David Solomon
CEO at THALIA THERAPEUTICS PLC
Replay available
Interim results for the six months ended 30 June 2026 hosted by Thalia Therapeutics (LSE:THAT) on Investor Meet Company. Replay available.

On 6ix: 6ix.com/event/thalia-therapeutics-plc-that-interim-results-for-the-six-months-ended-30-june-2026
Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.
0:00 Good afternoon, and welcome to the THALIA THERAPEUTICS PLC investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time via the q and a tab situated on the right hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and publish responses where it's appropriate to do so. 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, Lily, for the introduction, and welcome to the THALIA interim results for the first half of twenty twenty six. I'm David Solomon, CEO of THALIA THERAPEUTICS, and joining me on this call today is Luke Kerrance, our CFO.
0:47 So we'll start with our safe harbor statement. THALIA THERAPEUTICS. THALIA 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 a type of leukemia, and also to treat cardiovascular disease. We'll talk about how we conduct ourselves in cardiovascular risk risk reduction. Joining me is an experienced management team and experienced board, many with proven track records in RNA therapeutics.
1:34 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 two main types now of therapeutics or three, but we focus on two of those. On the left side of the slide, you see microRNAs, and they these microRNAs are short bits of RNA that regulate gene expression. And so far as a 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 Miriston, which is also called VAT one, which is an anti microRNA one twenty six 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 Mirastin, our treatment for AML, and its progress in the clinic.
2:32 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 a gene completely. And insofar as a gene causes a disease by silencing or shutting off that gene for protracted periods of time, you can certainly modify or even cure the disease. We're developing a bispecific gene silencing medicine against two key targets in cardiovascular disease, PCSK nine and LP little a. Both of these targets are known to cause stroke and heart attack when at high levels, and, we look forward to discussing how we reduce those levels to reduce cardiovascular risk. We also have at 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.
3:28 I wanna first give you our corporate highlights for the first half of the year in 2026. It's been a rather busy first half of the year for us at THALIA THERAPEUTICS. I joined the company in February 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 N four 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, an United States Delaware c corporation called Sanmirna Therapeutics, and that is a company that has an exclusive license, from the City of Hope Medical Center in Los Angeles, California to a medicine called MiraStim and a whole field of use and IP and know how around lowering, miR one twenty six. And we'll talk about our medicine that was licensed from City of Hope called Mirasen, how it treats AML, and how we're advancing that to shareholder value over time. We recently also announced that a a patent for Mirastin that already exists in other geographies was now granted in China that also helps our story to add value to the company over time.
4:44 In terms of our cardiovascular medicine, we have a long acting dual siRNA or bispecific RNA that targets both PCSK9 and LP, and we've laid down a new patent for that. And we've initiated preclinical development together with WuXi APTEC 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 Nuvec, as you may know, was already at Enfor Pharma, and will tell you a bit about our work with University of Strathclyde to show that Nuvec can be perhaps an appropriate delivery system. I'm also really delighted that Luke Cairn, 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.
5:46 So I I joined the company in February 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 in the case of Zealand, and we have similar aspirations to do the same with THALIA THERAPEUTICS.
6:33 As I mentioned, Luke Cairns 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, David. Yeah. Obviously, I've I've been with the company since it's joined AIM in in 2017, initially as a I'm an executive director. My background is is corporate finance, almost exclusively in the small cap markets. I was lastly a nominated adviser and head of corporate finance and managing director of Northland Capital, which is now part of SP Angel. But yeah. And I've sort of lived and breathed small cap companies and delighted to sort of take a more formal role to help THALIA through the next stages of development.
7:27 So in terms of the engines we just published, I mean, obviously, everyone knows we're we're pre revenue. So the key thing is is really where we are with our our cash position and ability to deliver on on our our various programs. So we had cash of 1,500,000 as at the end of the period, but that's not really the the full story because we had receivables of of 1,000,000 due from from the place in which we announced in at the end of the month in June. And then we had the second tranche, which was subject to shareholder approval received in July of another 495,000. So of the 1.5 we had at the end of end of the period, we've we've added another one and a half to that. Of course, that's all before the cost of the transaction and commissions and what have you. One of the great things about the fundraiser we did was obviously the director participation and the vendors from Saint Merna, which shows great support and belief in what we're trying to do.
8:24 We could have taken more, but we are mindful of dilution and obviously we're would have liked to do a higher price. And, you know, we did it as close to market as we could. But we felt we we needed to raise enough money that we could deliver on the the milestones that we're seeking to do over the next twelve months, which David will talk to. But particularly, the completion of the Phase one study with Miriston following the Sanmurna acquisition. The operating loss is sort of in line with expectations. It is higher on the G and A, which is largely down to the appointment of David and the additional cost in terms of gearing up for the Sun Motor acquisition and focusing on that transaction.
9:14 And here, can see it reflecting the numbers. These are all straight out of the interims, which are published today. As I say, the the GNA was 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 some other, which would increase the the balance sheet further. But, yeah, the revenue here that they're just small license fees, but obviously, they're they're not material. So so nothing to speak of there. And as we go through this period, the R and D numbers will be going up materially as we advance the three projects.
10:05 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 Sanmirna, 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 of significant value. The Sanmirna acquisition specifically brought on a very differentiated phase one 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 Miirsten, really targets the root cause of AML, and lots of preclinical work has been done. So approximately six years of preclinical work, including toxicology testing, has been done, including patents filed up to the point that we acquired the asset. So we believe now within the clinic with results coming in the first half of twenty twenty seven, we think this clinical asset will be accretive and be a key key value driver for the company.
11:21 Also, the terms of the acquisition and the milestone structure also minimizes dilution to existing share shareholders and allows the possibility of significant growth. 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 2,750,000 was oversubscribed, and really funds the pipeline all the way through the Meresten phase one readout in the first half of twenty twenty seven. 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 Bernard shareholders, but really chain has been a change of outlook for the company because we're going from a delivery platform that is usually licensed non exclusively to holding, you know, the exclusive and proprietary rights to two medicines, one already in the clinic with results coming soon.
12:21 So, really, this 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 wanna 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 Meresten or also known in our nomenclature as that one. It targets miR one twenty six, and it's used for the treatment of acute myeloid leukemia and as well into phase one, in fact, completing phase one shortly with our intended readout as disclosed within h one twenty twenty seven. There will also be interim readout of those data before the final readout, and so there'll be a multiplicity, if you will, of of milestones and news flow for the Meresten asset.
13:18 The second asset that we call that two is a dual acting gene silencing medicine. It is a bispecific medicine of both PCSK nine and LP 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 six months or possibly even once yearly medicine, 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 six months, and get the desired effect of lowered cardiovascular risk in terms of fewer heart attacks and fewer strokes.
14:06 Many people who followed the company earlier as N4 Pharma will know about Nuvec. This is a silicon nanoparticle that we now call VAT three, and we're testing it in preclinical studies to see if it can actually be a delivery vehicle for RNA therapeutics. So more more to come on that as well. I wanna now change gears yet again and focus specifically now on, our lead asset, that one or Merestin. And Merestin 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, eighty three thousand people currently have AML, twenty two thousand new cases annually, sadly, one thou eleven thousand five hundred deaths representing about one point eight percent of all nonaccidental deaths in The United States, but only an approximate thirty three percent five year survival, which equates to about the same five year survival for all comers in pancreatic cancer, which, as you know, is an extremely aggressive form of of cancer, of a malignancy.
15:13 The market, however, for AML is not small. It's currently about 3,590,000,000 today, and 2,750,000 of that is from one medicine, venetoclax, that is used to treat all patients with AML. And sadly sadly, those patients all become resistant to venetoclax, and we believe that MERESTIN will overcome that resistance, and I'll tell you more about that. So our target, miR one twenty six, is in fact a validated target for AML. MicroRNAs, as you might know, is a 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 one twenty six. The field is really heating up, in fact, because in 2024, the Nobel Prize was awarded to both Ambrose and Ruffkin for their work on microRNAs, and the company Regulus in early phase two studies was acquired by Novartis for 1,700,000,000 US dollars, and therefore, we believe that now this modality in RNA therapeutics, microRNAs, is also extremely important. In terms of AML, miR one twenty six is elevated or overexpressed in AML, and we know that lowering it, reduces, the disease, and, a high level of miR one twenty six is a much poorer prognosis for the disease.
16:37 We think specifically that lowering miR one twenty six can reduce the the resistance to medicines like venetoclax, and we'll tell you a bit more why. The discoverer of Miriston, the inhibitor and the therapeutic against miR one twenty six, is named Guido Marcucci. He's currently the chair of oncology at City of Hope in Los Angeles, and he 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 oncology globally. The paper that was published, you can see in the middle part of the panel, is about the inhibition of m r one twenty six by Miriston, 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 Mirastin.
17:32 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, THALIA for this, the peers and the, and and the investigators in the AML field and including in this leading journal are all very enthusiastic about the finding of Meresten in the role of treating AML and AML patients. I can give you, one example of an experiment, albeit this one in in, in rodents. It 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 two hundred and forty days.
18:33 In the black bar are animals that have been been treated or have the have the defect in mice that results in AML. And you can see that at day zero, a hundred percent of the animals are still alive. But by the time you get to about day eighty or ninety, the animals start sadly succumbing, and by approximately day one hundred, all the animals are dead in the black line. When you treat these animals with either placebo at day sixty, that's the line in black, and when you treat them with Merestim, you can see that, a cohort of animals keeps surviving, and you have, still animals alive at day, 200. And in fact, it it changes the median survival rate of animals from eighty nine days to a hundred and fifty four days, which is extraordinarily significant in the treatment of AML. Again, albeit this is in mice, but the same study is now, extant 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 the, again, the difference between the red line and the black line, demonstrating that there is an increased survival when you treat the animals with Mirastim at day 60.
19:51 We are now in conduct together with City of Hope in a phase one study in AML patients. This is a study of up to 20 patients. Enrollment began in, in November, and it expects to conclude very shortly. And we've guided it will have results in the first half of twenty twenty seven. The primary objective in this study is, of course, like all phase one safety and tolerability, and there are secondary endpoints or objectives to look at the efficacy of this medicine in these patients. Normally, a phase one 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, so very late stage patients, which are the ones you would like to, at the end of the game, target with virustan.
20:38 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 one, dose two, dose three, dose four, so we can find the appropriate doses to use in a pivotal or registrational phase, phase two study. So, I think what's important to say here is this is an extremely aggressive disease. Patients succumb, rapidly, and we believe that this very new and specific mechanism of action of Meresten lowering miR one twenty six could, on top of venetoclax, be a 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 one data coming in h one twenty twenty seven.
21:36 With that, I'm gonna 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 a cartoon of what our medicine looks like. You can see that there's a double stranded sequence in blue against PCSK nine and a double stranded sequence in sort of red orange against Lp. Both PCSK nine and Lp levels, when elevated, suggest an increased risk of heart attack or stroke. PCSK nine goes up when you are obese or have type two diabetes or eat a inappropriate highly highly fat containing diet or all of the above.
22:33 Whereas, Lp is genetically linked when you have high Lp levels. Even if you've 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 the LPO delay on the genetic side, by lowering these two targets, we can reduce the 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, hone in on the liver by the little bits you see on the right side of the l p lullae moiety. They're 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.
23:28 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 Fierce 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, you know, three to 7,000 patients over up to five to ten 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 Meresten in AML, where we believe we can take the medicine all the way, given that the phase two or registrational trial is limited in terms of the number of patients and the time it takes to conduct that study.
24:27 So we have a real strategy about how to use the two 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 exiting the company earlier as N for 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 our milestone chart over the next several years. Here we are end of twenty twenty six. I wanna focus on the top line above the timeline. We have mentioned earlier here that we've acquired Sanmirna Therapeutics, which has the exclusive right to to operationalize Meresten, the medicine to treat AML that we now call that one. We will have phase one and interim results during the rest of 2026 coming up, but we will have top line phase one results within h one twenty twenty seven that will certainly be about safety and tolerability and may include also some aspects of efficacy as well.
25:35 Towards the end of twenty seven, after consultations with the FDA and other regulatory agencies, we'll begin phase two in what we hope are registration or pivotal studies towards an approval for that one for Meresten. And we believe that somewhere in '28 or early twenty nine, we may be able to get a a submission for a new drug application from the FDA that will allow us to begin commercialization of Meresten in the appropriate patient population. On the bottom line, under the timeline, 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 Nuvec, and we'll report those data. And in 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, THALIA shareholders.
26:55 So our outlook and milestones in 2026 for that one, or Meresten, our lead asset in AML, will have, interim readout for the balance of the year 2026. We'll have top line data in, the first half of twenty twenty seven. 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 that preclinical work and pathway engagement will continue through h one twenty twenty seven, including discussions and engagement with with the FDA. For Nuvect, that we also call that three, we continue experiments with University of Strathclyde to look at targeting Nuvec towards the liver, which is the main site where you'd want to have and deliver RNA therapeutics like gene silencing medicines.
27:48 Importantly, as Luke alluded to, this is really a cash game. 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 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 m four pharma to THALIA, where we now have, three pillars. We have, an RNA therapeutic in MERISTIN to treat AML that's well into the clinic, and we'll have, results coming in 2026, top line results in 2027.
28:39 For that too, our long acting cardiovascular medicine, we're advancing it towards clinical studies in patients, and we continue to study and advance Nuvec. The upcoming milestones, are I think are significant, insofar as I've described them to you for both that one and that two. And, again, we're well funded through completing phase one for MERISTEN 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 as shareholders, but we also brought on new investors, including significant investment from the vendor group from Sanmirna.
29:28 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, in THALIA that we think will be valuable for shareholders. So I thank you. And, Lily, I turn back to you, and we look forward to addressing all the questions that you may have in the in the period to follow. Thank you very much. That's great. Thank you very much for your presentation. Ladies and gentlemen, please do continue to submit your questions just by using the q and a tab situated on the top right hand corner of your screen. Just while the company take a few moments to review those questions submitted today, I'd like to remind you that recording of this presentation along with a copy of the slides and the published q and a can be accessed via 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.
30:19 There was much talk of having product to sell eventually. Being that is only in one phase one yet again, how many years away is any revenue? Is Nuvec now realistically on hold? So a really good question. And, you know, 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.
31:19 The one that's closest for us is in in fact, MERSIN or that one. It's now in the clinic, and, you know, 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 one data coming up, we'll be in a much better position to be able to advance it towards, towards revenue. The other part of the question was about Nuvect, and, of course, we continue to, to study Nuvect to see if it's a valid and valuable delivery system for our own homegrown RNA therapeutics. That's great. Just turning to the next question here. What type of data should we expect from the interim update on myristin in h two twenty twenty six?
32:10 Yeah. So we have guided that there'll be interim data. And as you know, the phase one study is done, open label and in cohorts, of patients, as you can see on clinicaltrial.gov, three at a time as you escalate the dose. And, we 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 in front of us to be able to discuss those data with you. Thank you. Just moving on here. For the top line data expected in h one twenty twenty seven, what does success look like? Understanding the PE safety, what efficiency data can we expect?
32:56 Yeah. So like all phase one 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 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 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.
33:48 That's great. What is different about that zero zero two cardiovascular program? So that too, the bispecific medicine, is different than others because others are advancing either a gene silencing medicine singularly against PCSK nine or singularly against Lp. We believe that the combination medicine, PCSK nine and Lp, will address both genetic risk and and behavioral risk in one medicine that can be injected not once every month or once every three months as current gene silencing medicines, but perhaps once every six months or once every year for even better compliance. And we think by addressing those two 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 ten years.
34:48 Thank you. Just turning to the next question here. What should investors watch for in the in terms of updates? Well, again, as we mentioned, on our on our milestone slide, I think the interim results of Mirosten will be key. The top line data on Mirosten 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 our and new investors.
35:37 Thank you. The next question we've got here reads, what sort of timescale are THALIA working to? For instance, are THALIA looking to take that that one right through to production for a saleable product, or will be will we be looking to partner at the earliest possible time phase after phase one? 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 one 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 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, you know, 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.
36:40 Thank you. 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? Yeah. So we have partners in mind for that one. I can't discuss who we're talking to or what those discussions are at this point. But, you know, as they advance, we will keep the market apprised and, obviously, any conclusion. But right now, it's early days. I I am sure that most companies, partners, investors are, really waiting with bated breath on the interim results and the phase one top line results. And so we're progressing rapidly with all good speed to generate those results and those announcements. And at that certain point in time, we'll be able to come back and discuss this topic further.
37:27 But I would say, you know, look. We're we're confident that this is an exciting modality, a unique mechanism of action. And as usual, again, I'm the CEO, and I see the glass half full. But, you know, I'm here because I believe Mirosten will actually become a medicine, and therefore, we think it's a wonderful time to, you know, enter into the share simply because I think there's significant news flow to follow in the coming, weeks, months, and, and and half year. That's great. Just, turning to the next question here. As you look ahead to the Norriston phase one readout next year, what would you regard as the most important characteristics in the data beyond simply meeting the study endpoints that would really strengthen the assets profile further for development yourselves or potentially with a partner?
38:15 Yeah. It's a really good question because victory for a phase one study, as I mentioned earlier, is predicated on safety and tolerability. So if we look at sort of the layers of what victories look like, I think the first victory is that the medicine is safe and well tolerated. The second victory is that the medicine is safe and well tolerated and shows some parameters of efficacy, meaning you start to see white blood cells returning in patients that have a paucity or no white blood cells whatsoever. And significant or major victory is that you see in a broad group of patients at different doses an enormous amount of hematopoiesis or generation of white blood cells that suggest that this medicine at a range of different doses brings, some level of efficacy.
39:01 Again, I would caution that the trial is only up to 20 patients, and so any efficacy is rather anecdotal. And it's an open label study, so all the patients are getting Mirastin. And the true measure would be studying against placebo to look at the delta, of the Mirastin response versus the placebo response. And we're not at that level of study yet, but that would be what we would look for in a phase two study. That's great. And just turning to the next question here. When do you expect to release the first of the interim readouts from our trial with that one? Will it be q four twenty twenty six, or will you wait until 2027? So our guidance remains the same. Our guidance is that at some point within h one twenty twenty seven, we'll release the top line data from the phase one study of MERESTIN in AML. And I can't say more other than we're working with All Good Speed and together with our partners at City of Hope to complete the trial and generate those data ahead of an announcement.
40:01 That's great. I think go ahead, Lou. There is another question that's just come through. How big and how long would a phase two program be, And could it be residential? Would you consider marketing an AML product yourselves, or is the plan to license it? So ahead of answering those questions, let's say we'll end with these last three questions, the one you just addressed and the two on the screen in the interest of time. But the question can you repeat that question again? Because I I missed part of it, Lily. Of course. It's how big and how long would a phase two program be, and could it be residential? Would you consider marketing an AML product yourselves, or is the plan to license it? So a phase two study would certainly try to be a pivotal study or registrational study because I think in in acute leukemia with with the orphan designation possible and possible fast track status, we'd want the next study to be the one that requests FDA approval. In terms of the design of the study, I can't give any specifics now because we first have to wait the results of the phase one study that also may have some efficacy readout. So I I can't answer that further, but it is entirely possible that we can take it all the way. But, of course, along the path, if if a a large pharma company views this as valuable, we'll certainly answer to those discussions. Logic says that since all patients in AML are treated with venetoclax,
41:32 and venetoclax sells 2,750,000,000 US dollars worth of medicine today. And this medicine, our medicine, Meresten, can, can assure that patients remain on venetoclax. Certainly, producers of venetoclax would be one logical either partner or acquirer of what our asset or our company. But, again, it's early days. What we're excited by is that we're in the middle of a trial where, we think there's a high probability of advancing the medicine towards further and registrational studies. That's great. And just another question we've got here is, would you consider working with TGA Australia for the phase one process and tax benefit?
42:20 We currently don't have any plans of working in Australia at present. In terms of the phase one, we have the full funding for it, and we're working exclusively with our partner at City of Hope. So but I'd love to be introduced to any prospective partners in Australia and elsewhere as, all partners are welcome to, enter into the story and help build value for shareholders. That's great. And then, just a final question we have here reads, in October 2023, Tempest Therapeutics, skyrocketed by nearly 4000%, roughly 39 times to 40 times in a single trading session. The game was triggered by, updated data from a phase one b two clinical study for experimental, liver cancer drug. Are we likely to see similar game with that in 2027?
43:12 We have high hopes for MIRASIN, that one, and high hopes for THALIA. I can't express what the magnitude of the accretion will be. Certainly, what Tempest did was extremely significant. But what I do know is that when a company first gets its clinical results, insofar as the clinical results start to guide to where a medicine could go in a unique offering to treat a hard to treat disease like AML, certainly, level of accretion can be significant. I can only point to my own earlier experience as the CEO of Silence Therapeutics where we were at 40 p at one point. We entered into partnerships with two large pharma, brought on a lot of nondilutive funding, and, essentially, we had approximately a a 12 to 15 x accretion over the course of six to ten months.
44:03 And so these large levels of growth are are possible. Again, the, you know, the result is in the pudding here, and we'll do everything we can to report accurately and precisely the results of our phase one study, and we look forward to shareholder and investor participation in our growth. That's great. Thank you for answering all those questions you can from investors. And, of course, the company can review your questions submitted today, and we'll publish those responses on the Investor Meet company platform. Just before redirecting investors to provide you with their feedback, which you know is particularly important to the company, David, could I please just ask you for a few closing comments? Yeah. I wanna thank all the participants for joining our interim results, for h one twenty twenty six today. We're excited that the transition of THALIA is now complete, that we are now a clinical stage, RNA therapeutics company with significant assets in both oncology and cardiovascular disease.
44:58 And we look forward to joining the journey and updating you in the near term and the medium term about all of our results as we advance. So thank you again for your time. That's great. Thanks for updating investors today. Please ask investors not to close the session as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete, and I'm sure will be greatly valued by the company. On behalf of the management team, we'd like to thank you for attending today's presentation, and good afternoon to you all.
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