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TOPIC: Q2 2013 conference call

Q2 2013 conference call 09 Aug 2013 05:10 #729

  • myownhedgefund
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Well since no one has commented yet I guess I'll start us off with that was the worse call in over 6.5 years I have owned this stock.

They need a deep pocketed partner now or someone needs to take them over.

The cardiology program is in shambles
Eurpoe is a regulatory mess
No guidance on how long they expect current vash to last them
Missed the Q on revenues and I bet they miss the lowered guidance for the yaer.
Canada is going to be big for them now...LOL :bash: Oh, and maybe Mexico...of course the nearly billion people in India was going to be such a big deal as well...now its Canada, Austrailia and New Zealand's massive populations !!!

Normally its takes the March call to determine the year for me but I am calling 2014 now....single digits for all of 2014 !!!!!!!!!!!!!!

Who wants to be the first rebutal ? :evil:

PS: There is a chance we wont even be on the list for the new stem cell regs in Japan (although perhaps foolishly I believe we will be)

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Q2 2013 conference call 09 Aug 2013 09:36 #730

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I listened last night and even re-read the transcript.

Main thing is that the need for ATHENA II defeats me- a higher dose clinic does not make sense to me and is contradictory to what has been said in the past. Must be an outsider view- i.e. potential partner.

Anyway- I will just focus on Roger Waters and The Wall today, which I will see in Frankfurt tonight. :nice:

Tomorrow I will probably have more interest in discussing the call. :bye:

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Q2 2013 conference call 09 Aug 2013 10:35 #731

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Nice Fas...enjoy tonight :cool:

I look forward to what additional comments you may have later.

While your thinking about them consider the following:

Why did ATHENA 2 have to be a completely seperate trial of what appears to be N=45 ? I wonder why ATHENA 1 control arm data could be used assuming 2:1 randomization as before ?

Why are some countries in EU not allowing a control arm for cardiology trials there ? Extremely strange.

I see JK has lowered his 2020 EPS for cardiology to $9.04...LOL Still far far too high. History now $11.49, $11.19, $9.04

Do you remember when we discussed dosing issuses ahile back ? CYTX was looking to increase the dose....I think it looks like they need a bigger response. :KO:
I dont buy the partnership theory wanting more data...unless they dont like what they see and besides why would they now be looking for a cardiology partner....I think they need one, especially in EU ....but are they waivering from keeping cardiology for themselves ?

Last consideration.....I think this call cast into a much clearer light of Mr Dean backing away. Sure Obamacare is a concern for his company but I still think there is more to the story. Lets see if he remains longer term. :really:

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Q2 2013 conference call 10 Aug 2013 11:17 #735

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Just a appetizer on my thoughts on the call, since I have to do some shopping and the A´s have matinee games in Canada for the next three days, which I simply cannot miss. Roger Waters was impressive but very "clinical" -I missed the emotions and zeal of the performers.

Two themes - first ATHENA enrollment.-

The "old Cytori song"- presenting guidance and not achieving- this time really bad I would think. Having 16 patients enrolled instead of being "ready" as predicted, is a hard nut to crack. I went back to the teachings of some of my contacts, who described this issue at another cell Company i.e. Aastrom-

What is evident is that Aastrom was paying a lot of money to a CRO to enroll centers but nobody was managing the doctors. The big CROs have access to lots of good hospitals, but just because they can push a protocol past the institutional review board does not mean the treating physicians are engaged in the process. The fact that Aastrom had 70+ centers and did not even enroll one patient at each center means that nobody was managing the physicians. Clinical trial management is a very hands-on, labor intensive, travel intensive job. Company personnel, often senior company personnel, have to be physically present in the enrolled hospitals several times a year speaking to multiple physicians on each visit to get the necessary attention and to keep the interest level high. CROs don't do that; they help chase case report forms but they don't advocate the sponsor's case.


I suspect that such is the case at Cytori also. I presume Minnesota and Texas Heart enrolled the 16. Minnesota has experience and was way first and at Texas Heart you do not need to motivate physicians like Perin and his boss. Scripps is just around the corner from the Cytori office- why did they not enroll? How many times were Kesten and Hedrick there? Questions galore. This is heartbreaking really.

My suspicion is that Cytori with all their VPs and senior VPs do not have a competent cardiac MD on the payroll. With Alex Milstein and Kai Pinkernell gone there does not seem to be competence for the main application. Since there is no VP clinical trials I presume this is Dr. Kesten responsibility- the most horrible first six months on the job for the guy surely- at least from an outsiders point of view.

I must say also that my perception is that Calhoun et al spend more time soothing angry or critical shareholders than doing the job they are paid for. That cannot be right.

second -cancelling ADVANCE and EU regulatory.
A lot of frustration came out apparently. However this should not be misinterpreted- its about conducting a clinical trial in the EU environment, where different MS (member states) apply different cGMP rules apparently. Tough, but known a long time- since 2007 to be precise. Has nothing to do with the regulatory process as such, which is VERY VERY favorable for Cytori. The therapeutic claims are all the evidence required.
I cannot withhold a sniping remark-

PRECISE started in 2007, was prematurely stopped and still has not been reported upon to the scientific community in a peer reviewed paper and published in some leading scientific journal as of mid 2013.
The wonderful paper from Naples is based on a trial started in 2010 completed relatively fast and in press as of today.


Catch my drift? Seijro Shirakama and his staff (20 fte´s) in Tokyo is doing a great job for Cytori and advancing everything- sales and regulatory.
I do not even know if there is anybody of stature in Zug - the head office of Cytori in th EU- cannot expect much if not driven from a "visible" organisation locally. Despite that the tech is adopted as evidenced by 23 clinical trials.
And like I said- at the place where 100 fte´s are working- they cannot get a patient enrolled two streets down. :evil: :bang: :bash:

I will have cooled down tomorrow and continue. :yep:
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Q2 2013 conference call 11 Aug 2013 12:56 #738

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Fas- I agree that they have been very slow in enrolling in additional test sites for the Athena 1 trial. I am not certain but would not be surprised that they have had to go back to the test sites and inform them of their intent to also run Athena II. This may have held back enrolment as sites waited for FDA approval and or changes. Certainly CYTX was aware of this change earlier but was not prepared to advise us as they knew that it would be received negatively. They prefer to allow the shit to hit the fan later than procatively advise us of Athena II ........... and appear yet once more to miss guidance.

As mentioned on the yahoo board ...... I believe that CYTX management correctly undertook the Athena 2 trial. The Precise trial was only 27 patients (randomised 2:1) and although it had very positive results there was no dose escalation so no definitive observations concerning dose optimization could be made. Also with regard to Athena 2 lets not forget that Mesoblast has done a dose ranging study from which it drew conclusions regarding optimal dosing .......... something that was not possible with the Precise trial.
I don't know whether Athena 2 was prompted from potential partner questions or not .......... it dosen't matter what the reason is, it provides answers to valid questions and we can no longer afford to cut corners.

If the two trials can be run concurrently in a expeditious and economic basis (and assuming successful data) this will provide invaluable confirmation of ADRC potency. Two small independently run multi-center trials run against placebo which provide positive statistically significant data will provide conclusive affirmation of efficacy. With Precise included three well run small trials with consistent statistically significant results are just as, if not more impressive than a large long running trial.

Lets hope they are quick in getting the data out so the market can finally start to evaluate the potential of ADRC........... and prospective partners finally realise that the asking price for participation is deserved. :winky:

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Q2 2013 conference call 11 Aug 2013 13:39 #739

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Yes John-

Possibly you are right- it does not matter all that much what prompted ATHENA II- after reading again, my guess is FDA and making sure.

My true thoughts I conveyed in an article which I wrote before watching the baseball game-


Global Healthcare and Cytori

I am still expecting something before the shareholders meeting. :grin:
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Q2 2013 conference call 11 Aug 2013 16:19 #740

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Fas...when you get a chance..check out my post #737 under topic, notes from housekeeper. Funny that because following the link to your second response on THIS thread everything is fine.

Back to the Q2 discussion...we all seem to agree that the communication stinks.
Again, there was talk of different dosing arms with ATHENA in the past...not done...now it is going to be done as a separate trial. Benefits of the additional data aside...this could have been done in the beginning and another communication mess avoided...let alone time and money.

As for news before the ASM...obviously they need cash for somewhere and soon with current estimates til the end of November. Interestingly, it seems they cut it real close with the deal getting the 5 million cash and still only lasting a few months more. I expect there is more PPS pressure short term.

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Q2 2013 conference call 12 Aug 2013 11:41 #745

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Just a note on the dosing discussion for ATHENA II, which as everybody noted was pretty chaotic, especially from Marc Hedrick´s side.

My knowledge is- cell therapy has a minimum threshold- that is- below a certain number of cells required for a therapeutic signal, the cells do virtually nothing. If you roughly know that threshold, the incremental benefit of more cells is pretty low. For PRECISE this was 20 Mio cells for the average patient or 0,25 Mio per kg of patient.

To my knowledge ATHENA was already upped to 30 Mio in the hope of improving the outcome. But than again- there is a lot of guessing here, since the in vivo mechanisms are still not very clear. Clear is that the cells play in concert with resident endogenous cells, which receptors are limited.

The only good reason to start upping again in dose is that scientists expect more from the stromal fraction i.e. the real stem cells in respect of differentiation. Here you have a lot of variability- 150.000 to 1.000.000 per gram of tissue in different patients, which makes the SistemicQC analysis tool very important in the clinic to predict and correlate to outcomes in patients..

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Q2 2013 conference call 12 Aug 2013 13:19 #746

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Nice ,article Fas, however, IMHO with management complete lack of credibility, how can you believe a word they say. Yhey say one thing and then take it back with an oops we made another mistake. time for another do over. The definition of insanity is doing the same thing over and over and expecting a different result. I expect no results from this mangement team and no matter how great the technology, unless there is a change at the top, the Company and shareholders are doomed. as mangement is rewarded for there inability to produce with options, I suspect that when they sell out we will be screwed again, while they walk away rich and float safely to the groud with there golden parachutes while the company crashes and burns. Just a sad and unacceptable state of affairs yet nothing is going to change. I again nominate Chris calhoun for worst CEO of the year.. Guess he will be getting some more options for that prize.

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Q2 2013 conference call 12 Aug 2013 13:41 #747

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So Fas, you are saying that maybe tweaking the "gimish" may have a improved efficacy ?

Again I ask, why now ?

What did they learn ?
Who?
Why ?
When ?

I dont believe they are shooting blind here with essentially a phase 2 trial. At least I hope not...but we are talking Cytori !!!
Is this from a interm look from Athena ?
Another unknown cardiac trial conducted privately ?

I agree Hedrick was a mess on the call trying to explain it.

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Q2 2013 conference call 12 Aug 2013 14:42 #748

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Roth-

You are wasting your breath to no avail. Rickey- the new BOD chairman is a friend of the Calhoun family. Friends to Marshall Cox- the father -in-law of Chris. At the inception of MacroPore it was really 2 CC board members and two Hedrick relation board members. The status quo is settled. There is more of a balance now in respect of independent members, but not really. Accept it- and NO- Cytori will NOT follow the path of your antibody invest.


Hedge-

No - they have not tweaked anything. I think the key here is that the traditional way of Pharma and FDA to have a dose escalation. Both are not very familiar with cell technology. Kolbert has been indoctrinated with the CYTX philosophy and acts like a jerk accordingly, but the FDA is also looking at say MSB treating the same type of patients with 20, 50 and 150 Mio doses, with different results.

Basically I think- more does not hurt- has some virtue maybe in some trans-differentiation and you are sure to use all the paracrine- cell-to-cell impact, whilst not hurting the patient with a bunch of basically useless cells.

My guess is- both ATHENA I and II will have a similar efficacy signal. :yawn:

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Q2 2013 conference call 12 Aug 2013 19:01 #749

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Thanks for the reply Fas....I obviously misunderstood what you were trying to convey.

If we are going to assume this dose escalation was basically for outside parties and perhaps maximize effect slightly...it is possible and perhaps plausable.
My problem remains is that is barely what was discussed.
Hedrick talked about lowering harvest size, finding lowest dose size, making sure pivitol passed (which implied lots of questions)
Later Calhoun talked about increasing harvest size.
The 2 top officers couldnt even keep their stories straight !!!!!!!!!!!!!!!!!!!!!!!!!

When they had the release advertising for Athena 1 canidates I suspected enrollment may have been slow but kept it to myself.

This mess seems suspicious as well but I will see how it plays out.

We desparately need a partner to take over trials/marketing. I sure hope you are right about news before ASM but I am very doubtful with time so short.

Oh, one last thought ...agree on Kolbert....called his evaluations BS from the start and $9.04 earnings for 2020 will be revised far lower !!!!!!!!!!!!!!!

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Q2 2013 conference call 14 Aug 2013 08:48 #763

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Comforting to know that on top of everything else nepotism ,florishes at Cytori. Well that certainly puts things in perspective, and I know I will sleep better knowing this. :bang: :bang:

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