Prescient Therapeutics Limited (PTX) Earnings Call Transcript

All right. Good day, everyone, and welcome to Prescient's shareholder briefing. While everyone settles in, I'll get through disclaimers and housekeeping. What we're discussing tonight is a session that's been put on for shareholders. The information that we're providing is general in nature doesn't consider your personal circumstances. You need to make your own decisions, whether it's appropriate for you. The education -- for educational purposes and past performance is not an accurate or reliable indicator [indiscernible]. There's a share purchase plan open at the moment. You need to make your own decisions about whether it's appropriate for you to participate in that or not. My name is Patrick Nelson. I'm the [indiscernible] host the session, but we're joined by James McDonnell, the CEO of Prescient and shareholders, we know that you'll be across most of the story, most likely. But the way we run the session is we'll start off with some questions for James around the SPP, upcoming milestones, commercial pathway. We'll then get it through -- James will go through a quick page term on the deck, probably for about 15 minutes, and then we'll come back, go through the [ SPP ] [indiscernible] then Q&A and go through any broader questions that you guys might have. I'll try and ask questions when they come up, but probably most of them will get tackled at the end. So if something comes to mind, put it in, no doubt there'll probably be some people thinking the same thought they misrouting the same question. I'll go through and we'll make sure all questions are answered. Now as a reminder that if you would like to receive the [ SPP ] booklet and or have it on hand in your e-mail, you just take yes in and we'll organize for someone to send across the details for you. It should be coming out of the post relatively soon. But regardless if you request it and we'll make sure that it gets sent across to you. So quick question -- sorry, a quick introduction on the company, PTX, one of the most advanced cancer therapies on the ASX, targeting cutaneous T cell lymphoma, which at its advanced stages, as seen by many clinicians as a death sentence. Terrible disease, patients are constantly itchy, many suffers from secondary infections, can't sleep. So for PTX, to have a remarkable Phase Ib results, which saw 100% of patients record either halt or reduction of their cancer. This is a great outcome. And for them to have 0 serious adverse effects is also an amazing outcome. So -- and look, even those that don't get the shrink of tumor that [ we're ] getting, they also can get really positive side effects such as itchiness stops, which brings back quality of life and sleep and obviously, length of life and so forth. So PTX has fast track [ open ] drug designation from the FDA, encourage this to move -- the types of cancers to find therapies that are effective, are then [indiscernible] in a Phase IIa study, 28% of patients have been enrolled, which means have been dosed and looking for 20 evaluable patients, 10 in each side of the doses, the 500 milligrams and 1,000 milligrams being the target for the dose optimization committee to meet the dose optimization, committee scheduled to meet later this year. Things are on track from the enrollment side of things, and this meeting is one of those critical stages and a major milestone for the company as it needs commercialization, and it's going to be one that a lot of people are looking at, including big pharma and mid-tiers and generics and so forth that we want to see. The results of this -- this is already a rare stage for a biotech to get to. And this next stage, indeed will be a rare feat, an exciting time for shareholders and the company. With fast track designation, there is a possibility for that IIb study to become a registration study. Look, have a dose as well as a registration study. Both of these are really big stages and the start of commercialization phase where big pharma and others get involved -- start to get involved. So at a perfect time, we have a journey that we feel that we as investors have been on with Prescient but we're really getting to a big inflection point, and it's exciting. So look, it's an interesting [indiscernible], a very well-run company, $9 million cash. The company has done a great job being steward of the finances. And so getting to that point, -- [indiscernible] get to a couple of questions on the SPP. So thanks for joining us. And why [indiscernible], what makes this the right structure?

Good question. SPP at the moment, it's -- we have near-term milestones coming up. We're well funded. They often say it's better to raise [ money ] when you have money. And the SPV structure is we saw last time, we have 58% above what we -- the point that we did last year. It was a very good and effective method for us and so we've chosen to do it this year.

Yes. And so where does this [ raise ] get you to? There's additional funding? How far does this get you along?

This funding will certainly get us through that milestone you mentioned there in terms of the dose optimization committee. They will provide guidance on the continuation of the study. If we need to go to another dose optimization committee, we'll go there. And as it progresses, we'll probably use a little more cash. But we'll certainly get to the point of -- once we have that dose which really is a very good approach for us to take. And that's when we start talking about to the FDA and we talk to partners and all those sorts of things start [indiscernible].

Yes. Okay. And I mean, you've sort of spoken about some of those stages, but can you talk through, again, you don't know whether you're going to be a dose set with 20 available, 30, or 40, but just what are these milestones that line those up for us, please?

Yes, certainly. After 20 valuable patients, so 10 in each of the dosing arms. That's the first one we'll see, and we expect that later this year. The DOC or the Dose Optimization Committee will review each arm for safety and tolerability and efficacy and then make a determination about the dose and then provide guidance to us about how the study will progress. It's likely that we may need further patients. So we had 15 in each arm, but we'll take guidance from the dose optimization committee. So it's at the point we get the doses when we will also then move to the type B FDA meetings. That information will be very helpful for us because we'll have safety tolerability, efficacy in a dose. And that information provides us an ability to interrogate the data with the FDA and then look at that pivotal environment as the next step.

So through the commercialization standpoint, are you having any engagement from any of the parties of pharma, bid, mid-tier, et cetera. What's that engagement being like what sort of conversations have you been having?

Yes. No, we've had some good conversations recently in San Diego. I had a number of meetings. And it's about PTX-100 and understanding what the next data reads are and those sorts of things. This is a -- in the sweet spot of a number of companies because it's moving to more derisked manner and, therefore, more favorable in their commercial opportunity.

We saw [ Sobi ] recently did that deal with [indiscernible] on a CTCL drug. I mean what transpired there?

That was a great transaction for me or for us, I guess, in terms of understanding that we're in CTCL. We have a Phase II study progressing. This company [indiscernible] had just completed their Phase II program and have now signed a very large transaction, USD 580 million for their program. And so that's encouraging. It validates why we're here, not only for patients but also for commercial value.

Is it the sort of deal that you'd like to do? Is it the sort of deal that is it a line up well for CTCL? Or would you sell the whole company? Or what are you thinking?

Well, I mean each deal is particular to the company. I mean [indiscernible] program, so they could be a deal based on that. I mean we will look at the deal. But from a perspective -- yes, it's a healthy deal and it's a nice benchmark to have in the back pocket to know when you're talking to companies, what sort of numbers you're talking about and what the bigger potential could be.

Yes. And the -- some of those companies, you're talking about mid-tiers, generics, big pharma groups and so forth. I mean, at what point are they representing or are they making deals? At what stage, what do they need to see from Prescient?

Yes. Well, I mean I think [ Sobi ] is a good example of that. They're making deals at the end of Phase II moving into pivotal. And so that's -- that's kind of where our sweet spot will be. These companies need derisked assets that they can afford and that they can then go into a branded environment. You mentioned generic companies. Well, it's actually the branded companies owned by generic companies that we're talking to because they are the ones that are driving the performance of those larger companies. And so it's all about having a de-risked asset that can move towards a good commercial opportunity, and we're seeing that in terms of CTCL.

Yes. Very good. I think maybe we let you run through the slide deck, and then we'll come back for some more Q&A at the end of that. So James, I'll leave you with the floor.

It's brilliant. So here's our safe harbor disclaimer for forward-looking statements, et cetera. The [ bids ] might get into this in terms of the company. And you can see a company snapshot from a week ago, 21st of August, $9 million and in the cash position at the end of the financial year and a reasonable market capitalization. And you can see the year of trading there. So some highlights. So we talk about PTX-100 of their lead candidate in it. It's a candidate we've licensed from Yale. It's impacting a pathway, which is implicated in about 22% of all cancers. So really, we're pioneering a platform, which has applicability into 1 of 5 cancers. PTX-100 is actually first-in-class. And so there are no other GGTs inhibitors in the clinic as yet. And so we're progressing at an advanced stage, and that's very handy and I'll talk about that in a moment. We're progressing in a rare blood cancer, which interestingly exhibits initially in the skin. And we're doing this following our Phase Ib program where we saw some encouraging data. And we have a near-term milestone, as we've mentioned previously, and that's expected at the end of this year in terms of the Phase IIa dose optimization committee, reviewing what we've seen so far at the halfway mark and they're making -- providing a recommendation and we'll see some interesting information from there. And the most recent comment that we're talking about with Patrick was there creating value. I mean, the [ Sobi ] deal really did demonstrate this value in this environment, not just for patients, but also for the investors and our company. So we're preparing the groundwork for that. So it's a busy time, but actually an exciting time. So I'll just go quickly through our background. We know the normal cell division. We see from the Cancer Foundation, this model, I've added the mediated by [ Ras ] family component just to give you an idea of where we sit because when we look at our mode of action on how PTX-100 works, the [ Ras ] family proteins do play a big role, and it's what we -- that process is what we disrupt. And so normally, the body does use [ RAS ] proteins, but they -- when they're not functioning normally, they switch on and they switch off in mutated [ RAS ] environments and therefore, tumor environments, they don't switch off. And so they remain switched on. And so the [ GGTAs ] is used as a pathway to actually add a [indiscernible]. So basically a little arm that holds -- that allows the protein to hold on to the cell membrane and trigger downstream effects which are pro tumor. So if we move to the right there, you see PTX-100 blocks the activity of [ GTT ]. So it actually sits in the prenylation pocket and prevents those RAS proteins in the [indiscernible] group getting together and that disrupts their ability to hold on to the membrane and therefore, signal downstream. So it's an antitumor type approach. Now we've recently worked with the [indiscernible] and do some in vitro work. And that really supports our mode of action. You can see there that the AI and physics modeling really demonstrated that PTX-100 fits nicely within the pocket of the [ prenylation ] part of the [ GGTAs]. The central graph there shows an in vitro work using a [indiscernible]. And so with the green graph moving to the right, it demonstrates that PTX-100 binds strongly to the [ GTTAs ] and the fourth graph, which I'm quite excited about. You can see here that we're looking at the anchoring of a [ REP-1], which is a [ REST ] family protein and the amount of -- which has changed the exposure of PTX-100. And you can see there's a 40% to 60% reduction in the amount of [ Ran ]attached to the membrane in 4 different cell [indiscernible] when would be the control. And so that's encouraging. So 4 different cell lines, 4 different cancers than we see in effect. So that will be data we use for our nonclinical package as we progress through the regulatory processes. I mentioned first in class, and we've said this a lot, but it's been really helpful for regulatory designations. We're moving through without competing with other [ GTT's ] inhibitors. The KOLs are coming to us in this space, and we're creating more data for potential other tumor types as we progress. So it's a handy spot to have. So PTX-100 and CTCL and why are we here? Well we started looking for what we think would be an ideal indication [ ras ] involvement really an unmet need, those sorts of things. We've come across to CTCL based on our 1b program because we meet those requirements in terms of where we're going for our program. And you can see our outcome from the Phase Ib study was 43% objective response rate, no drug-related serious adverse events and picked up some FDA Fast Track designation and also U.S. and EU orphan drug designation. So we're in a good spot. And so in a good spot to move through a Phase II program. So CTCL, it's a white blood cell disease of cancer. So the T cell, which should be working in the immune system, but it's not, it's progressing to the skin, where it attacks that, eventually ends up in the noise in the blood. So it's progressive cancer. Initially, if it's present in the skin, it's causing quite a lot of quality of life issues in terms of itching, [indiscernible] infections, social isolation and those sorts of things are really challenging and [indiscernible] and fatigue. It's rare. So there's about 8 per 1 million patient population in the western or particularly in the U.S.. That means there's about 3,000 new cases a year and the most -- in the biggest market in the world for pharmaceuticals. CTCL actually has 2 main forms of subtypes for -- listed as mycosis fungoides and Sezary syndrome. So it's probably worth understanding a bit more about them. So mycosis fungoides is the most common subtype between 50% or 70% of the cases, typically, it appears in the skin and then progresses through the nodes [indiscernible]. Sezary syndrome is the next large subtype, which is about 5%, so quite a significant difference there. It's more aggressive. It appears in the skin, but then quickly involves the blood. And so it's quite a challenging subtype to have. And so when we -- when I mentioned challenging, it's more about the outcomes in advanced stages. And so if you look at this graph, in the purple bars, you see next to the mycosis fungoides early stage. These are stage 1a to 2a. The most challenging part there is perhaps more quality of life and less of the prognosis of survival. But we know and we've seen that quality of life is a real challenge. But as you get to the advanced stages and also the Sezary syndrome stage, not only your challenge from a quality of life perspective, you also challenged from a survival perspective. So this is a really challenging disease, and clinicians are really looking for therapies that make a difference because it is not looking good. So existing therapies are a modest efficacy, some safety and tolerability issues, most patients have few options now. And because of that PTX-100 has received a fast track designation in mycosis fungoides based on their early Phase Ib data. So that's -- that shows you how much unmet need there is. We have that fast track information. So when you're treating CTCL, firstly, you get topical therapies, you then might get some chemotherapy, but then you get the second-line therapies, which are used -- which are more advanced. On the top right -- on the top left there, you can see some biologics carrying payloads. One of those is [indiscernible]. On the other side, you can see 4 biologics, so antibodies taming particular antigens. I'll point out that the first one, [indiscernible] is specifically indicated for CTCL, but also the third one [indiscernible] the IP is actually [ lacutamab ] and that's -- it's the drug that's involved in the deals we've been discussing, which I'll talk a bit later. And you can see down at the bottom, there's [indiscernible]. And in the middle, you can see how the [ RAS ] family proteins, they add that [ general ] group using [ GGTAs ] attached to the cell membrane and start signaling in the tumor basis. So let's group all those together in terms of what does it look like. You can see this 4 main groups. But PTX-100 sits right in the middle and as separate. So you can see that by impacting the [indiscernible] pathway, you impact tumor growth. And this is very helpful because when you combine that unique mode of action with a very favorable safety profile, it becomes a likely backbone of future therapies so that future combination approaches. So let's look at our Ib data. And you can see it's on the right there in the green, 43% overall objective response rate, 100% clinical benefit. The bottom there is 0 adverse events related to PTX-100. So that was the encouraging data that has sent us into this Phase II program. We have benchmarks or we -- internally, we call that a target product profile of [ TPP ]. And you can see what the targets are there and our results from a Phase Ib were very favorable. We can see [indiscernible] there, which is one of those products that carries a payload, a biologic reached modest objective response rate, but quite serious at best event rate. And [indiscernible] is one of the biologics targeting antigen. Again, a modest response rate, but significant serious adverse events. Now [ latutumab ] is the drug that we've been speaking about where they've completed a transaction for USD 580 million. You can see that they have reasonable really good data in actually Sezary syndrome, not so good in mycosis fungoides. So they're quite strong in that 5% subtype and less strong in the larger subtype. And so with that, they've been able to really sign a good transaction. So that means to us, what that means is that we're playing in the right space and this commercial benefit of being in the space. So if we mentioned the adverse event profiles, and you can see PTX-100 so far is looking pretty favorable, which means that it will suit a combination approach. We see we've got a unique mode of action. And if that continues in our studies, it will be very, very well used combination approach. So we talked about Phase 2, and this is the first part of the Phase II, the Phase IIa and we're enrolling our refractory relapsed CTCL patients of mycosis fungoides or Sezary syndrome subtypes, 2 previous lines of systemic therapy failure at least and 40 patients. Now we've moved to a dose optimization component based on project optimism from the FDA. So we've got 2 arms here. Overall, the study is set up for 20 evaluable patients in each arm, but we have a dose optimization committee there, which has a chart which says that we'll look at the data when there's patients in each arm, 10 evaluable patients in each arm, and we'll review each for safety and efficacy and whether there's an ability to provide a dose recommendation at that point and then provide a recommendation to us about how to go forward. So that's an important milestone time for the study. So the real look how we're progressing. You can see endpoints there, which are quite comprehensive. Objective response rate is a high hurdle, but it's standard in the space, and it's what the FDA and the [ IND ] approved. And you can see secondary endpoints there, which will provide lots of data -- the skin response is a specific CTCL measure. So that will be very helpful from a clinical standpoint. So quite excited about that one as well. We will determine safety tolerability. And as you've heard, quality of life is a big issue in this space. So we're actually measuring that as well. So we're running our program, and this is our clinical trial plan. It's ongoing in the Phase IIa. And the expected plan is fairly standard there. But when you have orphan drug designation and a fast track designation, you have greater opportunities to talk to the regulator and following identification of a dose and having safety and some efficacy data and things of that. We'll be moving to a Type B meeting with the FDA and really discussing, interrogating the opportunity about running a pivotal program. Now we mentioned [ lacutamab ] is running a program where they have an accelerated pathway for sugary syndrome and a confirmatory component for CTCL as a whole. And so you can see the FDA are being creative in what they're doing in this space. And so the opportunity for a pivotal study is there, but it's very much dependent on the agreement with the FDA on endpoints and the patient numbers, et cetera. So that's our goal, and we'll be progressing towards that as we get more information. So we move to the addressable market. We do know that the addressable market is $1.2 billion based on third-party data. We've seen that there's 3,000 new patients per annum in the U.S. This is the U.S. only. The reason why we're talking about that market is that market is a substantial market and will make -- will be very encouraging from a commercial standpoint and partners really do focus on that market as our first goes. So that's why we're [indiscernible] here. We've seen and I put this slide in because it's [indiscernible] or [ monalizumab ] is the drug name. This is a demonstration of what you can do to a market when you have a unique mode of action and there's a clear unmet need of patients really looking for new therapies. This product was launched in late 2018. So this is data from 2020 to 2025 and you can see that modomalizumab is used in early and late-stage second-line therapy. So that means even those patients that are suffering from quality of life that have perhaps longer in terms of survival, are still getting [ mogamulizumab ] because they've run out of other options. So that's encouraging for us. And this graph grows at the same rate as the total market. So this is a really strong indicator of a very clear unmet need in the market, and we have a unique mode of action and will make a difference and therefore, it's encouraging for PTX-100. It also provides a really good pricing comparison. So when we start talking about market access, there's some really clear evidence of what's going on. So we're at the expansion kind of stage where we're looking at our Phase II program. We really would like to get to that pedal study and complete that complete commercial -- commercial pathways for potential partnering and then look at other -- at their point, looking at other indications such as other orphan diseases. But if we get more IP looking at larger cancer types and then really working on those commercial pathways and leveraging our competencies and looking at the company as a whole. So some really good things happening there. And so it's an exciting time. So we've put these milestones up for PTX-100, and I guess the first one there is the really pivotal one in terms of what's to come. The [ DAC ] with 20 evaluable patients. That is a pretty significant milestone. We'll work on some extra French sites. And if we need to get to the 40 valuable patients, you can see the time of that. So -- and then the Type B meeting. Those time periods will change according to information gain from the earlier GOC meetings. So we've got the team. We've been working at this. We've really rationalized the team and also rationalized our consultants and we got very good support from the Board of Directors. So we're progressing with a really strong value proposition with PTX-100 being first-in-class, appealing to -- disrupting a pathway, which has involved indicated in 22% of cancers. We're advanced. We've got some good efficacy numbers. We've got great FDA designations, and we will be creating the data that will generate future partnering discussions. So we're in a good frame at the moment, and we are progressing the Phase II study. So the share purchase plan. So I'll I can discuss this, Patrick or --

Yes. Sorry, my camera was giving me a death spiral. Very good. So yes, look, I mean, the share purchase plan is -- gives you the opportunity to pick up stock at 80% to the [ VWAP ], the 10-day [ VWAP ] leading into the period. There's a nice discount to last year price. And it gives the company the funds it needs to advance PTX throughout dose optimization committee review and into the later stages of development and general working capital and costs associated with offer and so forth. So we're advising on the SPP. We advised on a couple -- I've got my Internet -- sorry, my camera just disappear on me there. It's -- this offer closes on the 8th of September, so I really encourage you to get busy [indiscernible]. But if you haven't got the offer docs just type yes or if you'd like to receive, I should say, the offer docs, whether you just want them on hand, they're just typing the yes and we'll make sure that we get those across to you.

Look, I think let's maybe move into questions. I can see a couple of questions coming through. And if anyone has any further questions, please go right ahead and ask. So there's been one or 2 questions around like what are similar [indiscernible] and transactions that have been done, I know you mentioned [ Sobi ]. And look, we did a bit of work on this. in the lead up to the campaign and looked at a number of different companies. Interestingly enough, I was talking to an analyst the other day who has done some work on Prescient and they were saying comps in Australia because there aren't really that many companies has advanced as Prescient that are in the clinical phase as present they to get a comp, they were having to go into the U.S. And I think that the fact that we don't have that market creates opportunity to buy here. I think with the stage that the company is at, at the moment, some significant inflection points. It is an interesting opportunity. So I guess we look through it, there are lots of different examples that we went through. I think [ Mirati ] is one that is interesting. I mean they sold their [ RAS ] inhibitor. It was focused on slightly different cancer, but otherwise, quite similar, slightly bigger market. They went through a similar process to what PTX are targeting and also received orphan drug in 2021. And in December '22, the FDA gave them accelerated approval, and they took that drug to market in '23 and were bought out by Bristol-Myers Squib in October that year, 10 months after getting that accelerated approval the $7 billion. So I'm not saying that that's the journey for PTX. But certainly an example of how fast things can move and the sort of money that these things trade for. That's [ Mirati ] was -- that's orphan drug designation during Phase I to buy out in a 2-year period. We see those deals happening at this stage, right? So I guess what the sort of -- what are the things that you need to achieve from here are when you need to put in base James to put yourself in the best position to do the best possible deal?

Well, we need to be engaging with companies which -- we are engaging with the mid-tier, the large generic companies that have branded product divisions and things like that. Because the more we engage, the more competition between these companies occurs as well. And so we -- as we progress through the Phase I, the Phase II program, and we receive data, which we share with our partners, it increases the momentum of those discussions. And so companies are looking at -- for assets, which are derisked in that late Phase II programs heading into pivotal programs. Typically, not the large part, the super large pharma companies like Pfizer, things that they require to run their organizations really large disease type. So orphan drug is a really great niche for those mid-tier to other large pharmas that are looking at strengthening their [indiscernible] parts of orphan diseases and rare diseases where there's a high revenue number associated with it in terms of margins there. So our goal is to create momentum within the discussions with partners and new data, which we gain from our Phase II program.

I mean as time goes by, you're seeing increased engagement?

Yes. I mean, everyone is very focused on key milestones just like us. The soonest information comes from the Phase I program, there will be -- engagement will go off the scale. And I will be extremely busy, which is the good time. These discussions because, as you mentioned, there are not many assets in this space, we get to engage and we get to talk in a more global sense, which is also handy. A global deal is something that I would prefer. You're able to manage the situation much better than that. than having multiple deals. But ideally, the first goal is a global deal, and then we'll see what happens after that. But we're engaging -- I engage with 15 companies just in [ Bion ] in San Diego recently and some others in Europe. So we are increasing that engagement and they're looking at the next level of information we can provide in terms of the study.

And I mean from the conversations you're having, is there any indication on the type of company that, like is it big pharma, a mid-tier, a generic? Like where does the -- are you getting any sort of --