Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
To those new or those who may not know ACT currently has 21 hESC lines registed at the UMASS Human Stem Cell Bank and registry..
Lines can be viewed here:Click Letter M
http://www.iscr-admin.com/Default.aspx?Action=select+sc+for+view
The Massachusetts Human Stem Cell Bank provides the biomedical research community with expertly maintained human ES (hES) and reprogrammed (iPS) cell lines to facilitate studies into the properties and potential therapeutic applications of pluripotent stem cells. The Bank cultures, characterizes and distributes quality controlled hES and iPS cell lines derived in Massachusetts and beyond.
http://www.umassmed.edu/mhscb/index.aspx
This is not directly to posters here so much but it is important to clarify, imo as I even get mail stating "the blind will see" and many different forms of that. I thought Mr. Caldwell phrased the clinical trial expectations quite well below.
"It is our expectation that the therapy which we’ll apply will have an impact on either slowing down or arresting the progression of the disease. We’ve seen that in our animal models. There have been some very dramatic results when we’ve applied it into animals and we are extremely hopeful that we will see the same types of results when we apply it into humans.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57868481
Nothing will be ignored, there is a process with clinical trials and each Phase has an emphasis. Caldwell stated the following,
"Remember the initial Phase I Clinical Trial is solely to determine the safety of the therapy. There will be a requirement to error on the side of caution in administering the therapy to the first quadrant of patients in the Trial. Typically, once a quadrant of patients is treated you will have 90 day, 6 months and one year data points. However, those details are within the providence of the FDA to determine."
Once the IRB approval is in and prior to any trial, much of the info you are asking about will be posted here:
http://clinicaltrials.gov/ct2/results?term=%22Advanced+Cell+Technology%22
Myoblast info from years ago can be found at the following link and you will see the kind of info that will be made public
http://clinicaltrials.gov/ct2/show/NCT00626314?term=NCT00626314&rank=1
all phases will be required as they have not yet proved anything with regard to humans plus they haven't even started the trial yet.
Safety first then effectiveness.
fwiw, From Oxford article previously posted 4 of 52 acknowledgements to ACT...
10. Klimanskaya I., Chung Y., Becker S., Lu S.J., Lanza R.Human embryonic stem cell lines derived from single blastomeres. Nature 2006;444:481-485.
11.CrossRefMedline11.?Klimanskaya I., Chung Y., Becker S., Lu S.J., Lanza R.Derivation of human embryonic stem cells from single blastomeres. Nat. Protoc. 2007;2:1963-1972.
36. Klimanskaya I., Chung Y., Meisner L., Johnson J., West M., Lanza R.Human embryonic stem cells derived without feeder cells. Lancet 2005;365:1636-1641.
52.?Lanza R.Stem cell breakthrough: don't forget ethics. Science 2007;318:1865.
The Roslin MOU,
If in fact, as PR stated, that there is or will be major demand for the ACT GMP clinical grade hESC's this has the potential to produce substantial revenues through "commercialization licenses, including milestone and royalty payments" even with a 50/50 split. The process to create GMP clinical grade HESC's has more to it than I first suspected. The following article from Oxford Journals really is a must read for those interested. On the surface setting this up sounds simple but is quite an undertaking.
Having protocols in place to create, store and distribute GMP hESC lines acceptable to both FDA and EMA may have more umphh to it than I first suspected, provided the large demand is there as ACT has predicted and provided the MOU turns into a signed contract.http://hmg.oxfordjournals.org/content/17/R1/R48.full
Aznavour,
The product has been approved by FDA! To me, that is huge!
Aznavour, ACT has been cleared to move their testing into human trials. NO PRODUCT has been approved. ACT will first use their stem cell line to show/prove safety and then move forward to hopefully show positive results regarding SMD.
Some of you have asked for general guidelines and possible timing for some of the recent announcements.
SMD Trial:
Received clearance Nov.22. Caldwell had stated 60-90 days for IRB approval. That puts us around late January to late February. Once approved, enrollment of patients may begin.
As soon as we receive clearance from the FDA, we will finalize our investigators and sponsoring eye clinic or hospital and begin a process to gain IRB (Institutional Review Board) approval to conduct the trials at that particular site. Typically, that process takes 60-90 days depending on the institution’s internal protocol approval requirements. Once IRB approval is given, our investigator can begin the enrollment of volunteers in our Phase I clinical study. Critical factors in the timing will depend on our financial condition, how quickly we can enroll patients in the study, the amount of patients who will be allowed to initially be treated and the dosage escalation requirements approved by the IRB and FDA.
http://www.sec.gov/Archives/edgar/data/1140098/000101376209001648/form14a.htm
AMD IND:
Approx. filing date was Nov 30
From CHMN Blog:Dec 19
"We expect to receive feedback on our AMD IND filing from the FDA, and potentially approval to proceed with a Phase I/II Clinical Trial in the U.S., in the coming weeks"
Orphan Designation in Europe for RPE Cells+SMD:
Pr'd Dec 23..it is noted they act within 90 days(or before if no questions) This puts us on or before the end of March
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58081800
Roslin MOU:
Not sure.
Single Blastomere Patent:
First 10 days of January(my guess based on non human patent approval transactions)
Myoblast Program Phase 2:
First half of 2011
Hiring of New CEO:
not sure, the sooner the better, imo.
Audited 10K:
This is the next scheduled financial filing due March 16, 2011
No..eom
ysung,
That may be but we have been down this road before and for me when it is approved, then we will know. I am assuming things will be more expedient than the last IND but I will make no predictions.
I feel somewhat reluctant with the possibility of the clinical trial going for SMD, possible AMD and then SMD in Europe all at once. Currently, it seems like a full plate especially with no partner announced as of yet. We will see what transpires..
ysung,
Well, since the blog post we have had two announcements for that region.(see below). IMO, the Orphan Designation approval will move things forward on all fronts. Prior to trials common sense dictates at the very least an office or headquarters and a likely parter of some form. Make no doubt ACT is pushing the "global technology platform" as they even used those words win last 8K when disclosing the issuance of shares. More is on the way but initial approval is paramount, imo.
Roslin Agreement To Store and Distribute ESC's
Filed for Orphan Drug Desig. for RPE Cells to treat SMD
undrdg,
It should be noted that back in the day we had holders of our debt that held more than 5% of OS#. Those folks filed SC 13G's and SC 13D's of ownership and 144's were filed showing proposed sales. You can go here and view a few from 2005.
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001140098&type=&dateb=&owner=include&start=280&count=40
Now we have 40-50 holders, none own more than 4.99% so you see no filings. Shares are sold when Registration statements are declared effective.
undrdg,
One thing for sure, selling pressure is evident. There are many areas the selling shares could be coming from. The latest 68MM(this number will increase no doubt)could be part of it, it may have started in the .20 and higher range with warrants or it could be CD holders who have shares left or Bristol having some of the 50MM they got @ .02 from their lawsuit settlement or all of the above. Take your pick, the sellers are out there. To answer your question about share sell activity with the last 8K, there is no trail. You would have to call "Optimus CG II, Ltd., a Cayman Islands exempted company" and ask how many shares they sold into the market lately....good luck on that one..:)
For those asking, yesterdays 8K issuing approx 68MM shares without registration is explained below. The exemption is used based on the following,
(8K)
Optimus CG II, Ltd., a Cayman Islands exempted company (the “Investor”) in exchange for the settlement and release of certain claims against the Company acquired by such Investor from a creditor of the Company
(8K)
The Settlement Shares were issued in reliance upon the exemption from registration provided by Section 3(a)(10) of the Securities Act of 1933, as amended. Pursuant to the 3(a)(10) exemption, the terms and conditions of each of the settlements and related Section 3(a)(10) exchanges were approved by the Superior Court of the State of California for the County of Los Angeles on December 21, 2010 with respect to the First Claims, and December 23, 2010 with respect to the Second Claims, each after a hearing upon the fairness of the terms and conditions of the 3(a)(10) exchanges. The Investor participated in each of the hearings.
____________________________________________________________________
(Exemption)
Corp Fin Analysis of Section 3(a)(10) Requirements
The Securities Must Be Issued in Exchange for Securities, Claims or Property Interests
The Section 3(a)(10) exemption is available when securities are issued in exchange for other securities, not for cash, and the fairness of the exchange is approved by a court or a governmental entity. The fairness hearing must be open to everyone to whom securities would be issued in the proposed exchange.
The Section 3(a)(10) exemption is available without any action by the Corp Fin staff or the SEC.
mail,
"rock, does this poster from yahoo have it right regarding the last 8K?"
The first sentence is correct, the rest of it horse chit..unbelievable
Re: Taz-ACTC- Or Others 19 minutes ago
They take the average trading price for 4 day period to determine the total number of shares issued to convert the debt. This offering was part of the 33 million dollar debt to equity exchange the CEO negotiated after the FDA hold was lifted. the price was lower when the deal was struck so I would expect the share count to drop from the original date the deal was done. The price was .06 a share when he said they would have a debt equity exchange as part of their proceding forward with trials. tlcnev this could go as low as .12 before it bounces back but it will jump on the start of the trial.
bythepool,
OS# of approx 1.2 Billion minus 158MM (all insider stock options, warrants and debenture conversions)puts the float in the ball park of 1.042 Billion. In February you can add approx. 100MM that will no longer be restricted.
Jon,
You asked for clarification on the warrant wording,
We will not receive any of the proceeds from the sale of Common Stock by the selling stockholders. We will pay the expenses of registering these shares.
The above statement is correct. ACT will NOT receive any money when the sellers sell their common stock. But, if you read further (below) it will tell you we receive money when selling stockholders exercise the warrants. Another words, warrant holders send ACT the exercise money prior to receiving shares.
. If all of the warrants the underlying are shares of which are included in this prospectus are exercised for cash, we will receive $16,594,755.
That provision expired January 31, 2010. long ago..eom
Killtoy,
fwiw, there are no "dumb" questions. Hopefully this step by step from your post will clarify.
Do you think the settlement shares will hit the market immediately @ or below strike price?
There is no strike price. This was a pre-arranged deal, again. The lawsuit did not go to trial and a verdict was not issued. Example: Agreement was reached between parties that $10MM was owed. So, the number of shares owed is determined by current pps(or trailing 4 days according to 8K) and of course a 20-35% discount to actual PPS.
So in this case take the $10MM and divide by 15 cents/share and you now have the amount of shares issued. All ACT has to do is give the transfer agent the go ahead and shares are transferred. Most are done electronically right to holders account and they can be sold whenever holder chooses.
I guess what I'm trying to ask is the outstanding shares is 1.1 billion that leaves about 600 million that can still hit the float, how many of those you think actually will?
As of December 9, 2010, the Company had 1,139 Billion shares
add in todays 68MM...OS# is north of 1.2 Billion.
The fully diluted share count will include the numbers from both S-1 filings which total approx. 290MM shares of warrants and financing conversion for a toral fully diluted count of 1.5 Billion
Of the 290MM is S-1's, how many will eventually hit the float? All of them, imo. Leaves ACT about 250MM shares to work with before asking for more shares or doing a reverse..Hope that helps some
Killtoy,
I don't understand what you're asking?..eom
johan,
painful for sure but what's new
yep, it isn't the least bit new. Knowing the past history of pps spikes here and knowing all the shares yet to hit the market via S-1 filings and pre-arranged court settlements I find it incredible we still hear the "who is selling" BS along with the "naked short selling" BS. The dilution has always been 95% of the pps problem of sustaining higher levels and will continue until most of the shares remaining are chewed up. The euphoria always overides what is actually taking place just as it did on our run to .29 back in 2009.
rumit,
3rd parties+fairness hearing+approved by the Superior Court of the State of California should or probably does ring a bell? Like the 280MM shares to pay off $1MM+ in debt?
Anyway, I am not seeing or sure where you get the $13MM or the .19 figures.
This one shows $2.4MM and 16MM shares= .15 cents per share
On December 22, 2010, Advanced Cell Technology, Inc., a Delaware corporation (the “Company”) issued an aggregate of 16,000,000 shares of unregistered common stock (the “First Settlement Shares”) to Optimus CG II, Ltd., a Cayman Islands exempted company (the “Investor”) in exchange for the settlement and release of certain claims against the Company acquired by such Investor from a creditor of the Company (the “First Claims”). The face value of the settled First Claims was approximately $2.4 million.
This one shows $8MM and 52MM shares = approx .15.4 cents per share
On or about December 27, 2010, the Company issued an aggregate of 52,000,000 shares of unregistered common stock (the “Second Settlement Shares” and collectively, with the First Settlement Shares, the “Settlement Shares”) to the Investor in exchange for the settlement and release of certain claims against the Company acquired by the Investor from Alexandria Real Estate - 79/96 Charlestown Navy Yard, LLC (“ARE”), a former landlord of the Company (the “Second Claims” and collectively, with the First Claims, the “Claims”). The face value of the settled Second Claims was approximately $8.0 million.
ysung,
The content and goal seems to be in line with business plan. I am not a huge fan of PR'ing MOU's as they don't represent a signed contract but rather both parties agree in principle to their duties. I would suggest the PR was issued for a couple of reasons.
1)It buried the 8K announcement of more shares
2)It gave them yet another opportunity to pound the "hESC lines derived using our proprietary ‘embryo-safe’ technique" which will soon lead to the announcement of issued patent.
We did have a prior tie with Roslin during the Geron lawsuit
Start Licensing License - On August 30, 2006, we entered into a Settlement and License Agreement with UMass and Start Licensing, Inc. (indefinite license period). See description of this agreement above. Pursuant to this agreement, we granted Start Licensing a worldwide, exclusive, fully paid-up and royalty-free license, with the right to grant sublicenses, to certain patent rights for use in connection with all uses and applications in non-human animals. The agreement was reached in connection with the settlement of the patent interference actions. The terms of the agreement also includes an initial payment to us, which has been made, and certain milestone payments. In addition, under the agreement, Start, Geron Corporation and Roslin Institute ("Roslin") each agree not to sue us under certain patent applications owned by Roslin.
8K,
Well, I am not overly surprised it was settled prior to trial date.
I was hoping it wouldn't be as many shares as it is but deep down I was expecting it as this prior post indicated.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56605231
The issuance of shares has been never ending and yes these shares can be sold when received.
Pursuant to the 3(a)(10) exemption, the Settlement Shares may be resold without registration under the Securities Act.
http://www.sec.gov/Archives/edgar/data/1140098/000101376210003148/form8k.htm
No, nothing to do with that. It means that the updated info ACT supplied to security holders listed in S-1's meets the disclosure requirements of the SEC.
SEC has declared both amendments to S-1 "effective",
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001140098&type=&dateb=&owner=include&count=40
No PR on the "non-human" patent approval that I am aware of.
11/800,366 is the "human" method which is more significant and most likely will be PR'd. In mid Sept the Stem Cell-Derived RPE Cells patents were Pr'd.(note: both of these patents were issued Sept.14th and PR'd the same day. I would suggest the same MAY happen with the hESC patent)
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54368736
Application No. 11/267,555
Patent Number: 7,838,727
CLAIMS:
1. An in vitro method of producing a culture of non-human mammalian embryonic stem (ES) cells, comprising: (a) obtaining a blastomere from a non-human mammalian embryo; (b) culturing said blastomere with ES or embryonic carcinoma (EC) cells to form ES cell colonies containing ES cell originating from said blastomere; and (c) isolating and culturing the ES cells originating from said blastomere.
http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7838727.PN.&OS=PN/7838727&RS=PN/7838727
Application No. 11/800,366
Patent Number: NOT YET ASSIGNED
CLAIMS:
1. A method of producing human embryonic stem (ES) cells, comprising: (a) culturing a blastomere obtained from a human embryo in medium containing less than 5 mM glucose to generate a cluster of two or more blastomeres; (b) directly or indirectly contacting the cultured cluster of two or more blastomeres with embryonic or fetal cells; and (c) culturing the cluster of two or more blastomeres of (b) to produce ES cells.
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080057041.PGNR.&OS=DN/20080057041&RS=DN/20080057041
elk,
well, if there are positions being taken by any hedges, mutuals or other institutional companies/managers they will be reported and I hope we have some. The risks of doing things any different would be a stretch unless they are small companies not meeting SEC thresholds. Even if we applied to an exchange today it would be months. Links below are not directed at your post elk but rather general info for the board.
Section 13(f) is a pretty well known rule among the players, even in the hedge fund blogs. http://www.hedgefundlawblog.com/section-13f-of-the-securities-exchange-act-of-1934.html
Some examples of institutional investment managers include registered investment advisors, banks, broker/dealers and insurance companies. However, the definition is not limited to registered entities. It includes corporations and pension funds that manage their own investment portfolios. It also includes investment advisors to hedge funds and other private investment advisors.
How frequently must Form 13F be filed?
(good read)
Form 13F must be filed within 45 days of the end of each calendar quarter. The initial report must be filed at the end of the first year in which the institutional investment manager exceeds the $100 million threshold. For example if an institutional investment manager exceeds the $100 million threshold for the first time in July 2007, the firm will need to wait until January 2008 to submit its first report no later than 45 days after December 31. The firm must then file subsequent reports within 45 days of the end of each calendar quarter.
http://www.ria-compliance-consultants.com/form13f_section_13d_schedule_13g.html#6
List of Section 13F Securities
3rd Quarter ?? FY 2010
http://www.sec.gov/divisions/investment/13f/13flist2010q3.pdf
interstate,
No place to see if warrants have been exercised. Unless the Compnay says something it will probably be mid March when the audited 10K will disclose what was exercised. Do I know for sure? No, I am assuming based on common sense and the fact the debtholders can double their money. If I held those warrants I would have sent the exercise notice in after we rolled .20, watched it progress upwards until I saw the buying pressure level off and then done my business. I can't fathom that none of the 50 ccompanies and individuals listed here under the S-1 warrant filing(page 24) aren't interested in doubling up their money..
http://www.sec.gov/Archives/edgar/data/1140098/000101376209001837/forms1.htm
I believe the 10 cent warrants were very instrumental in the deal making when we restructured our debt after default.
hopeful,
we are NOT more unstable than 6 months ago. Up 15-16 cents/share from FDA approval..seems pretty good to me. The same questions were being asked way back when we had the run to .29. Back then we had 260MM shares enter the float at unreal prices(1/2 of one cent)and everyone kept asking "who is selling?"..Now we have up to 200MM warrants that can go off via the debtholders. The debtholders for example, fill out a warrant exercise form for 10MM shares at 10 cents and fax it to ACT. Debtholders send a check to ACT for $1MM.
Debtholders receive shares a few days later and sell their shares for an easy $2MM, profit of $1MM. These folks are in it for the money, not long term investing like we hope to have in the future. This causes selling pressure, just like the last run. Take your normal traders, shorts and all the other normal activities and you have your drop. It will eventually dry up and future news will put us one more rung up on the ladder. With positive news and trials, ACT will stabilize and move forward. It takes time...That is why it is important to know what is waiting in the wings, if you know and expect then what is happening would be of no surprise...
farviewhill,
with all due respect, you don't really think what is going on is the average joe selling, do you? There is big money being made, just like the last run to .29.
but many folks seem content to make a few bucks and get out over the long weekend. Big mistake, imo.
To those mailing, I am not going to respond individually again today on the pps action.(holiday break..:) Many who mailed post here, so the following is meant for all.
My message below from 2 weeks ago stands. We will not transform overnight. The past history with ACT and spiking pps was important to know as well as the large amount of warrants and possible new financing shares that could be sold into this run as well what the 40-50 debtholder companies have set aside. Couple that with normal retraces and all those good things and you have it. ACT has made great strides and is very much on the right track and eventually the transformation will be in place provided the clinicals go as planned. If the warrants are being exercised in great numbers then at least ACT will be receiving some serious dough for their treasury instead of just plain ol' "selling pressure"..
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57637297
louisa & sportsguy,
I by no means was implying that some haven't or won't buy, the fact remains there is no reporting of such. IMO, I don't expect to see what you and I are hoping to see. This is considered a speculative play on the OTC, even with recent good news. I hope you prove me wrong and they take 200-500MM out of the float...:)
Well louisa, I was planning on signing off with that message later today butttt......OK....:)
Happy Holidays - Merry Christmas To All
louisa,
and I assume the institutions and hedge funds , who, imo, are buying like crazy
I would like nothing better than to have Institutions and Mutual Funds buying up large chunks and setting them aside as a growth stock. If they were doing the above, at the very latest they would have to report with SEC 45 days after year end and many companies report quarterly. Currently, nothing filed to amount to anything and to be honest I am not holding my breath that they will. This is one of several big reasons I am hoping the big exchanges are in managements future plans.
johan,
There is mega info there on the whole process for those interested. While I am not positive it seems from what I read that an EU partner/affiliate or whatever is needed for the market license but not necessary to make application as PR described today. I would assume if orphan designation is approved the partner, if there is one, would surface or ACT will announce how they meet market license guidelines. Maximum 90 day wait(see below)
Submission Deadline List:(go to link to view dates submitted and time frames)
Note: In accordance with Article 5.5 of Regulation (EC) No 141/2000, the COMP will reach an Opinion on a valid application for orphan designation within 90 days. Please note that the dates provided above correspond to the COMP meeting falling on or just prior to day 90. Opinions may be reached earlier than day 90 if no questions are raised by COMP.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000037.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580024c5d&jsenabled=true
European Medicines Agency:
This section provides information about the incentives available for the development of orphan medicines (medicines for rare diseases) in the EU, plus guidance and procedural information on applying for orphan designation for a medicinal product.
Applications for designation of orphan medicines are reviewed by the European Medicines Agency through the Committee for Orphan Medicinal Products (COMP).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000123.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028e32&jsenabled=true
More information on the Committee for Orphan Medicinal Products (COMP)More general information on medicines for rare diseases (orphan medicines)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000034.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac058002d4eb
What are the criteria for orphan designation?
The medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union at the time of submission of the designation application (prevalence criterion), or ;The medicinal product it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and without incentives it is unlikely that the revenue after marketing of the medicinal product would cover the investment in its development, and;Either no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorised, or, if such method exists, the medicinal product will be of significant benefit to those affected by the condition.Companies with an orphan designation for a medicinal product benefit from incentives such as:
Protocol assistance (scientific advice for orphan medicines during the product-development phase);Direct access to centralised marketing authorisation and 10-year marketing exclusivity;Financial incentives (fee reductions or exemptions);National incentives detailed in an inventory made available by the European Commission.Since 1 February 2009, orphan medicinal products are eligible for the following level of fee reductions:
Full (100%) reduction for protocol assistance and follow-up;
Full (100%) reduction for pre-authorisation inspections
50% reduction for new applications for marketing
authorisation to applicants other than small and medium-sized enterprises;
Full (100%) reduction for new applications for marketing authorisation only to small and medium-sized enterprises;
Full (100%) reduction for post authorisation activities including annual fees only to small and medium sized enterprises in the first year after granting a marketing authorisation.
The funds made available by the Community for fee exemptions for orphan medicinal products amounted to €6,000,000 in 2008.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800240ce
louisa,
If you are speaking of the Caldwell company that was involved with funding, it is Andwell. Once his wife deals with the shares Andwell has(see post below), I don't believe we will see the Company involved with ACT again, jmho.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57913172
Advanced Cell Technology's Chief Medical Officer Featured on National Radio Show About Biotech Breakthroughs
Advanced Cell Tech (OTCBB:ACTC)
Intraday Stock Chart
Today : Thursday 23 December 2010
Dr. Robert Lanza, the Chief Scientific Officer of Advanced Cell Technology (OTCBB: ACTC) was featured and interviewed as "one of the leading scientists making breakthroughs in his field" on Explorations in Science with best-selling author and television personality, Dr. Michio Kaku.
The hour long radio program on science and technology is broadcast each week on WBAI New York City (99.5 FM), and re-aired on stations across the country. The segment focused attention to the future of biotech and included a discussion about Lanza's background including his experiments in the field of animal cloning as well as a brief discourse about his research involving myoblast stem cell therapies.
For only the second time in history, the Food and Drug Administration approved the human trial of a therapy developed from embryonic stem cells when Lanza and the team at Advanced Cell Technology secured approval for human trials of their retinal pigment epithelial cells to treat Stargardt's Macular Dystrophy.
Robert Lanza, M.D. is considered one of the leading scientists in the world. He serves as Advanced Cell Technology's Chief Scientific Officer, and Adjunct Professor at the Institute for Regenerative Medicine, Wake Forest University School of Medicine. He has hundreds of publications and inventions, and over two dozen scientific books, among them: "Principles of Tissue Engineering," which is recognized as the definitive reference in the field. Others include "One World: The Health & Survival of the Human Species in the 21st Century" (Foreword by former President and Nobel laureate Jimmy Carter), and the "Handbook of Stem Cells" and "Essentials of Stem Cell Biology," which are considered the definitive references in stem cell research.
He is a former Fulbright Scholar, and studied as a student in the laboratory of Richard Hynes (MIT), Jonas Salk (The Salk Institute), and Nobel laureates Gerald Edelman (Rockefeller University) and Rodney Porter (Oxford University). He also worked closely (and coauthored a series of papers) with the late Harvard psychologist B.F. Skinner and heart transplant pioneer Christiaan Barnard. Dr. Lanza received his B.A. and M.D. Degrees from the University of Pennsylvania, where he was both a University Scholar and Benjamin Franklin Scholar.
Dr. Michio Kaku is a theoretical physicist, best-selling author, and popularizer of science. He's the co-founder of string field theory (a branch of string theory), and continues Einstein's search to unite the four fundamental forces of nature into one unified theory. He is a NY Times Bestseller List author and has appeared on television (Discovery, BBC, ABC, Science Channel, and CNN to name a few), written for popular science publications like Discover, Wired, and New Scientist, been featured in documentaries like Me & Isaac Newton, and hosted many of his own including BBC's recent series on Time.
Investors interested in hearing a full recording of program may do so at:
http://biomedreports.com/2010122361754/advanced-cell-technologys-dr-robert-lanza-on-on-explorations-in-science.html
Biotech investors interested in accessing the news portal's complete database of clinical trials and upcoming FDA decisions can also access that information at:
http://biomedreports.com/fda-calendar/fda-calendar.html
News developments and live healthcare sector updates are available constantly via twitter at: http://twitter.com/BioMedReports
About BioMedReports.com
BioMedReports.com is a news portal covering the biomedical news and financial sector. BioMedReports is not paid or compensated to report the news and developments of publicly traded companies in the healthcare sector of the markets.
Media Contacts Only:
Mary Davila
Assistant Editor
BioMedReports.com
e-mail: Email Contact
Tel: +1 323 472 4480
Fax: +1 888 210 3556
ACTC INFO: Quick Snapshot on Current Events
The following info is a basic quick snapshot of some current material that may save some new investors/prospects time and possibly help the ol' timers as well in some cases. Much much more detail and history available but per request by a moderator this should help gain a "quick" perspective on what is happening.
ACT is a biotechnology company focused on developing and commercializing human embryonic and adult stem cell technology in the emerging field of regenerative medicine.
SEC Filings and Insider Transactions:
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001140098&type=&dateb=&owner=include&count=40
ACT Website:
http://www.advancedcell.com/
Headquarters:
33 LOCKE DRIVE, MARLBOROUGH, MASSACHUSETTS 01752
10,607 square foot of office and laboratory facilities
Monthly Rent..$12,596
Santa Monica, CA.
700 square feet of corporate office space
Monthly Rent..$2,170.
Employees
"As of December 1, 2010, we had 14 full-time employees, of whom 6 hold Ph.D. or M.D. degrees. Eleven employees are directly involved in research and development activities and 3 are engaged in business development and administration. We also use the services of numerous outside consultants in business and scientific matters."
Current Events/Buzz:
Below are the two big Press Releases that were the catalysts for our move from .04 to today. After 10 years of pre-clinical work the FDA clearance to validate our technology via human trials was critical and the follow up IND into the much larger Dry AMD market resulted in a mass media blitz garnishing some much needed credibility for ACT and put a spot light on future potential.
November 22, 2010:
FDA Clearance to begin trial Using hESC's to Treat Macular Degeneration
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56967329
November 30, 2010:
ACT Files IND with FDA to Treat Dry AMD
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57199488
____________________________________________________________________
Current Status on FDA Approved Clinical Trials:
1)SMD Phase1/2..Human embryonic Stem Cells
Clinical sites and investigators are being finalized and will need approval from the IRB and management hopes sometime in the first quarter of 2011 they can recruit and treat patients.
2)Myoblast Phase 2:Adult Stem Cells
Inherited with Mytogen purchase. Management is looking to restart in first half of 2011.
http://clinicaltrials.gov/ct2/show/NCT00626314?term=NCT00626314&rank=1
____________________________________________________________________
NIH..National Institute of Health
Cell Lines approved by the NIH are ELIGIBLE for Federal Funding.
Currently ACT has one line NIH approved..MA135
http://ih.advfn.com/p.php?pid=nmona&article=43196491
7 additional stem cell lines derived at ACT are currently under review by the NIH. New NIH guidelines are on hold as a lawsuit has things in flux right now.
http://grants.nih.gov/stem_cells/registry/pending.htm
Five of these lines were produced without embryo destruction using ACT’s proprietary single-blastomere “embryo-safe” technology.
NED 1, NED 2, NED 3, NED 4 and MA 09
MA 09 is the cell line being used for the SMD Trial and the IND filing for the larger Dry AMD trial.
ACTC cell lines divided into different groups:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46769530
___________________________________________________________________
Share Structure
AS#
Authorized shares: 1.750 Billion
OS#
As of December 9, 2010, the Company had 1,139,314,444 shares outstanding
FLOAT:
Approx. 1.019 Billion(OS# minus approx 120MM restricted, 100MM become free trading in February)
Fully diluted #
approx.1.450 Billion(unused financing lines, options and warrants yet to be exercised)____________________________________________________________________
FINANCING:
Currently ACT has available Money lines of approx $10 Million. When needed, ACT can draw on these funds and are converted to common shares at a discount to pps. The bulk of those monies rest with the following players.
Series A-1 Convertible Preferred Stock:
Volation Capital Partners LLC
Series B Preferred Stock:
Optimus Capital Partners, LLC
JMJ Financial:
The above are funds we can rely on. Management has stated they feel these amounts will carry us through the Phase1/2 trial. Also note that there is approx. 175-200MM warrants priced at .10 the bulk of which are owned by the debenture holders we were/are involved with.
For the first time in a long time we have warrants that are "in the money." ACT retains all the dollars from the exercise of these warrants so it is possible, and more likely by the day, we could see $17-$20MM to advance our work. Yes, the approx. 200MM shares are sold into the market when holders choose. We have the volume now to eat them up if they are exercising and selling now. Many more dollars will be needed for ACT's future but we are now in a better position to partner or receive funds from actual investors in the science.
We are close to done with Convertible Debentures (2005, 2006 2007 and 2008 are history.) Less than $1MM left on 2009 debenture.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57288411
Advanced Cell Technology Receives Federal Grant for Nearly $1 Million
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56180038
____________________________________________________________________
Revenues/ License Agreements:
Revenue for the nine months ended September 30, 2010 was $615,474
%of Revenue Produced by Licensees:
Transition Holdings..25%
International Stem Cell Corporation..18%
CHA Biotech and SCRMI..16%
Exeter Life Sciences, Inc...15%
START Licensing, Inc...12%
Genzyme Transgenics Corporation, Terumo Corporation, remaining %
____________________________________________________________________
Partnerships/Joint Venture(JV):
SCRMI(Stem Cell and Regenerative Medicine International)
ACT holds a 40% interest in the joint venture and CHA Bio & Diostech, Ltd. owns a 60% interest.
SCRMI FOCUS:
http://www.steminternational.com/our-focus/
September 23, 2010: We are pleased to announce that, in conjunction with Dr. Kwang-Soo Kim, PhD of Harvard University and McLean Hospital, SCRMI has received a $1.9 million Director's Opportunity Award from the NIH.
http://www.steminternational.com/news-and-publications/
____________________________________________________________________
ilong4actc,
likely the mastermind behind orchestrating the elimination of 33 million indebtness to 900,000!!!
since the restructuring agreement with debtholders everything was scheduled to be paid off by year end, no mastermind to it. The $3MM payoff was early, that's all. The $33MM number is the same as when you make your very last house payment to bank and you say you relieved yourself of $250K(original principal amount) in debt the last year.
(from blog by Rabin)
The monthly amortization of these debentures and conversion to equity of other indebtedness clearly had a deleterious effect on ACT stock.
While it was no doubt damaging to pps, Rabin was a part of it too.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57788027&txt2find=rabin