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TOPIC: Q214 Call- careful Hedrick-like progress

Q214 Call- careful Hedrick-like progress 12 Aug 2014 04:18 #2011

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Introduction

The call held on August 11 2014 was progress in Cytori matters. No doubt about it. Surely many of us would have liked a lot more, but we have known Marc Hedrick now for twelve years too and know that he is extremely conservative (too much really- one needs of bit of Randal Mills and Gil van Bokkelen occasionally too) and therefore unlikely to sing the praise of Cytori technology under the background sound of the Harlem Gospel Singers and at the same time go over the (management) sins of the past and promising new intellectual spirit and business improvement at the same time.




There were a lot of small things that one could like- first hesitant steps so to speak., but not all too convincing. Especially the ATHENA issue from a timing and relational cause perspective could have been much stronger. CEO like and not MD like, leaving no doubt in the listeners mind about the forthcoming FDA response.

Anyway- I will simply make a tiny list of things I liked and what I disliked. That will come after the break, in my next post.
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Q214 Call- careful Hedrick-like progress 12 Aug 2014 05:26 #2012

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What was good

1. Key obviously was the explanation of Japanese forthcoming regenerative law. Basically the notion that Cytori will have NOTHING NADA to do with that based on first responses from the public exposure queries. That law will apply to iPS cell technology and cultured stuff. Autologous- non-cultured cells will be based on Japanese DEVICE legislation however WITHOUT the BURDENING (presently existing) stem cell guidelines, which severely hampered progress. Those barriers will be gone after November and clinics can start.

2. Having Ken Kleinhenz in the call was excellent. - the device regulations world wide should be better explained- he is the guy to do that and should be available in future calls.

3. The focus on the BS. Thereby saying that the goal is still to add therapeutic partner development funds be it from a commercial or governmental perspective. This is key priority setting.

4. Focussing on cost awareness and saving sounds good, but if you think about it, should be a no-brainer or "normal business behaviour" when cash is scarce.

5. The realization apparently that the Scleroderma feasibility study (also) has something to do with the ADRCs virtues in respect of auto-immune modulation. I bet this was hard for Hedrick to do and align with the rest of the scientific ADRC community.

6. Only personal- am glad Saad is gone. I did not trust a lot he said in personal conversations, so did not have a financial contact for 7 years. A former audit manager as new CFO is often very good and successful.

What I did not like

1. On Japan we have been told that WITH the Stem Cell Guidelines- 9 (nine) clinics and studies were ongoing in November 2013. As shareholders we have a right to know what they are and receive status reports on ALL of them, together on the indications which will be tackled after the elimination of the Guidelines in November.

2. No news on the Hamstring clinic. Do not get why this is being ignored.

3. Not mentioning the indication Hedrick wants to pursue in the US. Why the "secrecy???????" Does NOT align with openness at all and just adds to secrecy again. My bet- Osteoarthritis or something more auto-immune related. :grin:

4. A few more things, which I will not mention :cool:
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Q214 Call- careful Hedrick-like progress 12 Aug 2014 06:05 #2013

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There was a REAL big thing at the call that I despise tremendously, which is- allowing two analysts to voice their stupid questions to get information about revenue numbers behind the komma so to speak.

Total waste of time and totally irrelevant as long as Cytori is developing therapies- just has revenues as a side kick by selling to developers and is not purposely selling disposables to surgeons performing elective or reimbursed procedures on some reasonable scale. :bash: :bang: They should call the CFO after the call with their dumb questions. :bang:

Would love to hear smart guys though who care about the platform and its development .

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Q214 Call- careful Hedrick-like progress 12 Aug 2014 09:31 #2014

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As disappointing as the last several weeks have been, I at least came out of the call with more information than I can ever recall getting out of any of CC's transcribed messes. Even though Marc fumbled at times, he at least brought a different approach to the call and was bright enough to bring in Ken to go into detail around Japan.

Sounds like BARDA is in the bag - let's hope that the dollar figure brings upside, additionally the promise of seeing Cytori technology through trials on the government's checkbook. But, where does this put the pps when announced? It certainly should be higher than $1.65!

I like the focus and streamlining operations to align with a core business strategy. Opposed to the days of going after everything that had the look of promise, and then failed miserably - and then leaving shareholders guessing on what in the world was transpiring.

The capital raise is a dark cloud that will never go away unless something miraculous comes about. I shouldn't say miraculous, but at this point in time we've heard so many broken promises, so perhaps we should give Hedrick a fair shake now that he's in charge. If it's shareholder friendly (as he indicates that's his preference), perhaps he has something up his sleeve.

Goodbye Mark Saad - good luck in your new gig. I don't know him personally, but am okay with replacing elements of the old regime. We know where that had gotten us over the past several years. :KO:

Since sales are so paltry, what is Clyde Shores up to? Just curious. I'm not so sure it makes sense to pay an individual this salary (package) when revenues are so small, unless he's the only salesperson in the field. But, what do i know? Staying positive and assuming he just was brought on a little too early? :yep: investing.businessweek.com/research/stocks/people/person.asp?personId=9639861&ticker=CYTX
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Q214 Call- careful Hedrick-like progress 12 Aug 2014 13:22 #2015

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Not understanding what Clyde Shores has accomplished that warrants this compensation . Anyone ?

Annual Compensation*
Salary 329,469
Total Annual Compensation 329,469
Stock Options*
All Other Compensation 35,000
Exercisable Options 144,994
Unexercisable Options 169,606
Total Number of Options 314,600
Total Compensation*
Total Annual Cash Compensation 389,706
Total Short Term Compensation 3299,469
Other Long Term Compensation 35,000
Total Calculated Compensation 643,816

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Q214 Call- careful Hedrick-like progress 14 Aug 2014 08:26 #2016

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Michael-

Apparently a lot of folks have the same issue.

Basically David Oxley takes care of emerging markets- I guess everything except US, Europe and Japan i.e. the major medical markets. He is now also General Manager of Cytori China, which smells like an entity to be founded there.

Thereto Seijiro Shirahama runs Japan and the only stuff sold really were Puregraft and similar stuff, which is now gone. Only thing is- if you get commercial partners, you require a commercial expert to "deal" with them.

Anyway- had my other eye done yesterday- very smooth and I am living in a different world now- not bad at all. :woohoo:
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Q214 Call- careful Hedrick-like progress 16 Aug 2014 16:25 #2024

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Fas,

I had the opportunity to speak with Hedrick a few days after the Athena news and before the earnings call. I asked him about the hamstring trial and was surprised to learn they have not treated anyone and they may not follow through. Hedrick was very clear that he wanted to expand the number of indications in the pipeline and concentrate on the ones with the shortest path to reimbursement.

My guess on a new US clinical would be related to either Scleroderma or ACL repair. Hedrick stated in the call that he wanted to have regulatory approval, a clear clinical plan and funding before discussing any new indications.

One point worth making is the $32.6 million number that was stated in the original Barda announcement for option #1. Everyone has already forgotten the words "up to" $32.6 million. My point is the larger the number, the higher the cost for a phase II FDA approved US based trial on thermal burns. If the FDA is kind to Cytori, the number of patients required will be less and the cost of the trial will be less and take less time. Everyone is hoping for a large number perhaps because of the 7.5% profit margin (excess reimbursement over true costs). I am hoping the FDA will conclude from the results of the proof of concept stage that safety and efficacy can be determined with a much smaller number of human patients. Hedrick was willing to say there is a great deal of excitement from all parties within the government about this contract. This comes from knowing how well the pigs healed. My read is that $10 million is better than $32 million because we need speed to approval and reimbursement.

I have been pushing Hedrick for some opinion if the FDA could fast track the Barda thermal burn trial if results are very strong along the way. If there is a significant difference in the way treated patients heal versus untreated patients, at what point does it become inhumane for the FDA to deny treatment to a human being with 3rd degree burns? Hedrick said the FDA doesn't view trials that way and they would not fast track the therapy. :bash:

The thermal burn trial will be conducted at burn wards around the country. Unlike the Athena trial where there is a very narrow criteria to be accepted into the trial, all patients with 3rd degree burns in the burn ward qualify. The trial should, in theory, move very quickly. Problem is "quickly" is not a word familiar to the government or Cytori, at least thus far. The details will be out soon, but this is all I have been able to get from discussions.

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Q214 Call- careful Hedrick-like progress 16 Aug 2014 17:32 #2025

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With burns...there are effective treatments...thus no unmet need...thus no fast track.

Scleroderma would seem a logical clinical in November and could even qualify for fast track.

DOV..those BARDA comments are interesting for a faster completion....but what of the pricing of "additional work" ? That is supposed to be the reason for the slow up in the decision.

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Q214 Call- careful Hedrick-like progress 16 Aug 2014 17:37 #2026

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Just to follow up a bit...a even more exciting clinical in November would be a expanded wound healing application given the impression the healing of the burn/radiation wounds of the trial pigs had on the government entities.

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Q214 Call- careful Hedrick-like progress 17 Aug 2014 05:12 #2027

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Thanks Lewis,

Hedrick stated in the call that he wanted to have regulatory approval, a clear clinical plan and funding before discussing any new indications.


Those are a lot of "wishes" or "demands" from somebody who has been President of Cytori for 12 years and has been (also) responsible for the management of those past 12 years.

Most translational work is/has been done in Europe of course- about 35 studies. I presume the "regulatory approval" would come from there- that is what CC also used to say - "leverage CE mark/EU approvals towards straight pivotal studies in the US - the fastest route to the US market". If the funding should be there- than a partner should be there with deep pockets- and Cytori and that partner should have clear deliverables and a pathway from the FDA to tackle that.

Yes- scleroderma as an orphan disease would be a good candidate. The fact that we know -NADA- about the other 30 plus studies is plainly sad and another example of the inadequacy of the information flow to shareholders in the past.

That information flow -I feel- has not improved to a satisfactory level since Hedrick took over. I personally feel he needs to step up here in a dramatic fashion.
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Q214 Call- careful Hedrick-like progress 17 Aug 2014 08:34 #2029

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Hedge, I have no idea what the additional work with Barda is all about. Hoping for the best.

I just reviewed my post and noticed that the $32.6 million that I wrote only came through as $.6 million. Strange, but I think everyone gets my point.

Regarding the FDA, if the cell treated burn victims heal must better and faster than the "standard of care" treated patients, I would like to think the FDA would use sound judgement and blow the whistle and end the game. Maybe 60 Minutes could help with that.

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Q214 Call- careful Hedrick-like progress 17 Aug 2014 08:40 #2030

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This board has its ways with numbers. test test

Never could figure this out very well: $ 60.6Mio $60.6Mio $ 60.6 Mio $60,6 Mio

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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:

Q214 Call- careful Hedrick-like progress 17 Aug 2014 08:43 #2031

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So- by this test- the BB code works with a "$" sign - that means- it takes a written $ as code instead of Dollar sign and swallows itself (the $ sign) and the next number until it meets a "dot"

So if you have numbers in your post- simply add a "space" or "blank" after the $ sign :


Compare .999.999.99 to $ 1.999.999.99
0.50 to $ 500.50

the difference in writing solely being the : space between $ sign and number.

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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:

Q214 Call- careful Hedrick-like progress 17 Aug 2014 10:29 #2033

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Q214 Call- careful Hedrick-like progress 17 Aug 2014 10:40 #2034

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FDA pulled the rug from under CYTX many times / that shit is about to end. BARDA fixed that and now we don't have FDA intentionally subverting the company....,,because they CANT get away with it. Too much sunlight...., they'll get cash , it could be painful .... Question is to what degree.

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Q214 Call- careful Hedrick-like progress 18 Aug 2014 12:56 #2035

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Fas, below is a further review/analysis on the scleroderma trial.

www.medscape.com/viewarticle/830058

'' In addition to improvements in the Raynaud's Condition Score and Cochin Hand Function Scale score, patients reported a significant improvement in their general health status by month 2, according to the Scleroderma Health Assessment Questionnaire (P = .001), which was sustained throughout the 6-month follow-up period.''

"Women who were previously unable to apply make-up or cut their children¹s food for them, or [were] otherwise unable to do simple tasks of daily life, report that they are now able to do these tasks with ease," and "[t]he study carefully quantified these changes and others with validated clinical tools and demonstrated statistical and clinical significance in a number of parameters," Dr. Daumas said.

I guess that in the past CYTX has proven that there are no low hanging fruit ......... but if I had to choose, this is the one I would go with.

General health is a bit vague for most normally healthy people but for those who are suffering from an autoimmune disease ......... perhaps not. :winky: In any case, this is an indication that should be able to provide a quick data turnaround, subject to enrolment constraints. The question is would the existing trial results be sufficient for the FDA to allow CYTX to go straight into a pivotal trial? Do we have CE mark for scleroderma? I think not?

Given the orphan status of this indication, the autologous nature of the treatment and that it does not involve systemic injection into a vital organ one would hope (foolishly?) that the FDA would allow a pivotal given the hereto excellent safety profile of the trial data to date.

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Q214 Call- careful Hedrick-like progress 18 Aug 2014 14:25 #2036

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Do we have CE mark for scleroderma? I think not?


Thanks for the comments John. No- we do not have such CE mark for the specific application, but to be perfectly honest- I think Cytori would not even mention an additional claim on Celution on a application, which they have not "publicized" to date. I think its all a big mess.

But - coming to think of it- Hedrick probably would have meant FDA approval to start a study and not regulatory approval elsewhere in the world. :whistle:

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