Prescient Therapeutics Limited ($PTX)

Earnings Call Transcript · May 5, 2026

ASX AU Health Care Biotechnology Special Calls 41 min

Highlights from the call

Prescient Therapeutics Limited (PTX:AU) reported its earnings for the fiscal quarter ending March 2026. The company highlighted its cash position at $11.9 million and emphasized its progress in developing PTX-100, a first-in-class GGTase inhibitor targeting the RAS pathway, which affects 22% of cancers. The company did not provide specific revenue or earnings figures, but management focused on the clinical development of PTX-100, particularly its application in cutaneous T-cell lymphoma (CTCL). The company received Fast Track and orphan drug designations from the FDA and EMA, signaling potential expedited pathways to commercialization. No changes to financial guidance were explicitly mentioned.

Main topics

  • PTX-100 Clinical Progress: PTX-100 is the most advanced inhibitor of GGTase in clinical development, targeting the RAS pathway involved in 22% of cancers. The Phase Ib trials for CTCL showed a 100% clinical benefit rate with no serious adverse events. The company is progressing to Phase IIa trials with 12 active sites recruiting patients.
  • Regulatory Designations: PTX-100 has received Fast Track and orphan drug designations from both the FDA and EMA. These designations could expedite the approval process and enhance market entry opportunities.
  • Market Opportunity: The CTCL market is projected to reach $1.2 billion in the U.S. by 2034. PTX-100's unique mode of action and favorable safety profile position it well to capture market share.
  • Phase IIa Trial Recruitment: The company has recruited 18 out of 20 patients needed for the initial cohort in the Phase IIa trial. The Dose Optimization Committee will evaluate data 4 months post-dosing to determine progression to Phase IIb.
  • Cash Position and Funding: Prescient reported a cash position of $11.9 million, which is deemed sufficient to reach upcoming milestones. Management is continuously evaluating funding options.

Key metrics mentioned

  • Cash Position: $11.9 million (Reported as of the latest quarter, sufficient for upcoming milestones)
  • Clinical Benefit Rate: 100% (Phase Ib CTCL trials, no serious adverse events)
  • Phase IIa Recruitment: 18 patients (Out of 20 needed for initial cohort, recruitment ongoing)
  • Market Size Projection: $1.2 billion (Projected U.S. CTCL market size by 2034)

Prescient Therapeutics is making significant strides with PTX-100, particularly in CTCL, supported by strong clinical data and regulatory designations. The company's cash position appears adequate for near-term milestones, but ongoing recruitment challenges and the need for further funding remain risks. Investors should watch for updates on Phase IIa trial progress and potential partnerships, which could serve as catalysts for the stock.

Earnings Call Speaker Segments

Patrick Nelson

Attendees
#1

Good afternoon, everyone, and thank you for joining us today for Prescient or PTX's investor briefing. While everyone settles in, I'll go through some housekeeping and disclaimers. Presentations that Reach hosts are suitable for self-directed investors who they have the experience and capabilities to make their own informed decisions and information in today's presentation is general in nature. It doesn't consider your personal circumstances. You need to decide for yourself whether it's appropriate for you. And we're providing information for educational purposes, past performance is never a reliable indicator of future performance. My name is Patrick Nelson. I'm the MD at Reach. I'll host the session, and we're joined by James McDonnell, the CEO of Prescient to run us through today's presentation. So the update that we're providing today is off the back of the 4Cs and the release of the new investor presentation, which was released to market last week. We will also touch on some of the items out of the 4Cs, which I'll do in the Q&A. But we're here to see the page turn on the new presentation. So James will run us through that presentation and it will be followed by a Q&A at the end. I imagine that it will take about 20 minutes to run through the page turn, somewhere around that. And so there will be plenty of time for questions at the end. So the -- now we're aware that there are some new investors on the call today and a lot of shareholders are joining us. The -- so I'll do a quick introduction as we run through things, but let -- to set the scene and then hand over to James. So PTX have developed a unique -- and I'll just quickly just check something from what's appearing on my screen. Okay. We've got it where we need to get it. All right. So PTX have developed a unique technology, which is a platform that can stop some forms of cancers from reproducing. And it does this by attacking the biochemical processes referred to as the RAS pathway that are behind 22% of all cancers. So whilst this technology is a platform that can potentially help with 22% of all cancers or 22% of all cancers, PTX first have chosen to prove their technology on cutaneous T-cell lymphoma, which is a cancer considered by many clinicians to have no viable treatment, therefore, a death sentence and it's a terrible, terrible disease. In their Ib clinician trials for CTCL, an astonishing 100% of patients cancer stopped growing or reduced and 0 patients experienced a serious adverse effect, which is particularly important as a lot of cures for cancer can be worse than the cancer itself. They chose CTCL for a number of reasons, but including the fact that it's an orphan disease with very limited treatment options. And the FDA and other regulators are much more likely to support or fast track orphan diseases. And whilst a rare disease with limited treatment options, it still represents a $1.2 billion market in the U.S. alone. The strategy has been very successful. So the company has received Fast Track orphan drug and IND designations from the FDA. Recently, EMA gave them fast track. They also moved at great pace with CTCL being now one of the most advanced therapies on the ASX. Now moving into IIa, they have the potential that IIb could become a registration study. And beyond the results for CTCL and now this advanced therapy, there are broader applications for this technology. As mentioned, it can help with up to 22% of cancers. So we've been involved with PTX for a number of years now, and we've been very impressed with the team that are behind it. now seeing going from Ib to IIa, the recruitment, which there were some references to in the 4Cs and James will no doubt provide some outlines in there. But it is successfully moving through into this IIa with a near-term potential commercialization and partnerships coming through. It's a very exciting time for PCX. And beyond the fact that this is doing something which has a meaningful impact on people's lives and for the sufferers of CTCL that are going through the trials, and we'd love to see this get out there and be available to everyone that has that terrible disease, there is that broader application of this technology, which we think is a very exciting and a biotech story coming out of Australia, and it's a privilege to, in some way, be involved. So James, thank you very much for joining us today. I will now hand the controls over to you.

James McDonnell

Executives
#2

Thanks, Patrick, and I'm very pleased to be delivering this new investor deck today. It's got some good stuff in it. So I'm excited to get through it. So let's see if we can -- yes, here we go. So the usual disclaimer and safe harbor from Prescient. But let's see where we are. So in the company snapshot, we see that on the 4C, we released our cash position at $11.9 million. And obviously, we've been trading over the time. So we begin with our focus. And our focus, it's all about focus. We are really bringing hope to patients with cancer. We're focused on oncology. We're pioneering a therapeutic, which has a biology that impacts 1 in 5 cancers, and we're creating value for both investors and the patients. And so when I talk about pioneering, I talk about our lead asset, our unique value proposition. PTX-100 is the most advanced inhibitor of GGTase in clinical development. And that biology impacts 22% of cancers. So you can see here with CTCL, we are one of the most advanced on the cancer therapies on the ASX, where efficacy in the Phase Ib results are very good and patients experienced clinical benefit, either stable disease or an improvement in their disease. And FDA granted orphan designation and particularly Fast Track designation, which is very encouraging. The clinical data we have generated to date is allowing us to have discussions with future partners. So moving forward, which is a little bit of background. And so with cancer, we see that the normal cell goes through cell division into the healthy tissue. The abnormal cell goes through -- has a genetic variant and then multiple cell divisions to the linear tumor. We just highlighted there where these cell divisions are mediated by the RAS process. And so with PTX-100, we licensed it from Yale. It is the first-in-class drug candidate and most advanced in the clinical development. It's an inhibitor of a particular enzyme called GTTase-1. Now RAS proteins that are really targeted for drug development. The mutations caused by RAS really create cells and tumors that grow and worsen. And GGTase is an integral part of that RAS pathway. And so having an impact on GGTase impacts the tumor growth that is triggered by the RAS family proteins. So let's look at this in a little more detail. So typically, RAS proteins, when they are mutated and are on, fully on, they continually signal down the RAS pathway. So GGTase RAS proteins, they attach to the cell wall and they either trigger migration, proliferation or survival. And that's where you get the tumor growth. Now with PTX-100 being able to block the GGTase-1, we inhibit that prenylation process. And so RAS family proteins downstream are not able to attach to the cell wall and therefore, the pro-tumor effects are inhibited. Now we mentioned that it is first-in-class and it's the first GGTase inhibitor in clinical development. There's real benefits of being first-in-class. Firstly, and we've seen it with the eligibility of the regulatory designations, we have orphan drug designation. We have Fast Track designation from the FDA, and we have orphan drug designation from the EMA. And so this is very encouraging. The other advantage of first-in-class is that we're not competing against other GGTase inhibitors. We're really setting the benchmark, and that's important. And of course, being first to market creates a strong presence with the clinicians. And therefore, they are engaged in this development. And so it's very helpful as we progress with these clinicians. And of course, we are further progressed. And so when we're looking at the biology that affects 1 in 5 cancers, there's an opportunity to go further into other treatments. So let's look at where we sit in the CTCL environment. And you can see here, it's a complex slide, but it's simplified in terms of the types of drugs that play a role. And you can see the biology -- the biologics, which play a role in attacking an antigen on the cell surface induce cytotoxicity. And on the top left, we have some biologics that carry a payload and they cause cell death. And down below, we see tumor gene suppression, which is the HDAC inhibitors and epigenetic approach affecting the DNA. But you see PTX-100 right in the middle there. For tumors to grow, migrate and proliferate, they rely on the RAS family proteins. And by inhibiting that process, we can see cell death, reduced migration, survival and proliferation. So it's a very handy differentiated mode of action. It also lends itself well to combination therapy. And we've already see interest in HDAC inhibitors combined with PTX-100. And of course, with the biologics, it's more likely to be a sequential approach. So it's really creating interest in the clinical community. So let's look at PTX-100 and CTCL. So why are we in CTCL? Well, firstly, it's our strategy. When you're looking for a first indication, you need to look for something because of the biology, which is a strong RAS involvement, high unmet need, strong likely support regulatory-wise, a reasonable market, and it's going to make a difference from a competition perspective. So that's why CTCL was selected. There is RAS involvement. It's an orphan disease and therefore, attracts designations. We are looking at a disease where it's often described as a death sentence for those who have advanced disease, and we'll talk about that in a moment. And of course, the market size is $1.2 billion estimated in the U.S. market in 2034. $1.2 billion is a big market. So so far, we've got some really good results in Phase Ib, 100% of clinical benefit. So patients experienced either a stable disease or an improvement in their disease. So -- and we did this with no adverse events related to PTX-100. We've received FDA Fast Track designation and orphan designation, and we also received orphan designation in EU. So our strategy is playing out. We have the data. We're doing stuff. So I mentioned it's considered a death sentence CTCL, and let's put that into context. So this graph represents CTCL, mycosis fungoides in the early stage and in the advanced stage and Sezary syndrome. Now these are 2 of the main subtypes for CTCL. And as you can see, if you're stage from IIb on, your 5-year overall survival is not great. And if you're stage later than that, it gets worse. To the point where you have a 1 in 5 chance of surviving 5 years. This is a very serious disease, but it's not the only issue associated with this disease. When you look at the impact of the disease, the itching that occurs, the secondary infections, the fact that it appears all over your body, is social isolation, the sleep disturbance and the fatigue, the quality of life is seriously impacted as well. So poor prognosis and severe quality of life is not a great one. So let's see where we go next. So we see that CTCL patients have limited options. This is a disease of the white blood cells. It's part of the immunity and it's challenging the body. These T cells are present in the skin where they divide and really affect the skin. And eventually, it ends up in the nodes, the viscera and the blood, and that's a very poor progressive disease. The current treatment options are modest and often cause patients adverse events, which are not very good. So there are limited options in refractory and relapsed CTCL patients are really looking for options. We also know that there's 3,000 new patients in the U.S. alone every year, and it is increasing. So this is a disease with a clear unmet need. So where do we sit with our clinical data? So you can see with our Phase Ib sub-analysis, the CTCL cohort is doing quite well. When we measure -- when we do these Phase Ib studies, we'd like to know what the benchmarks are we're measuring against. And as you can see there, we've benchmarked a response rate, clinical benefit rate and duration of response and serious adverse events. We've got Lymphir, which is the most recently approved FDA product at 36% and really the serious adverse events looking above our benchmark requirements. But when you look at the 7 evaluable patients in the PTX-100 CTCL alone arm, we see a 43% response rate, 100% clinical benefit rate and a strong duration of response and also 0 adverse events -- serious adverse events attributed to the PTX-100. So this is a very good outcome, and it's obviously led us to move towards Phase II. And when I look further at that favorable safety profile, when you just look at adverse events as a whole, you can see a number of competitors or current products in the market have quite significant adverse events and PTX-100 in current studies showing very modest adverse events. So this is quite favorable. This means we're not adding to the fragility of the patient, and it's a good candidate for combination, different mode of action, good for the patient. So it's a very strong position. So I mentioned we've moved now to Phase II. And our Phase II is divided into Phase IIa and Phase IIb. The Phase IIa has a dosing component to it. And you can see here that 40 patients will be randomized to 2 different doses. A dose optimization committee will review the data and determine what the dose is to move to a Phase IIb. Now, the Dose Optimization Committee charter indicates that they will start looking at the results from the first 20 patients, so 10 in each arm. And when they do that, they'll assess the dose, the activity and the safety and determine whether the study continues to the 40 patients or what the choices are they have. Now this is a multicenter study. And currently, we have Australia, the U.S. and Italy enrolled and engaged in sites. So we have 12 active sites looking at recruiting patients. So it's going -- progressing as we saw in our 4C. So currently, the clinical status. So we are progressing in the Phase IIa. And as you can see here with our FDA engagement, we've got some pretty good designations in terms of the orphan designation, the Fast Track designation. To me, the Fast Track designation means an awful lot. It means that we are able to communicate with the FDA. They've acknowledged there is a clear unmet need, and this is an expedited pathway. So what could this mean? So this could mean that we look at the Phase IIa data and progress to the FDA and discuss with them the potential to move into a registration study in Phase IIb. Now with this potential and with the right agreement with the FDA, this means that we will accelerate into the approval pathway. We'll be faster commercialization. It's a healthy market size, and we'll also start looking at opportunities in other cancer pathways. So there's a potential development efficiencies if this occurs. And so this is a very exciting component. It's obviously data dependent and FDA dependent, but we'll certainly progress through that. So when we talk about this addressable market, and we talk about 3,000 new patients per annum in the U.S. alone, we see that it's estimated that the -- in 2034, the CTCL market alone will be $1.2 billion. So this is pretty a significant market and is commercially attractive. And so what does that mean if you're in that market? So here's an example of what that means. So you can see here the top line is the CTCL U.S. market between 2020 and 2025. And the yellow line is the entry of Mogamulizumab which is -- has a 28% overall response rate and it entered the market in 2019. And as you can see, it grew its own market share. It actually grew the total market. And so a new entry expanded the market itself. And this holds well for PTX-100. We have a unique mode of action with positive outcome, will enable ourselves to grow our own market share. Good treatment duration will even improve that more. And then we already have pricing comparisons for a commercial entry. So this is very positive from a commercial standpoint and will help as we progress. So our CTCL program is progressing. Our Ib results really exceeded the existing benchmarks and drugs available in the market. The FDA support is significant in terms of the Fast Track designation, the orphan designation. The market size is healthy. And our current -- we're currently in Phase IIa. And with data and engagement with the FDA, there is a potential for a IIb registration study. And also, this progress allows us to look at other indications and start moving through Phase I and II studies for other cancer indications based on this biology. So what do I mean by that wider opportunity? So as we mentioned earlier, RAS pathway alterations affect about 22% of cancers. So that's 1 in 5 cancers have RAS involvement. So there is an ability to look at these cancers as we improve our understanding of mode of action and look at cancers which have a high RAS involvement, we can initiate studies with quick preclinical straight into Phase Ib, Phase II, and that is broadening our platform. So that fits well with our expansion strategy. You can see that we are CTCL-centric at the moment. And we so far have demonstrated Ib -- Phase Ib efficacy and safety, and we continue to do that. The FDA support with orphan drug and Fast Track designation. Our goal is to complete a IIb registration study based on results from the Phase IIa and FDA engagement. And of course, the CTCL commercial pathways, the opportunity is significant, and this really is looking at potential partnering of the asset. Our expansion is to look at the other indications. The biology is present in 1 in 5 cancers. And so that's where we will progress. And this also strengthens our commercial pathways as well. Now we talked about all the data and things like that, but you don't do this without the right implementation and the right team. And often, you hear it's all about the people. And in this situation, it is about the people. We have an experienced team. We are implementing a Phase IIa study. And as you can see from the 4C, we are progressing that study. This team has experience in cancer, blood cancers as well as M&A. And so -- and have been represented in the large -- experience from large companies. So we have the right team on board. So let's go back to where we started. We have PTX-100, the most advanced selective GGTase inhibitor currently in the clinical development. The biology represents a platform opportunity. So potential applicability to 22% of cancers. For us, our first disease target in CTCL, it's most -- one of the most advanced on the ASX. Efficacy results are good. Patients are benefiting. FDA granted key designations in terms of orphan drug and Fast Track designation. And early clinical data is allowing us to have partner discussions that will continue as we progress with further data. So we're well placed. So thank you for your time, and I'll now pass back to Patrick, and we'll go through some questions.

Patrick Nelson

Attendees
#3

Thank you, James. Yes. And look, just use the question box if you would like to ask a question, I can see a couple have come through and Trav have asked a very good question. Trav with the first cohort of 20 patients, how long until data can be reported?

James McDonnell

Executives
#4

Yes. The Dose Optimization Committee will look at the GRS scores and -- Global Response Scores, and they typically come 4 months after the patient is first dosed. So there's a 4-month lead time there.

Patrick Nelson

Attendees
#5

So you've got 18 recruited so far, another 2 to get to 20. And then how long before you get that --

James McDonnell

Executives
#6

Yes. The Dose Optimization Committee will evaluate the data from 20 evaluable patients. And so typically, once they hit that point, it's 4 months. They need to get a PET scan, they need to get a number of scans to determine their progress in terms of how well they performed on PTX-100.

Patrick Nelson

Attendees
#7

So let's say, another month to get another 2 in. Is that ambitious or--

James McDonnell

Executives
#8

I mean we do have 12 sites actually looking for patients. It's a rare disease. So it's not easy to predict. But it's -- yes, all I can say is that we've got--

Patrick Nelson

Attendees
#9

So 4 months after that date. So let's say, if it's in a month or 2 from now, that would be sort of -- September, October.

James McDonnell

Executives
#10

Yes.

Patrick Nelson

Attendees
#11

That's --

James McDonnell

Executives
#12

I mean, yes, based on where we're progressing that would make sense. Yes.

Patrick Nelson

Attendees
#13

Okay. You mentioned obviously the 100% halt, 43% of that is decreased. But the patients that just simply see the disease halt. I mean is there any other benefits associated for just not getting worse for those patients?

James McDonnell

Executives
#14

Yes, there are. And when I presented the disease, we had the 5-year overall survival on one side, and we had the quality of life on the other. This is a really impacting disease. And so if you can create a stable environment where the itching is reduced, are able to sleep, less fatigue, I mean there's a significant benefit for these patients from a quality of life benefit. So yes, it's very helpful and something that clinicians consider in this space.

Patrick Nelson

Attendees
#15

The French testing centers, I mean this is a question from Anthony. When do you expect these to be open? And why are they slower than the Italians?

James McDonnell

Executives
#16

It's a good question. Well, the French bureaucracy is more challenging than the Italian bureaucracy. And we are -- the French sites we're expecting later this year. So it's -- yes, it's sometimes -- we just have to wait on the bureaucracy. We're active. We're keen to get those sites up and running, but it takes time and process, and the French are very big on that process.

Patrick Nelson

Attendees
#17

Maybe just reiterate cash position. There's a couple of questions around funding. So cash position and any comment around future funding?

James McDonnell

Executives
#18

Yes. No, we've got say $11.9 million in the bank. That's definitely enough to get us through milestones. And as a biotech, we're always looking at our cash position and what we might do next. So yes, we're looking at it.

Patrick Nelson

Attendees
#19

Any progress on recruiting in Japan?

James McDonnell

Executives
#20

We continue to look at that. We are actively speaking with some companies. It is an attractive partnering opportunity for us because they do have orphan drug designation there and market exclusivity. It makes sense for us to go there, and that's something I would like to do. And so we are actively talking to companies in that space.

Patrick Nelson

Attendees
#21

Is there any guidance or will there be any guidance on early patients in the IIa showing results?

James McDonnell

Executives
#22

The dose optimization committee will look at the first 20 patients that are evaluable. And we will go from there. That's the first real look at the data. It would only be interim because, of course, these patients need to go through to the end of the study and overall response rate is only determined at the end.

Patrick Nelson

Attendees
#23

You expect the market to be USD 1.2 billion -- well, in the U.S., it's USD 1.2 billion market. What will be the other target markets beyond the U.S.?

James McDonnell

Executives
#24

Well, we have orphan designation in the EU environment. So there's some significant markets in that space, Germany et cetera. We'll look at that and certainly Japan. So the 8 major markets we'll focus on for partnering opportunities because there is a market opportunity there.

Patrick Nelson

Attendees
#25

And how do we think about how this -- your go-to-market strategy and the adoption of PTX-100, I mean, what practically drives usage and revenue once you get, once you're commercialized?

James McDonnell

Executives
#26

Yes. Down the path, as we get our marketing authorization approval to go to market, we would be certainly making that news widely known. But with CTCL, the clinicians are very easy to identify and they're well connected. We have some significant clinicians and key opinion leaders in our study and study sites. So that on its own will be helpful. But there are -- finding these clinicians won't be hard. And so it will be a matter of us speaking to them, but also their own internal discussions and awareness of CTCL and PTX-100 response rates. Yes.

Patrick Nelson

Attendees
#27

The Mogamulizumab.

James McDonnell

Executives
#28

Mogamulizumab.

Patrick Nelson

Attendees
#29

Yes, Mogamulizumab. My memory has failed me there. But I mean, is that a way to think about -- I think there was a slide on it.

James McDonnell

Executives
#30

Yes.

Patrick Nelson

Attendees
#31

Is that a way -- like you made some reference to that. Is that sort of the way we can think about the adoption and --

James McDonnell

Executives
#32

Yes. I mean I've come from a commercial background, and I've looked at examples. And this is an example, which I feel is quite relevant to PTX-100. It was a unique mode of action. It was -- it has strong data in its history and some mycosis fungoides overall response rate of 28%. When it came to the market, it changed the whole market. It grew it. And the growth of that market is pretty much determined by the growth of Mogamulizumab. So as I said at the time, it grew its own market share, and that was significant in terms of dollars, but also benefits to the patient. That's a good example of what is likely to happen with PTX-100 being a unique mode of action and entering the market.

Patrick Nelson

Attendees
#33

Look, this slide here, how PTX works, I pointed Cory to, because it was a question around safety. And the question was why does PTX deliver such a clean safety profile? What is actually happening here? Is it because it doesn't kill the mutation? Could you talk us through?

James McDonnell

Executives
#34

It's a good question. It's our mode of action. We know what PTX-100 does, and we know we have clinical outcomes. And those clinical outcomes without serious adverse events. So we are disrupting a pathway. The reason for that safety profile is an example of what we see. We would need to do more work, but it's continuously shown in our early phase studies to be very, very favorable for patients. And so we do have adverse events, but they're very mild and at 4%, typically gastro. It's just -- yes, it's the way it is. And it could be the fact that we inhibit an enzyme, which plays a role in the signaling of the RAS protein families and the prenylation of those, and therefore, it doesn't impact other areas as much. But all I can say is that the data shows that there are no serious adverse events associated with PTX-100.

Patrick Nelson

Attendees
#35

So the purpose of the CSIRO work that you're doing at the moment or that they're doing, I mean, what are you hoping to get out of that?

James McDonnell

Executives
#36

Well, we would like to understand our mode of action a little more. And what we've seen to date is that PTX-100 binds to the protein at the active prenylation site without the assistance of anything else. It goes in there and it stays in there. That's really good. And so preventing prenylation of RAS protein family -- family proteins prevents them from doing their signaling for migration, proliferation and survival. And so that's very helpful. And it doesn't need -- it appears to have anything else it needs to do. It just does that. And so we need to understand that mode of action more because then along with other cancers, which have a higher RAS involvement, we can look at those as potential next in our platform approach for PTX-100.

Patrick Nelson

Attendees
#37

And so just talk about that platform. So you probably made the case for why you're a platform just then.

James McDonnell

Executives
#38

Yes.

Patrick Nelson

Attendees
#39

Then like how do you deploy your technology? Is it going after the next CTCL? Or is it in partnership with some other indication or therapy? What are your thoughts?

James McDonnell

Executives
#40

Yes. It's -- there's probably 2 lines here. I mean we talk about combination therapy as well. So I think we would be looking at how we do in combination, but also new cancers and opportunities to discuss with partners about what those new cancers might look like, how we might fund that and those sorts of things. As we progress with CTCL, we get the opportunity to look at those things. And as we understand our mode of action a little more, we also get further opportunities to do those things. So we're currently in a good space waiting for the Phase IIa data to then really lead us forward.

Patrick Nelson

Attendees
#41

Yes, very good. So is there any kind of any cancers that you -- or indications that you've considered at this stage? Or is it still TBC?

James McDonnell

Executives
#42

It's really TBC. I mean that's the development team will work on that. There might be a little bit of preclinical work they do to help us with that. But yes, it's a TBC. Our focus is CTCL. We need the study to go through.

Patrick Nelson

Attendees
#43

Yes. A couple of questions, and I'm not sure to what extent you can make a comment here, but David has asked and James a similar question. So are there any early patients showing encouraging results? Or are you happy how the trials are going so far?

James McDonnell

Executives
#44

I'm happy. We're implementing a very good study. We've recruited 12 patients in the last 4 months. And we've got 12 active sites really looking for our next round of patients. So I'm happy for that.

Patrick Nelson

Attendees
#45

So if Phase IIa is as strong as you would hope or is a replication of Ib and the FDA supports a IIb registration study, what does that actually mean for Prescient?

James McDonnell

Executives
#46

Well, that would be a nice place to be. That means a significant inflection point for Prescient. That means we are very close to commercialization. We're talking to partners that really feel that they have a derisked asset and they'll be looking for that partnership. And so it's a good spot to be in. It allows us also then to start looking at our other platform opportunities. And so yes, that would be.

Patrick Nelson

Attendees
#47

What sort of partnership deals are struck at that point?

James McDonnell

Executives
#48

Well, I mean, there's various jurisdictions such as the U.S., Europe, Japan and things like that. I mean it's all about the types of deals you might get would be milestone upfront payments and then royalty payments and things like that. So this other -- this opportunity at that time. Once you have -- if we have progressed to that registration study, yes, it's a good place to be playing.

Patrick Nelson

Attendees
#49

Without naming names, are you in discussions with any potential partners?

James McDonnell

Executives
#50

We are continually discussing with our Ib results, it allowed us to reengage and we are actively doing that. And so the various fora that we will be going to, to actually engage with these partners as well, and that's an active part of what we're doing.

Patrick Nelson

Attendees
#51

Very good. Now I am just scrolling through the question list, I think I got through everything. Joseph has asked, when will we see results from the 12 sites.

James McDonnell

Executives
#52

Well, the -- it will be about the 20 patients that are evaluated by the DOC in that point. So it's about recruitment to that -- those 20 evaluable patients and then 4 months after that, the DOC will get to see some data. And that's -- there will be some interim news at that point.

Patrick Nelson

Attendees
#53

I mean there's quite a jump up in patients in the last quarter. Could we see something like that again now that you've got these sites open and maturing?

James McDonnell

Executives
#54

It would be encouraging if we did. It would be probably ahead of what we would expect. But certainly, we do have 12 active sites looking for patients around the world.

Patrick Nelson

Attendees
#55

In terms of--

James McDonnell

Executives
#56

Sorry to cut you off. [ Maybe to ] finish. Three in Australia, 6 in the U.S. and 3 in Italy. I mean those are -- it's a broad range. And so they're all looking. It's a rare disease, so it's a little hard to predict.

Patrick Nelson

Attendees
#57

Yes. Okay. And in terms of where you are now with predicting patients, is that where you expect it to be at this moment in time or ahead of where you expect it to?

James McDonnell

Executives
#58

Possibly a little ahead, but I mean, it's all about finding the right patients to enroll. And so predicting patient recruitment in a rare disease, it's never a fun thing to do. Yes.

Patrick Nelson

Attendees
#59

All right. Look, I mean, from -- in terms of getting through and presenting the deck and getting through some questions, I think we've covered all the terrain that we set out to today. Okay. David Hansen makes a comment -- sorry, to mention his surname. Mentioned that there is a trials website only has 3 clinical trials website -- maybe we'll take that question on--

James McDonnell

Executives
#60

David, I mean I've spoken to the CMO and they are looking at that. And I know you look at that site a lot for information. And so I will further speak to the CMO and see what's going on there.

Patrick Nelson

Attendees
#61

Joseph has commented, is Miles Prince still involved.

James McDonnell

Executives
#62

Miles Prince is our lead investigator and leading the site at Epworth. And so he's still involved, yes.

Patrick Nelson

Attendees
#63

Excellent. All right. Look, I thought that was a really concise well-delivered presentation, James. So much appreciated, and thank you for a lot of people turned up for the presentation today. Thank you for everyone's questions. If there's any follow-on questions, you can come via the investor portal. You can speak to any advisers here, and we'll happy to coordinate answers to anything there. Other than that, we'll be waiting for some news flow and looking forward to providing more updates in the coming months. So thank you very much for everyone taking the time to join us. And to James and the Prescient team, thank you very much for all your hard work, and it's great to see things continue to evolve, and it's very exciting to see this move forward. So James, with that, I'll leave the last word with you, and we'll call the session to a halt.

James McDonnell

Executives
#64

Thanks, Patrick, and thank you, everyone, for joining. It's a new deck, and it was a pleasure to deliver it. There's a little more information in there as we progress our study, and it is progressing, and I'm pleased that you're joining us to -- monitoring the progress. And thanks for being part of it and your continued support is much appreciated. So thanks for joining today.

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