Sareum Holdings plc ($SAR)

Good afternoon, and welcome to the Sareum Holdings plc Interim Results 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 Executive Chairman, Dr. Stephen Parker. Good afternoon to you, sir.

Hello, and good afternoon to everybody on the call. Thank you for joining us. Today, we announced, as you know, the unaudited interim results for the 6 months to the 31st of December last year. And we will take the opportunity as well as looking at those numbers to give you an update on the progress that we're making. There is, of course, the usual disclaimer. Do please remember that we will be talking about forward-looking events, which may or may not happen or may or may not happen to the extent that we're describing. So that's very usual, but it's as well to remind you. Just then to remind you about the company, we have the 3 programs, TYK2 JAK1, 1801 and 1802 and the Chk1 inhibitor, SRA737, and we will be talking at greater or lesser length about all of those today. During the period or since the period, I should say, we have restarted the Phase 2 enabling tox program for 1801 with a new leading global CRO. As we were able to say this morning, all subjects have commenced dosing in that study. As you know, we were unfortunately had to discontinue the previous study with a different CRO after the unexpected findings that came about there. We have -- so that unfortunately set us back about 6 months. Then the Phase 1 data, of course, just to remind you, gave a very favorable safety and tolerability profile in human patients. And the pharmacokinetics support 1 dose -- daily dosing, which is very good. So we're working to optimize the formulation -- the capsule formulation of 1801, and that is nearing completion. 1802, as we indicated at the end of 2025, we think we've got as far as we can in scoping out the opportunities with 1802, but it's probably better carried out by a third party with expertise in blood cancers. So we will be -- we're putting together a package to support a licensing program for that. Then we continue to look for partnering opportunities for SRA737. That exercise is moving forward, I'm pleased to say. And of course, one of the things that is appealing to that program now is the extension of the IP, which we announced this morning and the fact that there is now an active IND in the U.S. So anybody who takes on that program will be able to move forward in a very rapid manner. Lastly, the CNS collaboration with Receptor.AI is progressing well. There's a second batch of compounds in synthesis after the second round of predictions. So with that, we'll just give you a quick reminder of what the pipeline is looking like. So going towards the end of Phase 1 for 1801, getting Phase 2 ready, coming towards the clinic for 1802 and obviously, the earlier program in the neuroscience area. So with that, I'm going to pass you over to our CSO, Dr. John Reader, who will take you through those programs in a little more detail. John?

Thank you, Stephen. Yes. So to talk about the TYK2/JAK1 space, first of all, and in particular, SDC-1801. We see this as a very supportive commercial environment with really well-validated science. We talk about science. First of all, there's a TYK2 inhibitor, selective TYK2 inhibitor from BMS called Sotyktu, has no Black Box warnings, and that gives us great confidence in the TYK2 class. Earlier first-generation JAK inhibitors do carry Black Box warnings, it should be said. Then Abbvie's JAK1 inhibitor Rinvoq, does have a Black Box warning, but has been extremely well tolerated in long-term safety studies, and we're not really seeing any of those effects that are warned about in the Black Box labeling, extremely good safety profile. And then more recently, Priovant's dual TYK2/JAK1 inhibitor, brepocitinib is the first targeted therapy that's achieved a positive registrational trial in a skin disease dermatomyositis and believe Priovant are moving forward to NDA with that molecule in the near future. So good precedent there. There's a wide commercial potential. I mean psoriasis is a disease that affects over 125 million people worldwide. There was an approximate market size of $29 billion back in 2023. BMS are forecasting peak sales of $3 billion for Sotyktu. Takeda have paid $4 billion for Nimbus Therapeutics TYK2 inhibitor, which was in Phase 2 at the time. And just for Japanese rights in the Alumis TYK2 inhibitor, Kaken Pharmaceutical paid $140 million. So you can see there are some big deals in the area. And I think that's reflected in the broad potential applicability of these molecules. So not only is so TYK2 approved for psoriasis, but also for psoriatic arthritis. Likewise, Rinvoq's approved for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis and inflammatory bowel diseases. And there are TYK2/JAK inhibitors that have successfully completed or currently undergoing clinical trials in a whole range of different autoimmune disorders. You can see the list there. I don't propose to go through them all, but many opportunities in a wide variety of autoimmune diseases where these molecules could find applicability. So why do we think SDC-1801 has the potential to be better? Well, we have this differentiated mechanism and a strong safety profile. Just the overview of 1801, it's a selective TYK2/JAK1 inhibitor, which is being developed for autoimmune diseases with an initial focus on psoriasis. Positive data from a Phase 1 clinical trial, which we carried out in Australia. We did a single ascending dose, a multiple ascending dose, a fairly standard design of Phase 1 trial, and we saw really favorable safety and tolerability profile for the molecule and a pharmacokinetic profile supportive of once-daily dosing. And we also saw some dose-responsive pharmacodynamic biomarker reduction. So although these were healthy volunteers, we were able to show an effect on the immune system and a reduction in inflammatory proteins in the blood of these patients. So since the Phase 1, we've been working on these Phase 2 enabling activities. And as Stephen mentioned a moment ago, post period, we restarted the GLP toxicology program for SDC-1801 and dosing is ongoing. This followed the discontinuation of a previous study where unexpected findings were observed in more frequently in the control group. So we were able to confirm through subsequent analysis that the findings were unrelated to SDC-1801. They were driven by the vehicle that we were using to deliver SDC-1801. So current dosing is expected to complete mid-2026 and the full Phase 2 enabling regulatory package is anticipated to be complete by year-end. We have been manufacturing and have completed manufacture of a GMP batch of SDC-1801. That's complete and in storage ready to move into a clinical trial. And formulation optimization is nearing completion. So this is getting capsules, which are able to dose the required amount of compound for the Phase 2 trial with a sensible number of capsules per day. So we're looking to dose 1, 2, maybe 3 capsules per day to achieve the exposures that we want to in a subsequent Phase 2 trial. Now I mentioned brepocitinib 2 slides ago. That's the Priovant molecule that's moving forward, have a successful Phase 3 study in dermatomyositis. How do we stand apart from brepocitinib? Well, I think the main side effects caused by brepocitinib at high doses, so up to 100 mg per day are these effects on key blood cells, so in particular, neutrophils and reticulocytes. These are clinically relevant reductions. It means brepocitinib can't move forward at 100 mg per day. But in contrast, our molecule at equivalent doses, 140 mg per day, which gave us the same kind of exposure as brepocitinib at 100. We don't see any of those changes to blood cell count. Brepocitinib also causes an increase in kidney function marker, creatinine, and that's seen at doses just above 30 milligrams. In contrast, we don't see any effect on those kidney markers even at 140 mg per day, our top dose. And then the pharmacokinetic profile of the molecules are different. We believe we have an advantage. We certainly have a longer half-life. So 17 to 20 hours gives us coverage of the target over a longer period compared to brepocitinib. And although both are suitable for once-daily dosing, brepocitinib because of its shorter half-life to get the exposure, they need this higher Cmax. So they get a spiky PK profile, a high maximum concentration and a low minimum concentration, whereas we get a nice smooth PK profile, which is ideal for JAK inhibitors. So we believe that 1801 may offer a safer alternative to brepocitinib. We have none of the clinically relevant effects on blood cells or kidney function and an advantageous PK profile, which should allow us to move forward with a higher dose of SDC-1801 compared to brepocitinib. Now we think brepocitinib has demonstrated that dual TYK2/JAK1 inhibition can be more effective than single TYK2 or a dual JAK1/2 inhibition in clinical studies. And what I'm showing you here is data from several clinical studies. So just a word of caution, it's difficult to compare between studies. These are different patients, different protocols, different timings, et cetera. So -- but I think the data does support the fact that dual TYK2/JAK1 inhibition is more effective. We're looking at here, the PASI-75. So this is a 75% reduction in psoriasis symptoms. That's for PASI either. Psoriasis area and severity index, a score of psoriasis symptoms, and it's a common clinical goal to achieve a 75% reduction. And you can see that brepocitinib does better after 12 weeks dosing at a 30 mg dose than deucravacitinib or the selective TYK2 inhibitors, deucravacitinib and TAK-279 and is better than the first-generation JAK1/2 inhibitor, baricitinib. Brepocitinib additionally has shown meaningful symptom improvements in patients with a whole range of diseases. You can see the list at the bottom there. And so I think it's really demonstrating the potential of dual TYK2/JAK1 inhibition. And if we have a better molecule than brepocitinib, we would hope to achieve even better results in subsequent clinical trials. And why we think there's a good chance for that for 1801 to have potential best-in-class efficacy. We're comparing molecules now in different psoriasis clinical trials, and we're looking at PASI 90, so 90% improvements in PASI scores in psoriasis symptoms. And that's really become the gold standard score for psoriasis patients now in clinical trials. You can see on the slide that biologics such as Skyrizi or BIMZELX, these are IL-23 antibodies. So Skyrizi, you get an 18% of patients achieved PASI 90 after 4 weeks, and then that improves to 75% after 16 weeks. The newer Oral IL-23 inhibitors, so these are oral peptides that inhibit IL-23, such as icotrokinra, 56% PASI 90 score after 16 weeks, and that improves as time goes by up to 65%. The TYK2 single inhibitors, so TYK2 and zasocitinib, TAK-279 are less effective. So TYK2 27%, PASI 90, improving to 33% after 24 weeks. Zaso a bit better. Now if you look on that slide, the week 4 top left, you're seeing brepocitinib at 100 mg once daily. Pfizer carried out a Phase 1 trial in psoriasis patients where they dosed for 4 weeks, and they saw really spectacular results at this 100 mg once daily dose. About 90% of patients were achieving PASI 90. And just a reminder, though, that's great, but this 100 mg once daily dose is not tolerated. It can't be taken forward. If you see the exposure that I've put on the slide, this is AuC, the area under the curve. It's a measure of how much compound is in the blood during the dosing period, 7,600 nanogram hours per milliliter for brepocitinib. Our molecule in the MAD D cohort, that's the top dose, 140 mgs per day, achieved a similar area under the curve, 7,000 nanogram hours per ml. However, we didn't see any of those side effects that brepocitinib demonstrates at that level of exposure. Importantly, for this analysis to make any sense, I have to point out that 1801 has a similar potency to brepocitinib in whole blood -- human whole blood cytokine assays. So we're getting the same exposure as top dose brepocitinib without the side effects. That's why we believe 1801 has the potential to achieve the same PASI 90 scores as repo at 100 mgs per day, but without those dose-limiting toxicities. And that's why we are prioritizing SDC-1801 in our portfolio. Moving on to SDC-1802. It's another member of our TYK2/JAK1 inhibitor family being developed for cancer and cancer immunotherapy applications. We've completed a number of translational studies now in different preclinical models of cancer to support potential further development of a molecule. The strongest cancer response we've seen are indications of significant unmet medical need and primarily in hematological cancers such as T-cell Acute Lymphoblastic Leukemia, T-ALL and B-cell lymphoma. We've looked at 1802 both as a monotherapy as a single agent and also in combination with existing therapies, and we've seen some interesting efficacy results using both paradigms. But really, as our priority must be SDC-1801, we've taken the decision to press forward with 1802 in collaboration with a partner. We think that's the best way to progress this molecule. And so we're putting the data pack together to initiate that process very shortly. And then we also want to expand our knowledge, our experience with TYK2 and JAK1 inhibition into central nervous system diseases targeting neuroinflammatory diseases in particular. Again, there's a strong scientific rationale for inhibiting these 2 kinases in the CNS. A lot of evidence coming out in the literature, supporting, in particular, the role of TYK2 in these diseases. The diseases that really represent areas of high unmet medical need, multiple sclerosis, Parkinson's disease, Alzheimer's disease, for example, there are many others and lots of published research indicating TYK2 as a key neuroimmune modulator in these diseases. So we wanted to make use of our experience and our existing data sets went back and looked at our existing collection and screened some of the molecules in models to look at how well they got into brain and into the CNS. And we found 3 that passed the blood-brain barrier, One, in particular, showed real promise of good high levels of free drug in the brain. And so we've been working with Receptor.AI from that starting point. They designed the first batch of compounds, which were synthesized and have completed their early-stage testing in both biochemical and ADME assays and then worked with Receptor again for a further batch of compounds, which has been designed and is currently undergoing synthesis. Again, there's a wide market opportunity. I mean, these are big diseases, many millions of patients affected with really limited treatment options. And brain penetrant kinase inhibitors, in particular, to address these inflammatory diseases in the CNS are an emerging prospect. Just to talk a little more about this collaboration with Receptor.AI then. We announced it in August. The initial 4-month partnership was designed to complete 2 phases of chemistry, which we're well into the second phase of now. So we were able to complete the first design test -- sorry, design, synthesize and test cycle well within the 4-month period and then Receptor designed the second round of chemistry, which is what we're doing at the moment. They've done that using their virtual screening and predictive PK modeling. We've been responsible for compound synthesis testing and ADME profiling, et cetera. Importantly, we own all of the intellectual property and the compounds arising from the collaboration. And the objective is obviously to use these results to inform selection of a lead candidate or candidates for CNS diseases for future development. So moving finally on to SRA737, our selective Chk1 kinase inhibitor. Again, there's a well-validated scientific principles underlying this program. Chk1 is a part of the DNA Damage Response pathway, which is a well-validated pathway for cancer therapeutics. The molecule itself is very well tolerated in clinical studies. And there are synergies between Chk1 inhibitors, including 737 and many different types of chemotherapy, targeted therapies, immunotherapies, huge array of literature reporting interesting findings and synergies with Chk1 with other agents. There are currently no approved Chk1inhibitors, so that creates a first-in-class opportunity for SRA737. There have been earlier generation Chk1 inhibitors, which have failed in clinical trials, mainly due to their selectivity profile leading to dose-limiting toxicities. Frequently, that off-target effect has been an inhibition of checkpoint kinase 2 which our molecule is well clear of. We have a very good selectivity profile against checkpoint kinase 2. And we think that creates a great opportunity for a selective checkpoint inhibitor such as SRA-737. Again, there's broad potential applicability in a wide range of diseases, clinical and preclinical data to support a selective Chk1inhibitor in multiple settings in combination with chemotherapies, other DDR inhibitors, immunotherapies and targeted therapies. So 737 is a clinical-stage oral, selective inhibitor. It's completed 2 Phase 2 trials as monotherapy and in combination. We hold the license for 737 on improved economic terms, currently 63.5% of all future revenues compared with our previous 27.5% share. The positive data shows excellent tolerability as a monotherapy with limited efficacy, but very promising activity when combined with low-dose gemcitabine, particularly in anogenital cancers where there is significant unmet medical need. We have an active IND with the U.S. FDA, that's an investigational new drug application to conduct a Phase 1 trial in patients with acute myeloid leukemia and myelodysplastic syndromes. And we have a sufficient stock of SRA-73 capsules to conduct that trial and a stock of active pharmaceutical ingredient, API, that's the stuff that goes in the capsules to make many more capsules. So as Stephen mentioned earlier, a company picking up this project could hit the road very quickly, get this trial running very rapidly if that's attractive. We're looking and continuing to explore the partnering opportunities, including relicensing, partnering or potentially internal development to maximize the value of the 737 asset. Okay. I'm going to hand over to Tim now to take you through the preliminary financial results.

Thank you, John, and good afternoon, everybody. So if we first look at the income statement, we can see expenses have remained pretty similar to what they were last year, so the half year figures are within an approximation of about half they were for the full year. The share of loss of associate, that is the income or expenses with the partnership with the CRT Pioneer Fund for the 737 project. Now that we are the full owners of the 737 program and the CPF are out of the picture, that line will soon disappear once all the historical numbers aren't reported. And so yes, loss -- well, a tax credit of GBP 200,000, so loss for the year of GBP 1,652. That was in cash terms, I'd say approximately half what it was last year. Actually, you'll notice on for the full year figures, there's a finance charge associated with the warrants. This is just an accounting factor. I'll go on to in more details because it appears on the balance sheet as well. But it's -- no cash is moving out of the company due to this charge. It's just an accounting factor. So looking at the balance sheet, yes, so GBP 2.5 million in cash. Trade and other receivables, I'll just touch on that because I've seen a question posted on that. So around GBP 750,000. GBP 200,000 of that is due to the tax credit noted in the income statement. Yes, so that answers one of the questions that's been posted. Again, we see the warrant charge on the balance sheet. So it's an accounting factor to do with the warrants. Many of these warrants were 4-year warrants from nearly 4 years ago, and they will expire throughout the year. So that sort of accounting anomaly, if you like, will disappear off the figures soon. So yes, so leaving net assets for that sort of around GBP 1.2 million, but as the warrant liability goes away, that GBP 1.6 million will come back on to the net assets. Okay. So that's a quick tour around the numbers. There's obviously a fuller description of everything in the statement released this morning. With that, I will hand back to Stephen to sum up.

Thank you, Tim. So just briefly summing because you've heard it all now several times. We're moving forward with 1801 with the Phase 2 preparation mainly based around the toxicology study, but also the formulation work, which is making good practice. 1802, as we said, we are putting together a package of the data collected so far for a partnering exercise, and we would hope to find a partner to take that up in the blood-based cancer area. 737, we continue to make progress in looking for and speaking to potential licensees for the area. As you saw, we are continuing to bolster the IP estate in that area so that we're trying to ensure that this is not a wasting asset going forward. And we're hoping to be able to report back to you later in the year on progress in the CNS area once we've completed the synthesis of this new batch of proposed compounds from the AI exercise, and they've been tested in the lab. So looking forward, I think we're going to have a very interesting year through 2026. I thank you for being with us still. I know this has been a long and winding road. But nonetheless, we are very pleased to have you with us as our shareholders. And with that, I'm going to pass back to Tim, who's going to be the MC for the Q&A side. So thank you all very much.

[Operator Instructions] I would like to remind you the recording of this presentation along with a copy of the slides and the published can be accessed dashboard. Dr. Tim, at this point, if I may hand over to you to chair the Q&A, and I'll pick up from you at the end. Thank you.

Thank you, Alex. Okay. So let me start with some questions that were pre-submitted before the event. So we'll work our way through pretty much all of those ones that have been submitted. And then we'll move on to as many of the questions submitted during today's presentations as we can. If your question isn't answered, it's because we might want to consider the answer rather than just give an off-the-cuff reply, if you like. But we will answer everything we can in a written set of questions that will be posted on the IMC website in a couple of weeks. So let me start off with some questions on 1801. These are about the current state of the tox study. So have subjects been dosed, some [ idea ] of time lines. There's been a number of questions, which I'm kind of grouping together here. But John, do you want to go through some of this?

Yes, sure. I think -- well, hopefully, the announcement today and the presentation have answered a lot of these questions, but it's all about when did we start the toxicology study. I think also just to say that when we made the announcement in February, dosing had already commenced a few days prior. We just wanted to make sure all was going well with that sort of difficult phase at the start of dosing when we made the announcement. So yes, all the animals are being dosed. That's ongoing. We stick to the original time lines at the moment. We're expecting dosing to complete in mid-'26 and the full Phase 2 enabling package by year-end. So in terms of how we'll keep people updated as we progress, which is I see in one of the questions here, I mean, as key milestones are reached and in line with regulatory guidelines, we'll provide the updates. The comprehensive data set at the end will be available under confidentiality agreements to potential license partners once the full package is complete and may or may not be submitted to regulatory authorities depending upon the strategy at the time. So if we're going to take it forward by ourselves or if we're going to partner at that stage, the appropriate regulatory steps will be taken. So hopefully, that addresses those questions about timing.

Thank you, John. Then sticking with 1801, how confident are we that the issues seen in the previous 1801 toxicity study will not be repeated in the current study?

Well, the -- so the adverse findings in the previous study, and just a reminder, we had to terminate that study on animal welfare grounds. We found a higher frequency of adverse findings in the control group animals. And we have -- since that study, we've changed the formulation. So we're using a different vehicle. We've also completed a short pharmacokinetic study to assess the tolerability and the exposure of several different formulations. We've selected the one that we think is best suited. Also, it has some precedent in long-term studies. So I'd say we're highly confident. But bear in mind, we're conducting a research program here. So there are unknowns. And let's see how the study develops. But I think we've put in place everything we could to give ourselves the best chance of success. We're working with a new CRO as well with extensive experience in long-term tox programs. So yes, that's all I can say really at the moment.

Great. Thank you, John. Then there's a question, yes, preposted and a number have come up during the presentation. It's really about the claim or who's at fault for the previous tox study? And is any compensation forthcoming? Stephen, I think you will address this one for us.

Yes. Yes, indeed. So this is the classic problem, which I'm sure most of you have experienced when you've taken your beautiful car to the dealer for its service and discovered that you ended up with a Friday afternoon job. And persuading then that it was that the issues you're now facing was the garages fault. Certainly, my experience has never been an easy task. And in the same way, with the details that we know, which we're not in a position to share, we find it hard to see how the outcome of the previous study could not have carried some degree of liability. However, the only way we're going to find -- we would be able to make that stick would be to engage lawyers and spend a great deal of time going through the courts because the CRO is not admitting liability. And I have to believe that there are better ways of using your shareholder funds. Than making lawyers comfortable and stringing things out through the courts. This was an international U.S.-based or U.S.-owned CRO. They have a lot deeper pockets than we do. And I would much rather that we were investing in our research programs to bring you a shareholder return than to pursue down this line where any recompense we got is going to be de minimis compared with the outgoings to try and prove the point.

Great. Thank you, Stephen. So I hope that's clear to everybody now. So moving on to 737. I've got a question on combination studies. So it's about the oncology sector placing a lot of emphasis on combination therapies, particularly for bypass 2 resistance. Can we provide an update on specific rationales being presented to our potential partners for combinations of 737. And there's a specific point about SRA-737 combinations with antibody drug conjugates and/or complementary pathway inhibitors such as WEE1 or BET inhibitors. John, can you pick that up, please?

Yes, sure. So the -- I mean, the clinical rationale for 737 is backed up by the Phase 1/2 data that demonstrated good tolerability as a monotherapy and promising activity in combination with low-dose gemcitabine. We saw that particularly in anogenital cancers where there's a significant unmet need. I think a selective Chk1 inhibitor targets cancer cell replication and DNA damage repair mechanisms. So there's clear potential for mechanistic synergy with a wide range of different combinations. But there's been a lot of publications, for example, around combinations with WEE1 inhibitors, with BET inhibitors, with PARP inhibitors, even with cancer immunotherapy, and that's specific to SRA737. So this data is all in -- is in our data room where we own the rights to it as such. And of course, we point out the literature to potential partners where they're not already aware of it. So ADCs, we don't have any specific data for 737 combinations with ADCs. It's a nice idea. I mean, likewise for targeted radiopharmaceuticals, there is potential there. Certainly, we'd be very supportive if a potential partner wanted to pursue that approach. But I think that this idea of rational combinations plays directly to 737 strengths because of its -- just its very good safety profile as a monotherapy lends it to being used in combination with other things. And in fact, the any toxicities we really saw from 737 were associated with on the target or Chk1 inhibition. So I think as a molecule to prove the hypothesis of combination with all sorts of different mechanisms, 737 is as good as you can get to do that job. And we have a better economic position, so 63.5% of future revenues, we can be flexible and gives us a strong negotiating position as we look to move the asset forward.

Thank you, John. Actually, another one for you now. On the TYK2 neuroscience program, I think this has been largely answered in the presentation, but it's when we receive information on the recent collaboration. I take it -- it will be the shareholders at large asking when we make it public rather than us as a company, but maybe you can address both bits of that.

Yes. So hopefully, I did answer it during the presentation, but just to reiterate, the collaboration is progressing to plan with Receptor. AI. We had a first batch of compounds designed, synthesized, got them tested in the early-stage assays, so the biochemical and the in vitro sort of test tube ADME assays, fed that data back to Receptor. They use that data to design a second batch of compounds and those are in synthesis at the moment. I'm expecting those to be completed within the month, and then we'll move them into the biochemical testing and the early ADME testing again. And then take a view as to what needs to be done next. So it could be that some of those molecules we then push forward into more advanced assays, start to look in Vivo. So all these molecules getting into the brain? Are they affecting the target in the brain? What are their general properties like all around? Or it could be that we need to go back to do another design phase, and that could either be with Receptor or it could be something that we're able to do ourselves with all of the information that we'll have gathered by that stage. So I don't think there's been a delay in the program. We're on track.

Okay. Thank you. Then there's a question on the commercialization of the TYK2 neuroscience program. So is the objective to secure an out-licensing deal at the preclinical or clinical trials authorization ready stage to capture the sector's premium for brain-penetrant compounds? So just to recap then, so the TYK2 neuroscience program is looking for blood say, blood-brain barrier penetrant selective TYK2/JAK1 inhibitors for neuroinflammatory conditions such as Alzheimer's, Parkinson's and multiple sclerosis. And as the question points out, there's a lot of interest from the industry in this area. So our objective is to advance these molecules through early validation and to position them for out-licensing at any point really. So I think we'd be happy to discuss partnering with these compounds as soon as we can. So whether that's through the journey -- throughout the journey through the preclinical stages or at the CTA regist stage, I think that's really -- we'll take a view of that depending on partner interest and what deals we can get. So I think if there's an early-stage deal, which we think is in the best interest of the company, then we take it at an early stage rather than wait to get the program CTA ready. So the collaboration with Receptor.AI, as we pointed out, has been conducted with our existing cash resources. We have completed testing of the first batch of compounds. Second batch is being synthesized, and we're able to share that data with potential partner companies as we get it under CDA. And if there's major significant advances, obviously, we'll report those to the market. We have some commercial and financial questions. So -- across the lead programs, what are the -- so specifically 1801, 1802 and 737, what are the specific value inflection milestones over the next 12 or 18 months? And what is the Board's strategy to monetize each asset? Stephen, can you take that, please?

Yes, of course. The long and off stated strategy of this company is to discover and bring to the point of early development assets, which can then be partnered into big pharma or other suitable companies to take them forward and take them to the market. And that has not changed. The -- and so therefore, for each of these programs, we are moving forward on that sort of to the same drumbeat. 1801 obviously is going further in-house at the moment, but we will be very keen to get a partnership or a licensing deal at the Phase 2 ready stage. 1802, as you heard, we've taken a decision rather earlier that this is a very specialist area with the blood cancers and that we think that the program will fare better if it's partnered into a specialist company at an earlier stage. And 737, as we said when we announced last year that we are -- when we took control of that program and increased our economic interest from 37.5% to 63.5% blended that this is something which we feel has a rightful place with a pharma company. There are various options and routes forward for the drug, and we are certainly talking actively to some partners at the moment to secure that transaction. Obviously, no deal is done until it's done, and I'm not going to put a time target against it, but we are confident that we can get an outcome for that. Thanks, Tim.

Actually, another one for you, Stephen. So the question says, every year, we always seem to be waiting for additional results or have unexpected delays. What are you doing differently this year to enable a deal to be conducted, well, within a reasonable time frame?

Yes, it's -- that's the thing with these sorts of partnering arrangements sort of from the outside, nothing appears to be happening until everything has happened. We are moving forward, sometimes faster, sometimes slower, but we are moving forward. And we do very much hope and believe that we are coming in towards a point where we can start to see tangible negotiations and deals struck in these areas.

Thank you. There's a question about 737. It's been returned twice once by Sierra, once by a U.S. start-up. So the question is how confident are we that it will attract a deal? Are we the only ones who see its value? Maybe I'll pick that one up. So we hold the license on 737, as we've noted on improved terms, so 63.5% instead of 27.5%. The Phase 1/2 data that previous partner, Sierra Oncology conducted demonstrated very good tolerabilities on monotherapy and actually much better tolerability than previous Chk1inhibitors. Also showed promising activity in combination with gemcitabine in a number of cancers, particularly anogenital, which is an area of unmet medical need. And then we maintain the open IND, as John noted, with the FDA for acute myeloid leukemia and myelodysplastic syndromes. And these are promising new areas for 737 that weren't really considered whilst certainly the Sierra Oncology as a partner we were looking at the program. So the AML and MDS areas have become highlighted in recent literature. So it's a new area that we can approach potential partners with. And then just to add to the commercial value of 737. We've received a notice of allowance from the patent office for a patent application. It's protecting the crystal structure of 737, but it extends the patent protection for the molecule out until at least April 2041. So we've got a good long patent life on the molecule. So an open IND, plenty of drug product to perform the trial and to make more capsules. We see a lot of value in the program, and we're working hard to find the right partner to move that forward. Another question on commercialization. I'll pick that one up. So noting the Board's upcoming attendance at BIO-Europe Spring, can we confirm we're actively leveraging the partneringONE system to secure meetings with potential licensees. And it's -- are the asset profiles of our various programs all registered on the program for potential partners to see. So perhaps just to explain how the partnering systems work, the BIO-Europe and the U.S. bio partners partnering meetings are all centered around a partnering system. BIO-Europe uses one [ coupon ] partneringONE . So it's where you can search for companies with specific interests and they can find us. So you request a meeting through the system. And if both parties agree, then it schedules a meeting slot for you. So we use that extensively to arrange our meetings at the conference and all of our assets, so 1801, 1802, TYK2 neuroscience and 737 are listed on the system. And I'm expecting to hold meetings with prospective partners on each of those. But I suppose with a particular focus on 1801 and 737. Also, the U.S. business development consultancy, which we have referred to a number of times, they will also be present at the meeting, and they will be able to assist us in meetings as well. Okay. So that concludes the pre-submitted questions. We have a little bit of time left to go through some of the questions submitted during the presentation earlier. So just to reconfirm that we'll attempt to answer all the questions we can. So we don't answer them today, we'll publish as many as we can in a written submission to the IMC website in a few weeks' time. So John, one for you. It's on the publication of the clinical trial for SDC-1801. Do we have any dates when that will be published? Have we had any feedback on that data? Can you give us an update on where we are with these forthcoming publication?

Yes, certainly. So no Phase 1 data for 1801 has been published yet. We have submitted a paper to a peer-reviewed journal, and this encapsulates all of the Phase 1 work and all of the data associated with that, and it's under peer review at the moment. So I don't have feedback on the time lines at the moment. We need to wait for that review process to complete and then potentially make any amendments that the reviewers may request, and then it will be hopefully published as soon as possible after that. Let's hope it's within the next quarter or so, but it's sort of out of our hands at the moment because we've submitted it.

There's a question, again, this one for you, John, on the GMP batch. I think it's probably referring to 1801, but I guess it could be critical 737 at all. But how confident that the -- it's the GMP batch that it's going to be okay for a Phase 2 trial. So can you comment about the stability studies that are ongoing?

Yes. Okay. So yes, the presumably SDC-1801. Yes, there's a batch of GMP-grade material that's completed synthesis last year and is in storage. Yes, in terms of stability, so we have conducted a series of studies, and we have commenced a series of studies designed to look at the stability of API, so the GMP batch. Also capsules, you need to do this with capsules as well. And so far, we've got a shelf life of at least 4 years for 1801 as a powder, if you like, the GMP batch. So yes, you look at things like does the crystal form change? Do the -- does the side effect profile change in any way? Does the water content change, things like that. Yes, no, all good out for 4 years at least. So we have a high degree of confidence that, that GMP batch will be suitable for use in trials in 2027. Yes.

Great. Thank you, John. A question about the U.S. business development consultancy. Are they primarily focused on 1801 or the broader pipeline too? I'll pick that one up. So their primary focus is on 1801 and SRA737. So we felt we ought to give them some focus as to what they were doing. And so yes, the higher-value clinical programs are their particular area of focus. But obviously, if they uncover respective partners interested in any of the other programs, then obviously, they'll hand them over to us, and we'd be the primary handler of those inquiries. Another question on the Phase 2 package for you, John. So on the Phase 2 enabling package, tox will be central to that. But what other key activities do you need ahead of getting that package finished? And can you comment on where you are with those? Can you say something about the formulation studies? I suspect those are the -- that's the other key activity involved.

Yes, that is the main -- I mean it's the CMC side of things, so the chemistry manufacturing and control aspect of things. So part of that, we've just spoken about the GMP synthesis of a new batch of API, active pharmaceutical ingredient that will go into the capsules and the stability studies that we conduct on that. And then the other key one is the formulation optimization that's going on at the moment. So we're working to develop a formulation that's suitable for delivering the required dose in a sensible number of capsules, let's put it that way, will be hopefully 1, maybe 2, maybe 3, possibly 4 capsules a day for a Phase 2 trial. And we are -- let's say, we're closing in on selecting our final formulation at the moment, hope to have that completed hopefully by the end of March or shortly thereafter. And once we've settled on that formulation, we will then need to conduct stability studies on that. So those stability studies start shortly after, and it's a sort of rolling program of stability that will probably take out for at least 3 years, possibly 4 years and you look at a variety of different conditions for storage of your capsules. So you mimic a sort of high temperature, high humidity environment. Those are called accelerated studies and then more, I suppose, more realistic storage conditions, so be like room temperature at 60% relative humidity, for example, or you might look at refrigerated conditions to store your capsule. So it's really -- those are the key bits of data that we'll need to generate between now and the end of the year in addition to the toxicology data.

That's great. Thank you, John. Okay. I see our hour is coming up. So perhaps I will hand back to Alex to sum up and say that we'll do our best to answer the rest of the questions online.

Yes, that's correct. Thank you very much. We will publish these questions into the platform as the team mentioned. But Dr. Stephen, if I may, just before I redirect investors to provide you with their feedback, just ask you for a few closing comments.

For being with us. Thank you for the questions that you've submitted both prior to the session and during it. I hope that you feel that we've been able to answer many of the pressing questions. Obviously, we look forward to the period coming and to present to you the full year figures, which will be sometime, I imagine, in October in the next of these sessions. So in the meantime, thank you very much. Thank you for your continued support. I know sometimes it feels a bit hard, but then this is biotech. So thank you again, and I will hand you back to Alex.

Fantastic. Thank you all very much.