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like any report like this interstate whether it is done by ACT or these folks it is very time consuming and all info is compiled and not released until study is complete and all data summarized. So it is new info published today. The idea that pieces of the study are let out prior to concluding the study makes no sense and the validity would be questionable if done that way.
ison,
Received:
October 15, 2009
Revised:
October 10, 2010
Accepted:
December 7, 2010
Published:
January 6, 2011
http://www.cell.com/cell-stem-cell/abstract/S1934-5909(10)00698-3#relatedinfo
Report filed at Cell Stem Cell,
http://www.cell.com/cell-stem-cell/abstract/S1934-5909(10)00698-3#Summary
mail,
"rocky, you pointed out where the NIH was a participant in funding this report. If this becomes an issue the NIH can halt trials?"
First and foremost, I am not saying or implying it is an issue. The report is coming out so we are discussing some items. Your mail has other flaws. The NIH does not have authority to halt trials. The FDA cleared us for trials and will be the body that can change that if they feel it is warranted. The NIH relates to FED FUNDING for the cell lines we have submitted. If cell lines are never approved by NIH it doesn't deter ACT from trials.
I don't have an answer for that..eom
hello jpetz and welcome,
Doubtful, imo. Studies like these generally don't come out or have any peer backing or clout until they are published which is tomorrow January 7 issue of the journal Cell Stem Cell. The publication should give us some more detailed info.
hES Cell Line: MA09
info can be found at the link below where you can click on different headings and see pluripotency tests, karyotype and much more. Once again, this line is all important.
http://www.iscr-admin.com/Default.aspx?Action=viewsc&StemCellLine=137&StemCelName=MA09
MA09 hRPE+ Orphan Status
http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-technologys-rpe-cells-granted-orphan-drug-status-from-fda-for-treatment-of-stargardts-m/
The MA09 line is the one the firm has been using for its "master bank"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46950661
Master bank explained by Caldwell
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53531326
johan,
It's possible, and I hope so.
Blastomere Program
The cells that were removed were cultured utilizing a proprietary methodology that recreates the optimal developmental environment, which substantially improved the efficiency of deriving stem cells to rates comparable to using the traditional approach of deriving stem cells from the inner cell mass of a whole blastocyst stage embryo.
http://www.advancedcell.com/our-technology/research-programs/blastomere-program/
johan,
I would assume Lanza will have to address as articles are already appearing using the 2 hESC approved trial companies(ACT and Gern)
http://www.latimes.com/health/boostershots/la-heb-stem-cells-20110106,0,4794543.story
I will take a very simplistic approach to what I read and know(which isn't much)and state the following. If the NIH, FDA or anyone else puts weight into the study and wants cultures or cells tested by this method, I would MUCH rather have it done now and remove any doubt verses having 2 trials ongoing and possibly a 3rd in Europe and have a problem arise. For all I know ACT may have used the (SNP) analysis..
Some of the key points, at least to me are the following. I honestly have no clue at this point if it will mean anything to our cell lines or trials. A response from Lanza is possible on the study.
1)These changes could not have been detected by traditional microscopic techniques such as karyotyping
2)instead used a high-resolution molecular technique called “single nucleotide polymorphism” (SNP) analysis
3) “The results of the study illustrate the need for frequent genomic monitoring of pluripotent stem cell cultures. SNP analysis has not been a part of routine monitoring of hESC and iPSC cultures, but our results suggest that perhaps it should be.”
4)The study was funded by the National Institutes of Health, the California Institute for Regenerative Medicine, the Hartwell Foundation, the Millipore Foundation, the Esther O’Keefe Foundation, the Edmond J. Safra foundation in Tel Aviv, the Legacy stem cell research fund, the PEW Charitable Trust, the South Korea Ministry of Education, Science and Technology, the Ministerio de Ciencia e Innovación of Spain, MICINN Fundacion Cellex, the G. Harold and Leila Y. Mathers Charitable Foundation and Sanofi-Aventis.
Does ACT have "pluripotent stem cell lines"?
For sure 5 of them are classified that way. Ned 1-4 lines and the all important MA09 line ACT will use for both RPE trials. The fact that the NIH proposed a change to include "pluripotent cells" should put that to rest, imo.
The NIH late Friday afternoon proposed changing the definition of hESCs issued in guidelines last July from "cells that are derived from the inner cell mass of blastocyst stage human embryos"
TO
"pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage." (See BioWorld Today, July 7, 2009, and Feb. 22, 2010.)
That change would allow ACT's five single-blastomere lines currently under review at the NIH to receive federal funding for research, if approved by the agency. ACT currently has an investigational new drug application (IND) under review at the FDA for a Phase I/II trial using its MA09 single-blastomere line to treat Stargardt disease, a genetic condition and the leading cause of juvenile blindness in the U.S., Lanza told BioWorld Today.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46950661&txt2find=MA09
NIH LINK:
http://edocket.access.gpo.gov/2010/pdf/2010-3527.pdf
sent to me via mail,
News Release
Date: January 06, 2011
Genetic Abnormalities Identified in Pluripotent Stem Cell Lines
A multinational team of researchers led by stem cell scientists at the University of California, San Diego School of Medicine and Scripps Research Institute has documented specific genetic abnormalities that occur in human embryonic (hESC) and induced pluripotent stem cell (iPSC) lines. Their study, “Dynamic changes in the copy number of pluripotency and cell proliferation genes in human ESCs and iPSCs during reprogramming and time in culture” will be published in the January 7 issue of the journal Cell Stem Cell.
The published findings highlight the need for frequent genomic monitoring of pluripotent stem cells to assure their stability and clinical safety.
“We found that human pluripotent cells (hESCs and iPSCs) had higher frequencies of genomic aberrations than other cell types,” said Louise Laurent, MD, PhD, assistant professor in the UCSD Department of Reproductive Medicine and first author on the study. “Most strikingly, we observed a higher frequency of genomic duplications in hESCs and deletions in iPSCs, when compared to non-pluripotent samples.”
The ability of human pluripotent stem cells to become every cell type in the body has made them potential sources of differentiated cells for cell replacement therapies. “Since genetic aberrations are often associated with cancers, it is vital that cell lines destined for clinical use are free from cancer-associated genomic alterations,” said senior author Jeanne F. Loring, PhD, professor and Director of the Center for Regenerative Medicine at the Scripps Research Institute.
The team identified regions in the genome that had a greater tendency to become abnormal in pluripotent cell lines. With hESCs, the observed abnormalities were most often duplications near pluripotency-associated genes; in iPSC lines, there were duplications involving cell proliferation genes and deletions associated with tumor suppressor genes.
These changes could not have been detected by traditional microscopic techniques such as karyotyping. The team instead used a high-resolution molecular technique called “single nucleotide polymorphism” (SNP) analysis, which allowed them to look for genetic changes at more than a million sites in the human genome.
“We were surprised to see profound genetic changes occurring in some cultures over very short periods of time, such as during the process of reprogramming somatic cells into iPSCs and during differentiation of the cells in culture,” Laurent said. “We don’t know yet what effects, if any, these genetic abnormalities will have on the outcome of basic research studies or clinical applications, and we need to find out.”
Loring concluded: “The results of the study illustrate the need for frequent genomic monitoring of pluripotent stem cell cultures. SNP analysis has not been a part of routine monitoring of hESC and iPSC cultures, but our results suggest that perhaps it should be.”
Additional contributors to the paper include Ileana Slavin, Ha Tran, Candace Lynch, Sherman Ku, and Joel Gottesfeld, The Scripps Research Institute; Robert Morey, UC San Diego and The Scripps Research Institute; Franz-Josef Muller, Zentrum für Integrative Psychiatrie, Kiel, Germany and The Scripps Research Institute; Andrew Schork and Carolline M. Nievergelt, UC San Diego; Julie V. Harness and Hans S. Keirstead, UC Irvine; Sunray Lee and Hyun-Sook Park, Modern Cell & Tissue Technologies Inc., Seoul, South Korea; Maria J. Barrero and Juan Carlos Izpisua Belmonte, Salk Institute for Biological Studies and Centro de Medicina Regenerativa de Barcelona; Marina Martynova and Rusian Semechkin, International Stem Cell Corporation, Oceanside, CA; Vasiliy Galat, Northwestern University; Chuck Murry, University of Washington; Ulrich Schmidt, Sydney IVF Stem Cell Laboratory, Sydney, Australia; Andrew Laslett, Commonwealth Scientific and Industrial Research Organisation, Clayton, Australia and Monash University, Victoria, Australia; and Ron Shamir, Tel Aviv University.
The study was funded by the National Institutes of Health, the California Institute for Regenerative Medicine, the Hartwell Foundation, the Millipore Foundation, the Esther O’Keefe Foundation, the Edmond J. Safra foundation in Tel Aviv, the Legacy stem cell research fund, the PEW Charitable Trust, the South Korea Ministry of Education, Science and Technology, the Ministerio de Ciencia e Innovación of Spain, MICINN Fundacion Cellex, the G. Harold and Leila Y. Mathers Charitable Foundation and Sanofi-Aventis.
Media contacts: UC School of Medicine: Debra Kain, 619-543-6163, ddkain@ucsd.edu; The Scripps Research Institute: Mika Ono, 858-784-2052, mikaono@scripps.edu
http://health.ucsd.edu/news/2011/01-06-genetic-abnormalities.htm
with all due respect, what does that have to do with the prior questions being discussed?
It is not better than anything in the past, it represents the highest discount I have seen for any financing up front. Those .02 shares you speak of were from lawsuits and "fairness hearings" to 3rd parties to pay debt.
that doesn't change anything, you don't see the following formula as a discount to Optimus?
(example given in contract)
For example, if the Tranche Purchase Price is $1,000,000 and the Closing Bid Price is $0.50, then the number of shares of Common Stock underlying the portion of the Warrant issued in connection with such Tranche shall be $1,000,000 x 135% = $1,350,000 divided by $0.50 = 2,700,000 shares of Common Stock.
There did not get their shares at a huge reduced price like agreements in the past
35% is right up there, don't ya think?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58449396
"The Optimus deal is especially interesting because it included the option to buy 63 million more ACTC shares at $0.16 apiece. Take Note: When the deal closed, those options were barely in the money...but now, barely a week later, they're already worth almost a cool $1.2 million!"
Great work by another Group that doesn't have the slightest clue. "options were barely in the money"..lmao and unbelievable
Obviously from mail some are confused on the Optimus shares and are wondering how they can make money..
Folks, it is key to remember that ACT received $7.5MM from Optimus.
The .16 shares were NOT based on that number. The converted shares are based on $10.125MM That results in 16.5MM more shares than if you use the $7.5MM number. That's over $3MM if they sold around .20
and still have the the approx. remaining 47MM shares left. So, how is it possible NOT to make some big profits? If you borrowed $200K from your local bank to purchase a home and the lender said the principal amount to pay off was $270K, would the bank make money off the xtra 35%? Hope that helps and relieves the notion Optimus
isn't making money..they all do and in a big way based on big dollars in speculative stocks.
(example given in contract)
For example, if the Tranche Purchase Price is $1,000,000 and the Closing Bid Price is $0.50, then the number of shares of Common Stock underlying the portion of the Warrant issued in connection with such Tranche shall be $1,000,000 x 135% = $1,350,000 divided by $0.50 = 2,700,000 shares of Common Stock.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47557881
rumit,
possible there is even more to it than that. The snippet below from PR. The bolded part could very well indicate the subscription agreements were converted also.
"ACT expects to end the year with approximately $15 million in cash and equivalents, and less than $1 million of debt. The Company recently strengthened its balance sheet by selling 750 shares of non-convertible Series B Preferred Stock to Optimus Life Sciences Capital Partners, LLC under a previously announced $10 million Preferred Stock transaction. ACT also eliminated more than $10 million of indebtedness through conversions and settled more than $10 million of other liabilities."
Per request,
Optimus: share history
250 Pref about 33MM shares were issued(conv. about .06)(first 9 months of 2010)
750 Pref. about 66MM issued subject to adjustment (initial conv..16)
3rd party resolution in lawsuit...68MM shares issued(initial conv price of .153) subject to 4 trading day adjustment from both issue dates. This conv. adjustment is over, around .165 based on adj. closing price not vwap)Adj, close pricing here,
http://finance.yahoo.com/q/hp?s=ACTC.OB&a=11&b=1&c=2010&d=00&e=5&f=2011&g=d
Total of 164MM...134MM in last week+
to those asking via mail where the Optimus transaction info is coming from here you are, sorry for not linking it up last night. It was posted here prior.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58347484
yep, close today ends the 5 day VWAP, adjustment determined Jan 6 and share swap needs to take place Jan.7
just the opposite actually. ACT is the one who determined when they called in the funds from Optimus. Instead of showing $7.5MM on year end cash they opted for $15MM. ACT could have done the deal at.26 earlier in DEC if they chose(see link). The Socius deal for the $25MM on the other hand was being formed early December as Pref. C share filing indicates.
http://finance.yahoo.com/q/hp?s=ACTC.OB&a=11&b=1&c=2010&d=00&e=5&f=2011&g=d
rumit,
Nope, tranche notice date was the 30th. Adjustment period ends tomorrow.
"The Warrant was delivered to the Holder by the Company, simultaneous with the Company’s delivery of a Tranche Notice under the Purchase Agreement, on December 30, 2010 (the “Tranche Notice Date”). Section 1.2.1 of the Warrant provides that the exercise price (“Exercise Price”) for each share of Common Stock underlying the Warrant shall be equal to the Closing Bid Price of a share of Common Stock on the Tranche Notice Date. The Holder exercised the Warrant in full on the Tranche Notice Date at an initial Exercise Price of $0.16 per share, being equal to the Closing Bid Price on the Tranche Notice Date, for an aggregate initial Exercise Price of $10,125,000. Pursuant to the Purchase Agreement and the Warrant, the shares obtained upon exercise (the “Warrant Shares”) must be delivered to the Holder on the Trading Day following the Tranche Notice Date."
We are talking about a deal done with Optimus, not Socius even though they are joined at the hip. Optimus would like to see the adjusted price lower, at least close to the .16 if possible. That is unlikely at this stage unless a substantial pps drop happens tomorrow. I don't have the tools to do a VWAP average for the 5 trading days but for the first 4 trading days the Average adj. closing price is about .19-.195. Optimus will come out well no matter what happens. The first 250 share round with Optimus netted us under $2MM for 32.5MM shares(conversion about 6 cents) And don't forget about this one..
http://www.sec.gov/Archives/edgar/data/1140098/000101376210003148/form8k.htm
Doen't that determine how many shares they get per warrant/common ratio?
It will determine the FINAL conversion price. That is why this was added as an amendment.(below)..johan, the deal was DONE at .16(initial exercise price) warrants were issued to Optimus and they exercised On DEC 30. Transfer agent had the 63MM+ common electronicaly credited to Optimus on Dec.31. fwiw, ACT could not have shown the $7.5MM as part of the cash on hand at year end without consumating the deal, meaning ACT got the money and Optimus has their shares.
"· If the Adjusted Exercise Price results in additional Warrant Shares being issuable to the Holder, such additional shares shall be delivered to the Holder within one Trading Day following the Adjustment Date.
If the Adjusted Exercise Price results in less Warrant Shares being issuable to the Holder, the excess Warrant Shares shall be returned by the Holder to the Company within one Trading Day following on the Adjustment Date."
The last deal. The 5 trading days is only for "adjusted price" reckoning. The 5 days started on tranche notice date, DEC 30 and ends tomorrow, Jan.5 It's all spelled out quite clearly, if the yahoo poster wants some info and links I will provide them.
johan,
nice theory but simply not the case. Warrants were not only issued to Optimus but exercised to common shares.
sutra,
first of all what you refer to are SEC filings, not articles. Secondly, each and every one of the 8K's were discussed at length here and each time it was pointed out how many shares would be added into the float. These shares are not going to long term institutional holders they are being distributed to venture capitalist who put large amounts of money into a speculative stock and have every intention of profiting on those shares. I don't use charts so you can take it from there.
Even with three(3) 8K's filed in less than a week each having neon lights flashing explaining what is going on/or will go on and we still need to hear it's the MM's, the shorts, and everything else. Some things never change here. The movie Groundhog Day comes to mind.
rumit,
They were one of many CD holders. The 30MM you saw only represents the amended debenture shares and warrants. This number still stands as todays 424B3's don't apply to that.
(22) Includes 11,576,670 shares of common stock issuable upon conversion of Amended and Restated Debentures and 19,027,990 shares of common stock issuable upon exercise of Amended and Restated Warrants.
(CLASS A WARRANTS + INITIAL CLOSING)
This 424B3 filed today matches up with initial closing
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000014/form424b3.htm
Midsummer Investment, Ltd 5,000,000 (8)
(8) Represents (i) 3,000,000 shares issuable upon conversion of Notes, and (ii) 2,000,000 shares issuable upon exercise of Class A Warrants, which the selling stockholder purchased at the initial closing under the Subscription Agreement.
http://www.sec.gov/Archives/edgar/data/1140098/000101376210003152/0001013762-10-003152-index.htm
(CLASS A WARRANTS +SECOND CLOSING)
This 424B3 filed today matches up with second closing
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000017/form424b3.htm
(13) Represents (i) 3,000,000 shares issuable upon conversion of Notes, which the selling stockholder purchased at the initial closing under the Subscription Agreement, (ii) 1,995,000 shares issuable upon exercise of Class A Warrants, which the selling stockholder purchased at the initial closing under the Subscription Agreement, (iii) 3,000,000 shares issuable upon conversion of Notes, which the selling stockholder purchased at the second closing under the Subscription Agreement, and (iv) 1,995,000 shares issuable upon exercise of Class A Warrants, which the selling stockholder purchased at the second closing under the Subscription Agreement.
(14) Represents (i) 3,000,000 shares issuable upon conversion of Notes, which the selling stockholder purchased at the second closing under the Subscription Agreement, and (ii) 1,995,000 shares issuable upon exercise of Class A Warrants, which the selling stockholder purchased at the second closing under the Subscription Agreement.
http://www.sec.gov/Archives/edgar/data/1140098/000101376210001297/form424b3.htm
(2) 424B3's filed updating Prospectus's,
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001140098&type=&dateb=&owner=include&count=40
most likely not if we sustain in this neighborhood..eom
What you posted is correct, parties amended the agreement. .16 is NOT set in stone because of the language. The "tranche notice date" was Dec. 30...so, you include Dec. 30 and 31 and January 3,4 and 5th. After those 5 days of trading the VWAP will be determined and the final adjustment will be made on January 6th. We either owe them shares or they owe ACT shares unless we land right on .16, then nothing happens..
sg,
I will make a couple points to your question. One, imo todays announcement was somewhat factored in as ACT has been reminding the world via PR's for last month. I am not undermining the importance whatsoever but I believe getting IRB approved treating first patient and reporting endpoints and results will be what the market awaits.
Secondly, as with our run back in 2009 we had a very large number of shares hit the float and it isn't much different this time around. How much or when these shares will be sold is anyones guess. It isn't just a couple companies as we have around 40-50 involved in financing and warrants. Warrants very well could be going out the door also on top of everything 8K'd. The S-1 filing will provide a much more recent OS# which will help us determine what was actually issued. ACT is not "cleansed" yet, it takes time to transform as I have pointed out previously. The volume is key to chewing up the sellers..
rumit and all,
the filing date of the Series C Preferred with Delaware should clear up any doubt that everything we have seen come through recently was initiated and planned by CEO Caldwell, not Rabin.
I, JEFFREY W. BULLOCK, SECRETARY OF THE STATE OF THE STAE OF THE DELAWARE, DO HEREBYE CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF DESIGNATION OF "ADVANCED CELL TECHNOLOGY, INC.", FILED IN THIS OFFICE ONT HE THIRTIETH DAY OF DECEMER, A.D. 2010, AT 5:30 O'CLOCK P.M.A FILED COPY OF THIS CERTIFICATE HAS BEEN FORWARDED TO THE NEW CASTLE COUNTY RECORDER OF DEEDS.
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000004/ex31.htm
rumit,
new version is correct, typos I suspect. Note the following, proof positive this was being done some time ago..:)
I, JEFFREY W. BULLOCK, SECRETARY OF THE STATE OF THE STAE OF THE DELAWARE, DO HEREBYE CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF DESIGNATION OF "ADVANCED CELL TECHNOLOGY, INC.", FILED IN THIS OFFICE ONT HE THIRTIETH DAY OF DECEMER, A.D. 2010, AT 5:30 O'CLOCK P.M.A FILED COPY OF THIS CERTIFICATE HAS BEEN FORWARDED TO THE NEW CASTLE COUNTY RECORDER OF DEEDS.
Authenticated: 12-30-2010
(new CERT filed in Delaware)
a. Upon any liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary, after payment or provision for payment of debts and other liabilities of the Corporation, before any distribution or payment shall be made to the holders of any Junior Securities by reason of their ownership thereof, but subject to the rights of the Senior Securities, the Holders of Series C Preferred Stock shall first be entitled to be paid out of the assets of the Corporation available for distribution to its stockholders an amount with respect to each share of Series C Preferred Stock equal to $10,000.00 the “Original Series C Issue Price”), plus any accrued but unpaid Dividends thereon (collectively, the “Series C Liquidation Value”). If, upon any liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary, the amounts payable with respect to the shares of Series C Preferred Stock are not paid in full, the holders of shares of Series C Preferred Stock shall share equally and ratably in any distribution of assets of the Corporation in proportion to the liquidation preference and an amount equal to all accumulated and unpaid Dividends, if any, to which each such holder is entitled.
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000004/ex31.htm
starfire,
They are covered,
FORM D
OMB APPROVAL
OMB Number: 3235-0076 Expires: June 30, 2012
Notice of Exempt Offering of Securities
http://yahoo.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHtmlSection1?SectionID=6928346-1136-16585&SessionID=l2R1HqxOZWHyxz7
rumit,
sorry for missing your point. They wanted the deal done by year end, $15MM on the books at close of year and probably a stipulation prior to Socius getting involved with better terms. Couldn't PR the new deal until old one was settled. Hurry up and get'er done..ACT could have called in the 750 share tranche anytime after the new year so it really made no difference except for swapping some shares back and forth.
rumit,
Not understanding your thinking rumit...
Optimus wired funds of $7.5MM dollars to ACT.
Multiply the 7.5MM times 135% which equals...$10.125MM
Take the 10.25MM and divide by .i6 conversion price
The result is 63.28MM shares of common
If Optimus sold the 63.28MM shares today at .25 it would total
about $15.8MM dollars
Summary: They paid out to ACT $7.5MM, could possibly sell for
$15.8MM....Profit of approx. $8.3MM..more than double their payout. Who wouldn't like that scenario?