Theracryf Plc ($TCF)

Good morning, and welcome to the Theracryf Plc Investor Presentation [Operator Instructions] Before we begin, I would like to submit the following poll. And I would now like to hand you over to CEO, Huw Jones. Good morning to you, sir.

Good morning, Alex. Good morning, everybody. Thanks for attending. I'm here. We've probably met before on these screens. And with me is Dr. Helen Kuhlman, our Chief Operating Officer. We're going to dwell today, particularly on 2 RNS releases made in the last couple of weeks, really about what the significance of the IP we've filed is and indeed the significance of through our smooth out manufacturing process, the 2 kilograms of clinical-grade material we've just manufactured readiness for eventual clinical trials. But I'm going to start with just orientating everybody to Theracryf. We are -- we have pivoted to a neuropsychiatry company. And what we do now predominantly is developing innovative therapeutics in specific neuropsychiatric disorders. Because we're public, the usual disclaimers apply. And here's the one-page summary as ever. We're [indiscernible] We're a classical biotech -- following a classical biotech business model. The key areas within neuropsychiatry that we focus on are addiction with our orexin-1 blocker or orexin-1 antagonist, which is a novel agent and best-in-class, we believe, suitable for addictions or impulsive addictions to food, alcohol and certain drugs. And that program is funded to all the data being ready for clinic readiness by quarter 3 of this year. That's not very far away now. Our second program within neuropsychiatry is fatigue. We've got a dopamine modulator, fatigue of brain origin, so not gym fatigue, but brain fatigue. And where do you get brain fatigue, multiple sclerosis, 8 out of 10 MS patients complain of fatigue and many of them require treatment, chemotherapy, long COVID even. So there are a number of central fatigues as we call it, that are suitable for treatment with our DAT inhibitor, which is yet unfunded to clinic readiness and a legacy program from Evgen in brain cancer. By way of structure, we're a virtual company. We're very capital efficient. We buy in or use academic collaborations to provide all the data that we require to develop our programs. And because of that capital efficiency, we're still in the top half of all listed biotechs in Europe for our cash runway if you measure it in months of cash remaining, top half performance in terms of preserving cash. The business model I touched on, we develop assets to early proof of concept or perhaps even early clinical work and then license out and monetize the asset to large pharma or large biotech. The team has been doing this for a good number of decades, actually, not just years. We've probably got 150 to 200 years of combined experience on the Board and the senior team in all the right areas that are required for running a biotech. So the opportunity then. There is a resurgence in interest in neuropsychiatry by a large pharma. Here are some deals, including one just a couple of weeks ago, the end of March, which I'm going to highlight. So these are the prices that late clinical biotechs can achieve when they're bought out by big pharma. And they're in the billions. They're in the many billions quite often. I'm going to dwell on one in particular. That's the bottom left there, March 31, where Lilly expressed, it's the first time a major pharma spent a lot of money on the orexin system. That's the same brain system that we interfere with, but the opposite brain system. That's the brain system that regulates via orexin, the sleep wakefulness cycle. Lilly paid up to GBP 7.8 billion with over GBP 6 billion upfront for Centessa, which is a name -- NASDAQ listed, excuse me, a public company with a sleep disorder medicine that interferes with the orexin system. And that was an orexin-2 agonist, a stimulator of the orexin-2 receptor. We'll come to it later in Helen's part, where we contrast what happens on orexin-1 versus orexin-2 when you block orexin-1 versus when you activate orexin-2 or indeed block it. The point here is Lilly noted at the bottom of that slide that orexin receptor biology is one of the most compelling opportunities. So orexin has arrived as a major target for pharma to manipulate for all sorts of different impulsive or sleep-wakefulness indications or disease areas. I can't do this section really without referencing our 14th of April RNS, where we had rejected a nonbinding proposal to acquire the neuropsychiatry portfolio predominantly. So the reason the Board -- and we dwelled on this in great detail, the reason the Board rejected it is very simple. It just didn't give us as shareholders a big enough return for what we think is the commercial value of these assets. It's really that simple. We can't say any more than we said in the RNS because it's subject, as you'd expect, to confidentiality clauses, but it's just the offer wasn't large enough in the Board's opinion, and it was unanimous that opinion, to represent the value that we are creating as an organization. And on that value, we have recently done a benchmarking exercise, and that is looking at all brain disease individual product transactions. So this is not a takeout. This is individual licensing deals in the millions in the brain disease space, not platform deals, not company takeout, just individuals. Preclinically, you get mostly upfront up to $26 million. At the end of Phase I, beginning of Phase II, that almost doubles. On the left-hand side there, in the other blue color, that's our market cap. It was our market cap when we made this slide, actually, the market cap is now somewhat larger, more than $8 million, but still there's a way to go. And that gap is the gap we try to close in terms of value creation in the business.

I think Huw if I can just sort of put the question back to you because... It's sort of representative, I think, of the critical stage we're in at the moment, this sort of transition between being a preclinical asset-driven company and a clinical company. And that's where you start to get more interest from potential partners is when you have clinical assets or clinic-ready assets. But obviously, you start getting approaches from companies that might see this as a really great cheap deal before we reach that critical milestone. And we're not actually that far off are we?

Indeed not. No. And the graph there on the left-hand side just reflects even on upfront payments, the sort of value difference that transitioning to full clinical stage gives you. So -- and that was part of the consideration that the Board took in rejecting that offer. So you're absolutely right, Helen. This is a very important inflection point for us. Right. I'm going to turn back to Helen now to talk specifically about our orexin program and the significance of some of the recent progress we've made. We made an enormous amount of progress. So over to you, Helen, when I sit with coffee.

Yes. So when we're looking at market opportunity, we come from a number of different directions. And one primary is what is the impact or what's the problem to the economy or to the health care part of the economy. And substance use disorders and addiction are a really big problem. They are a real drain to the economy in pure money-wise. So this is representative of a couple of U.K.-based facts around alcohol use disorder costing the NHS GBP 3.5 billion per annum. And it's also costing in terms of not able to get people into work, so they can't contribute to the economy in that productive way. And additionally to that, they are seeing a truncated life. So if you look at the average lifespan, people with addictions are living on average around 20 years less than someone without an addiction. So it's impacting people personally and it's impacting the economy. And so from a patient perspective as well, there's not really anything out there that helps people that suffer with addictions. And it's known I had a conversation with a KOL, key opinion leader not so long ago, who says even those people that managed to get clean, over 80% of them relapse within 6 months after getting clean. So it's a real and growing problem globally, not just in the U.K., but massive market, obviously, in the U.S. as well. So if I can get my cursor to work, I can... Thank you. So reflecting back on our portfolio, we have the orexin blocker. So talking about the orexin system, this is addressing the orexin-1 receptor. So orexin-1 receptor is involved in this aberrant reward seeking behavior, and we're looking to interrupt that to alleviate that sort of dependence part of the addiction. If you hit the orexin-2 receptor, that's what's involved in sleep. And in a very important part that we'll cover later is in the development of your drug, you wanted to be highly selective for the orexin-1 receptor because you don't want to create any sleep issues, namely somnolence or sedation when you're trying to help people not be addictive to their addictive substance. So our beachhead, that's our primary indication where we already have preclinical proof-of-concept data is binge eating disorder, but the mechanism would also be appropriate for alcohol use disorder, cocaine, opioid, a myriad of addictions. The value we see in this compound ourselves is that we really have a potentially class-leading program here, and that's in the selectivity for the orexin-1 receptor and the sort of potency of the compound. So how well it is exerting an effect and how it can address the receptor occupancy is called. So it needs to exert an effect during the course of the whole day and through into the evening. So you don't want any breakthrough addictive behaviors coming out. And we really feel that the profile we have does that. So on the second program, this is currently unfunded, but also very high potential commercial potential area is in this -- it's called apathy. -- the Americans like to call it apathy. We call it fatigue or central nervous system fatigue. So as Huw mentioned, this is not going to the gym and getting a bit tired. This is a real brain fatigue. People are lacking motivation. They can't get out of bed, they can't go to work. And it's really highly prevalent in a number of other diseases, and we are looking at multiple sclerosis as our primary indication. And that's because over 80% of all MS patients suffer with fatigue and they're looking at their clinician to provide some relief, and there is currently no licensed drug that can help them. By having a drug which modulates the reuptake of dopamine in the synapse, you create a gradual increase in the brain, which provides this sort of uplifting feeling but without having a spike, so without being a stimulant-like feeling. And so that's really important here for the profile. We want something that gives back the motivation, but we don't want it to be a drug of dependence, which would create other challenges in further development. So I've mentioned the mechanism. we're addressing the orexin-1 receptor in a very selective way. We are almost 2,000-fold selective for orexin-1 over receptor 2. So we are hoping when we get to the clinic, we won't see any sedation in people and indeed in patients. We've mentioned a number of addictions. It's known through the literature that the orexin-1 system is over activated during the dependence process. So when people start getting addicted to a substance and throughout. And that's really providing this reinforcing stimulus to people throughout their addiction. We've got proof-of-concept data in a binge-eating model in the rats. And we are currently in our 28-day tox study. So the very final toxicology studies that we need to create our sort of clinical data package to get approval to go into the clinic. We are partway through that. We -- in the recent RNS, we made an announcement that we had started dosing this month. The 28 days is -- actually, this is the last week of that 28 days in the first species. And we have all evidence so far to say we've got a very well tolerated and clean compound in our dose findings before we started this study, we had to be a dose range study where we went up to 1 gram per kilogram of body weight, and that's the sort of ethical maximum that you get from a regulatory perspective. And we didn't see anything of concern in those studies, which is really, really encouraging and gives us a high confidence at this time. So I know maybe people don't get so excited about the science and they get more excited about hearing around the deals, and we can talk more about potential partnerships that we would look to be doing. But I don't want to detract in any way from the substantial progress that we've made with this program over the last 12 months. Since we secured funding, we've set up a partnership with Pharmaron, who's been an amazing manufacturing and toxicology partner out in China. They have managed to optimize our process for manufacturing this compound, and they've also manufactured at great scale, so 10 kilogram scales, that's huge amounts for us to be able to conduct our toxicology studies, which is no sort of mean feat really when you think prior to this, we'd only made gram quantities that sort of lab bench quantities. And -- sometimes companies find that actually the process they have for making those R&D type quantities are not scalable. They don't translate to making large enough quantities. And that's a commercial killer, development killer for a program. So we're really, really pleased that we've been able to scale up to that 10-kilogram scale. And in doing so, the scientists, the chemists over in Pharmaron managed to find some really novel ways of doing this, so novel ways of improving the process such that our IP advisers identified a number of novel steps within that route that we could have possibly patented, and we've chosen to patent on the first basis, the strongest part of this optimization, and we released that RNS quite recently. And I don't know if I'm getting ahead of myself here, whether we've got other slides just on those RNSs, but maybe I'll move on. So we see, obviously, with the 28-day tox us coming to the conclusion of our preclinical program, and that will all read out towards quarter 3, end of quarter 3 this year. And that will enable us to have the data if we were able to put it together into what's called an investigator brochure that goes then to the regulators and you get an independent validation and approval of your data to take it into human. We've also made in GMP. So GMP is a really highly regulated process, and it's in a totally different laboratory setup under strictly regulated conditions, 2 kilograms of product which is what we call it human-grade materials, so GMP, good manufacturing practice. But it's where you have 2 operators, each checking each other's work. You have batch records of all of the batches. You have very stringent conditions within the laboratory, much higher than we had for that 10-kilo batch. So 2 kilo, although it's smaller, it's been done to a much more stringent manufacturing process that's applicable for human consumption. So it's very important, obviously, milestone for us to reach as well. I don't know if I've missed anything on this slide, Huw. My -- even with my glasses, it's hard to.

It's a busy slide, it's fair to say. I think the overall impression we wanted to give you from this slide is we release every -- by RNS or reach every major step in the process. We have this transparency policy. So every time something good happens, whether it's highly technical or not, we have a policy to release it. So what we've seen here is a series of releases over about a 9-, 12-month period that shows you the incremental progress we're making on this program. And the program is going very well under Helen's management. I want to dwell a little bit on what commercially perhaps a new manufacturing process patent means, Helen. So we didn't touch on that in the busy slide, but let's dwell a bit on this as we bring this presentation to a close.

Yes. So we exist really. So our partnering is all about how much is this worth to our partner. And ultimately, the partner is looking at how many years exclusivity can they have on the market. So once they've got approval for a commercial product, how many years can they sell that product without a competing product being able to come to the market and erode that market position. And that's where IP comes in and is deadly important for us. So we have composition of matter on the original orexin asset that we have, and that gives us 20 years protection from the time of filing it. So we have another roughly 12, 13 years in multiple jurisdictions left on that composition of matter. But you have to look that we've got further clinical development to go before we can get approval for commercial sale. So how many years do you then have? So you're always trying to add to your IP estate to give you further exclusivity -- so the manufacturing patent is really important in that by filing that this year, we have the potential to gain another 20 years of protection, that's exclusivity. So even if you watch the market in 5 years' time, you would have 15 years of market exclusivity to really kind of recoup and build your revenue on that product. So that's how important it is. And we'll be looking for other opportunities to provide additional patent coverage and patent exclusivity around this asset going forward.

Great. So a really powerful message for partnering as well. I mean it just reassures partners that you've got the maximum protection possible, which is our job. Our job is to optimize the asset for our business model, which is ultimately to partner for the right money. The other one is 2 kilograms. So you made 2 bags of sugars worth of material. You dwelled on the GMP process there, but I think it's worth highlighting that making 2 kilograms first time correct over a yield -- anyway, you covered that one, Helen, about the -- why we feel so pleased about making 2 bags of sugar.

Yes. I mean when you think each of these steps, so the scale-up that we did, we went from the grams to 0.5 kilo to 10 kilograms, and then we came back and we did this 2 kilogram at GMP. We've not had any failures in process in manufacturing process. We've not had any rejections. We've not had to go back and redo any part of the process, which is something you do find often when you're going with a new manufacturing process. We got higher yields with the 10-kilo and this 2 kilo than we were expecting and we had targeted of really nice, clean, pure product. So it's really satisfying. I think we got 2.57 kilos at the end of this campaign. And when you're kind of placing an order for 2 and you delivered more, that's really satisfying. You always like buy one, get one free.

Very good. So the summary then is we've got a class leader in the orexin-1 blocker in these substance use disorders and compulsive behaviors. The market is already worth over $40 billion. That's the addiction market in total, and it's growing to over $70 billion over the next 7 years or so. This is a very dull bullet we wrote preclinical studies progressing to schedule. There are lots of swings and arrows in biotech and very often these things don't work to schedule. This is a remarkably smooth progress that we've made on this program, and we're very pleased to report that the program is on schedule. We've generated some upsides from the program, particularly on protecting the asset even further than the industry standard protection we've already got. So it's an upside deal. So on budget, though does not cost us anymore. We are on budget for the program. It's going very smoothly and we'll conclude at quarter 3 where all the data are in-house. So a big milestone, full data package ready for submission in quarter 4. So that, I think, concludes the formal part of the presentation. I hope we've managed to get over our enthusiasm for the program. The reason it's our priority program, the reason it's the one that drives all the value and in the Board's estimation, when we refocus the business into neuropsychiatry this is why. We think we've got a winner on our hands here, and the winner is behaving itself in the last stages of preclinical development in not only that, we're making more than we thought we would make and we've got more protection than we thought we would have for the asset at the outset of the program about a year ago. So we're focused on neuropsychiatry. We're financed to deliver a major asset in neuropsychiatry from a data point of view. And we're flourishing in the sense that we are generating upsides on this program. So Alex, that's the formal part of the presentation done. Over to you now for highlighting that we're going to the next stage.

Thank you, very much indeed Huw and Helen for your presentation, [Operator Instructions] may just hand over to you to read out those questions where appropriate, and I'll pick up from you at the end. Thank you.

So there's a couple of pre-submitted questions, and we'll deal with them, and we try to deal with all questions on these webinars. Clinical readiness we've highlighted for the OX1 program. What should investors be watching for over the next few months in terms of milestones? Helen, do you want to cover the big milestones remaining for us on the IND-enabling program?

Yes. So I mentioned that we already released we started the 28-day tox. That is there is a number of studies ongoing at the moment, but I mean, that is the critical one that needs to be completed. And I think maybe calling it 28 days people think it's over in 28 days, and unfortunately, it's not. So you sort of -- you have a run into that dosing period, you dose for 28 days and then the animals recover for another 28 days, and then you have to analyze all of the data and tissues coming out of that. So it is a sort of 3-month end-to-end process. And we are obviously doing it in 2 species, which were nearly at the end of the first 28 days of the first one and the second one starts next month. So like I said, we should all be complete towards the end of quarter 3 with all of that data.

Excellent. And on target as ever. Thanks to you. The next question is, we're describing the OX1 blocker as potentially class leading. What data or characteristics differentiated from other orexin targeting drugs? I'll cover that one, if it's okay. produce a bit of variability. So class-leading, what are the characteristics of the orexin blockers and why is ours, we believe, the best. The main characteristic of our blocker is that it is the most selective for the target we want to hit. If you get off-target effects and all drugs have off-target effects. If you get off-target effects, in this case, the orexin system, the off-target effect is predominantly blocking the receptor 2 when we don't want to. We want to block receptor 1 to reduce the impulsivity. As Helen said, if you block receptor 2, you get sleepiness. We don't want that. We are the most selective by a large factor on blocking 1 and not blocking 2. That's the big, big win with this molecule. There are other things as well. It gets into the brain readily. If you're interfering with the brain system, you want to make sure you get there. It very readily gets into the brain. It's very potent. That is it works at very, very low concentrations. That's also very important. from a dosing and getting in the brain point of view. And it doesn't interact with anything else major. So these off-target effects are not just the orexin system. You can have off-target effects on any other body system. We don't have them, not at the sort of potency that we have for the orexin-1 receptor. So that's what we think is class leading, minimal potential for sedation, not hitting any others and getting to the place where it needs to work and sitting there for long enough. Those are the 3 big things that we believe make this class leading.

So the next one, there's, I think, a few that are in the same vein, just clicking down. So the given strategy to out-license earlier, are you already in discussions with partners? Or is that something you expect to progress closer to clinical data? And I think there's a couple of similar ones down. We're always in conversation with potential partners that we believe might be interested in these assets. And I have a number of relationships that are -- we meet up at conferences. We provide updates with data. We obviously do get into further conversations as you've seen. We've rejected an offer. So sometimes those progress into more concrete discussions. Often, they'll say, well, we're interested, but we'd like to see this data or that data, and therefore, we keep in touch. So I know it seems try to say we're always in conversations, but we are. And it's just getting, one, them at the right part of their strategy that they feel compelled to make a deal. Two, that, that deal is the right value. And three, there's normally a trigger point, right? You've reached a certain data point. Normally, 28-day tox actually is a really critical data point for these kind of discussions. So yes, sometimes they'll want clinical data, sometimes they're happy with preclinical data. But I think answering it not answering, but the fact is we're -- it's an ongoing part of the job is to build those relationships and keep potential partners updated.

I'm covered by confidentiality agreements. So obviously, we can't reach those agreements. Otherwise, things fall apart very quickly. And that covers a couple of the questions, which we will deal with specifically in this part of the session. There's a very good question here on a broader context, and thank you for it. What's the Board's preferred model for financing the company going forward? And of course, at the moment, we're not financing the company going forward. We've got the money in to generate this data. But there isn't a preferred model. We are looking at all the strands of financing the program going forward. That is dilutive and non-dilutive funding. And when we can say anything specific and concrete, of course, we will. It's an obligation for us, it's a legal obligation for us. So we've got another one, a rather predictable one, I'm afraid. The first part is 2 questions in one. Why did you not disclose how much the offer was when you issued an RNS? Because we couldn't. It's covered by a confidentiality agreement with another major party. If we were to breach that confidentiality agreement by outlining a complex offer for the neuropsychiatry portfolio, we'd be breaching any number of legal clauses. So we can't, we couldn't. And we are advised closely by our Nomad and by our legal counsel. And of course, they would say, look, you're prevented from doing this. All I can say is it was an upside. It's just that upside wasn't sufficient in the Board's opinion based on the value we think we've got in this asset and the other asset that comes along with it. Have you reduced your excess salary? I don't have an excess salary. This question comes up from the same person every time. There's a simply Wall Street article on this subject, mine specifically, which was published middle of last year, which says I'm 30% below market norm for AIM-listed companies. So we'll have a look. All this information is public. Have a look. It's not excessive, sir, you're wrong.

I don't believe my salary is excessive.

It's not published, but...

I've got a broken down ban outside my house, but I can't afford to get fixed. So when I can fix that, then maybe I might consider myself.

Maybe that's just talking about our compensation philosophy. We've got an option scheme. It doesn't vest at all until we get many fold increase in the share price over the offer price of the beginning of 2025. And it only fully vests and management are all in here, about 15% of the issued capital is covered under the option scheme. It only fully vest when we get a 10x is public, where we got a 10x increase in the share price over and above the offer price of quarter 1, 2025. So everything we do is as economic as possible, including our personal remuneration because we're driven to unlock this value. And our alignment with shareholders is entirely driven by share price. The way we bridge our low salary cap and everybody is on below market rate, by the way, is by aligning ourselves with the shareholder and making sure that if you win, we win as well, and we don't take that much money out of the business to make sure that the majority of it, and it is the vast majority is spent on unlocking the value of these assets. A complex and sensitive topic. Would the Board agree there buying shares in the open market will send a powerful message of support. No, actually, the Board doesn't agree. We can't even if we could. So we are guided by our Nomad and our legal provider, our legal counsel. So whilst it might have the effect for you, sir, I'm afraid we still can't until certain points. But the Board has always purchased shares when there is a fundraise, every single one. I've put in a 6-figure sum into this company of my own money. I've been diluted like everybody else. But we still, as a Board, continue to invest in the company with our own money as well as being rewarded as you'd expect to be in a professional role of the share price growing.

So the next one is about Stalicla. Can you tell us about why you never got the money from Stalicla? So I think we've covered this a number of times we're in dispute. We've issued a dispute notice. We believe we've triggered the milestone and they have refused to pay it. I think that's about as clear as we can get. We are in a constant conversation, let's say, between the management teams trying to keep the lawyers out of it as much as possible because that makes it very expensive. Currently, they have not been able to get their own fundraising away. So they don't have the money, I believe, to pay us even if they weren't in this current dispute. Taking them through arbitration would cost us more than the milestone is worth. I think we've said this before. We don't believe that's in the shareholders' interest. And that money is earmarked for progressing our programs and hopefully gaining value from those programs. But we are always attempting to resolve the dispute.

And I want to position SFX01 appropriately to where it is in our priority level. We just -- we don't count any of this particular deal as material anymore. We've focused this company on what we think are much larger markets with lower risks of technical success. We think the technical success of OX1 is very high indeed. We're not in high-risk indications like some of the cancers are, even though we're still looking after SFX-01 in a cancer study funded by the Dutch government. So we're not funding it ourselves. We are producing goodwill into that alliance, but it's somebody else is paying. The SFX1 is an increasingly small part of the value proposition of this company. And Orexin and that are the vast majority of it. So we -- whilst we manage the relationship, we're trying to resolve the dispute, we serve them a formal dispute notice. We don't think it's particularly material anymore. A technical question. Thank you. How quickly after taking a dose of OX1, does it exert its effect? And how long would the course of therapy be? Well, Helen, you're the expert there. How quickly does it work? And how long do you have to take it for? Well, there are some predictable...

I mean [ pharmacokinetically ], it would work almost as soon as get into the brain. However, I think really to feel fully feel that effect, you're probably talking days, if not a week or so of dosing before you get full control. For, let's say, for a Phase II PARADIGME, the dosing schedule would be 12 weeks. And probably when you change medicines with your doctor, if you ever take a medicine, they'll say, "Oh, let it go for 6 to 8 weeks, if not 3 months, and then we'll see how you feel. And that's really the case here. So it will get absorbed through the gut and that normally then peaks at about 2 hours, gets rapidly into the brain. So within a couple of hours, you'll have an effect on those receptors in the brain. But from a dosing point of view, you will be looking to take this chronically. So on an ongoing basis, if you have an addictive problem, you will take it for however long you need to. At the moment, there is no rationale for having breaks. So sometimes you see breaks in dosing to give yourself sort of a rest or washout period before going back on to drug. But at the moment, it doesn't look like there's any toxicology that's presenting itself that would require a washout, but things like that really only make themselves known as you go through clinical development.

So thanks for that one. The next one, at what stage do you expect to partner your assets with larger pharma companies? And I think we've covered that one in an earlier question, as Helen said, the conversations are always ongoing. Some people want a particular stage before the conversation gets serious. Some people are willing to engage at an earlier stage, and we have that engagement from another company, which we refused to accept because we didn't think the money was enough. So constant is that. And I say some people are prepared to do it early, some people later. Next question, Helen, this is for you # 12, I think. Has dosing started?

Has the 28-day tox study start in the second species? No, it's scheduled for the second week of May. The only reason it didn't start along with the first species is the facility availability. So this is a larger species than the first species. So it needs different conditions and the slots were available at this time. We could have done it earlier in a different facility, but it hadn't been -- sorry, audited by the major regulators. So you get facilities audited by the FDA, MHRA, things like that, which then give you obviously confidence in facility, but it gives your data confidence when you need to submit it for clinical authorization. So that -- it was schedule availability for it starting in May.

And it's fair to say the schedule we've published about all the data being ready by quarter 3 is still on schedule. So the start of that is not rate limiting. It will all deliver when we said it will deliver. Next one. Will you consider out-licensing earlier-stage assets to fund later stage ones? Yes. Yes, we are in a number of discussions on assets. So yes, and when there's progress as ever or if progress is terminated as we did in early April, we will, of course, let the market know. And another one highly related, I think, question 14. Are you in active discussions with any other potential partners? Well, I think we've covered it. We can't be specific, but we're always in discussion with potential partners. We go to all the major partnering conferences. We're in discussions with partners outside of those partnering conferences where there's kind of speed dating going on between companies who want to collaborate. So we are in active discussions with others, yes. I think -- yes, no more questions popping up. I think we've dealt with all of them as is usual. So to finish then, we have pivoted the company to what we think are higher gain assets that is assets that will ultimately produce a much higher shareholder return. We're working very hard on delivering those assets on schedule, and we're working very hard on the partnering effort that is our business model. So in summary, we are on target with the Orexin-1 program, the biggest value driver in the business by far. We are very pleased with the technical progress. And hopefully, we've given you a sense of that technical progress this morning. And we're pleased that there is interest in the Orexin system overall as we predicted when we changed direction. There is big pharma interest, there is biotech interest in the system that we identified many years ago as being a potential breakthrough brain system. So it's going well. We're still focused on neuropsychiatry. The financing is going well. We're on budget. So we're flourishing. We're getting a lot of interest in these assets and the company. Thanks very much for listening. Alex, I think that's all from us for now.

Fantastic. Thank you, Helen. Thank you very much indeed for updating investors today. Could I please ask investors not to close this session as you now be automatically redirected to provide your feedback, which will help the company better understand your views and expectations. On behalf of the management team, we would like to thank you for attending today's presentation, and good morning too.