Thalia Therapeutics Plc (THAT) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Valia Therapeutics plc Investor Presentation. review -- before we begin, I'd like to submit the following poll. I'd now like to hand you over to David Solomon, CEO. Good afternoon, sir.

Thank you, Lilly, for the introduction, and welcome to the Thalia interim results for the first half of 2026. I'm David Solomon, the CEO of Thalia Therapeutics. And joining me on this call today is Nick Kerns, our CFO. So we'll start with our safe harbor statement. Talia Therapeutics. Talia is derived from the name in ancient Greek to mean to flourish or to bloom or to blossom, and we are really dedicated to building a new RNA therapeutics leader in Europe and also globally. We have now a diversified portfolio of innovative RNA therapeutics to primarily treat cancer, and we'll touch on our medicine for hypogukemia. -- and also to treat cardiovascular disease, we'll talk about how we conduct ourselves in cardiovascular risk reduction. Joining me is an experienced management team and experienced Board, many with proven track records in RNA therapeutics. So we are now a clinical stage company, and we're focused on RNA therapeutics broadly. And for those who may not know, RNA therapeutics is largely broken down to 2 main types now. of therapeutics or 3, but we focus on 2 of those. On the left side of the slide, you see microRNAs. And these microRNAs are short bits of RNA that regulate gene expression. Insofar as the gene is upregulated and it results in disease by reducing gene expression, we can often modify or treat or cure disease. In our pipeline, we have miasten, which is also called V1, which is an anti-microRNA-126 therapeutic that targets the root cause of acute myeloid leukemia or AML, and we'll spend a significant amount of time on this call talking about miasten, our treatment for AML and its progress in the clinic. In the middle section of the slide is siRNA or also known as RNAi or RNA interference. This is a type of RNA therapeutic that actually specifically silences the gene completely. And insofar as a gene causes the disease by silencing or shutting off that gene for contracted periods of time, you can certainly modify or even cure the disease. We're developing a bispecific gene silencing medicine against 2 key targets in cardiovascular disease, PCSK9 and Lp(a). Both of these targets are known to cause stroke and heart attacks when at high levels, and we look forward to discussing how we reduce those levels to reduce cardiovascular risk. We also have at Thalia a delivery system called Nuvec, and I'll tell you a bit more about that delivery system and how we're addressing it to deliver our RNA therapeutics. I want to first give you our corporate highlights for the first half of the year 2026. It's been a rather busy first half of the year for us at Thalia Therapeutics. I joined the company in February of 2026, earlier this year as CEO to really lead the transition guided by the Board as an RNA therapeutics business. As some of you may recall, our name was earlier N4 Pharma, and we've now changed the name to Thalia Therapeutics to reflect our new strategy. As part of that strategy, we've also acquired a United States Delaware Sea Corporation called Sanara Therapeutics, and that is a company that has an exclusive license from the City of Cope Medical Center in Los Angeles, California to a medicine called Mirsen and a whole field of use in IP and know-how around lowering MiR-126. And we'll talk about our medicine that was licensed from City Cope called Mirersen, how it treats AML and how we're advancing that to shareholder value over time. We recently also announced that a patent for Mirersen that already exists in other geographies was now granted in China that also helps our story to add value to the company over time. In terms of our cardiovascular medicine, we have a long-acting dual siRNA or bispecific RNA that targets both PCSK9 and Lp(a). And we've laid down a new patent for that, and we've initiated preclinical development together with WuXi Atech in China to progress this bispecific or dual-acting medicine. And we'll tell you a bit more about the progress of that work and why this is an important medicine and what is our strategy to add value to the company to shareholders as we advance. And Nuvek, as you may know, is already at EMCOR Pharma and will tell you a bit about our work with University of Strathpd to show that Nuvec can be perhaps an appropriate delivery system. I'm also really delighted that Luke Karen, already a Director of the company, has also joined as CFO, and Luke will present the financial numbers on this call and be available on all other venues to be able to discuss our financial positions. So I joined the company in February of 2026, and I won't detail my background with too much time. But suffice it to say, I've been in the rodeo before, having been the CEO of both Zealand Pharma in Denmark now listed on NASDAQ and the CEO of Science Therapeutics in London now listed on NASDAQ as well. Both companies were small, both had innovative assets, both had competent teams and ultimately, through partnerships and through advancing the assets, ultimately, the value increased, and we were able to move the listings of both of these companies over to NASDAQ, increase value significantly into the billions in the case of New Zealand, and we have similar aspirations to do the same with Thalia Therapeutics. As I mentioned, Luke Kerns has joined now as CFO. And I'll now pass the word to Luke to begin by talking about his background in terms of Thalia and then present our financial results for the first half of the year. So to you, Luke.

Thank you. Yes, I've been with the company since its joined AIM in 2017, initially as a Nonexecutive Director. My background is corporate finance, almost exclusively in the small-cap market. l a nominated adviser and Head of Corporate Finance and Managing Director at Northland Capital, which is now part of SPA. But yes, and I sort of live and breathe small-cap companies and delighted to sort of take a more formal role to help Thalia through the next stages of development. So in terms of the interims we just published, I mean, obviously, everyone knows we're pre-revenue. So the key thing is really where we are with our cash position and the ability to deliver on our various programs. So we had cash of GBP 1.5 million as at the end of the period, but that's not really the full story because we had receivables of GBP 1 million due from the place, which we announced at the end of the month in June. And then we had the second tranche, which is subject to shareholder approval received in July of another GBP 495,000. So of the GBP 1.5 million we had at the end of the period, we've added another GBP 1.5 million to that. Obviously, that's all before the cost of the transaction and commissions and what have you. One of the great things about the fundraise that we did was obviously the director participation and the vendors from Sala, which shows great support and belief in what we're trying to do. We could have taken more, but we are mindful of dilution. And obviously, we would have liked to higher price, and we did it as close to the market as we could. But we felt we needed to raise enough money that we could deliver on the milestones that we're seeking to do over the next 12 months, which David will talk to, but particularly the completion of the Phase I study with Mersen following the Samer acquisition. The operating loss is sort of in line with expectations. It is higher on the G&A, which is largely down to the appointment of David and the additional cost in terms of gearing up for the Samer acquisition and focusing on that transaction. And here, you can see it reflected in the numbers. These all straight out of the interims, which we published today. As I say, the G&A was up. This is all proportionate with sort of building the team to go forward into becoming a clinical stage company. One of the things to note, obviously, is the balance sheet is getting stronger. This doesn't factor in the acquisition. So post period end, we'll obviously have the acquisition of Sun, which would increase the balance sheet further. But yes, the revenue here, they're just small license fees, but obviously, they're not material. So nothing to speak of there. And as we go through this period, the R&D numbers will be going up materially as we advance the 3 projects.

Thank you, Luke. Now I'd like to change gears and focus a fair bit of time on our portfolio of new therapeutic medicines and our approaches. I'll start, however, with our acquisition of Sanmina, as Luke alluded to. This acquisition, we believe, is transformational because it brings significant shareholder value and possibility through bringing on clinical stage assets and assets that are already acknowledged in the marketplace to be of significant value. The Sanmerna acquisition specifically brought on a very differentiated Phase I asset from City of Hope Medical Center, which is the largest comprehensive cancer center in the state of California, 14,000 employees. This asset called Mirersen really targets the root cause of AML and lots of preclinical work has been done. So approximately 6 years of preclinical work, including toxicology testing has been done, including patent files up to the point that we acquired the asset. So we believe now within in the clinic with results coming in the first half of 2027, we think this clinical asset will be accretive and be a key value driver for the company. Also, the terms of the acquisition and the milestone structure also minimizes dilution to existing shareholders and allows the possibility of significant growth. And we're very pleased that a lot of existing shareholders, including directors participated in the financing that happened at the time of the acquisition. The financing in the middle box of $2.75 million was oversubscribed and really funds the pipeline all the way through the Mirersen Phase I readout in the first half of 2027. It also funds all the IND-enabling studies of our own assets, including the bispecific cardiovascular medicine. And therefore, we think that this will be a win-win for both Thalia and San Berna shareholders, but really has been a change of outlook for the company because we're going from a delivery platform that is usually licensed nonexclusively to holding the exclusive and proprietary rights to 2 medicines, one already in the clinic with results coming soon. So really, this acquisition has been a key step in the transition to a clinical stage company. It's added a new class of RNA therapeutics and really allows near-term value creation for our stakeholders and shareholders. So I want to turn to the pipeline per se, so we can focus on each of the pipeline items and extensions. As mentioned, our lead candidate is called Misen or also known in our nomenclature as VA1. It targets MiR-126, and it's used for the treatment of acute myeloid leukemia and is well into Phase I, in fact, completing Phase I shortly with our intended readout as disclosed within H1 2027. There will also be an interim readout of those data before the final readout. And so there'll be a multiplicity, if you will, of milestones and news flow for the misen asset. The second asset that we call VAC2 is a dual-acting gene silencing medicine. It is a bispecific medicine of both PCSK9 and Lp(a) to reduce cardiovascular risk. It's currently in preclinical studies. But I think the important thing here to say is both of these targets are involved in the increased risk of heart attack and stroke. And we believe that our medicine will be able to reduce that risk. And by being a once every 6 months or possibly even once a yearly medicine, it may have the possibility of reducing global cardiovascular risk where you don't worry about compliance, but you inject the medicine once a year, once every 6 months and get the desired effect of lowered cardiovascular risk in terms of fewer heart attacks and fewer strokes. Many people who followed the company earlier as Infor Pharma will know about Nuvec. This is a silicon nanoparticle that we now call VA3, and we're testing it in preclinical studies to see if it can actually be a delivery vehicle for RNA therapeutics. So more to come on that as well. I want to now change gears yet again and focus specifically now on our lead asset, that1 or mirasten. And Mirasten is used to treat a very rare blood cancer, but albeit one with a specific and high incidence and prevalence, and that's called AML or acute myeloid leukemia. In the United States, 83,000 people currently have AML, 22,000 new cases annually, sadly 11,500 deaths, representing about 1.8% of all nonaccidental deaths in the United States, but only an approximate 33% 5-year survival, which equates to about the same 5-year survival for all comers in pancreatic cancer, which, as you know, is an extremely aggressive form of cancer of malignancy. The market, however, for AML is not small. It's currently about $3.59 billion today and 2.75 million of that is from one medicine, venetoclax. -- that is used to treat all patients with AML. And sadly, those patients all become resistant to venetoclax, and we believe that Mersen will overcome that resistance, and I'll tell you more about that. So our target, MiR-126 is, in fact, a validated target for AML. MicroRNAs, as you might know, is a new and important class of RNA therapeutics. These are short noncoding single-stranded pieces of RNA regulate gene expression and can regulate multiple genes, including MiR-126. The field is really heating up, in fact, because in 2024, the Nobel Prize was awarded to both Ambrose and RoKem for their work on microRNAs and the company Regulus in early Phase II studies was acquired by Novartis for USD 1.7 billion. And therefore, we believe that now this modality in RNA therapeutics, microRNAs is also extremely important. In terms of AML, MiR-126 is elevated or overexpressed in AML, and we know that lowering it reduces the disease and a high level of MiR-126 is a much poor prognosis for the disease. We think specifically that lowering MiR-126 can reduce the resistance to medicines like venetoclax, and we'll tell you a bit more why. The discoverer of miasten, the inhibitor in the therapeutic against MiR-126 is named Guido Marucci. He's currently the Chair of Oncology at City of Hope in Los Angeles, and we published this extremely important paper in March 5 issue of the Journal Blood, which, as many of you know, is the leading journal in hematology and oncology globally. The paper that was published, you can see in the middle part of the panel is about the inhibition of MiR-126 by miasten, and it results in enhanced venetoclax activity, the chemotherapeutic agent in AML. And therefore, we believe that it will allow patients to get a much better response, maybe even complete remission on venetoclax when they're also treated in combination with miricen. In fact, this finding was so important that the editors of blood put this paper on the cover of blood, you can see on the left side, and they also commissioned peers and colleagues to write an editorial or commentary that you can see on the right side about the importance of this discovery in the treatment of AML. So apart from our enthusiasm at Falia for this, the peers and the investigators in the AML field and including in this leading journal are all very enthusiastic about the finding of miricen in the role of treating AML and AML patients. I can give you one example of an experiment, albeit this one in rodents that sort of hits on the point. The experiment seen on the left side of the slide is what we call a Kaplan-Meier survival curve. You can see on the x-axis going up the percent survival of the animals and the time on the bottom axis on the X-axis going out to 240 days. In the black bar are animals that have been treated or have the defect in mice that results in AML. And you can see that at day 0, 100% of the animals are still alive. But by the time you get to about day 80 or 90, the animals start sadly succumbing and by approximately day 100, all the animals are dead in the black line. When you treat these animals with either placebo at day 60, that's the line in black. And when you treat them with, you can see that a cohort of animals keep surviving and you have still animals alive at day 200. And in fact, it changes the median survival rate of animals from 89 days to 154 days, which is extraordinarily significant in the treatment of AML. Again, albeit this is in mice, but the same study is now excellent in humans, and I'll detail that in a second. The right side of the slide shows the same experiment, albeit when you put human AML into these animals, and you can see, again, the difference between the red line and the black line, demonstrating that there is an increased survival when you treat the animals with Neiastim at day 60. We are now in conduct together with City of Hope in a Phase I study in AML patients. This is a study of up to 20 patients. Enrollment began in November and expects to conclude very shortly, and we've guided it will have results in the first half of 2027. The primary objective in this study is, of course, like all Phase I, safety and tolerability, and there are secondary endpoints or objectives to look at the efficacy of this medicine in these patients. Normally, a Phase I study would be in healthy subjects. This study is not only in patients with AML, but it's specifically in patients with AML that have relapsing and recurring disease, a very late-stage patients, which are the ones you would like to, at the end of the game, target with Miden. And because we're studying secondary endpoints like the formation of new hematopoietic cells or new white blood cells, we'll be able to actually determine if there's any efficacy as we escalate the dose. You can see we're doing dose escalation here or dose finding, dose 1, dose 2, dose 3, dose 4, so we can find the appropriate doses to use in a pivotal or registrational Phase II study. So I think what's important to say here is this is an extremely aggressive disease, patients to come rapidly. And we believe that this very new and specific mechanism of action of miden, lower end of MiR-126 could on top of venetoclax be a key modality to increase survival and treat and perhaps even cure patients with AML. And therefore, we're very excited for both interim data coming up, but also the top line Phase I data coming in H1 2027. With that, I'm going to change gears yet again and now focus on our cardiovascular medicine, which is a gene silencing medicine to lower cardiovascular risk. As opposed to a microRNA medicine, this is what's called RNA interference or RNAi or siRNA. And you can see in the cartoon at the bottom left of the box at the bottom, a cartoon of what our medicine looks like. You can see that there's a double-stranded sequence in blue against PCSK9 and a double-stranded sequence in sort of red orange against Lp(a), both PCSK9 and Lp(a) levels when elevated suggests an increased risk of heart attack or stroke. PCSK9 goes up when you are obese or have type 2 diabetes or e inappropriate highly fat-containing diet or all of the above, whereas Lp(a) is genetically linked when you have high Lp(a) levels, even if you're thin and run marathons, your risk of a heart attack or stroke can increase by two to fivefold if the levels are significantly high. So our belief is that by targeting both PCSK9 on the behavioral side and Lp(a) on the genetic side by lowering these 2 targets, we can reduce the incidence and prevalence of stroke and heart attack. And by having a once-yearly medicine, we can lower that risk arguably globally through single injections once a year in global populations. The way these medicines work essentially is once injected in, they get into the bloodstream, honing on the liver by the little bit you see on the right side of the Lp(a) moiety. They are then cleaved inside the cell. They get into the genetic machinery and ultimately lower the expression of the gene for up to a year and therefore, lower the risk. And so it's these medicines that in the hands of others now are also showing some promise, we believe this is extremely interesting. And I can tell you that when an article was published in Pierce Bio last year about this approach, we've been approached by several large pharmaceutical companies that have shown interest. The strategy here is ultimately to license this and partner with a large pharmaceutical company. We cannot do the large cardiovascular outcome study ourselves. That involves 3,000 to 7,000 patients over up to 5 to 10 years. But on the other hand, by partnering this, we can get nondilutive money upfront. We can get validation of our approaches and those monies can help accelerate the work on mirersen in AML, where we believe we can take the medicine all the way given that the Phase II or registrational trial is limited in terms of the number of patients and the time it takes to conduct that study. So we have a real strategy about how to use the 2 assets to grow value for Thalia and its shareholders. Finally, I'd like to comment briefly on our third asset, our third pillar called Nuvec, which was exited in the company earlier at Infor Pharma, and we continue to study in a preclinical mode that this can deliver RNA therapeutics. And as we have more data, more results, we look forward to sharing them with you as well. So this is our milestone chart over the next several years. Here we are end of 2026. I want to focus on the top line above the time line. We have mentioned earlier here that we've acquired Sanruna Therapeutics, which has the exclusive right to operationalize mirden, the medicine to treat AML that we now call that one. We will have Phase I and interim results during the rest of 2026 coming up, but we will have top line Phase I results within H1 2027 that will certainly be about safety and tolerability and may include also some aspects of efficacy as well. Towards the end of '27, after consultations with the FDA and other regulatory agencies, we'll begin Phase II and what we hope are registrational or pivotal studies towards an approval for that one for mirden. And we believe that somewhere in '28 or early '29, we may be able to get submission for a new drug application from the FDA that will allow us to begin commercialization of Mirden in the appropriate patient population. On the bottom line under the time line, you can see that for the bispecific cardiovascular medicine, we filed a patent earlier in 2025. We've entered preclinical studies, as I've mentioned, and we continue patent work on that. We look forward in 2027 to have more preclinical data on the bispecific cardiovascular medicine and also engagement with the FDA towards what studies in humans will look like. All along the way, we're continuing to work for now on Nuveq and we'll report those data -- and later in 2028, we expect to submit an IND to begin first-in-human studies for the cardiovascular medicine. So a significant amount of news flow and milestones coming up that we think will bring accretion to the share and bring value to Talia shareholders. So our outlook and milestones in 2026 for that one or Mersen, our lead asset in AML, we'll have interim readout for the balance of the year 2026. We'll have top line data in the first half of 2027. For our cardiovascular program that we hope to ultimately partner with a large pharmaceutical company, we're making progress in our preclinical development that's ongoing. We -- that preclinical work and pathway engagement will continue through H1 2027, including discussions and engagement with with the FDA. For Nuveq that we also call that 3, we continue experiments with University of Strati to look at targeting Nuvec towards the liver, which is the main site where you want to have and deliver RNA therapeutics like gene silencing medicines. Importantly, as Luke alluded to, this is really a cash stream. And what I can tell you is that following our oversubscribed July 2026 placement, we have ample cash to -- for all our key development programs, as I mentioned, funded through the next value inflection points. And therefore, we're comfortable in our cash position to deliver the value that I've just described ahead of doing any further experiments or clinical studies. So really to summarize our investment case, we have a differentiated RNA therapeutics approach now beyond M4 Pharma Italia, where we now have 3 pillars. We have an RNA therapeutic in Mersen to treat AML that's well into the clinic, and we'll have results coming in 2026, top line results in 2027. For that2, our long-acting cardiovascular medicine, we're advancing it towards clinical studies in patients, and we continue to study and advance Nuveq. The upcoming milestones are, I think, are significant insofar as I've described them to you for both that one and N2. And again, we're well funded through completing Phase I for Mersen and also for completing our cardiovascular IND-enabling studies that are now underway. Again, joining me is an experienced management team, a very committed and experienced Board. A lot of the investors re-upped in the funding that we just had as as shareholders, but we also brought on new investors, including significant investment from the ender Group from Sanmina. And I think applying now a strict capital discipline in executing our strategy on time and on budget will be key in advancing. And I think that really sets the scene for what we are about to do and accomplish in Thalia that we think will be valuable for shareholders. So I thank you. And Lilly, I turn it back to you, and we look forward to addressing all the questions that you may have in the period to follow. Thank you...

Recording of this presentation along with a copy of the slides and the published Q&A can be accessed by your investor dashboard. We have received a number of questions throughout today's presentation. And if I may just start off with the first question here, which reads as follows. There was much talk of having products to sell eventually. Being that is only in Phase I yet again, how many years away is any revenue? Is Nuveek now realistically on hold?

So a really good question. And ultimately, the goal of any biotech company is ultimately to productize our work to commercialize it and ultimately to develop revenue. But revenue can come in many forms. It can come in the form of a partnership where we get significant up to tens of millions in upfront nondilutive payments that is in the form of revenue that supports the company. It could be that we also, at a certain point in time because our assets are considered valuable now in the RNA therapeutic marketplace that someone either buys an asset or buys, in fact, the whole company. But of course, what we aim to do now is advance the medicines towards revenue themselves before any of these deals happen. The one that's closest for us is, in fact, Mersen or that one. It's now in the clinic, and we can't guide exactly to the date that we'll have revenue or what that revenue will look like. But like all biotechs, it's significantly along the value-generating pathway that you see in valuable biotechs. And we believe that with the Phase I data coming up, we'll be in a much better position to be able to advance it towards revenue. The other part of the question was about Nuvec. And of course, we continue to study Nuvec to see if it's a valid and valuable delivery system for our own homegrown RNA therapeutics.

That's great. And the next question here. What type of data should we expect from the interim update on Men in H2...

Yes. So we have guided that there'll be interim data. And as you know, the Phase I study is done open label and in cohorts of patients, as you can see on clinicaltrials.gov, 3 at a time as you escalate the dose. And we will guide that at some point in the balance of 2026, we should be able to announce some of the interim data, both in terms of safety and perhaps even efficacy. But again, we'll wait until those announcements are in front of us to be able to discuss those data with you.

Just moving on here. So the top line data expected in H1 2027, what does success look like understanding the PE safety? What efficiency data can we expect?

Yes. So like all Phase I studies, the primary endpoint is, in fact, safety and tolerability. So success means that the medicine is safe and well tolerated. And given that it's progressed already through a number of patients, and we continue to enroll, recruit and accrue patients, it can be logically extended that the medicine thus far is already safe and well tolerated. And so you can expect that success is measured by that safety and tolerability. In terms of efficacy, we'll be looking at different biomarkers of new hematopoiesis or new generation of effector or end-stage immune or white blood cells. And as we have those data on hematopoiesis, we'll share them in press releases, and we'll be able to discuss those data as we go forward.

That's great. What is different about that 002 cardiovascular program?

So that too, the bispecific medicine is different than others because others are advancing either a gene silencing medicine singularly against PCSK9 or singularly against Lp(a). We believe that the combination medicine, PCSK9 and Lp(a) will address both genetic risk and behavioral risk in one medicine that can be injected not once every month or once every 3 months as current gene silencing medicines, but perhaps once every 6 months or once every year for even better compliance. And we think by addressing those 2 targets, we'll be able to have sort of the next-generation medicine for the reduction of cardiovascular risk. There's already a level of interest from pharmaceutical companies, and that's exactly what you want as you think about a medicine, not for tomorrow, but for the next 10 years.

The next question here. What should investors watch for in terms of updates...

Well, again, as we mentioned on our milestone slide, I think the interim results of Mirden will be key. The top line data on Mirden will be really important because it will be the first time that this company as a publicly traded company expresses and announces clinical results on the path to an actual medicine product. And then, of course, we will continue to advance the other medicines that we have, specifically the dual-acting cardiovascular risk-reducing medicine. So all those will be key, and we look forward to sharing those updates with the markets and with our shareholders and new investors.

Next question we've got here. What sort of time scale of Falia working to? For instance, are Falia looking to take that one right through to production for a salable product? Or will we be looking to partner at the earliest possible time phase after Phase I...

You always have a development plan that is about ultimately commercializing the medicine ourselves. But along the way, if a partner wants to come and partner next week or after the Phase I data, we're delighted to enter into those discussions insofar as they're valuable for patients, caregivers and ultimately, importantly, for our shareholders. And so our job and the job at the level of the Board and our fiduciary is to assure shareholder value, and we'll do so at every turn as we advance these medicines. And so we can't say when the medicine will be actually commercialized, but we're well into that path now. But there are multiple opportunities short term, midterm and long term to be able to extract shareholder value that will bring returns to shareholders from their starting positions.

Just moving to the next question. Do you currently have a partner in mind for that one? Or have you been approached by any institution showing an interest in that one?