Prescient Therapeutics Limited (PTX) Earnings Call Transcript & Summary

While people settle in, I'll just quickly provide the disclaimer and the housekeeping for this session. This opportunity is for eligible PTX shareholders only. You need to be a self-directed investor who has the experience and capability to analyze the investment and make an informed decision that is suitable for yourself. Any information contained in today's presentation is general in nature and does not consider personal circumstance, you need to consider for yourself, if it is appropriate for you. The information we're giving you is for educational purposes only and past performance is not a reliable indicator of future performance. Great. With that said, hi, everybody. I'm Christian Riedel, Executive Director here at Reach. I'll be hosting the session today. I'm here with James McDonnell, CEO of Prescient Therapeutics. Hi, James, thanks for dialing in. So James will give an update on how PTX is progressing and provide information around the share purchase plan. So he'll first go through the presentation, then I will give an overview of the offer, and then we'll open the floor for Q&A. Before we start, I'd also like to frame that we're running several of these webcasts during the SPP, and they're all very similar in how they're structured. So if you attend one, you don't really have to attend the others. And the questions might differ slightly, but they are very much similar otherwise. And I'd also like to note that we probably have a very wide range. We've got a lot of people online today and very wide range of people, very likely some people who've been following all the recent webcasts and are really across the story and other people who might have not looked at it for a couple of years. And we're trying to accommodate all these groups. I hope we can do the best, but please, if you are in one of these extreme groups, excuse us, if not everything applies to you. We expect the presentation to take about 25 minutes. [Operator Instructions] I just want to remind people that the current SPP closes on the 15th of July, so if you decide to invest, don't delay your application, it might close early as well. So -- but 15th of July is the current closing date. Before I hand over to James, just a few points to introduce the company for -- mostly for the people who haven't looked at it in a while. So Prescient has the technology whose first application in CTCL has shown outstanding results. CTCL is a cancer of unmet need, it's effectively a death sentence for many patients. In Phase Ib trials, PTX saw 64% of patients experiencing a halt or a reversal of their tumor growth while also maintaining an excellent safety profile with minimal adverse events. And they're now advancing through their Phase IIa trials off the back of these significant results. So if you believe they can replicate these results here and turn their Phase IIb into a registration study, then they have an opportunity to go into a $1.8 billion market from there. And that's very excited -- exciting because that's where the deals start getting done on the commercial side. So a really clear pathway here to market. They already have the FDA supporting them. And I'm saying that because the FDA granted them the Orphan Drug Designation and also more recently, Fast Track Designation which gives them a lot of confidence that they can pull this off. So from an investor perspective and shareholder perspective, it's an exciting stage where they're at now, where it could potentially become one of Australia's big biotech success stories. Again, to request the SPP offer booklet or be called by our advisers, just type yes into the chat box at any time, and we will make sure we can assist you with the process. With all of that out of the way, James, handing over to you.

Thanks, Christian. And it's a pleasure to be presenting to our shareholders today and taking you through Prescient Therapeutics. So here we go, here is our safe harbor. So Prescient Therapeutics has two asset streams. Firstly, a targeted therapy and then our platforms in CAR-T. And those platforms in CAR-T, we're working on validation and partnership. But today, we will predominantly be talking about our focused asset, which is our lead asset in PTX-100. And we're doing that because it's really engaged with a challenging disease. We've seen some really good early results. As Christian mentioned, we've had FDA support in terms of Orphan Drug Designation and most recently, Fast Track Designation, which is significant. The market's healthy. We've already started our Phase IIa, and there is a potential for a Phase IIb registration study, if things go well. So that's the top line number there, and those are really good opportunities for us. But first, let's talk about our technology, which is PTX-100, and it's a RAS pathway disruptor. Now when we talk about cancers, we see that a normal cancer goes through cell division and then healthy tissue, but the abnormal growth or the genetic changes that occur that then create a cancerous cell division is there. Often that's moped up by our immune system. But when that is not the case, we end up with the malignant tumor, and that's what we think we're targeting today. So when we look at our technology, we see that RAS is present as a mutation in up to 22% of cancers. So it has become quite a target, and our PTX-100 is the first-in-class targeted therapy. It is able to target geranylgeranyl transferase-1, and by targeting it, we disrupt the RAS family pathway. And by disrupting that pathway, we can increase program cell death or apoptosis, reduce growth, survival and migration of cancer cells. So that's the encouraging -- that's the technical behind PTX-100. So what does that mean? So when we say 22% of cancers have RAS mutations present, that means there's a lot of cancers that have RAS mutations, some more than others. And at the moment, we've taken a really challenging disease, T-Cell lymphoma through to our Phase II stage. But there are other more RAS-involved tumor types such as pancreas, lung, et cetera, as you can see here. So that's preclinical work that we need to do. We need to fine-tune our commercial and our clinical components for those tumors. And as I mentioned, we're progressing to Phase II with T-cell lymphoma, but specifically cutaneous T-cell lymphoma. And I'll cover that as we progress, but cutaneous T-cell lymphoma is really a challenging disease. It's rare, where the T cells or the white blood cells really migrate to the skin, they divide uncontrollably and attack the skin. Now it's classified from Stages 1 to 4. And Stage 1 is relatively indolent. But as they start progressing and becoming refractory and relapsed to treatment options, they end up getting to quite a challenging disease environment, and this is a problem. And so with patients end up with limited options, and there's a clear unmet need, and that's been reinforced by the fact that we've been given Fast Track Designation by the FDA. You can see that there's 3,000 patients -- new patients in the U.S. alone per annum, and the market is pretty healthy. You can see by the pictures that this is a -- not only is the disease challenging the body, but it's also socially challenging. It's really challenging the quality of life for these patients. So that's an important factor when we look at patient motivation. Now we have Professor Miles Prince, he's our primary investigator. And if you haven't seen the Q&A on our website, I would encourage you to look at the Q&A with Professor Miles Prince, it will give you a perspective from a patient and a clinician's perspective, how challenging these diseases are. But from our clinical results, we see that Miles as our principal investigator, has seen some really good results from patients who have really struggled with having very few options. And so when we talk about these good results, we talk about our Phase Ib responses. And so when the study was set up, we set it up with -- in mind with benchmarks that we would like to achieve in terms of response rate, 30%; clinical benefit rate, 45%; and hopefully less than 30% serious adverse events. And then to put that in perspective, Lymphir, which is an FDA-approved product for treatment for CTCL has a 36% response rate. The duration is around 6 months. And you can see some -- quite a number of serious adverse events. So from the Ib perspective, we saw a 45% response rate. And for our clinical benefit rate, which is a patient with a progressive disease, if they end up with stable disease or better, that's a clinical benefit. And this is what is happening, 64% of the patients experienced a clinical benefit. We saw a 10-month duration in that study and a 4% -- only a 4% serious adverse event rate, which is quite favorable. What do I mean by favorable? Well, when you look at other CTCL products, which are approved in the market, you can see that they come with some serious adverse events. And you can see that PTX-100 there at the end of the graph stacks up pretty well in terms of in that graph. So this is what I mean by a favorable safety profile. So therefore, it suits the fragile patients, and these patients become very fragile. But also, it allows it to be really helpful for a combination approach. And when you speak to clinicians in the T-cell lymphoma space, they talk about a really active tumor microenvironment where single-agent therapies may not be the way to go, where they -- I think the evolution will be into a combination therapy. So if you can add a unique mode of action without really contributing to the serious adverse events, it really stands up well for a combination therapy. So PTX-100 would stand out well in that space. So from our Phase Ib, we need to consider and we decided to move forward to the Phase II. There's lots of things to consider when you do that in terms of the patients, the design. And interestingly, the dose, FDA have a Project Optimus, which means that they are really looking for an optimal dose rather than the highest effective dose. So that's a consideration. In terms of the patients, where are they? Are they a metropolitan or are they really spread out? Are they hard to get? This is a rare disease, where the clinics, the experts -- we've already seen that these patients have a challenged quality of life, and so they are actually quite a motivated group. And then when you're considering your Phase II, what engagement can you have with the FDA. Now this is what we were considering when we started. And since that time, we've received Fast Track Designation, so a lot of these things become a potential here. So we do get ongoing dialogue under that designation. The FDA do get inputs into the Phase IIb, and there is a potential based on efficacy, safety and dosing results that there's a potential to go in the Phase IIa, potential to be a Phase IIb registration. So I mentioned we're doing CTCL. That's because we saw more responders in the Phase Ib. They have fewer therapies available to them, so there's a greater need. We think we can get a much better study, and it made sense to go that way. But we're not forgetting about the peripheral T-cell lymphoma. We feel that there's a better way of approaching them, they sit within a very competitive environment where they all get picked up quite often in Phase I studies. But we will use an investigator-led program. And with the investigator-led program when they publish their results, they can then submit that to a compendium in the U.S., and they -- through that compendium, they will be able to access for their patients through their payer and insurance program, PTX-100. So those are two ways of doing it. So in terms of the Phase II study, we see that we have refractory/relapsed cutaneous T-cell lymphoma patients. They have failed two systemic therapies before, and they'll be randomized into two different dosing in the Phase IIa. Now you can see there's a dose optimization committee there as well. And that as an open-label study, they'll be reviewing the data in that Phase IIa, most likely around the 20-patient mark because that would give some substance to the data, and then understand what that looks like, and they'll decide whether to go to 40 or whether they have a result that may actually mean that they will engage with the FDA, and look for protocol amendments in terms of the Phase IIb or what that would look like, potential for registration. So all those questions come into play once we get a set of data that we can work with. So this is the regular drug development. And so we're progressing along that with PTX-100 in CTCL. And you see we have some nice FDA engagement there, but particularly that Fast Track Designation, which is an expedited pathway. And so when you have an expedited pathway, if you have really some good efficacy results and the dosing stands out, there is a potential to move to that Phase IIb registration study. So that's what a Fast Track Designation enables us to do in terms of the continuous engagement with the FDA and then really look at what can really happen because they've issued this FDA designation because they recognize that patients have a clear unmet need, and the goal is to get treatment to those patients as quick as possible. And of course, it saves time and money. So these are the results that have led us to where we are today. And you can see that the clinical benefit rate is quite healthy for these challenged patients. And also, a favorable adverse event profile. So we've seen patients who have failed other things actually respond to PTX-100 in the Ib. So this is what we're looking for. So the path forward, we really -- we are targeting the FDA so the U.S. market, they have already provided us IND. And now the Fast Track means that we can really continue that engagement. But the other component with the Fast Track Designation is that we can get a rolling NDA. And so that means you're able to submit parts of your dossier, which you will probably have up to speed before the end of the registration study to the FDA for them to evaluate. Typically, for a Phase III study, you would wait for your results, you would then compile your package and then submit it, and that takes about 18 months before you end up with an approval. So the goal with the Fast Track Designation is to start a rolling NDA and therefore, reducing that time period. So again, expediting the pathway. And of course, once we get there, we have Orphan Drug Designation. And this means that we have a 7-year exclusivity in the U.S., and we will apply for 10 years in Europe. And so this is really helpful because it's higher prices. It's really, really beneficial, it is protection that is important to orphan drugs. And so this is why it's given there. It's an incentive for companies to develop these drugs. And so it starts once we have marketing authorization, so it's up to us to be ready for that because any delay is a delay that is being calculated as a cost within your peak year sales. So that's how you would value a delay. So it's very important to be ready. So we'll be ready for a T-cell lymphoma market with our CTCL approach and also with our PTCL approach in compendium. And so you can see in the U.S., it's a significant component of this $1.8 billion market. In terms of our milestones, well, we've already started the study with patients dosed, we've already received our Fast Track Designation. We'll be submitting for EU Orphan Drug Designation on August 29 and the EMA will respond on their time. I expect the first U.S. site to be not very far away. European sites, we're working on documentation. And then it's about the continuous data or it's about the data, and this is most likely to be around the 20-patient mark, and so we're guesstimating when that might be. But as we progress through the study, we'll have a clearer picture of when that might be. So we'll just keep an eye on that. And of course, we have our cell therapy milestones there in terms of validation and ongoing partner discussions. We have a really solid team. And you can see this team, a team that have got experience in terms of developing drugs but also in deal-making, and that's both at the management team level and the Board of Directors level. So you can see the companies where we gained that experience from, and this will be important as we progress. So in summing up, PTX-100 in cutaneous T-cell lymphoma is really progressing based on solid PTX-100 Ib results, we are looking to progress the CTCL and also PTCL with the compendium approach into a really strong market. In terms of our technology and in fact, being a first-in-class targeted therapy, you can see by inhibiting the RAS pathway, which is mutations are present in 22% of cancers, you can see there's a lot of potential there. So we need to work in developing our commercial and our clinical strength in other tumor types as well. So with that, I'll hand back to Christian.

Amazing. Thank you, James. Short and sharp. That's how we like it. Great. So next, I'm going to talk about the SPP offer. While I do that, if you have any questions, just put them into the chat box, so then we have them ready to go when we're done with this offer slide. So you can see the details here on the screen. The company is targeting to raise $7 million at an offer price of $0.04. That represents a discount of 16.7% to the volume-weighted average price of the 15 days leading up to the SPP being announced. We are -- we from Reach are managing this SPP together with the company, and it closes on the 15th of July at 5:00 p.m. East Coast time. It might -- having said, it might close early. The company raised similar amounts in their SPPs in 2020 and 2022. It has -- I think it has more shareholders now. So do not delay your application here, PTX is one of those companies that has really been able to rely on very loyal shareholders in the past and hence the SPP. Again, to request your personalized forms, just type yes into the chat box and our team will get in touch. Would help us if you're investing with an entity that is not a personal name. If you also name that entity, then we can better connect your investment with your name. Thanks a lot. Our comment here is that having worked with the company ourselves for, I think, over 5 years now here with Reach, this opportunity with PTX-100 has been over 10 years in the making. We're now seeing the final stages of a program which had amazing results so far and now has a great team behind it that James just explained, is fit for the purpose of the stage of where they're at now. There's also a much bigger platform opportunity here. However, these guys have put a laser focus on cancer of unmet need, which is the most tangible opportunity, and which got them, therefore, FDA support via these designation being Orphan Drug and Fast Track. If they are successful in making Phase IIb a registration study, it can kick off a commercialization phase. And I'm sure we're going to talk about this in the Q&A, but that's where deals are getting done, and that's what they are trying to achieve with this raise. Look, the value that is implied by the SPP price and where the company is trading at the moment, I don't know if it reflects all of that. Obviously, that is entirely your own determination to make. You as the shareholders have an opportunity here to support the company and do something special here, not just for the patients, but also potentially for investors. And if this becomes one of Australia's next biotech success stores.

Perfect. Let me sort through the questions here a little bit. I got some questions from Peter. I'm going to ask [indiscernible] to jump on the slide with the study design, which is titled Progressing PTX-100 Through Phase II. First question is how many patients are enrolled in IIa? If you could talk about that again.

There will be a total of 40 patients enrolled in IIa, but that is the IIa, but the dose optimization committee can actually decide based on results and as their ongoing surveillance of result to close out earlier if they feel that they have identified an optimal dose. And that's when they will engage with the FDA and will look at what our protocol amendments may be and the potential for a IIb registration study. So at the moment, the expectation is that they'll look at around 20 patients, and then they'll continue to look. And so that's where we see that sort of rolling out.

And now that you mentioned that you had that -- we don't have to jump to that slide, but you had that milestone slide up where you say you have intermediate readouts potentially like end of this year, more likely early next year. That is like for those first 20 out of those 40 patients. So that will be quite a significant event, if I understand that correctly.

Yes, we would hope that we will be able to provide some interim data in that 20-patient range. It's reliant on enrollment and recruitment. And so we'll keep monitoring that. And at this stage, we think it's more likely to be in the Q1, where we can get some sort of interim results, but it is dependent on patient enrollment. I mean we have the Australian -- the third Australian site is active next week, and there will be three U.S. sites coming on stream pretty soon as well. So there will be an increase in that patient enrollment.

Maybe a question related to that from Anthony was what is the minimum number of patients under the NDA that you require before you start submitting to the FDA?

Well, that's -- it's a good question. It's -- it will be based on the negotiation around that Phase IIb, and that will be determined by the efficacy, safety and dosing information we gain from the Phase IIa. And so at the moment, we say we have 75 patients in the Phase IIb, but this is almost a placeholder, if you like. And so the number of patients will be determined in that negotiation, remembering that we do have Fast Track Designation and the FDA recognized a clear unmet need. And so we'll be looking at finding out what that Phase IIb looks like once we have a clearer picture from the Phase IIa. So it's a bit hard to say a patient number, but it's a bit of a moving target. But you can see we've placeholded 75 patients.

And staying on this flow chart here and summarizing a few other questions. So can you give people a feel what has to happen for IIb to become a registration study? Like in terms of results, like do you need to replicate Phase Ib? Do you -- yes, that kind of stuff.

Well, it would -- it's really up to the FDA to define what that would be, and that's at that discussion point. I wouldn't guess what the FDA would like to see. But I do know that they provided a Fast Track Designation based on the results of the Phase Ib. And so that's an indication perhaps. And it will also be determined by what comes out of the Phase IIa. So it is -- it would be great to have solid results from the Phase Ib, but what that would mean from a registration perspective is really up to the FDA. But the good thing is that with our Fast Track Designation, we do have more engagement with the FDA. It's not structured like it would be if we didn't. And so therefore, we have a great opportunity to actually negotiate what Phase IIb would look like.

Understand. Quite a few questions about the SPP. Why now? How much? So maybe I'll try to work through them on the SPP itself, and we can stay on this slide because it probably relates to that. So $7 million raise, how far does that get you? What do you want to achieve after spending all of that?

Well, we -- it will get us significantly way through the Phase IIa and certainly, well past milestones that we have projected, particularly the interim data milestones. And so this is key to make sure that we are well funded past those points because at those points, we get a look-see at the data, and that really changes the dynamic of what we're seeing. So it's -- it could be a significant inflection point. So we needed to make sure that we -- you don't run out of cash, but you also have a comfortable amount of runway to actually then go through and evaluate what those interim data readouts mean and things like that. And so -- and that changes the dynamic in terms of what you do commercially and that opens up partnering, licensing and those sorts of things depending on what the results are. So we needed to extend our runway with our cash, and this is why we're doing it.

Okay. And yes, we've got a few people who are asking kind of questions about what happened to OmniCAR. So I think for context, I think there might be a few people here who just last time looked at this a couple of years ago and saw Steven Yatomi-Clarke presenting about CAR-T. What do you say to those people?

Well, CAR-T a few years ago was quite significant. It was a very progressive market. And also, there was a lot of available capital for CAR-T at that time. Since then, there's been some evolution. There's been some technical challenges, particularly with OmniCAR that we've had to work through, and we're still validating those changes. But in the meantime, the market is also very sophisticated and challenged. We're in a preclinical environment where we will look at partnering because the expertise and that the cost to take that through requires significant capital. And that capital currently really isn't available in the markets. And the capital was more -- much more available 3 years ago. So I mean, the development changes and the focus has changed, and that's really where we're sitting with CAR-T and cell therapies at the moment.

And then that -- maybe expand a bit then the decision to pivot to focus on PTX-100?

Yes, yes. Well, when we look at our assets, and you can see we've got two asset streams here, the cell therapies and the targeted therapy. When we're in a Phase II environment with a targeted therapy with a really solid Phase Ib results, that's our opportunity. And so we have a certain amount of capital and a certain amount of resource. So we need to target it where we're most likely to get a response. And we are closer to market. We're already in the clinic. And so the decision is really to pivot and really focus on PTX-100 as we progress it through CTCL and that T-cell lymphoma environment and really to market. And we are encouraged by the FDA Orphan Drug Designation and also the Fast Track Designation. So it's, in some ways, validating the choices.

And then staying on this road map, I think you touched upon the fact that like if IIb becomes a registration study, that is kind of a phase where commercial deals can be made. Is that -- I mean, if you look at the Australian biotech landscape and like see Dimerix, they are in their final phase before going to market, in their case, it's Phase III. Is that something that you meant by that? Or is that something comparable?

That's kind of exactly what can happen at that time. So when you're into a registrational approach, you need to look at what are we going to do at the end of that approach? Because as I mentioned before, we have an Orphan Drug Designation. We need to be ready to go once we have our approval. And so you have to weigh out, can we do that on our own? Do we partner it out? Do we license it out? Or is there an M&A opportunity? So those come into play at that point. And so Dimerix have done partnering deals, and I think they are over $1 billion in value in their partnering deals. And so that allows them to get into the market using a partner and gain a royalty base. And so those are the questions we have to ask and answer as to the ideal approach. Now it's an orphan drug. Can we do it ourselves and those sorts of things, those are exciting questions to have to answer. And that comes when you're in a registrational approach. And so that's kind of what we're looking at. Mirati sort of took it themselves. And then after 10 months, they are acquired in a M&A deal with Bristol Myers Squibb. But different market and obviously, that was [indiscernible] so not -- it's an example, but not a CTCL example. So those are the things that we look at, and that's what we'll have to decide.

And we got a question here from [ Vinny ]. Did the FDA Fast Track Designation increase your confidence in getting Phase IIb into a registration study?

It does increase our confidence because they have acknowledged that there is an unmet medical need. There's patients who they would like to get therapies to as soon as possible. And therefore, these types of things can happen. And so increasing engagement with the FDA means that we will be suggesting a Phase IIb registration study. It will be dependent on efficacy, safety and dosing results from the Phase IIa and timing of that. But yes, I mean, if we didn't have Fast Track Designation, it would be a little less encouraging, but we do.

A few more slides about the product itself and how the results compare, maybe we can jump to the first results slide. First question here from Eric is Lymphir for all TCL or just CTCL?

Lymphir has been approved for CTCL alone. So it is -- yes, and so that will be rolling out -- is starting to be rolled out in the U.S.

And maybe from there, your Phase Ib data, did that include only CTCL patients or both? And maybe how -- yes.

It's a good pick-up. As I mentioned in the presentation, there are a T-cell lymphomas, consist of cutaneous T-cell lymphomas and peripheral T-cell lymphomas. And so the Ib results have a group. And you can see on this slide that the PTCL patients are more fragile, if you like, they have a more aggressive disease. And so even with those patients in and we still had some really good results, response rate and clinical benefit rate. And so that's one of the reasons why we moved to CTCL. We saw probably more responses and we felt it was a more -- a better opportunity to move into CTCL with their Phase IIa. But with PTCL using a compendium approach, we can still access commercially that -- the U.S. market using the compendium because the compendiums in the U.S. list both approved and unapproved indications and the payers and the insurers use the compendium as part of their approach to approve access.

Question from George about Orphan Drug Designation. You said ODD gives your exclusivity for 7 years in the U.S. Does that mean that if PTX-100 gets approved, it kicks Lymphir out of the market?

No, no. What it means is that there's -- no other copies of PTX-100 can enter the market. And when you think about this market, patients are refractory and relapsed and there's a clear unmet need. So these patients go through therapies a lot. And so the patients are available to us. So Lymphir will still be in the market, but you saw a duration of response of 6 months, a response rate of 36%. So there are patients out there. And so having exclusivity of the only PTX-100 in the market really drives -- it's first-in-class, so new mode of action, clinicians were very interested in trying it out because patients haven't been exposed to this approach before.

Okay. So let's just go through some of the questions here. One moment. So yes, just to follow up on the last thing you said. So you basically -- are you saying that you would pick up like some Lymphir patients because they have failed this -- I mean, because you have evidence that they have failed or how would...

Yes. So when you look at our study, I mean, the CTCL patients who have failed two systemic therapies. And so this is what happens in the CTCL space. I mean, if you're a phase -- you have Stage 2 and things like that, you end up cycling through therapy options. So the longer duration of therapy you have, the more those patients will stay on your therapy. But with Lymphir with the 6-month duration, they may respond, 36% may respond, but their response rates are only 6.5 months. So the patients become available. And so they essentially cycle through therapies, and that's what happens. Sometimes they'll be rechallenged after they've had a previous therapy. And this is the dynamic in the market at the moment. And this is what I picked up recently in San Diego with the T-cell lymphoma conferences is that the clinicians are really starting to think about combination therapies because the single-agent approach in an active tumor microenvironment isn't really working so well. And so this is, again, why we mentioned the PTX-100 being quite useful in that space. It's a first-in-class, so a new mode of action, but without some serious adverse events, which can also allow it to be combined with other therapies. So it's quite an exciting dynamic marketplace as well.

David is asking whether you can talk about any unit economics of the drug if it gets to market, like where you -- like production costs and where you might sell it. I'm not sure what you can, can't say there and disclose there, but just putting it out there anyways.

Yes. I mean, we will certainly be targeting the U.S. as a key market. But as I mentioned, we'll also be looking for EU Orphan Drug Designation. And this will provide access and then the U.K. as well. So we do plan to market as broadly as we can using those Orphan Drug Designations. We -- the CMC side of things in terms of development is something that we're working on at the moment. Yes, we manufacture it. It's small molecule, so we don't have some of the challenges of biologicals and that's where we go. I'm not quite sure whether I answered that question, but...

Yes, it's more talking about -- do you know how much Lymphir sells for, and how much you would sell PTX-100 for...

Well, at this stage, we haven't done the pricing. You typically do that a bit closer to the market, and it depends on the value you provide and things like that. In terms of the cost side, we don't have -- like for instance, CAR-Ts are very costly, and they charge a big price, but the difference between the cost and the prices is actually quite small. And so you have to weigh up cost of goods and also -- and value in the market. And so we will look at that as we progress.

We have one Lymphir question. This is from Brad. How could the FDA approve for market Lymphir when the results were as they were? I'm not sure you can talk about...

I haven't thought about it, but I guess it's an indication of what the FDA believe in terms of there is a clear unmet need in this patient pool and to approve a product like that is really what they have. And so mogalizumab is another one, which has I mean, these -- this is what they have available to them, and this is why they are approving it because that's what they have available. And patients, as I mentioned, keep cycling through these therapies. So they are typically all refractory and relapsed. So to provide a new mode of action to the CTCL patients is really important. And so this is what we're targeting.

Yes, I guess it comes back to this unmet need, which means -- the bar is very low, like Lymphir is better than nothing, but for you now to beat that would make you obviously a stand-out drug, so that makes sense. Got one -- got so many questions. Paul is asking about Professor Miles Prince. Why doesn't he join the Board? Like maybe you answer the question a bit more broadly for those people who don't know Miles Prince so well and maybe expand a little bit on him. And I'm not sure whether you can answer Paul's question but give it a go.

Yes. I mean we sometimes create a scientific advisory committee, and we do that every now and again. But Professor Miles Prince is a very, very busy person. And his incentive is about the patient and really providing options for those patients. And so he has been fantastic in terms of our principal investigator. He's globally recognized and that being on the Board is not an option for him but being on a scientific advisory group when we need them, we could certainly manage that. But in terms of our Board, we've actually strengthened our Board with our new Chairman with James Campbell. And we've also added Melanie Farris, who is really strong in governance and risk. And so we're strengthening the company significantly in terms of the directors, but also on the management team with Dr. Marissa Lim and her experience in drug development, et cetera. So the company itself is really strong in terms of the team and moving forward, but Miles we would use in a more scientific manner and that sort of environment.

I think everybody who wants to learn a bit more about that angle can go on the website and there's videos from Miles Prince talking about this.

Yes. The Q&A is really -- that gives you some idea that he's quite [ passionate ] over there.

Yes. So I think he's a pretty worldwide renowned expert on the matter. So I think PTX is probably very lucky to have him. Let me just work -- what about -- we've got a question here from Jason saying -- talking about the wider applications of PTX-100 as a RAS disruption technology and how it could apply to 22% of the cancer. And the question is, is there any anything in the data for CTCL that gives you confidence or that could be recycled for when you look at other cancers?

Well, I mean, RAS mutation being present in 22% of cancers is top line, some cancers have more RAS mutation involvement than others. But we found that for T-Cell lymphoma, CTCL, this really is a proof of concept. And we're seeing in the Ib results in T-cell lymphoma, it's really, really strong. And those are quite strong cancer performance results. So we are encouraged by that, but there needs to be work done for each cancer. And we will look at the preclinical and move forward with that. We need to strengthen our commercial side of that as well. And when you look at these cancers, you can see that it's quite broad. And so it sort of opens us up to speaking to other companies as well and sort of looking at what can be done in that space. And so we're really focused on the Phase IIa and then CTCL because that's really a key driver. But we are almost obligated because of our RAS pathway disruption to actually look at these other tumor types and see whether the downstream effect of interrupting the geranylgeranyl transferase and the RAS pathway has a particular benefit to these cancers, and that's what we'll be working on.

Daniel is asking what is -- what do you think is the main difference between you and Steven Yatomi-Clarke, the previous CEO.

Well, I think, Steve came from more of a banking and scientific background. I mean, I'm a pharmacist, but I've been at the commercial end. And like I've been at the end where we're going. And so I've worked in the U.S. market as the Head of Global Marketing and really taking products through there. And so I have an understanding of drug development. And so it's almost a really nice handing of the baton time, to be honest, because we're now in this progressive clinical phase, where we're now heading towards a more commercial component. And so understanding what we need to have in place at that commercial end is really important. So understanding the payer environment in the U.S., the access environment in terms of the clinicians and things like that, understanding what's going on in Europe and those. I mean, my commercial global positions have led me enter that space and previous experience with liquid tumors is really helpful here. And so it was one of the exciting points of actually joining Prescient because it is a first-in-class and a really encouraging tumor types and working with people like I have worked was before. So I guess -- does that answer? Yes. I mean -- so Steve was much more early phased and I'm more commercial coming back. And we've kind of met in the middle. And so the baton change was actually pretty timely.

Yes, I think it's -- to provide a bit more context here from our view, I think what happened, like the events over the last years were first was this strategy pivot to focus on the PTX-100 opportunity, which is the much more tangible financeable opportunity. And then your hire happened after that strategy change to kind of hiring someone who would fit that path. Is that fair to say?

Yes, I certainly fit the targeted therapy approach more than I fit the cell therapy approach, if you like. That's much more preclinical. And so we're in a clinical phase environment. So I mean -- and this is really where we're heading towards that commercial end. And so this is -- the timing was great.

Yes. I mean, Phase II is definitely a very interesting spot to be in biotech. So very good. We've already gone over time a bit, and I noticed we have so many questions. I hoped I could address most of them, but we're out of time. We have another webcast we have to run. So I'm going to call the session to a halt here. And thanks, everybody, for dialing in, for taking the time. Again, if you're interested in participating in the SPP, please type yes into the chat box and we'll get in touch with the required steps, a very straightforward process. And again, deadline, 15th of July with potential that it might close early. With that all said, James, I'm going to leave the final word to you.

Thanks, Christian, and thank you, everyone, for joining. It's been a pleasure to present to our shareholders and shareholders that have been really supportive through the journey with Prescient and PTX-100. As you can see from the presentation, there's a lot going on, and I hope you're encouraged by that. We do have an SPP, and I encourage you to participate and then continue the support that you've given us over the time. So thanks again for joining, and we'll see you soon.

Amazing. Thanks, and goodbye, everybody.