Theracryf Plc (TCF.L) Earnings Call Transcript & Summary

Good morning, and welcome to the Theracryf Plc Half Results 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 your questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll. And I would now like to hand you over to our CEO, Huw Jones. Good morning to you.

Thanks, Alex, and good morning, everybody. Thanks for attending our half year report Investor Meet webinar. With me here in London is our Chair, Alastair, our CFO; Toni and our COO, Helen, we're very excited. We've come more handed because we're very excited about the progress we've made in a relatively short period on our now lead asset. But before we start in earnest, we are a public company, we're AIM listed because the usual disclaimers will apply. So to remind you then, first, before we get to the news that has excited us greatly in this half year, we'll remind you of who we are. We're AIM listed, Tcf.L. We're a brain-focused biotech with a relatively reset at the start of this period, refocus. So the key areas for us now are addiction very certainly with our Ox-1, orexin-1 Blocker blocker, an antagonist of the orexin-1 brain system. It's completely novel. Patents are granted across the world. It's suitable because it switches off a fundamental network in the brain in a number of different addictive conditions, so-called substance use disorders. And those substances are food, alcohol and certain drugs. And we're funded with this program as a result of a raise we did at the beginning of the year when Alastair joined us to clinic readiness. What does that mean? We're funded through the last stage of preclinical research and development to get us ready to give to man by quarter 3, 4 of next year. And we're really excited about the progress we've made and the capital efficiency that's come into that process. We have another asset, which is targeting fatigue and narcolepsy shorthand, we call it DAT, it's a dopamine modulator that we are pretty keen on bringing to your attention. And then there's the legacy program in SFX-01, which is a grant-funded program in brain cancer. We're virtual. Majority of the operational team are sitting in front of you. There's a few more. We're highly capital efficient. And if you measure us by the number of months remaining on the cash runway, we're in the top 20% of all listed European biotech companies. That means we've got a very long runway relative to our peers. The business model then is to develop the early proof of concept as early as possible before monetizing the assets. That could be preclinical, more likely early clinical data and then license out our assets to large pharma or large biotechs so they can take on the large-scale trials and the commercialization of our novel assets. The team in front of you plus the Board and the other members of management have a couple of hundred years combined experience of doing this of developing high-value assets and monetizing them in drug development, in management, in funding and in M&A activity, all key aspects of the job that we need to do as a small-cap biotech. I'll hand over to Alastair now, our Chair, to talk a little bit about why he joined again and a bit about the opportunities that Theracryf has to offer.

Thanks, Huw. Good morning, everyone. Yes, it's great to take the opportunity, I think, to talk you through what I saw in the company, the strategic focus that we went through when I came on board and why I think there's a really strong investment opportunity in an investment case. As Huw mentioned, when I joined, we had a strategic review of the opportunities to deliver shareholder value and so I'm going to talk about in a minute, is delivering that shareholder value on a short time scale. It's not all about jam tomorrow, biotech story of 10 years from now. There are opportunities to deliver significant shareholder value through the development of the assets that Huw mentioned. So that was a very important review, I think, that reset the company's focus and allowed us to really focus on the key assets that I'll focus on in the next couple of slides. So as Huw mentioned, the Lead program is focused around addiction. And it won't, I guess, come as any surprise to anybody that addiction is enormously costly both in human terms. In terms of the death, you can all read the figures. I don't need to go through them all, but the deaths and the shortening of life due to various addictions, the obvious ones that you can think of drug abuse, alcohol abuse, food and binge eating, which you'll see on the bottom. If you look at the economic costs, not just the human cost, but the economic costs, and this really drives the commercial interest, of course. The economic costs just in the U.K. So these figures are just in the U.K. running to many, many billions due to a range of different addictions. And of course, that is what drives the commercial interest in new and improved treatments for these types of disorders. So that has driven a significant resurgence in what we call CNS central nervous system disorders in the last few years. And again, you can read the slide. I don't need to talk through all of those, but there are some very, very significant deals done for companies and assets that have novel innovative improved approaches to treating disorders. And large pharma has renewed interest in CNS. It was an area that I think was very quiet for a decade or so, but now is a very hot area and a hot topic. So really, that's sort of -- those sorts of deals on that previous slide that I just spoke about, those are what most people hold in their heads as the -- why am I investing in a biotech and they think about these long-term ultimate buyouts, ultimate sales of assets. But as I say, one thing I really wanted to stress today is there are much shorter-term returns for shareholders. And this slide on the right-hand side does sort of reflect those total deal values through licensing of the types of assets that Huw and Helen will talk about in a moment, our lead treatment for addiction. The total deal value includes royalties over a period of time and so on. But what I think is more interesting to make my point that there is a biotech value curve where shareholders can receive a significant return on a much shorter time scale. If you look at the graph on the left, preclinical is the stage that we are currently at. We are, in fact, advanced preclinical stage, as Huw mentioned, looking to be clinic ready next year. And those are the upfront payments received for assets in that preclinical phase of development, exactly where we are now. And in Phase I, which would be the first phase of clinical development, I'm sure you're sure, roughly double the value. So that also explains to you why the strategy very often is to take assets into the clinic to really get that improved value for shareholders through having that clinical stage asset. And to really make the point, I think, as clearly as possible, and these are all in U.S. dollars, of course, to make them comparable, the current market cap of Theracryf is a fraction of the sorts of deal upfronts that we can expect for our lead program. So I think that really sets the scene for the investment case that I saw when I came in, in February. The very quick one-line summary is a class-leading treatment for addiction, heavily derisked because we're very close to the point of getting to clinic readiness. So the lead program that Huw and Helen will talk about is an antagonist, something that blocks a biological pathway in the brain known as orexin-1, and that is known to affect addiction behavior. So that's not -- might it work, might it not work. It is known to be effective in the treatment of these reward-seeking behaviors. In the preclinical studies that we already have in hand, so this is data we already have, we've clearly shown that it has -- our drug has best-in-class properties, and we'll talk a little bit more about that as we go through the presentation. Furthermore, the program is heavily derisked, as I mentioned, by having a very large body of data developed over many years, both in Theracryf and in Chronos, where we acquired the asset from. And it's a pretty short path now, less than a year to being clinic ready for Phase I studies. And I would say also the derisking given by colleagues sitting here on my left, the huge amount of experience of taking this process through successfully into clinical development is obviously very comforting. So CNS, as I mentioned, has enjoyed a massive level of renewed interest from large pharma. And I would say that the -- and certainly, what I saw when I joined in February was the potential of this orexin-1 asset alone, let alone anything else that's in the pipeline and other opportunities. The orexin-1 asset alone, the value of that is not reflected in the current valuation of the business. So I think that's about as strong an investment case as I've seen for any company that's come across my desk in the recent past. With that, I will hand over to Helen, if I may.

Thanks, Alastair. So just to talk a bit more in detail about the prioritized pipeline we now have for the CNS disorders. Our orexin-1 blocker, we have a wealth of preclinical data, which really underpins our confidence in this program. And our beachhead indication will be binge eating disorder. This is a very well understood clinical development path. And it's actually something that's got a lot of interest currently with GLP-1s lines progressing into the clinic. However, the differentiated mechanism we provide, we believe will address those addictive properties that satiety alone is not going to touch. And to remind you some statistics that we've talked about previously, the majority of patients with binge eating disorder are not overweight or obese. They're of regular weight. So we don't want to stop them from eating normally. We just want to control the their substance seeing behavior. Of course, we had expansion opportunities for indications. It's well known that the orexin system is overstimulated or upregulated in other substance use disorders. And what we're doing with inhibiting this orexin system is we're bringing it back down to normal levels. So we are looking to go into alcohol-use disorder as an expansion opportunity and also other addictive disorders, opioid use disorder, a very, very large market, especially in the U.S. and cocaine use disorder. Where we see the value of our program amongst the competitor environment is really we have a potential class-leading compound. And with that, we have significant differentiation. So by class leading, that will be ultimately more efficacious, so it provides a better effect for patients, and it will have less side effects potential. So we're able to control that addiction without any other negative effects, as I said. We don't want to stop people enjoying every day activities or create what's commonly known as anhedonia. We have a fantastic profile for our compound. It's very, very important. We have high-selectivity for the orexin-1 receptor over orexin-2 and that's because if we hit the orexin-2 receptor, we'll be sending patients to sleep. And we really don't want to do that. And that was a big challenge for other pharma developers in this area where they actually fail to get products through the clinical trials because they saw sedation in patient populations. We have as yet the most selective compound discovered. So we believe that we won't see this liability when we get to our clinical studies. So our next CNS program is a dopamine modulator. This is also a fantastic commercial opportunity. So the beachhead indication here is for fatigue in multiple sclerosis. And that's because a large proportion of patients with MS suffer with debilitating fatigue so much so that they go to their clinician and they ask for help and irrespective of whether they're having a flare within their MS condition or they're being dosed with other products that actually contribute to that fatigue around 80% of all patients have issue with what we call central nerve system fatigue. So that's not just -- I've been to the gym and I'm very tired. This is a terrible debilitating fatigue when they just struggle to kind of get out of that or interact with daily living. So we believe we can provide an opportunity here for a first approved drug for MS patients with fatigue, providing them with relief and less side effects than other products that are currently used off-label products that don't have approval in this indication. Of course, fatigue of brain origin give us a large expansion opportunity. Also, we have things like chemotherapy-induced fatigue states. I think everyone is aware of the issues with long COVID disorder, but also other indications such as narcolepsy, where we contribute to alertness, but with less potential side effects. So this unique mechanism is really driven by a high selectivity for dopamine transporter. That means that we can raise dopamine levels gradually without a stimulant-like effect. There's a stimulant-like amphetamine would be a really negative side effect in this indication. And we believe we have a really differentiated opportunity here with the dopamine modulator.

Thanks, Helen. Now to the substance of the report we want to deliver to you. So at the start of the period, we pivoted, we changed strategy and raised money around that strategy to -- with Alastair's encouragement and backing, changing to a strategic focus on our orexin-1 antagonist. Why do this? There's a question that's come up about this? Why do it? Well, we look at these -- we weigh these questions really heavily. We think what is the best chance of technical success, what's going to get there? What's going to get to a meaningful readout in the clinic. What's going to get to the sort of deal values that Alastair outlined in the investment opportunity. So that you combine the market size, the chance of success and the chance of getting serious monetization over a near-term series of milestones for one asset in your portfolio. And that's what we went through. We went through a serious strategic review. And what came out was the Ox-1 asset we acquired previously, why? Because it's got the best chance of success. It's a heavily derisked program. It's got the best chance of a substantial deal and some near-term milestones associated with it. What we've done in the period is made a huge progress towards the clinic in the last 6 months to the 30th of September, real progress to the use in the clinic with the asset that we prioritized. It's on track for a regulatory submission at the very latest in the fourth quarter of next year with lots of other interim steps, which are newsworthy on the way to getting regulatory submission. How do we do this? Well, we are a virtual company, as you know. So we appointed a top-tier global CRO, contract research organization, CDMO contract development and manufacturing organization called Pharmaron. And with 2 levels of intense management by Theracryf, Pharmaron undertaking the manufacturing, toxicology and the key development steps in finalizing the dossier needed to get permission to give this to humans. And that's very, very well ahead. And with remarkable capital efficiency, I've been doing this 40 years, I have to say this is one of the most efficient, most successful programs at this stage I've ever been associated with. It's going very, very well, thanks to our team and the work being done at Pharmaron provider. Manufacturing is on or slightly ahead of schedule actually. We scaled up to 0.5 kilogram, which is a large amount from lab quantities, testing quantities through to kilogram quantities and that came in early. We rushed to put an RNS out to say that we have scaled up the 0.5 kilogram early. 10 kilograms is on track. That's a very substantially greater amount of drug that we're manufacturing, and we're learning a lot about the manufacturing process as we do so, making it more efficient, eventually cheaper to make, which is a key thing for all potential drugs. And these are critical activities. And the way you do these, the way you improve the formulation, the way you improve the efficiency of production are all critical factors for the regulatory submission we've been making mid next year to late next year. We've worked very hard on formulations, the way that you add things to the drug to make it for example, more absorbable in the body, so it gets with greater efficiency into the bloodstream and eventually into the brain, we've got a very good formulation. We've selected. And we selected a second species for toxicology. So government regulatory authorities tell you need species for toxicology. We selected our second species, so now we have two very different species. One of them is close to man to test high quantities of the drug, which is why we're making tens of kilograms. And we've done some early work in those species, both of them, and they're both looking very good for the toxicology work that will start early in the new year. On the commercial protection side, we've been granted a patent in Korea, which is itself a large market, actually a sophisticated health care market. But really, it's one of the last pieces of the jigsaw for global coverage. We already have granted patents in Europe to 2038 and granted patterns in the United States to 2039. So this is one of the last pieces of the jigsaw. So there's one more to come. I'll come to that in questions of global coverage, which is in composition of matter -- composition of matter patents do matter. They matter because they're the strongest form of patent cover you can ever get for any pharmaceutical product. And that's the type of patent that we have granted in Korea during the period. And Edward joined us nominated by Northern Standard Limited, a major shareholder of us in the year, during the period as a nonexecutive Director. We're very happy to welcome Ed on to the Board. Post period then from September to now, 0.5 kilo ahead of time, it's outperforming expectations. The work with our team, our consultants and our provider is currently outperforming expectations of delivery and of budget actually. So we're in good shape from getting the job done on time and indeed on target financially. We've started as well the clinical grade material. So the materials we've been making so far are for experimental use for toxicology, for example the clinical-grade material has to perform to an even higher standard because it's eventually going to be given to people like you and me, to man. So that's called GMP and the GMP material manufactured is underway. It takes a little bit longer because of the higher standards you have to adhere to. And we started that on time, on target. So I'll now hand over to Toni here, who's on my left, to talk a little bit about the financial performance during the period, over to you, Toni.

Thank you, Huw. And as you know, the team has updated you on the progress of the company, especially led by the orexin-1 program, I think it's important for us to give you an update of what does it look like in our financials within our numbers. So post tax loss, GBP 1.3 million, only GBP 100,000 more than in the previous period, reflecting how we already stressed, how we are very capital efficient is that we are accelerating the orexin-1 program. And in terms of cash outflow from operations, the same GBP 1.3 million, up GBP 100,000 from the previous period, so we are very mindful of our cash. And then we put a second line here also to reflect the cash used in operations, including the change in working capital and the R&D tax credit that we received recently. It's around GBP400,000 from the HMRC. So GBP 700,000 is really the total cash used in operations, including changes in working capital and tax received. So cash balances. So reminding you that we did in the previous period, a fundraise of GBP 4.25 million to accelerate orexin-1 program. And here at the end of the period, our cash balance is of GBP 3.5 million about 3 times more than in the previous period, GBP 1.2 million. So we're in a strong cash position. And with that, we also reiterate our unchanged guidance. So we are currently funded until the end of 2026 and until the clinic readiness of the orexin-1 program. And how does that compares our peers? On the European listed biotech companies, we maintain here in the top 20% in terms of the cash runway measured in months in length. So we are very happy to be in a very, very strong position to continue accelerating the program and deliver shareholder value to you.

We made a point about near- and long-term news flow. So Helen is now going to take us through what's coming for you as investors in the news flow forecast.

So again, just to reflect on this year, and I don't want to downplay any of the amazing progress that's has been made this year with the upcoming news flow, but I also want to get you as excited just as excited as we are about what the early 2026 is going to bring us. We -- from drawing down our funding to tendering, to contracting, to delivering on the initiation of the scale-up of orexin, we have delivered fantastic progress, and the team has been amazing throughout this year, but we have some really critical milestones coming up towards the end of this year, the beginning of 2026. We continue with the manufacturing scale-up of our drug substance, and we believe that the manufacturer of the 10-kilo batch will be completed towards the end of the year, beginning of 2026 on schedule. And the team of Pharmaron has made amazing progress in improving efficiency of that production and generating that amount of material. It's no mean feat to go from tiny quantities sort of packets of sugar as you have to say, you steering the coffee to really large bags of material. So we are then using that material and turning it into the formulation required for toxicity studies. But during that process, as we mentioned, we're making clinical-grade material to be available for any clinical activity, and that will be ongoing from now until quarter 2 in 2026. The material that we've already made, which is that 0.5 kilo batch is in formulation right now, and that will be used to explore the dose ranges that will need to go into those 28-day tox studies. And now this is very important because we put in high doses in those studies so that we can see what window we have of tolerability. So we often talk about things like therapeutic index. And what you want is a wide gap between the amount of drug that a person has to take to be effective for that condition over the amount of drug that they would start seeing side effects. And at the moment, an issue for us actually, which is a good thing, is that we believe there's going to be a very large window of therapeutic index or window. And that means we have to put a lot of material into these studies, hence why we're scaling up to 10 kilos. But after that MTD and what's called DRF or dose range finding studies that we'll read out at the end of quarter 2, will have a firm handle on the doses that we'll be taking forward into the 28-day tox studies. Those 28-day tox studies will be initiated quarter 1 and will complete around quarter 2, 3 time. And this is where you give repeat dosing of your products, and you see if there is any potential accumulation of issues that might be in a cardiac liability, it might be a liver toxicity issue or any other issue. Now from the data that we have achieved to date, we believe this looks like potentially a very clean compound. So we have confidence going forward into these 28-day tox. But this will give us the data that we need to submit to any authorities that will give us the approval to go into the clinic. So around quarter 3, that will be the combination of all of those data packages that we'll put into what's called an IB, investigator brochure that you can share with authorities that give you permission to go into man. And as we've reiterated before, we'll have that quarter 3, quarter 4 2026 will be in a position, we believe, with an approval for taking into healthy volunteers.

Thanks, Helen. So the investment case and effectively getting to the end now we've got superb progress very quickly and with great capital efficiency. There's more progress to come to finish the job, and that job finish comes at the first 2, 3 quarters of next year with interim very important milestones on the way. We're very confident about the potential of this agent, very confident about the potential for safety of this agent and the fact that we're going to get permission to give demand in a relatively short time from now. So we've got this diversified portfolio. We've brought slightly to your attention the other part of the portfolio. That's the fatigue and narcolepsy asset. We're a class leader in the orexin-1 blocker. It blocks a pathway that's fundamental to addictive behaviors regardless of whatever the patient is focusing on as their addiction of choice, it's making great progress. I can't tell you how pleased we are about the efficiency of the work so far and the great output we've achieved in a short time with a small team and with relatively little money. And we don't think, as Alastair said at the beginning, this is yet reflected in the valuation of the business. We're funded through these key inflection points. And you've seen the news flow forecast, which is a minimum news flow by the way, that we'll generate over the next period. So we are very focused on delivering shareholder value through this program and others where we can. We're financed to do that and we're flourishing. The final word on the formal bit of this is the business is flourishing both in terms of its technical progress and its capital efficiency. And I'd really like you to take those two messages. We picked a high-value asset out of all the things that we could have done, and we've done that very seriously and very deliberately. We believe in the value of that asset. Others do too from what the discussions we're having in the outside world and that we're flourishing in terms of the progress we're making with that asset. So that's the end of the formal part of the presentation, a little longer than usual because we really wanted you to understand the value of this business and the progress it's made in the short 6 months to the end of September and the month or so after that.

So we'll take questions now. We've got some pre-submitted and we've got some live questions, and we'll deal with those as they come. So there's question about the patent in Korea that we did spend a bit of time on how does it expand commercial opportunity and other remaining jurisdictions. Well, Helen run as a patent estate. So I'll let you take that one, Helen.

Okay. So there is one remaining jurisdiction still to grant, but we have noticed that it should grant imminently, but that's been a while now. I actually had a conversation with our patent attorneys the other day, and it's Canada, apparently they're being slow for everyone. But that will give us broad depth of coverage. Our main focus really is U.S. market for addiction. That is the largest market opportunity, and we already have grants there. But it's always good to go where other second, third commercial opportunities are. So we have that European coverage. Traditionally, in biotech, it's always good to get things like South Korea, Japan, other Asian territories because they are big markets in themselves. So that's the strategy we've done with this patent portfolio. And it's really sort of coming to completion now and it's then maintaining that and looking for other opportunities where we could extend our IP coverage throughout the development program that we're currently doing.

Thanks for that. We've got one here about if you're selling them about the possibilities, are you buying more shares? We've been in a close period until this morning, as you can imagine. Every member of this group and every member of management have put their own money into this company into the tens of thousands. Mine runs into the hundreds of thousands in this company. So yes, we have backed it with our own cash. Alastair here has taken his year's fees in shares, not in cash as our incoming Chairman and has also invested his own cash on top of taking his fees in shares. So yes, we're heavily, heavily motivated by our stock price and our valuation. And we're frankly, a little frustrated that we're not seeing the value yet that this program has generated even in the last 6 months to the end of September. So yes, we are enthused and we have put our own skin in the game to very substantial amounts, frankly.

And just to add to that, Huw, if I might and I'd be more than happy to invest further. That's not in question. I mean Huw's given the obvious formal close period explanation, but there are obviously, ongoing, for example, commercial conversations around potential licensing with partners. And if we are in the middle of any of those conversations and we bought shares and ultimately, a deal was struck, we would look -- we would -- I suspect we would be in trouble. So I think you need to be aware that we are constantly working on potential deals and so forth that may make it difficult for us even though we're not in a formal close period. But I obviously believe every word of what we've just described to you in terms of the investment case. And when there's an opportunity, I'll be more than happy to buy some more shares.

Thanks for that, Alastair. There's a 2-part question here that's been asked before by the same person, but we'll answer it again. The second part is about money. How much are you drawing in salary? That's public. Just look at the annual report. If you also look at simply Wall Street, you'll see an analysis of my take from the company, which is well below average for our sector. There's a recent survey that we use the benchmark and all our salaries are below sector average because we've shifted our remuneration strategy into share-based payments to align ourselves really tightly with the shareholder group. We believe in this asset. We believe that there is money to be made out of this asset. We put our own money in, and we're not taking as much as the rest of the market, out of the business. Our salaries. We're not rich individuals. We have mortgages to pay and all the normal things. So there has to be a level of salary. But I can tell you, and you can look it up for yourselves that, that level of salary is below average and balanced in share-based instruments to make sure that we are as aligned as possible while doing the day job with the value accretion that we seek to get out of this company.

It might just be worth adding because I know it's been sort of highlighted before about our LTIP share scheme, which Toni along with our broker generated a new LTIP when we closed the last financing round, and it was totally driven by share price accretion. So as of yet, we've had no, I guess, what's the word besting rewarding, but that's how sort of aligned we are with trying to get value for the business and our shareholders.

We only got our options when we get 10x value accretion that was published when we issued the LTIP. So just to reinforce that we really do believe in alignment, and we really do believe in the asset and we put our money in. And any money we make out of it, just like ordinary shareholders is heavily dependent on that value growing. There's another one expansion of Ox-1 into other disorders such as OUD. Is there scope for nondilutive grant funding? Yes, there is. It's difficult at the moment given the geopolitics that are around, particularly in the U.S., where there is the majority of grant funding for these kind of assets, we know one competitor that's in a U.S. grant, but that was granted before the current -- should we say disruptive element of U.S. grant the world there is -- there's [ ICBCT ]. So there are -- we are looking all the time at nondilutive funding sources historically. Helen and I, in particular, have got a good track record of developing nondilutive funding. We've got one for our legacy asset, for example, so yes, we are looking at it. Thanks for the question. So the -- so geopolitics is in the way, but there are other grants potentially available. Just trying to close off then on how much funding will be required to pursue Phase I study to sell? Well, we're looking at that at the moment. We're planning Phase I, as you'd expect when we're through this period and Phase I will either be done in partnership or by ourselves. And those planning discussions, including the country that we should do the Phase I study in are currently subject to the management team planning. So we're designing the protocols now, and we're looking very shortly for quotes for Phase I. I can't give you a hard number yet. But I think you'll expect to see our reputation for capital efficiency and getting a lot done for a little to continue there if we do it solo or we may well do an early partnership and then we do it in partnership to be discussed. No firm answer for that as yet. Okay. A couple of legacy questions then. So on sulforaphane, it has an effect on the Nrf2 pathway. Is there an out-licensing opportunity? Yes. We're constantly looking for out-licensing opportunities for the whole portfolio. As yet, there is nothing firm over and above Stalicla, which is another question coming in. So I'll deal with that one. No, we did do a deal with Stalicla. We believe we delivered our part of the second milestone for that. And the honest answer is Stalicla is still raising money. They have been raising money constantly since the dispute, and they haven't yet concluded that fundraise. And so I think any resolution of that dispute will be tightly tied into our partners' fundraising activities. We're still working on ways internally to get around the dispute. We believe we're in the right. And we'll, of course, update everybody as soon as there's anything else to say on that one. So that covers a couple of...

Maybe to add on that, that in our cash runway and our cash balances, of course, we do not account for any future milestones. So our cash runway until the end of next year is without any potential milestones from Stalicla or from anybody else.

A question that has come up in line with the salary question that we clearly try to answer every single question that comes up on these is why bring Ox-1 to the form and SFX-01 to the background. I hope we've covered that for you, and it's clearly about a combination of technical risk and the price at the end. And when you look at all those things in a detailed strategic matrix, Ox-1 wins. It wins as the best investment opportunity that we currently have in this business and a near-term investment for monetization. So we look at it seriously, sincerely and sweat a lot over these big decisions because pivoting is never something you should do trivially. And we did that at the early part of this year with Alastair joining the Board. And we -- so far, it's gone to plan. We were right to pivot that. What we've done with SFX-01 and the legacy program is get grant funding for it back to nondilutive funding question earlier. If you're doing very high risk research, which glioblastoma is, you get somebody else to pay for it. So therefore, the capital drain from shareholders' funds is not relevant to that program. We've put all the capital on a very large proportion of it, Toni you can correct me on the Ox-1 program and very much so far, so good.

Just to add to that, Huw. That strategic focus on what can actually deliver the best value for the company and the shareholders that driven by me and the management team when I joined, that was absolutely the right thing to do. It would be absurd to spend GBP 1 of shareholders' money on SFX-01 when we have the orexin program at the stage it's at, with the opportunities that it presents. So that is the position that we set out in spring of this year. And just to give you an independent non-exec view on progress and other management teams said how excellent that progress is that is absolutely the case. We sat through a Board meeting last week. And rarely do these developments follow time schedule and budget. But in fact, we're ahead of schedule and slightly behind budget. So it has been an excellent delivery of a new strategy we've put in place in spring of this year.

Thanks, Alastair. Just a couple more questions then. There's some pre-submitted ones too. I hope you get the person who asked the question about SFX-01 resolution that where we are tied up with the Stalicla fundraise. We'll give you -- as soon as we know, we'll tell you anything that there is to say. An outline design for Phase I back to orexin priority program. We're delivering at the moment through the medical group and the [ ClinOps ] Group which are one person each by the way back to capital efficiency, the design for the Phase I. It looks like it's going to be pretty standard, which is good news. There are no difficult or special conditions needed for Phase I for the orexin-1 blocker. It's going to be called SUD and MAD, single ascending dose, multiple ascending dose in volunteers. We are looking carefully at whether there's any other things we'll be looking carefully for sedation actually, because other members inferior members of this class orexin blocker have shown sedation because we are the most selective ever discovered the chance of sedation is almost as near 0 as matters. But we look for it, just to prove that if not there, proving negative is quite difficult, but we'll be looking for it. And looking for sedation is pretty much the only special condition in that Phase I outline design. So a couple of other questions we hope we've dealt with. Biotech stock are high risk. How should investors look at these? And I'll turn it back to Alastair for that one again because he's the newest risk taker in this group.

Yes. I think we've covered that -- I hope we've covered that well in the presentation. I think the -- very often a misconception is that there is only a return to shareholders on a very, very long time scale in biotech. That isn't the case. There's many examples, both of companies that we've all been involved with another completely independent companies where value is delivered to shareholders by delivering key developmental milestones, which are recognized by potential partners through commercial deals, recognized by the market, and that should drive shareholder value. That is what we are striving for. That is what we are all aligned with as Huw said. So you definitely should not have the view that biotech is -- you hear it quite often on the bulletin board. It just isn't true that the biotech is a jam tomorrow story. There are multiple milestones in the early part of next year and throughout next year, where we really ought to be able to deliver some return from shareholders.

And another one, just to make sure we've dealt with everything. The last question that we have currently, unless anybody else wants to quickly type is the GLP-1, the Ozempic, Wegovy, Mounjaro world, Helen dealt with it ahead of the game actually in the rejection. And there is anecdotal evidence. And there are some clinical plans on going on the GLP-1s in substance use disorders. So two perspectives here. Binge eaters are not all fat. They do not seek to lose weight. They manage the binge eating with excessive exercise, purging, being throwing it up afterwards or long periods between binge episodes. What we would seek to do with Ox-1 is just to switch off the impulse to binge in the first place in a non-obese population. So that's good. And we expect the side effect profile of Ox-1 to be significantly better. You will not have visual disturbances. You will not have pancreatitis. You will not have nausea or constipation as likely side effects from our Ox-1 blocker. Those have all come out in clinical trials, of course, if there is any more likely the absence of them. And so there will be a cleaner but complementary approach to GLP-1. People are obese, wish to lose weight and reduce impulsivity. There's no reason that eventually, these two drugs can't be given together to create a synergistic effect between impulse reduction and weight reduction in those few patients who require both. So hopefully, that covers the GLP-1 question that comes up fairly frequently. It's unproven yet on the GLP-1s as to whether it will work in substance abuse, no reason we can't use both together. So that now, I think Alex concludes the formal part of the presentation, and I believe we've dealt with every question that's been posed to us in this session. So -- no, there's one more, yes. Okay. You mentioned increasing shareholder value of primary via licensing deals. Are you open to a full buyout of the company or certain assets? I think as biotech professionals in a small-cap biotech, we are always open to all options. That is a single product deal, which we've done previously for SFX-01 as a multiproduct deal or indeed, there's a full takeout. I think the Board would weigh that at that time, that happy time. It's a very high-class problem to have. There is an active market, as Alastair outlined in the beginning, for neuropsychiatry, in particular and big deal flow in neuropsychiatry. Now that wasn't there even a handful of years ago. So the answer to the last question coming up is yes, we have to be open to all approaches that improve shareholder value. It's what we're about. It's what we have aligned our compensation with and it's what our day job is to grow shareholder value. That's the right thing for shareholder value we'll do whatever deal comes our way, or the deals that we're currently looking to pull off proactively because the process is quite a long run, and we're engaging, as you'd expect, with the right audiences currently in all the partnering meetings and outside of those.

That's great, Huw and the rest of the team. If I may just jump back in there as so you have addressed all the questions from investors today. How about, Huw, before we direct investors to provide you with their feedback, which is particularly important to the company. Could I please just ask you for a few closing comments?

Thanks, Alex. Yes, we've dwelled on it. We've repeated the message. And the message is we are capital efficient, we've pivoted, we've backed a major asset with major potential and we're going very well with that asset. We are better than on target currently after our strategic refocus in the first quarter of this year. So I just really do want everybody to understand the enthusiasm and the sense of pride we've got really about the progress that we've made in a relatively short period for a relatively small amount of money, capital efficient going well. Alastair, any further things from you?

No, I think that's exactly it. We took a very sanguine pragmatic view of how to drive value. And we came up with a strategy, which attracted a significant amount of capital. And as I said, there's a completely independent, not exec. I can confirm the progress has been excellent, and we're slightly ahead of schedule in terms of delivering on that.

Fantastic. Thank you all once again 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 Board can better understand your views and expectations. This will only take a few moments to complete and I'm sure will be very valued by the company. On behalf of the management of Theracryf Plc, we would like to thank you for attending today's presentation, and good morning to you all.