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TOPIC: Cytori-Questioning the Past,Present and Future

Cytori-Questioning the Past,Present and Future 11 Jul 2014 10:32 #1868

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A lot has been written in the preceding thread about challenging Cytori on disclosing more information and asking Management questions in area´s where it is absolutely clear that large voids exist in public knowledge or corporate communication on aspects of the business.

But there must be a BASIS for this stuff- best thing is to take Hedrick´s outlook i.e the management letter in the Annual Report as this basis- i.e. how the present is perceived with a view forward,

That management letter starts with ATHENA and BARDA- since we know enough about that, lets simply eliminate those parts- the rest reads as follows-

New generation Celution Device
I would also like to highlight an important aspect of our BARDA contract that is often overlooked. That is the potential for significant development support from the United States government for the next generation Celution® technology. This proprietary technology is the foundation of every Cytori Cell Therapy treatment and is at the core of the business model. Though critical for successful implementation of a BARDA directed medical countermeasure, the next generation system will be a significant improvement on current technology based on its automation, cost effectiveness, processing time and performance enhancements. This combination of features will create a unique autologous cell therapy ecosystem at the bedside, capable of integrating into many clinical settings and targeting a wide range of medical conditions. We will update you on the timeline as we get closer to launching the next generation Celution® System.

Device Platform
Furthermore, the next generation system, with its inherent performance and cost benefits, allows Cytori to expand its clinical pipeline into new areas where cost, processing time or performance is critical to the value proposition. Orthopedic and sports medicine related conditions, wound healing,
and aesthetic indications are just a few areas that could be better addressed by this next generation system.

Development Applcation Platform
Building on the forthcoming next generation platform and incoming data from investigator driven studies, Cytori intends in the near term to expand its clinical pipeline and target indications into new areas. Some of these will be facilitated by external support, as is the case for burn treatment funded in part by the U.S. government, urinary incontinence funded by the Japanese government, and others.
Additionally , Cytori will fund some new indications as company sponsored trials similar to our cardiovascular trial. Expanding this clinical pipeline is critical to the ongoing success and value creation of the company.

Important new commercial relationships
From a commercial perspective, Cytori has narrowed its efforts and related spending and is selling the current research based Celution® 800 primarily to customers interested in some form of clinical study using Cytori Cell Therapy. These customers are typically outside the U.S. and represent either academic medical departments or ‘early adopter’ physicians and clinics. These sales have resulted in some revenue to the company but more importantly, provide a tremendous amount of clinical feasibility experience, safety data, information on efficacy, and generation of intellectual property. Our near term goal is to continue these research sales, endeavor to move the commercial organization to a positive contribution margin and begin to leverage important new commercial relationships


Longer term- doing the "Obvious"
We intend to expand this network over the near term as a cost effective way to increase the footprint of our technology. Longer term, the combination of the next generation system, expanded clinical data, regulatory claims and reimbursement will be key to driving revenue growth and overall corporate value.

Financial "Houdini" Strategy
While we remain focused on clinical development and commercial success , equally important to many of our shareholders with whom I have spoken, is to ensure that Cytori grows in financial strength and is able to take full advantage of its technology. I wholeheartedly concur. As CEO, I will personally do all I can to ensure we wisely invest our resources and focus the use of those resources on only those projects most likely to bring the highest return on investment

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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:

Cytori-Questioning the Past,Present and Future 11 Jul 2014 11:09 #1869

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"Very high level evaluation of the Letter"

To me this letter is ONE hundred percent wishful thinking and unrealistic.

On the one hand - COMMERCIALIZATION- is the only mentioned source of funds, but that will happen for the low hanging fruit - wound healing, sports medicine etc with the new generation device, which still is not there and first approvals are required.

Before you can sell -you need regulatory approvals which are not there in some key markets- and if you want to expand your OWN developed application platform you need MONEY or THERAPEUTIC DEVELOPMENT PARTNERS. At present Cytori has none except BARDA and that is early stage in the US. Obviously - a pivotal cardiac trial needs the same - a partner since Cytori have proven themselves to be incapable of driving efficient clinics.

In Europe approvals need to be switched from Celution 800 to the new device and similarly in Japan for the apps in development.
Money is needed for regulatory processes in the US and Japan, so basically NO commercial partners are required , but APPLICATION DEVELOPMENT PARTNERS.
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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:

Cytori-Questioning the Past,Present and Future 11 Jul 2014 13:28 #1870

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Anyway- the purpose of this thread is to accumulate questions to the Company, to once and for all eliminate "non-confidential" questions raised in respect of the development of Cytori as we know it.

I intend to channel this through "friendly addresses" who have more clout than all of us in enticing Cytori to work on answering them. Last time I did not particpate on posing questions to Tom Baker. Obviously, this time I will, but I hope (and expect) that all the smart raccoons that read here, will contribute.

I intend to make some kind of matrix for sorting the questions by :

1. Importance - a. critical, very important to understand b. medium importance- probably has some importance c. nice to know
2. Development phase: a. past b. present c. future
3. Category- a. shareholders (WS-PPS-Meetings etc) b. Internal Finance- (funding of business, accounting, reporting) c. Organization- (people, partners, BOD, Management) d. Technology- (device, competition etc etc) e. Applications -should be clear f. regulatory issues g. commercialization efforts h. all other topics.

Next contribution- the statements from Michael and John leading up to this

Any comments so far???

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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:

Cytori-Questioning the Past,Present and Future 13 Jul 2014 07:34 #1871

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Hey Guys (and possibly some gals)- My wife has disallowed reading on the web, since I apparently have done too much of that and had tremendous trouble and pain with the operated eye after that. So.. I have to take a break until that is fixed.

Forget the third post- I will be concentrating on what John wrote:

Additional capital raisings AT THIS PRICE LEVEL smacks of incompetence. The proof of concept is so strong that I cannot believe that all the Big Pharma/Bio companies are devoid of commonsense and do not recognize the opportunity that ADRC and Celution in particular provide. I believe that we are not serious about negotiating a deal, Management must deliver soon.
The final BARDA announcement must include sufficient data that we can make a judgement as to the value of our investment. While I do not intend to sell my holdings I am reticent about buying more ........ even at these levels.
I think we need to make a list of potential catalysts and hound management from now on for information that we are righfully entitled to ........... and overdue

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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:

Cytori-Questioning the Past,Present and Future 14 Jul 2014 10:09 #1873

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Cytori continues to disappoint. The annual meeting on July 31 is a very important one and hopefully , shareholders will get some relevant information that may restore some credibility to this companies savaged reputation. It is this lack of credibility, honesty, communication, execution,cash, partnerships and management that has CYTX trading just above a 52 week low. I have gone back and read over transcripts from the Q4 2013 earnings call and other pertinent info and would like to share some observations and feedback is certainly welcome.
During the Q 4 call management sited 4 objectives.
1. Completing Athena enrollment. That has not happened, continues to be delayed and move at a snails pace
2. BARDA approval on proof on concept. This has been achieved ,however the picture remains very cloudy and this event has not served as any type of catalyst to improve pps or shareholder confidence. Management during this call taunted the up to 56 million dollars that could be received upon approval. Within a few months of this call the number was dropped to 36 million. That is 20 million dollars . With expectations now lowered , shareholders and the market with very few exceptions expect far less then the 36 million and who knows under what terms. A positive quickly turns into a non event.
3. Increasing demand for product and services and contract revenue. A big F here. Take a look at the sales revenue generated despite the hocus pocus accounting of Mark Saad. Note that losses for the next quarter are expected to increase based on what 4 analysts who came out last week with recommendations after BARDA news.
4. Improve cash position, another F as the cash on hand is wasted on inflated salaries of management that has been no more then parasites for years, sucking what they can out of the company, in salary and free shares while delivering nothing at the cost of the PPS.
5. Publication of precise data was met with a great big so what. Another catalyst that was to be a driver of the pps and create momentum is a bust.
6. Sports medicine no info, updates, and a failed attempt by CC to make a deal in Europe in this area to perhaps save face.
7. Clyde shore's attempts to increase commercial business another failure.
8 Japan legislation passed over 6 months ago and we still don't know if they have been able to translate from Japanese to understand what the legislation says. The must not have been able to do so as we have yet to hear anything and talk about generating revenue shortly after it's passage, another broken promise as we have nothing to show for this .
9 China legislation passage,another question mark , no information or update of progress. China was to be a huge source of revenue. Perhaps, but when ? KT who ? and has Lorem Vascular hired anyone other then a secretary to answer the phones.
I could go on but by this time I have had to make my point and that is that nothing has changed at CYTORI. The culture is sick, and there is no accountability. CC was a sacrificial lamb, fired to appease angry shareholders, and Hendrick will be next with the promise of a CEO who will be fit to lead. My bet the next CEO is brought in to position the company for sale . If things are not as bad as they appear, nobody appears to be buying it nor are they buying shares of Cytori.
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Cytori-Questioning the Past,Present and Future 14 Jul 2014 14:35 #1874

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Roth,

Your arguments are valid and the disapointment within the core of Cytori investors is palpable. You did not even mention the delays in the Okyanos project. I think that we as investors have a right to more information. Fas's idea of presenting a list of the most important questions on the mind of the investors is a great one. Your thoughtful listing of some of the most pressing issues will be a great source for the investor presentation.

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Cytori-Questioning the Past,Present and Future 14 Jul 2014 17:15 #1875

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roth we are still years away from real, meaningful, progress with management and sales.

Fas...if you were feeling better your list would have been interesting though who knows what the value of the answers would have been...we went down this road once before didnt we ? :cry: :puke:

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Cytori-Questioning the Past,Present and Future 16 Jul 2014 13:33 #1876

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Fas, listen to your wife and look after your eyes.

As for the questions that should be posed to management here is my contribution. They are not listed in order of importance:

1. Scleroderma 2nd stage trial - SCLERADEC II .
www.plastie-aphm.fr/Evenements/Scleroderma-workshop/Program
Present at this training forum was Cytori’s Fraser, Kesten and Meskini.
How big is this expanded multicenter trial going to be?. Who is funding it? Does it have reimbursement potential?

2. ADVANCE trial .
Six month data for all patients from this trial should already be available. Twelve month data for the majority of patients should be close. How about a heads up?

3. Japanese Government funded trial in SUI.
How many patients were planned to be included in the trial ? How many enrolled so far? What is the trial format and objectives? Preliminary data?

4. New desk top Celution device.
Will BARDA or DOD be funding further development of the new Celution device? Given existing approval of 800 Celution device this is no longer an initial analysis of a new device. Will they assess the quality of the new machine’s output, or are there material differences in the cell processing application? How long will it take to get EU & Japanese approval for the new device?

5. Partnerships
Is Astellas still privy to the developments at CYTX and do they continue to have board access? Has their right of first refusal to a liver indication lapsed or is it still open? Is Astellas still conducting research and is CYTX being kept up to date of R&D findings to date
There is a huge range of applications for ADRC. Whatever happened to all the potential partners that were in discussions with CYTX?

6. Lorem Therapeutics.
Developments in China and the rest of the franchise countries are not mutually exclusive or contingent on one another. What is happening in Australia, Hong Kong, Malaysia and Singapore? Australia and Singapore already have device approval.

7. Cryptoglandular Fistula (and other indications) :
We expect publication (announcement) of data relating to various wound healing indications that have received CE approval. The CE approval is given to Cytori, NOT the research institution/corporation that undertook the research and as such should be a matter of public record. If a doctor chooses to use Celution on the basis of CE approval in an intractable case shouldn’t he have access to the data? Why have they not been commercialized yet given the extreme need for intractable cases? Is commercialisation contingent on something , and if so, what?

8. BARDA animal trials.
Cytori owns the data in the BARDA trials. They should disclose data concerning both the burn and radiation injury to internal organs in the large animal studies. This provides valuable information to existing shareholders ……….. and heaven forbid ……… potential future investors!


Fas, your comments concerning the need for Therapeutic Developmental partners instead of Commercialization partners is valid. We need assistance in the pivotal trials (ATHENA?) due to funding constraints. Commercialization is simply part and parcel of the deal process. We need succesful pivotal trials for reimbursement. To complete them we need funds.

A major partnership would provide the validation for all the hard work that has been undertaken so far. It would be a shame for shareholders, patients, hard working CYTX employees and the bankrupt healthcare system to be deprived of the benefits of ADRC due to managements desire to control and maximise their "ROOI" = Return On Our Investment.

ADRC address an incredibly broad range of conditions. However there are literally thousands of researchers chasing stem cell and gene therapy solutions to these conditions. The window of opportunity is still open but that does not mean it will be there forever.
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Cytori-Questioning the Past,Present and Future 16 Jul 2014 15:58 #1877

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Love the list of questions rongside...It would be a accomplishment to get half of them honest answers !!!

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Cytori-Questioning the Past,Present and Future 17 Jul 2014 09:48 #1878

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Hi John- thanks a lot for the list. I will start working on the vehicle (modus to present to the right folks at Cytori). I think you got most of the important ones- I will add- the Japanese peripheral disease study (40 patients and should be ready) - the bone studies Amsterdam and Basel- the Fraunhofer collaboration- the names of the countries funding clinical studies- the status of India and Apollo Hospitals- and Canadian Celution approval.

Hedge- last time around - the goal was to get answers on board questions from Tom Baker. We got answers and they were decent answers. :bang:

All- reviewing CYTX statements on certain issues is a painful affair- sometimes I have the impression, that they do not know what is going on- at other times they are plainly lying and deceiving- its very frustrating- example????

this is from CC Transcripts from the past 15 months:

Q4 2012- March 7 2013 Transcript
Now we can announce that our early feasibility study on both men and women with urinary incontinence has been expanded to a larger multi-center trial funded
by the Japanese government. Nagoya University has received a grant in the amount of JPY 500 million or approximately $5 million to fund the clinical trial, amend the labeling for this indication and establish reimbursement. We intend to provide more detail on this trial throughout the year.

Q1 2013 May 9 2013 Transcript
More recently, an early feasibility study in urinary incontinence in Japan has expanded to a larger multi-center trial funded by the Japanese government. Nagoya University has received a grant in the amount of ¥500 million, or approximately $5 million, to fund the clinical trial, amend the labeling for this indication, and establish reimbursement. We anticipate that these investigator-led studies will be a growing aspect of our business strategy.

Q3 2013 November 7 2013 Transcript
As part of the Musket discussion on Japan
And then in the background, we have things that are going on irrespective of this new law, for example, as you know, we have a urology trial that's going, it's multi-center led by Nagoya, which would be geared towards not just early approval, but approval and reimbursement.

Q1 2014 May 12 2014 Transcript
Dr. Gotoh from Nagoya has studied ADRCs with stress urinary incontinence. We originally had positive results from 11 male patients published in the International Journal of Urology in 2013, and more patients have also been treated beyond this.
So MHLW, an arm of the Japanese government, has agreed to fund that study, which should be a pivotal trial in Japan going forward, and we're currently under negotiations regarding the details of that trial with Nagoya University, MHLW and ourselves. :bash: :bash:

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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:

Cytori-Questioning the Past,Present and Future 17 Jul 2014 10:47 #1879

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"reviewing CYTX statements on certain issues is a painful affair- sometimes I have the impression, that they do not know what is going on- at other times they are plainly lying and deceiving- its very frustrating"

FAS,

Asking the same questions and expecting different answers may not be insane in this case. The crux of the issue is whether or not we believe in managements ability to move this company forward and achieve the financial success that all of us seek, based on the ability of the science to help people.

There is no room for either ineptitude (" I have the impression, that they do not know what is going on"), or deceit ("at other times they are plainly lying"). I feel as though we have given Dr. Hedrick enough time to re-invigorate the shareholders confidence in Cytori. That can only be accomplished by instituting a comprehensive assessment of the companies priorities, goals and expectations. This assessment should address all of the questions posed by this board.

If the answers are not what we hope, then we should be informed of the mistakes that have been made or the conditions that have changed that have caused those initiatives to fail, or not measure up to the level of success that we were led to expect.

We have a chance to clear the air and set a new base for shareholder expectations. I hope Dr. Hedrick embraces this opportunity to create a renewed confidence in the ability of Cytori to acheive the great things her investors envision in the future.
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Cytori-Questioning the Past,Present and Future 18 Jul 2014 10:33 #1887

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Fatboy-

I think you are totally correct and so far Hedrick has not used the chance to restore credibility period.

There is only ONE way to do that- and its NOT answering all the questions that John and I have on the past, which past Hedrick seems to be dealing with in a similar fashion as his predecessor.

Key is this-
equally important to many of our shareholders with whom I have spoken, is to ensure that Cytori grows in financial strength and is able to take full advantage of its technology.

If you look at the Shareholders letter above- nowhere is the pathway stated in order to achieve that financial strength.

Money is key and showing how we will get it to have the room to manouvre - but all shareholders of Cytori- present and past- know that and they still have not seen the "solution".

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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:

Cytori-Questioning the Past,Present and Future 18 Jul 2014 10:38 #1889

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Anyway-

My eyes are a bit better now (but I do require reading glasses which I do not have as yet)-

ao, will continue with the list- anybody can bring up points in this thread - and will publish early next week.


I did find my "message-bringer"- he will meet the BOD on July 31 and the other guys too that day of course. :cool:

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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:

Cytori-Questioning the Past,Present and Future 18 Jul 2014 13:51 #1891

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You are exactly right FAS. The ability to fund the pursuit of the science :yep: is the primary issue. Without that there is nothing. :yep:

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