Full Year 2026 Theracryf PLC Earnings Call

September 28, 2026

Speaker #2: Sounds good.

Huw Jones: Sounds good.

Speaker #3: Good afternoon. Welcome to the Theracryf PLC Investor Presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time via the Q&A tab, situated in the right-hand corner of your screen.

Lillian: 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 can be submitted at any time by the Q&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 is appropriate to do so. Before we begin, I would like to submit the following poll. I would like to hand you over to Huw Jones, CEO. Good afternoon, sir.

Operator: 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 can be submitted at any time by the Q&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 is appropriate to do so. Before we begin, I would like to submit the following poll. I would like to hand you over to Huw Jones, CEO. Good afternoon, sir.

Speaker #3: 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.

Speaker #3: Before we begin, I'd like to submit the following poll. I would now like to hand you over to Hugh Jones, CEO. Good afternoon, sir.

Speaker #2: Thanks, Lillian. Good afternoon, everybody. Thanks for attending our slightly delayed final results to the 31st of March 2026. And I think the reasons for that are obvious. With me here on the webinar are Dr. Alistair Smith, our Chair, and Tony Heinonen, our Chief Financial Officer. Together, we'll take you through the results to the 31st of March and an equally busy period in the post-period.

Huw Jones: Thanks, Lillian. Good afternoon, everybody. Thanks for attending our slightly delayed final results to 31 March 2026. I think the reasons for that are now obvious. With me here on the webinar, Dr. Alastair Smith, our Chair, and Toni Hänninen, our Chief Financial Officer. Together, we will take you through the results to 31 March on the equally busy period in the post period. We are AIM listed, of course, and a private company, so the usual disclaimers apply. To start then, I will hand over to Alastair to bring you up to speed with who we are and what we do.

Huw Jones: Thanks, Lily. Good afternoon, everybody. Thanks for attending our slightly delayed final results to 31 March 2026. I think the reasons for that are now obvious. With me here on the webinar, Dr. Alastair Smith, our Chair, and Toni Hänninen, our Chief Financial Officer. Together, we will take you through the results to 31 March on the equally busy period in the post period. We are AIM listed, of course, and a private company, so the usual disclaimers apply. To start then, I will hand over to Alastair to bring you up to speed with who we are and what we do.

Speaker #2: We're AIM-listed, of course, and a private company, so the usual disclaimers apply. To start, then, I'll hand over to Alistair to bring you up to speed with who we are and what we do.

Speaker #4: Great, thanks, Hugh. Good afternoon, everyone. Well, 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.

Alastair Smith: Great. Thanks, Huw. Afternoon, everyone. Well, as I'm sure you know, TheraCryf is focused on improving the lives of individuals with neuropsychiatric disorders. The way in which biotechs generate returns for shareholders relies on building strong data sets around commercially valuable drug molecules to deliver licensing deals. The best value is generated from more advanced assets, particularly clinical-stage assets. 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 addiction, into the clinic to generate that commercial interest is what the company's 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.

Speaker #4: And the best value is generated from more advanced assets, particularly clinical-stage assets. Demonstrating safety in a Phase One study is a key value inflection point for us.

Speaker #4: Now, progressing our lead asset—which is an OX1 blocker with applications in addiction—into the clinic to generate that commercial interest is what the company has been focused on since raising capital last spring.

Speaker #4: 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 now.

Alastair Smith: 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 drug candidate in a hot commercial area within touching distance of getting into the clinic, and valued significantly below where I would expect it to be. I'm delighted to say that my confidence in there being a significant potential return for TheraCryf shareholders has only strengthened in the last 18 months because our OX1 inhibitor sailed through the final two preclinical hurdles, which Huw will talk about, and those are manufacturing scale-up. We were chatting earlier, I mean, I can't tell you how many drugs fail because they can't be manufactured. The chronic, that's long-term toxicity in a couple of animal models.

Speaker #4: Early last year, when I joined the board, what I saw was a potentially best-in-class drug candidate in a hot commercial area, within touching distance of getting into the clinic.

Speaker #4: 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 18 months.

Speaker #4: Because our OX1 inhibitors sailed through the final two preclinical hurdles—which she will talk about—and those are manufacturing scale-up, and we were chatting earlier.

Speaker #4: I mean, I can't tell you how many drugs fail because they can't be manufactured. And the chronic—that's long-term toxicity—in a couple of animal models.

Speaker #4: So, the asset sailed through those in the last 18 months, and Hugh's going to take you through that progress and give you a forward look for that asset as well.

Alastair Smith: The asset sailed through those in the last 18 months, and Huw's going to 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 pre-clinically, is a dopamine modulator, which has applications in treating fatigue of brain origin, such as in patients with multiple sclerosis. Both of these assets are attracting attention from partners and acquirers, as I mentioned. Let me hand over to Huw and Toni, who are going to take you through the presentation. Huw, Toni?

Speaker #4: Our second asset, which we won't speak about in any detail today, but is also well-advanced preclinically, is a dopamine modulator. It has applications in treating fatigue of brain origin, such as in patients with multiple sclerosis.

Speaker #4: 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 going to take you through the presentation.

Speaker #4: Hugh, Tony?

Speaker #2: Thanks, Alistair. So, a quick look at the neuropsych portfolio here. Many of you have seen this before. RRX, in one antagonist or blocker, the beachhead indication—that is, the first one you go to—will be binge eating disorder.

Huw Jones: Thanks, Alastair. A quick look at the Neuropsych portfolio here. Many of you have seen this before. Our orexin-1 receptor antagonist or blocker. The beachhead indication, that is the first one you go to, will be binge eating disorder. 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. It's a wide open market, a very large one. We're excited about that. There are expansion opportunities for OX1 as well. That's in alcohol use disorder and, for example, cocaine use disorder. As 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 OX1 versus OX2. Many of you heard this before.

Speaker #2: This is more common than anorexia and bulimia combined. There's only one drug that's ever been approved for binge eating disorder, and that's only in the US and Canada.

Speaker #2: 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's in alcohol use disorder and, for example, cocaine use disorder.

Speaker #2: As 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.

Speaker #2: It's the most specific for OX1 versus OX2, and many of you have heard this before. If you block OX1, you reduce impulsivity—the impulsivity to overindulge.

Huw Jones: If you block OX1, you reduce the impulsivity, the impulsivity to overindulge. If you block OX2, 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. That's what we've got here. We've got the most selective for the one we want to hit versus the orexin 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-1 antagonist, and that's very viable in data.

Speaker #2: If you block OX2, 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—you can't drive, can't operate machinery.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: It reduces that urge to overindulge. So it's the optimal profile for an Rx in one 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 has been a very pleasant surprise.

Huw Jones: That's the equity raise we did just at the start of the period we're reporting today, and how well it's gone has been a very pleasant surprise. Normally, there 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. Quick word about that. We cannot not mention our dopamine modulator. It's 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 8 out of 10 patients complain of fatigue. 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 less people to fall asleep at inopportune moments over schoolwork, et cetera.

Speaker #2: Normally, there are a little hiccups along the way. Well, we've had almost none with this program. It's sailed through, as Alistair IR said, both large-scale manufacture and long-term toxicology.

Speaker #2: Quick word about that. We can't not mention our dopamine modulator; it's another very promising, class-leading therapeutic, potentially. The beachhead here is fatigue in multiple sclerosis.

Speaker #2: There's nothing approved for fatigue in MS, even though eight out of ten patients complain of fatigue. There are specific ways to measure fatigue in MS, so it's clinically a very tractable indication.

Speaker #2: The expansion then—any fatigue of brain origin: chemo, long COVID, and even narcolepsy, that genetic condition which causes some people to fall asleep at inopportune moments in school, work, et cetera.

Speaker #2: We have some preclinical data there as well. It's unique. Nothing has been approved in MS. And it's the most selective yet for the dopamine transporter and nothing else.

Huw Jones: 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. So, another promising part of our portfolio that we could probably do more communication with. As Alastair said, there's interest externally in both of these programs. To the period then. The period to 31 March. The orexin-1 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 Q1 2025, 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.

Speaker #2: So, another promising part of our portfolio that we could probably do more communication with. And, as Alistair said, there's interest externally in both of these programs.

Speaker #2: To the period, then. The period to the 31st of March. The RX in one addiction program—clinic-enabling work—that is the last few stages.

Speaker #2: Of work before you get permission to go in, man. After that, raise in quarter 1, we’ve—it was a board observation, actually, a couple of board meetings ago—that the execution of this program has been flawless.

Speaker #2: Both managerially and in terms of the way the asset has performed in manufacturing scale-up and in toxicology, we've stayed on track. We've always maintained, and that is submission for use in man in the fourth quarter—Q4—of this year.

Huw Jones: We've stayed on the track we've always maintained, and that is submission for use in man in the Q4 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. 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. The mini pig is 40 kilos, so you need a lot of drug. 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 2 species, rat and mini pig. Dose ranging, maximum tolerated dose, that's 100 times the expected dose for therapeutic use. I stress that, 100 times.

Speaker #2: Now, there's more news on that one coming up as a result of the top-up raise we did last month. Manufacturing scale-up: we made nearly 11 kilograms of it.

Speaker #2: Manufactured via a streamlined process, which was completed on schedule. We're using a large species, mini pigs, for the toxicology work that's just finished.

Speaker #2: And the mini pig is 40 kilos, so you need a lot of drug. And we've successfully made a lot of drug in a streamlined process.

Speaker #2: 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 100 times the expected dose for therapeutic use.

Speaker #2: I've stressed that 100 times. The FDA guideline is to make it at least 10 times. We've gone to 100 times and found no adverse observations at those really high doses.

Huw Jones: The FDA guideline is make it at least 10 times. We have gone to 100 times and found no adverse observations at those really high doses. We have completed the set of patents as well. We now have global coverage of granted patents. Not patent pending, these are all granted now and strong. The last two territories to grant were Canada and Korea in the period. Now we have global coverage of granted patents for OX1. A bit more on that as well in the post period. Edward Wardle joined us in the board during the period, as Northern Standard Limited, which he was nominated by, has over 20% of the company by share number. We are very happy to welcome Ed onto the board during the period. To Toni then, for the financials.

Speaker #2: 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.

Speaker #2: The last two territories to grant were Canada and Korea in the period. So now we have global coverage of granted patents for OX1.

Speaker #2: A bit more on that as well, in the post-period. Ed Ward will join us on the board during the period, as Northern Standard Limited, which he was nominated by, has over 20% of the company by share number.

Speaker #2: 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.

Huw Jones: These are the bare numbers, and I think Toni has a few other remarks to make around them.

Speaker #3: Sure. Thank you, Hugh. Thank you, and good morning, everybody. So, post-test loss was $3.5 million, which is up by $1.6 million from the prior year.

Toni Hänninen: Sure. Thank you, Huw. Thank you, and good morning, everybody. Post loss, GBP 3.5 million, which is up by GBP 1.6 million from the prior year. If you look at the GBP 1.6 million, out of that, 75%, so GBP 1.2 million increase in the operating loss is driven by the external R&D spend. To ensure that we put all the money, majority of the money and the increase here into advancing the OX1 asset, which is the highest priority of the company. The rest, GBP 400,000, is as between 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. But noting over there that our salary is the same as once we had three or four years ago.

Speaker #3: And if you look at the $1.6 million, out of that, 75%—so $1.2 million—increase in the operating loss is driven by the external R&D spend to ensure that we put the majority of the money, and the increase here, into advancing RX in one asset, which is the highest priority of the company.

Speaker #3: The remaining $400,000 is split between the option package. We do have a new option plan from last year, so we are aligned with the shareholders' interests.

Speaker #3: As well as some adjustments in the salaries, but nothing over there that our salaries are the same as the ones we had three and four years ago.

Speaker #3: And for the directors, we are paying ourselves about 15% less than we paid three or four years ago. So we're here to really ensure that the resources go into developing RX1, in line with our strategy.

Toni Hänninen: For the directors, we are paying ourselves about 15% less than we paid three or four years ago. Here to ensure that the resources go in developing OX1 in line with our strategy. Cash outflow from operations, GBP 2.7 million, versus GBP 2.4 million a year ago. We did receive here also a GBP 400,000 R&D tax credit. We can see our cash management has been very tight during the period, which then results into a cash balance of GBP 1.5 million at the end of the period, which is end of March. This does not include the top-up raise that we get the approval in Australia to go on to man, as well as focusing on partnering discussions. With that, I will hand it back over to Huw.

Speaker #3: Cash outflow from operations, $2.7 million versus $2.4 million a year ago. We did receive here also a $400,000 R&D tax credit. So you can see our cash management has been very tight during the period, which then results in a cash balance of $1.5 million at the end of the period, which is end of March.

Speaker #3: This does not include the top-up raise. We get the approval in Australia to go on demand, as well as focusing on partnering discussions.

Speaker #3: So, with that, I'll hand it back over to Hugh.

Speaker #2: Thanks, Tony. So, 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 patent the improvements we’d made in manufacturing.

Huw Jones: Thanks, Toni. 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 patent the improvements we had made in manufacturing. You can only make it in this improved way, and we have now patented that, and we have submitted in two territories this year for an extended patent protection for the asset. That gives us a very high probability of protection till 2046. That is the most you can get sitting here today. The reason why we did that, it is really important for partnering that a potential partner knows that you have a very long protection on your asset, because of recouping the costs of our development, large scale development, and marketing through the patent life in sales.

Speaker #2: You can only make it in this improved way. We've now patented that, and we've submitted, in two territories this year, for extended patent protection for the asset.

Speaker #2: So that gives us a very high probability of protection until 2046. That's the most you can get, sitting here today. The reason why we did that is it's really important for partnering—the potential partner knows that you've got very long protection on your asset.

Speaker #2: Because of recouping the costs of our development, large-scale development, and marketing through the patent life in sales, I'm very happy to see a pleasant surprise just after the period of discovery of new patent or patentable information that we've now submitted as a patent.

Huw Jones: Very happy to see a pleasant surprise just after the period of discovery of a new patent or patentable information that we have now submitted, as a patent. Very high probability of that one. As well as making 10.6 kilograms for toxicology work, we have actually taken the manufacturing to the next step, and that is human-grade material. It is called GMP or good manufacturing practice level material that is suitable for humans. We expected two, we made 2.6, so a very high yield out of our new process, and it was delivered ahead of schedule. Manufacturing is going extremely well, and if you cannot manufacture, well, you cannot sell it. If you cannot manufacture at reasonable cost, you cannot sell it at a profit. These are very important, unusually good findings this early in a development program.

Speaker #2: 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.

Speaker #2: It's called GMP, or Good Manufacturing Practice level material. That's suitable for humans. We expected two, but we made 2.6—so a very high yield out of our new process.

Speaker #2: And it was delivered ahead of schedule. So manufacturing is going extremely well. If you can't manufacture well, you can't sell it. If you can't manufacture at a reasonable cost, you can't sell it at a profit.

Speaker #2: So these are very important, unusually good findings, this early in a development program. First species tox started and was unfinished during the period, with that very high margin of safety that I mentioned earlier.

Huw Jones: First species tox started unfinished during the period with that very high margin of safety that I mentioned earlier. The second species dosing has completed. The top-line data are out, and they are clean. We are very happy to say that the two species toxicology is a pass, and that is key in getting the clinical permission in Australia, as we will 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 and as a management and considered that the way the proposal was structured and even the valuations in it just did not unlock the value we thought and others think that there is inherent in these two programs, orexin-1 and DAT. We kindly rejected it and let us keep talking as we do with all potential partners.

Speaker #2: And the second species, actually, the second species dosing has completed. The topline data are out, and they're clean. So we're very happy to say that the two-species toxicology is a pass.

Speaker #2: 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.

Speaker #2: Just after the period, we looked at it very carefully as a board and as 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 is inherent in these two programs, RX in one and that.

Speaker #2: 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.

Huw Jones: We said a nice no, and continued close engagement with everybody who you would expect to be engaged with in this neuropsychiatry field. The top-up raise, GBP 1.05 million gross from 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 is another big box ticked in the partnering list. Can you make it? Can you make a good margin? Do you have extended IP, and 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. To the outlook then. The toxicology write-ups are being done now.

Speaker #2: Then the top-up raise—$1.05 million gross—from new and, some new and mostly existing shareholders. Thank you. That allows our runway to extend for partnering discussions and allows us to get that key milestone of approval in Australia for clinical use.

Speaker #2: 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 has a qualified third party looked at your data and deemed it good enough and safe enough for administering in the test setting to human beings?

Speaker #2: Those are the things we anticipate still this year. Huge partnering tick boxes there. To the outlook, then: the toxicology write-ups are being done now.

Speaker #2: 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.

Huw Jones: 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 Q4 will then be written up into a regulatory format, to Australia. We've selected Australia for very good reasons. In Q4, 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. 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 arrives. 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.

Speaker #2: All the reports in the fourth quarter will then be written up into a regulatory format. For Australia, we've selected Australia for very good reasons.

Speaker #2: So 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.

Speaker #2: And we anticipate, before the end of calendar year 2026, to have that 'yes' decision in our hands. Of course, we'll let you know as soon as that arrives.

Speaker #2: So, a lot of work is going on by the team, compiling this dossier and getting it ready to submit to the Australian regulators through our newly approved Australian entity.

Speaker #2: So, clinical use approval is 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.

Huw Jones: Clinical use approval expected imminently, certainly before the end of this year. Partnering discussions are continuing, and as ever, as Toni 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. A good outlook for us for the rest of this year and into the early part of next year. A little bit more detail if you want it, in anticipating a question on this really, as to why Australia. We've hit all our preclinical, and clinic-enabling milestones in the last 12 to 18 months. We're on schedule. The clinical-enabling work is complete. It's being written up as we speak. Why Australia? Well, because of speed.

Speaker #2: So, a good outlook for us for the rest of this year and into the early part of next year. A little bit more detail, if you want it.

Speaker #2: 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.

Speaker #2: We're on schedule. The clinical enabling work is complete, and it's being written up as we speak. Why Australia? Well, because of speed. The Australian process is a bit like the MHRA process here in the UK was, 25 years ago.

Huw Jones: The Australian process, a bit like the MHRA process here in the UK was 25 years ago, and I can 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 Research Ethics 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? 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 is conducted in. That's a ward, basically, a private ward where volunteers come in to receive test drug. That's overseen by a clinical research organization in Australia. We're just about to finish negotiations with our preferred partner there.

Speaker #2: And I can 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.

Speaker #2: 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.

Speaker #2: Is it safe? And we've shown in our tox data that it clearly is in the tox species. They monitor the trial, and the institution where the trial is conducted is basically a ward—a private ward where volunteers come in to receive the test drug.

Speaker #2: 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 the sponsor.

Huw Jones: Then we are ultimately responsible through our Australian entity as the sponsor. The timeframe 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. After that, there's another 10 days for us to register the trial with the TGA, the formal Australian regulator. That's the process in Australia. Speed is the main reason for going there. There are two other reasons, and they're financial. 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 as an advanced tax credit.

Speaker #2: The time frame for that ethics review is four to six weeks. It's remarkable, still, that they can do it in that time. And they still can.

Speaker #2: The Australian data are accepted worldwide. It's a first-world country from a drug regulatory point of view. So that four to six weeks is intense.

Speaker #2: But it gets there, and then after that, there's another 10 days for us to register the trial with the TGA, the form of Australian regulator.

Speaker #2: So that's the process in Australia. Speed is the main reason for going there. There are two other reasons, and they're financial. The Australians still have a very generous R&D tax credit regime.

Speaker #2: You can get more than 43% of your R&D investment in Australia back as an advanced tax credit. And that tax credit, you can remove from the country into the top co.

Huw Jones: That tax credit you can remove from the country into the top co. It is a very generous tax credit scheme. It is still there, and that means that the weakness of the Australian dollar, second financial piece, means that you get the job done quickly and for about half the price of anywhere else. 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. News flow. This is the news flow from the original plan there in the white boxes. This is the additional news flow that our AUD 1 million-odd top-up gives us. Down the bottom there, we have established TheraCryf Pty Limited, which is the Australian entity, and that will be sponsoring the study.

Speaker #2: So, it's a very generous tax credit scheme. It's still there, and that means that, combined with the weakness of the Australian dollar—second financial piece—you get the job done quickly and for about half the price of anywhere else.

Speaker #2: So probably a third of the price of doing it in the United States. Speed, efficiency, and cost are the three reasons to be heading to Australia for this study.

Speaker #2: News flow. So, this is the news flow from the original plan—they're in the white boxes. And this is the additional news flow that our £1 million odd top-up gives us.

Speaker #2: 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 potential providers and even go into the wards that the study may well be conducted in.

Huw Jones: We have sent our key guy down there to look at 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 have tested it in. The ultimate species, that work is ongoing, and we will announce when that is complete. We will announce when we have a clinical research organization in Australia. We will 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 I study with as a partner.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Our modeling suggests we get a very high level of drug in the brain. Another partnering tick, depending on who we conduct the Phase 1 study with as a partner.

Speaker #2: 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.

Huw Jones: Along all of this time, business development or partnering discussions are ongoing. They have been ongoing for a substantial period of time, and as I said earlier, there is 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, brings us to the end of the formal part of the presentation in the summary. Over to Alastair to sum up for us.

Speaker #2: So, with the news flow forecast and the enhanced news flow from the recent raise, that brings us to the end of the formal part of the presentation and the summary.

Speaker #2: So, over to Alistair to sum up for us.

Speaker #1: Thanks, Hugh. Thanks, Tony. Well, I'm not going to repeat everything that's been said, but I'd like to make a couple of final points.

Alastair Smith: Thanks, Huw. Thanks, Toni. Well, I am not going to repeat everything that has been said, but I would like to make a couple of final points. I mean, the reason we all invest is to see a return in that investment, right? So the company totally shares the frustration of our shareholders that despite doing exactly what was set out 18 months ago and having the science gods smile on us as we have described, so there has been no delays, no hiccups at all, the share price has remained pretty static. What I would say is that the OX1 program, which you would expect to be the nearest to commercialization through partnership, has been hugely de-risked over the past 18 months, and significant value has been added in terms of deal-making potential, as Huw described, even if that has not yet been realized in the share price.

Speaker #1: I mean, the reason we all invest is to see a return on that investment, right? So the company totally shares the frustration of our shareholders that, despite doing exactly what was set out 18 months ago and having the science gods smile, as we've described, there have been no delays, no hiccups at all.

Speaker #1: The share prices remained pretty static. But what I would say is that the OX1 program, which you would expect to be the nearest to commercialization through partnership, has been hugely de-risked over the past 18 months.

Speaker #1: And significant value has been added in terms of deal-making potential, as Hugh described, even if that hasn't yet been realized in the share price.

Speaker #1: 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 listening.

Alastair Smith: The fundamentals of TheraCryf have strengthened considerably since I joined. We will double down on turning that into real shareholder value. Thanks very much for listening. I think we have some questions to answer, Huw.

Speaker #1: I think we've got some questions to answer, Hugh.

Speaker #2: Well, we do, Alistair. And I'll read them from the screen. So, "Why Australia?" is the first pre-submitted question. I think we've covered that.

Huw Jones: We do, Alastair, and I will read them from the screen. Why Australia is the first pre-submitted question. I think we have covered that. Speed, efficiency, cost. What progress have you made with partners? Well, clearly in this public forum, we cannot give you a lot of detail on that. Suffice to say, we have been engaged with certain partners for a good length of time. We have had partners in data rooms examining the data. The tox data and the manufacturing data that is emerging now are being added to those data rooms and strengthening the proposition, as Alastair mentioned. Much discussion ongoing. What makes OX1 promising? It is promising because it addresses a universal mechanism of impulsivity. That impulsivity relates to food, drugs, even gambling in some cases, although gambling is not yet seen as a clinically treatable condition.

Speaker #2: Speed, efficiency, cost. And what progress have you made with partners? Well, clearly, in this public forum, we can't give you a lot of detail on that.

Speaker #2: 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. The tox data and the manufacturing data that's emerging now are being added to those data rooms and strengthening the proposition, as Alistair mentioned.

Speaker #2: There's so much discussion ongoing. So, what makes OX1 promising? It's promising because it addresses a universal mechanism of impulsivity. That impulsivity relates to food, drugs, and even gambling in some cases, although gambling has not yet been seen as a clinically treatable condition.

Speaker #2: But it will stop you, or reduce your urge to overindulge. And why is patent protection important? I think I mentioned, for partnering—the longer, the better.

Huw Jones: It will stop you or reduce your urge to overindulge. 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 will make in non-dilutive funding of TheraCryf, potentially, and indeed for their own investments in large-scale trials and marketing. That is why the patent protection is very important. We live with data and patents. That is our entire value as a business, as an industry. What are the plans for DAT and SFX-01? SFX-01 comes up every now and again. DAT, we mentioned, I think, that there is partnering interest there too on several fronts. We will pursue those, as well as OX1, which is equity-funded through to the Australian permission. SFX-01 is really a legacy program now.

Speaker #2: For partners to get protection, to recoup the investments they'll make in non-diluted funding of Theracryf—potentially, and indeed for their own investments in large-scale trials.

Speaker #2: And marketing. So that's why patent protection is very important. We live with data and patents—that's our entire value as a business, as an industry.

Speaker #2: What are the plans for DAT and SFX01? SFX01 comes up every now and again. DAT, we mentioned, I think that there is partnering interest there too on several fronts.

Speaker #2: So we'll pursue those, as well as OX1, which is equity-funded through to the Australian permission. SFX01 is really a legacy program now. We took the hard decision as a board, 18 months ago now, when Alistair joined, to prioritize heavily on those assets that we think will give us the quickest and largest return for shareholders.

Huw Jones: We took the hard decision as a board, 18 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 are all shareholders on this call. We prioritized OX1 and DAT, and deprioritized SFX-01 for quite complicated technical reasons. Nonetheless, we think that is 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 is safe, and it is likely to have an effective profile. Those are the plans on the other parts of the portfolio. SFX-01, funded by grants currently, just in case there is an upside to reveal there. We are not holding our breath on that one.

Speaker #2: We're all shareholders on this call, and so we prioritized OX1 and DAT and deprioritized SFX01 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.

Speaker #2: So those are the plans for the other parts of the portfolio. SFX01 is funded by grants currently, just in case there is an upside to reveal there.

Speaker #2: 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 non-diluted through a deal or diluted.

Huw Jones: When will phase I for OX1 start, first patient in? Good question. That is subject to funding, be that non-dilutive through a deal or dilutive, or both, actually. We do not have a first patient in date yet. What we have focused the raise this year on is to get that clinical overview, somebody really interrogating our data and saying, "Yes, it is good enough for man in a first study." We do not have an OX1 start date yet. It is likely to depend on a large number of factors. But sometime in 2027, first half, would be a fair estimate of that subject to funding in one way or the other. Will there be any milestone dividend for shareholders? Well, it sort of depends on the milestone, really.

Speaker #2: Or both, actually. So, we don't have a first patient in date yet. What we've focused the raise this year on is getting that clinical overview—somebody really interrogating our data and saying, yes, it's good enough for man in a first study.

Speaker #2: So, we don't have an OX1 start date yet. It's likely to depend on a large number of factors. But sometime in 2027—first half—would be a fair estimate for that, subject to funding in one way or the other.

Speaker #2: 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.

Huw Jones: 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 will be a decision at the time for the board. Same question, how far advanced is the protocol for the OX1 phase I? Another good question. And what will the endpoints be? The protocol is very advanced. It has been written internally. It is now with our advisors in Australia. It is going to be fairly standard volunteer study. When you do a phase I 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.

Speaker #2: The rest will be a decision at the time for the board. Same question: How far advanced is the protocol for the OX1 Phase One?

Speaker #2: Another good question. And what will the endpoints be? The protocol is very advanced; it's been written internally. It's now with our advisors in Australia.

Speaker #2: It's going to be a fairly standard volunteer study. When you do a Phase One study, you do a single ascending dose—that is, start with a homeopathic dose.

Speaker #2: Build it up slowly, with safety being the first endpoint you look for. Any side effects, any safety signal, as you increase single doses of the drug up to very high ones.

Speaker #2: And we know now, because of our safety margin, that we can't go very high with those doses. You follow that with a multiple ascending dose study.

Huw Jones: 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 4 to 6 days. Final number of days to be confirmed between us and our Australian advisors. And then you check again for safety. And the second thing you check for is, does the drug get into blood? And how much of a swallowed dose gets into the blood? To the urine? How is it eliminated by the human body? And as we said, with the spinal taps or lumbar punctures, technically, we will be measuring it in the fluid that surrounds the brain, which will tell us how much is getting into the brain as well in humans. We know that in every other species, and it is high.

Speaker #2: That is, give it every day for four to six days. Final number of days to be confirmed between us and our Australian advisors. And then you check again for safety.

Speaker #2: And the second thing you check for is: does the drug get into the blood? And how much of a swallowed dose gets into the blood?

Speaker #2: The urine—how is it eliminated by the human body? And as we said, with the spinal taps or lumbar punctures, technically, we will be measuring it in the fluid that surrounds the brain, which will tell us how much is getting into the brain as well, in humans.

Speaker #2: We know that in every other species, and it's high. It's just one of those partnering checkpoints to say, yes, it gets into the brain at the expected level.

Huw Jones: It is just one of those partnering checkpoints to say, yes, it gets into the brain at the expected level, which is at more than half what you see in the blood. So those are the endpoints. They are safety first, as always, and they are then pharmacokinetics. That is, the behavior of the drug in the human. How it is absorbed, how it is 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? 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.

Speaker #2: Which is more than half of what you see in the blood. So those are the endpoints there—safety first, as always. And then, pharmacokinetics.

Speaker #2: That is, the behavior of the drug in humans—how it's absorbed, how it's eliminated, and whether it gets to the organ of interest, in this case.

Speaker #2: The brain. One more question on the board here: Have you had any firm indications that an offer, or a better offer, will be made at any specific stage of the current timeline?

Speaker #2: Assuming each stage is—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.

Speaker #2: 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.

Huw Jones: And we deemed it not quite well enough. I cannot really negotiate in public with potential partners here. It is 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. It is a 50/50 call whether you have got a deal before clinical or during clinical. We are in discussions on preclinical deals if they are 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. That is very dynamic at the moment. There is a lot of stuff going on in that discussion, in discussions with third parties on both that and OX1.

Speaker #2: 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.

Speaker #2: And there are—it's a 50/50 call whether you've got a deal before clinical or during clinical. We're in discussions on preclinical deals, if they're big enough.

Speaker #2: 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.

Speaker #2: There's a lot of stuff going on in that discussion, in discussions with third parties on both that and OX1. 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.

Huw Jones: As soon as we know something, as soon as something firm happens, of course we will make sure that it gets out into the market. It looks like that is all the questions submitted, well pre-submitted and during this webinar. Thanks for them. Lily, we will hand back to you.

Speaker #2: It looks like that's all the questions submitted, both pre-submitted and during this webinar. Thanks for them. Lily, I'll hand back to you.

Speaker #1: That's great. Thank you for answering those questions you received 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.

Lillian: That is great. Thank you for answering those questions you have from investors. Of course, the company can review all questions submitted today, and we will publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Huw, could I please just ask you for a few closing comments?

Operator: That is great. Thank you for answering those questions you have from investors. Of course, the company can review all questions submitted today, and we will publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Huw, could I please just ask you for a few closing comments?

Speaker #1: Just before redirecting investors to provide you with their feedback, Christian has something particularly important for the company. Hugh, could I please just ask you for a few closing comments?

Speaker #2: So, it's been a period of delivery and implementation of plans. We set up what we were going to do, and we did it.

Huw Jones: It has been a period of delivery of implementation of plans. We set out what we were going to do. We did it. We did it smoothly, efficiently. Efficiently in terms of science, efficiently in terms of capital use, and Toni has given you some background on how that capital use was broken down. Majority to R&D. We have 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&D spend is complete on the OX1. As Alastair mentioned right at the beginning, we are very optimistic of unlocking value in this unique portfolio. 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 will just say thanks very much for listening, everybody, and for your questions.

Speaker #2: We did it smoothly, efficiently—in terms of science, efficiently in terms of capital use. And Tony's given you some background on how that capital use was broken down.

Speaker #2: The majority is allocated to R&D. We've had approaches, and we are in discussions on partnering the portfolio, which is a big push now for the next two quarters.

Speaker #2: Now that the large R&D spend is complete on the OX1, as Alistair mentioned right at the beginning, we're very optimistic about unlocking value in this unique portfolio. Each of these are class-leading assets.

Speaker #2: 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.

Speaker #1: That's great. Thank you for updating investors today. So 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.

Lillian: That's great.

Operator: That's great.

Huw Jones: Thank you.

Lillian: Thank you for updating investors today. Could I 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 best 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-

Operator: Thank you for updating investors today. Could I 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 best 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-

Speaker #1: This will only take a few moments to complete. And I'm sure it'll be greatly valued by the company. On behalf of the management team.

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