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TOPIC: Kolbert on Khanna Meeting

Kolbert on Khanna Meeting 20 Jan 2015 07:35 #3219

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Last Wednesday Cytori had Dr. Khanna explain the STAR clinic to analysts and interested folks - this is the high level summary:
  • Last week at J.P. Morgan Healthcare Conference in San Francisco, Cytori held an analysts debriefing event featuring a prominent thought leader in the scleroderma space, Dinesh Khanna, M.D., M.S., Frederick G. Huetwell Professor, Associate Professor of Medicine, Director, Scleroderma Program, University of Michigan, med.umich.edu/scleroderma. Dr. Khanna helped us understand the underlying science and real-world treatment protocols used today to treat scleroderma patients. We left the meeting impressed with the science, the opportunity, and the strategic business plan now being developed at the company.
  • Recall that, last month, the FDA granted Cytori conditional approval for an investigational device exemption (IDE) for an ADRC pivotal study in scleroderma. The "STAR" trial will be a modest-sized, 80-patient, phase II/III pivotal trial based on phase I data (proof of concept) from an investigator-initiated trial in France that was published late this summer.
  • In the phase I SCLERADEC-I trial, the ADRCs were shown to be well tolerated, and patients had significant improvements in hand pain and mobility at six months post-ADRC injection. Improvements were significant (50%) across four validated key endpoints (Cochin Hand Function Scale, Visual Analogue Score for pain, Raynaud's Condition Score, and Scleroderma Health Assessment).
  • The Celution System is regulated as a class III medical device by the FDA. This, combined with an orphan indication, means that one modestly sized pivotal trial should be enough for approval in the US. In the following pages, we review the basis for Celution in scleroderma.


Details: Phase I study results. Twelve Scleroderma patients received autologous ADRCs by subcutaneous injection into each finger. Primary endpoints were safety and tolerability at two and four months, which were met, and no adverse events reported. Secondary endpoints showed sustained, statistically significant improvements for hand and disability pain, Raynaud’s phenomenon (discoloration of extremities and pain due to lost blood flow), and quality of life at two and six months. Key data points: hand disability was reduced, as measured by a decrease from baseline in the Cochin Hand Function Scale at both two months (47.4%) and six months (56.0%); hand pain was diminished, as measured in Visual Analog Score at both two months (37.8%) and six months (41.7%); Raynaud’s phenomenon was reduced, as measured by a decrease from baseline in the Raynaud’s Condition Score at both two months (53.7%) and six months (67.5%); and overall quality of life was improved, as measured by a decrease from baseline in the Scleroderma Health Assessment Questionnaire scores at both two months (45.2%) and six months (42.4%).
What is scleroderma? Scleroderma is an autoimmune disorder that causes skin fibrosis and destructive changes in blood vessels. Scleroderma is a systemic disease that affects the major organs, but most commonly causes changes in the skin and hands, often resulting in disability, diminished mobility, and pain. Care is largely palliative and is based on treatment standards for Raynaud’s phenomenon. There are 75,000 scleroderma patients in the US alone, and most have hand manifestations of the disease.
Valuation. We assume Cytori will be successful in scleroderma and multiple other indications utilizing ADRCs (thermal burns, stress urinary incontinence, and osteoarthritis). We apply a 25% risk cut to our therapeutic model and a 30% discount to financial models for FCFF, discounted-EPS, and SOP to arrive at our new $7.00 price target.

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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:

Kolbert on Khanna Meeting 20 Jan 2015 11:37 #3220

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These analyst have the same credibility as management in San Diego...LOL :evil: :cry:

With current PPS and market cap CYTX is "off limits" to about 98% of institutional investors other than the same hedge funds that have pushed us around for pennies.
North of a 700 million market cap in a year ??????????? Currently cash left for how long ???

How about Maxim just wants to beat Roth as the lead in the next raise this time !!!! :bang: :winky: :really:

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Kolbert on Khanna Meeting 20 Jan 2015 12:43 #3221

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Both analysts belong in the Adam Fuerstein hall of shame. The drivel they write should be illegal. This is why when one talks about doing your DD, you have to laugh, as this has been the only type of bullshit available about this company other then what has been written by Adam Fuerstein and as it turns out that scumbag was 100% on the mark.

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Kolbert on Khanna Meeting 20 Jan 2015 12:50 #3222

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These analyst have the same credibility as management in San Diego...LOL


hedge- I think this is pretty sad, but I am sure we all agree that he is right this time with his predictions on reaching market with the apps in question. :puke:

However, only a partner deal will save us from much more dilution beyond the horrifying finance deals we had since September.

But I do not trust Rickey and Hedrick for one cent and am bracing for the worst....whilst still adding a few shares here and there to cover my ass when they have acted in good faith and are successful in navigating through the mine fields... :evil: :bye:

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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:

Kolbert on Khanna Meeting 20 Jan 2015 14:39 #3224

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I believe they will do well with the scleroderma app.
Osteoarthritis...jury still out
Burns/wounds....certainly some portion of the market. I see chronic diabetic wound treatment as perfect market for Cytori but this is likely a non US indication for some time. Hard to heal burn wounds and areas with limited range of motion would seem to be the best fit...not counting the unthinkable of course.
You know my thoughts on what is public on SUI...so that is "show me"
Again...until the above takes off....is that really worth 700 million for this company given the history ? That is what I question !!! If it is then I guess I will be quite happy in a year. I'm taking the under though. Even with CXT2 sales. I do still hope someday our time comes.

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Kolbert on Khanna Meeting 28 Feb 2015 09:22 #3578

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I was just thinking of Adam Feuerstein. He usually comes out with a negative article on Cytori when his buddies are in trouble with their short positions. I haven't seen anything from him this time which either means his buddies have covered and made a killing or he can't figure out how to damage the stock price given all of the new credibility the FDA and COMP have given Cytori.

On another note, the odds must be high that Cytori has been tapping their ATM during this rally. They are operating full steam ahead with their trials and with very little money in the bank. They don't have to report using the ATM until the 1st quarter results are out or they chose to do so during the upcoming conference call. Also, it would not surprise me if there was a 13G filing early next week.

My biggest question is if the COMP opinion is the first step in receiving orphan designation, what steps follow and how long does that process take? The answer will provide a clear timeline to revenue growth and profitability and therefore stock valuation.

Funny that my first thought after reading the Star site expansion to 20 was: "that will delay the results and cost more although it does demonstrate a high interest level." The volume doesn't make sense to me. Anyway, looking forward to the conference call.
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