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Plus Therapeutics, Inc. (PSTV)

Q2 2015 Earnings Call· Sun, Aug 9, 2015

$5.83

-2.67%

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Transcript

Operator

Operator

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.

Marc Hedrick

Analyst

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…

Marc Hedrick

Analyst

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

Operator

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

Jason Kolbert

Analyst

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.

Marc Hedrick

Analyst

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.

Jason Kolbert

Analyst

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?

Marc Hedrick

Analyst

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…

Jason Kolbert

Analyst

Thank you, Marc. Appreciate the overview.

Marc Hedrick

Analyst

Thank you, Jason. Appreciate the question.

Operator

Operator

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

Steve Brozak

Analyst · 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.

Marc Hedrick

Analyst · WBB Securities.

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.

Steve Brozak

Analyst · WBB Securities.

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?

Marc Hedrick

Analyst · WBB Securities.

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.

Steve Brozak

Analyst · WBB Securities.

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.

Marc Hedrick

Analyst · WBB Securities.

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.

Steve Brozak

Analyst · WBB Securities.

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

Operator

Operator

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

Dan Trang

Analyst · 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.

Dan Trang

Analyst · Stonegate Capital Partners.

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

Operator

Operator

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

Marc Hedrick

Analyst

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.

Operator

Operator

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