Ocata Therapeutics Inc fka OCAT

[rocky301]

From JHam;
http://investorstemcell.com/forum/advanced-cell-technology/3091.htm

Conference Call Highlight Summary.
Hey everyone! I listened once again to the conference call this morning and took down some notes. I thought I would post some of the main highlights of the call to make it easier.

SMD/AMD Trials

- Gary on the upcoming trials, "Absolutely transformative trials in the history of regenerative medicine"

- Two patients (one for SMD and one for AMD) were to have been selected yesterday, Friday June 10th

- Selection of patients will be announced next week or the week after

- After selected, patients will begin one week of immunosuppressants followed by RPE injections thereafter

- Gary said the company WILL announce when the injections have taken place and added, " I'm sure as you can imagine, there will be plenty of publicity around what 's happening in this"

- According to Johnson & Johnson, in terms of dollar value, AMD is the #1 most unmet medical need in the world

- ACT will announce two other sites besides Jules Stein and Casey Institute

- ACT will be releasing preliminary trial results by early October

- If Phase I trials are going better that expected, ACT may seek to terminate the trial so that they can shift to a more "pivotal trial immediately"

- Dr. Lanza said the attachment of the RPE cells to the Bruchs Membrane is not a concern

Before end of 2nd Qt.

- Finalizing patients

- Starting SMD/AMD trials

- EMA approval (could happen early 3rd Qt.)

2nd half of this year

- File IND for Myopic Retinopathy

Other Programs

- IND for Hemangioblast (hopefully) to be filed in the next 12 months

- Myoblast will be partnered out to a third party. Gary said they are making great progress with this and to look for more info in the near future

Europe

- EMA has informed ACT that the review process of the CTA for SMD has begun

- Gary will meet with the EMA in July to find out what they need to get trials underway in EU

- ACT is "absolutely seeking compassionate use" for SMD. Depending on CTA approval in EU, ACT could see compassionate use by the end of 2012, but more likely 2013

- Patent issue in EU. Statements in front of EU courts proclaim it is required to destroy embryo. Attorney General has now been made aware by ACT that there are alternative methods to extract a cell without embryo destruction. He was unaware of this at the time the statements were issued to the court. EU countries may decide to go about this issue independently. UK is very Pro-Stem cell research so trials will probably start there

Miscellaneous

- ACT should have agreement inked with Roslin in the next few weeks. However Matt Vincent implied it would be much sooner, "tomorrow"

- ACT will be applying for October CIRM grant. Gary has met with the CIRM President

- ACT is working on a video that will explain everything the public needs to know about the upcoming trials

China/India

- Gary speaking about hiring other C level staff: "...but once you get outside the science and into the operational and the financial operations of the company, and the logistics of day to day running a company with operations not only in the U.S., but Europe, Korea, and hopefully soon doing things in China and India, you know obviously it is quite overwhelming"


Administration

- Lanza will renew his contract which is set to expire at the end of September. "I'm not going anywhere" stated Lanza

- Gary Rabin has been trying to create a culture of more openness and transparency with shareholders

- The search is very active to find more C level staff. ACT hired global executive search firm Spencer Stuart 3 months ago to help in finding a Chariman, CEO, CFO, CBO. So far thrilled with two candidates with a third visiting Marlborough soon