Prescient Therapeutics Limited (PTX) Earnings Call Transcript & Summary

Good afternoon, and welcome to Prescient Therapeutics Investor Briefing. My name is Patrick Nelson, I'm MD at Reach. I'll be facilitating the webcast today. But to run the session, we are joined by Prescient, CEO and Managing Director; Steven Yatomi-Clarke. Thank you for everyone taking the time to join us today. Now in today's session, Steven will discuss Prescient, how we're positioned -- how they're positioned at the forefront of the current revolution within oncology, a larger sector in health care, which is $280 billion. Now they're going to be going through their OmniCAR, CellPryme platforms, which can potentially enhance cancer therapies and move them from treatment towards personalized care and cure. Now last week, the company signed an agreement with Thermo Fisher Scientific, which is designed to accelerate the development and commercialization of a highly scaled version of Prescient's OmniCAR cell therapy platform. And Steven will talk about this in today's session. And I note that -- and welcome to the session, shareholders and new investors. So we'll say we'll go through a full presentation so that you can get a good understanding of Prescient and many talks about OmniCAR will outline the Thermo Fisher agreement and go into this in some more detail. But obviously, Thermo Fisher a major crew for the business, a global leader in scientific instrumentation and services and with $40 billion revenue -- annual revenue, this is an opportunity. This program is an opportunity to develop next-generation OmniCAR cells that can be produced with greater efficiency, lower cost and unmatched reproducibility. So if you're on the session today, and you would like to stay abreast of Prescient's news and announcements, type PTX, which is the ASX ticker into the chat box and we'll ensure that you're invited to future presentations and kept up-to-date with new -- with investor updates. So PTX, you can put into the chat box at any time. And we'll make sure that that information is set or just put PTX into your watch list, your trading watch list. Expect the session to run for about 40 minutes. There will be a question-and-answer session at the end of the presentation. If you'd like to ask a question at any time, put it into the chat box. We like the sessions to be interactive. So please ask questions. If we don't get to them on -- as we're going through things, all questions will be asked at the end of the presentation. Any advice contained in today's presentation is general only. It doesn't take into consideration your personal circumstances. You need to decide for yourself whether it's appropriate to you. The sessions such as this are an opportunity for you to hear directly from the company. It's an opportunity for you to ask Steven questions directly and to give you the information that you need to be able to make an informed decision should you wish to make an investment. But we would encourage you to do your own research and speak to an adviser if you need to. As far as Prescient goes, we've worked with Prescient for some time now and very excited to be involved with this business. They're a biotech company predominantly active in CAR-T therapy, which is a promising cell therapy with the potential to revolutionize cancer treatment. The company has key licensing agreements with CAR-T pioneers, UPenn, Oxford and has collaborations with Peter Mac Cancer Research Center here in Melbourne. They also now have this agreement with Thermo Fisher. PTX Omnicare and CellPryme and next-generation platforms developed with UPenn and Oxford and Peter Mac and can potentially enhance cancer treatment, making it safer, more scalable, effective and more affordable for cancer patients. And this ongoing progress -- the ongoing progress of its targeted therapies, PTX-100, 200 through the clinical studies and towards commercialization. PTX also recently announced major news, which we've mentioned the Thermo Fisher, but also the Q-Gen cell therapies to produce its OmniCAR cell lines for upcoming clinical trials. And we saw not so long ago, the Omnicare patent in the U.S. being signed until the -- 2039, which is a key plank in the protection of the OmniCAR platform. And the U.S. FDA grant orphan drug designation to the PTX-100 and which was -- which is another significant milestone with ongoing significant news flow, the company is advancing quickly towards becoming a central platform of the CAR-T revolution. But today, we're joined by the CEO, Steven Yatomi-Clarke, who took over as the CEO in 2016 and is overseeing its progress from start-up phase. He manages the team here in Australia and the U.S. and has been instrumental in the strategy and the business development. And so Steven, you should now have control of the slides, I'll pass over to you.

Thank you very much, and thank you to everyone who's taken the time to join this call. I understand that there's a bunch of new listeners today on the back of the Thermo Fisher announcement, and so they should be. So delighted to walk you through the story and spend a particular amount of time on the new development since we've last spoken, but I'll take the time to describe the whole business, where in oncology, find ourselves in the enviable position of being sort of the front of the wave instead of scrambling out the back of it alongside everyone else. It's a good place to be. We're capped at about $140 million depending on the day with some nice growing liquidity, which is fantastic, and we think this is just the start. To introduce the company through its investment highlights. So we have a simple business model, as we like to say, license from the best and work with the best. And some of these are household names really. So we're just piggybacking the expertise and the irreplaceable infrastructure that you couldn't hope to replicate at universities like Yale, Penn, Oxford and Moffitt and also Peter Mac here in Australia, we should be very proud to have a reputable institute like them here in Australia. And as of last week, we can add the first commercial one to this as well, which is Thermo Fisher, and I'll explain why they're so good at what they do. So again, there's a real sleep at night factor with respect to our science and our partners and we're looking to leverage that and complements out incredibly capable team internally. So we've got lots of shots on goal, which is really good. You'll see that on the pipeline slide in a minute why that's important. And it's given rise to 2 cell therapy platforms that, in turn, has yielded some internal programs and also external opportunities. And we also have our 2 foundational assets, targeted therapies, which are in the clinic now and producing results as we speak. As a result of having such a diversified pipeline, there's no shortage of news flow and not like a black box type of biotech that is waiting 3 years for the readout of a study or longer and nothing to talk about in between. So one way of describing what we have. So we've got 2 cell therapy platforms, OmniCAR and CellPryme. I look forward to introducing you to them. But even though their platforms, they have yielded 3 products internally, next-gen CAR-T therapies. And these are AML, glioblastoma and HER2-positive solid cancers. And we also have the targeted therapies, 100 and 200. So that is one way of representing that. But in a traditional pipeline slide, you can see there that we've got our foundational assets at the bottom already in the clinic, but you can see how OmniCAR is growing out. It's a platform that's yielded those 3 programs and now with Thermo Fisher, another platform extension on various applications, really doing a version 2 OmniCAR that's going to make this highly scalable and, again, very reproducible. And we've also got CellPryme, which is another cell therapy platform technology. CellPryme-M has been announced. That is a cell therapy manufacturing enhancement that produces a superior cell type. And CellPryme-A remains undisclosed and we're looking forward to that coming out of stealth mode before terribly long. That's progressing well. So let's start with those ones at the bottom there, those green ones, the targeted therapies. I'm going to start with PTX-100, which is a first-in-class inhibitor of the RAS pathway. This was licensed from Yale University and has a clinical trial underway here in Australia under the leadership of Professor Miles Prince, so arguably the most preeminent oncologist in the country and an expert in T-cell lymphomas. We just got orphan drug designation a few weeks ago from the U.S. FDA, which is a real good hue for this particular molecule. For those that don't know what this means is the FDA guarantees market exclusivity from approval for 7 years. So no one else can compete on this for 7 years and you show me one other business where the regulator will guarantee no competition for 7 years, and that's where we find ourselves, which is a great spot to be. The competition, especially in peripheral T-cell lymphoma, which we're focusing in on now, this is showing the frequency of adverse events of toxicities, which can lead to hospitalization, just using what else is out there now. And you can see anywhere between 25% to 30% all the way up to over 80% toxicities, whereas PTX-100, we have not seen a single adverse event related to our drug, which is remarkable. It's good for 2 reasons. It's better for patients, especially fragile patients have been knocked about a bit. So it's safer in its own right, but it also lends an opportunity to add this with other drugs for synergistic benefit. Now you can't put 2 toxic drugs together because that has a cumulative bad effect. But what we have here, an antagonistic effect some would say. What we've got here is an opportunity to add a safe drug to another drug for enhanced benefit if that's where we want to go as part of this clinical development. But at the moment, this drug is standing on its own 2 feet quite comfortably. Early clinical activity, we did not expect to see, especially in a Phase I in T-cell lymphoma. So the expected progression-free survival of using what drugs that are out there now is about 4 months in 1/4 of patients. So that is to say that 1/4 of patients will derive some benefit, some a lot, some little. But on average, you're lucky to see it exceed 3, maybe 4 months. We've had 1 patient for 12 months, another one for 32 months and counting and to represent this in like a swimmer plot there, it shows that red dotted line is what you can expect with everyone else's drug. I'd only pay attention to the blue ones there, which are the T-cell lymphomas. And we've got a couple more of [indiscernible] in this expansion cohort. This was from the basket study. We're now in the expansion cohort and looking forward to sharing that data with you very shortly. But drug looks to be working. So this is 8 to 12 patients. We're looking to have this fully recruited this year. And again, in this area of unmet need T-cell lymphoma, not just peripheral T-cell lymphoma, but also a type of one that presents on the skin called cutaneous T-cell lymphoma. It's a very short path to market, but just to illustrate the market opportunity, at least in PTCL, there's only 6,000 patients a year or less than 6,000 patients a year in the U.S. alone, but when a drug sells for, Folotyn, which doesn't work particularly well. It only works in 27% of patients for 3 to 4 months and it sells for $0.5 million. So it shows you that this is a very big market opportunity and that the bar is not set, very high for PTX-100. So if we can continue to demonstrate utility, efficacy and safety, in a way we have all been very, very pleased indeed. So that's just one drug. We'll now talk about our second drug, PTX-200, switches off a different type of pathway. This is in a disease called acute myeloid leukemia, it's a type of blood cancer, where people die within 4 to 6 months of relapse. And despite that very intimidating and grim background of patient expectation, prognosis, we've had 4 complete responses, 4 complete remissions and another partial remission on this study so far. And this drug also has U.S. FDA orphan drug designation on it as well. So that is due to read out this year as well. So let's change gears now and speak about the platform technologies, either PTX-100 or 200 that the -- either of those are company makers, they're ticking along. But I'm going to spend a bit more time here talking about our cell therapies. And before I dive into it, it's important to know how the process works because this sounds like science fiction, but it's not. So blood is collected from a cancer patient. And from that blood, we extract the immune cells, which are called T-cells, which are very good at fighting infection, but not cancer. They don't recognize cancer. So outside of the body, we take these cells and genetically reprogram them to recognize cancer. And we do that by putting a gene inside these that express a certain receptor that can now latch onto the cancer. That is called a CAR-T cell. So whenever I say CAR-T cell, you should be thinking of the patient's own immune cell that is now turbocharged and enhanced to now recognize and kill the cancer. Millions of these have grown up and they're getting back to the patients. So they're getting an enhanced version of their own immune cells. And it's not science fiction. It's science fact. It's for the very first time in medical history, very conservative clinicians adhering to use the word cure and who would have thought we'd be using that. So durable long-term remissions, not in all patients, but in many more patients than has otherwise been possible. And you look there at the bottom right is the latest CAR-T therapy to be approved by the FDA on a 98% response rate. I'm laughing because it's just such a good news for the field where people with myeloma, you'd normally expect 20% to 30% historically, and this has got 98%. I mean it's quite remarkable. And the exciting news is for patients, for doctors and for shareholders is that it is just the start. So this is as clunky as it's ever going to get. So it is booming. This has only really happened in the last few years, if you can believe, that it's given rise to 6 approved therapies so far. But again, durable remissions. This is based on real world data. There's been 15,000 patients who will benefit from these therapies, this is real, I promise you. And it is just starting. And in fact, global data forecast that from almost a standing start a couple of years ago, they expect this to exceed $37 billion in 6 years, which is just astonishing from a standing start and it's just going to keep getting bigger and bigger and bigger. Imagine being at the forefront of this wave, and that's where Prescient is. Penn has -- University of Pennsylvania pioneered this with Kymriah, the very first CAR-T approved, and that is just the start. And the very same people, University of Pennsylvania, that pioneered CAR-T developed the solution to taking this to the next level, and that is what we have licensed. So these are the challenges that Penn saw as well. I won't dive into all of these in great detail. But basically, if you think of it like there's a living cell which grows and divides in your body, obviously, a doctor cannot control it. You can't redirect it from one cancer type to another. If the tumor mutates, bad luck. And also these cells get puffed out very quickly and die and in stop killing the cancer. Then you got to get them to the site. So this is just a summary of all of the problems facing current generation CAR-T, as wonderful as it is. And basically, the bottom line is whilst it benefits some patients remarkably, for all of them, it's unsafe. And for some of them, it's less effective and it's unsustainable and it doesn't last. Now how do you change all of this? Well, that's where we come into it. So between our 2 platforms, you can see that we take every box and you can see -- you'll hear on this talk how these actually synergize with one another to overcome all of the obstacles that current cell therapy faces. So basically making all of these safe and effective and sustainable and long lasting, which is exactly what you want. I'm going to speak about the OmniCAR platform for a few slides. And again, this was developed by the same people who pioneered CAR-T, University of Pennsylvania. Prescient has a global exclusive license on this. The key as they saw it was to modularize the CAR-T. So instead of having a construct like this, there is on the right, they have modularized it. These 2 parts -- so you've got the part that binds to the cancer and then you've got the cell, but they come together with 2 bits of Velcro there and a covalent bond, and you get an armed CAR-T cell. I'll have a little cartoon on the next slide explaining how this works a little more intuitively. But basically, this is a genuine platform technology. We're not touting a particular cell type. We're not touting a particular binder or antigen. We are a genuine platform, which means we can use any target on the cancer and therefore target any cancer and we can target -- we can use any immune cell. So we can work with anyone else out there. The key is in modularizing it. And if you want to modularize it, come to us, that's how you get an improved cell therapy. So this is how it works. So you've got the T-cell, think of it, you've got -- everything about the regular CAR-T cell that stimulating domain there that makes the cell grow and divide and half of the Velcro sitting there. At this stage, the cell is alive, but it's not doing anything. It's waiting obediently for the command until the doctor then administers quite separately the targeting ligand with the corresponding bit of Velcro, which attaches to the cancer and the 2 bits of Velcro come together and bang, the whole thing switches on and it kills the tumor cell on demand. So this simple active modularity, it's very elegant. It seems very simple and in some ways it is. It's a lot more complicated than that. But this simple act of modularity enables you to overcome all of those obstacles that I had on the previous slide. And I've listed them here. I won't labor at this announcement, is now on the ASX platform for you to read. But basically, it enables single handedly to overcome all of these issues. So it's a very, very clever system. And it doesn't need you to over-engineer anything either. So if you think about it, conventional CAR-T, as wonderful as it is, it's a soldier in the immune system fighting cancer, but the soldier only has one map, only has a single weapon and only hit 1 target, you cannot redirect it to hit any other target. And most disturbingly, you can't control or communicate with the soldier mid-mission. Whereas with OmniCAR, this simple act of modularity means that we've got a soldier in the immune system that you can arm with any weapon including several at once, can give any map for multiple deployments, can direct against any target, including several targets at once. You have full communication and control even mid-mission, which is super important and can even send images back in real time. So as I've said before, to those who have heard this, if you remember nothing else, when you hear CAR-T, that's on the left, and you can see where we're taking this to the next level, not only for us, but for anyone else we can help develop this enhanced soldier which is an incredibly exciting opportunity for us. And this is just a summary of some of the features. There's data behind all of these. I won't bore you with it, but just the illustrative purposes. It means that instead of giving a cell with uncontrolled activity, we can actually titrate up the level of activity of a cell like remote control. You can tune it up and tune it down. You can even switch it on and off, which is really good not just for the safety, if there happens to be a deleterious event, you can switch the therapy off, not -- but switch it on again, it's also going to create a more persistent cell phenotype that lasts longer. You can redirect it from one cancer target to another without a new cell. You don't have to go to the expense of a new cell, just with a new binder you can switch these out and you can even target multiple tumor antigens all at once with this one cell therapy by having multiple binders. So think of OmniCAR as like a LEGO set for immune cells and with that LEGO set -- as you know with LEGO, you can build a house, a car, you can build a whole new world, and that's basically what OmniCAR is enabling doctors to do and researchers to do. Obviously just some data showing what it says on the label that you can switch it on and it starts killing the tumor and the subjects live longer. And the more you give, the more tumor you kill. This is showing that we can arm these and it kills tumors nice and steadily. That's what this shows. You can get a nice killing curve. But if you let them rest and these unarm again, you've got to make daughter cells in this case. If you rearm it, it acts exactly the same. So whether it's pre-armed or re-armed what the doctor wants to see and the regulator wants to see is how predictable is this, and this is not only the same level of killing. It's the same kinetics of killing, which is exactly what you would want to see and gobsmackingly obedient to this system. And this is another one showing -- and this is -- that was world first data. This is also a world first data showing that you can redirect a single cell, in this case, putting 2 different tumors, brain cancers there, on expressing the green antigen, 1 expressing the red antigen. And you arm it with OmniCAR only against the Red one, and bang, all of those cells start to get killed straightaway, and it leaves the green ones alone, which is exactly what you want until you add the binder, the green binder to the cell and then you get rapid redirection. So it stops killing the red ones, and it starts killing the green ones superfast. What does this mean? With a single cell, you can redirect this cell therapy from one tumor type to another tumor type without any new cells, and that's not been done before. So this all sounds nice, but think about it in terms of cost of goods as well. If you want to do this with a regular CAR-T, you've got to make 6 different constructs. And I don't care if they're off the shelf or not off the shelf. The same rules apply. 6 manufacturing, 1 on the 6 vectors. This is super expensive, hundreds of thousands of dollars for each one, times 6, whereas with OmniCAR, you do the hard work once. You just make the cell once and because it's a LEGO set, you can plug and play all of these binders, which are infinitely cheaper, onto it. There's no delay. There's a single IND for the regulators, one release criteria and you've got infinite flexibility with no time delay. So even from a COGS point of view, it's an absolute no-brainer. So I'm just going to now touch on our internal programs. So what are we doing with this incredible platform? Well, it has yielded 3 internal programs for us. We did a big strategic review a little while ago. And we think we're going to go after tumors where CAR-T shows promise, but where current generation is stumbling. That's the best place for us to start. The first one is with acute myeloid leukemia. As you might recall, is a disease that we understand very well. Now this is a disease that grows very fast and mutates very quickly. So oftentimes, conventional CAR-T, by the time you make it, the tumors mutated and you've got the wrong target. Whereas this, you can chase that tumor down and arm it against 1, 2, 3, 4 different things and really chase that down. You can also titrate it up for improved safety, which is very important in a very fragile patient. We've also got a HER2 program. You might have heard of a drug called Herceptin, well, that targets this same thing. Unfortunately those drugs eventually stop working, and there's nothing for patients. This is, we think, is going to win where other CAR-T has failed because you're able to give multiple doses of the binder as if you're giving 5, 6, 7 different administrations of the CAR-T and give it enough time to chew through all of those protected layers that the cancer build itself, builds itself like a force field, and we overcome that. And we're also on the top of brain cancer called GBM. Think of that like AML, it's very -- grows very aggressively, and it changes. So again, the same advantages that we confer to AML are going to be in GBM. Amazingly there are very, very few programs around the world targeting more than one target on GBM. One target might have -- it might have a temporary shrinkage of the tumor, but really if you want to move the needle, you're going to have to address more than one. And that's what OmniCAR can do as a Lego set. That's the beauty of the system, one of the beauties of the system. We also announced during last week, there has been steady progress across all of the programs, but the first of the clinic is looking like AML. AML has got its nose in front. And we have appointed Q-Gen Cell Therapeutics to manufacture these. Work has commenced. This is all in preparation for clinical studies. A lot of CAR-T companies find themselves flat-footed where they finished their research and they realize, let's do a clinical trial now and realize they do not have the slots because a lot of these manufacturing slots are spoken for well in advance. Well, we've thought ahead. We've got the slots. We've got a wonderful Australian company here who are licensed to make these the humans, not for research, for human trials and do so for big international pharma companies as well. So we're going to be using them, and we're doing the tech transfer right now. And we're also -- you're going to hear about CellPryme in a moment, which is our other platform. I said we'd be our own first customer, and we will be. We're going to drop CellPryme into these manufacturing arrangements so that we are producing a superior phenotype of cell that lasts longer and more youthful type of cell that's going to kill for much, much longer. And yes, there will be more detail on this in the coming months. And I would be hopeful that much of that, if not all of it, will be positive. So I'm very pleased with how things are progressing as we move towards the clinic. And the bottom line is, folks, that this is all looking very, very real now. So that's fantastic. Also during the week -- at the end of last week, we announced this a bit of a landmark for Prescient is an agreement with Thermo Fisher to develop the next -- to enhance the whole platform of OmniCAR. So for those that don't know, Thermo Fisher are a global leader in providing scientific instrumentation, reagents and services. Again, $40 billion in revenue. One of the many areas of expertise they have is cell and gene therapy, and that's a big growing area for them. So we really couldn't be aligning ourselves with a better -- a better positioned company worldwide. And this agreement got traction unusually quickly, which is fantastic. In short, what they're going to be doing is help us make a -- make OmniCAR in a much more scalable, efficient way. At the moment, in order to insert genetic material into these cells, what the industry standard uses, you use, what's called lentivirus. It's a virus that -- it's a non-infective virus, it's not a pathogenic virus, it's a naked one, but you use that to -- you put your genetic material into it and it infects the T-cells to express your CAR construct. Bottom line is it's very, very expensive. It's not incredibly efficient. And what Thermo Fisher have designed is a method to get your genetic material very efficiently without using any viruses straight into the cells. It's faster. It's quicker. As a result, much, much lower cost of goods. They also have an automated closed-end manufacturing. At the moment, when you're manufacturing CAR-T cells, what you're really doing, to put it crudely, you're giving cells to a bunch of different manufacturers, and you're hoping that they all have a green thumb. And that they're all going to make it effectively and make it the same. Think of it like, if you were to -- Jamie Oliver was to issue his recipe book to a bunch of different people, they're not all going to cook it the same, right, even though the recipe is what it is. So what -- we're taking the variability out of that through this closed-end manufacturing that we hope will be able to take this instead of just giving the recipe book, it will be an absolute closed-end system, any lab that has a Thermo Fisher instrument in it. And you can see what's in it for them. We'll be able to take this and with unprecedented reproducibility that's not been done before. And we're also working with them on gene edits. So we're editing the cells. They've got some really good gene-editing capabilities. And we're going to be exploring other enhancements, tweaking some genes as well, knocking things in, knocking things out, to make these cells work a lot better, for a lot longer. Importantly Thermo Fisher is carrying the entire cost of this, so we're not allowed to disclose. In fact, you could probably tell from the announcement, there were many things that we probably couldn't say that I would have liked to, but we're not carrying the cost at all. And the cost is substantial and quite frankly, we couldn't afford to do any of this work. So that is a tremendous hue for Prescient and its shareholders in terms of what it's doing. It's almost doubling our pipeline by having this next version of OmniCAR that's really embracing ourselves for reproducibility. So these are the aims and outcomes, again, with -- where petition is like it's a version 2 of OmniCAR that can be automated for unmatched reproducibility, to do it faster and cheaper. And again, these functional enhancements. We hope that this work will be done. It's slated in for the next 12 months. But what we're hoping is that we're going to have the outcomes of this within that timeframe so that we can start to incorporate these changes into our own OmniCAR programs. We may not have it in time for the AML one, but that's all right. AML was going to be well and truly lowering without this. But our other programs, we hope to incorporate these advantages. So really extending the lead. We've got advantage on top of advantage on top of advantage here. You can see how we're positioned. And this is off balance sheet, which is just remarkable for Prescient shareholders. Again where do we hope this will position OmniCAR? Well, it's not just for technical success. This is with an eye for commercial success. So what you want, again, using that recipe book analogy, you want to be able to have a manufacturing protocol and process that you can transfer easily to third-parties and that's amenable to decentralized manufacturing. You know what, there's a reason why the Novartis of the world have to manufacture -- create their own manufacturing capabilities because when it's not scalable and decentralized like this, you have to control everything yourself. So it's like to extend that metaphor before, if you don't, for want of a better term, trust what the other kitchens are doing with your recipe book, guess right, you have to build the mother of all kitchens and control everything that goes out. Now that's probably not the future. Think of it like it's basically like manufacturing cars by hand before the production line came along, and that's what we're doing here. So this is ideal for multicenter treatments, which is important during our clinical development, but also during commercial rollout to be able to take this package and really decentralize that. And that, as if anyone that reads anything about the sector, the big holdup in greater take-up in CAR-T therapy, even though it's growing at an astronomical rate is supply for this very reason. And you can see how we're positioning ourselves for success there as well. There are additional potential benefits. So I use those words carefully. I do not want to annoy Thermo Fisher by putting words in their mouth, but so early access to their facilities, yes, and they're getting their internal expertise and state-of-the-art equipment, but also regulatory support for the CMC package, for the manufacturing package for our regulatory filings and also a willingness from Thermo Fisher to support us as our various programs grow and advance. So we're delighted to be working with Thermo Fisher, and I think that is evident as to why. As if all of this isn't enough, we've got another pillar to the business called CellPryme. It's another platform that is involved in cell therapy enhancements. This is basically developed in-house by Prescient in collaboration with Peter Mac. It produces superior cells. It can work with any existing CAR-T process. It's ready for the clinic right now. There's no more preclinical development for CellPryme-M at least, and we own all of the IP, even though we developed it in collaboration with Peter Mac. So a really good spot to be. There's no fee leakage there. So it basically produces a better type of cell that lasts longer and they can locate the tumor and chew through that force field once it gets there. So it is an absolute no-brainer. So for context, for those who are new to the story and getting confused by how these technologies sit side by side, OmniCAR is the modularity and that confers all sorts of benefits like multi-targeting and redirection and control and all the rest of it. We can use any target and any cell, but OmniCAR isn't tied to any particular cell agnostic, where CellPryme makes a superior cell type that lasts longer and finds the tumor. But we're working with our next-generation cell therapies. But guess what, CellPryme-M can work just as well with current generation CAR-Ts. So it can enhance those as well. So you can see how, again, though, that list of challenges that the whole industry needs to face, you can see how this really complements OmniCAR and can help third-parties as well. This is a bit of a no-brainer. At the risk -- bear with me, this is a very brief science lesson as to why this is important. And that's because not all T-cells are equal. They mature. And basically, going from left to right, you've got very naive cells that last a long time, but don't kill the tumor. And right at the other end, you've got the effect of T-cells, which chew through the tumor very quickly and don't last long, they die very quickly. Now what is unfortunate is that in this soup of cells that every manufacturing process makes and it is a soup of these cells. Currently, current processes make way too many of these. So they chew through the tumor like crazy and then they get exhausted and they die. All of the third-party data, I told you that these have curative intent, these CAR-T therapies, when investigators have gone back and said, what is special about these patients that have had such amazing long-term durable remissions? They have these cells. So you want more of these cells, in particular, you want those central memory T-cells. And what's special about CellPryme, it pushes them to that desirable phenotype, and that is why this is highly significant. I've just got some data here backing up some of the statements. So I won't turn this into a deeper science lesson, but basically it makes 50% more of these good cells. And by doing nothing more than taking an existing party right now and by doing nothing different than adding CellPryme to its manufacturing process for 12 hours, 24 hours, you double the tumor killing and you double survival by doing nothing else, except for making them, dropping CellPryme in during the manufacturing process. So this is an absolute walk-up start for everyone. So again, depending on the types of cells, there's different cell populations. We have got more of the good ones and less of the undesirable ones. And we actually doubled the proportion of a population of cells called helper cells. As the name suggests, helper cells are important in helping T-cells respond to kill the tumor and last longer. And so these are desirable as well, and we don't increase both of these by 50%, it's by 100%. We also create significantly more, it's called chemokine receptors. These are the things responsible, think of it like a sniffer dog amongst -- at a border of crossing, trying to work out where the drugs are. It snips the breeze and hones in on a gradient of scent. That's what tumors, basically T-cells do with tumors, and we're putting more of these noses on the sniffer dogs where it can actually track down the tumor. And so this is highly significant, especially in solid tumors when we're creating CAR-Ts for solid tumors. So this is a little bit of a walk-up start. It doesn't need any more development. It's ready for the clinic. And as I said, we will be our own first customer. We're going to be using this in the agreement with Q-Gen as well, but we won't stop there by any means. So bottom line is these cells, they last longer. This phenotype can last decades. They can find the cell, when they get there, they can chew through that force field. They're more stable. And in a surprising finding, they've got very potent antiviral properties as well. We are focused on oncology, but there seems to be a growing interest in using cell therapies for viral infections, and this would be a no-brainer for that as well, will stick into anything. So what do you do when you've got these platforms that can do anything? Well, we're very focused. So we've got these 2 platforms; OmniCAR and CellPryme, we're using them to develop our own internal programs here in green, but also both programs amenable to external opportunities. So we really have a shovels to the gold rush positioning here, where regardless of people's programs, we feel that one or the other or both platforms can help third-parties and diversifies our risk where we're able to get more bang for your buck by having more Prescient assets off our balance sheet that we will have upside exposure to and earlier revenue potential. So just to give an example of how this works with a partner, there might be an upfront fee for early-stage agreements like ours. This is probably not a very big one, if it exists at all, but that's not important. It's all about, to a lesser extent, the milestone fees as they develop these and royalties on sales. That's where you make your real cheesecake is not only on a percentage of sales, but also milestone, sales milestones as well. The good thing about this, it's a scalable business model. You can do this with multiple partners, and you get a nice cumulative revenue model. So that's where we're positioning ourselves. This is the long game. This is not easy to do, but this is the opportunity before us and why Prescient is so unique. And again, this is a different way of displaying that we've got in-house and external opportunities. I just want to finish on the end game for Prescient, which is an ecosystem. This has never been done with medicine. It's been done, Apple's done it with electronics. It's never been done with medicine. We think that OmniCAR can be the very first enabler of patient-centric therapeutic ecosystems. So we see a world in the not-too-distant future where a patient with cancer goes to the clinic and the tumor gets characterized to determine its antigens. And guess what, step 1 happens already. This has been happening for a number of years and is getting better and better and better. Like as a standard now, a patient will -- a hospital will now produce an antigen profile. But what will happen soon is that a doctor will be able to say, based on your profile, I need a certain number of binders, A, B and D, to match that tumor exactly and you plug them straight on to an OmniCAR cell and the patient now has a bespoke therapy. So traditionally, personalization and efficiency are opposing forces and quite the opposite here. So what makes this an ecosystem is that anyone creating a binder, you can tag it and put it in the app store with OmniCAR's technology. Anyone working on a really interesting cell type, and there's many companies out there thinking that their call is going to win, God bless them all, tag them and put it in the app store. And the doctor and the patient will have at their disposal, all of the tools they need to create a therapy that is tailored exactly for that patient. And if the tumor happens to slip through, you've only got 99% of the tumor, you just rack in another binder. And that's why this is a cycle here. So the enabling technology and attack here is only CAR, and that is the end game. So in short, we're in the biggest health care market, oncology. We're in the fastest-growing area. It's growing to $37 billion almost from a standing start in 6 years. And who's at the forefront of this? It's the company that has -- can make these therapy scalable, controllable, any target, any cell with the top pedigreed and honestly, and on heart, that is Prescient. Prescient finds itself in that sweet spot from a top-down analysis. And that's it pretty much. In summary, just as a reminder, all blue chip assets, any company would be proud to have any one of these. We've got all of them, top pedigree. We work with the best, superior position and business model there, having internal programs and external opportunities. It's a highly scalable business model and the shovels to the gold rush positioning. And if that wasn't enough, we've got this tremendous tailwind where we find ourselves at the forefront of the fastest-growing area of the biggest segment in the industry. So a really, really good position to be in, exciting times and lots of news coming out. So that is it, Pat, and I'll hand it back to you while I catch my breath.

Thanks, Steven. Look, we've got quite a few questions in the chat box, and I'll do my best to summarize. Some of these are quite a bit of double up. So if you feel like I've not done to your question justice, please just retype it in. [ Tom Jose ] asks, well, Steven, congratulation on the Thermo Fisher agreement. How did it come about, please? And the extension of that was, did you approach them? Did they approach you? But maybe if you could talk about how that agreement came about.

Yes, there's only so much I can say as you can appreciate, and I do not want to start off my relationship with Thermo on the wrong foot. So I'll be guarded with what I say. We knew of each other. And our Senior VP of Scientific Affairs, Rebecca Lim, had actually helped develop some products with them before in her former life. So she had the ear of a few people. And when they heard about what we had, the areas of collaborative potential became very, very apparent and things then moved very quickly.

Thank you. And I know there's quite a few people on the session today that are not shareholders and haven't been to a session before. If you want to stay -- if you want to follow PTX, type PTX into the chat box. And as any key news come through like Thermo, the FDA approval, any of those news flows come through, we'll make sure that they've sent out to you and you're invited to subsequent briefing. So just type PTX into the chat box. Now in terms of the few people asking questions around the compatibility of Thermo, what Thermo Fisher's developing and CellPryme-M, could you make a comment on that?

I would rather not make a comment on that now. But yes, so Thermo Fisher, let's be clear, Thermo Fisher are not in the business of developing therapeutics per se. They sell devices and reagents and services and I think want to position themselves for the opportunity to sell more of those. So yes, so let's just stay tuned there.

Okay. Now a few people asking for updates on partnerships with CellPryme. Maybe that might be worth just explaining the sales model around CellPryme, that might be helpful there. I know that any partnerships will be announced, will probably need to be announced -- will probably need to be announced for an ASX announcement. So probably not too much that can be added. But maybe, Steven, if you could just talk through the sales model for CellPryme.

Yes. So CellPryme is something that we can put into a manufacturing process that already exists and produce a bit of phenotype. I don't want to give the impression that that means that you can start selling it just like you -- we're selling powdered milk. That's just not how it works. So we do need to -- we've only launched this a couple of months ago, and we've got an amazing hearing. We now need to keep following up all of those leads. And this has a much lower hurdle for adoption than OmniCAR. OmniCAR is truly disruptive in many ways, even though it can complement what people are doing, but needs them to redesign things. That's a higher value and higher hurdle for adoption by third-parties who currently got their current constructs. By contrast, CellPryme-M, I describe, is almost like a -- think of it like a high-value reagent. So it might be a lower margin opportunity, but might be more easily incorporated. So the challenge for us is to pass the due diligence and get in front of the people who make these and convince them that this is worth doing with some CMC amendments. And again, we're having all of the conversations we need to have. But I just want to be clear here, whilst we're painting an exciting picture of upside and potential, I don't want people to think that this is like going [indiscernible] and selling -- having -- we have 12 licensed and 12 agreements by the end of the year is simply not how it works. But we're very encouraged by the interactions we've had. And regardless of any of that, where, as I said, we're going to be our own first customer. I know that doesn't pay the bills, but that is going to be producing the very first sell for us. Why is that important? In addition to enhancing our own program, we're also going to be generating the very first clinical data. So what we're not doing is going to anyone else saying, please, can you generate some clinical data for us and validate this for us? We'll be doing it ourselves. So that's the good news from that point of view, and blatantly, as soon as we start showing some clinical data that helps things even more. I don't think we need to wait that long, and I'd like to be -- I'd like to certainly continue the momentum we're having with our CellPryme discussions.

Thanks, Steven. Just a couple of questions about Q-Gen. I might wrap them up. But Ben has asked and Lisa has asked a question. Do Q-Gen have the ability to produce the Thermo Fisher OmniCAR sells? And then probably further to that, can you please explain the significance of the agreement with Q-Gen in a bit more detail?

Yes. So apologies if I didn't do this adequately on that slide. So I'm not sure if Q-Gen have the latest Thermo Fisher equipment there. That's Q-Gen's business. But certainly it wouldn't be a very big barrier to. I think from what I have heard in the industry, you would be hard pressed to find a cell manufacturer around the world that did not have some form of Thermo Fisher equipment in it. So I don't think that's going to be too much of an impediment. So the significance of the Q-Gen announcement is that we are now with an eye to the future and encouraged by the preclinical data that we're seeing. We're all about marching to the clinic with purpose and that is in preparation for that so that we're doing all the tech transfer and all the optimization that we require in advance of that so that we're producing the best types of cells that we can. This involves initially doing production runs on healthy blood samples from healthy volunteers. And then we move to actual AML patients that are not on the trial so that by the time we do our clinical trial, there is all the protocols and everything is optimized, not just for making T-cells, but for making T-cells from AML patients. So we can't over-stand. There is nothing harder to make in the whole therapeutic universe than immune cells. It is the hardest thing to manufacture. So that's why I think there's only a couple in Australia that are even licensed to do so. And we've got our slot with one of them. As a result, these are often booked out well in advance, and you just cannot get your manufacturing slot and you have to wait your -- at the behest then of other people may be pulling their programs and hopefully not extending them in order to get your slot. What I'm saying is that we've got our manufacturing slot secured. So significant from a number of viewpoints and Q-Gen, delighted to be working with us too, being a local company.

[ Haney ] has asked, in relation to CellPryme-M, if the tech was to be picked up by a company with an asset already in clinic/approved, will they need a new IND from FDA?

It's a very, very good question. Our regulatory advice is that you would not need a brand new IND. And for those on the call that aren't familiar, in order to do a clinical study, you need -- think of it like the driver's license from the regulatory body, in the U.S. it's the FDA, in Australia it's the TGA. You cannot do a trial without that driver's license. And that driver's license is extremely thorough. Our understanding from our reg interactions is to make CellPryme -- to make a CellPryme enhanced product is a very minor amendment to the manufacturing component of that IND. So it will be very achievable.

All right. [ Sarah ] has asked, in many presentations, you talk about PTX-100 or 200, if successful, can be a company maker. Can you please share with us your definition of the term company maker?

A company maker is something that further derisks the entire company and could potentially give you a drug on market. That's the raison d'etre of every biotech and if it's not, then it should be. So what we're saying is -- and the business model in Australia, unfortunately, is that you get to a certain stage and then you out-license it because very few companies can capture the entire value chain and have the capabilities of running a definitive study and getting something on market and having their own sales force. Companies like [ Telix ], excellent company in my personal opinion, not an endorsement, do your own research. But they are an example of a company, in that case, radiopharmaceuticals. It's got nothing to do with what we're doing, but who want to capture that. They are not satisfied in getting to a certain stage, putting on your bets closed and trying to partner with people, they can carry it the whole way. So we've got the opportunity in front of us here with PTX-100 and 200, especially with 100, to be honest, is that we have the capacity in the event of technical success to carry this a lot further than would otherwise be possible. And therefore to capture a lot more value and by not being forced to partner it early. And that is in the Australian context, especially the definition of a company maker. I'd remind you that there are far too many companies listed on the ASX in my personal opinion that have a single product or have a single trial even. And I think there'd be -- I think most companies would be very proud if they had either PTX-100 or 200. We happen to have both.

Is there any -- I don't want to put you on the spot here, but I will, and you don't have to answer the question. But I think maybe where Sarah is coming from is, I mean, what do you compare it to its success too?

I -- well, you don't -- you compare it against being a research company forever in a day and just having a 20-year development program, don't you? So if you're asking me to compare it to existing drugs, we can do that, it's probably best for an analyst to do that. Compare it to what's out there. I've given some examples on PTX-100 in particular, about what the competition looks like. And I'd invite you to have a look at that as to what a defensible comparison is. But really, I guess, the point here is that we're not asking shareholders to take 10, 15, 20 years of development risk here. I'm saying within you've got a nice, diversified pipeline, and we are quite different from those single product companies who are 10, 15 years from any value creation.

Thank you, Steven. Thank you for everyone taking the time to join this session today. Steven, I'll leave the last word with you and we'll call the session to a hold. Just a moment. Thank you.

Thank you, everyone. Yes. So again, this slide says it all. We've got 4 blue-chip assets. They're all producing data. We've got momentum on basically every aspect of the business. We're in a great position with this great tailwind. And I think we're starting to see the first dominoes fall. And you can see that how active we have been and that this is perhaps now the first commercial bit of validation that, yes, we have something real here that we'll want to align so to speak. So an incredibly exciting opportunity, an incredibly exciting time to be involved in Prescient. And it's all based on this incredible data and incredible positioning, and I think we could all be very proud of where we're at and where we're going. So with all of that in mind, many thanks to everyone and look forward to welcoming you as a Prescient shareholder. Have a good day.