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Plus Therapeutics, Inc. (PSTV)

Q2 2018 Earnings Call· Tue, Aug 14, 2018

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Second Quarter 2018 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

Good afternoon. Thank you, Ian. Welcome to our second quarter 2018 earnings call. My name is Marc Hedrick, President and CEO of Cytori. And joining me on today’s call is our CFO, Mr. Tiago Girão. On the call today, I will provide an update on the company’s oncology and cell therapy programs, then Tiago will update on financial performance. After which, I will update on forthcoming milestones. Then, we will have time for Q&A. To begin with, regarding our Cytori nanomedicine platform. Cytori is developing and manufacturing chemotherapy drug, ATI-0918, a generic pegylated liposomal doxorubicin hydrochloride to be bioequivalent to the European reference drug. We intend to position this as a high quality US made product with maximal clinical effectiveness. Our nanomedicine team in San Antonio, Texas continues to complete manufacturing and non-clinical related activities that will support a marketing authorization application or MAA to be filed with the EMA next year. Our goal is to be either the first or second generic on the market in Europe. The company also continues to engage and evaluate potential commercial partners for ATI-0918 in Europe, the Middle East, North Africa, North America and Asia Pacific regions. As mentioned before, the global market for this drug is estimated to be approximately $400 million to $750 million annually and in Europe, we estimated an annual market opportunity at approximately $120 million to $300 million. Furthermore, regarding Cytori’s ATI-1123 chemotherapy drug product candidate, this is a phase 2 ready albumin-stabilized and pegylated liposomal docetaxel. First the stabilization enhances the integration of the liposolic API docetaxel. It provides liposomal stability. The peg on the liposome surface extends blood circulation time while reducing mononuclear [indiscernible]. Regarding this drug, Cytori is continuing to develop it to address the shortcomings of docetaxel which has been a workhorse chemotherapeutic drug…

Marc Hedrick

Analyst

Thank you, Tiago. Let me just update on major forthcoming milestones and we’ll have a time for Q&A. First of all, our major goal is to complete the ATI-0918 development program and the manufacturing related obligations that are absolutely required to prepared and file for NAA with the European Medicines Agency. Number two, we tend to receive orphan drug designation feedback from the FDA and 505(b)(2) pathways feedback also from the FDA regarding our ATI-1123 product. We intend to continue to ramp size up and hopefully enroll patients soon in the Barda funded US RELIEF clinical trial. And then from a clinical perspective, in terms of reporting data, we plan to report three and six-month EU SCLERADEC II clinical trial data for scleroderma hand dysfunction and then also report six month and one year Japanese ADRESU clinical trial data for post-surgical male stress urinary incontinence. And with that, I will turn it over to you Ian and we’ll open up the floor for Q&A.

Operator

Operator

[Operator Instructions] And our first question is from the line of Jason Kolbert from H.C. Wainwright.

Jason Kolbert

Analyst

Congratulations on getting the rays done. Can you talk a little bit about the financing plans going forward and the emphasis around 9/18 and the BD activities, because while I'm glad to see that cash balance rise, I was hoping to see more cash on the balance sheet. Can you also talk just a little bit about what the pathway might look like to file and scleroderma in Europe and to file for SUI in Japan, so that we can understand kind of the magnitude of those opportunities as you work to kind of, elongate the cash one way into those two catalysts while looking at how to use 9/18 as a tool to elongate that runway as well?

Marc Hedrick

Analyst

We did supplement the balance sheet in the recent capital raise. As you mentioned, we were hoping to raise additional capital to provide enough run way to get the 0918 drug to approval which we didn’t do. So as Tiago mentioned, the plan is to use a variety of methodologies including business development to prolong the pathway. In addition, they’ve done a great job in trying to keep a lid on excess burn and staying focused on key programs that add value which we intend to do. So on the BD side and partnering side, as mentioned, there are a number of things that are ongoing, engaged with multiple parties. The challenge there is just predicting the timing, which is very difficult to do and to provide concrete guidance at this point, which we can’t, but we’ll continue to move the ball forward in all those different levers that Tiago mentioned with the hope that leveraging most of all those is definitely the opportunities, which we’re engaged with multiple parties. So regarding the second two questions, in terms of what’s it going to take and what’s your plan to seek potential approval for scleroderma and for SUI. Let’s take SUI first, because that’s, I think a more clear pathway. Regarding SUI, the plan is to try to expedite the readout on that trial. We’ve said that it will likely take data by early ‘19 and maybe an opportunity to get data in early 2018 which then, sorry late 2018, that now would allow us to go ahead and file for approval, which takes about a year, so about a year from data. We should be hearing back as to whether we have approval in another 6 months as to whether there is reimbursement. So that takes the process to launch with reimbursement to about 18 months. There may be some opportunities as I mentioned to expedite that, but we are already having those discussion with PMDA in Japan. As it relates to Scleroderma, it’s a little bit more of a merchant process. So our plan is to evaluate the data. It’s a smaller clinical trial. There is a clear path to provide these conditional approvals with the idea that you come back with additional clinical data later for full approval and then we’ll just have to, we’ll guide to that after we see that data and that will likely be, if the data is positive 2019 event.

Jason Kolbert

Analyst

And we’re really looking forward to seeing some good things happen in that remaining or part of this year.

Operator

Operator

[Operator Instructions] Our next question is from the line of Yale Jen from Laidlaw and Company.

Yale Jen

Analyst

My question is regarding 0918. As I recall that last -- during the last earning calls, you have talked about one of the competitors may extend their application in Europe, for their liposomal doxorubicin. So, where you see things are in that competitive space and I have another follow-up.

Marc Hedrick

Analyst

Yes. On the last call, I mentioned Taiwanese companies have had open submissions. That’s been opened for approximately well over a year and the EMA has been active on that. So as far as we know, that’s still active, but within the public disposition in that. We do think that there are other potential competitors in that market, although we don’t have any specific information about those other competitors, but we do anticipate other competitors in that market and I think from our perspective, the goal is to get that get the drug manufactured and on stability testing, so we can file next year and do that as soon as possible. It really is – it is much a timing issue as it is anything else. And so that is number one priority. So the goal again is to get that product made and with stability testing and filed from EMA approval, next year, with the goal being the first or second generic to market. But what we think is a market of approximately $120 million to $300 million.

Operator

Operator

At this time, I'm showing that there are no further questions over the phone lines. I'd like to turn it back to you Dr. Hedrick for any closing or additional remarks.

Marc Hedrick

Analyst

Just like to conclude by thanking everyone that participated either with questions or by listening on the call. Thank you of course to our employees and I wish you a good evening. Thank you.

Operator

Operator

Ladies and gentleman, thank you. This does conclude today's conference call. Please disconnect your lines at this time and have a wonderful day.