Prescient Therapeutics Limited (PTX) Earnings Call Transcript & Summary

Hello, everyone. My name is James Campbell. And as the Chair of Prescient Therapeutics, it's my pleasure to welcome you all to this year's Annual General Meeting, the 2026 AGM. I'd like to start by acknowledging and paying respects to the traditional owners, the traditional custodians on the land from which we are collectively meeting today. Shareholders will be able to participate and view Rive -- sorry, of your live webcast of the meeting to ask questions and do cast direct votes at appropriate times, whilst in -- whilst the meeting is in progress. The company secretary has advised that we have complied with the relevant requirements for convening this meeting. and a quorum is present. And as the time is 11:00, 11:00 a.m., I formally declare the meeting open. Are those slides presenting, Tony, I don't see it on my screen.

They're up on mine.

Sorry?

They're up on mine.

Yes, they're James.

Okay. Thank you. So I'm joined today by my fellow directors, Dr. Alan Evans, Dr. Ellen Fogel, Dr. Gavin Sheppard and Ms. Melanie Ferris. I'd also like to welcome our Chief Executive Officer, Mr. James McDonald, our Chief Operating Officer; Dr. Rebecca Tunstall and our company secretarial representatives, Tony DiPietro and Marias Goracova. In addition, we have Rossetrepresenting company's external auditors, William Buck, Ross is in attendance and he'll make himself available during the meeting to answer questions on the accounts at the appropriate time. The notice of meeting is being 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 side or on the ASX announcement platform. I'll take the notice of meeting and to explain it the statement as read. The format of today's meeting will start with an overview of the meeting participation process, which is what we're doing now, followed by a Chair address from me, we'll then have an operations presentation from our CEO, James MacDonald, followed by a Q&A session on business operations. Then we'll address the formal business of the agenda, and this will be followed by a Q&A session on the formal items of business. following which shareholders will be provided after 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. I'll now hand over to Tony to outline the questions and the poll procedure for today's meeting. Thanks, Tony.

Thank you, James. As mentioned earlier, shareholders will be able to comment and ask questions and cast vote at the appropriate time. We may experience some time lag with virtual attendees and this may cause some delay in your text questions or comments coming to our attention. We encourage you to lodge them as early as you can. Shareholders wishing to ask questions via text. Please take note of the following instructions. Please take the Q&A icon located at the bottom of your screen. Type in your questions in the Ask the Question box, and press the send arrow. Your questions will be addressed at the appropriate time. Shareholders wishing to speak and ask a question and audio questions facility is available during the meeting. please follow this procedure, please select the raise hand icon located at the bottom of your screen. We'll be placed in a queue and authorized to speak when we reach the Q&A session. Prior to asking your question, please state your full name and who you are representing. Regarding voting at today's resolutions on today's resolutions, all shareholders, proxy holders authorized corporate representatives and attorneys of shareholders who are entitled to vote will be able to do so by a webinar poll. It is important to note that if you have lodged your 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 authorized corporate representatives who have not voted yet prior to the meeting, please cast your votes on each of the resolutions when the poll is opened. For proxy holders, we have a summary of proxy votes, which detail the voting instructions, if any, for the items of business. By completing the voting via the webinar pole when instructed to vote in a particular manner, you are deemed to have voted in accordance with those instructions. As advised in the notice of meeting, where the Chair has been appointed proxy on behalf of a shareholder, James Campbell as Chair of the meeting intends to vote those in favor of all of the resolutions. When the poll is declared open, a poll window will appear to vote simply select the direction in which you'd like to cast your vote. The selected option will be marked. To submit your votes, simply click the submit button. You will have the ability to change your vote up until the time voting is closed. I will now hand back to James for the chair address.

Thanks, Tony. Good morning, and welcome to Prescient Therapeutics AGM for 2026. A year ago, I spoke to you about PTX 100 moving from Phase I into Phase II. This year, that study has genuinely become a global trial. It's now reached the enrollment threshold for its first planned dose optimization committee meeting, a review which will convene in December. That progress is the focus of my remarks today. At the start of the financial year, the '25, '26 financial year, 1 patient has been enrolled in our Phase Ia study in relapsed or refractory T-cell lymphoma patients, cutaneous T cell and on patients. One year later, by the 30th of June 2026, enrollment had reached 26 patients and subsequent to that, by the 30th of September this year, enrollment was at 29 patients. That growth in enrollment has come from steady site expansion. We opened our first U.S. site VCU Massy Comprehensive Cancer Center in July 2025. In December 25, we received European authorization to commence the trial and opened 3 sites in Italy. And by April 2026, 12 sites we're enrolling across Australia, the U.S. and Italy, with European expansion expected to take the network up to 16 sites. In September, the study reached the prespecified enrollment threshold for its first planned dose optimization committee review, that's 20 event available patients, 10 in each of the 2 dosing arms. Patients are considered evaluable upon completion of 4 cycles of treatment. The committee, which compose which consists of clinical and biostatistical experts will convene in December this year. who will review the safety and efficacy data from both dosing arms to provide guidance on continuation of the study for further development, and we'll update the -- and we will update the market following the recommendation of the review committee. The December review is a planned milestone in the study's dose optimization design. It's not completion of the study. Enrollment continues internationally towards the full target of 40 evaluable patients. From the regulatory point of view, in November 25, the European Medicines Agency granted PTX-100 orphan drug designation in cutaneous T-cell lymphoma, covering both the white costes Fungoides and the assay syndrome subtypes. This complements the U.S. FDA's orphan drug designation for all T-cell lymphomas and fast track designation for relapsed or refractory mycosis fungoides. PTX-100 now holds orphan status in both the U.S. and Europe. From a scientific point of view, our collaboration with CSIRO used AI and computational modeling to build a 3-dimensional model of PTX 100 and the way it binds to its target enzyme. That work has deepened our understanding of how PTX 100 engages its target. And the next step is to map the downstream biological effects, which will help guide patient selection and the choice of future indications. Subject to the outcome of the dose optimization committee review and to available funding, we're also considering a further study of PTX-100 in peripheral T-cell lymphoma. Consistent with our focus on PTX-100, investment in our cell therapy platforms, Cell Prime and OmniCAR has been limited. Research with the Peter Mac Cancer Center on cell primary continued and BD discussions for both platforms are ongoing. Financially, we reported a net loss of $7 million for financial year 2. This was a 4.4% reduction on the prior year. We received a $4.3 million R&D tax incentive refund in January 26. The Cash at the 30th of June 2026 was $9 million with a great majority of spending in the financial year directed to clinical and research activity. Subsequent to the year-end, in September 26, we completed a capital raise of approximately $6 million. This comprised almost $4.8 million through a share purchase plan to existing shareholders. and $1.2 million to a follow-on placement to sophisticated and professional investors. Both of these were at $0.065. And I think refreshingly, no options were attached to those -- to that raise. These funds take the PTX-100 program beyond the December review and into its next stage of development. On behalf of the Board, thanks to every shareholder who participated in both existing and new. The Board continues to manage spending carefully and recognize that delivering the full program, including a Phase IIb study will require further funding. And just a quick touch on the leadership. I want to thank our CEO, James McDonnell and his team for a strong year of execution. In under 2 years, James has taken a Phase IIa program from a single site to functioning multi-country trial while running the business with financial discipline. In July 26, Dr. Roslin Wilson joined us as Chief Medical Officer. Ros brings more than 30 years of global oncology drug development experience and now leads our clinical development strategy. Also, I'd like to thank Dr. Marissa Lim for her contributions as CMO, and I wish her well in her semi-retirement. Finally, I'd like to thank my fellow directors for their guidance and diligence throughout the year. Looking forward, our priorities for financial year '26, '27 are clear and concrete. We're going to complete the dose optimization committee review in December 26. We're going to complete European site activation -- sorry, we plan to complete European site activation and continue enrollment towards 40 evaluable patients and to prepare for the Phase IIb study, which subject to agreement with the FDA has the potential to be a registrational directed study. We'll evaluate complementary assets that could build optionality into our pipeline, and we will continue to manage this business very, very financially efficiently. On behalf of the Board, I'd like to thank the patients who take part in our trials and their families, the clinicians and the researchers who work with us and you, our shareholders, for your continued support. I'll now hand over to James for his CEO presentation. Thank you.

Thank you, James, and we'll progress past the slide for a disclaimer and move on to our executive summary slide. The executive summary, I would like to point out 4 key elements here. First is the PTX-100 is a unique and first-in-class asset, which inhibits a significant oncology pathway, the Ras superfamily pathway, and it's plate only GDT's inhibitor in the clinic at this stage, I'd like to also stress that we have progressed the Phase IIa program significantly and 29 patients are currently enrolled across the globe and dentures. And we have reached that threshold amount of 10 evaluable patients in each arm, and we're expecting that Dose Optimization Committee in December. We have a clear pathway. These regulatory designations from the FDA and fast-track designation provide strong support for us to engage with the FDA and the potential for an accelerated pathway. The European orphan drug designation also complements the fact that we have value value for our partners and also value for the shareholders as we progress. We have that near-term catalyst that James has pointed out, which is the dose optimization committee meeting coming in December, where we get the first real look at the Phase IIa study in an interim basis and our recent capital raise ensures that we are funded well past these milestones. So moving on, today, we have a snapshot of the company snapshot on the next slide. And this slide is as of Friday, and it's very similar to today. And you can see our available cash at the end of the September [ 4 ] and actually the first of October, where funds were received from our capital raise of $11.8 million. And I'd like to thank the shareholder support for our $6 million raised in the recent capital raise through SBP and placement. We have progressed and set significantly higher than we did at this time last year on our share price, and I'm very encouraged by that support. If we move to the next slide, we see the financial numbers here from our financial numbers at the end of the 30th of June 2026. We had a net loss of $7 million, which was down on the previous year and like to really highlight the fact that we artistically we have a lot of fiscal discipline, and we have reviewed the business in terms of how we manage certain aspects. I'd like to thank Dr. Rebecca Tunstall for our efforts and really defining the way we manage CMC. This is a critical component to the business. and she has been able to realign the way we run our CMC program. We have consultants now in Australia. We have more control and more cost effectiveness in that process. And it's very important because as we know, we have seen a lot of complete response letters. So that means they have -- FDA has not approved a product, which is a result of CMC. So we're very focused in this space. We have -- over the year, we have estimated our $3.44 million R&D tax incentive, which we expect to receive later this year. And you can see our net assets and cash at the end of the year was strong. So, all in all, uses is the top, a stable cost base and a strengthened balance sheet, a very successful financial year of implementation and execution. So if we move to our next slide and really highlighting our implementation and execution theme, you can see that we have some significant aspects here. And James mentioned the progress of the Phase IIa study, in September, we had 7 sites. By March, we had 11. By June, we had 26 patients enrolled 14 in that quarter. And we have now reached the point in September this year of achieving the 20 evaluable patients, which triggers the dose optimization committee first look. There are other key components in these milestones, particularly the orphan drug designation in Europe, which provides additional value and this is the value we're after for partnering and obviously, for shareholder value. There's various components there. But all in all, a very solid year of milestones and also I'm very pleased that we're able to attract Dr. Roslin Wilson as our Chief Medical Officer, a very high-caliber CMO and joining the executive team. In the next slide, again, focusing on the fact that we are very focused in the implementation, execution of our Phase IIa program. You can see the progression of patient enrollments as we go through the year. And I understand we also have a number of patients in screening at this stage. So we expect this enrollment to continue and the dose optimization committee meeting will will definitely be in December this year. If we move to the next slide, I would like to thank the Board for the support during the year, support in direction has been very helpful to be able to call on experts in the areas of various aspects as we discuss the progress of the program. And I'd like to thank my senior management team for the support during the year as well, and also Ross joining us recently. And also acknowledging Dr. Marisol, who participated in this year and who has moved on in semi retirement. If we move to the next slide, I really want to bring us back to our key lead asset, which is PTX-100. This is the first-in-class GGTase inhibitor. We licensed this from Yale through our Phase I program and then a refined Phase Ib program, we've settled on a lead indication, which is relapsed refractory cutaneous T-cell lymphoma. We setted on that from results that we saw in the cohort CTCL cohort in the Phase Ib or 43% objective response rate, clinical benefit and no drug-related adverse events. We have our FDA Orphan Drug and Fast Track and European orphan drug support there, which allows us to engage with the FDA more and the potential for a fast track registration approach, but also really providing value for partnering and shareholder value. In the Phase II a optimization is underway, and we're expecting our interim look at the data at data in December. And of course, PTX-100 disrupts the RAS family pathway, which is involved in 1 in 5 cancers. So we will definitely be looking at what other tumor types can be implicated in our target with PTX-100. If we move to the next slide, I would like to highlight the cohort here of the CTCL cohort and responses. If we look to the right of the slide, -- we see the PTX 100 Phase Ib responses, the objective response rate of 43% and 0 adverse events there down the bottom. If we move to the left, we can see benchmark in clinical practice terms, but it can also be framed as the target product profile. And so we need to know what we're expecting as we progress through our study. So the objective response rate serious adverse events here of less than 30% as well. If we look at the 2 products in the middle there, Lima and Poteligeo, both are approved FDA CTCL products. You can see around the objective response rate target, but quite seriously above the serious adverse event profile there. Now lacutamab is the next product listed, and it is an investigational product, an antibody product having a particular antigen. It has just completed its Phase II program. And you can see with [ Cesar ] syndrome, it has quite promising results and more modest for mycosis fungoides, and not so bad for serious adverse events. Now I put this product in this slide to demonstrate the fact that lacutamab is owned by Innate Pharma and Innate Pharma have recently signed a deal with Sobi Pharma -- the deal involves a USD 75 million upfront payment. And this will fund their Phase III pivotal program. It involves USD 505 million of milestone payments through to registration and double-digit royalties from sales. Now I state that because it really reinforces why CTCL was an appropriate lead indication for us. There's clear value in this market, and there's clear value demonstrated by this recent signing. So we progress well with our value creation. If we move to the next slide, we move into our progressing Phase II program. And we've talked about the study a lot. Phase IIa is a dose optimization study where 40 evaluable patients who have received at least -- 2 lines of prior systemic therapy for refractory relapsed CTCL are randomized to 2 different dosing arms. The dose optimization committee there is there to establish a dose among other things, including safety and tolerability. Now we have reached the midway point of 10 evaluable patients in each arm. And so this is happening in December. If we then move to the Phase II endpoints, our endpoints overall in our Phase II program, the primary endpoint is objective response rate. To the secondary end point there, the first one, skin response using MST is very clinically relevant and a number of clinicians are very keen to see data from [ MSP ] from our patient pool. This is a cutaneous T-cell lymphoma and therefore, skin response is very critical to the progression to the development of treatment for these patients. And so clinicians are very focused on that. We have talked about CTCL being quite an impact on quality of life. And the good thing in this study is that we have a number of quality of life measures within in the secondary elements. And so there was good solid data to come from our study. If we move to the next slide, -- we see -- we are building beyond CTCL, but we are very, very focused on CTCL at the moment. With the Phase IIa program, we would be demonstrating efficacy and safety. We have various designations from the regulatory agencies, which allow us to engage and offer potential for an accelerated program. We aim to complete a registration study. And of course, with these designations, the value that we've seen from recent deals and also data we will establish commercial pathways and partnering opportunities. Now the expansion component is there. James has already mentioned the components that we would consider, but there are other RAS-driven tumor types that we will certainly look at. We may do that in an orphan drug approach first. And then as we strengthen IP, we'll go in a broader sense. -- our partnering discussions continue with Omnicare and Cell Prime in the cell therapy platform environment. I have to say this is a very challenging environment at the moment, but we continue to engage potential partners. And of course, we continue to review complementary assets as we go through our program. We move to the next slide. We have some approaching milestones. And the main milestone, which I'm sure everyone is looking forward to is the first dose optimization committee meeting, which is expected to be in December. And by the end of the year, we also hope to be able to release the name of PTX 100, the international naming nomenclature name, which is going through the process at the moment. PTX-100 is the study definer at this stage. We'll need a name and that name we hope to release later this year. The first half of 2027 will be about the French site activations -- enrollment. As you can see there, we hope to finish by our 40 evaluable patients. So those are patients that are received 4 lines of therapy and they become evaluable. And then at this stage, we have a second dose optimization committee listed in the second half of 2007. However, the dose optimization committee can choose to say that we would like to review data at 30 evaluable patients or whatever patient number they choose. So there may be other dose optimization committee reviews happening in the interim there and FDA Type B meeting to discuss the Phase IIb design following the information we gained from the Phase IIa program. There's lots to look forward to. We continue to have a compassionate access patient from the Phase Ib and complete response in receiving therapy. And of course, continuing partner engagement is critical to the success and value creation as we move forward. If we move to the next slide. we come to our summary slide really effectively what we started with PTX-100is unique and first-in-class and does offer an opportunity in terms of interrupting the Ras family pathway pathway. We are progressing. We have an implementation and execution focus. And therefore, Phase IIa is progressing. We have 29 patients enrolled as of September, and our goal is to continue that active recruitment. We have clear pathways. We understand that we needed and we have obtained various regulatory designations, which allow us to speak with the FDA and really encourage and has the potential for an accelerated pathway. But this also provides value for partnering and value for shareholders in terms of what we can engage for agreements moving forward. And of course, the near-term catalyst with the dose optimization committee, the first time that the interim data will be reviewed for the Phase IIa program. So it's an exciting time. So with that, I'd like to hand back to James and take questions.

Thanks, James. So we'll now take -- we'll address some shareholder questions, and I note that some of the questions here on the screen, you have kind of touched on during your presentation. So we'll address the questions that have been submitted prior to today's meeting and questions that have come up in the Q&A during this presentation. The questions on the formal business. Any questions on the formal business of the meeting will be answered after the last resolution. We remind shareholders, anyone should state their name and who they represent prior to asking any questions. And does anyone have any questions or comments on the business operations.

So James, we've received some written questions, if no one's asked for a verbal question. So I will read them out, if you like. And allow you to choose who you may think should answer. So from [ Matco, ] Willow Phase IIa trial be considered complete once 40 patients are enrolled or are evaluable.

We'll take that to James.

Thanks, James, and thanks, Murdoch. The Phase IIa program will be complete when the 40 evaluable patients have completed the study. and the dose optimization Committee have reviewed that data. So it is any valuable patient, as I mentioned, is a patient who's received 4 lines of therapy and then progresses through the study. And so once that those patients are finished, the study will finish.

Thank you, James. So we've got a couple of questions here from Michael Keroulle -- your communications have described the Phase Ib results as both a 43% objective response rate and a 100% clinical benefit rate with a mean duration of response beyond 12 months -- can you reconcile those 2 figures explicitly stating the denominator, the response criteria and the assessment period for each.

So we'll take all of those questions from Michael. James can answer them. James, you may want to go back a couple of slides ago, you had a slide that I think were pretty helpful in answering this question.

Yes. We had the Phase Ib data there.

That will be the one. Yes.

Yes. So the 43% response rate is in relation to the objective response, the 12.4 months duration is duration of response. So patients in terms of individual patient numbers, there was an average of taken from the study. So all patients received clinical benefits. So the average of 12 months is based on all the 7 patients in the study, so 7 patients I probably need to address this more specifically, James.