCO?



A2. No, all of that has been retired as part of the capital restructuring announced in an 8-K filed June 11, 2010. As a result, Socius and its predecessor company, Optimus, hold no preferred shares of ISCO at all.

Q3. Is the company running out of money?



A3. Based on the monthly "burn" rate of about $550,000 for the last 15 months ($562,000 for the last quarter), the proceeds of the company's most recent financing of $7.5 million after the repayment of the outstanding preferred stock of Socius and Optimus would give the company at least 12 months of "runway," even without any additional revenues from operations, licensing or partnerships.



I could go on, but this is pretty long. Next week, I'll have more updates.

For transformational profits,

Patrick Cox

To learn more about Patrick Cox and Breakthrough Technology Alert please click here. © 2010 by Agora Financial, LLC. 808 St. Paul Street, Baltimore, MD 21202. All rights reserved. No part of this report may be reproduced by any means or for any reason without the consent of the publisher. The information contained herein is obtained from sources believed to be reliable; however, its accuracy cannot be guaranteed.

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