Prescient Therapeutics Limited (PTX) Earnings Call Transcript & Summary

Thanks, Steve. It's now 12:00 p.m. You may start the meeting.

Thank you, Melanie. Good afternoon, all. My name is Steven Engle, and as Chair of Prescient Therapeutics Limited, it is my pleasure to welcome you to the company's 2024 Annual General Meeting. I would like to start by acknowledging and paying respect to the traditional custodians of the land wherever those participating at this meeting are located. This meeting is being held virtually and shareholders will be able to participate, ask questions and cast direct votes at the appropriate times whilst the meeting is in progress. The company's Secretary has advised that we have complied with the relevant requirements for convening this meeting and that a quorum is present. As the time is now 12:00 p.m., I formally declare the meeting open. I'm joined through the webcast today by my fellow directors, Dr. James Campbell, also Dr. Gavin Shepherd, Dr. Ellen Feigal and of course, our Managing Director and CEO, Steven Yatomi-Clarke. Unfortunately, Dr. Allen Ebens was not able to join us. Also in attendance is our Company Secretary, Melanie Leydin. In addition, we have the representative of the company's external auditors, William Buck, in attendance at this meeting. The Notice of Meeting has been given in accordance with the company's constitution and copies of the notice are available on the company's website, the share registry's online voting site or on the ASX market announcements platform. I will take the Notice of Meeting and explanatory statement as read. The format of today's meeting will be a Chair address from myself. We will then have an operations presentation from our CEO and Managing Director, Steven Yatomi-Clarke, followed by a Q&A session on business operations. Melanie Leydin, our Company Secretary, will then explain the meeting participation process. We will then address the formal business of today's agendas and this will be followed by a Q&A session on the formal items of business, following, which shareholders will be provided an extra 30 seconds to vote on the resolutions. Once the poll is completed, the results will be tallied and released on the ASX platform later today. So I will begin with my presentation. Can you go to the first slide? So we'll be talking about primarily the PTX-100 program because it is the fastest to market. In my address, I'm going to focus on the accomplishments. And so here's a snapshot of some of those things. For PTX-100, we've not only had but continue to generate encouraging data for the program and for the product. Also in parallel, we've been generating broader awareness amongst the KOLs, the thought leaders in the medical field at key global conferences, and Steve will give you more detail on that. And then, of course, we've been planning and preparing for the Phase II study in the CTCL patients. And this has consumed a great deal of our time and efforts. In the case of CellPryme, one of our 2 cellular therapy programs, the preclinical work is largely concluded. We've generated a compelling body of data demonstrating the ability to enhance other people's cell therapies. And so we're now in the process of engaging partners to try the product out and actually put it into their processes. In the case of OmniCAR, as you know, we've been troubleshooting and problem solving for a particular issue called tonic signaling. This is of the unarmed cells before we move forward with the program. It's been a very complicated challenge regarding -- requiring a multidisciplinary effort. And we'll give you a little bit more sense of that as we go along. In addition to all that, we've done it within budget. We ended the year with about $14.5 million in the bank and we feel good about that. And we've continued to upgrade the staff and otherwise make changes as we've moved from earlier stages to later. Thank you. What's the most compelling activity is that PTX is really entering a major inflection point. This is a map we call the biotech value map. Across the top, you can see the different phases of drug development, from discovery to early development to late development. And so we've entered the late development phase with the Phase II study once we get that up and running. What's important about that is that the early development piece, there's an incredibly low success rate in the industry in general. And so the fact that we're now on the other side of what we call the value of death, I think, reflects well on the product as well as on the team for getting us there. And we're looking forward to seeing a rapid rise in the value of the product as we go through the Phase II studies. Now, I'm going to stop and Steve is going to pick up the slides and finish it off. Steve?

Thanks, Steve, and hello, everyone. It's a delight to be speaking with you again today. And I ask for your understanding and apologies in advance, I've got a terrible tickle and get into coughing fits, but I will soldier on. This will be a -- it won't be an investor presentation, of course, because the good thing about these AGM presentations is everyone already knows the company, but I want to focus on really what some of the key highlights have been for the year and what the challenges have been and will be and need to be overcome and what the future looks like. So I'll start off with PTX-100, which as everyone knows, is our lead asset and our first-in-class molecule that we've licensed from Yale. And this is a summary of basically what we've been doing this year. Obviously, the Phase Ib trial is ongoing and pleasingly, still got 1 patient on therapy with a complete response. But over the course of the year, we've recruited that very steadily, which is fantastic. We've undertaken all the analyses that we need to take, not only from a clinical point of view, but also the correlates and whatnot looking at PK. As Steve alluded to, we've been very busy this year presenting our data at specialist lymphoma forums, and that's enabled us to get invaluable feedback from these clinicians who at the end of the day are going to be the people determining the purchase of drugs. So the fact that they've been so enthusiastic and we've built awareness with them is great. The fact that they've been able to help us fine-tune our strategy has been invaluable. We've also sought input from a number of other experts, necessarily, including reg experts. And that's culminated in us focusing our strategy, I'll get to that in a moment, and submitting that to the FDA and ongoing correspondence, which continues to this moment ahead of an imminent IND submission and submission of that protocol as part of that. And also as we've said last year, and I'll keep saying it, in drug development, manufacturing is often underappreciated. And oftentimes in Australia, at least, we're very familiar with what it takes to undertake a CMC campaign -- a manufacturing campaign for early-stage programs. A lot of companies have the luxury of then a Phase II program to fine-tune that ahead of what they hope is a registration study. We've got the enormous challenge of kind of leapfrog that and get basically commercial ready, get ready for that registration study straight off the Phase Ib. And we've -- it's been a body of work there and continues to be and can't be understated because without that, we don't have very much. So we're focusing basically on CTCL, and I'll describe why. This is our first -- our Phase Ib study focused on T-cell lymphomas, which included peripheral and cutaneous, peripheral being sort of spread throughout the body, is blood -- contained in the blood and cutaneous basically is -- has skin involvement as well. The focus of this is basically to fast track this trial as much as possible. And our rationale is here -- basically there's also a higher degree of confidence based on the data we've got. There were -- we had a fair few patients who had success on this trial on our Phase Ib trial. So we've got a higher degree of confidence based on actual data. But also there's a greater need for new therapies. And as a result, even though it's a rarer disease than PTCL, we think it's likely to recruit faster. There's a patient -- a larger patient pool there and you contrast that against peripheral, it's more prevalent, but there's an increasing amount of competition there in the clinical trial space. Patients don't typically last very long with refractory disease in PTCL. So the patient pool is diminished and you get a lot of patient drop-offs and a lot of disease progression that you're battling against. With CTCL, again, smaller disease, but the patients live longer and have -- therefore, we've got a larger patient pool whilst the incidence is smaller, the prevalence is larger. The bottom line is that we think we can get to a result that is valuable for Prescient with the beachhead, if you like, being CTCL. It doesn't mean we're not interested in PTCL. It means that we'll be spearheading our development program with CTCL. And as a reminder, it's a disease of -- what happens when T cells become malignant and this is the skin involvement here. And we've -- this is quite graphic, but this is what happens when cutaneous T-cell lymphoma gets out of control. So it's not the largest market in terms of patient numbers. Again, new patients a year in the U.S. alone is about 1,000, just in the U.S., but they think it's approaching a $1 billion market opportunity. And there's not very much there. So what I'm saying is if there's a successful new drug, you can actually help grow that market. A relevant case study, which was approved just a few months ago is LYMPHIR. LYMPHIR is a fusion protein that has been -- that got approved from Citius. It's a version 2.0 of a drug that was previously approved and then withdrawn and the estimated cost of this is about $200,000 a year, including to a U.S. analyst report. It was approved on an overall response rate of 36%. It had a duration of response of 6.5 months. It wasn't without its safety concerns. It had an SAE rate of about 38% and almost every patient had some sort of adverse event. But this is the new kid on the block and one that we're comparing ourselves to as a very relevant case study for what we're trying to do. I think we're all very familiar with the Phase Ib design and the fact that we've got orphan drug designation for this and let's look to the future. But I'd invite you to judge any drug in this disease with 3 criteria. The first one being safety, how safe is it. And again, SAE rates are about 30% or more of the time, you get a drug-related serious adverse event in this particular indication. And we saw in the previous slide, 36% for LYMPHIR. The other one is the response rate. And again, it's about 30% of patients respond. Again, LYMPHIR was slightly better than that. And then the third criteria to judge them on is how long do these responses last for. And again in CTCL, it's 9 to 13 months depending on the agent and the stage of the disease. And we saw that LYMPHIR was about 6.5 months. So this is the criteria that we think is a good rule of thumb to measure success against. And okay, we only have Phase I data, but really it's -- we've got -- against all of these criteria, we believe we stack up quite well. Small amount of data, but we think we've got -- we're winning on all of these metrics basically. And we've got an especially high conviction on safety given not just the number of patients that have gone through the study, but how long they've been on study and how many doses they've received, combined with the prior previous study not undertaken by us sort of reconciles the fact that we've got a higher degree of confidence on safety than one might otherwise have from a smaller Phase I study just because of the duration of how long the patients have been on study. So this has given us the confidence to plan for this Phase II trial. So as I mentioned before, we're in dialogue with the FDA. We've made clear before that they're going to be focusing on dose optimization as part of Project Optimus and non-clinical data. And we believe that these are already readily addressable and we think we are on track for an IND submission. So, yes, so that's the status. I mentioned the CMC and the key vendors that have been appointed and rigorously screened. We've gone to a lot of effort, especially given the rising cost of clinical trials, to make sure that we put out requests for proposals with many vendors for each function and interviewed them and found the best ones that were not only the most cost effective, but the most appropriate fit and have the highest degree of confidence in. So we've got all of these lined up and selected and ready to go. Now these are all the things underneath the surface that go into a trial such as this and pleasingly everything is on track. This is roughly where we're at now. So this is our best current guess. With all the caveats of drug development, it's -- we know that there's a degree of uncertainty of how long these things take and whatnot. But again, if we can get this IND allowance imminently, then we'll be ready to open that study. That study can be ready to go at the end of this year and first patient in very early next year. We anticipate, subject to finalization with the FDA that the trial in CTCL, which is going to be our Phase II study, is going to comprise roughly 2 parts, which is going to be probably dose optimization and then the efficacy component. It would be irresponsible to go out and make estimations on what that trial is exactly going to look like until we get the final blessing from the FDA. But that's where we've got a degree of confidence that it's going to roughly contain those components. After that first component, the optimal dose, that can feed into subsequent studies. I mentioned before that we're still interested in PTCL. It would be good if we can increase our experience with this patient population under the current protocol. And if we decide to move ahead, we can drop in -- we can be informed by -- of the optimal dose from the CTCL study, so we can benefit that as well. So I think I've made a good overview of the progress we've made. The data continues to progress and it's all about the data. And we've presented this at global conferences and it's been very, very warmly received and also inputted that into the design. The challenges that we'll face here, recruitment for rare disease. It's not a very common disease. I gave the rationale as to why we're focusing on cutaneous. It's a largely unmet need. There's still -- there's a couple of competitors there, but none of them work particularly well and we think there's certainly room for us. But recruitment in rare diseases is always a challenge. CMC campaign ongoing. That's the manufacturing campaign. It's not only to provide for this current study, but also need to demonstrate commercial potential batches. So it goes beyond this actual campaign. And of course Project Optimus, this is not a Prescient requirement, but again, it's an additional requirement now placed on drug developers. It's not just -- it's no longer just what is the -- what is the highest dose you can give. Yes, you have to do that work, but then it's what's the optimal dose with respect to safety versus efficacy. And so that's what the first part of this component will be. It's not a Prescient requirement. It's a requirement that the FDA will have of all drug developers. And going forward, I made mention of this, the IND submission is imminent and hopefully that gets allowed without amendment. If they require future amendments, we will make those and then it will be open. And that will change the game for us that this trial that's been in planning for so long and refined will finally be open. It will put us into that new league that our Chair spoke of. We'll expand this overseas. We're going to start the trial in Australia. So we'll run that through the TGA. That's all, again, in train at the moment. So it'll be initiated here in Australia, of course, with the principal investigator being Miles Prince and open a few other Australian sites. But we're going to take this overseas as well, the U.S. and a couple of sites also in Europe and also look to increase our experience with PTCL. As I mentioned, that's -- we've got the potential to do that and seek alliances in this disease. And again, there are people who know what we're doing and we're always updating them. And again, when we jump into this next phase, it's another reason to go back to these folks and sharpen their attention on this. So that's PTX-100. It's been our focus unashamedly. I'll touch on some of our cell therapy platforms. But it's impossible to do so without talking about the challenges that the whole sector has faced. I don't know how appreciated this is in Australia, but it's a tough slog out there and has been for a couple of years. The cell therapy sector is very capital constrained and people have cut their programs significantly. I think the sector jumped the gun, and I was guilty of this, too when the first CAR-T therapies were approved, we thought the business model was validated. And it turns out that despite 7 approvals now, only 2 of these have a chance of being profitable just because of logistics and a bunch of other things. So the box warnings didn't help and we think we're through the worst of that. But certainly, it has discouraged people for investing into the next wave of therapies coming through. So it is very tough. It continues to be tough. Yes, we know the therapies work, but we now know that that is not in and of itself sufficient. So there's a large degree of -- there's many challenges that the sector has got to overcome. People have cut back their pipelines. There's over 700 CD19 programs, for example. Many of those, in an attempt to differentiate themselves, have moved to autoimmunity. We're talking about RA, we're talking about lupus, we're talking about MG and other such diseases. It's just shifted one crowded play into another crowded play. So we've got a long way for this to play out. I think also the emergence of allogeneic cells has not -- it's probably behind schedule, perhaps for the same reasons. And also, the whole cell therapy sector is facing competition from other modalities and we saw an approval of a novel T cell engager, which can do a lot of the things that CAR-T is claiming to do, but with controllability and also disruption from new things like in vivo cell therapies. Ironically, the best cell therapies may not involve any cells. It could just be some RNA, for example, delivered via an LNP or a viral vector to make the body make the CAR-T cells and that is certainly much, much cheaper to do than is currently done. So they're the challenges that we're up against. But again, as you know, we're about trying to solve some of these challenges, if not all of these challenges with our 2 platforms. So it's just a reminder that, yes, we don't have all our eggs in one basket with here's our one particular program, one particular cell type. I think we saw many of these challenges and deliberately positioned ourselves to try to solve them and not just for us, but for third parties. So it's not just the current therapies, but all of these emerging cell types that we've -- that we're seeing and developing now. So I stand by -- I think we feel validated by the fact that we positioned ourselves quite intelligently because not all of these are going to make it through and those that do will probably be well placed. As you know, we've got CellPryme-M, which can be used in manufacturing. We've got CellPryme-A that can be used in an adjuvant setting, which work very differently. Our progress to date is that our preclinical studies have been largely concluded with outstanding data, I've got to say, really world-class data that's been very well received. We've presented this globally. It's been very well received as it always has been, but the data has matured. We've got our collaborators at Peter Mac also finalizing how CellPryme can work with what's called the tumor microenvironment, which is basically the immune microenvironment surrounding the tumor that protects it from the immune system and enables these cancers to grow and metastasize. We've got some interesting data coming out that we look forward to sharing with you. We've also got a number of parties underway, hopefully, channel partners for CellPryme-M that are testing this under confidentiality agreements and material transfer agreements and they like what they're seeing. We have to make sure that CellPryme works with their particular situations and their particular ingredients. So that all takes a little bit of handholding and collaboration through that. But once we get through that, hopefully, there's some good results and there'll be some -- there will be an outcome, but it is good to have some tension in the process and a number of horses running in that race at the same time. I made mention of some of the challenges that the fact that some collaborators, especially for CellPryme-A, we had lined up to do some studies. But everyone is encountering the same thing, which is we like the idea, but we have no money. So that's a constraint. But hopefully that will loosen up and that will turn the corner and we can find more willing third parties who have as their resources improve. And going forward, we're going to publish alongside our collaborators on CellPryme's involvement in the tumor microenvironment. I made mention of the due diligence that's happening with CellPryme. And we're going to continue to seek clever value-adding ways of getting CellPryme-A into the clinic. That doesn't have a big burden on our balance sheet, if any. So we're going to still continue to push for that. I think it's also worth mentioning with the wave of innovation happening with cell therapies, CellPryme, and CellPryme-A in particular, is still going to be very relevant. Even if there was an in vivo CAR-T, which didn't involve anything, you would still need to prime the immune system. And we still think this has a very relevant place. So again, positioning ourselves very cleverly. And OmniCAR, let's not forget OmniCAR. This was the modular system that was licensed from Penn and Oxford and basically is a way of directing any immune cell to any particular target on any cell. So a very novel platform there to modularize cell therapy. As disclosed last year, we encountered some problems that we know needed solving. This tonic signaling, we didn't know what the problem was, became progressively evident, but we know it needed to be solved before it could safely be used in the clinic. And so we spent all of 2024 trying to solve for this issue, identifying the issue and trying to solve for it. It involved a number of disciplines, including cell biology and bioinformatics and protein engineers, both within Prescient and with collaborators, including CSIRO and Peter Mac, of course, and other protein experts. So it's been a huge, huge lift. We've designed and tested many variants and the development effort is on time and on budget. And hopefully, we've got some -- we've got some results coming out very shortly and hopefully it's good news. And that will be faced with a go/no-go decision at that stage. But I can't underestimate how challenging this has been over the last year with no guarantee of an outcome even to this day. And if it was solved right now, then we realize that we're still confronted with a very hostile cell therapy environment. So it's going to be a task to -- even if we had a successful construct right now, we don't have a very receptive sector. So there is that. And there are also the challenges, just to be open, other modalities like in vivo can overcome some, maybe not all, but some of the challenges that modularity is looking to address in terms of safety, for example, and look, it's mostly safety and cost. And going forward hopefully, we'll have these results concluded by the end of the year and we'll have a go/no-go determination. What happens then? If it's a no-go, that's very clear. If it's a go, we'll look at the development plan again and take the opportunity to revisit the development plan and acknowledge that the landscape of cell therapy has shifted and be able to tweak that development plan. At the end of the day, though, we think that despite the shift in the landscape and emerging technologies that modularity can still play a very important role in the future of cell therapy. So in short, in summary, should I say, these are the major catalysts to look towards in the following year. Focus is unashamedly on PTX-100 with some of our regulatory interactions coming to a head and having this trial open and then started in Australia and then expanded overseas. We've got the option also of increasing our experience with PTCL under the current contract. Ongoing with CellPryme with -- hopefully, we get some good results for testing by our potential partners. And it would be wonderful if we can get CellPryme-A into the clinic with a partner. And I mentioned OmniCAR before with our problem-solving exercise coming to a head, and we'll have a go or no-go decision there. So that is that. We put a version of this up last year just to remind ourselves and our shareholders what we're working towards. These are aspirations in the event that everything is successful -- now we know in drug development, not everything works, which is why we have a portfolio. And even if they work, things don't necessarily go to plan or to timetable. But if they do, it gives you an idea of what we're all working towards. And these are the shots we've got in the barrel, right? So we've got 100 could be approved in CTCL. In the event of success, we'd be in a follow-on study for PTCL. We'd be looking at other combinations and even earlier lines of therapy. So it would be good to really own T-cell lymphomas as a monotherapy in combination, both cutaneous and peripheral. So that alone is a company -- any of those would be a company maker. It'd be great if in that time frame, CellPrymeM was generating modest revenues that'd be recurring revenues and hopefully ramping up with a strategic partner. And CellPryme-A could even be -- because of the nature of the molecule as an adjuvant, can be used in combination with CAR-Ts, it could have completed a registration study by that stage. And if OmniCAR is back on track, then that'll be back into -- within that time frame in clinical development and maybe quite mature clinical development. So that's what we're at. And just to finish off where our Chair brought us to is here's basically where we're at in the life cycle of a biotech company. And to be fair, I think this chart has pretty much replicated some of Prescient's share price history as well, right, which is it's easy to sell an idea early on when you've got a concept in the absence of a lot of early data and you get a lot of enthusiasm there. But eventually, you've got to just knuckle down and get the work done. And that's what we've been doing. And what I'm telling you now, without any guarantee of success, is that Prescient is entering this phase now where we've got that data, all that risk is diminishing. That hard work is behind us. We're building here on 15, 20 years of development that's in our rear vision mirror now. And we're on the cusp of this trial right now that is going to put us into a different leg. So not only will it be a Phase II trial, but we're hoping that certainly, the second component of this trial, in particular, will enable registration. And that box would move further to the right in that case. So, yes, we realize it's been a tricky year for the share price. And I think that's a culmination of going into a planning mode where we really -- it's not the most news flow-friendly environment, plus a very tricky biotech environment. But when we look at what the company is doing and what it's achieved, we're entering this new phase imminently. And that's where we find ourselves. So I'll hand back control of the presentation to the Chair.

Thanks, Steve. Excellent. Our Company Secretary will now outline the question and poll procedure for today's meeting. Melanie?

Thanks, Steve. As mentioned earlier, shareholders will be able to comment, ask questions and cast votes at the appropriate time for each item of business. Visitors are reminded that whilst we welcome you at this meeting, it is a shareholders' meeting, and you may not comment or ask questions. We may experience some time lag, and this may cause some delay in your text questions or comments coming to our attention, and we therefore encourage you to lodge them as early as you can. Shareholders wishing to speak and ask questions via text, please take note of the following instructions. [Operator Instructions] Regarding voting on today's resolutions, all shareholders, proxy holders and authorized corporate representatives who are entitled to vote will be able to do so via the webinar poll. It is important to note that if you have already lodged a proxy form and voted prior to the meeting, you do not need to vote again at this meeting unless you wish to change your proxy instruction. For those proxy holders, shareholders and corporate representatives who have not yet voted prior to the meeting, please cast your votes on each of the resolutions when the poll is opened. For proxy holders, you will have a summary of proxy votes, which detail the voting instructions, if any, for each item of business. By completing the voting via the webinar poll, when instructed to vote in a particular manner, you are deemed to have voted in accordance with those instructions. Where the Chair has been appointed proxy on behalf of the shareholders, Steven Engle as the Chair of the meeting, intends to be voting in favor of all of the resolutions outside of the spill resolution. With regards to the poll procedure, we will be -- we will open voting shortly so that your votes can be cast during the formal business section of the meeting. When the poll is declared open, a poll window will appear. To vote, simply select the direction in which you would like to cast your vote. The selected option will be marked. To submit your vote, simply click the submit button, and you'll have the ability to change your vote up until the time the voting is closed. I'll now pass back to you, Steve Engle.

Thank you, Melanie. We will now address shareholder questions which were submitted prior to today's meeting and any received in relation to the business operations.

Sure. There were some questions received prior. So I'm going to go through those first, and then I'll go through the ones that have come through on the Q&A box. So the first one, which I'll address to Steve Yatomi-Clarke, what is the commercialization plan timetable for each of the products under development and the individual budget allocation?

I think we sort of covered that off in the CEO presentation. We haven't put forward our exact budgets at this point in time because we still don't have the final tick from the FDA on the protocol. But we know we've got enough funds for the first component of that study, the IIa, which would be a huge valuation inflection point for us.

Will further fundraising be required to deliver successful results?

Well, we can deliver successful results with what we have right now in terms of inflection points. Of course, we've always said we're going to need more funds to raise the -- to complete the entire study. That hasn't changed. But we believe we can deliver value with the funds we have on hand. But biotechs are always looking to top up the coffers and you can certainly do more things or do them quicker or both with more funds and that has always been the case. I'd just remind everyone that we've always run Prescient very astutely. We try to strike a balance between progressing our trials and -- or progressing our programs and delivering value whilst being fiscally responsible. You can't stand in one spot, but you don't want to be overspending, and we try to strike that balance. And we've always been responsible custodians of shareholder funds.

Thank you. What are the specific further requirements to conduct the PTX-100 Stage 2 registration trial?

I think we sort of covered that off in the presentation already about the steps that we'd need to do.

Yes. Has there been consideration of submission to the TGA for registrations of PTX100? And if not, why not?

Yes, there has, as covered off in the presentation. We'll be kicking off that trial in Australia.

What is the Board's view, dedicated focus on development, registration and commercialization of PTX-100 before current funding becomes a serious issue?

Again, I think that was covered off in the development plan that was spelled out.

Yeah. Why has there been -- why has there not been emphasis on TV and radio presentation of PTX-100 1b earlier and continuing critical stage patients cancer cures to date? REACH podcasts do not cover the broad public market.

Not easy to get free-to-air TV coverage and radio. Notwithstanding that, there's other ways to access that we have tried, but often mid-trial and especially -- yes, especially mid-trial, it's very difficult to get news when it's not -- when it's incremental. Miles presents very well. I'd love to get him back on the radio. So it's -- we have an ongoing PR effort. But I think the important thing is that the world doesn't give as much attention to TV and radio as it used to. And there's other channels, novel channels that we can access, both online print and online audio and visual that we do use quite novel channel. I've been educated on this over the last few years, but it's a way of reaching many more eyeballs than would otherwise be the case just through TV. So the short answer is we'll continue to try to do that, but it's not the only way to do it. And we're not just relying on webcasts.

Thanks, Steve. Steve Engle, I'll pose these to you as Chair. What action has been taken to preserve shareholder equity or shareholder value?

So, as Steve has indicated, we continue to manage the budget and to control the spending quite well over time. We've been very careful when we became concerned about what was going on with OmniCAR. In terms of needing to do additional preclinical work, we reduced the spend in that area dramatically. And so we're hoping with additional positive results, we'll be able to step that back up. But that's the kind of agility we have about making these kinds of decisions and we will continue to do that. We finished the year with $14.5 million in the bank and relative to our spin rate, gives us quite a bit of time. Steve has indicated that we're going to need additional capital to complete the kinds of things we need to do for PTX-100 as well as some of the other things we're working on. But that's part of being in biotech and we've always been quite upfront about that situation. But in the meantime, we're trying to control costs as best we can during this period.

Thanks, Steve. Why -- another question, why is there not an independent shareholder on the Board to provide direct representation and feedback as shareholder funding is essential to support the ongoing research?

Yes, a couple of things. First of all, we do have 5 independent directors out of the 6. But that's not quite -- I think what's being asked here is do we have someone who's a large shareholder. I mean, everybody on the Board owns shares. But for that, you may know that relatively recently, in the last few months, we brought on Dr. Shepherd. And Gavin is not only a physician, but is also an investor in the Australian biotech market and is very aware of what goes on as well as has quite an investor network. And so we've sought to do that because we make sure we were getting the feedback that we need as we go through these different kinds of decisions. And so we feel like we have taken action and are moving forward with his help to think through these different decisions.

Thanks, Steve. And does Steven Yatomi-Clarke plan to hold his existing shares following his departure?

Yes. So I'm not looking to comment specifically on Steve's decision. I don't think that's what we do as part of the Board. Nonetheless, Steve has been here for over 9 years and still holds all his shares. And in fact, as he's had, he's invested to buy more over time. And so I think Steve very much feels not only dedicated, but really wants to see the company succeed. And I think you can look at how Steve responded. Yes, he's going to be leaving us. But on the other hand, he has given quite a bit of time for us to be able to do the recruiting effort. And so we have initiated that effort. We're going through that -- some of that work right now. And as soon as we get a better idea of who the new CEO is, we'll let you know. But in the interim, Steve has been very dedicated and loyal to the company. And I think he believes very much in what we're doing. And so I'd expect he'll hold on to his shares. But I can't comment for him.

Thanks, Steve. Just moving to the Q&A box now. Back to Steven Yatomi-Clarke and operations. What are the key advantages to PTX in generating awareness of PTX-100 amongst KOLs at key global conferences?

What are the advantages of awareness? I don't see there's any disadvantages.

In generating awareness.

Yes. Well, that's -- it's essential. It's essential. Otherwise, you're developing a drug in a vacuum. So you absolutely have to be in front of the people who are going to be end users of your drug and know the sector better than anyone else. So it forms 2 -- there's 2 big advantages. One is to build awareness for recruiting for your study and making sure that you've got the best people in the best centers to maximize your recruitment and generate that enthusiasm so that it's not just another trial open. These are people who are actively screening and are champions for the drug. It gives them an opportunity to ask questions from investigator to investigator, for example, and really get behind some of the data, behind the poster and really ask the questions and engage their enthusiasm. That's invaluable. But what's especially important is in getting their advice of what's worked and what's not worked. Most of this unpublished, knowing what is behind the -- sort of beneath the surface to help design the best protocol, the best study that you can. And that's almost impossible to do without any feedback. So awareness is absolutely paramount. Also at these conferences, you build industry contacts and there are people waiting and watching and asking their own commercial questions, and that's ongoing. Do people write agreements on the basis of a Ib? No, but I can tell you -- well, I can promise you, if you wait until the end of a Phase II study and then disclose your data to the world for the first time, I think that would be a mistake. So it's about engaging early and engaging often with those people as well. So there's no disadvantages to building awareness at conferences with people who matter.

Thanks, Steve. Given the timing shown on the Phase II trial start, how long do you think before you have enough data to determine the optimal dose?

I think we covered that off on the -- in the slide deck as well. I think that we had that as our estimate that we had there is early '26. But we're planning for -- maybe we can get a look-see beforehand. But that's what we presented on our slide as our best current guess with the caveat being we haven't got protocol approval from the FDA yet.

Thanks, Steve. Steve, there is another question in the Q&A box that's in relation to our formal resolutions. So we will answer that in that section. So you may now proceed with the formal matters for today.

Great. As there are no further questions, I will now move into the formal business of today's meeting. Firstly, if you have a question on any of the items of business, please follow the questions process, which was previously outlined by our Company Secretary. We will address your questions after the last resolution. Before opening the poll, I wish to remind shareholders that the poll will remain open for an additional period after we have considered all resolutions. I now declare the poll open. I refer you to the slide that is in front of you right now and in the Notice of Meeting, which was received and consider the financial report of the company, together with the directors' report and the auditor's report for the financial year ended 30 June 2024. These items are contained in the annual report, so I will ask that they be taken as read. The annual report is available on the ASX announcement platform or on the company's website. The Corporations Act requires the accounts and reports to be put before shareholders at the Annual General Meeting. However, except as set out in Resolution 1, which is to be considered later, there is no requirement for a vote of members to be taken on them. No written questions to the auditor were received by the cutoff date, 5 business days for this meeting. Questions may be directed through myself to the auditor in relation to the conduct of the audit, the audit report, the company's accounting policies or the independence of the auditor. As this matter does not require a vote, we will now move to the first resolution. I now refer you to Resolution 1, which is to consider the adoption of the remuneration report forming part of the directors' report for the financial year ended 30 June 2024. The remuneration report is set out in the directors' report and the company's 2024 annual report. The remuneration report sets out the company's remuneration arrangements for the directors and key management personnel of the company. The vote on this resolution is advisory only and does not bind the directors or the company. The full resolution is displayed on your screen along with proxy votes received for this resolution. I move that the shareholders consider and, if thought fit, pass the ordinary resolution. We now move to Resolution 2, which relates to the election of Dr. Gavin Shepherd as a Director of the company. Dr. Shepherd's profile has been provided on Page 4 of the Notice of Meeting. The full resolution is displayed on your screen along with the proxy votes received for this resolution. I move that shareholders consider and, if thought fit, pass the ordinary resolution. I now refer to Resolution 3, which refers to the reelection of Dr. James Campbell as Director of the company. Dr. Campbell's profile has been provided on Page 4 of the notice of the meeting. The full resolution is displayed on your screen, along with the proxy votes received for this resolution. I move that shareholders consider and, if thought fit, pass the ordinary resolution. I now refer to Resolution 4, which refers to the approval to issue 1,415,000 options to Dr. Gavin Shepherd. The full resolution is displayed on your screen along with the proxy votes received for this resolution. I move that shareholders consider and, if thought fit, pass the special resolution. I now refer to Resolution 5, a special resolution, which pertains to the renewal of the proportional takeover provisions in the company's constitution. The full resolution is displayed on your screen along with the proxy votes received for this resolution. As this resolution is a special resolution, it requires 75% of the votes cast in favor to be deemed as passed. I move that shareholders consider and, if thought fit, pass the special resolution. I now refer to Resolution 6, a special resolution, which pertains to the approval of the company's 10% placement facility. The effect of the resolution is to allow the company to issue equity securities under ASX Listing Rule 7.1A during the 10% placement period, which is defined on Page 7 of the Notice of Meeting. The full resolution is displayed on your screen along with the proxy votes received for this resolution. As this resolution is a special resolution, it requires 75% of the votes cast in favor to be deemed as passed. I move that shareholders consider and, if thought fit, pass the special resolution. I now refer you to the final item of business, Resolution 7, which is a conditional resolution upon at least 25% of the votes cast for Resolution 1 being against the adoption of the 2024 remuneration report. I note that shareholders are asked to consider this resolution at today's meeting. However, if fewer than 25% of the votes cast on Resolution 1 are against adopting the remuneration report, then there will be no strike and the vote results on Resolution 7 will not be considered at this meeting. The full resolution is displayed on your screen, along with the proxy votes received for this resolution. As Chair, I will vote undirected proxies against this resolution. I move that shareholders consider the ordinary resolution. We will now go to shareholders' questions. Please note, during this time, the poll will remain open to enable you to complete your voting. Melanie, did we receive any questions on any of the resolutions or does any shareholder wish to speak to any of these resolutions?

Thanks, Steve. Yes, we did receive a -- a question through the Q&A box. This is just regarding the rem report. How can the Board justify a payment of a large bonus to the CEO just with reference to the share price between July '23 and '24 and no significant value-adding milestones were reported?

So in our case, we saw several things happen that justified that, but the most critical was the movement forward of the key program, which was the PTX-100 program. I think we've talked about that in what we've been discussing here. And that's just a huge step for us in addition to which Steve and the team identified the issues related to the OmniCAR program and put in place a way to evaluate those and to come up with solutions. And in parallel, there's been a huge amount of work on the business development side. And so this always takes time. But I think Steve and team have managed to pull off over 60 meetings in the last 1.5 years or so and build those relationships, which is always interesting because, of course, we're not like -- we're not in the center of San Francisco or some place. But Steve and the team have managed to get quite a bit of attention on what we're doing and getting doors open. And it will be a while to turn those into deals. But I think out of the group that we've been going after, we'll be able to move forward with that. So for those as well as just running the team and the kinds of things you would think about and keeping it within budget and so forth, the Board felt that Steve had done a very good job in the last year.

Thanks, Steve. There's no further questions through the Q&A box and nothing online. So you may move to close the poll.

This concludes the Q&A session, and we'll now close the poll.

Thank you. I'll just conclude on here. The company has not received notice of any other business and as such, concludes the formal business of today's meeting and I now declare the meeting closed. After the votes have been counted, the results of the poll will be released to the ASX later today. And we thank you for your attendance, and we look forward to your continued support.

Thank you, everyone.

Thank you, everyone. That concludes the meeting, and I will now close the webinar.