Prescient Therapeutics Limited (PTX) Earnings Call Transcript & Summary
November 29, 2022
Earnings Call Speaker Segments
Melanie Jaye Leydin
executiveThanks, Steven. The time is now 11:00 a.m. You may start the meeting.
Steven Engle
executiveThanks, Melanie. Good morning, all. My name is Steven Engle, and as Chair of Prescient Therapeutics Limited, it is my pleasure to welcome you to the company's 2022 Annual General Meeting. I would like to start by acknowledging and paying respect to the traditional custodians of the land, wherever those participating at this meeting are located. To ensure that shareholders and their representatives can attend the meeting safely, this meeting is being held virtually. Shareholders will be able to participate and view a live webcast of the meeting, ask questions and cast direct votes at the appropriate times whilst the meeting is in progress. The company secretary has advised that we have complied with the relevant requirements for convening this meeting and a quorum is present. As the time is now 11 a.m., I formally declare the meeting open. I'm joined through the webcast today by my fellow directors: James Campbell; Allen Ebens; and our Managing Director and CEO, Steven Yatomi-Clarke. Also in attendance is our company Secretary, Melanie Leydin. In addition, we have the representatives of the company's external auditors, William Back, in attendance at the meeting. The notice of the meeting has been given in accordance with the company's constitution, and copies are available for you on the company's website, the share of registry's online voting site or on the ASX market announcements platform. I will take the Notice of Meeting and explanatory statement as read. The format of today's meeting will be a brief Chair address from myself; a presentation by our CEO, Steven Yatomi-Clarke; followed by consideration of the formal business on today's agenda. Following our presentation by Steven, we will provide an overview of the Q&A and voting procedure for today's meeting. You will then have an opportunity to ask questions on the company's business operations. Following this Q&A session on the business operations, we will move into the formal business for today's meeting. And on conclusion of the formal business, there will be a further Q&A session held, giving all shareholders the opportunity to ask questions in relation to the formal business. As previously noted, this is a virtual meeting, and shareholders will be able to ask questions and cast direct votes at the appropriate times while the meeting is in progress. Questions that are received during the meeting, which are of similar nature will be grouped and answered at the appropriate time. If you have any questions, which you feel were not addressed at today's meeting, we invite shareholders to contact the company via phone or e-mail. And now I'll give my address. Dear shareholders and colleagues, since we last met in this forum a year ago, Prescient has made significant progress on a number of important fronts. As a result, the business today is in an excellent position with the balance sheet to execute on its plan and the talent and team to deliver. And this includes a number of items: The ongoing excellent safety and efficacy data from PTX-100 and PTX-200; the granting of orphan drug designation for PTX-100 by the U.S. FDA for peripheral T-cell lymphoma; the development of robust and reliable manufacturing and supply agreements for Prescient's OmniCAR cell therapies as well as the public unveiling of OmniCAR's complementary CellPryme-M manufacturing enhancement platform and CellPryme-A adjuvant therapy. Another example is the partnership established with the University of Texas MD Anderson, which gives the company access to additional expertise and technologies that will enable the creation of a new generation of safe and effective CAR-T therapies for blood cancers. This collaboration is a testament to the quality of Prescient's medical technology assets. Together, these achievements strengthen Prescient's position as an emerging global leader in biotechnology and especially in [ looping ] CAR-T therapies beyond their current limitations. Importantly, each of these milestones help reduce many of the risks associated with the business our size, as we position to help transform a multibillion-dollar industry. Steven Yatomi-Clarke will make some more comments on the market and the industry in his presentation. But I wanted to add to that perspective. Even as this is a challenging market for capital and equities, the need for new medical therapies continues to grow. With an aging population and without innovative therapies, health care costs will grow faster. Development of therapies for oncology indications remains a primary target of investors, of doctors and, of course, in search to help patients. And this is true for dealmaking with corporate partners as well. And PTX is well-positioned. And we know that the biology revolution not only continues, but it actually looks like it's going faster, whether it's CRISPR; other gene therapies; RNAi, which was used with our vaccines or cellular technologies, they're all progressing surprisingly quickly. I often tell people that the key is to stay alive for the next decade because there's so much changing at this point in time. Since the first chimeric antigen receptor T-cell therapy or CAR-T, as we call it, was approved in 2017, cellular therapies have revolutionized the treatment of certain hematologic malignancies and achieving unprecedented efficacy. So innovation in this business is still key and innovative companies are critical. I also note that the general FDA approvals have increased, helping company and also the partners we're working with. I believe that the cellular therapy industry is experiencing a shift similar to that, that occurred with the adoption of monoclonal antibodies, which is now over $100 billion a year business. At first, Big Pharma was reticent. Basically, we were told that they're in the pill business. They don't do antibodies. And then successes with drugs like the B-cell lymphoma drug Rituxan came and everyone began to shift. In fact, we began to hear that certain companies had to have both candidates and capabilities of the monoclonal antibody kind. I think that same thing is going on right now. It has already started, but we're going to continue to see it because even now, not all the pharmaceutical companies are involved in the area. Initial therapies for CAR-T-based hematologic candidates have attracted attention and spending. More will come with continued success. As of 2021, improved cell therapies generated more than USD 2 billion in sales and the market is expected to reach as much as $37 billion by 2028. Our modular approach can help build a key innovation gap in the cellular therapy area. For example, significant challenges, including safety and logistics have hindered the broader adoption of cell therapies. Prescient's OmniCAR platform promises to reduce many of the logistics and manufacturing complexities that have constrained the uptake of this very important CAR-T cell therapy while also addressing the complex safety issues. I have to say recently, Steve and I attended the Cellular Therapy Meeting on the Mesa, where Steve spoke and listened, and I listened to a number of the presentations. Steve's presentation was unique in that it is the only one that spoke to the advantages of the modular approach that Prescient is developing. Prescient's capital raise in October was a significant derisking event and it's important. It's clear, given the ongoing market uncertainty. Global investment market volatility, as you know, shows no sign of abating, placing stress on valuations and stock prices across sectors, especially early-stage companies reliant on capital. As the business continues to grow and expand its clinical programs, the Board and management team is committed to delivering on the standards of corporate governance expected of the company seeking to improve human health. This ranges from shareholder transparency and accountability to our reporting in medical and patient-centric decision-making. I hope this update highlights some of the key facets, company's achievements, current direction. Obviously, Steve will have more to say. My thanks go to my fellow directors for their commitment to the company. And a special thanks goes to our Managing Director and CEO, Steven Yatomi-Clarke and his team, are the substantial achievements this year. The company also acknowledges the support of the Australian government through its R&D tax incentive scheme, which enables us to reinvest back into our R&D programs. And of course, I wish to thank all our shareholders for your support. All of us remain very focused and driven to succeed, and our mission to improve cancer treatment by giving doctors the tools they need to help patients with cancer live longer and better quality lives. At this moment, I'd like to hand it over to Steve for the CEO presentation.
Yatomi-Clarke Lee
executiveThank you, Steve, for that. Just sharing my screen now. Hopefully, you can see this. Excellent. So again, building on what our Chair has said, it's been an amazing year. It's been in progress. It's been about positioning You've heard [ about one third ] to this. It's also about resilience. You'd never guess from the macro headwinds that even existed if you're looking at what we were achieving at an operations level with Prescient. It's been an incredible time. And it's really -- it's just a new beginning for us. It's -- we've got a lot of operational momentum. This is not an investor pitch deck, it's more a year-end review, but necessarily, I'll be diving down into various aspects of the programs because all of you are shareholders, it's -- none of this is going to be new to you. But there'll be some new slides and some new perspectives, given what we're talking about today. Look at this pipeline, this is the pipeline of a much bigger company. And I think we should be very, very proud that we've got the cutting-edge pipeline like this that is relevant, that is diverse in its risk, but it's also focused. Often you get diversity at the expense of being focused. We are very, very focused. For example, in the case of OmniCAR, our beachhead is going to be our AML program. But we've got some nice work coming in behind that. So again, nice risk diversification, lots of news flow, lots of value creation here. Let's just touch on some of the key achievements during this year. It's been an incredible year, and let's start with our targeted therapies. We've had excellent progress on the PTX-100 trial. As you might recall, sort of global bottlenecks resulted in delays in our manufacturing of that by some months. Luckily, we're able to make up that time. That trial, it's hard to believe it was initiated in April of this year. This expansion [indiscernible] CAR-T cell lymphomas, but we've made a good ground on enrollment since then. It's demonstrated in that meantime, not just on ongoing excellent safety, which is something that established drugs in this setting do not exhibit but also encouraging activity in terms of sponsors and also the durability of those responses. And there's also progress on our PTX-200 trial in AML, which has also expanded following our fourth complete remission in this awful disease. OmniCAR has just been a hot bed of progress, our internal programs across AML, Her2-positive so [indiscernible]. Lots of work in the background. We're not in a habit of drip feeding each experiment to the market, but we are very, very pleased with how this is all going. There's new learnings, especially when you've got a novel platform that can do things that haven't been done before. You expect setbacks. We've had very few of those, and those that have been there have actually opened new doors and new learnings for us. So it's been an incredibly energizing experience. So we've had a lot of technical success there. A key highlight of the year was our strategic collaboration with not only the largest cancer center in the U.S., but the largest in the world, the MD Anderson Cancer Center. And in terms of cell therapy, it is over twice as active as #2 in the U.S. in cell therapy. So we couldn't be in better hands using their proprietary database. I'll touch on that a little later on. So the first example of a third-party app in our app store, if you like, being from the absolute crème de la crème, which is fantastic. We've also announced a collaboration with a large international company that needs our permission each time we name them. So you know who they are. You can go back to our announcements from back in August, September and see who they are. But we know them and love them. They're doing our platform extensions on OmniCAR. And again, we couldn't be in better hands there to take this to the next level by doing nonviral transduction, removing those bottlenecks and making close-end automated manufacturing to make this decentralized and scalable. We announced Qgen manufacturing cells for our upcoming clinical trials. So we have had the time slot where the manufacturing slot, should we say, for our clinical trial and doing the tech transfer and optimizing that process in preparation for that. So it's all getting very real. We also had a key OmniCAR patent granted in the U.S. and continue to build awareness. We get a very full dance card wherever we go and everyone leans into the OmniCAR slides. It's certainly the right technology at the right time. During the year, if you can believe that we unveiled 2 cell therapy enhancement program, CellPryme-M, which is their manufacturing enhancement, which we announced in June. It produces a more youthful cell type that's correlated and necessary for a better response and more durable response. And this is ready for the clinic right now. And we also unveiled a little later on CellPryme-A, which is an adjuvant therapy used alongside cell therapy, which overcomes a really hostile tumor microenvironment. I'll touch on this a little bit later for those that want a little bit more of an explanation. But it basically helps these cells expand once they're inside the body and to penetrate this force field that solid tumors build around them and they thrive in, to tear that apart and let these expanded cells get into where they need to get to is going to be crucial in solid tumors. And that's what CellPryme-A does. And it works even better when it's used alongside cells made with the CellPryme-M process. Important to note, and we should fly this up the fly quite high. CellPryme was developed in-house, so we owe nothing to anyone. And it's really credit to our internal team and our collaborators at Peter Mac that we can take an idea, take it through development and demonstrate the concept quite robustly that we've got a cell therapy enhancement technology that's relevant to 2 important parts of the therapeutic process, that it's relevant, and that it works and we all did that now. So I think that's really a testament to the company. It's something that you should all be very, very proud of. This is not something we've had to license that someone else has done the hard work on. So I'd like to thank our collaborators and our internal team for their hard work there, too. I'll spend a bit of time on the elephant in the room, which is the market backdrop. It's been a real headwind. There's been considerable headwinds of late, especially in technology and biotechnology companies. Why is that? Because these companies tend to have valuations dependent on future events. So inflation tends to erode those valuations disproportionately. But it's forgetting one thing is that despite inflation, when you're in health care and especially in where we are in health care, there is almost perfect elasticity of demand. Which is to say that let's say, inflation did happen to run rampant and the cost of a cancer therapy went up. It's not like you're going to stop using a cancer therapy when the alternative is death. So it's important to keep that in mind, too. Also, the geopolitical uncertainty, which hit at an especially vulnerable time at the start of the year when there were already some shakes in the sector and the market. And this was compounded in fact, the first dominoes to fall were the tourist investors. It's always their general list investors. It's not necessarily the sector specialists who understand the science. It was those who pass in and pass out the hot money, if you like, that set them up and then send them back down. So those tourist investors that became enamored with health care investments during the pandemic when the importance of health care was brought to the forefront of all of our minds. They were the last to arrive and the first to leave. And when they leave, they're left with -- the sector specialists left holding the bag. The other point to note is that a lot of hot money back in 2020 in the sector, especially in the U.S. gave rise to a lot of early-stage companies. There's nothing against early-stage companies, but the disproportionate number of new early-stage companies meant that the risk that is associated with earlier stage deals meant that there were proportionately more bad news events or delay events and whatnot. And so that was getting a disproportionate proportion of headlines. But when you look at what's happened, it looks like flat is the new up. When we're looking at the technology, the value of technology across the market, it's been stable for a long time. I'm talking about enterprise values. So when you look at the market caps of companies and strip out the cash, you're sort of left -- and the debt, you're left where you add back the debt. You're left with the technology value, if you like. And you can see here, it's been stable since late July or early July. So this is hopefully a good spring with signs of stabilized. Fingers crossed. But let's think about what green shoots should investors look for and I've listed some of them here. First signs that these tourist investors have departed. It looks like there's a lot of evidence that, that's happened. And looking not necessarily the end of inflation but seeing route to where that might be and stabilizing rate movements, especially will be very valuable to the sector that you don't even need to be at the worst of inflation. Just need to be able to see through to the end of it. There's a lot of pressure also to cover short positions and we're already seeing that happening now. And what's been fascinating, which a lot of observers don't realize is the incredible fund inflows of the last 12 months in the U.S., especially, 10 of those last 12 months have had big net inflows of going to biotech fund managers looking for investments. In fact, over $1 billion on average a month. And that money has got to find a home. And there's also some commentators saying that early in the year when there's this less pressure for redemptions, we should see some of that money being put to work and get traction. Also, I think that it's fair to say that sometimes industry lets down investors and health care is not immune to that either. But I've got to say, in the last couple of years, it's continued to deliver. Of course, there have been hiccups, but the delivery has been nothing short of astounding. So again, the industry is still doing what it needs to do. They're delivering on from a technical front -- on the reg front, and also commercially. So eventually, that should be rewarded as well. Lastly, there's a lot of cashed up companies. We're talking about larger companies here and some of them have mandated that they've got some big revenue targets and that they can only bridge those gaps through mergers and acquisitions. So that should reignite some interest again. We've already seen the first couple of deals happened in the last couple of months, which is another sign that some industry observers look for so -- to when the word is hopefully going to start to turn. So these are some of the factors to look out for. Let's look at some another quick reminder about some of our programs. PTX-100, we all own and love this drug. It's licensed from the Yale University. It's in a trial here led by the esteemed Professor Miles Prince. It's in an expansion cohort in T-cell lymphomas, as I mentioned earlier, which started in April. We've -- we're getting towards the end of this recruitment, which is fantastic. We're hoping that the next trial, fingers crossed, could be a registration study. A big gastric surround that. It looks like, as we speak, the FDA is, if you like, moving the goal posts on that, what that looks like for an accelerated approval. So we'll get better clarity on that in the coming months. But regardless, we're marching forward, it's -- we're confident that whatever way -- whatever development plan we take forward is going to be much shorter than would otherwise be possible. And again, pralatrexate, as you know, is an example of the size of the prize that is available to a drug in this setting. And the data that we are seeing in T-cell lymphomas is really, really encouraging, especially from -- not just a response rate, but the durability of these responses. So again, to have one very good partial response, almost a complete response and 3 PRs and 1 ongoing. In fact, it's looking like there's a -- that should be a fourth one there as well and 2 stable disease is fantastic. Another way to look at this is that only 2 patients got worse, despite the fact to that these patients have failed between 4 and 6 prior lines of therapy, only 2 patients got worse on this trial, which is remarkable. And here's one example of a before and after shot of a woman who, failed a 6 prior lines of therapy with cutaneous T-cell lymphoma. I mean, the power of this image is that you can see quite visibly these lesions disappearing. What you can't see is the benefit to this patient's life. She's got a new lease of life. Imagine being in pain and discomfort to the point where you can't sleep, you can't move, you can't dress. To be able to get your life back and have a good quality of life is something that we need to take into consideration to -- when looking at the magnitude of the effect of this drug. So that's really encouraging. Also, as I mentioned during the period, PTX-200 continues to show really interesting data in AML. We had a fourth patient with a complete response and another one with a partial response. And we've expanded another few more patients in AML to [ eke ] out a bit more data. And this drug as well like PTX-100 has U.S. orphan drug designation from the FDA. I think it's important to talk about this going just to be perfectly transparent. The landscape of AML from when we started this trial to where it is now has shifted considerably as to what the standard of care is. For 40 years, there were no drugs approved and in the short space of time, lots of different targeted therapies depending on the mutations have been approved. So I mean, the landscape is changing here. We need to take this into account when looking at where to from here, for the next trial for AML. So we just want to be open and upfront about that. But what a fantastic position to be in where the drug is actually exhibiting activity. So that's good news. Let's talk about now about how we're positioned in the cell therapy sector. And we know that where we are today is in a short space of time, CAR-T has just boomed and it's based on real-world data. As our Chairman mentioned, this year alone has been $2 billion of sales. But in 6 years from now, it's going to go from $2 billion to $37 billion in 6 years. Despite the fact that the current generation is very clunky, they're difficult to make. There's a shortage there's bottlenecks in manufacturing. Despite all of that, the market is booming. Why? Because they work. Bottom line is that we've got curative potential in certain malignancies. And despite the macro headwinds, look at the growth here, there's been an 80% increase in the number of programs in CAR-T, 14% more clinical trials and 63% more antigens being discovered and worked on. And it's really important to know this when you're -- basically, when you're picking your investment. It's hard to know which antigen is going to win, which target is going to win. And that's why we feel Prescient is so well-positioned to be able to be agnostic on all of this. And I'll give you an example here on this slide here, understanding the landscape in heme malignancies. This is how we invest very heavily in researching and understanding week-by-week, the movements in what people are doing here. This is in blood cancers, very, very crowded and a handful of indications. 65% of all researches are only done on 4 of them. Very, very, very crowded in solid. It's -- there's a longer tail there. It's more distribution, and that reflects the fact that there's greater heterogeneity of antigen expression on solid tumors. The good thing is we -- not only do we know this but we're agnostic on all of these targets. So we can work with all of them. But in working out who you need to work with and where you need to be, understanding this is crucial to assume that one of these is going to be the winner. You can see -- you can see the risk here in looking -- if a company was just to select a single target, thinking that, that one is going to win when you look at this landscape, and the fact that it's continuing to grow. As you know, we're looking to solve the problems confronting the current generation of CAR T. I've listed them here. I've described them many times and you know them. And I just want to highlight that we're looking to solve not 1 or 2 of them but all of them. And in fact, where these overlap between OmniCAR and CellPryme, they do so very differently by different mechanisms, and that creates some synergy for an even better way of creating therapies that are safer and more effective and longer lasting, et cetera. So again, to illustrate this in a different way, how this landscape can be broken down. There are people with different cell types, different targets, as I mentioned, different indications and the different ways of making them. And at the moment, there's 6 approved CAR-T therapies on the market right now. They're all just in this space. They're all autologous T cells. So firstly, they're all T cells and they all come from the patient. They focus on 2 targets right now for 2 different groups of blood cancers and they're made in the same way. But where we're going is beyond that. So there's a myriad of other companies working on other cell types, working on a bunch of those other targets and new sort of hundreds of targets I just showed you in the previous slide. Looking at indications beyond some of these low-hanging blood cancers. These are other heme malignancies but also solid tumors and even has application beyond cancer altogether. Once you have something that's controllable, you can start looking at non-oncology indications like autoimmunity. And there's different ways of making these as well. And what I want to convey to you is that through our 2 different platforms, OmniCAR and CellPryme, we are able to address all of them. I just want this slide to sink in. is that with Prescient, your investment in Prescient, you are hedging your bets on where this sector is now and where it's moving to. You don't need to pick a winner because we can work with all of them. And hence, our platform. So we've got our in-house programs and you know what they are and we're going to use our platforms to make product. Platforms have to make products, otherwise, what are they there for. They have to result in products. And as you've heard me say, you judge the quality of a tree by the sweetness of the fruit it produces. And that's what we do with our 3 programs here. So we are deploying both OmniCAR and CellPryme to make products. But beyond that, we can work with these other parties. We can -- they can use OmniCAR, if they wish. They can use CellPryme, if they wish or they can use both. But the point is that we have not only got our own programs, but we've got basically selling shovels in a gold rush with respect to this huge growing sector in CAR-T. So highly scalable and a great way of giving shareholders leverage to other people's technology and efforts of our balance sheet. And again, the end game here about when we're talking about the landscape. How we can pull together technologies instead of having them compete against one another. So again, to being able to match a patient's antigen profile with binders and plug those into cells that are ready and give that patient a bespoke controllable therapy. Again, MD Anderson, the first example of a third-party app in this App Store. Other people on the -- working on interesting cell types will be different cells in this App Store, too. So again, the beauty of Prescient for the very first time, we think we can pull together through the power of OmniCAR therapies or what would otherwise be competing against one another, in order to make the world's best therapies for individual patients. Again, top-down analysis since market. We all know that health care is relatively recession-proof, but the biggest market in health care is oncology, without a doubt, approaching $0.5 trillion in a few years, if you can believe that. And you look at what is the fastest-growing area in oncology and that is cell therapies. And when you look at -- okay, who is at the forefront of the fastest-growing area in the largest market? And you just know that someone that can work with anyone that can make next-generation technologies, that can work on any seller, on any target, and make them safer and controllable. And guess what, it helps if it comes from the very people who invented this thing. And when you run that top-down analysis, you're going to get Prescient. So it's a very, very defensible position during uncertain times, especially. A little reminder on OmniCAR. You know what it is, it's the module system that we've licensed from Penn and Oxford and building on this, it's separating the targeting ligand from the signaling domain. And when these 2 bits of [indiscernible] come together, you get unarmed CAR-T cell, and we're agnostic on the ligand and we're agnostic on the immune cell. Some of the features here that you've heard me speak about being able to control the activity once you infuse them, being able to switch them on and switch them off and switch them back on again. Being able to redirect to target in real time with -- just by simply switching out the binder. It's something no one's been able there to do and be able to plug multiple binders onto this to have a multivalent CAR. So this is just a summary of some of the key features of OmniCAR. And what I've got here is, hopefully, you can see these in real time. So what we've got here, we often get asked, "How do these work against a conventional CAR?" Well, what you've got here is on the left is a conventional HER2, the best one, the best workhorse there, that Peter Mac have. And then on the right, you got OmniCAR. Basically the red cells are the live cancer cells. And as they die, they become green. And you can see this, as I'm speaking to you, you can see how quickly the OmniCAR ones are killing it and becoming green. So when someone asks us, "Well, how do these work head-to-head?" We can say it's at least as potent as conventional CAR-T, what you're seeing in front of you qualitatively says it's actually even better. So historically, these types of control efforts have come at the expense of being effective. What I'm showing you here is evidence that there is no compromise at all. It's at least as good as what is out there. You've seen this data, too, it's just a really powerful example of how we're able to redirect the cell getting 2 different types of brain cancer cells, one expressing the HER2 in grain; the other one, EGFRviii in red, resembling I guess, what a patient would have. A patient would have a mixture of different cancer cells expressing different antigens. And when you give an OmniCAR that's been armed with EGFRviii, you get rapid cytotoxicity against those cells, and it leaves the other ones alone, which is what you want to see. And at 20 hours, we had a binder at -- why at 20 hours? That's enough time for daughter cells to be reproduced that are unarmed. And at 20 cells, we don't add any new cells. We just add the binder and you see something really interesting. It stops killing the red ones and starts smashing the grain lines. So you get rapid switching from one antigen to another. So when we had the binder, it stops killing the EGFRviii and starts killing HER2,all with no new cells required. As far as we know, this is a world-first experiment and something that really raises eyebrows whenever we present it. And this is relatively new data. Two people asked, "Well, how long do these remain armable for?" In this case, 3 weeks. So this is in mice, where we're incubating these tumors, and we're not -- we're giving them OmniCAR that is -- that doesn't have any binder. And you can see that it's -- the tumor is growing in the presence of this unarmed OmniCAR cell, which is what we planned because the OmniCAR cell demonstrates here that it's not active until we make it active. At 21 days, at 3 weeks, we add the binder and bang, you see it's ready to go and it starts smashing these tumors. And by then, these tumors in these mice, they are much, much bigger than they should normally be. It's been growing for 3 weeks unchecked. So these are very, very big tumors that's able to reduce not only an immediate cytotoxicity, but very powerful cytotoxicity. This is describing our MD Anderson relationship in illustrative form. So we've got our 2 binders there, CD33 and CLL-1. The TCR-like binders is the same as MD Anderson's. They are wanting to piggyback our system, I guess, and create a truly multivalent product that is going to be what we're aiming for as the world's best therapy for blood cancers. So that comes from their ECLIPSE program, which is the jewel in the crown of MD Anderson, their words. And for them to entrust this crown jewel of theirs by -- through this strategic collaboration is really a feather in the cap. And the fact that it's the jump-off point for Prescient with an external party is pretty amazing. We've started right at the top there. So -- and again, the first example of a third-party app in our app store. Again just touching on CellPryme. And if you're wondering where CellPryme fits in the scheme of CAR-T, CellPryme-M is when you're manufacturing the cells outside of the body, and they're starting to expand. You drop it into CellPryme-M. M is for manufacturing, and A is for adjuvant. That's given to the patients, that's injected into the patient alongside the CAR-T therapy. And it produces a whole bunch of benefits without giving too much of the science lesson. T cells mature, they go on the left-hand side there, to the naïve cells. They last a long, long time, don't do any killing. Right towards the other, the effector cells. They do a bunch of killing, but they die quickly. They finish before the job is done. And what we know is that current CAR-T processes make too many of those and not enough of these. You need more central memory cells. And in fact, when you look at third-party data, these so-called miraculous killers where people are 10 years cancer-free. It so happened that the bag of cells they got, the soup of cells, happen to be very rich in this population of cells. So all the efforts, all the green thumbs around the world during this manufacturing process are trying going to make these more youthful cells. Why am I telling you this? Because when you add CellPryme in into the manufacturing process, you push the phenotype towards this desirable phenotype. Not only does it lock in that phenotype, it can actually play the type backwards and send a more mature cell into the small youthful cell phenotype. It's quite unbelievable. And that's the cell type you want. So basically, these cells last a long time. In fact, this phenotype can potentially last decades. So it's longer lasting. They can get to where they need to get and they can penetrate the tumor once you get there. And there's a couple of other benefits there, including some potent antiviral properties. CellPryme-A, this is the one given to the patient, especially important in solid tumors that have this tumor microenvironment, which is the force field around of itself. It builds like a greenhouse, if you like, that the tumor thrives in. It grows quickly and it spreads because it's got this force filled around it, which includes like a physical barrier, a very fibrotic barrier that it's difficult for immune cells, the good cops, to get in and kill the tumor. And what CellPryme-A does, amongst many other things, it basically improves survival and kills these tumors by reducing this force field, reduces problematic Treg cells by 2/3. It dramatically increases the expansion of these CAR-T cells in the host. In fact, up to ninefold expansion -- increase in expansion, ninefold. And it can help penetrate this force field to this TME by up to fourfold, and it synergizes even better once you give it CellPryme-M. And if you're wondering how all of our technologies work with one another, just as a reminder, OmniCAR is about the modularity and modularity confers control and flexibility and multi-targeting. It's agnostic on the cell, it's agnostic on the binder. But CellPryme-M is about making a better type of cell, a more youthful type of cell that does its work better basically. And CellPryme, and it can work with a next-gen or a conventional CAR-T. But CellPryme-A can work with all of them. OmniCAR, CellPryme-M, from the third party as an adjuvant. So in summary, we've got the key building blocks for Prescient's value there. These are fantastic pillars for the business to grow. And each of them is a potential company in their own right. It's a really great footing for the company. The major catalysts that we're going to work towards next year, when you've got a pipeline as deep as ours, these catalysts come from multiple places. Some catalysts are more meaningful to the company than others, which are more needed like bricks in a wall being built on top of one another, but I've just listed some of the major catalysts there, which is included in the PTX-100 readout on this T-cell lymphoma cohort. Also a clarification on the next steps. As I mentioned, the FDA is currently moving the goal posts on the approval process for drugs with this type of approach. But regardless, it's going to be an exciting time for us there. With AML, with OmniCAR -- pardon me, it's going to be an incredibly -- it's going to be a watershed year for Prescient when we're actually looking and as of this meeting, committing to getting into the clinic well ahead of schedule. We were scheduled to be in the clinic in 2024. It's now going to be 2023, the second half of 2023. So you're going to see some very persuasive data in AML for OmniCAR coming out soon, that is underway. That is being optimized right now, and that study is going to be initiated again in the second half of next year, probably the end of Q3, beginning in Q4 at this stage. And looking forward to sharing with you our objectives for that study and what success means and also who's going to be leading that study. As always, we're going to be continuing to build awareness of our incredible programs, especially as data unfolds, getting their continued engagement with -- across industry and institutions and also key opinion leaders and investors. And of course, we are developing programs for ourselves, but what we're hoping to do is some of these seeds to take root and to be able to -- with third parties and be able to leverage our technologies external to the company for a benefit through collaborations and hopefully through licensing. I want to make it very clear that this is a long game that we've got to play. There's a reason why there's only been, I think, a couple of deals done in the last 10 years in Australia in the biotech sector. It's very hard to get licenses. And the earlier they are, it takes a different shape. But nevertheless, I think we've got such compelling technologies that I think we're backing ourselves in and have actually set it as a catalyst would like to work towards in the next year for this journey to actually get traction and take route. So in summary, I'd like to remind our shareholders about what we own together, and it's a company with 4 blue-chip assets. We've got 2 next-generation platforms and 2 targeted therapies. They couldn't come from better places, from Yale, from Penn, from Oxford developed alongside Peter Mac. A real sleep at night factor resides on all of these assets. We've got a fantastic positioning of good blend between our internal programs and our external opportunities, which means that we're highly scalable, with a shovels to the gold rush positioning. And if all of that wasn't enough, we've got the right technology at the right time with these incredible tailwinds as this sector is exploding. We're agnostic on the cells and the targets, and we can assist all of them. So again, we're backing ourselves in for a big year operationally. We thank you for your support and looking forward towards another tremendous 12 months ahead of us. So many thanks.
Steven Engle
executiveSteven, thanks so much. That was excellent. Always nice to know when the year you've just had is the best year yet, right? And so we look forward to more of this coming year. Our company Secretary will now outline the question and poll procedure for today's meeting.
Melanie Jaye Leydin
executiveAll right. Thanks, Steve. As mentioned earlier, shareholders will be able to comment, ask questions and cast votes at the appropriate time for each item of business. Visitors are reminded that whilst we welcome you at this meeting, it is a Shareholders' Meeting, and you may not comment or ask questions. We may experience some time lag, and this may cause some delay in your text questions or comments coming to our attention. We encourage you to lodge them as early as you can. Shareholders wishing to ask questions via text, please select the Q&A icon located at the bottom of your screen. Type your questions in the ask a question box and press the send arrow. Your questions will be addressed at the appropriate time. Shareholders wishing to speak and ask a question, an audio questions facility is available during this meeting. Please select the raise hand icon located at the bottom of your screen. You'll be placed on queue and authorized to speak when we reach the Q&A session. When you're asking your questions, please state your full name and who you are representing. Regarding voting on today's resolutions, all shareholders, proxy holders and authorized corporate representatives who are entitled to vote will be able to do so via the webinar poll. It is important to note that if you have lodged a proxy form and voted prior to the meeting, you do not need to vote again at this meeting unless you wish to change your proxy instruction. For those proxy holders, shareholders and authorized corporate representatives who have not yet voted prior to the meeting, please cast your votes on each of the resolutions when the poll is opened. For proxy holders, you will have a summary of proxy votes, which detail the voting instructions, if any, for the items of business. By completing the voting via the webinar poll, when instructed to vote in a particular manner, you will deem to have voted in accordance with those instructions. Where the Chair has been appointed proxy on behalf of the shareholder, Steven Engle, as Chair of the meeting, intends to be voting lease in favor of all of the resolutions. With regards to the poll procedure. We will open voting shortly so that your votes can be cast during the formal business section of the meeting. When the poll is declared open, a poll window will appear. To vote, simply select the direction in which you would like to cast your vote, the selected option will be marked. To submit your vote, simply click on the submit button, and you'll have the ability to change your vote up until the time the voting is closed. Thank you, Steve.
Steven Engle
executiveThanks, Melanie. We will now address shareholder questions, which were submitted prior to today's meeting and any received in relation to the business operations. Melanie?
Melanie Jaye Leydin
executiveThanks, Steve. We haven't -- we didn't receive any prior to the meeting. We've got the Q&A box open, ready for any questions on operations. There's no questions come through yet and no audio questions. So I'll just give it another few -- 30 seconds and see if anything comes through. But nothing coming through at the moment. There is another opportunity for questions at the end of the meeting with our formal business. So Steve, you might like to proceed with the formal matters.
Steven Engle
executiveGreat. Thanks, Melanie. As there are no further questions, I will now move forward. Firstly, if you have a question on any of the items of business, please follow the questions process, which was previously outlined by our company Secretary. We will address your questions after the last resolution. Before opening the poll, I wish to remind shareholders that the poll will remain open for an additional period after we have considered all resolutions. I now declare the poll open. I refer you to the first item of business set out in the notice of meeting, which is to receive and consider the financial report of the company, together with the Director's Report and the Auditor's Report for the financial year ending June 30, 2022. These items are contained in the annual report. I will ask that they be taken as read. The Annual Report is available on the ASX announcement platform or on the company's website. The Corporations Act requires the accounts and reports to be put before shareholders at the Annual General Meeting. However, except to set out in Resolution 1 to be considered later, there is no requirement for a vote of members to be taken on them. No written questions to the auditor were received by the cutoff date, 5 business days before this meeting. Questions may be directed through myself to the auditor, in relation to the conduct of the audit, the audit report, the company's accounting policies or the independence of the auditor. As this matter does not require a vote, we will now move on to the first resolution. Melanie, I now refer you to Resolution 1, which is to consider the adoption of the Remuneration Report forming part of the Directors' Report for the financial year ended June 30, 2022. The Remuneration Report is set out in Directors' Report in the company's 2022 Annual Report. The report sets out the company's remuneration arrangements for the directors and key management personnel of the company. The vote on this resolution is advisory only and does not bind the directors or the company. The voting percentage of proxies have been received for Resolution 1 and are outlined in the presentation. 94.5% in favor or 0.16% against and open was 1.34%. I move that shareholders consider, and if thought fit, pass the ordinary resolution. As the next resolution concerns myself, I will now hand the meeting over to Melanie.
Melanie Jaye Leydin
executiveThanks, Steven. We now move to Resolution 2, which relates to the reelection of Mr. Steven Engle as a Director of the company. Mr. Engle's profile has been provided on Page 4 of the notice of meeting. The following percentage of proxies have been received for Resolution 2 and are outlined in the presentation, 97.78%, in favor; 0.99%, against; and 1.23%, open. I move that shareholders consider, and if thought fit, pass the ordinary resolution. Thanks, Steve.
Steven Engle
executiveThank you, Melanie. I now refer to Resolution 3, which refers to the approval of the issue of equity securities under company's Executive Option Plan. The following percentage of proxies have been received for Resolution 3 and are outlined in the presentation, 87.16%, for; against, 11.54%; and open, 1.3%. I move that shareholders consider and if thought fit, pass the ordinary resolution. I now refer to Resolution 4, which refers to the ratification of the prior issue of 14,289,992 shares under ASX Listing Rule 7.4. The following percentage proxies have been received for Resolution 4 and are outlined in the presentation. In favor is 93.9%; against, 4.71%; open, 1.39%. I move that shareholders consider, and if thought fit, pass the special resolution. I now refer to the final item of business, Resolution 5, a special resolution, which pertains to the approval of the company's 10% placement facility. The effect of this resolution is to allow the directors to issue equity securities under Listing Rule 7.1A during the 10% placement period, which is defined on Page 7 of the Notice of Meeting. The following percentages of proxies have been received for Resolution 5 and are outlined in the presentation. In favor, 93.16%; against, 5.43%; open, 1.41%. As this resolution is a special resolution, it requires 75% of votes cast in favor to be deemed this past. I move that shareholders consider, and if thought fit, pass special resolution. We will now go to shareholders' questions. Please note, during this time, the poll will remain open to enable you to complete your voting. Melanie, did we receive any questions on any of the resolutions or does any shareholder wish to speak to any of the resolutions?
Melanie Jaye Leydin
executiveSteve, there's nothing comes through the Q&A box yet and nor in the audio facility. So we'll just give another 30 seconds whilst they're completing the poll and any questions. Thanks, Steve. There's no further questions. You can probably move to close the poll, please.
Steven Engle
executiveSure. We will now provide shareholders with an additional 30 seconds for poll voting to be completed.
Melanie Jaye Leydin
executiveThat one has been done. So we can...
Steven Engle
executiveAs the additional time is up, I now declare the poll closed. The company has not received notice of any other business, and as such, concludes the formal business of today's meeting, and I now declare the meeting closed. After the votes have been counted, the results of the poll will be released to the ASX later today. Thank you for your attendance, and we look forward to your continued support.
Melanie Jaye Leydin
executiveThank you all. I'll now close the webinar.
For developers and AI pipelines
Programmatic access to Prescient Therapeutics Limited earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.