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TOPIC: Re-chewing the news of sustained 2 years benefit

Re-chewing the news of sustained 2 years benefit 22 Feb 2016 06:19 #6463

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The announcement was just released ahead of the CC...

Data Reports Sustained Benefit at Two Years with Single Administration Cytori Cell Therapy for Scleroderma
02/22/2016
Data presented at 4th Systemic Sclerosis World Congress

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today reports new data demonstrating a single administration of Cytori Cell Therapy™ (ECCS-50) achieved a sustained improvement in hand dysfunction at two years in patients with scleroderma. Scleroderma is a rare autoimmune disease that results in hardening of tissue from a buildup of fibrotic tissue in the fingers, skin and other organs and tissues.

The trial findings were presented by trial co-principal investigator Dr. Guy Magalon on February 20, 2016 at the 4th Systemic Sclerosis World Congress in Lisbon, Portugal. Cytori will host an investor conference call at 8:30 a.m. Eastern Time today, February 22, 2016, to discuss two year follow up results from the SCLERADEC I trial. In general, the data showed a sustained two year improvement in hand symptoms and function across multiple endpoints in patients with scleroderma following single administration of Cytori Cell Therapy™ (ECCS-50).

Major findings at 24 months following single administration of Cytori Cell Therapy™ (ECCS-50):

Hand dysfunction assessed by the validated Cochin Hand Function Score (CHFS), showed a 62% reduction in hand dysfunction at two years (p<0.001).
Raynaud’s Condition Score, a patient-reported measure of the severity and frequency of Raynaud’s Phenomenon, decreased by an average of 89% over baseline at two years (p<0.001).
Hand pain, as measured by the standard 100mm Visual Acuity Score, and the Scleroderma Health Assessment Questionnaire (SHAQ) score at two years both showed improvement of 50% over baseline (p=0.01 and p<0.001 respectively).
Improvement of 20 % in grip strength and 330% in pinch strength at two years (p=0.05 and p=0.004 respectively)
Continued reduction in the number of ulcers from 15 at baseline to 9 at one year and 6 at two years.
“Hand dysfunction in scleroderma is both disabling and hard to treat,” said Dr. Guy Magalon, who presented these data on behalf of the team at Assistance Publique-Hôpitaux de Marseille (APHM). “The standard treatments we rely on for these patients are often not effective or are poorly tolerated because of side effects. The broad efficacy signals along with a very favorable safety profile makes ECCS-50 one of the more promising new therapeutic options for these difficult to treat patients.”

SCLERADEC-I led by Principal Investigators Pr. Brigitte Granel and Pr. Guy Magalon and the Cell Therapy Department of APHM by the team of Pr. Florence Sabatier, is a 12 patient, French, single center study aimed at measuring for the first time the safety, tolerability and potential efficacy of Cytori’s ECCS-50 locally injected in patients with hand disability due to scleroderma. Scleroderma has orphan designation in Europe.

“The scientific findings of sustained symptomatic and functional improvement coupled with the direct patient feedback we have received from other scleroderma patients treated apart from this trial leads us to be optimistic about the potential for ECCS-50 to help patients worldwide,” said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics Inc. “The follow on approval trials, STAR and SCLERADEC II are enrolling, our EU compassionate use (or Managed Access) program has launched and we remain on track to submit to US FDA in mid-2017.”

Results at 12 months of follow-up for this trial were published in the August 2015 edition of Rheumatology. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through one-year post-treatment.

Management Conference Call Webcast

Cytori will host a management conference call at 8:30 a.m. Eastern Time today to further discuss the two year follow up results of the SCLERADEC I trial. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1 (877) 402-3914, Conference ID: 56735683.

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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:

Re-chewing the news of sustained 2 years benefit 22 Feb 2016 08:36 #6464

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I was a bit late for the CC and therefore only could listen to the last 40 minutes or so, but despite that- I thought this was great.

We should have had that Call at the first announcement to clarify and have major PPS impact, but alas that opportunity is gone and maybe re-chewing is good too. :grin:

Nice to hear the Kiwi accent of John Fraser (Chief Scientist I believe he is now), who has been around since joining MacroPore with Hedrick in October 2002 and also Steve Kesten- both do well in a CC, which is not a natural thing for most folks.

Still- yes- my main concern remains money too- so it was interesting to hear that there is a lot of interest to partner scleroderma in Europe and Cytori already

turned down

:KO: an offer in the US to partner scleroderma in the US!! As we know they want to do it by themselves.

OA was mentioned to this respect- that with time they expect the placebo effect to wain and longer term- i.e. 48 weeks- the actual results to further improve.

All in all- nice call. :nice:

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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:

Re-chewing the news of sustained 2 years benefit 22 Feb 2016 08:55 #6465

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Fas, I am late too to the webcast, by 30 minutes.

Yet, people seem to sell into the rally, as before.

MESO is doing great, with just a pre market PR.

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Re-chewing the news of sustained 2 years benefit 22 Feb 2016 13:29 #6468

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MESO is doing great, with just a pre market PR.


MESO has cash, CYTX needs cash. Same old story. Nothing good can happen until they solve this problem or at least get the debt amortization pushed out by 6 months to get some breathing room. When market cap is so small - negotiating power suffers as there are no good alternatives. Even though these Scleroderma data are great, Cytori is dealing from weakness and any partner knows their situation. The hole is deep.

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Re-chewing the news of sustained 2 years benefit 22 Feb 2016 13:33 #6469

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Thanks, WST

A lot of shares have been changed hands around 0.18
actually, someone is unloading a lot of shares at 0.18 (as it was at 0.19).

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Re-chewing the news of sustained 2 years benefit 26 Feb 2016 21:15 #6484

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***Still- yes- my main concern remains money too- so it was interesting to hear that there is a lot of interest to partner scleroderma in Europe and Cytori already
turned down
:KO: an offer in the US to partner scleroderma in the US!! As we know they want to do it by themselves.***

Are we really in a position to be turning down offers? Are they willing to put this company on course for a R/S while the cash continues to melt away like the winter snows? I realize we are not dealing from a position of strength at this juncture, but to be thumbing our nose at someone willing to inject some life in this walking corpse, seems absurd.
Have we not forgotten the miscues of one Chris Calhoun and his plethora of partners from the past.
For fuck sakes, let's make a deal, we're 20 cents away from being nobody. :bang:

d9
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Re-chewing the news of sustained 2 years benefit 26 Feb 2016 21:46 #6485

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d9

I hear where you are coming from but remember there is no loss to management in a R/S

Too bad salaries also don't have to suffer a R/S...then management of any company may be more shareholder friendly.
Also, loss of management options in a R/S is meaningless as well since they are easily granted a new in the tens of thousands....or even hundreds of thousands.

Our only hope rest in the confidence they express in the August call....to me, I felt they really seemed to think they had a pathway to some cash. Lets hope it wasn't via OA app or the offer refused in US scleroderma talks.
Of course, its really pure speculation on my part of what I thought I heard in terms of confidence. I didn't like the last earnings call at all. Even with a deal, a R/S may still be necessary.

PPS action has been a litter firmer. I would like to see more volume though. At least 2 million+ share days.
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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 08:37 #6486

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I re-listened to the call. They did not say they turned down a deal.

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 09:39 #6487

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Joncon, I was responding to an earlier post, as I have not heard the call in its entirety.

d9

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 10:34 #6488

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Joncon63 wrote: I re-listened to the call. They did not say they turned down a deal.


I wrote this and am pretty- that is 100%- sure they did. The matter however further has zilch importance to me, so we just let it ride. :grin: :grin:

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 11:13 #6489

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fas is correct -- he did say they turned down a deal.

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 15:43 #6492

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Not trying to be difficult, but that is not how I heard it.

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 15:45 #6493

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If they did, and they don't know for a fact they have money coming in from elsewhere, that would be very stupid. But I guess par for the course

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 16:39 #6494

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Joncon,

I just listened to the replay. It is not easy to hear it, but Hedrick did say (almost under his breath) that "we have already turned down a healthy offer in the US". This statement was made at 46:19 into the call. When I heard it live, I thought it said that IF they got a healthy offer, they may not turn it down. Ad libbing a little bit, but close enough.

You made a very logical statement which I interpreted as Hedrick saying he feels confident a partnership in the EU will happen in due time. Hedrick surely remembers the Calhoun statement: "very very very soon" which got him fired. He will not make the same mistake.

In my mind, there are two opportunities left prior to the end of May for Hedrick to get the stock price above $1 and avoid a reverse split. Most people believe a 1:10 reverse split will simply provide more room for the shorts to attack the stock. I happen to agree with that scenario. Cytori has a very long history of being manipulated by the shorts and people like Adam Feuerstein are their puppets. (didn't hear from him after the two year results). On the other hand, the real institutional investors cannot buy stocks that trade below $3 per share and some have $5 per share rules.

Hedrick needs to get investors to believe Cytori is selling a DRUG and not a medical device. He has two opportunities to do so: the March 3rd conference call is the first and a real scleroderma partnership that solves the balance sheet issue forever is the second. In my opinion, the number is $40 million. Pay off the debt and then have enough cash to get the company profitable. I think the Japanese commercial update and the MAP update are telling us that revenues will surprise to the upside. I expect a headline on Thursday that looks like this:

Cytori Reports Record Product Revenues
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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 17:00 #6495

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DOV wrote: Joncon,

Hedrick needs to get investors to believe Cytori is selling a DRUG and not a medical device. He has two opportunities to do so: the March 3rd conference call is the first and a real scleroderma partnership that solves the balance sheet issue forever is the second. In my opinion, the number is $40 million. Pay off the debt and then have enough cash to get the company profitable. I think the Japanese commercial update and the MAP update are telling us that revenues will surprise to the upside. I expect a headline on Thursday that looks like this:

Cytori Reports Record Product Revenues


Yes DOV- I believe you are right. The device vs drug issue has been a major obstacle in anyone understanding the potential of the Company- I mean we are not a one trick pony like KOOL- but a better ISRG Company where the consumables or scissors are the therapeutic. Thats what folks apparently do not understand, so we will make them.

Its as simple as that.

And once they do- we will explain to them, that CYTX has an extremely favorable regulatory pathway- something to do with device regulations, which even Hedge does not understand a 100%- that will get get us faster to market than all competition. :grin:
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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 19:25 #6496

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DOV...agree if the R/S comes it must be done correctly. Correctly meaning short selling pressure cant break us under a buck again. At some point market caps matter vs price.
Fas...you aren't still busting on me about the PMA vs phased drug approval route are you...LOL ???
Or am I lacking somewhere else ?
Its OK...I'm a big boy :) :grin:

BTW...I long gave up on ISRG as a potential model of PPS appreciation and now favor EW. Note..I am not calling for specific prices or market caps.

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Re-chewing the news of sustained 2 years benefit 27 Feb 2016 21:02 #6497

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Thank you, DOV.

I see you're a well trained man.

Many blessings.

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Re-chewing the news of sustained 2 years benefit 01 Mar 2016 13:33 #6515

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I emailed Tiago and asked for clarification on Hedrick's comment.

My question was: Can you please clarify whether Marc said we turned down a healthy partnership offer for US scleroderma treatment?

His answer: I don't think he said that, he said that we are focused on licensing Scleroderma in the EU, and prefer to keep the US. But if the right offer was made, we would consider licensing it globally (including the US).
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Re-chewing the news of sustained 2 years benefit 01 Mar 2016 13:58 #6516

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Basically what DOV suggested it said.

One has to listen closely to the replay.

Thanks for the follow-up Joncon63

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Re-chewing the news of sustained 2 years benefit 02 Mar 2016 02:45 #6517

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Joncon63 wrote: I emailed Tiago and asked for clarification on Hedrick's comment.

My question was: Can you please clarify whether Marc said we turned down a healthy partnership offer for US scleroderma treatment?

His answer: I don't think he said that, he said that we are focused on licensing Scleroderma in the EU, and prefer to keep the US. But if the right offer was made, we would consider licensing it globally (including the US).


It still is my view that the statement "we have already turned down a healthy offer in the US" is of a different nature and I would not refer to it as being "semantics" or something. What I recall is, that Europe and the US have always been "worked on" separately and this "global partner possibility" for scleroderma, never has been mentioned, as a result of the often repeated desire to handle this internally.

Thereto- I tend to listen rather carefully too, but I understand that Girao likes to tone this down :whistle: Hedrick´s statement was not very "considerate to shareholders" in view of past events, experiences and "state of the nation". :bye:

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