Earnings Labs

Alaunos Therapeutics, Inc. (TCRT)

Q2 2017 Earnings Call· Mon, Jul 31, 2017

$2.54

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the ZIOPHARM's Second Quarter 2017 Earnings Call. All this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] I would now like to turn the conference over to our host for today, Dr. Laurence Cooper, Chief Executive Officer. You may begin.

Laurence Cooper

Analyst

Thank you very much, operator, and good afternoon everybody from ZIOPHARM's. Today with me in the conference room is Caesar Belbel, our Chief Operating Officer and Dr. Francois Lebel, our Chief Medical Officer. We'll begin as usual with our forward-looking statements. I will not read this toto, but please refer to the ZIOPHARM website if you should have any additional questions or need information. So Slide 3, this is titled what has ZIOPHARM accomplished to succeed? This is the slide that really differentiates ZIOPHARM from others in our space and we have four technologies which we are reducing the practice that clearly mark us as different and special from others. In the upper left hand side is our approach to gene therapy and this is based on the non-viral transfer of DNA plasmid that are coated from what's called the Sleeping Beauty System and this is an ability therefore for ZIOPHARM to insert genetic information into cells such as T-cells and to render them capable of targeting cancer cells for instance CD19 on B-cell malignancies. And as the yellow text in the box says, we had already achieved success in clinical trials. So we've checked that box if you would. On the right hand side is the switch system that we're using to control gene therapy products act as they've been administered. Many of our competitors deliver cells or agents to the body and then hope for success. With this type of switch system, we can guide for success using a drug or veledimix or small molecule called veledimix. And this accesses the components of a switch system called the RheoSwitch system. Also in yellow is that we've achieved success in clinical trials. So again, we've checked the box there. In the bottom left hand side, is the type of…

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from Reni Benjamin of Raymond James. Your line is now open.

Reni Benjamin

Analyst

Hey, good afternoon, and thanks Laurence for the update and congrats on all the progress. Maybe just a couple of questions, one we had quite an eventful month, this month with Novartis panel. Do you have any takeaways that you can provide from the panel, any learning’s that you might be applying to your programs and in particular I guess differentiations in terms of manufacturing and the use of non-retroviral systems versus the FDA focused on?

Laurence Cooper

Analyst

Sure. So Reni I think the, yes I mean several to be honest, the first is the sort of sharing from Novartis about the heterogeneity of that product. I think this was a moment that the FDA will have to contemplate. Clearly the clinicians in the room wanted the technology advanced and also as a pediatric oncologist, I’ve taken care of patients with refractory ALL, I'm delighted that there are options like this available. But it is one thing to excitement around the clinical efficacy, but there is another set of concerns or at least to say headwind that one has to contemplate with respect to the heterogeneity of the product. The time it takes to make the product if I remember is 22 days, that’s a long time for a child to wait with ALL. You know there was also concern about the integration, pattern of integrations from the lentivirus system. All of these can be addressed with the non-viral system. If you can get the manufacture down to under two days, the heterogeneity is no longer part of the process. It's ascribed to the patient. If you can get the – if you can use Sleeping Beauty versus lentivirus, the pattern of integrations is much different and in fact we published that in the JCI Paper, it’s truly a random integration pattern which is different from using a virus. And if you can rapidly manufacture T-cells, then that child or that patient can receive the T-cells before their disease gets out of hand. So this looks like a lot there to be honest to kind of dive into and I think it's important that the FDA ruled favorably, but I think as in many technologies that’s the first chapter, it’s the first era if you would and I’m interested in moving on to what is I think a safe ground where there really is a commercialization anchor to the types of thing we're doing and because the elephant in the room is the cost and that's really where we're going to make progress.

Reni Benjamin

Analyst

So that’s a perfect answer to my follow up, which is when does the POC kind of hit primetime and what are the potential hurdles? So for example, training somebody at the site of – at the point of care what’s involved there, the variability of transaction outside of your hands and into these other institutions and anything else we may not be thinking about?

Laurence Cooper

Analyst

Sure yes. So those are excellent questions and it's really the reason why ZIOPHARM has gone through these generations of technologies. I thought of point of care when I was first talking to the Board about the job and joining ZIOPHARM. And but it became clear that you couldn't just show up one day and say you're going to do point of care T-cells, you had to have essentially the elements. You have to tick the boxes if you would. So part of the answer to your question is that we de-risked the program all the way along, like now the Sleeping Beauty is here to stay, it worked. In the second generation trial, I'll be able to share with you in the public space, but I can tell you that the regulatory learnings in the second generation trial are the direct lead in to having essentially the regulatory overview of the point of care go well. In other words, we're contemplating many of the regulatory release criteria in the second generation trial for what's needed in the so-called third generation trial. But your point good in the last one is that okay ZIOPHARM, you get all this going, you get it going at MD Anderson, how do you scale it up? And the reason it’s scalable is that we have deliberately generated T-cells that have their own ability to grow in a competitive environment. I didn't want to develop technology that is so refined or nuanced that you had to essentially have just the perfect amount of T-cells going to a patient for a graft. I wanted to take advantage of T-cell biology, T-cell behavior, and the key there is the IL15 because in our models you can give low doses of T-cells that have the IL15 that is expressed and those low doses of T-cells come in and graft in those animals. See, you don’t have to hit the nail on the head, you just have to be in the proximity and then you let the T-cells if you would do the work for you.

Operator

Operator

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

Tony Butler

Analyst

Thanks very much, Laurence. I do have several questions, but I will keep it to two minimum here. One is on the Phase 3 or pivotal trial and I'm curious because you won't be able to limit steroid used and if it's true it will have an effect, why then move forward in a single arm study because the real benefit would be illustrated in a comparative trial? That’s question one and back to point of care, one concern always is that you get T-cells that end up having exhausted and one could argue if you rush it, they become increasingly exhausted at an increasing rate, how can you actually keep it to a level where there if you will more…? Yes thanks.

Laurence Cooper

Analyst

Okay, so this is first one first is the steroid piece. So first of all there are neurosurgeons in the United States for instance, whose standard of practice is to go very little to no steroids and because people have grown up if you would in an era where they now understand that steroids have a double edged sword. Now back in the day before people really understood that steroids were modulators, they were giving them for issues of edema, swelling of the neurosurgery, now I think sophisticated neurosurgeons recognize that the amount of steroids that can be given to patients can be reduced and indeed we've had patients excuse me we’ve had practitioners on our trial who have given no steroids. So as we go through into the pivotal trial, we're going to give guidance about the steroid dosing and we can’t absolutely say what the dose would be because that’s obviously a neurosurgical expertise, but we can certainly give guidance. And when we've talked and this is part of the reason why it's taken a while, when we've talked to our colleagues and our thought leaders really around the world now to get this next pivotal trial going, they are very comfortable with us, very comfortable. So it's not like given 100 milligrams of steroids in that, there is a lot of flexibility in the system and I think a real understanding that low dose steroids is completely acceptable practice. Your other point about the single arm trial versus a randomized trial; I guess I just want to just debate that with you Tony just a little bit because when I picture the single arm trial, what I'm picturing is that the patients are enrolled and then after a period of time, the envelope is broken open and…

Operator

Operator

Thank you. And our next question comes from Keith Markey of Griffin Securities. Your line is now open.

Keith Markey

Analyst

Hi, thank you for taking my question. Laurence, I was wondering if you might, I know it's a little bit early yet to talk in detail about the upcoming clinical trials that you planned for the second half of this year, but I was wondering if you might be able to give us a little bit of guidance on the sizes of those trials and or perhaps talk about just how much of your credit that you have already with MD Anderson might be able to cover those costs.

Laurence Cooper

Analyst

Yes, certainly keep - us a good question so, so we're you know the two cell therapy trial CD33 CAR trial and the NK-cell trial will both be right in the MD Anderson, the both the investigator initiated trials and the money at MD Anderson that there are already the I think it's about $27.3 million that is well essentially covers the cost of those trials so, we're very comfortable there. We're also going to open up a part of a number of trials like but one of the trials and it will be MD Anderson for the combination trial where we are giving anti PD-1 and Adenovirus that control Veledimex in that combination trial also can be well handled by the cash that's on hand that MD Anderson. So, I think we see that cash position as a little bit like a bank account if you would one of which we can draw down for not only the trials that I described but really to be honest for the years to come and that's really the reason why we're just delighted about working with MD Anderson. They have the patients, we have the infrastructure to do the trials and we have an essentially the cash position to make sure they're well executed.

Keith Markey

Analyst

So if I can elaborate or perhaps interpret what you're saying it sounds like the trials will probably relatively small.

Laurence Cooper

Analyst

Yes, we haven't got a great detail; I mean eventually you'll see it in our clinical trial and what not. But yes, I mean these are going to Phase I cell therapy trials, typically speaking they come in the sort of 10 to 30 range number of patients.

Keith Markey

Analyst

Great. Thank you very much.

Laurence Cooper

Analyst

Sure, thank you.

Operator

Operator

Thank you. And our next question comes from Swayampakula Ramakanth of HC Wainwright. Your line is now open. Q - Swayampakula Ramakanth Thank you, and a couple of really quick questions. The first one being on the DIPG trial of the pediatric brain tumor trial, I was wondering what kind of data would you need to provide to the FDA before you can start this trial in the pediatric patients and is there anything on the preclinical side that you can either present at a public meeting or you’ve already presented?

Laurence Cooper

Analyst

This is Dr. Lebel, I'll answer that one.

Francois Lebel

Analyst

Yes, so the we're in the process of activating site in I think we have communicated before that we for the pediatric trial DIPG is very rare disease. But obviously as Laurence has indicated it is uniformly lethal for these children so, we're working on the West Coast with UCSF in Chicago. I can release at Northwestern and at Dana Farber. So we're actively now answering question from IRB. So we anticipate – and at the same time we've opened the stereotactic arm in adult so, we're really getting very, very close now to open this study and so far the FDA has that no objection to our trial.

Swayampakula Ramakanth

Analyst

Okay, good. The next question I had is on the - what sort of data should be expect at the SITC conference and also the SNO conference later this year.

Laurence Cooper

Analyst

Sure. So I'm just going to pay myself down for the SNO conference. And we'll have updates on the clinical trial, the frontline trial with that leading into the pivotal trial and then we also have some preclinical data that I think you'll find very interesting and I'm not going to share with you again the embargo, but you'll essentially have those two major updates of the clinical and the non-clinical program for brain tumors.

Swayampakula Ramakanth

Analyst

Okay, good. Thank you very much.

Laurence Cooper

Analyst

Sure, thank you.

Operator

Operator

Thank you and ladies and gentlemen this does conclude our question and answer session. I would now like to turn the call back over to Dr. Laurence Cooper for closing remarks.

Laurence Cooper

Analyst

Yes I'd just, there as a brief closing say thank you for listening and paying attention and we look forward to another successful quarter. Thank you.

Francois Lebel

Analyst

Thank you.

Operator

Operator

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