US stock - ACTC.OB, now changed to OCAT (Ocata Therapeutics)

IpohMan69

With Authorized shares count of 2.7 billions and Outstanding of about 2 billions; ACTC just announced that it is proposing to do a reverse split of between 1 to 20 and 1 to 80 pending shareholder voting results, to up listing from OTCBB to NASDAQ stock exchange.

They held a conference call this morning announcing the last quarter result, the current statuses of the company, the trials and also future planning. Here are the highlights beside just the normal quarterly results talks :

The 1st Cohort for SMD is complete and the results of this stage will be submitted shortly for review in order to advance to the 2nd Cohort.

The 2nd Cohort will consist of 100,000 cells... beginning soon.

First AMD patient(78 years old women) has stable improved vision. First SMD patient(51 years old woman) shows continuous improvement in vision!

The results of the 3 SMD patients injected since the Lancet article have shown THE SAME RESULTS as the first patients injected. ACTC will be aggressive in its posture relative to proposing a Pivotal Phase 3 Trial and Trial Termination for SMD trial. Two additional trial sites will be announced in the next few weeks.

Due to extreme difficulty in finding patients who meet the current AMD patient requirements, a new protocol request will be submitted to the FDA to allow for a wider swath of potential candidates. 2 patients who were close to approved failed the last round of testing requirements, hence the delay. Because of this, proposal for a Protocol change to FDA in the Dry AMD Trial in enrolling less advanced Dry AMD patients which will be very favorable to treating younger patients with intact and viable BMs to show engraftment of injected RPE cells and vision improvement.

Litigation is "largely behind us." Now the focus in on fixing the capital structure. 2 billion shares for this company at this stage of the game is not normal and puts ACTC at a disadvantage.

Have consulted with some of the largest healthcare investors in the world consisting of, or in addition to, 15 large mutual funds. These companies/organizations and other potential investors/partners all say that they love the science but that ACTC needs to work on its capital structure.

A R/S allows for a NASDAQ listing and will only commence the R/S with assurance that a NASDAQ listing is pending.

ACTC intends fully on becoming a large global biotech company, and in order to do this, a R/S, getting off a "penny stock" board is essential.

45,000 shareholders of ACTC exist. The average ownership is $5,000 per investor. Although ACTC has increased from 26,000 or so investors to 45,000 investors recently, there is a general lack of ability to bid the share price up to appropriate levels. This will only change when the company is listed on the NASDAQ and investors with millions of dollars of capital can bid up the pps. However, the company is not interested in reducing the market liquidity, that is buying back shares.

The amount of A/S's will decrease at the time of the split and there was an error in the latest proxy report stating otherwise. Reassured that the written report was an error and that A/S's would be decreased at the time of a R/S.

ACTC is preparing development of IPS ventures.

Confirmed that most of the major biopharmas are "all over ACT", in other words, they are in discussion.
A Joint Venture would be great, but at this time not in the company's best interest as it would leave too much value on the table. At some point, in a better position. Have to do what's right for the company.

China is still in play. Negotiations are ongoing. There are challenges but more importantly... Rabin was more specific to the Corneal Platform, as a huge market in China, as there are no source of donors for these type of surgeries.

Summary from my viewpoints:

All and all this is very positive, especially this will ease some of the folks that worries about the risks associated with penny stock. Like I said all along, I am in it primarily of the science, if the science works and prove itself, the gains in appreciation of the value will come. Back in my mind R/S is always something that I think will come up, but just did not expect it that soon. Reverse split to avoid a "delisting" order is always bad but reserve split from position of strength to up listing to major exchange is usually good strategy. Below is a link about uplistings misunderstanding.

http://www.thestreet.com/story/1 ... plisting-works.html

Let assume the final R/S is 1:80, this will reduce the float from 2 billions to 25 millions. Whatever you owned now in term of the number of shares will be lower but your percentage of ownership in the company will not change.

Let's assume you have 500,000 shares now...and the company revenue is 1 billion
Without a split...(I'll round to 2,000,000,000 shares on the market to make calculations simpler).

1B (revenue)/2B(shares) = .50 per share
YOUR STAKE : 500,000 * $.50 = $250,000

With a reverse split...(lets say 1 to 50)
Shares you now own=10,000
Total Shares in the company=40,000,000
1B(revenue)/40M(shares)=$25 per share
YOUR STAKE : 10,000 * $25 = $250,000

Look out for the JV offers in the future, we will get at least one. And if that JV is, let says 4 billion (this is not too much because the projected market potential of AMD alone is 25 billion in US and Europe, an unmet medical needs). With the same after split of 1 to 50, which make it 40M outstanding shares,  the price per share would be $4000M(jv offer)/40M(outstanding shares) = $100.

And if you have 500 shares of ACT, that will equal to 500 * $100 = $50,000.

I have to say I am day dreaming!!!!

Again to me, it is high risk, until it gets to NASDAQ but the huge potential of rewards outweighed the risk, with or withou NASDAQ; by multiple folds, thus here I am. They are doing a reverse split now, I can certainly see the possibility that they can do a forward split or multiple forward splits in the future, LOL.

This is just my personal views and predictions, please do your own DD and make  your own judgement!!!

Nachogy

The thing I am worry about the R/S is that once it is splitted, the price will usually drop dramastically.

I am thinking of should I sell my shares now and wait till they have done the R/S or not....

As they already mention, JV will not be happened soon. I guess it will take another year or more? Who knows?

-----edit-------

I took it back, the R/S will not affect the price drop. I was thinking about increase the outstanding share earlier.

I used to hold citigroup share while they do the R/S and it does help to boost up the price thought. I hope this time it will do the same.

IpohMan69

Nachogy,

Looking at the financial report of this company, if you have been following it, is pointless because there are in R&D/clinical trials phases, a typical biotech. That means, they are burning money with no to little renevue. But their future is bright with great potential, that is what I am buying in for.

For those of you do not have a chance to listen to the CC or may have hard time following the conversation during the CC( I do too, can get majority of the points but still might miss some), here is the transcripts, thank to an iCell member.

http://investorstemcell.com/foru ... ses-media/15356.htm

IpohMan69

Some good videos in general about the field and the views from different aspects regarding regenerative medicine, while we are in the boring/waiting mode.

One of the hard core opponents of the embryonic stem cells research, who himself is a Doctor, can be seen in the third video; David Prentice. As in the vidoe you can heard that he just want the federal government to ban the funding for embryonic stem cell research and allocate them to only adult stem cell. The other doctor is more open minded and agreed that both fields should be explored. This is inline with my view, to get the best of both world.

http://www.aarp.org/health/condi ... inside-estreet.html

IpohMan69

I am from Ipoh as you can see and amazing and felt good to see that there is a doctor in Ipoh is up to speed with the potential treatment.

For any of you that is in Ipoh, may be you can go visit this doctor and get more info about the potential of stem cell in ophthalmology.

http://ipohecho.com.my/v2/2012/0 ... in-retinal-disease/

I did not find this link, it is one of the iCell member found it.

Nachogy

Ipohman, have you received a mail to vote by using proxyvote?

If I am not mistaken, this is vote as follow:
1. Select the new director.
2. Ratification of XXX as registered public accounting film (not sure what is this)
3. R/S no less than 1/20 and no more than 1/80.

I went to proxyvote but not quite familiar with all these. I think most people will concern about 1 and 3?

IpohMan69

回复 86# Nachogy

Nachogy,

Yes I have them in my e-mail but have not done the voting. I have 3 e-mails because I have them in three different accounts. Haven't really read through the proxy but I would probably not going to spend time on it. Members in iCell forum pretty much disect it for all the important stuff.

I am not sure about the second item you listed also but I would not worry about it. I will vote "for" with them but probably do it the last minutes. I believe this will pass as we evidently see that being in the OTC with billions shares just does not pan out with any great news released. But this is good thing for me, as I said all along, allow me to accumulate more over time, yeah.

Since I am here, information shows that a reportor from Bloomberg.net might do a story on ACT with effect of R/S because he joined iCell and ask for interview with shareholders of ACT. He seems legit and noticed ACT on his radar. Few members have spoke to him and some member also try to dig info about him to verify. Is there going to be an article and if there is ; how is the article going to turn out, we will see probably within couple of months. Here is the links to all the bits and pieces if you are interested.

http://investorstemcell.com/forum/act-main-forum-general-topics-science-press-releases-media/17103.htm

IpohMan69

I am smiling..............

ACT announced the 2nd patient of AMD is done and today they announced the third AMD patient is also done. First cohort of the AMD trial is completed.

http://www.cnbc.com/id/47114661

http://finance.yahoo.com/news/ac ... -dry-123000091.html

For me, what this implies is that for sure safety is not a concern at all. We have total of 7 injections, 3 SMD in US, 1 SMD in UK and 3 AMD in US.

I am even smiling more with this statement from the CSO :"The data we are reviewing seems to be pointing in the appropriate direction, With the treatment of the latest two dry AMD patients, we look forward to having more significant points of reference to understand the progress of the trial and consider the endpoint design for the next phase. "

And I am very happy that the stock is still being not recognized by the mainstream, as again, it will allow me to accumulate more, more bangs for the bucks.

Nachogy

I was about to pose this but you are ahead of me.

So there are 100% success for AMD trial for this?

This for sure is a pretty good news before the voting for next week. With more of this kind of good news, it probably a good sign to do R/S and listed on NASDAQ.

IpohMan69

No it is not 100% success yet. We are far from that although it is trending that way.

The first cohort of AMD ( 3 patients) injection is completed. It is still an ongoing trials. It just implies that it is probably safe to say that the procedure itself is safe because this is the 7 injections and all patients torelated well and recovering. If there is any safety concern for even the procedure itself, FDA probably put a brake on it.. Long term safety is still in the air. Like Dr. Schwartz said in Mesa video, they probably follow these patients for years to come, 5, 10 15 etc to study the long term safety, especailly to check teratoma/tumorigenicity after the cell proven to be working. A single cell can form tumor, let along there are thousands of them, that is the main concerns of stem cell therapy.

Sucess in these FDA trials is really relative to the definition by the guidelines/agreement within FDA approval committee. For sure if we have 10 out of 10 patients in 2 year run of trials with all have no safety issue, no sign of tumor, stop the progressive lost of vision it will consider success, let alone if there is restore of vision. If some how with total of 20 injections later after 3 years, one out of 20 developed tumor, will it consider as 100% success, no. But is it still a success, yes 95%. Will they stop it becuase of that, this is up for debate. And after 100 injections, let say two have tumor, then this now becomes 98% success. Essentially, they will try to balance the pro vs the con. If statistics shows that it can cure 98 percent of the AMD/SMD patients the chances of approving the therapy would be high, my guess. That itself probably a success in ACT book and in my book. Of course I made up these number now. There could be that only 70% success short term and if that is the case, this will be a risky investment. Again, use your common sense to evaluate your position regarding to this investment. Risks vs rewards...LOL.

These days even with the approved drugs on the market and in the trials, FDA for sure has statistics that shows most if not all have side effects harmful to some. But they still approve it because the majority will benefit from them.  

Remember, many of us view this as a paradigm shift in medical history where therapies with drugs will be obsolete when more and more stem cell treatments proven to be able to cure the past uncureable disease with nothing like the side effect of drug model. The major concerns(side effect) of cell therapy is teratoma forming.

Nachogy

Ipohman, I am sorry I should be more specific.
I mean it is 100% successful for all the AMD patients from the trial so far.

I bet next week will be an interesting week. With 2 good news within a week, I am looking forward to vote for RS for the upcoming voting.

By the way, are you awared of the petition to tell the FDA to change their process for approval? Not sure if you got it or not, but here is the link: http://www.change.org/petitions/ ... kthrough-treatments

IpohMan69

回复 91# Nachogy


    It if you are talking about the procedure itself, yes it is 100% successful. But in term of efficacy, we only know about the data for the first AMD patient, featured in Lancet paper, Sue was her first name. But the other two are just injected not too long ago. I will wait until we get DSMB report to proceed with 2nd cohort to consider 100% successful of the first cohort. If they are safe and approved by DSMB, there will be some efficacy data because again, this is cell therapy, if they are safe, they will start working with their mother nature magic. Just hang in there, will you?

You need to vote before the meeting. The meeting will announce if they have enough vote to proceed.

Yes I am aware of the petition and signed too. I am #38. LOL.

Nachogy

‎428是个大日子，除了净选盟3.0外，还有这股的股东大​会。这个星期对我来说是个充满变数也是非常有趣的一个星期。

IpohMan69

Again, another key piece of information confirmed.

http://www.businesswire.com/news ... nitoring-Board-DSMB

Again, what this means, unlike drug model, these are highly purified terminally growth RPE cells differentiated from embryonic stem cells; thus if it is safe, it will have efficacy indications.

Good luck to all who are invested.

IpohMan69

I have attended the annual shareholder meeting on 4/26 via webcast and also the quarterly result meeting on 5/9 for the first quarter via phone.

For the SHM, there are a lots of new pipeline information about the direction of the company. One of the highlight is a PPT slide said "Not a matter of if we will partner, but more likely a question of when to partner". You can see the slides here below.

http://www.advancedcell.com/docu ... 4.26.12---final.pdf

It is a lot of information and the main thing for me is the company is still on track and evolving. I like this company to have a big spike now but at the same time I am also fine with if it takes a slow and steady progress for another 2 to 3 years at these prices level. Reason being, if it rocketed now, I have enough shares to accomplish my goal. On the other hand if it is going to "drag on", I am happy too because it will also allow me to accumulate more as I have said all along. I managed to add more @.078 yesterday and not worry about the dipping because I know the company potentials is still huge and growing and will make it one day, all just my opinion. Remember I said that this company has the potentials of Apple/Microsoft in it infancy? Look at the pipeline that they can work with using hESC or iPS; they are partnering now with a few top academic school doing pre-IND research. RPE cell of current trials is only one of the many that they are working on, but this is the easiest one thus came the “low hanging fruits” strategy set by the company for generating revenue in the near future.

The key piece of information I got out from the quarterly meeting is Marcus Hilton(first patient in London) is doing very well and gain some vision acuity improvement. Remember this phase I trial in Europe is supposedly for safety only. But we know if it is safe, it will work, as proved by the first two injections in US that published in Lancet paper. The finance side of the quarterly meeting for sure looks ugly but this is given and it is not the objective that I am investing in;  as this is R&D shop thus mainly spend money doing research and maintaining the company operations.  We know that the company cash on hand now and also some credit leverage will only last the company till sometimes first quarter of 2013. Thus the company will need infusion of cash. Will it be by selling more share from the 500 million pool of the unuse authorized shares which will cost more dilution for current shareholders, or will there be a JV by then? This will be a million dollar question for anyone……….

If you have been following the company, you probably see the news about the announcement recently that another trial site is added, this is also one of the top 5 in ophthalmology practice. Thus 4 out of the 5 is now working with ACTC, doesn't this prove something?

http://www.marketwatch.com/story ... pe-cells-2012-05-02

http://health.usnews.com/best-hospitals/rankings/ophthalmology
-GLTA-

IpohMan69

This is really a great news in general for Stem Cell companies and patients in the future. I am hoping that ACTC will be the first in US, let's see! In this case it will help those families that suffer this  complications of GvHD, some cases are fatal.

http://www.reuters.com/article/2 ... May-2012+BW20120517

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002286/

IpohMan69

ACT is named as one of the defendants in an SEC civil lawsuit. SEC is mainly going after some individuals but since ACT did transactions with one of them, we are also part of the guilty party too. Thus you are seeing the pps is going down a bit.

http://www.sec.gov/litigation/complaints/2012/comp22381.pdf

http://biz.yahoo.com/e/120531/actc8-k.html

I read thru the SEC pdf file about the civil lawsuit a bit and believe that this is not a big\disastrous issue in grand scheme of things going on within ACT. This is a mishap by former CEO Bill Caldwell, who is also deceased. Worst case would be ACT would have to pay monetary fine. Any lawsuit that is not brought again to stop the operations of ACT is not going to worry me that much. As long as the science and clinical trials is allowed to go on, one day this company will be a world class company. I will use any low pps to my advantage to accumulate more as my fund allows me too. This is just my own opinions. I have been warning that this is a high risk/extremely high reward stock and will be a roller coastal ride along, thus doing your home work and define your objective if you are going to invest in it, is important. I will try to put forth as much info, good or bad; as I can but ultimate win/lose is yours.

IpohMan69

回复 97# IpohMan69

http://www.guardian.co.uk/science/2012/jun/04/stem-cell-first-human-trials

Finally, some news about Marcus, the patient in UK; confirming that even though this is safety trials, efficacy is also observed. This is a pretty good article except most part of what Prof. Pete Coffey said about hESC; his knowledge about embryonic stem cell, especially what he does not know what is going on in ACT labs. I don't blame him as he is not working for ACT and probably have no interests about those ppt slides put out by ACT in meetings and conferences.

Gosh, the investing world is just clueless about this slowly unfolding of break through. Until one day........and I am so looking forward for that day.

IpohMan69

Amazing with internet and prime example of sharing information and helping fellow investors for information. Someone from ihub found this. This is further confirming the coming China JV, this is a government website of 吉林省人民政府 www.jl.gov.cn.

http://www.jl.gov.cn/zwgk/yatabl ... 120502_1192305.html
And below is the google translated to English version. I read both and pretty accurate on the translation.

Proposal on the formation of the joint national local Engineering Research Center (Engineering Laboratory) in the province.

With the changes in China's aging population, diet and lifestyle behaviors, cardiovascular disease, cancer and diabetes has become a serious threat to China's population the health of major diseases. In addition, the yearly number of age-related diseases (such as retinal macular degeneration), is increasing the blood shortage "and organ transplantation in the treatment of major demand for donor organs, has been on the development of China's social, economic and health progress of the cause had a tremendous impact has become a major social issue for the central government at all levels need to be resolved.

Tissue repair due to illness or injury caused by the loss of cells and tissues of the body part, the body formed by the defect repair process. Regenerative medicine is to replace or treatment of artificial recycling of cell / organ tissues and organs and loss of function due to trauma or disease. This new treatment concept came into modern medicine treatment techniques known as regenerative medicine, which is based on stem cells. Visible regenerative medicine with stem cell technology as the core has become the most promising medical treatment. At present, the field coincided with the innovation and application of the breakthrough stage, it is our country the best time of stem cell regenerative medicine industry start-up and industrial layout.

In recent years, stem cell research and applications are increasingly subject to a high degree of social concern, in particular, higher expectations of health care. This also contributed to the stem cell research experts to China for Stem Cell Biology to lead the world on the basis of ensuring the medical safety, seize the opportunity to step up research. Although the industrialization of China's stem cell agency is formed, but compared to developed countries, China's investment in this area appears to be dispersed and weak. Therefore, the establishment of tissue repair and regeneration of Medical Engineering Research Center "urgent Otherwise, the huge Chinese pharmaceutical market may once again developed countries of technological monopoly. In order to prevent repeating the mistakes of chemicals is almost no independent intellectual property rights in China, early completion of stem cell research and its applications "national team" is the top priority to maintain our advantage in the field of stem cell research.

Jilin University of Pathobiology, Ministry of Education Key Laboratory of the key units of the national "211", "985" project construction. Is also stem cell engineering and technology center in Jilin Province, Jilin Province, in tissue repair and regeneration Engineering Research Center, Jilin Province Stem Cell Tissue Engineering Technology Innovation Center, Jilin University into the main body of the Institute of Medicine. Laboratory staff of 32 people, including 15 professors ("Cheung Kong Scholars" one, the Changjiang Scholars and Innovative Research Team in a 4 person, Jilin University the Tang Aoqing Distinguished Professor), associate professor 5 people and 5 lecturers. Researchers for more than 85% of returned overseas personnel.

The laboratory covers an area of ??3,000 square meters, has to carry out the cell biology, molecular biology, biochemistry, pathology, physiology, immunology, molecular imaging and other laboratory equipment and facilities, including local meet the GMP standard of cell culture, flow cytometry (sorting, analysis), micro laser cutting, confocal microscopy, an inverted fluorescence microscope, ultracentrifuge, high-speed refrigerated centrifuge, real-time quantitative PCR, paraffin (frozen) slicer, pathology collection system, the whole automatic biochemical analyzer, laser Doppler in vivo imaging of small animals, small animal ultrasound. Laboratory to major national needs, focusing on the national long-term scientific and technological development Plan (2006-2020), combined with the Jilin Province of social and economic development needs in the national "863", "973", the National Natural Foundation of China and Jilin Province Science and Technology Agency major projects, project support, through the accumulation of more than 10 years, laboratories in stem cell tissue engineered organs and its application of tumor pathology, biology, diabetes, gene therapy and research areas, significant progress. Among them, an international leader in the development of stem cells for vascular tissue engineering; Construction and clinical application of tissue-engineered skin has been quite successful, on behalf of today's international wounds in the skin of the latest development direction; industrialization of the development of innovative biological drugs and their corresponding agents become a new growth point of national and local economic construction; secretion can be regulation of genetically modified stem cell bank to establish a large number of people with diabetes to bring the new gospel; stem cell differentiation for tissue-specific cells for myocardial infarction and cerebral ischemic injury new breakthroughs.

Laboratory to the original technology and Changchun Yatai Group, Vision Express Biotech Co., Ltd. co-operation has become a successful example of guitar Colonel enterprise cooperation. Autologous tissue engineering organizations, and the Institute for Regenerative Medicine at Wake Forest University in the United States, as well as the world's leading stem cell company - Advanced Cell Technology (ACT) to carry out clinical trials of embryonic stem cells to repair tissue lesions, exciting experiments a result, not only for patients with blood diseases, cardiovascular and cerebrovascular diseases, gospel, will also become the local economic construction and industrial restructuring, new growth points.

Proposed local United Engineering Center, will rely on the pathobiology of Jilin University Ministry of Education Key Laboratory of Yatai Group, Institute for Regenerative Medicine at Wake Forest University in the United States, as well as the world's leading stem cell company Advanced Cell Technology (ACT ) co-operation, to carry out the following research and development and conversion: (1) human embryonic stem cell-derived retinal pigment epithelial cells (RPE) to treat age correlation macular degeneration (AMD),: (2) human embryonic stem cell-derived into blood cells in the treatment of ischemic disease: ( 3). Human adult stem cell myoblast treatment of ischemic cardiomyopathy and congestive heart failure. And strive to in five years, the design and manufacture of biopharmaceutical products with independent intellectual property rights to develop a dust treatment is of clinical value, and ultimately industrialization, so that more people benefit. At the same time, have a major impact on the local and national economic construction and social development.

For example, to stem cells in the treatment of macular degeneration (AMD) AMD number of patients more than 50 million. In the U.S. alone there are 15 million patients, the capital market of about 200 to 300 billion U.S. dollars. Chinese people over the age of 55 and AMD incidence of approximately 5.5% over 70 years old up to 15%. AMD is the main reason for elderly blind, the medical profession is the lack of effective treatment for dry AMD treatment. With the aging of the world's population, the AMD treatment can be a great challenge of the medical profession, but the same has brought unprecedented opportunities for the ACT, Inc. (high-tech industry leader in stem cell therapy). A conservative estimate, in the United States alone, AMD's potential market, plans to invest over 25 billion. (Sponsored by: Li Yulin)

IpohMan69

Another good indication that the trials for ESC derived RPE is cruising along and doing fine. If it is not, this trial that going to be started in Korean in conjunction with CHA bio and ACT would not get the green light. When it is started, the SMD trials will have footage in Euro, US and Asia.

http://www.clinicaltrials.gov/ct ... 2F2012&lup_d=30

Another article with positive outlook for the regenerative field.

http://www.huffingtonpost.com/20 ... time_n_1609987.html

An article about the patentability of stem cell research. The new Guidelines for Examination in the European Patent Office(EPO) came out on 20 June 2012 seems to be favorable for ACTC becuase of "Non-embryo destructive". This is only a blog that specialize in patents, IP etc. We will have to see the development of this regarding stem cell lines in Euro in the future.

http://ipkitten.blogspot.com/201 ... follow-brustle.html