Theracryf (LSE:TCF) — Final Results for the year ended 31 March 2026

0:01 Good afternoon, and welcome to the THERACRYF PLC investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time by 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 Hugh Jones, CEO. Good afternoon, sir. Thanks, Lily, and good afternoon, everybody. Thanks for attending our slightly delayed final results to the 03/31/2026, and I think the reasons for that are now obvious. With me here on the webinar, Doctor. Alastair Smith, our Chair and Tony Heinenen, our Chief Financial Officer. And together, we'll take you through the results of March 31 on equally busy period in the post period. We're AIM listed, of course, and a private company, so the usual disclaimers apply.

0:58 To start then, I'll hand over to Alastair to bring you up to speed with who we are and what we do. Great. Thanks, Hugh. Afternoon, everyone. Well, as I'm sure you know, THERACRYF 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 one study is a a key value inflection point for us. Now progressing our lead asset, which is an OX1 blocker with applications in addiction, the clinic to generate that commercial interest is what the company has been focused on since raising capital last spring.

1:51 As you can imagine, addiction is an enormous market, and our lead asset shows class 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. Now early last year when I joined the board, what what I saw was a, you know, best in class drug candidate in a a hot commercial area within touching distance of getting into the into the clinic and and and valued significantly below where I would expect it to be. So I'm delighted to say that my confidence in there being a significant potential return for THERACRYF shareholders has only strengthened in the last eighteen months because our o x one inhibitors sailed through the final two preclinical hurdles, which she will talk about, and those are manufacturing scale up, and we were chatting earlier. I mean, I can't tell you how many drugs failed because they can't be manufactured.

2:50 And the chronic, that's long term toxicity in a couple of animal models. So that the asset sailed through those in the last eighteen months, and and Hugh's gonna take you through that progress and give you a forward look for that asset as well. Our second asset, which we won't speak about in any detail today, but it's also well advanced preclinically, a dopamine modulator, which has applications in treating fatigue of brain origin such as in patients with multiple sclerosis. And now both of these assets are attracting attention from partners and acquirers, as I mentioned. So let me, hand over to Hugh and Tony, who are gonna take you through the presentation. Hugh, Tony? Thanks, Alastair. So a quick look at the neuropsych portfolio here. Many of you have seen this before, our orexin one antagonist or blocker, the beachhead indication that is the first one you go to, will be binge eating disorder.

3:45 This is more common than anorexia and bulimia combined. There's only one drug ever been approved for binge eating disorder and then only in The US and Canada. So it's a wide open market, a very large one. And we're excited about that, but there are expansion opportunities for OX1 as well. That's in alcohol use disorder and, for example, cocaine use disorder. And we're looking carefully at those markets as well. And in partnership, of course, we'd be led by the partners to which direction clinically they want to go. What's special about it? It's the best. It's the best ever discovered, class leading potential. There's a ton of technical data that supports this. It's the most specific for OX one versus OX two. And many of you heard this before. If you block OX one, you reduce the impulsivity, the impulsivity to overindulge.

4:34 If you block OX two, 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 cause sedation, can't drive, can't operate machinery. And that's what we've got here. We've got the most selective for the one we want to hit versus the erection 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, just what you need in reducing that urge to overindulge. So it's the optimal profile for an orexin-one antagonist and that's verifiable 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, are little hiccups along the way. Well, we've had almost none with this program. It's sailed through, as Alastair said, both large scale manufacture and long term toxicology.

5:37 Quick word about that, we cannot mention our dopamine modulator is another very promising class leading therapeutic potentially. The beachhead here is fatigue in multiple sclerosis. There's nothing approved for fatigue in MS, even though eight out of ten patients complain of fatigue. So that's there are specific ways to measure fatigue in MS, so it's clinically a very tractable indication. The expansion then any fatigue of brain origin, chemo, long COVID, and even narcolepsy, that genetic condition which allows lets people fall asleep in inopportune moments in over school work, etcetera. We have some preclinical data there as well. It's unique, nothing approved in MS, and it's the most selective yet for the dopamine transporter and nothing else.

6:22 So another promising part of our portfolio that we could probably do more communication with. And as I was to say, there's interest externally in both of these programs. To the period then, the period to the March 31, the Orexin One addiction program clinic enabling work that is the last few stages of work before you get permission for go in man. After that raise in quarter one twenty five, we've 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 and that is submission for use in man in the fourth quarter of this year. Now there's more news on that one coming up as a result of the top up raise we did last month.

7:20 Manufacturing scale up, we made nearly 11 kilograms of it manufactured via a streamlined process, which was completed on schedule, and we're using a large species mini pigs for the toxicology work that's just finished. And a mini pig is 40, so you need a lot of drug and we've successfully made a 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 two species, rat and mini pig. Dose ranging, maximum tolerated dose, that's a hundred times the expected dose for therapeutic use. I stress that a 100 times. The FDA guidelines guideline is make it at least 10 times. We've gone to a 100 times and found no adverse observations at those really high doses.

8:11 We've completed the set of patents as well. We now have global coverage of granted patents, not pending. These are all granted now and strong, the last two territories to grant to Canada and Korea in the period. So now we have global coverage of granted patents for OxOne. Bit more on that as well in the post period. Ed Wardle joined us in the board during the period, as Northern Standard Limited, which he was nominated by as over 20% of the company by, share number. So we're very happy to welcome Ed onto the board during the period. So to Tony then for the financials, these are the bare numbers and I think Tony has a few other remarks to make around them. Sure. Thank you, Hugh. Thank you, and good morning, everybody. So Postdash lost 3,500,000, which is up by CHF 1,600,000 from the prior year.

9:08 And if you look at the CHF 1,600,000 out of that 75%, so CHF 1,200,000 increase in the operating loss is driven by the external r and d spend to ensure that we put all the money majority of the money and the increase here into advancing the r x one asset, which is the highest priority of the company. The rest 400,000 is split between the the the option package. We do have new option plan last year. So we are aligned, with the shareholders' interests as well as some, adjustments in the salaries. I'm noting over there that our salary is the same as once we had, three or four years ago. And, for the directors, we are paying ourselves about 15% less than we paid three or four years ago. So here, to really ensure that the resources go in developing direction one, in line with our strategy.

9:56 Cash outflow from operations, 2,700,000 versus 2,400,000 a year ago. We did receive here also a 400,000 r and d tax credit. So we can see our cash management has been very tight during the period, which then results into a cash balance of 1,500,000 at the end of the period, which is end of March. This does not include, the top up rates that we did, last month. So we just then increasing the cash runway and ensuring that we get the approval in Australia to go on demand as well as focusing on partnering discussions. So with that, I'll hand it back over to Hugh. Thanks, Tony. Some post period, which was just as busy as the main period, of course, as well as getting granted patents in Canada and Korea.

10:44 We actually discovered through the streamlining of the manufacturing process, a way to patent the improvements we've made in manufacturing. You You can only make it in this improved way, and we've now patented that and we've submitted in two territories this year for an extended patent protection for the asset. So that gives us a very high probability of protection till 2046. That's the most you can get sitting here today. The reason why we did that, it's really important for partnering that a potential partner knows that you've got a very long protection on your asset because of recouping the costs of us 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 a new patent or patentable information that we've now submitted as a patent, very high probability of that one.

11:41 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. It's called GMP or good manufacturing practice level material that's suitable for humans. And we made we expected two, we made 2.6. So very high yield out of our new process, and it was delivered ahead of schedule. So manufacturing is going extremely well. And if you can't manufacture, well, you can't 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 species tox started unfinished during the period with that very high margin of safety that I mentioned earlier. The second species actually, second species dosing has completed.

12:31 The top line data are out and they're clean. So we're very happy to say that the two species toxicology is a pass, and that's key in getting the clinical permission in Australia as we'll come to 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 and as a management and considered that the way the proposal was structured and even the valuations in it just didn't unlock the value we thought and others think that there is inherent in these two programs, RX1 and DAT. So we kindly rejected it, and let's keep talking as we do with all potential partners, but we said a nice no and continued close engagement with everybody who you'd expect to be engaged with in this neuropsychiatry field.

13:28 Then the top up raise, 1,050,000 gross from new and some new and mostly existing shareholders. Thank you. That allows our runway 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 can you make it a good margin? Do you have extended IP? And do you has a qualified third party looked at 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 tick boxes there.

14:14 To the outlook then, the toxicology write ups are being done now. So we'll be announcing some detail on those as soon as the write ups are complete. The in life period is done extremely encouraging there, 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 the in quarter four, we'll make a submission to the Australian HREC, as it's called, 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.

14:59 Of course, we'll let you know as soon as that arrives. 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 and 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 and 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.

15:47 A little bit more detail if you wanted in anticipating a question on this really, to why Australia. So we've hit all our preclinical and clinic enabling milestones in the last twelve to eighteen We're on schedule. The clinical enabling work is complete. It's being written up as we speak. Why Australia? Well, because of speed. The Australian process, a bit like the MHRA process here in The UK was 25 ago, and I'm not gonna remember that, in the sense that it looks for safety and ethics and gives you a quick decision as to going into man for the first time. The Human Ethics Research Committee, HREC, reviews the science in a very stringent way. It's just that they do it quickly. Safety is the main concern there. Is it safe?

16:35 And we've shown in our tox data that it clearly is in the tox species. They monitor the trial, and the institution that the trial conduct is conducted in, that's a ward basically, a private ward where volunteers come in to receive test drug. And that's overseen by 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 the sponsor. The time frame for that ethics review is four to six 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 world country from a regulatory drug regulatory point of view. So that four to six weeks is intense, but gets there. And then after that, there's another ten days for us to register the trial with the TGA, the former Australian regulator.

17:30 So that's the process in Australia. Speed is the main reason for going there. There are two other reasons, and they're financial. So the Australians still have a very generous r and d tax credit regime. You can get more than 43% of your r and d investment in Australia back as an advanced tax credit. And that tax credit, you can remove from the country into the Topco. 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 piece, means that you get the job done quickly and for about half the price of anywhere else. So probably a third of the price of doing it in The United States. So speed, efficiency, and cost are the three reasons to be heading to Australia for this study.

18:23 News flow. So this is the news flow from the original plan there in the white boxes. And this is the additional news flow that our 1,000,000 odd top up gives us. So down the bottom there, we've established THERACRYF PTI Limited, which is the Australian entity and that will be sponsoring the study. We have sent our key guy down there to look at prevent potential providers and even go into the wards 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 every species you've tested it in. The ultimate species, that work is ongoing, and we'll announce when that's complete. We'll announce when we have a clinical research organization in Australia. We'll be measuring it in human blood, human plasma, human urine, and human cerebrospinal fluid. So a subgroup of the Australian volunteers will get a spinal tap to extract some spinal fluid to check what level of drug we achieve 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 one study with as a partner.

19:32 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 indeed in our DAT program from a partnering point of view. So that with the news flow forecast and the enhanced news flow from the recent raise to the end of the formal part of the presentation in the summary. So over to Alastair to sum up for us. Thanks, Hugh. Thanks, Tony. Well, I'm I'm not gonna repeat everything that's been said, but I I'd like to make a couple of final points. I mean, the the reason we all invest is to see a return in that investment. Right? So the the company totally shares the frustration of our shareholders that despite doing exactly what was set out eighteen months ago and having the the science gods smile as we've described, so there's been no delays, no hiccups at all. You know, the share price has remained pretty static.

20:30 But what I would say is that the OxOne program, which you would expect to be the nearest to commercialization through partnership, has been hugely derisked over the past eighteen months, and significant value has been added in terms of deal making potential as you described, even if that hasn't yet been realized in the share price. So the fundamentals of THERACRYF have strengthened considerably since I joined, and we will double down on turning that into real shareholder value. So thanks very much for for listening. I think we've got some questions to answer, Hugh. What we do Alastair, and if I read them from the screen. So why Australia is the first pre submitted question. I think we've covered that speed, efficiency, cost. And what progress have you made with partners?

21:17 Well, clearly in this public forum, we can't give you a lot of detail on that. Suffice to say, we've been engaged with certain partners for a good length of time. We've had partners in data rooms, examining the data, and the tox data and the manufacturing data that's emerging now are being added to those data rooms and strengthening the proposition, as Alastair mentioned. So much discussion ongoing. So what makes OLX1 promising? It's promising because it addresses a universal mechanism of impulsivity. And that impulsivity relates to food, drugs, even gambling in some cases, although gambling is not yet seen as a clinically treatable condition, but it it will stop you or reduce your urge to overindulge.

22:09 And why is the patent protection important? As I think I mentioned for partnering, the longer the better for partners to get protection to recoup the investments they'll make in non dilutive funding of THERACRYF potentially, and indeed for their own investments in large scale trials and marketing. So that's why the patent protection is very important. We live with data and patents. That's our in our entire value as a business, as an industry. What are the plans for DAT and SFX o one? SFX o one comes up every now and again. DAT, we mentioned, I think, that there is partnering interest there too on several fronts. So we'll pursue those as well as OX1, which is equity funded through to the Australian permission.

22:55 SFX01 is really a legacy program now. We took the hard decision as a board eighteen months ago now when Alastair joined to prioritize heavily on those assets that we think will get us the quickest and largest return for shareholders. We're all shareholders on this call. And so we prioritized OX1 and DAT and deprioritized SFX-one for quite complicated technical reasons, but nonetheless, we think that's validated the way OX1 has sailed through the clinical enabling work and identifying Australia as a place to get permission there to have somebody really look over the data carefully and concur with us that this is suitable for man, it's safe and it's likely to have an effective profile.

23:45 So those are the plans on the other parts of the portfolio. SFX1 funded by grants currently, just in case there is an upside to reveal there. We're not holding our breath on that one. So when will Phase one for OX1 start? First patient in. Good question. That's subject to funding, be that nondilutive through a deal or dilutive or both, actually. So we don't have a first patient in date yet. What we've focused the raise this year on is to get that clinical overview, somebody really interrogating our data and saying, yes, it's good enough for man in the first study. So we don't have an OX1 start date yet. It's likely to depend on a large number of factors. But sometime in twenty twenty seven first half would be a fair estimate of that subject to funding in one way or the other.

24:38 Will there be any milestone dividend for shareholders? Well, it sort of depends on the milestone really. The general pattern for biotech is if you get a deal and you publicize a deal, then the share price responds and shareholders benefit in that way first of all. The rest would be a decision at the time for the board. Same question, how far advanced is the protocol for the OX1 phase one? Another good question. And what would the endpoints be? The protocol is very advanced. It's been written internally. It's now with our advisers in Australia. It's going to be fairly standard volunteer study. When you do a phase one study, you do a single ascending dose that is start with a homeopathic dose, build it up slowly, safety being the first endpoint you look for any side effects, any safety signal of increasing single doses of the drug up to very high ones. And we know now because of our safety margin that we can go very high with those doses. You follow that with a multiple ascending dose study that is give it every day for four to six days, final number of days to be confirmed between us and our Australian advisers, and then you check again for safety. And the second thing you check for is does the blood get in does the drug get into blood and how much of a swallow dose gets into the blood to the urine?

26:01 How is it eliminated by the human body? And as we said, with the spinal taps or lumbar punctures punctures technically, we will be measuring it in the fluid that surrounds the brain, which will tell us how much is getting in to the brain as well in humans. We know that in every other species and it's high. It's just one of those partnering checkpoints to say, it gets into the brain at the expected level, which is more than half what you see in the blood. So those are the endpoints. They're safety first as always, and they are then pharmacokinetics, that is the behavior of the drug in the human, how it's absorbed, how it's eliminated, and does it get to the organ of interest in this case, the brain. One more question on the board here. Have you had any firm indications that an offer or better offer will be made at any specific stage of the current timeline assuming each stages.

26:56 If not, what do you think might trigger a viable approach at an acceptable level? Well, yeah, we have had in the offer that we rejected a firm indication of the valuation of that neuropsych portfolio. And we deemed it not quite well enough. I mean, I'm not I can't really negotiate in public with potential partners here. It's dangerous to do so. We expect to be negotiating offers on one or other parts of the portfolio in the current timeline to your question. We expect every stage to be passed successfully based on the smoothness of the program so far. And there are, you know, it's a fiftyfifty call whether you've got a deal before clinical or during clinical.

27:41 We're in discussions on preclinical deals, if they're big enough. It may be better for the shareholders overall in the medium term to pass the clinical milestone as well before confirming a deal. And that's very dynamic at the moment. There's a lot of stuff going on in that discussion, in discussions with third parties on both that and OxOne. As soon as we know something, as soon as something firm happens, of course, we'll make sure that it gets out into the market. It looks like that's all the questions submitted, both pre submitted on during this webinar. Thanks for them. Lily, we'll hand back to you. That's great. Thank you for answering those questions you can from investors. And, of course, the company can review all questions submitted today, and we'll publish those responses on the Investor Meet company platform.

28:30 Just before redirecting investors to provide you with their feedback, which you know is particularly important to the company, Hugh, could I please just ask you for a few closing comments? So it's been a period of delivery of implementation of plans. We've been we set up what we were gonna do. We did it. We did it smoothly, efficiently efficiently in terms of science, efficiently in terms of capital use. And Tony has given you some background on how that capital use was broken down, majority to R and D. We've had approaches. We are in discussions on partnering the portfolio, which is a big push now for the next two quarters. Now that the large R and D spend is complete on the OX1. So as Alastair mentioned right at the beginning, we're very optimistic of unlocking value in this unique portfolio.

29:21 Each of these are class leading assets, and we hope to be able to tell you a lot more about the partnering as the next couple of quarters develop. I'll just say thanks very much for listening everybody and for your questions. That's great. Thank you for updating investors today. Now please ask investors not to close this 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.