Plus Therapeutics, Inc. (PSTV) Q2 2015 Earnings Report, Transcript and Summary

Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Second Quarter 2015 Earnings Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be opened for your questions following the presentation. [Operator Instructions] Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Cytori's future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Cytori's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Cytori advises you to review these risk factors in considering such statements. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Cytori's President and Chief Executive Officer. Sir, you may begin.

Thank you, Riley, and good afternoon, everyone. Welcome to our second quarter 2015 conference call. As Riley said, my name is Marc Hedrick; I’m the President and CEO. And joining me today is our Chief Financial Officer, Tiago Girão. I would like to advise you that we had two press releases today. Both are posted on our website and after the call, a copy of this transcript can be found there. On today's call, I would like to update you on our lead clinical programs specifically for scleroderma and osteoarthritis and then go into some detail on the timelines related to both of those. Then Tiago is going to discuss our financials and then we’ll go to Q&A and then talk about milestones. So let’s jump right in and talk about our scleroderma program and focus first of all on the United States. So the Phase III pivotal trial called STAR is officially underway as of July and that’s when we received the green light to move ahead from FDA on some protocol changes and updates to the solution system. And that’s roughly on plan to start that as we originally announced in 2015. We anticipate that most of the 20 approved sites to be up and running and screening by October of 2015. We originally announced more conservative if you will timelines for enrolment of the 80 patients for that trial was anticipated to be approximately a year. But we’re hoping that positive experience that we’ve had with our osteoarthritis trial and some of the strong relationships that we’ve developed with patient advocacy groups over the past year or so could potentially compress that timeline to less than a year. But we’ll know more over the next quarter or two, how enrolments ultimately are rolling out. So recall in that trial that the primary endpoint is improvement in hand function at six months. But there are a number of other secondary endpoints as well. So assuming that the data is positive, then we plan to wait to submit to FDA upon full 12 months dataset, which is the current plan as it is, is this is an approval trial. So in terms of the big picture we anticipate at least today filing for PMA approval sometime in 2017. So regarding STAR specifically, as an organization our focus right now is on enrolment and getting the trial fully enrolled but we are anticipating a successful trial outcome and therefore in parallel we are actively formulating a U.S. go-to-market strategy for this as a rare disease indication. Now in terms of enrolment and generating a real buzz around this trial in the scleroderma communities, because we want to ensure that patients that need this therapy know about the trial we’re tactically planning on working closely with the scleroderma foundation to help support getting the message out in terms of e-mail blasts, and other notifications to patients that might be interested in the trial. That will really start in earnest after Labor Day. We also intend to leverage our world-class leading U.S. rheumatologist who have access not only to these foundations, but also the patient groups to help us get the word out on the trial as well. And then we’ll view some of the same standard promotional tools and activities that we use successfully and ACT-OA trial - specifics website, social media and other aspects to help drive enrolment. So we’re optimistic that the combination of these activities could help us on the upside to get this trial enrolled on or ahead of schedule. I can tell you just from my interactions over the last few months around the trial that it’s really heartening to see some of the excitement that we’re seeing not only for our technology in the rheumatology space, but also for this trial specifically. And I’ll just give you one brief example, last month Steven Kesten, our Chief Medical Officer, and myself attended Scleroderma Foundation Annual Meeting in Nashville, Tennessee. And while we are there for a couple of days, we spent time talking to patients. There were advocates that worked for the foundation and then doctors, many of whom are on our scientific advisory board that were there. And it was really validating to me to come away knowing that what we have learned from our SAB and from our market analysis that this hand complication of scleroderma really is the major source of disability in these patients and a primary clinical need for them. We really don’t see much in the pipeline for them. So it’s great to see that and that was very validating, and I can just say to investors that are interested in the disease or the therapeutic options available for these patients I would highly recommend the Scleroderma Foundation website and potentially attending this annual meeting, it’s full of great resources and information on the disease. So the longer term data from the pilot trial in Europe called SCLERADEC-I has recently been accepted and is impressed. And it should be out shortly. A few months ago, we released the top line data and showed that there is a long-term maintenance of the effect of ECCS-50 therapeutic out to about a year. The French team continues to follow those patients and they are now out to about two years and they continue to be impressed about the longevity of the response with a single treatment. In Europe, the SCLERADEC-II orphan phase III pivotal trial is moving ahead. Now there is a follow-on trial to this original SCLERADEC-I trial, and we have all the full approvals in Europe, and sites are screening patients and we’re on track for September trial initiation and likely the first patient will be dosed or treated of the planned 40 patient of this trial by October. And just as a reminder, there are four clinical sites in that trial all in France. The trial site in Marseille where the original work will be done, will be the lead site and then there will be a fifth site in the trial that will handle the therapeutic cryopreservation responsibility. And I think that’s a good opportunity to highlight a unique aspect of this trial in the placebo patients as part of the trial protocol can be crossed over at six months, these are the patients that didn’t receive therapeutic after unblinding, and they can be crossed over to cryopreserved version of the ECCS-50, if they opt for that. So that’s great for those patients that don’t get - they will get treated and get randomized placebo, but it’s also great for us, because it gives us valuable data on the preservation of cellular function in cryopreserved cells. It also helps us drive a model potentially for retreatment of patients using those cryopreserved cells and for us it’s really the first full on clinical validation of the cryopreservation protocols for clinical utilization. So really does a lot for us and we’re looking forward to getting that data above and beyond a specific clinical data for approval in Europe. So in parallel with this trial, just as we’re doing in the U.S. We are actively involved in launch and reimbursement planning in Europe. We are engaging with the EMA authorities and our consultants that are helping us with the launch planning as we prepare for an EMEA orphan drug application upon trial completion. So in terms of the interim activities there are some options for us, and we would like to expand on our early positive experience using prelaunch or named patient programs, which we've been testing out over the last few months. Named patient programs are permitted under EU Drug Legislation, but they’re governed by individual member’s states. We've treated three patients thus far as single country and although named patient programs are reimbursed for use of new technologies they do have some downsides in that they are used for only for specific named patients and they can have a significant administrative burden associated with them. That can take time to fill that out for individual patients. But we really at this point in our technology development where we are at late stage clinical trials, but we’re not formally approved are really in the sweet spot for moving that forward and that can be a source of revenue going forward in Europe and we intend to leverage that as much as we can. And then finally with respect to Europe, as I’ve mentioned previously, our global scleroderma strategy is to take this product direct in the U.S., but identify a suitable commercialization partner for the EU region. And as we announced last week, I’m pleased to have on board our new Head of Business Development and General Counsel, Jeremy Hayden. We recruited Jeremy from Volcano after the Royal Philips acquisition and he has actually started to fully engage in spearheading these efforts with respect to scleroderma. And also I’ll say he is working on our discussions around potential partnerships in osteoarthritis and orthopedics as well. So that’s my transition to osteoarthritis and discussing our program there. So during Q2 we announced that our U.S. Phase IIb pilot trial in osteoarthritis was fully enrolled and it was enrolled substantially ahead of our timeline. The reasons for the accelerated enrollment can largely be attributed to a couple of factors. First of all, there is really strong demand both from patients and from doctors for this therapy. Our sense is they really want something beyond the currently available therapies recommended by the American Academy of Orthopedic Surgeons. On the entry level treatment there is non-steroidal Celebrex, weight loss, physical therapy and so forth and then there really isn’t much from there to knee replacement. Something in that gap would really be attractive to patients and doctors based on our research. Secondly and very importantly the workflow just flood out was easy for the doctors. In some cases, the doctors were doing two cases a day and one case, they can do three cases a day. So that’s good validation at the work flow is implementable in orthopedic practices with this technology. So that was the good to see. And we’re hoping that some of these factors in terms of work flow and strong patient physician demand was spill over into other trials, but that remains to be same. Hope we can say thus for in terms of data for our ACT-OA trial, is that the procedure was well tolerated and that there was essentially no complications in the 94 patients that were treated. And based on the rapid enrollment, we have gone back to the drawing board and accelerated our timeline for a possible Phase III U.S. trial for osteoarthritis. Right now we’re anticipating a draft of the phase III trial plan very soon and we’ll be communicating on the phase III design with the FDA this fall. So my plan is that by the time that the data is ready for analysis in Q1 we’ll have a pretty good idea on what our final phase III trial design looks like. So the timing for our phase III to be as early mid 2016 and anticipated time to enroll should be about a year, but given our experience with the phase II, if we have enough sites and the trial protocol supports that it could be potentially less. Now the decision to proceed on the trial is really based on the couple of key things that should be obvious. First of all we need to have strong phase II data and then secondly, we need the availability of those resources and hopefully the partnership support but we’ll have other ways that we can potentially financially support that trials well. To give you a little bit of a rough estimate on what we’re thinking right now in terms of that trial looking at the distal elastic supplement trials that if gone through FDA approval. We’re estimating that given the reasonable power and scenarios of up to about 400 patient trial and a budget is in the neighborhood of about $20 million for that Phase III approval trial here in the U.S. For me let me talk a little bit about some of the forthcoming pipeline indication, so in terms of Urinary Incontinence, the ADRESU trial which is spelled ADRESU trial is a Phase III approval trial by cellular therapeutic for male Urinary Incontinence after prosthetic surgery of prosthetic intervention. It’s a unique therapeutic approach and that we put a cellular therapeutic into these center itself, which is not closing, but we also mix some of the cells with some of the patients own adipose tissue and put that into the submucosa or the lining where the scar exist to try to create function, so it has got of a two pronged approach in effect which is very unique. The trial is sponsored by Nagoya University, but it is supported though by the Japanese Ministry of Health, Labor and Welfare as well as Cytori. We now have all the full IRB and PNDA approvals and the trial is a four site open label control trials, controlled in sensitive patient is acting as their own control over time. It is a multi-center trial in 45 men again funded fully by the MHLW except for the fact that Cytori is supporting the trial on terms of equipment support and training. In the trial website was supported in our recent press release announcing the final approval and we are ready to go for that trial. The enrolment initiation on that trial has slipped a little bit from a forecast at Summer 2015 start, so likely is September 2015 start that is because of red tape issues within the approval process that were largely out of our control. So right now we are really optimistic that this could be a first approval in Japan and we’re optimistic for few reasons, first of all just the permissiveness of the environment over there from a regulatory perspective, they are the new Japanese Regenerative Medicine Laws, which we discussed previously, we think that helps us. The magnitude of the clinical improvement needs patient and the supporting data in some of the key secondary key points that we’ve seen also give us reason to be hopeful. Furthermore there has been a lot of substantial pre-negotiation with PNDA leading up to this trial though it has taken a lot of trial, kicked off and up and running that help system and finally it certainly helps that the MHLW is financially supporting this in a big way at a major national university. So it gives us optimism that this could break the ice in Japan. In terms of enrolment, the timeline and the timeline to approval and reimbursement it should be a reimbursement trial, approval trial. We will be in a better position to forecast our enrolment rate once we get some quarter or two under our belt, we will let you know, but I anticipate right now it is going to take over a year to enroll that trial. As we get up and running now, our plan would be to expand how we work with the institutions involved and leverage some of the things that we know about getting trials enrolled quickly and helps speed enrolment of that as much as possible. Now we will update you as that moves forward. So now let me move down our pipeline to our thermal and radiation injury program and right now we are in the preclinical phase in terms of our contract work with the U.S. government, it is a develop medical countermeasure against a nuclear - nation event here in the U.S. The current development work consist of three things, worked on the next generation solution technology, we call CTX2 we are also conducting further preclinical work and we are also conducting some clinical feasibility studies which have now begun as a lead end to help maximize the chance - our chances of having a successful Phase II clinical trial. And all of these are going on simultaneously, so upon successful completion, the mutually negotiated contractual milestone, it is our intention to file for FDA approval beginning U.S. feasibility trial for Burn therapy. The goal is to get a treatment as a medical countermeasure for patients that have been radiated and burnt, but the trial being conceived is a burn related trial and our best estimate right now is that trial will a 2016 event, but we’ll have to keep you posted as we move forward on the contract and on the timeline, but on the whole, I can tell you that the contract activities are going well and certainly the threat environment regarding therapy remains. So I think with that, I’ll take a break, and turn it over to Tiago to discuss in more detail our financials. Tiago. Tiago Girão: Thank you, Marc, and good afternoon, everyone. Our cost reduction initiatives implemented throughout 2014 and 2015 continue to deliver significant results. Our Q2 operating cash burn was above $4.8 million, which is materially consistent with Q1 and significantly reduced from $9.2 million in Q2 of last year. We continue to work on expense reductions, working capital management and operating efficiencies with focus on G&A and sales and marketing reductions, but as we completed enrolment in our ACT-OA trial well ahead of schedule and enrollment has begun on our phase III STAR trial we expect somewhat higher operating burn in the second half of 2015 when compared to the first half. That said we are decreasing our operating cash burn guidance by about $1 million to approximately $24 million for the full fiscal year 2015. With respect to operating expenses, research and development expenses excluding share-based compensation were $5.9 million in Q2, compared to $3.8 million in Q1 and $4.5 million in Q2 2014. The decrease in spend related to the prior quarter and prior year is primarily related to clinical trial related expenses, mostly attributed to the rapid ACT-OA clinical trial enrollment. Further, our Q2 R&D spend was approximately 67% of our total operating cash expenses, as compared to 56% in Q1 and 43% in Q2 2014. This big increase is in line with our plan to focus our investment into clinical activities. With our effort to turn our sales into profitability, we continue to manage down sales and marketing expenses, which excluding share based compensation were down to approximately $600,000 in Q2 compared to $800,000 in Q1 and $1.8 million Q2 of last year. We continue to expect positive margin contribution from our sales and marketing team in the near-term. G&A excluding share-based compensation was $2.3 million, which is consistent with Q1 and significantly reduced on $4.2 million in Q2 of 2014. We have experienced G&A expense decreases across the board with the main drivers being headcount reduction and decreases in professional services showing that our renegotiation of service contract efforts are paying off in a meaningful way. With respect to our revenues. In Q2, we recognized $3.5 million in product and contract revenues, compared to $2.3 million in the preceding quarter and $1.3 million in Q2 of 2014. Product revenues were $1.6 million during this quarter, compared to $935,000 in Q2 of last year. As discussed in our last call, Cytori and Lorem Vascular received Chinese FDA clearance for the solution system in April. And Lorem placed its opening order, which we partially fulfilled during Q2 with the balance of fulfillment expected to occur in the remainder of the year. I am confident that Lorem Vascular has been diligently involved in their implementation commercial plan. At this time, they are in active discussions with key hospitals in China, around building a user base in a number of indications leveraging publishing data with an emphasis in osteoarthritis, heart failure and aesthetic markets. The company is targeting first cases this fall and plans to capture patient registry for their portfolio of therapy options, allowing capture of objective clinical data to support [expanded] [ph] claims and market access adoption. They are an important partner of Cytori and we are excited about their progress. We are reaffirming our product revenue guidance of $5 million to $8 million for 2015. Contract revenues are driven by activities with BARDA, who continues to fund ongoing research and development activities required to enable a pilot trial in thermal burn. Contract revenues were $1.8 million during Q2 compared to $1.4 million in Q1 and $356,000 in Q2 of last year. We are reaffirming contract revenue guidance of $6 million to $8 million for the year. With respect to our balance sheet, at June 30 we had approximately 23.8 million of cash and outstanding debt principle of approximately $17.7 million. The reduced operating cash burn restructured debt and Olympus liability, and the proceeds from our Q2 financing activities significantly strengthened our balance sheet and based on current projections provided liquidity for over 12 months of operations without further capital infusion. Operationally we’re laser focused on the execution of our key clinical objectives with continued emphasis on phase III scleroderma and Phase IIb osteoarthritis U.S. trials With that, I’ll turn back to Marc for our forthcoming milestones.

Hi, Tiago. Thanks a lot. Appreciate that. I would like to finish up this afternoon by focusing on as Tiago said some key forthcoming milestones over the remainder of the year. First of all, in terms of publications and data releases. There are number of things in the queue over the next couple of quarters, I want to just remind you of. I’ve mentioned some of them before, but just hit those again. As I mentioned the long term follow up data from SCLERADEC-II is [is in press] [ph] and we [indiscernible] planned release but as mentioned previously the data looks good. The Athena interim six months data has been submitted to the American Heart Association meeting and we’re waiting for feedback on the acceptance of that abstract in theory that would be presented there. The Athena 12 month data, we’ve just obtained and that’s under evaluation and will keep you posted as to how we’re going to put that data out there and then we have some other burn publications that are pending as well. So a number of things coming forth for the publication and data release side. In terms of milestones related to trial, as we announced this morning we begun enrollment of U.S. STAR and there is a lot of data around the trial itself in that press release. We’ve also plan on forthcoming announcements on the EU SCLERADEC-II approval trial in Europe and the Japan ADRESU trial relatively soon and we’ll announce both of those. Also data from the U.S Phase IIb ACT Osteoarthritis trial, which was ahead of schedule means we’ll move forward the release of that data to likely a Q1 release in 2016. By mid-2016 as I mentioned, we should be ready for a phase III OA trial pinning the data and the funding and we’ll announce that once we decide to move forward with that and the burn trial as a Phase II could be 2016 event based on a number of factors what I’ve mentioned previously. Also I think where to point, where we can begin very cautiously but begin to discuss the timing of approval filings for the FDA, EMEA related to scleroderma. So completion of the enrolment and our two scleroderma approval trials by approximately mid-year, it looks like the European study may be - because its 40 patients might be a little bit of ahead of the U.S., but we should be ready to file both to EMEA and FDA thereafter so middle of next year. And so we are conservatively estimating one year review cycle in the U.S. and approximately a 1.5 to two year review cycle in Europe for those approvals, but as I mentioned we intend to move forward as rapidly as we can with the name patient program in the interim. So let’s move on to Q&A Riley if we could and then after Q&A turn it back to me and then I’ll close out.

[Operator Instructions] Thank you. Our first question is coming from Jason Kolbert with Maxim.

Comprehensive update, I’m sure we could spend a lot of time talking about all these programs, but can you just take a moment with me and start kind of at the end, which is what’s the timeline on BARDA, what are the next events and help me understand when you talk about a trial in 2016, what do you mean and how does that translate into a procurement contract so that Cytori will benefit? And I have a follow-up question where I wanted to just make sure I understand the business model around scleroderma and how you’re going to differentiate servicing and reimbursement particularly if you’re going to be potentially treating patients in Europe ahead of the U.S.? Thanks.

Hey Jason. Thank you so, let me - feel free to jump back in if you want me to clarify but in terms of BARDA, recall we have this $100 million contract framework and so forth; we completed a early preclinical proof-of-concept work and now we’re doing some cleanout preclinical work, some clinical feasibility work, which means we’re doing dry runs of the procedure in the burn room, or an operating room for a number of patients but not giving them back to [sales] [ph], just to prove the feasibility out and so forth. And then we’re also developing CTX-2 which will be faster, less expensive and we will be more efficient and robust in terms of getting [self to cell] [ph] dosage. So all those things are going on in the background. So once we have that data feasible, we have the timeline for CTX-2, the preclinical data we’re doing proves out then we’re in parallel [writing] [ph] the IDE and then we would take that data and then we would submit that to the FDA. So there are a lot of moving parts there which makes it a little bit difficult to calibrate exactly when that will be submitted, when FDA would approve it and then we will start enrolling. But to be clear that would be a Phase II trial not a pivotal trial. And then the question then becomes after that Phase II trial is complete what are the next steps and so there are a couple of different scenarios that we’re discussing with the Government one of which would be to go from that trial, if successful to a Phase III trial and that is built into our contract framework with BARDA and that would potentially be a path forward and then get full on approval for Burn. Another way to proceed would be to get the Phase II data which roughly corresponds with the timeframe that we could have approval in the U.S. for scleroderma and then with the U.S. FDA approval for - under the PMA framework for the device and coupled with the Phase II data that might be sufficient from BARDA’s perspective to drive a acquisition contract and use of the technology off-label in the instance of a national emergency. So part of the idea behind this is they would pre-deploy this technology around the country and then have special work instructions to use in the case of a natural disaster. So there might be some strategy there about just going to the Phase II, getting clinical trial approval and something else and then going to acquisitions so forth, so that could be really mutually beneficial for us. So I think right now it is a little premature to say what - how that will happen, we did have a number of options [indiscernible] for Phase III and then a potential government acquisition contract based on Phase II data.

That is perfect, actually it cleared things out for me quite a bit and just do me a favour and just opine with me a little bit on how you’re thinking the business model is going to develop along the lines for scleroderma and just confirm for me right now that you see scleroderma as kind of the leading driver for company and the leading focus, is that correct?

It is Jason. On some many levels, it is a great indication for us and so let me tell you why I’m saying that, so from a mechanism of action perspective what the things that are going off trajectory in scleroderma patients, the cellular therapeutic that we produce with our system seems to be perfectly tailored by accident for scleroderma patients. In terms of the ischemia, the fibrosis and the chronic inflammation. So it looks like a great match on a mechanistic perspective. Secondly, it is a tough disease, it is a rare population, but it is not that rare, and the thing that really bothers these patients most is their hands. There are lot of things in development for the pulmonary disease, which kills them, but their major source of disability is their hand and there are very few clinical trials related to developing something for the hand and that was confirmed recently at the meeting. So there is a nice unmet opportunity there, that if you contemplate premium pricing assumptions that are consistent with other drugs that are on the market such as Bosentan which is an endothelin 1 antagonist that’s just coming off patent by the way, but it’s used to provide new ulcer formation in scleroderma patients that’s $93,000 a year. So there are good analogs both in the scleroderma hand world and also in the rheumatoid world for premiumly priced therapeutics for this group of patients. So that kind of leads me now to commercial model and this is what’s really cool for us, and why this is such a great indication for us. I think the fact that we have European drug approval and it opens up not only fast track because it’s orphan, but it opens up a possibility of maybe coming out of the device based commercial model and go into more a drug based model. And here is how it might work; so we might not sell the device or the consumable, but we might have a clinical account specialist that would go right into the hospital where we’ve predeployed our device and consumable at really a very reasonable working capital investment, quite frankly. And then we would - they would take the tissue, they would give it to our technician and we would give them back the drug at the end of the procedure and then any extra drug that’s left over, therapeutic that’s left over, we take cryopreserve and then hold that for the patient to be thawed and then sent if they need subsequent treatment. So in Europe and the US for scleroderma, we see a model that maybe allows us to own the means of production and then effectively sell a service as well as a drug to the patient at the bedside and that’s given a number of patients in the U.S., that 40 or so major scleroderma sites in the US we think that model makes a lot of sense. And then finally just sort of as an appendix to that answer, it helps us with some of these other indications that we’re looking at, for example we announced that our licensee Kerastem/Bimini has received approval from the FDA for an Alopecia trial. The preliminary data looks good, but it would help us to differentiate a market like scleroderma where we think we can get premium pricing whereas Alopecia might have different pricing dynamics to our partner. So we think it really opens up a new avenue for us in terms of product differentiation and pricing differentiation.

Thank you, Marc. Appreciate the overview.

Thank you, Jason. Appreciate the question.

[Operator Instructions] Our next question comes from Steve Brozak with WBB Securities.

Hey, good afternoon gents. Looking at what you just said, Marc, as far as scleroderma being the lead, I’d like to follow that with a couple of questions about and specifically about what you’re seeing and monitoring the results. Have you and can you tell us, if you’ve seen any kind of differences, as far as between 6 months and a year on blood flow to the hand and any other kind of follow-up or visibility of granularity you can give us on that. And couple more on specifically on scleroderma.

Hi, Steve, thanks for the question. I could tell you on the whole that the 12-month data not only confirms the response that we’ve seen at 6 months but it helps. So take it now like this, it looks like that the value that was rendered to these patients at six months exist at 12 months. In some cases there is maybe a little bit of return to base line, in other cases there is continued improvement and it depends on what endpoint you look at. But I think the thing for me that it does and I think we’ll be able to talk about this more as it rolls out but it begins to really clarify the mechanism of action picture here. We know from preclinical work that we’ve done and some other groups that we work with and some groups that are completely independent for us, how these kinds of therapies plausibly would work in a variety of preclinical settings. Now we have enormous amount of robust clinical data over about a year for how it seems to be working in terms of clinical output and I can see some nice overlaps between what we’ve seen pre-clinically historically and what we’re seeing now clinically so I think it’s going to really help clear up the mechanism of action picture.

Well, actually that leads to the follow up given the fact that you can see that, given the fact that it is fairly small community, one of the enrolls giving you feedback in terms of what are they saying because obviously this is one where as you put it as an unmet need, what do you seeing as far as their expectations being match or the next what they’re looking for as far as how quickly they can get to the next step?

Yes, so from the patient perspective preliminary trial and again supplementary trial but we have videos, quotes specific feedback from all those patients, videos of how they’re using enhance and so forth so that the patients are excited. The physicians in France that continued to follow these patients now out to about two years. It looks like there is continued benefit from these patients out to that level that’s anecdotal, I don’t have any data to give amount but that actually makes us feel good and any affect on the physicians there is that the, they believe in the technology, believe that it works. Here in the U.S. where we really just have the 6 months data that talk about the top line 12 month data. I think there is a lot of interest in fact you look at our scientific advisory board and you got some leading rheumatologists that are populating that and in fact, that this is an unmet need shows that there is a lot of interest. I think it’s just going to, it’s going to be a process over the next six months and I can tell you we’re going to be very visible unaggressive in terms of getting the word out about the therapy both the patients and the physicians over the coming few quarters so that they know this is an emerging therapy for this group of patients.

Well that leads to me into the last question. Given the fact that you started to see this clinical result and the evidence and that you do have a good graph and understanding of the mechanism of action. And Cytori is always basically been a company that believes in working with collaborations and having external clinicians, what other areas do you think you’re going to see interest and have already seen interest in collaboration and in furthering the technology and I’ll hop off half the queue and jump back in.

We continued to get emendated is probably too stronger word, but we do get a number of reverse enquires regarding partnering with institutions for itself cell therapy trials not only orphan indications are more niche indications, but major indications that in the urologic field, renal, erectile dysfunction, aesthetic, breast, crohn's disease, wound healing, hepatic disease and we think that they are potentially role for the therapy in those. and I think one things that’s driving it in part is the kind of a emerging concusses from a regulatory perspective that just doing this in your backyard will not meet, but increasingly unified regulatory approach to cell therapy, the bar has been set high, we set it. And anybody else that wants to treat patient is really going to have to meet that far and I think that put us in a nice position to be able to help and support many of these trials but the flips side is we’re capital constrained and over the last year or two, we become incredibly focused on getting to market and we’ve got two trials, one in Europe and one in the U.S. that could get us approval and reimbursement relatively quickly. We have a new up and coming indication in Japan that could do the same for us there and then I think we consider we build of that in a strategic way to broaden our potential portfolio of indications not to say we aren’t doing some measure targeted collaborations with some of these but we’re doing that very carefully while we continue to focus on the things that will drive shareholder value.

Well great. Thank you for taking the questions and I look forward to the progress. Thank you again gentlemen. Tiago Girão: Hey thanks Steve.

Our next question comes from Dan Trang with Stonegate Capital Partners.

Hi guys, thanks for taking my question. Most of my questions have already been answered but one question that comes to my mind is how confident do you feel about your growth in China with LorraineH Vascular? Tiago Girão: I think right now we’re still really in the early days of testing that and then we are 8,000 miles away from what’s going on in the day-to-day basis. We have very frequent calls with them, I think we are very confident that they are fully 100% committed to succeeding in that market, they are making the kinds of investments and moves that one would hope to see from a committed partner. So that’s all good, it’s a big country, they’re focusing in on some key hospitals and they’re commercial - in some ways it’s a pre-commercial approach right now is to see key thought leading hospitals, hospitals that people know about China would immediately recognize. Get the technology in there. So there is not an economic burden to get in that and place it. Get them active with consumables and treating patients, and then based on that then leverage that out into next year hospitals and build a pricing framework that may we’ve largely built around self-pay, which is very possible over there given how their reimbursement system is organized to begin to drive utilization. So but they are well capitalized obviously, they are making the right hiring moves they are spending the time and we are working with them. So given their invitations we have about not being on the ground with them I think we are optimistic that they are doing the right things. But it will take a while and it’s, I think they’ve got some contractual commitments, they have to make and we’ll hold them to those, but at the end of the day. We think the technology works and it’s going to work, just as well here in the U.S. in our clinical trial. So it’s going to work there, I think 50 end of the day, that’s going to move the market.

Okay. All right. Thank you. Tiago Girão: Thanks, Dan. End of Q&A

There are no further questions at this time Dr. Hedrick, do you have any additional or closing remarks?

I do Riley. Thank you guys for the questions, we appreciate it and I would just like to conclude by thanking our team and employees here at Cytori, it’s been tough few quarters for them and I hope to your shareholders that their hard work and their focus is evident to you. And I would just like to publically acknowledge them for their efforts and from my perspective kind of looking what they have done in a very short period of time, has transformed the company from where it was or what it has been to a company that is now a late stage therapeutic company that has a number of active approval trials lined up in three regions around the world, and these are trials that are cost effective in other words more simple to capitalize that have a achievable end points, they address unmet needs and needs including those that have substantial market opportunities. In addition, our team has completed a phase IIb trial in a rapid fashion that represents yet another potentially forthcoming late stage clinical trial opportunity for us and at the same time working behind the scenes with U.S government in contractual framework, increased to support from the government from little under $5 million to a little over $22 million. So I can’t tell you how happy I’m with the progress that we've made there has been a lot of work and execution in terms of our team, but I’ll keep you updated as transparently as possible and once again to our shareholders thank you for your interest and support. Hang in there and have a good evening.

Thank you. This does conclude today’s conference call. Please disconnect your lines at this time and have a wonderful day.