Ocata Therapeutics Inc fka OCAT

[louisa]

Chairman Wm. Caldwell blog today 12/6/10

DECEMBER 6, 2010
POSTED BY ADMIN
The Chairman’s Blog Post: A Big “Thank You” to Our Note Holders!
It has been a very eventful past month for our company:

> The FDA approved our Investigational New Drug (IND) application to commence a Phase I/II Clinical Trial for Stargardt’s Disease, a form of juvenile macular degeneration.

> The translational preclinical work began when Irina Klimanskaya, PhD, an indispensible member of our scientific team, first identified the human embryonic stem cell derived RPE cell in a petrie dish over six years ago.

> Our research team forged a relationship with Raymond Lund, PhD, considered to be one of the world’s foremost experts in vision restoration and retinal cell physiology, when he was at the Moran Eye Institute and subsequently followed him to the Casey Eye Institute at Oregon Health & Sciences University (OHSU). At OHSU, preclinical “Proof of Concept” and efficacy work was conducted utilizing Dr. Lund’s proprietary Royal College of Surgeons (RCS) rat model for retinal disease.

> At the end of November of this year, the company announced that it had filed a second IND for Dry Age-Related Macular Degeneration (Dry AMD), which represents a $25-30 Billion combined market in the US and Europe alone.

It is the company’s belief that both Stargartd’s Disease and Dry AMD can be treated with our retinal pigment epithelial (RPE) stem cell therapy. I am linking a presentation and summary description of our RPE program for those of you unfamiliar with our efforts.

It is with great appreciation that I want to thank those that participated in the various Debentures that allowed our researchers to achieve what most other companies have yet to do. The one company that preceded us on the FDA approval front has publicly admitted to spending many multiples of the amounts of capital our company raised to achieve a comparable milestone. We were able to bring together hedge funds, private investors, and foreign investors to finance multiple rounds when other entities struggled under the Bush-era investment “overhang”. The financial structures that were available to us were extremely tough. However at least they enabled us to secure the funds needed to continue our “translational work” from the scientific bench to ultimate FDA approval for human clinical use. This past week the company announced that the first four debentures have been extinguished and there is less than $900,000 to be redeemed over the next three months on the 2009 debenture.

While it has sometimes been a rocky relationship with our note holders, they supported us for the past five years despite having to weather the effects of the most unstable period in the U.S. capital markets in my lifetime. Some of the entities holding our debt were forced to liquidate. I believe I can say that all those that invested did not lose money on their investment in our company and many of them made substantial returns warranted by the risk they took with the investment. We are grateful to them and appreciated their support. Their capital allowed us not only to become one of the early pioneers in translating the science to therapeutic programs ready for human clinical trials, but it supported the development of a strong Intellectual Property (IP) position within the field. By way of example, we developed or acquired the rights to the following:

>The Single Blastomere technique for deriving ethical stem cell lines;

> The Parthenogenesis technology

> What we labeled as the ACTCellerate Technology Platform;

> Some of the earliest filings surrounding the iPS technology;

> and recently received issued patents securing our “freedom to operate” with our RPE-derived cellular therapeutic program.

We have licensed some of our technology to other companies, which have subsequently made these platforms their corporate technology “centerpiece”. For a variety of reasons we have retained exclusively some of our IP while licensing out specific “non-core” pieces. We have continued our strategy to license and collaborate with third parties utilizing our IP and should have more to say on this soon.

For those of you who are not familiar with our company’s history, it has been a challenging journey since I became CEO in 2005. We had the mysteries of science to overcome; the Bush policies impacting the funding of our sector; the “see-saw” operational ride resulting in significant “downsizing” in 2008, including layoffs and salary deferments; the deterioration of the capital markets leading into the sub-prime recession which was magnified to the point of a depression in the micro-cap capital marketplace; and the continual media abuse from those ethically opposed to our possible success. To combat these obstacles, we have a core of dedicated, talented and motivated employees; a world class Board of Directors and technical advisors; and a major dedicated “core” shareholder base that is committed to our long term success.

In the coming weeks we will be finalizing our clinical sites for our Stargardt Phase I/II Clinical Trial, working with their respective Institutional Review Boards (IRBs) to gain approval for commencing patient selection and completing the final testing of our clinical grade cells to be used for the Trial.

We have a full plate for the first half of next year. We will endeavor to keep our stake holders informed when the time is appropriate on the progress we are making.

Thank you for your continuing interest and support.

William M. Caldwell IV
Chairman and CEO
Advanced Cell Technology, Inc.

Executive Summary – ACT Macular Degeneartion Program
ACT Macular Degeneration Program

http://www.thechairmansblog.com/william-caldwell/2010-12-the-chairman’s-blog-post-a-big-“thank-you”-to-our-note-holders.html