Prescient Therapeutics Limited (PTX) Earnings Call Transcript & Summary

Well, good morning, and welcome to Prescient Therapeutics Investor Update. Thank you very much for joining us today. While people are in the process of logging in, I might run through some of the housekeeping matters to set the session up. My name is Patrick Nelson. I'm from Reach Markets. I'll host the session. However, to run it, we have Steve Engle, the Chair of Prescient and Steven Yatomi-Clarke, CEO and MD. And of course, we put this session on based on the announcement via the ASX this morning to cover off Steven Yatomi-Clarke's resignation. And there will be a couple of short presentations. But before we get going, any advice contained in today's presentation is general only. It doesn't consider your personal circumstances. You need to decide for yourself whether it's appropriate for you. Past performance is never an indicator of future performance. So with that said and done, I'd like to thank shareholders and investors alike for taking the time on short notice to join the session today. And we've got -- the format of it will be that Steve Engle will be making a short presentation, followed by a -- or a short statement, I should say. And then Steven Yatomi-Clarke will also be making a statement. And then we'll open the floor up for questions. If you would like to ask a question, just go into the question box. You can type your question in. I'll probably ask the questions at the end of the statements made by both presenters today. So obviously a significant announcement for the company and on short order, they wanted to get in front of investors and speak to it. And this is the opportunity. And again, thank you very much for joining us. So with that, all of that said and done, Steve Engle, thank you for taking the time and great to have on the session today. I'll hand now the floor to you, and I'll come back in a moment to -- if there are any questions and also then to reintroduce Steven.

Thanks, Patrick, and good morning, everyone. As indicated in the release that we just put out, Steven has let us know that he will be stepping down. And we expect that he will be in the position through the end of February 2025. And during that time, the company will be conducting a search for a new CEO. Following the appointment of his successor, Steve has agreed to remain available as a consultant to the company -- and if required, I can act as an Executive Chair until the appointment of the new CEO should that take additional time. So the Board and I are moving forward with this. We want to express our deep appreciation for Steve's effort, the leadership and vision for the company and building an international team over the last 8 years and taking PTX-100, which was really kind of a test tube stage when we began the company and now we're on the cusp of being able to start a Phase II study. In addition, Steve has really helped to expand what we offer in this nascent cell therapy field and has also really established prescient as a recognized leader such that we've had many, many conversations with potential partners. So as the technologies in the cellular therapy and PTX-100 continue to move forward, we expect that will be a very valuable set of relationships. Obviously, we'll miss Steve and wish him the very best in his new venture. So briefly, looking forward, with all those things in place that Steve has helped us do, there's never a good time to make the changeover, but we do think the company is in a very good condition. As we bring a new person on, we get that great opportunity to go ahead and strengthen the position, adding more experience, particularly later stage, potentially with commercialization capability as well as a larger network of partners and partnerships that we can bring through the additional new CEO. And we think Prescient will be a very attractive opportunity for the right candidate. We have the cash in the bank to start up the Phase II study and get it through the Part A at least. We've got our letter into the FDA at this point and waiting for approvals to move forward. And we also have the other program besides PTX-100, where we have several opportunities there, which we'll be moving forward on. So all of that, we think, bodes well for this search. And as we move through it, I'm sure we'll make comments. But in the interim, Steve remains with the company through the end of February. And I think that gives us some of the time we need to get through the recruiting process. Whether it will be all or not, I can't say at this point, but certainly gives us a real chance to do that. And I think this will be a very, very interesting next step for the company and really represent our beginning to bridge over hopefully into that not only positive clinical results of Phase II level, but potentially into looking at commercialization as well. We wanted to give Steve a chance. Steve, go ahead.

Thanks, Matt, and hi, everyone. Yes, I think Steve sort of said it all. I think the only thing I'd add is that I certainly wasn't looking for an opportunity. I realize that a lot of the questions that come whenever a CEO is departing, 99% of the time, they're either sacked by the Board or they're jumping ship and neither of those are the case here. So it's -- I certainly wasn't looking for anything. In fact, I've certainly turned down much bigger opportunities in the last 12 months because I thought, no, like Prescient, it's got to be better than Prescient. I couldn't find anything better than Prescient to be perfectly honest. There was things in the U.S. and in Australia. But this is quite a different opportunity altogether. I wasn't looking for it. But -- so I don't want anyone to think that in any way, I'm jumping ship or this is acrimonious. It's quite the opposite. Actually, it's been quite overwhelming the level of support from the team and the Board. And I guess there's never really -- you don't want to leave when things are bad, you don't want to leave when things are good, but sometimes you just know. But what I did want to do is to make sure that probably the best time for the company to leave is well operationally, we've got good momentum, and we can come back to that in a moment. But it's undeniable that we've got this amazing operational momentum. And I know I'm voluntarily stepping away, but I know I'm actually in a strange way, envious of whoever takes the seat because they're inheriting something that will be -- hopefully, a potential registration trial that will be underway and all of the other good things that we've got in the background, we're winning on the data, like the business is actually humming, whether it's reflected in the share market or not, it's -- that's another question. But with all of the headwinds we've got, but what we can say as a Board and an executive team that operationally, we've got fantastic momentum and in a great position. And I think that will position the company very well to attract the best possible candidate. And yes, so I'm happy to open up to questions.

Thanks, Steven. Sorry, just turning my camera on. Look, big news. You've been at the company for a very long time. You've spoken to why the decision now to an extent. But like is this -- are you moving in within the industry? Are you moving out of the industry? What can you say about what happens next?

Yes. We put a little summary in there. It's -- again, it's quite unique. It's not a competitor. As I said, comparing Precient against other drug developers, I was very, very happy to stay at Prescient and happy to be involved for as long as they'll have me afterwards, to be honest. I'm quite deeply attached to Prescient and extremely proud of what we've been able to do over the journey and how we're positioned. So I guess there's two answers to your question, Pat. One is probably with the head and one is with the heart. And with the head, as I said, there's never an ideal opportunity. But if the company is doing everything right, any company, it's really that leadership is a relay race. And in my opinion, I'm very, very proud of what we've accomplished in my time. And certainly, there have been so many challenges and precious few people know exactly what it's like tackling and overcoming those challenges. So there's that. But there's -- we're in really good shape. And that, I think, is a perfect time to do a handover or a transition is when things are going well. So that's with the head. And with the heart -- look, I know I'm going to regret this in many, many, many times. there's -- and someone else -- I'm actually very, very confident that someone else is going to be carrying the trophy when PTX-100 gets approved. I think there's a very, very, very good chance of that. And I'll be watching from afar with a great deal of pride and probably a little bit of regret, but I just -- I know in my heart, I have the advantage of facts and the fact is that my fingerprints will be all over any success Prescient has in the future. But I will certainly miss the team. For sure, no doubt, I'm going to miss the team. I'm going to miss the experts that we've got the honor of working with. I'm going to miss really focusing on a very narrow area and recruiting the best possible people to be involved in that. So that's the combination of years and years and years of work. And -- so that's what I'll miss. But the new gig is completely different. It's over $200 million backed into an RNA effort and the attraction of building an entire ecosystem is a vision that is very attractive to me. It will be an incredibly difficult challenge. But for those that know me well, it's not something that deters me.

Yes. And to the recruitment side, I mean, what sort of person do you think you need to replace you? Yes.

Maybe just speak to that for a second. Before I do, though, I just -- don't worry, Steve, we'll invite you to the product launch when the time comes. So as I indicated, you reach these points in the company, and it's a real opportunity to do a broad search and to evaluate a number of people in order to strengthen the position with someone potentially having more experience downstream, may have more partnering experience. And what you're looking for is a biotech executive with a vision for the next phase of the company, investor and financing experience, on the operations side, clinical research and manufacturing and then the ability to both market the product, but also to partner, which is its own specialty in these situations. We think of it right now as having 2 major directions as far as things like the PTX-100, which is targeting CTCL indication may be a situation where we can take it all the way ourselves depending on the results of the Phase II study and so forth. On the other hand, if there are multiple indications that are obvious and pharma partner wants to come in and help develop those, that's a different direction. But those are kind of common strategies for companies like us. And so I think those are the kinds of things we'll look for experience. And then also just the marketing of products like CellPrime and OmniCAR into these markets. I think we've done a great job of getting a number of pharma and biotech companies aware of what we're doing. And now the question is to move forward and get the product embedded into their process and into the products.

Yes. And for the next 5 months, I'll let you guys choose who answers this one. But for the next 5 months, while you're finding this replacement, what do you think the priorities are going to be?

The trajectory is set so far as I'm concerned. So we're doing an enormous body of work. We put out an updated presentation recently, an enormous body of work in getting this next trial up and running from CMC and reg efforts all the way through to site identification and onboarding and recruitment. We've appointed a range of CROs and whatnot to help us do all of that. We've submitted our letter to the FDA. So everything is -- basically, that's a long-form way of saying that we're getting ready to get this trial, optimally designed and up and running. We've chosen to focus on cutaneous T-cell lymphomas, and I can get into that on another call, but we find ourselves in this really nice position where we've got a unique opportunity to have leadership in an area where no one is looking at least, they're not looking yet. So all the activities that are leading up to that to initiate that study and have first patient in this year. In the meantime, we've got a number of parties, big potential channel partners evaluating CellPrime, and we're helping those through that process. And we're obviously still in that -- the redesign efforts for OmniCAR and there'll be news on that if that's a successful effort as well. So the trajectory is set. There's no change in trajectory. And -- yes, it's business as usual.

Very good. PTX-100, can we touch again on the milestones there? And you mentioned trajectory, but do you need a CEO to keep things moving along?

Thank you. Probably you do need a CEO to keep things moving along. But I think I know the spirit of that question, which is how hands on am I in that day-to-day stuff. I'm overseeing a lot of those activities, but we're lucky enough to have an excellent team led by Apali, who's just doing an enormous amount of work just getting everything up and running. Like honestly, you see it's tiny bit of the tip of the iceberg on what's involved in initiating a potential registration trial like this for a small company. It's enormous. So yes, it's a lot of work to oversee, and I dive down into deep areas where I need to and then and then resurface. But the trajectory is set and everything is underway. Do you need a CEO for that? Yes, you probably do. But guess what, I'm going to be around. So I don't think there's any loss of momentum there. It's very important to maintain that momentum.

If I can add on to that, Steve. I think the things we're looking for is, first of all, a positive FDA response to the letter we've sent out and in particular, the idea that this would be an accelerated approval type situation. And what that means is we'd be considering with the FDA's agreement that we'd be able to get the results, but also rather than running another Phase III trial immediately, we would be able to actually begin to move towards marketing and commercializing the drug, which would be a huge jump over the usual step of running another Phase III study. And as Steve has told you, that's very much driven by the fact it's a very rare disease situation, and we're showing good results. So that would be a transformative outcome for the company. And we still have to run the study, obviously, but that's the upside. And of course, the other way to go is that the agency says, "Well, we've got to go ahead and run the -- we'll wait." That's probably the most likely they'd -- wait for the Phase II results to make up their minds one way or the other. And depending upon how strong those are, they might still consider doing something. So of an accelerated basis. And lacking that, we run the Phase III trial as everybody usually does. But we think this gives us a real upside to the standard process. And as Steve said, this could be the trial, and that would be very, very exciting.

Just to clarify then, the FDA sort of will bless the process, but they never grant anyone an accelerated approval until they see data. That's not a present thing that how it works. So regardless of what happens, no one grants an accelerated approval before the trial starts. But I think the spirit of what Steve is trying to pave that path with the regulator to make sure that by the time we generate data and if it's good enough that it meets what they're hoping to see.

Maybe touch on a question around funding. So maybe with this topic in mind, I mean, what's your funding like now? And maybe in relation to PTX-100, how far does that get you?

A long way, which is a good news. Now we're in a good position. We've got, what, $14.5 million cash as at last reporting period just very recently. And we've -- we put out RFPs for all of our service providers. And believe me, we've kept them on their toes with getting very competitive prices back. So no, we're in very good shape. Look, we don't have enough to complete the trial completely. If we shut down everything else, then yes, maybe we would. But to get to where you want to do in a position of strength and anyone that's followed us over the journey knows that we never like to get ourselves into precarious positions. And I think we've always been very responsible with our fiscal management, but we've got enough cash to take us a considerable way into that trial, let's just say, certainly enough to deliver some very accretive milestones.

Very good. I welcome questions from the floor. And again, we did a big turnout on a very short turnaround on a time frame perspective. So we'll make the recording of this available to anyone that missed the start of it. 5 months is a long time. Obviously, by design gives you time to find someone in to come and replace you. But how do you stay motivated for a 5-month period, Steven?

Anyone that knows me doesn't really need to ask that question, but how motivated I am, I'm motivated by getting therapies to cancer patients urgently. I've said it many times that a single day could be the difference between just in time and just too late. And I'm a guy who will run hard to the finish line. And I've got my late father's voice in my head saying the job is not finished son. -- keep going. And straight after this call and after the flurry of these necessary calls, it's business as usual. We've got patients to treat and patients who are waiting. They don't care about what I'm doing. They need therapies. And the team knows that. We've addressed this with the team, and they know it's business as usual, and we'll be just marching ahead. So I don't need any additional motivation to keep running hard at this. This is -- the spectra of cancer is enough motivation for me or anyone I would have thought.

Yes. Steven, thank you very much. Steve Engle, thank you. I appreciate both your presentations, and thanks to the shareholders and investors who have made the time to get on to the call. If you missed the start of it, we'll send the recording out to you. If you've got follow-on questions, there is a question box on the website, but you can also e-mail in response to any of the comms that you receive from the company or -- and we'll coordinate and ensure that you get responses to those questions or you can call the Reach office as well. So again, thank you very much, everyone. Steven Yatomi-CLarke, I'll leave the last word with you.

Thank you. And look, thanks to everyone for their support over the journey. Just to reiterate, there's -- this is not any acrimonious departure. It's not like I'm being pushed out or I'm jumping ship. I think the company is in fantastic shape. And that's why the timing is what it is with this advent of this trial being positioned so favorably in cell therapies for when that sector recovers. I think that positioning there being agnostic and enabling is going to be a very wise one. Time will show. We've got a lot of great things ahead of us, and let's just keep delivering it. So many thanks for everyone's support over the journey, both internally and externally, and I look forward to speaking to you all soon.

Thanks, Steven. And also in the spirit of business as usual, we'll be hosting a proper full update on PREciENT -- in the coming weeks, we'll send out a note to everyone with ample warning to get into that. So thank you very much, and good day, everyone.

Thanks, everyone.