Theracryf Plc (TCF) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Theracryf Plc Investor Presentation. [Operator Instructions] 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 listed today and publish responses as appropriate to do so. Before we begin, I'd like to flip the following poll. I'd now like to hand over to Huw, CEO.

Thanks, Lilly. Good afternoon, everybody. Thanks for attending our slightly delayed final results to 31st of March 2026. And I think the reasons for that. Are now obvious with me here on the webinar, Dr. Alastair Smith, our Chair; and Toni Haenninen, our Chief Financial Officer. And together, we will take you through the results to 31st of March, an equally busy period in the first period. We aim listed, of course, and a private company. So the usual disclaimers apply. To start then, I'll hand over to Alister to bring you up to speed with who we are and what we do.

Great. Thanks, Jones. Good afternoon, everyone. Well, I'm sure you know, acre is focused on improving the lives of individuals with neuropsychiatric disorders. And the way in which biotechs generate returns for shareholders relies on building strong data sets around commercially valuable drug molecules to deliver licensing deals. And the best value is generated from more advanced assets, particularly clinical stage assets and demonstrating safety in a Phase I study is a key value inflection point for us. Progressing our lead asset, which is an OX1 blocker with applications in addition into the clinic to generate that commercial interest is what the company has been focused on since raising capital last spring. As you can imagine, addiction is an enormous market, and our lead asset shows class-leading characteristics. So not surprisingly, it's now generating interest from a number of potential partners and acquirers who are keen to see the human safety data. Early last year when I joined the Board, what I saw was a potentially best-in-class in a hot commercial area within touching distance of getting into the clinic and value significantly below where I would expect it to be. So I'm delighted to say that my confidence in that being a significant potential return for Theracryf shareholders has only strengthened in the last 18 months. because our X1 inhibitors sailed through the final 2 preclinical hurdles, which you will talk about on those are manufacturing scale up, and we were chatting earlier, I mean I can't tell you how many drugs fail because they come the manufacture and the chronic, that's long-term toxicity and a couple of animal models. So the asset sales through those in the last 18 months, and Hugh is going to take you through that progress and give you a forward look for that asset as well. Our second asset, which we don't speak about in any detail today, but it's also well advanced preclinically as a dopamine modulator which have applications in treating fatigue of brain origin, such as in patients with multiple sclerosis. And both of these assets are attracting attention from partners and acquirers, as I mentioned. So let me hand over to Huw and Toni, who are going to take you through the presentation. Toni?

Thanks, Alastair. So a quick look at the Eurosic portfolio here. Many of you have seen this before, our X1 antigens blocker. The beachhead indication that is the first 1 you go to will be binge-eating disorder. This is more common than anorexia and bulimia combined. There's only 1 drug ever been approved for binge-eating disorder and then only in the U.S. and Canada. So it's a wide open market, a very large one. We're excited about that. But there are expansion opportunities for OX1 as well that is in alcohol disorder and, for example, contains disorder, and we're looking carefully at those markets as well. And in partnership, of course, will be led by the partners to which direction clinically they want to go. What special about it, it's the best. It's the best ever discovered glass leading potential. There's a ton of technical data that supports this -- it's the most specific for Opn versus OX2 and whenever you heard this because if you block OX1, you reduce the impossibility to over in done. If you block OX2 it dose off you go to sleep. So what you want with an anti-addictive program is something that blocks the impulse or reduces the impulse but does not condition can drive can't operate machinery. And that's what we've got here. We've got the most selective for the 1 we want to hit versus the direction receptor, we don't want to hit class-leading in a number of other ways. It's a tablet. It gets into the brain very readily. It sits on its receptor for long periods of time, that's what you need. -- in reducing our urge to windows. So it's the optimal profile for orexin-1 antagonist and that's very viable in data. And that's the equity raise we did just at the start of the period we're reporting today and how well it's gone is -- has been a very pleasant surprise. Normally, there are little pickups along the way. While we've had all done with this program. It's sailed through as Alastair said, both large-scale manufacturer and long-term top ecology. We worry about that. We can't not mention our game modulator is another very promising class leading therapeutic. Potentially the reached here is protein multiple sclerosis. There's nothing approved for fatigue in TMS, even though 8 out of 10 patients complain of fatigue. So that's -- there are specific ways to measure for TMS. So it's clinically a very tractable indication. The expansion than any fatigue brain origin, Oncovin even not collect or genetic condition, which less people fall asleep in opportune moments in over school work, et cetera. We have some preclinical data there as well. It's unique. Nothing improved in MS, and it is the most selective yet for the domain transporter and nothing else. So another promising part of our portfolio that we could probably do more dedication with and that of us today there's interest externally in both of these programs. The period on the period to the 31st of March. The artisan program, clinical bring work that is the last few stages of work before you get commission for go in man. After that raise in quarter 1 '25, it was a board observation actually, a couple of board meetings ago, that the execution of this program has been flawless, both managerially and in terms of the way the asset has performed in manufacturing scale-up and in toxicology. We've stayed on the track. We've always maintained that, that is submission for us in man in the fourth quarter of this year. Now there's more deals on that 1 coming up as a result of the top upraise we did last month. Manufacturing scale-up, we made nearly 11 kilograms of it. Manufactured. we have a streamlined process, which was completed on schedule, and we're using a large theses, minnipig for the toxicology work has just finished. The minnipig so you need a lot of drug. Now with a carmaker lot of drug in a streamlined process. The formulation for those studies was completed and made ready. And then they started on schedule. That's 2-season many big dose-ranging maximum tolerate dose that's 100 times the expected dose for therapeutic use. I success that 100 times, the FDA guideline our guideline is to make it at least 10x. We've gone to 100x and found no adverse observations of those really high doses. We've completed the set of patents as well. We now have global coverage of granted patents not a pending is all granted now and so the last 2 territories to run to a Canada and Korea in the period. So now we have global coverage of granted patents for One but more on that as well in the post period. Edward joined us in the Board during the period as Northern Standard Limited, which he was nominated by of the company by share number. So we're very happy to welcome Ed on to the Board during the period. So to Toni for the financials. These are the numbers. And I think Toni has a few other remarks to make around them.

Sure. Thank you, and good morning, everybody. So post that loss EUR 3.5 million, which is up by EUR 1.6 million from the prior year. And if you look at the EUR 1.6 million out of that 75%, so EUR 1.2 million increase in the operating loss is driven by the external R&D spend to ensure that we on the money and increase here in advancing the action of 1 asset, which is the highest priority of the company, 400,000 between the package, we do have a new option plan last year. So we are aligned with the shareholders' interest as well as some adjustments in the salaries, but nothing over there that also sustain once we had 3 or 4 years ago and for the directors, we are paying also is about 15% test we paid 3 or 4 years ago. So here to ensure that the result is going developing action in line with our strategy. Cash outflow from operations, EUR 3.8 million versus EUR 2.4 million a year ago. We did receive here also 400,000 R&D tax credit. So you can see how cash management has been very tight during that period, which then result into a cash balance of EUR 1.5 million at the end of the period, which is 10th March. This does not include the top operate that we did last month. So which is then increasing the cash runway and ensuring that we get the pool in Australia to go demand as well as focusing on partnering discussions. So with that, I'll hand it back over to you.

Thanks, Toni, some post period, which was just as busy as the main period, of course, as well as getting granted patents in Canada and Korea. We actually discovered through the streamlining of the manufacturing process a way to hasten the improvements we've made in manufacturing. We call make it in this improved way. And we've now patented that, and we've submitted in 2 territories this year for extended patent protection for the asset. So that gives us a very high probability of protection until 2046. That's the most you can guess sitting here today. The reason why we did that is really important for partnering. The potential partner knows that you've got a very long protection on your assets, because of recouping the cost of our development, large-scale development and marketing through the patent life in sales. So very happy to see a pleasant surprise just after the period of discovery of new pattern information that we've now submitted as a patent very high probability of that one. as well as making 10.6 kilograms for toxicology work. We've actually taken the manufacturing to the next step, and that is human grade material is called GMP or comodato practice level material, are suitable for humans, and we made -- we expected to remain 2.6, so a very high yield on our new process, and it was delivered ahead of schedule. So manufacturing is going extremely well. And if you can manufacture -- when you can sell it, if you can't manufacture at reasonable cost, you can't sell it at a profit. So these are very important, unusually good findings this early in a development program. First, we see stocks started unfinished during the period. with that very high margin of safety that I mentioned earlier. The second is -- actually, the second dosing has completed. The top line data are out and they're clean. So we're very happy to say that the 2 species toxicology is a pass and that's key in getting the clinical permission in Australia as we'll come to give it to humans. On the business front, we did get an unsolicited proposal to acquire these neuropsych programs. just after the period, we looked at it very carefully as a Board, under the management and consider that the way the proposal is structured and even the valuations, it is, just didn't unlock the value we thought and others think that there is inherent in these 2 programs for Eximo and that. So we kindly rejected it and let's keep talking as we do with all potential partners. But we said a nice know and continued close engagement with everybody who we would expect to be engaged with in this new psychiatry field -- then the top-up raise, EUR 1.05 million gross from new and some of who are most existing shareholders. Thank you. That allows our run rate to extend for partnering discussions, allows us to get that key milestone of approval in Australia for clinical use. That's another big box ticked in the partnering list. Can you make it a good margin? Do you have extended IP? And do you house a qualified third-party look to your data and deemed it good enough, safe enough for administering in the test setting to human beings. Those are the things we anticipate still this year. Huge partnering take boxes there. So the outlook then the toxicology right sets are being done now. So we'll be announcing some detail on those as soon as the write-ups are completely in-life period has done extremely encouraging. They're very, very high safety margin. All the reports in the fourth quarter will then be written up into a regulatory format to Australia. We've selected Australia for very good reasons. So in quarter 4, we'll make the submission to the Australian HVAC, as I call the ethics committee and subsequently to the Australian FDA called the TGA or the Therapeutic Goods Administration. And we anticipate before calendar end, 2026 to have that yes decision in our hands. Of course, we'll let you know as soon as that arises. So a lot of work going on by the team of compiling this dossier, getting it ready to submit to the Australian regulators through our newly approved Australian entity -- so clinical use approval expected imminently, certainly before the end of this year. Partnering discussions are continuing. And as ever, as Tony said, because we're actually spending less on salaries, less on the board and more on R&D, capital management in this virtual company is as tight as ever to make sure that the bulk of the capital now goes to R&D and to partnering efforts. So a good outlook for us for the rest of this year and into the early part of next year. A little bit more of detail, if you wanted in anticipating a question on this really as to why Australia. So we've hit all our preclinical and clinic enabling milestones in the last 12 to 18 months were on schedule. The clinical enabling work is complete. It's being written up as we speak, by Australia. Well, because of speed, the Australian process a bit like the MHRA process here in the U.K. was 25 years ago, and I can remember that in the sense that it looks for safety and ethics and give you a quick decision are still going in demand for the first time. The human ethics Research Committee, RC reviews the science in a very stringent way. It's just that they're doing quickly. Safety is the main concern there is it safe, and we've shown in our top that it clearly is in the top species. They monitor the trial and the institution that the trial is conducted in that award basically a private board where volunteers come in to receive test drug and that's overseen by a clinical research organization in Australia. We're just about to finish negotiations with our preferred partner there. And then we are ultimately responsible through our Australian entity as a sponsor. The time frame for that tics 4 to 6 weeks. It's remarkable still that they can do it in that, and they still can. The Australian data are accepted worldwide. It's a first of all country from a regulatory drug regulatory point of view. So that 4 to 6 weeks is intense, but gets. And then after that, there's another 10 days for us to register the trial with the former Australian regulator. So that's the process in Australia. Speed is the main reason for going there. There are 2 other reasons on the financial. So the Australians still have a very generous R&D tax credit regime. You can get more than 43% of your R&D investment in Australia back other advanced tax credit. And that tax credit, you can remove from the country into the top co. So it's a very generous tax credit scheme. It's still there, and that means that and the weakness of the Australian dollar, the second financial fees means that you get the job done quickly and for about half the price of anywhere else, probably 1/3 of the price of doing it in the United States. So speed, efficiency and cost are the 3 reasons to be heading to Australia for this study. News flow. So this is the news flow from the original plan in the white boxes. And this is the additional news flow that our 1 million odd top-up gives us. So down the bottom there, we've established Theracryf PPI Limited, which is the Australian entity, and I will be sponsoring the study. We have sent our key guy down there to look at potential providers and even go into the words that the study may well be conducted in -- we are developing bioanalytical methods for humans. So you have to be able to measure it in is you tested in it. The ultimate we see that work is ongoing, and we'll announce we're not to complete to announce when we have clinical research organization in Australia. Will be ventilation human blood, hemoplasma, humanhurin and human cerebrospinal fluid. So a subgroup of the Australian volunteers, we'll get a final top to extract spinal fluids to check what level of drug we achieved there. Our modeling suggests we get a very high level of drug in the brain another partnering tick depending on who we conduct the Phase I study with as a partner. Along all of this time, business development or partnering discussions are ongoing. They've been ongoing for a substantial period of time. And as I said earlier, there's interest both in OX1, this program and leading our that program from a funding point of view. So that with the new flow forecast on the enhancement in flow from the recent raise brings us to the end of the formal part of the presentation in the summary. So over to Alastair to sum up for us.