Earnings Labs

Alaunos Therapeutics, Inc. (TCRT)

Q1 2017 Earnings Call· Mon, May 1, 2017

$2.54

-5.93%

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the ZIOPHARM First Quarter 2017 Earnings Conference Call. All this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the conference over to Amy Trevvett, Vice President of Corporate Communications and Investor Relations. You may begin.

Amy Trevvett

Analyst

Thank you very much, and thank you all for joining us today for ZIOPHARM's first quarter 2017 earnings conference call. Leading today's call will be Dr. Laurence Cooper, Chief Executive Officer. Also joining us on the call for the question and answer session is Dr. Francois Lebel, Chief Medical Officer; and Caesar Belbel, Executive Vice President, Chief Operating Officer, Chief Legal Officer and Secretary. Before we begin, as outlined on Slide 2, let me remind you that during today's conference call we'll be making forward-looking statements that represent the company's intentions, expectations or beliefs concerning future events. These forward-looking statements are qualified by important factors set forth in today's press release and the company's filing with the SEC, which could cause actual results to differ materially from those in such forward-looking statements. Information discussed on today's call is accurate as of today May 1, 2017 only. With that, I’d like to turn the call over to Dr. Laurence Cooper.

Laurence Cooper

Analyst

Thank you very much, Amy. Welcome everybody to our quarterly call. Slide 2, as Amy explained is our forward-looking statements and of course there is more details on ZIOPHARM's website if you are interested. Slide 3, so I would have said a few minutes review on this call talking about how ZIOPHARM has engineered for success indeed our competitive edge in cell-based therapy. So let's take a moment now on Slide 4 and look at the totality of technologies that needs to be embraced if wants to be successful in the CAR-T and indeed in the TCR, in other words, the space for the genetic engineering of therapeutic T-cells. But the first on the upper left, how does one manage cost? When seeing number in the late press, where these large numbers are associated with the cost of goods of generating generically modest by T-cells. The company that understands how to manage those costs will essentially trump the headwinds of payers and of hospitals that are having to negotiate essentially how to deliver on the expectation of patients. We at ZIOPHARM have made major headwinds in essentially managing the costs of the therapies I’ll share with you. On the upper right, you see the control after infusion. In other words, how is it that investigators and patients alike can control their T-cells after they’ve been infused? For instance, if T-cell is given to a patient with a lot of malignant T-cells, these T-cells are of course expressing CD-19, then those infused T-cells are synchronically activated and it becomes like a runaway engine. Those T-cells then takeoff, proliferate in an uncontrolled fashion. And while there has been dramatic anti-tumor sponsors including in our own work, those patients are at risk for toxicity. For instance, cytokine release syndrome. And we’ve seen some…

Operator

Operator

[Operator Instructions] And our first question comes from Keith Markey from Griffin Securities. Your line is now open.

Keith Markey

Analyst

Thank you very much for taking my question. I was just wandering if there would be a simple way of describing the difference between what you call a point-of-care therapy and a cell that has been modified to express Membrane-Bound IL-15 and either a CAR or TCR receptor?

Laurence Cooper

Analyst

Sure, Keith, thank you so much. So the point-of-care technology builds on the IL-15 data. So another word, point-of-care harnesses the IL-15 biology because what IL-15 does, it is provide a growth signal for T-Cells. So that when you have IL-15 present, in other words when its balance of the membrane, those T-cells have a growth advantage or proliferator advantage over their neighbors that done express IL-15. So, this allows one under the point-of-care platform to take those T-cells that express IL-15 and say for instance CAR or TCR and put them immediately into the patient and grow the T-cells through IL-15 biology in the patient and that's the major advance compared to for instance growing the T-cells in bioreactors and then putting them into patients.

Keith Markey

Analyst

Thank you. And so would it be reasonable to consider the program that you are going to be initiating in the clinic next year with Merck KGaA as a point of care therapy?

Laurence Cooper

Analyst

Sure, that's a great question. So, we haven’t actually reviled that level of details but I would remind you and the audience that they are really behind our technology with respect to the CBD system and the Membrane-Bound IL-15 as the control of the Membrane-Bound IL-15 under the RTS.

Keith Markey

Analyst

Okay. Thank you.

Operator

Operator

Thank you. And our next question comes from Reni Benjamin from Raymond James. Your line is now open.

Reni Benjamin

Analyst

Thanks for taking the questions and congratulations on the progress. Maybe just to start off, can you give us a little bit more color on the interactions that you had with the FDA which is recently announced and I guess what would you need to decide between historical single arm study versus a randomize study and can you brake it maybe a how large either those two studies might be?

Laurence Cooper

Analyst

Sure, so that's a great question. Thank you. So, our meetings with the regulators in America with FDA have now gone on and we have meetings in Europe with major regulators over there. As we essentially look at the totality of feedbacks that the regulators are getting us, we’ll have more to say about the protocol design and so we have to hold it there basically as we go through essentially that dialog.

Reni Benjamin

Analyst

Okay. And then just regarding the cash position in the exploration of partnership opportunities, have you started talking with partners, what’s the ideal partner sort of look like, is it one you might focus on ex-U.S. versus maybe worldwide. How should will you thinking about that?

Laurence Cooper

Analyst

Yes, so, we're open to whole of the above are enticing. Folks are now seeing the survival data and are recognizing especially in the background of the desperate need of these patients, so this could be a major advance. So we are in active discussions and we will have more to say as this solidifies.

Reni Benjamin

Analyst

Okay. And then just I guess one final one. What kind of trends - when we did the comparing contrast on the slides, clearly you talk about how much better the plasmid is over the viral but what kind of introduction efficiency do you see, because that would seem to be a importance. Right? And then also what is the half life of the Membrane-Bound IL-15 on the cell and how long does that stay even after you’ve get a cold shut off the switch?

Laurence Cooper

Analyst

Yes, sure. So in terms of the last part of the question first. The regulation and the up and down on and off the membrane of IL-15, we haven’t gone into those details yet but I had more to say is that biology start to transition to the clinical, so that stayed tuned if you would. If the transaction efficiency also I think is an important point. So I thank you for that. So, the non-viral system is able to stably introduce a gene whether of the Ad or the RTS expressing IL-15 or whether be a CAR that TCR. And once that cassette is hard wired into T-cells, it doesn’t matter whether that cassette came from a virus or came from a non-viral DNA plasmic. The T-cell than have to the bidding, if you would have to cassette. So the non-viral approach the great advantage of non-viral approach is that is able to insert these genes and particular able to insert the RTS system. So even if we have small starting numbers, I think we shows this - even we have small starting numbers, these T-cells then proliferate in the patient. And I think this is the real key now, because you are seeing us and you are seeing others recognize, so you don’t have to give large number of T-cells and we really want to challenge that further and say, what is essentially the fewest numbers of T-cells we can give, so we can use veledimex to drive the expansion in the patient.

Reni Benjamin

Analyst

Perfect, thank you very much and good luck going forward.

Operator

Operator

Thank you. And our next question comes from Tony Butler from Guggenheim Securities. Your line is now open.

Tony Butler

Analyst

Thanks very much, Laurence two questions really. One is, with the amount of capital currently available and the notion of moving forward in the pivotal trial for GBM. Can you give us a flavor for how sites might think about the notion that will you actually be able to complete the trials with the current capital that is where they want to engage despite the fact there maybe some financial risks, they would have to in gender, that’s question one. I want to actually ask question two if I may, based on the last question, which I think you answer very adorably. If you have RTG and its - let’s say the efficiency is not great, but yet those cells can proliferate. Aren’t you going have variability by patient, because what you really do need is maybe some sort of critical math or so, having RTS in them something around tend to be a. How can you ensure those patients have that if you will that number of cells are enough replication has occurred and if I get one other - I am sorry - but it's really around Merck KGaA. Clearly a good partnership, I might have thought or I wondered, if in fact some of the discussions you had with them already did include the adenovirus cell 12 veledimex program and so if you like to speak about that. Thanks.

Laurence Cooper

Analyst

So thank you that. So in terms of the cash and the starting of the pivotal trial. So we’ve had no problem identifying patients per sites, but indeed we have a waiting list for our program. For instance, as we transition to a Phase 3 company, it’s hard for us to manage fill the Phase 1 trial because we have so much interest in it. So that really has not been a concern. Your second question around the efficiency being transferred really is really good. But it makes an assumption that the efficiency of Sleeping Beauty is limiting and is not because the simple fact is, if you can take a look at recent product an electroporation, the insprints and if you wanted to, you don’t have to, but if you wanted to you can just take the entire look of insprints products and electroporation. And then you have plenty of cells. But the great beauty if you would Sleeping Beauty, is that you don't have to do this. By the engineering of the switch controlling IL-15 with the CAR you can start from relatively small number, it's not a big threat if you would on the manufacturing facility to do this. And then the last question, just remind me again, I'm sorry I just - on that? The Merck question, so I getting it at last, thank you. So the question around Merck and their interest in adenovirus and IL-12, I would just say that's just probably it's a conversations between us and I don't want to really go forward at this point.

Operator

Operator

[Operator Instructions] And our next question comes from Whitney Ijem from JP Morgan. Your line is now open.

Whitney Ijem

Analyst

A lot of my questions has been asked, so I'm going to ask a very forward-looking one. But as we look toward the point-of-care program, how do you guys think about it, or would could that look like from a GMP, kind of regulatory perspective and commercial perspective? What does that look like?

Laurence Cooper

Analyst

Sure, thanks Whitney. Obviously from a commercial side, you can see the major advantages. The simplicity of being able to generate the T-cells immediately infused into the patient. That technology we're managing very well in terms of our regulatory approach. And you see me do this now by having these generations if you would T-cells. The first generation was to firmly establish Sleeping Beauty system work, until I conceptualize this is never been done in humans before and now it has. The second part of this system is the second generation which is how does one shorten the manufacturing time and rolls in into that Whitney is a lot of the regulatory ideas I have will then smooth the transition from that second generation to the third generation. So in another words, we're working with the regulators now on the path forward, and we're not delivering point-of-care to them and saying here, look, swallow this whole idea, we're passing this slowly with them to make sure the patients are safe, to make sure the technologies are feasible, and then with the expectation this could will be essentially accepted. The other part of your question is as we kind of think forward in terms of how this disrupts the feels, I think you know is also equally we're managing carefully. We are given over to the idea and this is why we haven't built out large GMP facilities. We're given over to the idea these are just simply don't need them. And the costs that are encumbered by having large programs associated with GMP facilities that do viral transactions and large bioreactor facilities is just not scalable and it's just simply speaking, it’s just not going to be affordable. So we have to do better and I think this is a legitimate way forward about how we can improve on that science.

Whitney Ijem

Analyst

Got it. Thanks for taking the question.

Operator

Operator

Thank you. And our next question comes from Jim Birchenough from Wells Fargo. Your line is now open.

Unidentified Analyst

Analyst

Hi, good afternoon. It’s Nick in for Jim, thanks for taking our questions. Lawrence, just firstly, obviously I know you don't want to go into any detail about potential pivotal trial designs for adenovirus. But can you comment on where you are in terms of manufacturing and do you have a commercial supply is when you start pivotal trial will be using commercial material and I have a follow up, thanks.

Laurence Cooper

Analyst

Sure, that's a great question Nick, so thank you. So at the moment this is completely on our radar screen and in our real house but we are not disclosing what the exact tactics are right now.

Unidentified Analyst

Analyst

Okay. And then my follow-up is, going back to the point-of-care, and obviously the one of the goals of CD-19 CAR-T manufacturing campaign because is self-sterilizing. And so when you get to this point of discussing, what is the potential for transuding - tumor cells that haven't to get caught any for instance for any leukemic blood that happened - you pen. How do you get over that barrier in such a quick turnaround?

Laurence Cooper

Analyst

Sure. So couple of things, one is that the, where patients have tumors in other words, say if I have CD-19 positive malignancy, the return of that tumor cell to them is not where the patients start it. Right? So in other words, I haven’t changed the bulk in that tumor as a result of aphereising them. The second part of that is, we also had developed kill switches , so if there is a problem associated with the return of leukemia that maybe a little bit more grafter or so called and so on, we will able to handle that with our kill switch biology.

Operator

Operator

I’m showing no further questions at this moment. I’d like to turn the call back to Dr. Laurence Cooper for any further remarks.

Laurence Cooper

Analyst

Thank you very much, operator and thank you very much listeners. I wish you a good day.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect: Everyone have a great day.