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"so I am not anxiously awaiting Cortex's setting the stage for one."
I completely agree that a reverse split would be AWFUL in a number of ways. Existing shareholders get hurt. Future shareholders would wonder if COR will do it to them down the line. In fact I see it as needed ONLY as a last resort, as in very last resort.
I am not so sure that I agree that positive SA data gives cor a lasting, or meaningful, share price boost. I hope it does, and if they were in later studies, then I would give them a much better chance of sustaining a higher price.
I know setting the stage for a R/S or outstanding share increase would paint a bleak picture, but most things cor related seem bleak, at least to me, at this point.
I would just like to see them survive. A reverse merger seems ideal to me at this point. A somewhat cash rich entity to scoop them up, get the tech, and go forward with ampakines.
Cor is light on late stage studies to make them really attractive to a reverse merger, but those in the know may just take a shot on them, if the price is right.
Hope you are out of harms way out in CA.
Take Care.
"It doesn't make sense to not provide yourself with that flexibility."
This is what I just don't get. It must be that they figure there is just no way at this time they would get authorization for a reverse split/share increase, or they would be preparing for it. They are up against the wall without any arrows, (shares,) in their quiver to raise more funds.
Thanks for the update on BAM.
Do you know if Cor has any "super" voting class shares out there from years past?
Take care.
Hello enemem, I was hoping some with more experience might chime in on this topic, since I have almost no experience with reverse splits.
I have no idea why current investors would vote in favor of a reverse split, unless faced with, "our value will soon be zero."
Most reverse splits I have seen involve one or two people controlling vast amounts of "preferred" voting shares, like 40,000 to one, or some such thing, and then being able to reverse split away, uncontested, by keeping control of those voting shares.
Cor has been able to R/S before, when they were corx, but I don't know/remember the exact wall they were facing then.
I don't even know cor's current voting structure well enough to know what kind of preferred, if any, voting shares are outstanding, and if any are outstanding, who might own them.
GLTU
Hello GFP, Once again, I just don't see a way around a reverse split, unless there is some partnering, reverse merger, or total sale news soon.
I have never thought that Cor management was overly strong with financings, but I have never thought they were stupid either. So why haven't they taken any action on the outstanding share issue? IT IS THE ELEPHANT IN THE ROOM.
105 million authorized now should be about it, imo.
How can they not bite the bullet and reduce the number of shares out, raise the share price, and then raise funds at a 30-40% discount to the reverse split price? A 20-1 reverse split might just get them 20 million or so under that scenario. Then they are left with lots more room for further financings down the road.
Maybe they don't think they can get investor interest for a years worth of financing at any price, no matter how few shares would then be outstanding. I just don't get it. (not surprising)
Hope you are doing well.
Hello gfp, I was wondering if you thought that Frank Baldino, Jr., the founder of Cephalon, Inc. might take a shot with cortex?
He certainly seems to get involved at a level, "in the trenches" with some of his moves, and he doesn't have to worry too much about missing with a shot on Cor.
He seems like a guy that takes multiple shots on goal, and Cephalon has a history with sleep disorders.
From ACUS's website:
Frank Baldino, Jr., Ph.D., has served as one of our directors since 2001. Dr. Baldino is the founder of Cephalon, Inc., an integrated specialty biopharmaceutical company involved in the development of therapeutics for neurological disorders, sleep disorders and cancer. He has served as President, Chief Executive Officer and a Director of Cephalon since its inception in 1987 and is currently Chairman of the Board as well. Dr. Baldino holds adjunct academic appointments, including Adjunct Associate Professor of Pharmacology at Temple University School of Medicine, and Adjunct Associate Professor of Physiology and Biophysics and Adjunct Associate Professor of Neurology at Hahnemann University. Dr. Baldino is also a director of Pharmacopeia, Inc., ViroPharma, Incorporated and NicOx S.A.
http://investor.acusphere.com/directors.cfm
Thanks for any thoughts.
Hello gfp,
I know we have discussed this before, but I have long forgotten, if I ever knew
What would Cor need to do to issue a reverse split?
I mean time-wise. Do they need to have it voted on at a shareholder meeting?
Can it be voted on without a shareholder meeting?
Can the board make some sort of "special" proclamation and authorize one?
It seems a bit odd to me that they haven't moved on this topic yet. I mean they are nearly maxed out share wise, they are nearly broke, and they are nearly de-listed.
Seems like they are putting a LOT of eggs into the "we will merge/partner our way out of this" basket.
It just seems to me that at this point, the downside, from their view, of doing a reverse split, just isn't that great.
They get to stay listed, they get a bunch of "new" shares to issue if needed, and they get to keep the hope of Ampikines alive, not to mention their salaries.
Just thinking out loud.
Take Care.
SEC plans more subpoena power, enforcement units
http://news.yahoo.com/s/nm/20090806/ts_nm/us_sec_enforcement_subpoenas
SEC plans more subpoena power, enforcement units
By Jonathan Stempel Jonathan Stempel – 2 hrs 24 mins ago
NEW YORK (Reuters) – The U.S. Securities and Exchange Commission plans to issue more subpoenas and give people more incentives to cooperate with investigations as it works to tighten oversight of financial markets.
Speaking in New York, Robert Khuzami, the director of the SEC's enforcement division, said the changes will help the regulator as it focuses "on cases involving the greatest and most immediate harm and on cases that send an out-sized message of deterrence."
Khuzami, a former federal prosecutor, is presiding over a division much criticized by lawmakers for missing Bernard Madoff's $65 billion Ponzi scheme and for not doing enough to protect investors during the financial crisis.
The changes call for SEC staff to now generally have power to issue subpoenas by getting approval only from their supervisors, not the full Commission.
"If defense counsel resist the voluntary production of documents or witnesses or fail to be complete and timely in responses or engage in dilatory tactics, there will very likely be a subpoena on your desk the next morning," Khuzami said.
Other changes include plans to seek authority to submit more immunity requests to the Justice Department to encourage people to testify without fear of criminal prosecution.
The SEC also plans to create new groups to investigate cases involving asset management, foreign corrupt practices, market abuses, municipal securities and public pensions, and structured products. One group already exists to investigate subprime mortgage abuses.
Khuzami said the SEC also plans to create a new office to monitor incoming tips and complaints, and hire its first chief operating officer to boost efficiency and speed the reimbursement of funds to harmed investors.
Management will also be streamlined, and staff will need his permission for "tolling agreements" that give them more time to conduct investigations. He said these have become too common, causing delays that reduce the SEC's accountability.
DETERRENCE NOT ALWAYS "HIGH-PROFILE"
The SEC has had a number of high-profile enforcement cases in recent months, including penalties levied against Bank of America Corp and General Electric Co and insider trading charges brought against Angelo Mozilo, the former chief of mortgage lender Countrywide Financial Corp.
Speaking on the sidelines at the Association of the Bar of the City of New York, Khuzami said the emphasis on deterrence does not mean the SEC will overemphasize higher-profile cases at the expense of cases involving fewer investors or smaller amounts of money.
"Deterrent impact is not tantamount to high-profile," but could focus on novel areas of potential wrongdoing, Khuzami said. "It's not connected to big corporate cases necessarily."
He did say that the increased subpoena power may induce companies to be more aggressive in addressing wrongdoing to avoid "the necessity" of a subpoena. Some companies do not disclose SEC probes before subpoenas are actually issued.
While acknowledging a "general sense of renewed urgency" to aggressively root out wrongdoing, Khuzami downplayed the suggestion he feels pressure to do more.
"I would take issue with the premise that I am under pressure to bring enforcement actions," he said in a question-and-answer session after his speech. "No one has told me to bring more cases. What they have told me is we need to be vigorous advocates for investors."
On Wednesday, SEC Chairman Mary Schapiro told CNBC television that she would like by year end to see definitive rules governing short-selling, a practice blamed for feeding carnage in bank stocks. She also wants the regulator to work on many fraud cases with criminal authorities.
Before joining the SEC, Khuzami was a prosecutor for 11 years with the U.S. Attorney for the Southern District of New York, and was chief of that office's securities and commodities fraud task force for three years. He was subsequently general counsel for the Americas at Deutsche Bank AG.
(Reporting by Jonathan Stempel; Editing by Gary Hill)
Keryx, Aeterna to move ahead with late-stage study
http://finance.yahoo.com/news/Keryx-Aeterna-to-move-ahead-apf-4098796546.html?x=0&.v=1
Keryx, Aeterna to move ahead with late-stage study
Keryx Biopharmaceuticals, Aeterna Zentaris moving ahead with late-stage study on cancer drug
NEW YORK (AP) -- Keryx Biopharmaceuticals Inc. and its partner Aeterna Zentaris Inc. said Monday they will move ahead with a late-stage study of the prospective multiple myeloma treatment Perifosine.
The companies said they are moving ahead with the late-stage, or Phase III, clinical trial after reaching an agreement with the Food and Drug Administration on the study's design. The study will focus on patients who have relapsed. It will involve about 400 subjects.
Multiple myeloma is a form of blood cancer.
Shares of New York-based Keryx surged 56 cents, or 48.7 percent, to $1.71 in premarket trading. They have ranged from 9 cents to $1.58 over the past year.
Shares of Canada-based Aeterna added 6 cents to $2.68.
OT- atlshrug, sorry to hear about your father.
my father in law has been on aricept and it did seem to help a good bit. there would be long periods of seemingly no decline, pockmarked by relatively short periods, as in weeks, of severe decline, then the process would continue.
i did check on the loss of smell you mentioned and as far as we know he did not have that experience. we will certainly keep our eyes on it as he has three offspring who are wondering if they will be similarly effected. (his mother had the same symptoms of dementia as he is experiencing.)
thanks for the response and take care.
Aiming4, thanks for letting me get these ot posts in, they do help, and being able to pass on info to the offspring has helped as well.
i will respond with pm's, even to those with free accounts going forward, to lesson the impact on those looking for pure cor info. thanks again.
Thanks for your detailed response neuroinv. Looks like most things dementia related, it will take time. ugg.
The new neurologist has started a new medication, but I was "off duty" at the hospital when he came in, so I missed exactly what it was.
I know he will be getting speech therapy and a part time nurse at the assisted living facility he calls his "condo."
Unfortunately, increased falling is one of the symptoms of LBD, so we are keeping our hopes for him up....his original diagnoses was at 59, much to young....
Trying to keep my hopes up for ole cortex too.
Thanks again, and thanks for taking the time to continue to post on this cor board.
Take Care.
OT: Neuroinv, Board, Lewy Body Disease
Hello Neuroinv, I was wondering if you, or any other board members, are familiar with any companies working primarily on Lewy Body Disease ?
This past week, after a three day hospital stay, my father-in-law, was diagnosed with LBD, rather than the 5 year old original diagnoses of Alzheimer's.
As you can imagine, we are all trying to gather some info on this newly diagnosed condition, having never heard of it before.
Apparently, mixing up the diagnoses is fairly common, with many doctors as unaware of LBD as we are. I guess one could argue that dementia is dementia, and as such, the treatments are the same, but we are interested in anything out there now, or in development, that may help specifically for LBD.
This website mentions: "Lewy Body Disease is actually the second most common cause of dementia, accounting for up to 20% all cases, according to the Lewy Body Dementia Association. There is not yet a cure, and symptoms tend to worsen over time."
http://www.helpguide.org/elder/lewy_body_disease.htm
As well as: "Lewy Bodies are abnormal structures in the mid-brain: microscopic protein deposits found in nerve cells that disrupt the brain's normal functioning, causing it to slowly deteriorate. They were first discovered in 1912 by Frederick Lewy, a colleague of Alois Alzheimer (for whom Alzheimer's disease is named). "
I don't remember Cortex working specifically on anything intended for LBD, but it seems closely related to Alzheimer's and/or Parkinson's disease, so their may have been something way back......
Thanks in advance....
Hello gfp, Just a heads up that Jason was the guy from zacks that followed acus, including a positive speculative bias, at least until they were shot down 16-1 by the fda advisory panel.
I don't know/remember if his position changed after that.
His recommendations are tracked here if you are interested:
http://tipstraders.com/tipster.php?tp=233
I might be buying a little cor in here for a swing trade if the financing situation was better out there.
Maybe a reverse merger like snus will come to the rescue, rather than some of the other options out there.
Thanks for keeping up the cor posts, especially liked the ship at sea analogy!
Take Care.
Hello gfp, As you know, the non compliance letter should not have been a surprise to anyone. Cor's share price has been low for a while.
I still think they may reverse split, and issue new shares, if the price does not improve, but that is just a wag. I just don't see where the money is going to come from, in these times. Hopefully Cor will pull another rabbit out of the hat and partner before it gets to that point.
There are worse things that could happen, from a price standpoint, should old cor have to go off the amex and even into pinky land. The games there are so nuts that anything is possible.
I recently watched the position that I had entirely written off in my mind in acus, rise from .04 to .55 in a month, after it had been in pinky land for a while. I got over 90% of my original investment back. Unreal, and now we might just head to Ireland for a vacation to celebrate. I would have sold it for much less, but my wife ended up in the hospital, including a night in ICU, over a kidney stone, and much worse kidney infection, that took a stint and god knows how many bags of antibiotics, to get rid of. All that was going on during the crazy rise in acus's price, so I missed much of the early part.
GLTU in cor gfp,
(Aiming, I did sell out my last 8000 acus shares, that last little bit that I told you I would likely hold onto, the morning after we pm'ed. I just couldn't pass up .515 that morning, and within a few minutes of selling, it was at .36. I had taken such a beating, for so long, that I had to just let it go.)
Hello Wingnut57, While it is true that acus has a new projected pdufa date of 5/31/09, it does not mean that the FDA will rule by that date, as they are not required to produce a ruling on that exact date, the pdufa date is a target date for them. They often do produce a ruling on time, but not always, it's somewhat fluid with them.
Acus was granted an advisory panel meeting under the original, broader use indication, and the advisory panel ruled 16-1 against recommending approval to the full panel. Hence acus amended the intended user base and was granted this new date.
The 16-1 no go vote triggered a slide in acus's price from around .80 to .02 within a two to three week or so time frame around the last date. Acus had much more cash to survive then, than now.
You can look back at this thread to read up on the last pdufa date's coming and going.
All that being said, it can be argued that there is not a lot of "reason" to some FDA actions, so anything is possible, I guess.
Yesterday's late afternoon run up can be attributed, imo, to this pennytrader's news blub put out by yahoo at 2:54 pm, right before it popped 25+%.
http://www.thestreet.com/_yahoo/video/10502550/the-second-dendreon-wave.html?cm_ven=YAHOOV&cm_cat=FREE&cm_ite=NA&s=1#23643261001
gltu.
I sold off my last ACUS this morning near .50, and will be dropping the mod soon.
Overall, for me, it was a big gamble that failed, (the FDA panel shoot down,) and then acus somehow resurrected itself from the dead. I mean this thing was trading at .04 less than 30 days ago.
I feel very fortunate to have gotten 90+% of my original investment back.
Still, at the time, it was worth the risk to try and have caught the next "vnda."
Best of luck to all.
Thanks Bernie, Glad to see you and so many others have made some good profits in here!
Take Care.
Hello Asu, Glad to hear that your cor holdings didn't hurt as bad as you thought they might there for awhile.
Also glad to hear that you are hanging onto some, "just in case!"
Wanted to wish you luck.
Take Care.
Hello Aiming,
I was wondering if you are still holding any acus, and I wanted to trigger your msg with this post to make sure you knew that acus was running some in here.
I unloaded some this past week, not too much, about 15-20% of my holdings.
Take Care.
I think it shows just what a lot of cor posters have been saying, that it is really tough out there for financing right now. Ouch. I think cor should shut down as much as they can and hope the financing situation improves. It's survival time.
I remember clearly Neuro posting from a conference where some guy he didn't know practically begged him to let the guy present, just to try and get noticed. (I likely have messed up the details, but the concern of those attending that he sited from that conference, helped me stay out of the bio sector completely, save the one failed home run stock I am still holding.)
It is just too hard to raise capital right now, at least for my risk/reward, decidedly unscientific trading mind.
Take Care.
Thanks aiming, you must have had your cor news radar on tonight to get the news that fast.
Take Care.
Acusphere, Inc. Reports Q4 2008 Recent Business Highlights, Business Priorities and Financial Results
http://finance.yahoo.com/news/Acusphere-Inc-Reports-Q4-2008-bw-14803588.html
Press Release Source: Acusphere, Inc.
Acusphere, Inc. Reports Q4 2008 Recent Business Highlights, Business Priorities and Financial Results
Tuesday March 31, 2009, 4:15 pm EDT
Buzz up! Print Related:Acusphere Inc.
TEWKSBURY, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUS:PK) today reported financial results for the fourth quarter and year ended December 31, 2008, and commented on its business and progress to date. The Company continues to discuss its New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension following the receipt of FDA’s complete response letter in late February. Imagify is a Perfusion Stress Echo imaging agent targeted for use in detecting coronary artery disease.
Related Quotes
Symbol Price Change
ACUS.PK 0.0490 +0.0090
{"s" : "acus.pk","k" : "c10,l10,p20,t10","o" : "","j" : ""} Recent Business Highlights
Signed an agreement to terminate and transition the Company’s Collaboration, License and Supply Agreement for Imagify with Nycomed Danmark ApS thereby regaining the global rights to Imagify
Completed a successful Pre-Approval Inspection (PAI) by FDA
Announced a planned reduction in force of 40 people, or about two-thirds of the Company’s employees by April 2009
Deregistered the Company’s shares and suspended the Company’s SEC reporting obligations to reduce cash costs and enable management to focus more of its efforts on operating the business and enhancing shareholder value
Signed an agreement to terminate the lease of the Company’s current headquarters in Watertown, Massachusetts and relocate all Company personnel to its facility in Tewksbury, Massachusetts
Renegotiated payment terms under certain intellectual property agreements with payments totaling approximately $6.7 million due in 2009 reduced to $350,000 immediately, with another $350,000 payable upon a financing of the Company, and the remainder due in 2013
Sherri C. Oberg, President and CEO of Acusphere, said, “We have made progress in reducing expenses while we continue our discussions with FDA. While we were disappointed by the results of the FDA Advisory Committee meeting, we are encouraged by the FDA’s willingness to engage in further discussions which we are hopeful will result in a clearly defined path forward for Imagify.”
Business Priorities
Acusphere’s key current priorities are:
Working with FDA to determine the most appropriate path forward for Imagify
Continuing potential partnership discussions for Imagify and other drug delivery technologies with a wide range of parties
Continuing our efforts to reduce fixed costs and overall cash burn
The Company previously announced that it had received a complete response from the FDA for Imagify. The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. The Company was also invited by FDA to schedule a meeting to discuss alternatives for moving forward.
The Company announced today that it has signed an agreement to terminate and transition its Collaboration, License and Supply Agreement dated as of July 6, 2004, as subsequently amended, with Nycomed Danmark ApS. Under the Termination and Transition Agreement (the “Agreement”), Acusphere reacquires the rights previously granted to Nycomed to develop, promote, market and distribute ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension in the European Union, Turkey, Russia and the other members of the Commonwealth of Independent States. Imagify is designed for the detection of coronary artery disease, the leading cause of death in the United States. Both parties have agreed to an orderly transition of all records and other documents related to regulatory filings and the product from Nycomed to Acusphere. Each party to the Agreement shall incur their own expenses and there shall be no further payments to either party.
Ms. Oberg added, "We have been very pleased with our long-standing and beneficial arrangement with Nycomed. We also recognize that priorities change over time and wish to thank Nycomed for the great progress made in compiling the MAA for filing in Europe which we or another partner will move forward on as we now have the global rights to Imagify.”
Financial Results
The Company's financial results for the quarter and year ended December 31, 2008, are summarized in the accompanying table.
The Company recognized $0.8 million in collaboration revenue during the fourth quarter of 2008. These revenues were recognized in connection with its agreement with Nycomed for European marketing rights for the Company's lead product candidate, Imagify, and for the collaboration agreement associated with the licensing of its HDDS technology for oncology purposes to Cephalon in the first quarter of 2008. As of December 31, 2008, the Company had $17.7 million in deferred revenue.
Operating expenses for the fourth quarter of 2008 were $18.5 million, versus $13.2 million in the prior year period. In the fourth quarter of 2008, the company recorded a non-cash $9.2 million impairment charge against fixed assets. Operating expenses, before the impairment charge, were $9.4 million versus $13.2 million in the prior year. The decrease primarily reflects reduced expenses for salaries and contract services and lower research and development costs. Operating expenses in the fourth quarter of 2008 and 2007 include non-cash expenses of $2.7 million and $3.1 million, respectively, for depreciation, amortization and stock options.
The net loss after dividends for the fourth quarter of 2008 was $33.2 million, or $0.67 per common share, versus a net loss of $13.1 million, or $0.27 per common share, in the prior year period. In the fourth quarter of 2008, in addition to the aforementioned impairment charge of $9.2 million, the company recognized a one-time non cash interest charge of $14.7 million as a result of the beneficial conversion feature related to the Cephalon note.
As of December 31, 2008, the Company's balance sheet included approximately $23.1 million in total assets, comprised primarily of $16.5 million in cash and short-term investments and $4.1 million in property and equipment, net of accumulated depreciation. As of March 31, our unaudited cash balance is $5.7 million.
Total annualized cash savings from the previously announced reductions in staff are estimated to be approximately $3.9 million. The Company estimates it will take a one-time charge in the first quarter of 2009 of approximately $0.3 million associated with these reductions. Total annualized cash savings from the termination of the Watertown headquarters lease are estimated to be approximately $3.6 million with total savings, net of the one-time payment and deposit forfeiture, of an estimated $10.6 million through 2012, the original term of the lease. The Company expects to save approximately $800,000 in 2009 as a result of filing the Form 15 to deregister its shares. These actions, in combination with the previously announced deferral of intellectual property payments, are expected to extend the Company’s cash into the third quarter 2009 and provide additional time to explore strategic partnerships and financing alternatives as we continue to interact with the FDA.
Acusphere also noted today that its financial statements which will be posted on its web site at www.acusphere.com for the fiscal year ended December 31, 2008, contain a going concern qualification to the audit opinion from its independent accounting firm, Deloitte & Touche LLP. The going concern qualification is based upon the Company’s current financial resources. The Company will require significant additional monies to fund operations through and beyond the third quarter of 2009.
About Acusphere, Inc.
Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site (www.acusphere.com).
Forward-looking Statements
The above press release contains forward-looking statements, including statements regarding, the NDA submission for Imagify and likelihood of regulatory approval and the commercial opportunity for Imagify. There can be no assurance that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. The Company notes that effective as of March 3, 2009, pursuant to a Form 15 filing made with the SEC, it is not currently required to file periodic reports with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
ACUSPHERE, INC.
FINANCIAL HIGHLIGHTS
— In Thousands (except per share data) —
CONDENSED CONSOLIDATED OPERATING RESULTS
(Unaudited)
Three Months Ended Twelve Months Ended
December 31,
2008 December 31,
2007 December 31,
2008 December 31,
2007
Revenue $ 824 $ 667 $ 2,684 $ 2,667
Operating expenses:
Research and development 7,241 10,604 34,452 43,175
General and administrative 2,109 2,550 10,704 12,219
Impairment 9,161 9,161
Total operating expenses 18,511 13,154 54,317 55,394
Interest and other income/(expense), net (15,219 ) (62) (15,977 ) (886)
Change in valuation of derivative – income/(expense) (9 ) (12) (124 ) (117)
Net loss $ (32,915 ) $ (12,562 ) $ (67,734 ) $ (53,730 )
Dividends on preferred stock (241 ) (561 ) (1,687 ) (2,275 )
Net loss available to common stockholders $ (33,156 ) $ (13,123 ) $ (69,421 ) $ (56,005 )
Net loss per common share — basic and diluted $ (0.67 ) $ (0.27 ) $ (1.46 ) $ (1.31 )
Weighted-average shares outstanding — basic and diluted 49,275 46,274 47,412 42,627
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
December 31,
2008 December 31,
2007
Cash and short-term investments $ 16,450 $ 26,102
Current assets 17,703 27,367
Total assets 23,113 52,020
Current portion of deferred revenue 3,295 4,667
Other current liabilities 10,633 14,159
Long-term portion of deferred revenue 14,438
Long-term obligations, net of current portion 23,250 8,206
Stockholders’ (deficit)/equity (28,503) 23,740
Contact:
Acusphere, Inc.
Lawrence A. Gyenes, 617-925-3444
IR@acusphere.com
--OK let's use numbers: over $10 billion market. ---
In past, more "normal" bio investing years, the mere wiff of markets that size, that could take a chunk of any market that big, would usually send a bio flying fast. Lots of money to be made selling into those spikes, including cortex, as invariably most would fall shortly after the "rush."
Now it's anyones guess. Things have slowed way down from my limited view. My sense is as the sector has matured, and investors with it. Investors now realize, more than in years past, that profits are so far out in the future, and it is so hard to get products to the finish line, (through the fda,)that more and more just sit on the sidelines, or go looking for greener pastures. Those who used to get burned and moved on were quickly replaced by a constant stream of "new" money to invest and risk in the bio sector. A lot of that money came from real estate gains, bonuses, stock and bond gains, and of course wealth transference.
For now, those glory days are over. Now there is much less new money to put to work for most investors as 18 trillion has been wiped out. (last figure i heard, few weeks old.)
I am on the sidelines these days. Our core portfolio has been hit like most everyone, dividends are down, and we just don't see the need to take risks in this sector, at this time, so the trading account sits mostly in cash with some small moving to gold/silver. I doubt we are alone.
I have read some cases where a logical point is made that the shakeout we are in will be good longer term for bio's, as stronger ones will survive and prosper. I guess most droughts look like this as you can no doubt tell from looking at your charts. I just don't see many huge pops these days like I used to.
So in this market, those pops from .30 to 5.00 are few and far between. In fact there are fewer now then any time I can remember in the bio field. If cor gets some funding, without giving too much away, then the 10 billion market sounds much more exciting.
Now is a good time to enjoy/work on, other things, at least for me. Someone on this cor board, i think it was bladerunner, posted a writing from a former IMF chief economist, and though it was a long article, it was one of the best I have read on this board, coming from someone who should know.
Take Care and GLTU.
ahh, well anything close to statins marketplace, well there you go. as in launchpad for those getting closer. i missed that analogy.
gltu.
Well, I can only relate my limited experience with snus.
Their doc was similar in that:
If management changed, there were bonuses to be paid, though I think it was only for the top 2-3 people in snus's case.
The company was on fumes.
They were about to be delisted, which can be similar to the ongoing concern letter awaiting cortex, at least in my mind.
No one knew what was going to become of snus at the time, also similar to cortex's current situation, again in my mind.
Both are microcaps, though cor's worth should be much more, in my, not so humble opinion.....
It could also be, (very successfully,) argued that the financing environment now is much more dire than it was in May 2008, even further limiting cor's options.
Clearly something needs to happen soon.
Not trying to be mean, but .30 to 5 dollars for POC is just not that realistic, not in this environment. Shoot there are fda approvals out there now not bringing anywhere near those kind of percentages. POC is light years from fda blessings.
Anyway, I was just thinking out loud. I hope cortex does surprise us all to the upside and pulls off the deal of the year!
Take Care.
Last time I read a Bonus document something like what Cor put out, was not long before SNUS did a reverse merger. They were on fumes, needed cash, and reversed merged with OncoGenex, (OGXI) who had somewhere near 25-35 million in cash.
The snus board has apparently been removed from ihub, so I can't find a copy of the snus employee retention/management may change/ document, but I believe I posted one on that board when it came out.
Snus posted news, still on yahoo news, that it received a delisting notice on May 8th, 2008, and the reverse merger was announced on May 28th, 2008. The snus news feed only goes back to march 08 and I couldn't find the letter that reminded me so much of the Cor letter, so it may have been issued before that, or my memory may need some ampakines. I just remember the wording sounded so familiar when I read the Cor doc this morning.
Take Care.
Hello food4thought, Hope you are faring well.
I did post many times about cor's ability to come back year after year, and posted yearly highs and lows, going back many years.
I think cor had nearly 20 million in the bank back then and was falling into the .40's in an entirely different financing environment. A "screaming buy" were the words I used if memory serves. I was really a pain about it as I thought at the time that the sell off was REALLY overstated seeing how cor had funding in place.
No, I sure didn't see BAC, Citi, and so many others, falling so much, to say the least! I envy those that that saw it coming and went short early.
In years past I usually felt that there would be plenty of investors willing to take a risk on cor's promise, but now, with things as they are, I am not so sure.
If cor does reverse split, gets financing, sells off heavily, the capital markets improve, then I might think it looks great again. It's always fluid.
I will miss out if a deal is announced. Trying to be hunkered down and "prudent" at this juncture. Hopefully that will change soon as I like the challenge of active trading, just not with the bread money. We are also about to raise some cash specifically to begin picking up some larger, dividend paying "blue chips," if there are any left! Maybe a mutual fund with similar objectives at these beaten down levels instead. We will likely dollar cost average those funds over a year or two.
Back to basics for a while as there are so many beaten down stocks out there! If only we knew which ones might actually keep paying their dividends!
Take Care f4t.
Hello gfp, Do you know what happens to the authorized share count in the event of a reverse split? Does it shrink in line with the shares outstanding?
I don't know as I don't have much experience with reverse splitting stocks. If the shares authorized stay the same, and if cortex is forced into a pipe, then I would think the chances of a reverse split would be much greater as they could raise a lot more money.
Should the authorized shares shrink in lock step, then it's a wash, but cortex could still do a reverse split, then a small pipe, and then increase the authorized count, which would look like a more respectable level of total authorized shares for future funding needs.
Just thinking out loud.
Take Care.
Hello Asu,
I have some family members I want to show your post to, but I will have to "gentalize" it some, as their heads may spin off if I read it verbatim! First I will have to stop looking in the mirror, but who wants to do that
My wife and I have had a saying for years, "Well, we can always go work at Walmart." The great thing is, we both mean it as we have held jobs in our day that required the grind of daily routines for relatively low wages. Nothing demeaning about hard work. I remind myself that as a child I would sometimes eat dirt! (Explains a lot.)
Unfortunately a lot of what Bigworld was saying about weighing the benefits of starting a company here in the USA vs overseas, is very accurate, imo.
A company I was working for as far back as the mid 80's set up a manufacturing site in Ireland, and then Puerto Rico. At the time, I couldn't believe that it would be cheaper then just expanding our current site, but it was.
I can remember sitting in on some meetings where the prospect of increasing profits by setting up these sites in other countries were just too great to ignore. And all for the very reasons that both you, in your high wages remarks, and Bigworld, in his taxes remarks, cited. Plus, the city we were located in had an extra 5% city wage tax, on top of all the other taxes already out there, meaning we had to offer prospective talent more, just to come and work for us so their paychecks didn't take the extra 5% hit.
This all happened, from my limited perspective, toward the beginning of the manufacturing drain we have been experiencing every, or most, years since. It likely started before that, but I hadn't noticed as I was fairly young.
Anyway, the experience certainly cemented the fact to me, that taxes, as well as high wages, were powerful disincentives for some larger companies to setting up shop in the USA. Companies were, however, presented with a "new" currency risk, but most have managed the transition just fine.
I wonder what the odds are of companies like cortex might move, lock, stock, and barrel, overseas? I guess the brain research talent is still too great here, but there must be leaner, less regulated, very smart people overseas attempting to compete in a big way. South Korean's maybe?
Anyway, Take Care.
OT- Thanks to gfp and others as I am now much closer to finally being somewhat "hurricane prepared," and any other unforeseen, hopefully short term, disruption in fuel, food, and power. The diesel storage idea just made so much sense as we already have the truck, and once we have the diesel generator, the fuel can be used for both. Posting about the recent gas run here kind of put it in focus for us that we were underprepared, and because of where we live, we are kind of at the end of the list getting power back up. Lastly, I had no clue that one could fire rounds through a gun that the gun was not named for, as in a .357 firing a .38 special round. Never know what you might learn around here-) Thanks again.
I need to get grip, really?
Not sure what part of my post you took objection to, could it have been the comments about the market makers????
But what would you know about that... Oh, that's right, you only seem to show up when Cortex is on the ropes, and then you encourage selling as fast as possible.
Me, holding Cortex??? Not this time and have posted so.
Think I will head out back and work some on the pool that Cortex helped pay for. That's what we put in, instead of doing the addition.
OT, Gfp, I am PMing you.
Hello RBlatch45,
I think that a poster mentioned that there were 100,000 shares at the bid within a penny or two of the ask price, on that particular day.
If those were true bids, then the sale of 100,000 shares into them, would have only dropped the price a couple cents on that day. And Iggs would not have been correct.
Ahh, but therein lies the rub Were they true bids? Maybe they were only put there by the market makers/others, hoping someone would sell at the market, then they could see the market order come in, quickly cancel the current bids, and reenter them at a much lower price, sucking those sales down with them.
Of course we all know that nothing like that would happen in a perfect orderly market But if Iggs had put in his order to sell 100,000 with a limit order, then he/she could have figured out fast if those were true bids, and perhaps got out of cortex just fine on that day.
Anyway this sure is an ugly day, so far, for Cortex.
GLTU.
Form 8-K for ACUSPHERE INC
http://biz.yahoo.com/e/090303/acus.ob8-k.html
Form 8-K for ACUSPHERE INC
--------------------------------------------------------------------------------
3-Mar-2009
Costs Associated with Exit or Disposal Activities, Other Events
Item 2.05 Costs Associated with Exit or Disposal Activities.
On February 25, 2009, the Company began notifying employees of the Company's intention to eliminate 40 positions between February 25, 2009 and the middle of April 2009, or approximately two-thirds of its workforce. These employee reductions cut across all functional areas including manufacturing, quality systems, drug development, regulatory, finance and administration.
The Company currently estimates that, in connection with these employee reductions, it will incur pre-tax costs in the first quarter of 2009 of approximately $0.3 million, which is related to severance and benefit costs. The total annualized pre-tax cost savings that are expected to result from these employee reductions are estimated to be approximately $3.9 million. Although the Company believes that its estimates are appropriate and reasonable based on available information, actual results could differ from these estimates.
Item 8.01 Other Events.
On March 3, 2009, the Company voluntarily filed Form 15 with the Securities and Exchange Commission ("SEC") to suspend the Company's SEC reporting obligations. Upon the filing of the Form 15, the Company's obligation to file periodic and current reports with the SEC, including Forms 10-K, 10-Q and 8-K, will be immediately suspended. The Company is eligible to file Form 15 because its common shares are held of record by less than 300 persons.
Acusphere Announces Further Cost Reductions and Voluntary Filing of Form 15 to Suspend SEC Reporting Obligations
http://biz.yahoo.com/bw/090303/20090303006604.html?.v=1
Press Release Source: Acusphere Inc.
Acusphere Announces Further Cost Reductions and Voluntary Filing of Form 15 to Suspend SEC Reporting Obligations
Tuesday March 3, 5:30 pm ET
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere Inc. (OTCBB: ACUS - News) announced today its plan to substantially reduce costs while it continues its discussions with the U.S. Food & Drug Administration (FDA) about the regulatory path forward for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension. These cost reductions include a reduction in force, the termination of its lease in Watertown and the consolidation of operations at its manufacturing facility in Tewksbury, as well as the filing of a Form 15 with the U.S. Securities and Exchange Commission (“SEC”) to suspend the company’s SEC reporting obligations. These cost reductions are in addition to cost reductions previously announced in February 2009, involving the renegotiation of certain intellectual property agreements to push certain future payments into 2013.
ADVERTISEMENT
After successfully completing a Pre-Approval Inspection (PAI) by FDA, the Company announced today a planned reduction in force of 40 people, or about two-thirds of its employees, over the next several weeks. The reductions cut across all functional areas including manufacturing, quality systems, drug development, regulatory, finance and administration. These reductions are intended to extend the Company’s cash position to accommodate continuing discussions with FDA.
The Company also announced today the signing of an agreement to terminate the lease of its current Company headquarters in Watertown, Massachusetts and relocate all Company personnel to its facility in Tewksbury, Massachusetts. Under the agreement, the Company makes a one-time payment of $800,000 and forfeits its security deposit of $997,500. The Company will also make its final monthly payment of rent for March 2009 and pays estimated operating expenses of approximately $65,000 per month from April 2009 through July 1, 2009, unless the lease is terminated earlier by the landlord.
The Company also announced today that it has voluntarily filed a Form 15 with the SEC to suspend the company's SEC reporting obligations. Upon the filing of the Form 15, the Company's obligation to file periodic and current reports with the SEC, including Forms 10-K, 10-Q and 8-K, were immediately suspended. Acusphere expects the registration of its common stock will be terminated 90 days after the filing of the Form 15 with the SEC. As a result of the Form 15 filing, the Company's securities will not be eligible for trading on any national exchange and will no longer be eligible for trading on the OTC Bulletin Board. Following the Form 15 filing, the Company's securities may be eligible for quotation on the Pink Sheets.
An independent committee of Acusphere's Board of Directors voted unanimously to file the Form 15 after careful consideration of the advantages and disadvantages of continued reporting to the SEC. Suspending the Company's SEC reporting obligations will allow it to avoid the substantial legal, accounting and other expenses associated with reporting compliance and make those savings available for continued operation of the business. The suspension of the Company’s reporting obligations will also enable management to focus more of its time and efforts on operating the business and enhancing shareholder value.
Total annualized cash savings from reductions in staff are estimated to be approximately $3.9 million. The Company estimates it will take a one-time charge in the first quarter of 2009 of approximately $0.3 million associated with these reductions. Total annualized cash savings from the termination of the headquarters lease are estimated to be approximately $3.6 million with total savings, net of the one-time payment and deposit forfeiture, of an estimated $10.6 million through 2012, the original term of the lease. The Company expects to save approximately $800,000 in 2009 as a result of filing the Form 15 to deregister our shares. These actions, in combination with the actions announced last month, are expected to extend the Company’s cash into the third quarter 2009 and provide additional time to explore strategic partnerships and financing alternatives as we continue to interact with the FDA.
Among the anticipated reductions in staff are Lawrence A. Gyenes, Acusphere’s Senior Vice President and Chief Financial Officer, who will leave the Company after completion of the year-end audit and other transition activities. There is no plan to replace Mr. Gyenes at this time.
Sherri C. Oberg, Acusphere’s President and Chief Executive Officer, said, “These decisions are extremely difficult but both appropriate and necessary given the current financing environment for life sciences companies, our continued belief that Imagify will be approved and our improved prospects for financing on more favorable terms after reaching agreement with FDA on the regulatory path forward for Imagify. We greatly appreciate the dedicated efforts of employees who have enabled us to reach this critical point for Imagify. In particular, I want to extend my thanks and gratitude to Larry Gyenes who has been an excellent partner for me and a great leader for the Company as a whole.”
Mr. Gyenes commented, “It has been a distinct pleasure to work with the many fine people at Acusphere and to play a pivotal role in helping to extend or add to the available cash to permit the Company to continue the review process with the FDA. I wish everyone the best of luck in the weeks and months ahead.”
About Acusphere, Inc.
Acusphere (OTCBB: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Forward-looking Statements
The above press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding, the NDA submission for Imagify and likelihood of regulatory approval and the commercial opportunity for Imagify. There can be no assurance that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and its Form 10-Q for the quarter ended September 30, 2008. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Contact:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Investors:
617-925-3444
IR@acusphere.com
--------------------------------------------------------------------------------
Source: Acusphere Inc.
OT GFP and ASU,
I think the advisor was thinking that:
1. should there be a lack of confidence so big, that there is a run on the banks,
2. and then banks start to collapse,
3. that would cause a run on food, and that it might be a while to get food back into stores. Just because we haven't experienced it in our lifetimes, does not mean it can't happen. (ha, anyone who followed the recent acus fda advisory panel meeting, might be able to see the humor in that last statement, but that is for another post! ie, you can't test for everything!)
Not long ago there was a gasoline/oil pipeline issue in Texas, and many gas stations in our area went dry, and prices went way up on others, (there is still an investigation going on in our state capital on this gas run. In SC) This all happened in like one day. People called me on their way home from work to ask why folks were lined up at the stations. I had no clue, but learned fast. Atlanta, Charlotte, a lot of places experienced disruptions for a while, I think weeks. I wish I could say that I rose above the fear that day and remained calm, but I did not. I went and filled up all 3 of our vehicles, just like everyone else was doing so as not to run out.
So it is plausible to me that there could be a food run, in short order, should banks collapse, or experience a serious run on them. ugg, I don't like thinking about it. Not many see bank runs coming, or there wouldn't be one, by definition. They happen fast, just like that gas run.
ASU, there is no other place on earth I would rather live, and I have been to a few places in my day, including every state in our country, except HI. I have been fortunate to visit other countries as well.
There is no place like home, and I think the correction is/was long overdue and that we will eventually come out of it just fine. At the near peak of excess, a bank approved a huge home equity loan for us to build a large addition, without asking if I had a job. They knew me, but I didn't have much with them, and then they just ran my credit report.
It was for 6% fixed for 10 years and we thought we would do better leaving money in the market over that span, and not have to pay taxes on sales of our securities, and borrowing their money made semi sense at the time.
We choose to not do the addition. WHEW, I told my wife at the time that there was something seriously wrong, that the bank was so willing to just hand over money like that.
I like your advice on spending quality time with those close and loosening the grip of material things.
Maybe with all the money that some of the big pharma's have, one will come to the rescue of ole cortex just in the nick of time!
Take Care.
ps, gfp, I live in South Carolina, we ALL own guns
OT to Gfp and Blade,
I have been reading with interest these past days on both of your posts.
I just wanted to add my two cents.
First, and I really don't know how to say this without sounding "bloated," but here goes:
Every once and a while I sit in on a meeting with a Wealth Management Advisor, who only takes on "large" accounts. There are usually 4-6 of us in on these meetings as funds are comingled and complicated. Well at this last meeting, months ago, and I kid you not, there was talk about us getting some gold, and keeping months of food on the shelf, just in case.
The conversation happened at the end of the meeting, and with great reluctance on the part of the advisor, (who owns/runs his own business working under a large firm,) but he mentioned that he is gently giving his clients something to think about. There was even discussion about how to cut a gold piece up into 8 equal parts, should it ever be needed for bartering, as any more than that and the cutting gets difficult. Again, I kid you not, and I almost fell out of my chair. I don't know if he has actually gotten us any gold yet or not, but it is not something that one forgets easily.
Along those lines, as a teenager I dated a Mormon girl, and her parents kept 6 months food in a pantry and rotated it every time they went shopping, so the food idea is not new, for sure.
Lastly, I once met David Duke. He spoke on the campus of Coastal Carolina College, (now CC University,) around 1990. I had no idea who he was, or any of his background. The internet was just beginning to go mainstream.
I was invited at the last minute, I think by a fellow FCA member. I can remember him talking about welfare recipients, and why our hard earned tax dollars were going to help others, and so on.
He got a lot of applause during his speech, and I could see how easy it is for some to get caught up in that stuff if not listening to dissenting opinions. As an older student I think it was much easier for me to see that he wasn't for me, then it was for some of the young, more pliable, minds in attendance.
I keep reminding myself it is so important for us to keep check on who, and what, we let into our lives, as our species has always naturally congregated, and set up "governments," since the stone ages.
Anyway, the pressure is mounting around Cor and a bunch of other Bio's out there right now. I am currently Cor free, hunkered down, and pretty much stress free right now, but like Cor going forward once they solve their funding needs. I realize I might miss the boat should they partner, but there are always other boats
Thanks to both for taking the time to post.
Take Care.
""using water as fuel""
Hello GFP, Didn't that used to be called steam? For some reason that old farmer with the magnet in a wash basin sticks in my head, and I think the original article must have included a picture for the image to come back so vividly:) It was just inside a double barn door entrance....
When Epix got approval, it turned my stomach, as it happened so close to Acus's lopsided vote with the advisory panel. It just reeked of misdirection, by a few, to sway the ACUS panel. But I have sat in on a few business meetings in my younger days where a few in the room did just that, and it is hard to go against the tide sometimes...
Still, in retrospect, we don't regret the risk we took with the relatively small amount of capital, for the kind of returns we were hoping for. (ie 500,000+ with full approval)
Haven't sold any since the meeting. Not sure what the change in the NDA will bring ACUS, but clearly they are smart to not just let that advisory panel verdict ride, without trying some kind of damage control. Ceph might come in pick up the pieces before she goes belly up in May/June, so we might not lose 100%. Or it could bounce on a relatively positive outcome in May. Hope still springs eternal!
Not sure if we have any gold. At our last meeting with our advisor there was talk about getting some, but I don't know if that actually took place yet or not.
Keeping my eye on Cor, and still keep up with that board. If they get financing, and hammered, then I think I would be in there buying. Other than that, I am pretty stress free. Outside of the professionally managed money, our trading account is mostly money markets, and a bit in some balanced mutual funds. I guess "hunkered down" would be a good way to describe our current mode.
We are traveling some, went to vegas and stayed in a planet hollywood panorama suite overlooking the bellagio fountains. We had a blast, saw shows every night, and even came home with 2/3 of our gambling budget! Disney next with 3 year old God child and her parents.
Mostly I am just puttering around the property/garage getting ready for spring and working on some of my old tube amps/pre amps/tuners. I have tens of thousands of old vacuum tubes stored away from an old ham radio/tube shop owners business, and I really enjoy the sound. Currently working on a 1960/1961 Stromberg Carlson ASR-444 7027a/6L6 tube amp that I can only turn up to 1 1/2 without seriously stressing my speakers. I just love the punch, and "thickness" of those old amps! Currently looking for bigger speakers!
The markets are a mess and now is a great time to enjoy those things we can!
Take Care GFP and thanks for posting over on the cor board and keeping things interesting.
Hello tonyvanw, Stranger things have happened, and hope springs eternal! Meanwhile mostly cash and enjoying the finer things in life! Hope you are doing well.
Still hoping that Ceph scoops up the pieces at some point.
Take Care.
Form 8-K for ACUSPHERE INC
http://biz.yahoo.com/e/090217/acus.ob8-k.html
Form 8-K for ACUSPHERE INC
--------------------------------------------------------------------------------
17-Feb-2009
Entry into a Material Definitive Agreement, Other Events, Financial Statements and
Item 1.01 Entry into a Material Definitive Agreement.
On February 11, 2009, Acusphere, Inc. (the "Company") entered into an amendment (the "Third GE Amendment") to the License Agreement by and between the Company and GE Healthcare AS ("GE") dated as of June 1, 2006, as previously filed with the SEC with the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2006, and as amended on May 11, 2007, such amendment as previously filed with the SEC with the Company's current report on Form 8-K as filed on May 11, 2007, and as further amended on May 15, 2008, such amendment as previously filed with the SEC with the Company's current report on Form 8-K as filed on May 20, 2008 (the "Second GE Amendment").
Under the Second GE Amendment, the Company was due to make a series of payments due as follows: $5.5 million due on June 1, 2007, payable in two installments commencing on June 1, 2008, the first installment of $916,666.66 is due and payable on June 1, 2008 and the remaining installment is due and payable on October 1, 2009 in an amount consisting of (i) the amount of $4,583,333.34 in principal plus (ii) interest accruing on such principal amount from July 1, 2008 at the rate of 6% per annum until paid in full. Notwithstanding the foregoing payments, upon receipt of regulatory approval by the U.S. Food and Drug Administration to market AI-700 in the United States, or the approval of a Marketing Authorization Application to market AI-700 in Europe, prior to September 1, 2010, any then remaining balance of the $4,583,333.34 (plus interest accrued to such date) payable as described above would have been immediately due and payable in full. The Third GE Amendment provides that, in lieu of these payments, the Company shall make a series of payments due as follows: (i) $250,000.00 due on February 11, 2009, (ii) $250,000.00 due upon the closing of an equity or debt investment in the Company or credit facility made available to the Company in an amount of at least $5 million, and
(iii) $4,271,333.34 due on February 15, 2009 and payable with accrued interest at a rate of 6% on December 31, 2013; provided, that, within sixty days after the first commercial sale of AI-700 in the United States or Europe, prior to December 31, 2013, any then remaining balance of the $4,271,333.34 (plus interest accrued to such date) shall be immediately due and payable in full. The terms of the license agreement with GE are otherwise unchanged.
On February 12, 2009, the Company entered into a third amendment (the "Third BSP Amendment") to the Patent Transfer Agreement by and between the Company and Bayer Schering Pharma AG ("BSP") dated as of May 11, 2005, as previously filed with the Securities and Exchange Commission (the "SEC") with the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2005, and as amended on April 27, 2007, such amendment as previously filed with the SEC with the Company's current report on Form 8-K as filed on May 3, 2007, and as further amended on May 15, 2008, such amendment as previously filed with the SEC with the Company's current report on Form 8-K as filed on May 20, 2008 (the "Second BSP Amendment"). Under the Second BSP Amendment, the Company was due to make a series of payments due as follows: $200,000 on or before fifteen days following execution of the Second BSP Amendment and $1.8 million on or before fifteen days after May 11, 2009. The Third BSP Amendment provides that, in lieu of the $1.8 million payment due on or before fifteen days after May 11, 2009, the Company shall instead pay BSP a total of $1.8 million as follows: (i) $100,000 on or before fifteen days after the execution of the Third BSP Amendment;
(ii) $100,000 on or before fifteen days after the earlier of (a) the closing by Acusphere of an equity
--------------------------------------------------------------------------------
financing in excess of $10 million or (b) May 11, 2013; and (iii) $1.6 million on or before fifteen days after May 11, 2013. The terms of the patent transfer agreement with BSP are otherwise unchanged.
Item 8.01 Other Events.
On February 17, 2009, the Company issued a press release announcing (i) that it has submitted an amendment to its New Drug Application (NDA) for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension to the U.S. Food & Drug Administration and (ii) that it had completed the renegotiation of payment terms under certain intellectual property agreements. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
10.1 Third Amendment to License Agreement by and between the Company and GE
Healthcare AS, dated as of February 11, 2009
10.2 Third Amendment to Patent Transfer Agreement by and between the Company
and Bayer Schering Pharma AG, dated as of February 12, 2009
99.1 Press Release dated February 17, 2009, filed herewith
Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments
http://biz.yahoo.com/bw/090217/20090217006367.html?.v=1
Press Release Source: Acusphere Inc.
Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments
Tuesday February 17, 4:01 pm ET
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere Inc. (OTCBB: ACUS - News) announced today that it has submitted an amendment to its New Drug Application (NDA) for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension. Imagify is designed for the detection of coronary artery disease, the leading cause of death in the United States. The NDA was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million cardiac stress imaging procedures are done each year in the U.S. of which 6.5 million are conducted with exercise stress and 3.5 million are conducted with pharmacologic stress. If FDA accepts the submitted amendment, the Imagify indication will be limited to subsets of patients undergoing pharmacologic stress techniques. The amended indication is focused on patients where the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was originally filed. Since this is a significant amendment to the NDA for Imagify, it is likely that the FDA will push back the Prescription Drug User Fee Act (PDUFA) target date for their complete response letter from February 28, 2009 to May 31, 2009.
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The Company has engaged in discussions to reduce, defer or eliminate costs to ensure that it can fund its operations beyond the anticipated PDUFA date of May 31, 2009. The Company also announced today that it had completed the renegotiation of payment terms under certain intellectual property agreements. Payments totaling approximately $6.7 million due in 2009 will be reduced to $350,000 immediately, with another $350,000 payable upon a financing of the company, and the remainder due in 2013. In addition, the Company announced last week that the Board of Directors elected not to declare a quarterly cash dividend to holders of it 6.5% convertible exchangeable preferred stock that was otherwise payable on March 1, 2009, saving an additional $195,000.
Lawrence A. Gyenes, Chief Financial Officer of Acusphere, said, "We are very pleased to reach these agreements. These actions will carry us into June 2009 at our current burn rate and, together with discussions already in progress and other cost reduction initiatives, could allow us to explore strategic partnerships and financing alternatives following the receipt of the FDA response to our proposed amendment."
About Acusphere, Inc.
Acusphere (OTCBB: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008, filed in June 2008 and amended in February 2009. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Forward-looking Statements
The above press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding, the NDA submission for Imagify and likelihood of regulatory approval and the commercial opportunity for Imagify. There can be no assurance that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and its Form 10-Q for the quarter ended September 30, 2008. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Contact:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Investors, 617-925-3444
IR@acusphere.com
--------------------------------------------------------------------------------
Source: Acusphere Inc.
---How often in life do you wish you could go back in time--
I would like to go back to the Friday before Dec. 10th
That was a good day, and before, a never to be named bio I owned went from around .80 to todays .04. OUCH.
Cor could be doing MUCH worse. Still it is a little nerve racking in this finance environment to own any of them!
Still almost all cash now, except for my .04 shares and some underwater options.
Rather than participate in this market now, we will be hunkered down in a Planet Hollywood Panorama Suite next week and enjoying Penn and Teller, Blue Man, and KA.
Stocks are not the only things on sale right now!
GLTU asu.
Thanks MK, Acusphere Announces Publication of Imagify Phase 3 Trials in the European Journal of Echocardiography
http://biz.yahoo.com/bw/090121/20090121005315.html?.v=1
Press Release Source: Acusphere, Inc.
Acusphere Announces Publication of Imagify Phase 3 Trials in the European Journal of Echocardiography
Wednesday January 21, 8:00 am ET
Paper concludes that Imagify is well-tolerated and its diagnostic performance is comparable with nuclear imaging
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (OTCBB: ACUS - News) today announced that an original paper summarizing the Phase 3 clinical trial results for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, has been published in the current issue of the European Journal of Echocardiography. The paper concludes that Imagify Perfusion Stress Echo is well-tolerated, and that its diagnostic performance in chest pain patients is comparable with single photo emission computed tomography, or SPECT, perfusion imaging. The paper, entitled “Detection of Coronary Artery Disease with Perfusion Stress Echocardiography Using a Novel Ultrasound Imaging Agent: Two Phase 3 International Trials in Comparison with Radionuclide Perfusion Imaging,” is authored by Dr. Roxy Senior, Consultant Cardiologist and Director of Cardiac Research, Department of Cardiovascular Medicine and Institute of Postgraduate Medical Education and Research at Northwick Park Hospital in the U.K., among others. Dr. Senior was the lead clinical investigator for Acusphere’s clinical trials for Imagify.
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The paper appears in the January 2009 issue, Volume 10, Pages 26-35.
About Acusphere, Inc.
Acusphere (OTCBB: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Contact:
Company:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Investors:
617-925-3444
IR@acusphere.com
--------------------------------------------------------------------------------
Source: Acusphere, Inc.