ZIOPHARM Oncology, Inc. (ZIOP) Q4 2017 Earnings Conference Call March 1, 2018 4:30 PM ET
David Connolly - VP, Corporate Communications & IR
Laurence Cooper - CEO
David Mauney - Executive Vice President and Chief Business Officer
Bin Lu - Raymond James
Keith Markey - Griffin Securities
Swayampakula Ramakanth - H.C. Wainwright & Co.
Nicholas Abbott - Wells Fargo Securities
Good afternoon, ladies and gentlemen, and welcome to the ZIOPHARM Fourth Quarter and Year-end Financial Results Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Dave Connolly, Vice President of Corporate Communications and Investor Relations.
Thank you. Earlier today, we released our financial results for the fourth quarter and year-end 2017 with a press release available on our website, ziopharm.com. During today's call, representatives of the company will make a number of statements that are forward-looking, including statements regarding the potential of therapeutic candidates in our development pipeline, forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control including the risks and uncertainties described in our SEC filings. Results may differ materially from those projected on today's call and we undertake no obligation to publicly update any forward-looking statements.
We'll review our clinical development programs and financials and take a few questions from covering analysts today.
And now I'll turn the call over to Dr. Laurence Cooper, CEO of ZIOPHARM Oncology, who'll be in today's call.
Great. Good afternoon, everybody. Thank you, David and we're on Slide 3. With me here in Boston for the call is Dr. David Mooney, Executive Vice President, Chief Business Officer and also our interim Chief Operating Officer; and on the phone and from the road is Dr. Francois Lebel, the Executive Vice President of the Research and Development and our Chief Medical Officer. Since 2017, we advanced ZIOPHARM's 2 platform technologies, Sleeping Beauty and the control of IL-12. This foundation will make 2018 an exciting year for us.
With Sleeping Beauty, we have major milestones this coming year. We will move point-of-care into the clinical. And for the first time ever, we [indiscernible] patients with genetically modified T cells engineered without a virus and manufactured in under two days. Also these Sleeping Beauty modified T cells will be targeting neoantigens, the Achilles' heel of cancer and these will enter into the clinic under the guidance of Dr. Steven Rosenberg and his team at the National Cancer Institute.
Turning to IL-12 and the control of IL-12. In addition to advancing IL-12 as a monotherapy, we look forward to seeing data from a combination of IL-12 and an immune checkpoint inhibitor to improve outcomes for patients with brain cancer. We have shown already in three types of cancer that the controlled IL-12 is a powerful platform that can turn cold tumors hot. In other words, drive and activate T cells within the tumor and with this comes broad applicability across oncology.
Before however, we dive into these pragmatic updates, I'll turn the call over to David Mauney for a corporate development update.
Thanks Laurence, and thanks to all of you on the call with whom I have better acquainted with. During what's already my first five months here at ZIOPHARM. I'll head home a few of the messages that Laurence highlighted as well. After spending considerable time talking to many of you and asking for your feedback, for which I greatly appreciate the input, we have some good news. The good news is that the responses have been very consistent.
It is clear that we have tremendous enthusiasm and support, as we further validate and derisk our clinical platforms, and we are all excited about the multiple inflection points ahead of us in 2018. As we move through this year, we will pursue two paths towards driving up our company value. We will continue to work to advance our existing scientific programs for control of IL-12, point-of-care and PCRs for neoantigens, through a series of inflection points, and we intend to fortify our balance sheet. We have been working to focus our time and capital commitments first to the programs that are truly moving the needle and in the shortest time possible.
In this light, we recently unveiled a clear and concise two platform strategy at the JP Morgan conference, and are currently evaluating and refining our clinical and operating plans as we consider the potential of our current core value drivers. This clear, refined and broader view is resonating very well in these first two months of 2018. While we have had consistent interest in our story over the course of last year, we can say that the number and quality of third-party inbound inquiries and discussions as well business and financial meetings has increased substantially in 2018 already and with global reach.
As we have progressed and learned over the last few months in particular, we are certainly smarter and better positioned for value creation. For example, we saw great maturation in our clinical data in our IL-12 GBM patients, particularly in the second half of 2017, which furthered our understanding as to why patients could benefit from the control of this master immune regulator. And as Laurence said, with our cumulative data today, which as a reminder entails more than 70 patients safely treated across three oncology indications.
We believe we have now established that the control of IL-12 is a potential therapeutic platform for turning cold tumors hot. We have recently seen a very strong trend with major partnerships and acquisitions in this area, and we believe that controlled IL-12 is now positioned to potentially be a superior therapeutic alternative through other cytokines alone or in combination with checkpoint inhibitors. In other words, we have come to believe that controlled IL-12 is not just a GBM asset. On the cell therapy side, we had the benefit of seeing the recent and early data around the challenges facing bio-space platforms. The potential for a disruptive, next-generation technology that could address cost and scaled delivery is even more profound. And we believe this trend will only increase over time.
Again, keep in mind that we intend to take blood from our patient, genetically alter the cells without the use of a virus and reinfuse these altered cells back into the patient in two days or less and for the first time in history. And with our partner Presigen, we are exploring a new and disruptive model with which individual hospital systems are in control of manufacturing and distribution, which Laurence will soon expand on.
We are also working hard to improve other areas of our business. We are on the verge, for example, of launching new investor and public relation campaigns and we'll launched our new website and social media channels among other efforts as we push to become much more visible and understood in 2018. Our slide please. Turning briefly to our financial summary, you can see two brackets of assets. We have $68.2 million of cash and $34.6 million in prepayments available to us for work at MD Anderson. The $34.6 million at MD Anderson reflects our recent and final payment of $2.7 million made during the month of January, and is now stepped to fund support for our programs to be conducted at MD Anderson Cancer Center under the current Research and Development agreement.
And we have $68.2 million of cash, all at the end of January 2018 for use in bio pharm for programs like IL-12 and work at other institutions. I want to reiterate that all of our work at MD Anderson is already paid for with the prepayments that we will draw down over time. In fact, this covers us for all of the cost of work planned at MD Anderson for the next two years and includes the fully funded budget for all currently planned point-of-care CD19 work as well as other endeavors.
In summary, we are on track to execute our operating plan for the remainder of 2018 and reiterate our guidance for the year. We remain confident that we can soon demonstrate the value and therapeutic potential of our platform technologies for the years to come. Thanks again for your continued support and now I'll be turning it back over to Laurence.
Thank you, David. I appreciate your hard work and your expertise in corporate development. Your addition to the team just five months ago has been tremendously valuable. Okay. So let's dive right into the platform looking at Sleeping Beauty as well as IL-12 and we'll be on now Slide 7. Sleeping Beauty is our nonviral technology with which we can reprogram T cells with just DNA present and then turn them into weapons outside of the body to fight cancer inside the patients.
The Sleeping Beauty system leaves the introduced DNA into that T cell genome. So the genetic material coding for the chimeric antigen receptor or sometimes referred to as CARS, targets tumor antigens on the surface of cancer cells such as, of course, CD19. But also with Sleeping Beauty, we can read other DNA elements into the genome such as those coding for T-cell receptors or TCRs to generate to CAR-T cells that can probe beneath the cells surface to attack for instance solid tumors. The Sleeping Beauty system is being used not just to genetically reprogram T cells however. But we're using to implement that in an entirely new approach to manufacturing that addresses head on the fundamental problems facing CAR-T and TCR-T.
Mainly, we can avoid the cost and complexity of manufacturing T cells based on a virus. And thus, we can avoid the dependency on expensive and complex centralized manufacturing. In other words, Sleeping Beauty enables us to very rapidly manufacture patient derived T cells in less than two days and this is what we refer to as point-of-care. From Slide 8, we'll now examine how we're doing it at least from a conceptual, design point of view. Point-of-care T cells produced in under two days will really change the way CAR-T will be delivered.
Without the reliance on a virus, we can avoid essentially the manufacturer at remote facilities. Therefore, we can manufacture at hospitals and treat patients by eliminating is what you see on the left-hand side. Eliminating the need for an airplanes and trucks and manufacturing facilities used in the manufacturing approach. On the right-hand side, is our supply chain. This is what we refer to as point-of-care and just highly distributed manufacturing where if you just walk through the steps, 1, 2 3, 4, the patient undergoes apheresis. Then the Sleeping Beauty system genetically reprograms the T cells and then these are simply infused into the patient. Because that's where T cells belong.
T cells belong inside the patient rather than in the bioreactor, because then with the reprogramming of the T cells, they'll undergoing expansion and deliver antitumor effect to the patient at the time of need. So on Slide 9, we're also considered how this will impact the business of CAR-T. And we've developed a new business model for hospitals.
ZIOPHARM will provide patients and caregivers with a solution that addresses the cost and complexity and the scalability essentially of CAR-T. We know hospitals and providers have significant concerns about the payment models and the total cost associated with currently approved T-cell therapies. This is why together with our partners, Presigen and Intrexon, we're working with hospitals and health systems to change that model. We announced at the beginning of the year, an agreement that provides one prestigious health system an exclusive regional license to point-of-care T-cell therapy targeting CD19 with ZIOPHARM and Presigen receiving licensing fees and royalty payments.
This model, which may be replicated across the country as a win-win-win. For us, we will establish our market. For the hospitals, they'll improve measure of certainty with which they face an evolving and complex reimbursement model. And most importantly, for our patients and families, this manufacturing paradigm shift will significantly improve their access to groundbreaking CAR-T therapy. As this business model evolves, we'll provide more details on the agreement and the additional agreements that may follow.
On Slide 10. We'll dive a little bit more into our Sleeping Beauty data set. We've presented data from our first and second generation clinical trials that have evaluated Sleeping Beauty modified T cells now in 33 patients and counting with multiple types of CD19 express in blood cancers. We've reported these results in the Journal of Clinical investigation. We've undertaken multiple presentations just recently at Ashton in December and Keystones and [indiscernible] in February and many others. This data set as a whole provides the foundation for the point-of-care technology. We have demonstrated the system is safe, is tolerable, we have shown persistence of infused T cells. Indeed, I'll just remind the audience, that we've seen in some patients persistent of the T cells up to four years after infusion. We've shown disease response and we have shown long-term, year-long survival, patient survival.
Both the manufacturing and the release time of the engineer T cells in these first and second generation trials have been reduced that we've made improvements in the CAR structure along the way. The point-of-care trials captures these data and is now looking moving forward to put in place a very rapid manufacturing process for targeting CD19 on blood cancers. We're going to do this using the coexpression of CD19 specific CAR and the new molecule we invented membrane down to IL-15. The CAR provides the targeting and the IL-15 provides these T cells with the survival benefit. We've also rolled them into the fabric of the DNA, [indiscernible] which may be useful if there is an issue with for instance, adverse events.
With the Sleeping Beauty system, we emphasize our technology avoids the requirement for ex vivo. In other words, outside of the body, propagation or activation. In other words, there's no need now to build a bioreactor to culture T cells, which further reduces the cost and complexity. We plan to be in the clinic with our T cells manufactured under this point-of-care technology in the second half of 2018.
On Slide 11. Also in the second half of this year, we'll enter the clinic with our TCR program in collaborative with Dr. Stephen Rosenberg at the National Cancer Institute. This is an exciting approach that leverages Sleeping Beauty to genetically modify TCRs targeting neoantigens, which are unique to each patient's cancer. This took ZIOPHARM on the path to targeting cell of tumors and we're doing so with one of the best in the business. Developing T cell treatment for solid tumors is complex as new thinking is needed to tackle the worst of human cancers.
Let me share with you on Slide 12 how we're accomplishing this. To tackle solid tumors patients need a personalized approach to T-cell therapy. They need their own T cells genetically modified to express TCRs that target their own special set of neoantigens or targets. The only way to do this is by using the fastest and cheapest technology to manufacture T cells. So each recipient can benefit from a unique TCR or TCRs. That approach is entirely dependent on point-of-care. I emphasize there isn't currently no off-the-shelf or in other words preprepared T cells approach to targeting neoantigens within solid tumors.
Therefore, the technology required individual TCRs for individual patients. And thus, each product has been made in real time, which is perfect for the point-of-care technology. And as you can see on the diagram, the way this is accomplished is based on identifying neoantigens by sequencing and other downstream analysis of the tumor compared to the normal cell. These neoantigens then can be identified by the T-cell receptors. The reactive T-cell receptors are then cold and put into the Sleeping Beauty's expression system, genetically reprogrammed under point-of-care and infused into the recipient. This will be a very exciting technology.
On Slide 13, let me summarize how Sleeping Beauty and point-of-care platform has far reaching potential and has an attractive versatility. Our Sleeping Beauty DNA plasmid, kind of, accommodate interchangeable cartridges targeting CD19 for instance, CD33 and other CAR targets as well as TCRs targeting neoantigens. Thus, we have multiple shots on goal. Our trial, which will evaluate - which is currently evaluating the viability of CD33 as a target on AML is ongoing. And as a reminder, in this trial we're using a lentivirus approach. And if CD33 turns out to be a viable CAR target, we're going to shift to the Sleeping Beauty modified T cells targeting CD33 under point-of-care. Our collaboration with Merck KGaA is progressing as they also see value of the Sleeping Beauty system and the membrane down IL-15.
Slide 14. With the transition now from the Sleeping Beauty platform to the IL-12 platform. So Slide 15. ZIOPHARM is the first company to demonstrate control of IL-12, a master regulator of the new system. With it, we weaponize the patient's resonating immune system by turning cold tumors hot. Our IL-12 has been shown to work in multiple cancers. In recurring glioblastoma type of brain cancer, this work is the most advanced. And we'll point out that we do not know the antigens of the T cells are targeting. So this is different from the Sleeping Beauty system where you do know the antigens you're targeting. With IL-12, you don't have to know the antigens you are targeting.
Indeed, nobody knows what the antigens are offering since the good result in an antitumor results for patients with glioblastoma. But however - but we do know that if we can drive and activate T cells into the tumor, then the immune system can engage for cancer and destroy it. Where current neuroblastoma is inological desert. And with respect to T cells present in the tumor, they're simply very few to know resident T cells to take up the fight. With is needed and what we provide with IL-12 is a way to strike the match. That match lights the fire and unlike mask to a light, the T cells are cold to the glioblastoma cancer. What is unique is that we at ZIOPHARM can control the IL-12 in terms of its productions and the amount using the RheoSwitch technology. That is the secret sauce. Without control, you cannot safely harness the benefit of IL-12. Indeed, we can directly see from our clinical data that the tumor tries to defend itself from this invading army of T cells with an up regulation of checkpoint.
These checkpoints undermine the ability of the T cells to destroy the glioblastoma cells. Thus, these killer T cells benefiting from IL-12 may be further enhanced by combining with immune checkpoint inhibitor such as Nivo. Our data is the most mature with patients with recurrent glioblastoma. However, I want to point out that we do see opportunities in other cancer cell types.
Slide 16. The clinical application of the Ad-RTS-IL-12 plus veledimex is quite simple. The patient's tumor and in this case, a recurrent glioblastoma is easily injected with an inert antivirus, which contains the genetic machinery to control IL-12. These genetic elements are deposited therefore in the brain tumor. We don't have to get the virus into every brain tumor cell, however. Rather just a subset. So we can start making IL-12 under the control of the RheoSwitch. The patient takes the veledimex capsule daily by now and then this activates the switch to regulate the production of IL-12.
The T cells then are cold into action and these work as cellular scalpels to chip away at the brain tumor. We've been tracking the overall survival of our patients on our Phase I trial who receive the Ad-RTS-IL-12 of veledimex therapy. We had demonstrated 12.5 months of median overall survival at 11.1 months follow-up for patients who received 20 milligrams veledimex and that's a dosing regimen that we're advancing. This survival benefit appears superior so the current best available therapies. However, we also understand why these patients are benefiting. In other words, what's going on to support essentially the improved ability these patients to survive when IL-12 therapy is applied. First of all, we see tumor masses shrinking. Secondly, when we look in the bloodstream, we can see how the IL-12 is altering the ratio of effective to suppresser T cells in the purple blood. And again, this is consistent with an immune response delivered by IL-12. That ratio is proportional to the overall survival of the patients. Thirdly, we see improved survival with patients who receive low-dose steroids. Remember, steroids is given as part of the way patients recover from their neurosurgical procedure.
And then perhaps most importantly, fourthly, we see compelling evidence from biopsies. In this case, taking more than four months after the administration of the veledimex, demonstrating that the IL-12 causes an influx of these killer T cells into brain tumors and also on these immuno hits that chemistry slides, we see up regulation of expression of PD-1 and PD-L1. In other words, controlled [indiscernible] cells therapy for patients with brain cancer turns their cold tumors hot.
Slide 17. The control of IL-12 also turns other tumors hot, we've treated as David highlighted in his remarks over 70 patients with melanoma, breast cancer and glioblastoma. And our data with glioblastoma, is the most mature and I was just emphasize that we see T cells being driven deep into the tumor. We see up regulation of checkpoints. We see the T cells persisting months after the IL-12 administration. And again, perhaps, importantly here, we see a reassuring safety profile with this ability to control the IL-12.
On Slide 18. We'll summarize where we stand looking forward both at our monotherapy and our combination therapy in recurrent glioblastoma. Our Phase I trial evaluating the combination of Ad-RTS-IL-12 plus veledimex with the anti-PD-1 Nivo has been initiated. For our pivotal study, we plan to commence this trial in the second half of this year upon resolution of SA validations as I pointed out in my remarks at GPM in January. We're very excited about these two trials and we're confident we're going to make a difference for patients with recurrent glioblastoma. And further demonstrate the value of IL-12.
Slide 19. Again, building upon the themes really at this presentation and also our data set. Excitement is really going - growing for IL-12 as a platform that we can combine with checkpoint inhibitors across oncology. With immune checkpoint inhibitors alone, once these roughly speaking at 10% to 30% response rate. That response is for those tumors that are hot. In other words, those tumors that already have T cells within the tumor. What about those 70% or so tumors for whom immune checkpoint inhibitors apparently does not work. With IL-12, we believe we can make other tumors hot and pave the way for PD-1 inhibitors and others like PD-L1 and CTLA-4, et cetera to target many more cancers.
Slide 20. 2018 is shaping up to an exciting year for ZIOPHARM. Just some of the highlights, our combo trial with controlled IL-12 and nivolumab is initiated. Our Phase I study for pediatrics is enrolling and the randomized controlled trial is planned for the second half of this year. For the Sleeping Beauty platform, we look forward to entering the clinic with our third-generation trial infusing CD19 specific T cells manufactured in less than two days using our technology known as point-of-care. Our trial to evaluate CD33 as a target for patients with refractory AML is enrolling and we look forward to initiating the Phase I trial of the NCI targeting solid tumors. We further look for advancing our work with Merck KGaA.
Okay, that's the end of my prepared remarks and I'll turn it back to the operator now to navigate the questions. Thank you.
[Operator Instructions]. Your first question comes from the line of Reni Benjamin from Raymond James.
Q - Bin Lu
Hi, guys this is Bin Lu for Ren. I have several questions here, if you don't mind. First one is on your business and model for your CD19 POC product. So maybe can you just elaborate a little more on this model regarding like the per patient of fees that you'll be collecting. And also like do you or do the hospitals collect more revenues?
A - Laurence Cooper
Sure. Yes, let me just handle the questions one at the time. We may have to - let me into the number of questions, we've said everybody but let me go quickly here. So we haven't say much more than what I'm - I just said in the comments. And of course, we want to keep it that way, because we're in the business now of negotiating with multiple hospitals. And as we bring out those negotiations, we want to be able to keep potentially the rules if you would by which we're negotiating to ourselves. So I think at a later time, we'll bring that to the floor, but I don't think it's appropriate for today.
Q - Bin Lu
Got it, that's fair. So have you or can you disclose which major medical centers that you have signed the first agreement with?
A - Laurence Cooper
Yes, another great question, but not at this time.
Q - Bin Lu
Just last one from me is I think what more work do you need to do before you initiate the first trial for this POC product? And do you expect that this product could generate better efficacy or safety data as compared to the other 3 CD19 products?
A - Laurence Cooper
Sure, so thank you again. So for the - marching forward for the point-of-care, as you saw at ASH and as you saw Keystone, our preclinical data set looks superb. And that data set is really the work that is fed into the regulatory paperwork to essentially achieve institutional as well as federal approvals. We are well along in that regulatory pipeline. I probably leave it there. Our guidance is that we'll be in the clinic second half of the year. In terms of efficacy, proofs in the pudding. But I would say that IL-15 is a remarkable molecule. As you saw from GEN [indiscernible] work at the NCI. If IL-15 was present then the patients went into remission. So I think that's a very strong indicator of the power of IL-15.
Your next question comes in line of Keith Markey from Griffin Securities.
Q - Keith Markey
I was wondering, Laurence, that I understand you to say that the patients who received very low dose steroid in the IL-12 GBM trial are still alive, a 100%?
A - Laurence Cooper
So, it's a good question. So we last looked at the data in preparation for our major medical meeting. I think it was October. Thanks David. Yes, it was October and that's the last time we looked when those patients were alive. We will update that data at a medical meeting through the year.
Q - Keith Markey
Okay. And then I was wondering, what's the - how do you view the feasibility of using an injection of IL-12 to treat something like a visceral tumor?
A - Laurence Cooper
Yes, that's a great question. So we're - so just to kind of levels set here. When you are treating glioblastoma, patients unfortunately die, because the cancer - it doesn't spread metastatically. In other words, it's not growing outside of the head, it's growing within the head, but it's growing into the brain, which of course, is very valuable resource. That means that the IL-12 and the T cells that are going to work in that environment are working essentially across a plain of tumor that is within in a box, that's in cranium within your head. What you're getting at now is can the IL-12 biology works systemically. In other words, you treat locally. For instance a liver lesion and you see something where you - in other words a lesion is going away at a remote site that hasn't been treated. That's known as an abscopal affect and we've already shown, Keith, that absolutely happens and for instance, in our early work that we did with breast cancer and with melanoma, we had those abscopal. In other words, those systemic effects treat locally, see something systemically. So we are very optimistic that, that data set provides a foundation now for getting essentially into systemic disease and particularly as we think about turning cold tumors hot and potentially combining such therapy with other immune stimulants or inhibitors such as the PD-1.
Your next question comes a line of RK with H.C. Wainwright.
Q - Swayampakula Ramakanth
My first question is a little high level question. In terms of how you are utilizing some of the researchers that you have, especially, the GBM is an exciting indication to go after, but at the same time, you have your fingers in multiple places right now with the TCR, with the CD33 and the AML through the CD19 work and what not. So is the GBM worth somehow taking a backseat compared to the rest of them because here you are being ignited mode on the CAR-T and the others stuff...
A - Laurence Cooper
Yes, I hear you. No. I think really the opposite. It's like trying to pick your favorite child. We - both are loved equally. Both are different, right? ZIOPHARM has tried to be strategic here. We know that CAR-T works and - but we know that problem and the CAR-T is the cost on the scale. So yes, we're in a CAR-T race. So we're in a different CAR-T race. We're in the race to show investors that we have a manufacturing solution that will essentially blow the doors off the ways as other people are doing it. Significantly reduced cost of goods. So that's the race we're in for the Sleeping Beauty system. On the other side with the IL-12, the rates were in there is that we know for some cancers you don't know the targets. And we have to have a solution for that. In our data now that with IL-12 clearly shows that we can weaponize the patient's own immune system and that is a very compelling strategy, because it's bearing fruit. It's bearing fruit for not only monotherapy, but also combination therapy. So that's where you're seeing it. So yes, I think you are seeing a shaft in our focus, actually, because we've learned a lot and we're really thinking about these two technologies, a very rapid manufacturing and the IL-12 of these platform technologies to get some of the most fundamental problems with - of cancer.
Q - Swayampakula Ramakanth
Perfect. Then talking about the CAR-Ts and I know you take a lot of pride in how you have improved the manufacturing processes such that it has come down to hours instead of weeks. But one of the major issues I believe is still some of the toxicity and the safety profile of the CAR-Ts and how it is impacting off target tissues. So how - are you working anything on that front? Because it was just show both of them then you got a - your way ahead of the game.
A - Laurence Cooper
Right. So, it's faked in. It faked in. So I come from a transplant background and I have taken care of kids and they gone by my transplant for 20 years. And I witnessed the birth of T cells in these patients that are coming from stem cells. In other words, the slow growth, the measured growth of T cells that are ingrafted in that child. That learning I've now applied to the point-of-care technology. When we go and infuse T cells on the point-of-care. We are not going to be giving many T cells, now don't press me on how many we're giving. We will just leave it as that, but I know that those T cells can essentially nest within the patient and then grow out in this sort of kinder gentle of fashion in patient. And I think this is going to be very important. So while there are others that give large doses of T cells and then all those T cells are synchronously activated and they all make a whopping amount of cytokines and the patient has an adverse event. We expect our T cells to essentially grow in the patient with essentially the tumor chipping away at the tumor and have a much different safety profile than others.
Q - Swayampakula Ramakanth
So when would we get a first look on some of the safety profiles that you are talking about?
A - Laurence Cooper
Sure. So we'll be in the clinic either this year, second half of this year. And so that will allow the company then to take a look at that data. Is probably best to leave it there. And - but of course, you're right to emphasize it and I've been thinking about it for years. Thank you.
Your next question comes in the line of Jim Birchenough from Wells Fargo.
Q - Nicholas Abbott
Its Nick in for Jim. So perhaps just going back to the point-of-care. Laurence, what can you tell us about the device you are going to use. Is that a bespoke device you manufacture and supply?
A - Laurence Cooper
Yes, that's a good question. So at the moment, we haven't really developed much of the sort of the image of the point-of-care technology. Except I can say to you that it really relies on its simplicity and the device we're using, the electrocuted device we're using fits within that mindset.
Q - Nicholas Abbott
Is this the device that you will supply or is this device that you could go to with the broader companies?
A - Laurence Cooper
Yes, we haven't gone that far, Nick essentially, but there's learning and there's art within that technology that we prefer to keep to ourselves at this point.
Q - Nicholas Abbott
Sure, okay. And Laurence we've talked about this before in the past. You highlighted going from GEN 1 to GEN 2 of the Sleeping Beauty, reducing the lease testing down from 14 days to 7 days. Obviously, you have to release this product essentially, instantly. Do you have an agreement with regulators on how to do this or at least are - I know you have a roadmap but where are you in getting that degrees?
A - Laurence Cooper
In the road, right, we're drifting along that road. You know the - it's one thing to invent technology that's disruptive, right? And it's one thing to think through how point-of-care will get manufacture under two days. But it has to fit within the regulatory framework and that's a lot of the work the team is doing and has already done in the second generation trials. So I am fully aware that we're going to be making T cells and releasing T cells in under two days and we're right on target to do that.
Q - Nicholas Abbott
Okay. And then one more question and then I'll jump back in the queue. And that is you sort of got into this a little bit with the last question, but how do you think about dosing here? Do you think about minimal residual disease, bulky disease, ability to do sort of inter-patient dose escalation that if after a few days you don't see by a market hex then you would go back and give a higher dose which as you know the first off the shelf CAR-T ran into trouble with unexpected toxicity. That product was apparently more active they were expecting. So how do you handle that?
A - Laurence Cooper
Yes, so you never put a person on a trial that you wouldn't put you mother on the trial, right? So I'm a physician first and last. So we take this very seriously. So we're going to be dosing patients in a measured, careful way, because the last thing I want happen is something to [indiscernible] happens to the patient. So the dosing that I've settled on with the team is one which we think is appropriate we'll give a signal but it's also cautious and then we will work forward like most phase I trials do in terms of a dose escalation strategy.
I am showing no further questions at this time. I would now like to turn the conference back to Dr. Cooper.
End of Q&A
Great. Thank you, everyone. Again, if you have more questions, please reach out to Dave Connolly directly and his contact information is on today's release. Thank you.
Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.