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TOPIC: The Re-structuring Announcement

The Re-structuring Announcement 22 Sep 2014 08:44 #2282

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Cytori Consolidates and Restructures Its Operations, Provides Business Update 09/22/2014

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) today announced its updated strategy and plan to restructure its operations and reduce costs. In addition, Cytori has also provided an interim update on some important business items.

Corporate Strategy and Restructuring

Over the last few months, the Company’s board and management team have been carefully re-evaluating corporate strategy and the resources required to achieve the Company’s goal to be a leader in the cell therapy industry. Going forward, the Company will focus on delivering value by limiting its activities to: expanding the US clinical pipeline, building on current governmental and corporate partnerships and ensuring that its commercial efforts are cash flow positive immediately. To accomplish this, the Company has: (1) restructured senior management and the global commercial and development teams, (2) consolidated operations, and (3) reduced duplicative activities and unnecessary expenses. Dr. Marc H. Hedrick, Cytori’s President and CEO, noted: “Besides significant changes in strategy and expense reductions, we are also working in partnership with our lenders, with whom we have an outstanding relationship, to strengthen our financial position for the next 12-24 months. In this regard, our lenders have recently provided us a temporary waiver of the liquidity threshold that requires us to maintain certain minimum cash balances, and we are in discussions with them for the overall restructuring of the loan. I will provide more details on our restructuring and long term financial plan in forthcoming releases and on our Q3 conference call.”

As a part of the restructuring effort, Mr. Clyde Shores, Cytori’s Executive Vice President of Marketing and Sales, resigned and a number of other employees have left or will be leaving the Company after a brief transition period. After the transition period, the Company will have reduced the number of full time employees from a peak of 119 earlier this year to approximately 77 employees. As a consequence of these efforts, we estimate that we will incur a one-time restructuring charge of approximately $ 500,000. The consolidation and cost reduction initiatives over the past several months are expected to lower our operating expenses by more than $ 8 million on an annualized basis.

“My first order of business as the new CFO at Cytori will be focused on putting the Company on a sustainable financial path by both strengthening the balance sheet and significantly reducing expenses. I believe that the Company can be more effective in delivering near term value to the shareholders after these measures are implemented,” said Mr. Tiago Girao, Vice President of Finance and Chief Financial Officer of Cytori. “We will provide additional details on the steps we are implementing to improve the focus and performance of the Company over the next several months. Personally, I am honored to be part of the leadership team and to have the opportunity to bring Cytori’s ground breaking medical technology to suffering patients.”

Business update

Clinical pipeline update
-On September 19th, Cytori filed its responses and related data to FDA regarding the ATHENA trial hold. FDA feedback is anticipated in 30 days.
-Cytori has received conditional approval from FDA to begin a US IDE trial on patients with Osteoarthritis and enrollment will likely begin in the first quarter of 2015. In light of this approval and the restructuring, Cytori is assessing the merits of continuing its current RECOVER trial for acute muscle tears.
-Cytori anticipates that the U.S. pilot clinical trial for burn injury as part of its BARDA contract and subsequent receipt of the related m milestone, will move forward when the Company’s next generation system is available for clinical trial use, which is expected in 2015.
-The Japanese government sponsored pivotal clinical trial for urinary incontinence is undergoing review with MHLW and should commence enrolling next year.
-BARDA contract and next generation technology development
Activities related to Option 1 of Cytori’s contract with BARDA are now ongoing. Cytori is actively drawing on the initial m which supports research and development work while also covering a substantial portion of overhead.
-Cytori’s development of its next generation platform technology is proceeding. Initial product release is expected in 2015.

Commercial Restructuring & Revenue Forecast
Despite the impact of the cost reduction efforts, Cytori continues to anticipate modest overall revenue growth in 2014.
Overall revenue growth in 2015 and 2016 will likely continue to be modest but should show a positive contribution margin beginning in 2015 based on the combination of recent expense reductions and forecasted increases in sales to Lorem Vascular and other partners, as well as through Cytori’s leaner direct sales teams in both Japan and Europe.

The new regenerative medicine law in Japan has completed its public comment period and, based on current feedback, the Company believes the outcome could be favorable to Cytori’s business prospects in Japan in 2015 and beyond.
Warrant Exercise
In September, we received approximately $ 4 million as a result of warrant exercises following the amendment of the June 4, 2014 warrants as announced by the Company on September 8, 2014.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

The Re-structuring Announcement 22 Sep 2014 09:17 #2283

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My guess is that the launch of the new Celution system might be a real tipping point ... I had hoped for it to be ready by now, but it won't be before somewhere in 2015...

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The Re-structuring Announcement 22 Sep 2014 09:22 #2284

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This is all well and good but it is it too little too late. Let's be honest here. These are changes that should have happened years ago ,not days ago. Many of us saw and have commented on it for years. Cytori was a cash cow for overpaid mangers that milked the cash cow until it ran dry. The board comprised of all of it's experts and with it's experience was completely negligent in overseeing, what was going on at the company and allowed the same mistakes to be made over and over again. While this initiative is welcomed it is not new and to me the definition of insanity is doing the same thing over and over again and expecting a different result. Dr. Hendrik has been involved in every blunder that has happened over the years at Cytori and for the 5 years, I have unfortunately been an investor and have watched my very significant investment decrease 80%. At no time did I feel informed or that I was being told the truth about what was actually going on. While I did my DD , the information was only as good as what was available or reported. While never receiving any inside information, like many I was privy to comments passed along to certain privileged investors who were able to speak directly with CC, SAAD, Hendrik, Tom Baker and others and the information and insight that was discussed was off base and misleading. Not from those that passed along to us but specifically from the source. This is why I advise that any thoughts passed along by DOV and the likes are taken with a grain of salt and should not be relied upon. They are clearly opinions and not based on fact and perhaps based on innuendo which was passed by management solely for the purpose of keeping investors that they have brought to the party pacified. For all we know the new CFO is only here to structure the company for sale which at this point in time would not help any of us longer term holders out one bit and would only serve to deprive us of an opportunity to recover losses, which is a long shot at best. The shorts have decimated the stock and in truth were the only ones getting any type of objective information and have profited handsomely. Though not one to go so far as to suggest a conspiracy, I would not be surprised to find that upon investigation many shorts who have profited so handsomely are holding long positions to disguise intentions. I would make a point to say that I am not referring to DOV and the like. Dr. hendrik is no different the Chris calhoun. To date he has not been forthright at all with his promise to keep shareholders informed seriously. The Athena breach is the biggest indication of that to date. Mark Saad , is gone, but the damage done is much like the damage done to the Jersey Shore during hurricane Sandy. The aftermath is still being felt today years later and the financial scars and impacts to certain towns are still obvious today. Thus the seriousness of the incompetence and lack of effective leadership. Mr Rickey and the compensation committee have sat by and granted options and pay raises rewarding this incompetence and have yet to be taken to task. As for the science ,no question stem cells will play an important role in the future, but the years of waste a neglect may have damaged any competitive edge Cytori ever had. Pigs get led to slaughter and cytori has been lead to slaughter by the greed and failure for management to partner with companies that have brought Cytori and it's shareholders to the promised land. Now the company stands as a shell of itself, malnourished and suffering and who knows if they have the strength or will power to survive. This is the last chance the last straw so I strongly suggest that the BOD puts ego's aside and does the right thing and gets a capable leader to lead this final surge.
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The Re-structuring Announcement 22 Sep 2014 09:51 #2285

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Roth, I cannot fault your comments about the wasted opportunities. I agree that management made serious mistakes and over estimated their ability to deliver. They went down some blind alleys that possibly should have been obvious. Still I do not believe that Cytori management conspired to fail. Their greed was based on their belief of the merits of the technology. CC and all the others who left were well paid but lost a potentially much more substantial payday had they succeeded.

What's done is done. The restructuring is a serious step in the right direction and shows focus. Lets hope that they are also focused on a potential partnership agreement. The opportunity is huge given the scope of the technology. We need partnership money or a quick spate of significant news to raise the SP and issue additional shares.

If I was a potential partner I would be very interested in the intellectual property duration. How much life does Celution still have?

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The Re-structuring Announcement 22 Sep 2014 10:52 #2286

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Well we have all been screaming for communication...we got some !!! I dont think they had much choice with the PPS in the sub dollar range. I'll give my two cents worth comments.

First off a few months ago...evidently right about the time ATHENA was "quietly" being halted and kept from shareholders I re-evaluated the longer term potential of this company and came up with much much lower prospects for 2020 area and beyond. ( See my recent 2019 potential sub $ 10 comments on this board) Anyway...the next gen platform launch is on my personal target range from that period of reflection of 12-18 months so late 2015 area. New partnerships now look bleak as focus will be on building on current relationships and further loan restructure. I guess best hope here will be either Lorem or debt for equity exchange. Another government style deal also possible which could be helpful but less exciting to me. We'll see. As I have said many times ...this company has zero leverage !!! I expect more shareholder suffering in one for or another as we try to get off life support. The company does survive though. ( I would also note I suggested as this latest fiasco started to unfold that a out right sale should be considered)

A tip of the hat to Fas on the osteo suggestion.

Rothco.....I am going a bit with rongside in saying that I personally am going to try to move past the mistakes of past management because we cant change any of it. Dean had his chance to right this ship before we got this far but he chose not to. I do not believe he deserves his board seat and has contributated greatly to our current mess with not only his words but lack of deeds !!!!!!!!!! Beyond that the "inside track" has been the completely wrong place to be. We have all spoken to coporate officers of companies to gain a better understanding but this is one company I refused to do so.....I just didnt trust what was being presented. Following too deeply has burnt far more than helped those who did imho. While I too have been losing on this investment for years I have at least not chased the fairy tales and dug too deep a hole for myself. I like to think it enabled me to keep a independant mind but perhaps it was pure luck. I certainly took my YMB lumps as a glass half empty thinker with this stock at times but I kinda liked those days and given where we have traveled....well you know

rongside....If I were a potential partner I would be playing the hardest of hardball !
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The Re-structuring Announcement 22 Sep 2014 12:51 #2288

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FYI to all, both Hedrick and the new CFO are in NY this week.

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The Re-structuring Announcement 22 Sep 2014 12:56 #2289

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Titan, and that is relevant because? I sure wish i could get an hour of there time, while they are here.

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The Re-structuring Announcement 22 Sep 2014 12:57 #2290

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Well put Roth!

Hope it is not too little too late.

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The Re-structuring Announcement 22 Sep 2014 14:21 #2291

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Thanks guys- there were quite a number of good posts today.

A lot of things shot through my brain also while going back and evaluating where we seem to end up now. Fact is - yes ATHENA will start up again (ONLY if it can be funded), but it remains a risky trial with very sick patients. I think AMI would have been much better.
I have been told that NO patients have been treated in the Hamstring trial. Probably - being 8 months further in time - none will be treated.

So - now are main hope is Osteoarthritis- which should have been the application, which they should have started in 2006. Already many developers with marrow fresh cells on the scene here (Centeno etc and ADRCs in Europe). Thereto the Cell Surgical Network can do that too, so we have to hope for the FDA to become active. :bash: :whistle:

Yes- I think it is also just fair that all BOD members which have been around a while and brought us to this stage - step down.

That includes Rickey and my preferred Board would be Lyons -Chairman, Thompson, Naughton and a new Japanese member Kurokawa. Whether you like it or not- the music will play for Cytori outside the US.

Still- even at this stage I severely think the technology remains disruptive, which is the major cause of failure so far. Since CC et al knew that too, their greed destroyed not only their own lives. :evil:

They should be f*cking ashamed of themselves.


In respect of Hedrick-

since he (hopefully) knew the employees best- yes- he had to do the re-organization. Thats difficult for a new guy guy to do, without making grave errors. So - as far as I am concerned- Hedrick should take a step back too. He is severely "contaminated"

Lets hope Saad did not make an eternal rental contract for Callan Road- assuming >20 employees in Japan- >15 in Wales - that leaves not too many for the US in a building of 97.000 ft²... :KO:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

The Re-structuring Announcement 22 Sep 2014 15:33 #2292

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Roth, it is highly likely that the trip is related to raising money in one way or another. How shareholder friendly is the question. More relevant than anything else right now.
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The Re-structuring Announcement 22 Sep 2014 17:47 #2293

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Wouldn't you guys think KT Lim would be the most obvious choice for funding the company? That is exactly where I would go - maybe they have and he doesn't want to pony-up any more cash. But I would think that a billionaire with a 30 year agreement in place would see clearly the solution to this liquidity problem. If I had done that deal at 3 dollars , I would be all over taking the bank out and becoming the "lender" and also throwing more cash in the till here to move forward aggressively. The stock price would be 3x to 5x where it is in my opinion. Really surprises me that has not happened ........yet......I guess I'm too simple.
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The Re-structuring Announcement 22 Sep 2014 21:39 #2294

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I think they are flying in the wrong direction to meet with Lim....LOL

Also Oxford has been a equity holder here in the past trading in and out.

Something is being worked out...its obvious it cant be all debt as revenues just wont support it.

Forgotmorthanuno: Your 3x to 5x valuations are too high for today imho. Lets see what the year end share count is, how they plan to fund a oestoarthritis trial, and how they plan to proceed in japan, then we can try to honestly value the company.

BTW: I dont know about others but I must have read today release about 7 times...of course focus was on the pending changes...but I also found it interesting the changes on how they now describe the company...its in the "about Cytori" section at the end. Subtle but different.

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The Re-structuring Announcement 22 Sep 2014 22:40 #2295

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Hedge,

I noticed a slight change - specifically that they now included "thermal burns". The thing that popped out at me was Tiago Girao is now listed as the IR person on this particular release. This most likely confirms our suspicion that Megan is no longer with the company - I never received a response from her last week.

Here is today's release vs. a former release:

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease, thermal burns and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family.

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs™) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs™ improve blood flow, modulate the inflammatory response and rescue tissue at risk of dying. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family

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The Re-structuring Announcement 23 Sep 2014 10:01 #2298

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Mr. 5874,

The new language certainly reflects the value of BARDA.

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The Re-structuring Announcement 23 Sep 2014 11:15 #2299

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mr5874

Also this part in the beginning of the release:
*** to achieve the Company’s goal to be a leader in the cell therapy industry***

Where in the past they just claimed to be a leader in the field.

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The Re-structuring Announcement 23 Sep 2014 12:43 #2301

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To be honest- there are some wording changes on how Cytori describes themselves now compared to the past (that is an interesting subject on a LT basis :grin: ) but really short term nothing to get excited about..... just words with similar meanings.

Since Hedge read the thing so many times , I did read it a second and third time too. Did make me shiver occasionally...

Key to me is really the vagueness around the new generation Celution needed surely for the OA clinic (lets use OA for osteoarthritis going forward- saves a lot of energy). Nobody is his right mind will want to buy an Celution 800 CRS for 80.000 $, when relatively soon a similar piece comes on the market for 10K right????

From that perspective I found it positive that the plan is to have a positive contribution margin starting early 2015 on S&M expense (which should be 8 Mio or so in 2015).
Fact is though R&D plus GASE is about 35 Mio extrapolated. Saving 8 Mio thru redundancies and getting to 27 Mio instead sounds great, but does not impress me. I want to see clinical results which are impressive and for that Hedrick has to cooperate in disclosure and IR.

Somehow I do not think, he is capable of that. :evil:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

The Re-structuring Announcement 23 Sep 2014 13:32 #2302

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Fas,

It seems there are many with similar assessments of the situation. Survival seems to be paramount. Achieving it will be difficult.

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The Re-structuring Announcement 23 Sep 2014 13:54 #2303

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I viewed wording changes as a more honest description of where the company really is today

***new generation Celution needed surely for the OA clinic ***
Why cant they use the 800 celution ? Maybe we have a bunch sitting around.
The new celution version could be used and getting certain outputs approved thru the FDA was part of the conditional approval but I dont see why it has to be that way . Besides, many such trials are funded by grants...rarely does cost containment become a priotity. (Speaking generally here.)

As for expenses...clearly losses were going to continue for some time. DOV is dreaming that 25 million in revenues is even possible in 2015. I realize he is expecting much less and that was a high end hopeful thought.

As for still waiting on hidden trial results....is it possible that maybe they are not all that impressive ?

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The Re-structuring Announcement 25 Sep 2014 08:36 #2308

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Many things are going to have to be restructured from now on. Here are some random thoughts.

Survival of CYTX:

Our current state has been the outcome of incompetence, unrealistic expectations and greed. However,in my opinion the only way this company can go bankrupt is a conspiracy. I do not believe one exists within CYTX management, but would not be surprised if there is one outside the company. The bankers know they are not going to bankrupt CYTX but that does not mean they cannot maximise their profits by buying ridiculously low priced stock via cheap warrants and shorting. Lets not forget that the profits from inside information is not only earned by the parties negotiating the refunding, but also via their "associates", the insightful shorts. :evil:

CYTX has a BARDA funded trial. It also has an NIH funded LVAD Celution trial. We are waiting on Japanese SUI trial go ahead with the implementation of the new legislation. Scleroderma data is very strong and I would not be surprised to see an EU announcement with ramifications for the whole autoimmune segment. The ATHENA delay is just that, a delay which will be resolved. The Celution system has CE and international approvals in multiple indications (for which we are still awaiting data !!!!!!!) Our platform technology touches virtually every medical malady known to mankind........ except stupidity. :KO:

The total EV value of our company at this time is USD 84M being the market cap and the outstanding loan. This is rediculous. Companies with these sorts of IP assets do not go bankrupt by themselves. We will (should) survive. We are in a position of weakness only if we are negotiating with one party (the bankers). With the potential of the Celution device there is no reason that there should only be one party. If this is the case then I cannot distinguish incompetence from conspiracy. :puke: :cry: :bash: :evil:


New Celution Device: :nice:

Sell the Celution800 for USD 80K and undertake to replace it with three of the new cheaper/better models at no cost when the new device is approved by the authorities. An additional caveat could be that this would occur assuming meaningful translational research has been undertaken and results lead to approvals and/or reimbursement of treatment by medical authorities. The more machines out there, the more consumable sales, which is what we want.


FDA leniency of unlicensed/unapproved uses of ADRC by private Clinics in the USA: :bash:

If they (FDA) can't police all these clinics then they should simply issue a statement to the effect that : Patients who have undertaken stem cell treatments using unapproved technology or undertaken by labs that have not passed recent cGMP review can sue their doctors for non performance. Let the lawyers and malpractice insurance providers clear the system of the charlatans and hucksters. We didn't get 510k approval, but in the meantime tens of thousands of dollars are being charged to desperate patients for procedures that do not even provide valid data of efficacy.

Still a believer...... possibly a fool ....... too cheap not to buy some more. :bye:
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