Sareum Holdings plc (AIM:SAR)
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Earnings Call: H2 2025

Oct 23, 2025

Operator

Welcome to the Sareum Holdings PLC investor presentation. For this recorded presentation, investors will be in listen-only mode. Questions are encouraged, and they can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company can review all questions submitted today and publish responses when 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 Executive Chairman, Dr. Stephen Parker. Good afternoon to you.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Good afternoon, everyone. Thank you for joining us. It's a pleasure to be here to present Sareum's results for the year ended 30th of June 2025. I'm joined today by Dr. Tim Mitchell, our Co-founder and Chief Operating Officer, and Dr. John Reader, who is a Scientific Officer and indeed Co-founder. Together, we'll take you through our progress over the past year and, importantly, how we're positioning Sareum for the next phase of growth going forwards. Obviously, we will be paying your attention to the recent news around the toxicology study related to STC-1801. Before we begin, I'd like to draw your attention to the usual forward-looking statements. As always, this presentation will include forward-looking statements relating to future events and performance. These statements involve risks and uncertainties, and actual results may differ materially. We therefore encourage investors not to place undue reliance on them.

Now, before we move into the main part of the presentation, I'd like to take a moment to address the recent issues on everyone's minds. Let me start by saying that Sareum has made good progress across its pipeline and is entering the new financial year with confidence and momentum. We are, of course, frustrated by the unexpected and disappointing discontinuation of the GLP toxicology study for STC-1801, and I know that many of you shared that reaction. However, the adverse findings occurred predominantly in control animals and are unrelated to STC-1801. That outcome has reinforced, not diminished, our confidence in the molecule and the platform behind it. We're already in advanced discussions with several CROs to restart the study as quickly as possible using existing cash resources.

Our focus remains firmly on completing the phase II enabling package and progressing towards patient studies, whether that be with a licensing partner or, indeed, less likely, but possibly ourselves. The strong phase I results during this period, together with positive clinical readouts across the broader TYK2 field, continue to strengthen our conviction that STC-1801 has the potential to become a best-in-class once-daily oral therapy for autoimmune diseases. In parallel, we secured full rights to SRA737 on substantially improved terms, and we're actively assessing the best routes to progress and create value from this asset. Beyond these programs, our new collaboration with Receptor.ai is extending the relevance of our TYK2/JAK1 science into neuroinflammation, applying AI-driven discovery to identify brain-penetrant molecules. While the past year has brought its challenges, it has also strengthened the foundations for growth.

Sareum today is a focused clinical-stage biotechnology company with a clear path ahead, strong conviction in its science, and a set of tangible milestones to deliver. Let's just summarize this in the pipeline chart. As you can see, how the programs line up, STC-1801 leading the way in autoimmune disease, STC-1802 advancing in oncology, and SRA737 and the CNS collaboration broadening our reach. The message here is focus and depth. One scientific backbone, the TYK2/JAK1 pathway, applied across several high-value indications. With that overview in mind, let me hand over to John, who will take you through the opportunity behind STC-1801 in more detail, how it works, how it compares across the field, and why we are so confident in its potential.

John Reader
CSO and Co-founder, Sareum Holdings PLC

Thank you, Stephen, and welcome, everybody. I'll tell you about the TYK2/JAK1 inhibitor program, principally focusing on STC-1801. We see this as a very exciting area. The science is well validated, the significant commercial potential, and a broad potential to help patients in a number of different disease areas. The validated science is proven by the approval of the MS's TYK2 inhibitor, so TYK2. This was approved without the black box warnings that were given to the earlier generation of JAK inhibitors, and this boosts confidence in TYK2. AbbVie's JAK1 inhibitor Rinvoq, a selective JAK1 inhibitor, has been found to be extremely well tolerated in long-term safety studies and ongoing now that it's been marketed. Most recently, Priovant's TYK2/JAK1 inhibitor Brepocitinib is the first targeted therapy to achieve a positive registrational trial in the skin disease dermatomyositis.

Moving on to the commercial potential, there have been some very big deals in this area. Just on the field of psoriasis, it affects more than 125 million patients worldwide, has an approximate market size of $29 billion in 2023. TYK2 has got forecast peak sales of $3 billion. A couple of recent deals: $4 billion upfront acquisition of Nimbus's phase II TYK2 inhibitor by Takeda, and a phase III deal by Kaken Pharmaceutical to develop Illumis's clinical stage TYK2 inhibitor in Japan only, $140 million. The broad applicability in how we can help patients in numerous disease areas is also significant. TYK2, for example, has been approved not only for psoriasis but also for psoriatic arthritis. Rinvoq approved in rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis.

TYK2/JAK inhibitors have successfully completed or are undergoing clinical trials in many diseases: psoriasis, psoriatic arthritis, rheumatoid arthritis, Parkinson's disease, dermatomyositis, alopecia, non-infectious uveitis, hidradenitis, and suppurativa. We are seeing very positive effects from JAK inhibition in many different disease areas. STC-1801, we believe, has a differentiated mechanism and a demonstrated strong safety profile. It's a selective TYK2/JAK1 inhibitor, which we're developing for autoimmune diseases with an initial focus on psoriasis. We have positive top-line data from a phase I clinical trial with very favorable safety and tolerability profile, pharmacokinetics supportive of once-daily dosing, and dose-responsive pharmacodynamic biomarker reductions. Toxicology studies, obviously, we've put out disappointing news recently about the 16-week GLP toxicology study that has been discontinued following unexpected findings, which we observed more frequently in the control group animals that did not receive STC-1801.

We've recently had additional data that has confirmed that the control group were not dosed with STC-1801, so we can say that the findings are considered unrelated to STC-1801. We will restart this study as soon as possible, and we'll be able to complete it with the existing cash resources. The next steps in the program are obviously to resume the toxicology studies. The phase II enabling work continues. We have completed drug remanufacture, and formulation optimization is in progress to support the initiation of phase II clinical trials. The combined package of manufacture, formulation, and toxicology will inform the study design of any future phase II trial. How does STC-1801 stand apart from Brepocitinib? We talked about Brepocitinib a couple of slides ago. It's Priovant's dual TYK2/JAK1 inhibitor. If you look at the clinical data for Brepocitinib, we believe these are dose-limiting side effects, principally blood cell effects.

Clinically significant or relevant reductions in key blood cells were observed at higher doses of Brepocitinib. In contrast, STC-1801 showed no effect on blood cells at equivalent doses. Kidney function, Brepocitinib increases a marker of kidney function called creatinine, again seen at higher doses. In contrast, STC-1801 shows no changes in kidney markers, even at similar or higher doses. The half-life of a molecule for Brepocitinib is 6 hours- 8 hours. For STC-1801, 17 hours- 20 hours. That's the time it takes for a body to reduce the concentration of drug in the blood by a half. The dosing profile for Brepocitinib is once-daily dosing, but they get a very spiky PK profile. That's to say they get a high maximum concentration, and then it drops down to a low minimum concentration. This is a factor of the absorption of the molecule and its relatively short half-life.

In contrast, with STC-1801, we get once-daily dosing with a smooth pharmacokinetic profile. That means a lower Cmax, but we drop off to a higher Cmin. This is ideal for a JAK inhibitor, where a sustained concentration throughout the dosing period is advantageous. We think STC-1801 may offer a safer alternative to Brepocitinib. We've seen no clinically relevant effects on blood cells or kidney function and a potentially advantageous PK profile. A bit of evidence on this slide to support our idea that dual inhibition of TYK2 and JAK1 is more effective than inhibiting those kinases individually. We're comparing across clinical trials here. There are some caveats around that. They're different patients, different centers, different principal investigators, et cetera. Broadly speaking, considering this data, we're looking at the effects of these drugs on psoriasis patients after 12 weeks of dosing. Psoriasis trials are usually scored using this PASI scale.

That's the Psoriasis Area and Severity Index. A PASI-75 score means that a 75% improvement in most psoriasis symptoms has been shown. That's a very common clinical goal in psoriasis trials. The graph is showing the percentage of patients on trial that achieved PASI-75 after 12 weeks. If you look at the bars to the right of the diagram, that's Brepocitinib. You can see that placebo-adjusted response of about 65% of patients achieving that PASI-75 score after 12 weeks. That's outdoing both TAK-279, that's the Nimbus molecule acquired by Takeda, Ducravacitinib, also TYK2, and a dual JAK1/2 inhibitor, Baricitinib. Furthermore, Brepocitinib has shown meaningful efficacy in other clinical trials in patients with numerous diseases, including psoriatic arthritis, dermatomyositis, uveitis, atopic dermatitis, alopecia, hidradenitis suppurativa, and ulcerative colitis. This proves the potential for a dual inhibitor in these multiple different autoimmune diseases.

Moving on to STC-1802 in oncology, we've concluded our translational and preclinical studies on STC-1802. Our experience in the development of STC-1801 has been helpful and supports the process development of STC-1802, particularly in the chemistry field. We've increased the strength of our patent position and now cover several disease targets with STC-1802. The strongest validation for STC-1802 has been seen in hematological cancers such as T-ALL and B-cell lymphomas. We're reviewing our options for further clinical or for initiating clinical development of STC-1802. I think we're noting at this stage it may be preferable to partner this program. In August, we announced that we were expanding into CNS, that's central nervous system diseases, targeting neuroinflammatory diseases. This is in response to some strong scientific rationale that has emerged in the literature recently. There's growing evidence that TYK2 inhibition plays a key role in neuroinflammatory diseases.

Multiple sclerosis, Parkinson's disease, Alzheimer's disease, and others all represent areas of high unmet medical need. Plenty of research has been published by academic groups and by other companies confirming that TYK2 is a key neuroimmune modulator. Given our experience with the development of TYK2 and JAK1 inhibitors, we thought we would go back to our compound collection and have a look if any of ours were brain penetrant. I should say actually that STC-1801 is not brain penetrant, and it was partially selected on that basis. Looking at other compounds in the collection, we selected six that we thought had a good chance of getting into the brain, got them tested, and were pleased that three of the compounds did demonstrate meaningful blood-brain barrier penetration. One compound in particular showed strong levels of free drug in the brain.

The drug not only has to get into the brain, but it has to be not bound up by some of the proteins that are just naturally present in the brain and can stop the drug interacting with its intended target. That's equally important to getting into the brain. A really good starting point for a new program. The market opportunity is there. Neuroinflammatory diseases affect millions globally. There are limited treatment options for many of them. Brain penetrant kinase inhibitors are representing a new frontier in CNS therapeutics. We think the time and the evidence are right for us to make further use of our TYK2 JAK1 compound collection to press forward with this program. We announced a partnership with Receptor.ai back in August. They use their AI platform to power discovery acceleration.

There's lots of potential for the use of AI and machine learning in drug discovery where you're trying to solve multi-parametric problems at the same time. About the collaboration, then an initial four-month partnership to optimize brain penetrant TYK2 JAK1 inhibitors. Receptor.ai will support the work by using their virtual screening and pharmacokinetic predictive models. Obviously, absolutely key that these molecules get into the brain in meaningful quantities. We're overseeing the compound synthesis, the biological testing, and the ADMET profiling, and taking candidate molecules on into proof of efficacy or proof of concept in disease models. The terms are such that we own 100% of all of the intellectual property and rights to compounds from the collaboration. The results will inform selection of lead CNS candidates for preclinical development. Moving on to our CHK1 kinase inhibitor then, SRA737.

Again, a target with validated science behind it, broad commercial potential, and potential applicability to numerous oncology diseases and some non-oncology indications potentially. CHK1 forms part of the DNA damage response pathway. It's a well-validated pathway for cancer therapeutics. SRA737 has proven to be well tolerated in clinical studies. The synergies between CHK1 inhibitors such as SRA737 and many types of different chemotherapies, targeted therapies, and immunotherapies have been reported in preclinical studies. The commercial potential then, there are currently no approved CHK1 inhibitors, which creates a first-in-class opportunity. Earlier generation, less selective CHK1 inhibitors have not succeeded in clinical trials, and this has mainly been due to dose-limiting toxicity. This creates an opportunity for SRA737, which has much greater selectivity and has proven to be better tolerated in the clinic. The selectivity is really important.

I think the selectivity over the related kinase CHK2 really sets SRA737 aside, certainly from the early generation CHK1 inhibitors and potentially from some of the more recent and current CHK1 inhibitors. Clinical and preclinical studies support the use of a selective CHK1 inhibitor in many different clinical settings. I think because of the clean safety profile of SRA737 as a monotherapy and in the combination therapy trial that was run, we've seen that it's suitable for combining with other chemotherapies, particularly in solid tumor types with defective G1 cell cycle checkpoints, for example. Other DNA damage response inhibitors, for example, PARP inhibitors in ovarian cancer. We've seen some very interesting preclinical data when combined with immunotherapy in lung and colon cancers. Combinations with chemotherapy in blood cancers such as AML have all been seen in preclinical experiments. SRA737 is a clinical stage oncology asset with broad combination potential.

A selective CHK1 inhibitor, two phase I/2 trials completed. They were funded by Sierra Oncology and showed excellent tolerability as a monotherapy and in combination with chemotherapy. During the period, we have gained control of the program and increased our economic interest up to 63.5%. The clinical safety data supports the use of SRA737 in combination with other anti-cancer agents, for example, with immunotherapies in certain lung cancers and with PARP inhibitors or WEE1 inhibitors in, for example, ovarian cancer. The program was licensed to an unnamed U.S. biotech for a period of about a year. During that time, the biotech was able to open an IND with the U.S. FDA, also synthesized enough drug product, that's capsules, to give to patients, and also drug substance, that's the powder that goes into the capsules, to conduct a planned trial in AML and MDS patients, those couple of blood cancers.

This IND has now transferred over to Sareum, which would give potentially us or a partner rapid access to a clinical trial if we chose to go down that route. At the moment, we're reviewing the options. We're evaluating re-licensing, partnering with a project, or developing it internally to maximize the asset value. I'm going to hand over to Dr. Tim Mitchell now to take you through the preliminary financial results.

Tim Mitchell
COO and Co-founder, Sareum Holdings PLC

Thank you, John, and good afternoon, everybody. Normally at this point, we would be talking about audited financial results. We've had a slight delay to the audit, mainly for technical reasons. We need to do a thorough evaluation of the warrants that were issued along with some share issues earlier last year. Regulations these days require extra checking that we're IFRS and Companies Act compliant. The evaluation on the warrants and things will only affect the equity tables, so it's certainly not expected to have any effect on the income statement and balance sheets that I'm about to show you. Everything will be fully audited by the time we put the annual report out, which is generally next month, and we're not expecting any change to that. In terms of the income statements, our expenses, so that includes administration and R&D, are lower than last year.

That reflects the reduction in clinical trial costs. If you remember last year, we were in the middle of running the STC-1801 phase I clinical trial, which is quite expensive research. That trial has finished. The second half of last calendar year was really the tidying up and data analysis, which is much less costly than the actual dosing of patients. Share of losses associate is the previous partnership we had with SRA737. That line will essentially go now that that formal partnership has completed. The other operating income, new for this reporting year, is that UK tax credits appear as other operating income. That £240,000 represents the UK tax credits receivable to us. That results in an operating loss of just over £3 million. We've had a finance income, so that's essentially interest on the cash we've had in the bank.

Gives us, again, a tad over £3 million before tax. The residual £99,000 taxation there represents the tax credits available from Australia. For accounting reasons, they're treated separately to the UK tax credits. It's a loss for the year, just under £3 million, quite less than the previous year. If we look at the balance sheet, I think you can see it's very simple here. £3.5 million in the bank. We've got the usual balance of trade and other receivables. Net assets of £3.7 million. That's where we are. That's the extent of the results we're going to talk about today. Obviously, there's more details in the results statement that we released this morning, and there'll be the full audited results in the annual report coming up. With that, I will hand back to Stephen.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Thank you. Thank you, Tim. Let's just do a quick summary of where we stand, and then we'll go into the questions that you've submitted both during the session and prior to this starting. Just in summary then, STC-1801, obviously the major issue that we're spending our time worrying about at the moment, we are very confident that the issues that we've seen with the tox study are not drug-related. We're talking to several major CROs at the moment with a view to getting this new study started. It will be a new study. There's no value in picking up anything from where it was left off. We will be starting again with the species that was affected. The other species we are expecting to start imminently.

This is obviously the phase II enabling work, which will be very strongly supportive of our efforts to find a licensing partner or indeed to take the drug forward ourselves. STC-1802, a very interesting situation. The data coming through the translational studies suggesting strongly that we could be looking at something attractive in the blood cancer or some of the blood cancer indications. That we, on the whole, will be for patient groups, but they do have a fairly significant unmet medical need still. We'll be looking at how best to take that forward and whether we can enter some external partners to work with that program. SRA737, as has already been said, looking there to see how we can best take that program forward. I think that probably will be if we can with an external partner.

Finally, of course, the CNS area, looking forward to the data coming back from Receptor.ai and for us then to move to have the predicted molecule synthesized and to carry out the various levels of testing always required. There's a lot to do in this next year. Obviously, we'll look forward to keeping you posted personally at the AGM in December and throughout the year. With that, I'd just like to thank you all very much for being on the call. We know there's been plenty of questions coming in, and we'll do our best to get through as many as we can. As has already been said, those that we can't answer today will be amongst those that in the form sets that get answered when we've filled those out in a week or so's time and issue those through the platform. In summary, thank you very much indeed.

I'll just hand you back.

Operator

That's great, Stephen, Tim, John. Thank you very much indeed for your presentation. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the top right corner of your screen. While the company takes a few moments to view those questions submitted today, I would like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via our investor dashboard. I would now like to hand you over to Jessica Hodgson, Partner at ICR Healthcare, who will be taking us through the Q&A. Jessica, over to you.

Jessica Hodgson
Partner, ICR Healthcare

Thanks very much. Just reading some of the questions that have been submitted. Given the recent clinical and strategic developments around both SRA737 and TYK2/JAK1 1801, could the board please outline Sareum's current approach to commercializing these assets? Specifically, can you clarify how the company intends to translate scientific and clinical progress into shareholder value? Stephen, I think possibly one for you.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Yes, indeed. The strategy of the company remains unchanged in that we have always and continue to look for partners for our programs to a stage where we will maximize the value coming back to our own shareholders. We always used to say sort of late preclinical, early clinical. The market these days has moved on a bit, so we're probably talking about early clinical rather than late preclinical. Nonetheless, we have no intention of carrying out late-stage clinical trials or taking a drug to market ourselves. We will absolutely continue to look for partners in all of these programs where we can find attractive commercial deals for our own shareholders and hopefully get the drugs in the best hands to get to patients as soon as they can.

Jessica Hodgson
Partner, ICR Healthcare

Thanks, Stephen. Next question. I appreciate the focus has mainly been on STC-1801, but have the translational studies of STC-1802 produced anything of significance that you can talk about? I think possibly a question for John.

John Reader
CSO and Co-founder, Sareum Holdings PLC

Yeah, I can take this. I think we've addressed it in the presentation, but in essence, the translational studies for STC-1802 are complete. We've got a nice strong data set that shows both immune modulating and direct anti-tumor activity in certain cancers. Certainly, the most encouraging signals are in hematological cancers like T-ALL and B-cell lymphoma. That reinforces the rationale for taking the program forward. We're now reviewing how best to do that. It looks at the moment like partnering will be the most sensible route at this stage, given where our internal priorities sit.

Jessica Hodgson
Partner, ICR Healthcare

Thanks, John. Next question. Are you actively seeking a new Chief Executive Officer, or are you hoping one won't be required?

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Sorry, could you pull that one up?

Jessica Hodgson
Partner, ICR Healthcare

I think probably one for you, Stephen, yes.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Yes. I think the answer is that we're always looking out as to who is out there and available. At the moment, I think I continue to hope that one won't be required for the longer term. Certainly, if we are not going to be taking STC-1801 into phase two clinical studies ourselves, then I don't think that a CEO will add much value over and above the current board. If we were to take that decision to go into phase two, then I absolutely would want to see people joining the company with the relevant experience to maximize the opportunity at that stage.

Jessica Hodgson
Partner, ICR Healthcare

Thanks, Stephen. Next question. GSK's newly appointed CEO, Luke Mills, was heavily involved in GSK's merger with Sierra Oncology at a time when SRA737 was licensed to Sierra. Do you think there may be an opportunity to discuss the drug's future with GSK, or is that a closed door?

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Shall I pick that one up?

Jessica Hodgson
Partner, ICR Healthcare

Yeah, please.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

I suppose time changes things, and there are potentially always opportunities to have conversations. I think we should remember that GSK had the drug, along with several others, I should say, because Sierra had about four other compounds as well as its late-stage drug, which was the purpose of the acquisition. All of them got added, including one to AZ and one to a Japanese company. It was very clear at the time that GSK made that acquisition purely for the purposes of the NDA stage molecule, which is now approved and in the market. They had the opportunity once, unless something dramatic were to come up. I think it would be surprising they would want to look at it again. Obviously, we're always here to talk to them if they would change their minds.

Jessica Hodgson
Partner, ICR Healthcare

Thanks, Stephen. Next question, I think, is possibly for John. It's a question about STC-1801. The question is, has a paper been submitted to a journal for review and publication?

John Reader
CSO and Co-founder, Sareum Holdings PLC

Yes, it has. Submitted to a reputable journal, and it's undergoing the review process at the moment. Hopefully, it will be approved and published before too long.

Jessica Hodgson
Partner, ICR Healthcare

Thank you. Next question, I think, Stephen, possibly one for you. You said previously that the phase II studies are planned. How are these being paid for? You may have addressed this already, but I think good to address that question if we can.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Yeah, no, to be very clear about it, at this stage, we are not planning to take the drug into phase II ourselves. We absolutely do not have the financial resources to embark on a phase II clinical study. I would be very surprised if I ever said anything to the contrary because the financial position has never been that we could do that. Therefore, the planning of phase II is, if you like, as what we've always described as the phase II ready work, with hoping that we would then manage to secure a licensing partner that would actually take the drug into phase II trials itself.

Jessica Hodgson
Partner, ICR Healthcare

Thank you. Questions that have come in via the live chat. I think there's a question about the toxicology study. The question is, will it be another 16 weeks, or can you start from where the previous study got to? Possibly a question for John, I think, there.

John Reader
CSO and Co-founder, Sareum Holdings PLC

Yeah, it will have to be a completely new study. We have to start completely from scratch. We cannot add on to the previous study, unfortunately.

Jessica Hodgson
Partner, ICR Healthcare

Thank you. Another question around this study. Can we be clear where the issue with the toxicology test lies? Was this a failure with CRO processes, quality of the test subject animals, an issue with the expedient use, et cetera? More clarity on this would be helpful. I think possibly for John.

John Reader
CSO and Co-founder, Sareum Holdings PLC

Yes. This is a tricky one. I can't go into too much detail around this. It's quite a sensitive area, as I'm sure you can imagine. I think at the moment, it's fair to say that we don't know. We're obviously doing our very best to find out exactly what has happened, why we saw the results we did see. It may be that we actually don't get a clear answer to that, but we will do our very best to try to understand it. I think we started with a formulation that we've used successfully in the past, and it's not worked this time. It's very difficult to understand why that might be. Obviously, yeah, very difficult to answer. We're looking into it. If we find something that robustly explains the findings, we can share them. I'm not 100% confident that we're going to get to that point, however.

Jessica Hodgson
Partner, ICR Healthcare

Thank you. A couple of questions about the AI program. One question, when will we hear results on this? I think possibly a question for Stephen.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

I am very happy for John to dive in here as well. The expectation is that we will have proposed molecules from Receptor.ai by the end of this year. That, of course, is a starting position because those molecules will then have to be synthesized so we have actual chemicals to run tests on to see if the predictions that the AI system is making are enough in practice. We certainly, in terms of the actual collaboration with Receptor.ai, at the end of this year is when we're looking forward to meaningful dataset.

John Reader
CSO and Co-founder, Sareum Holdings PLC

Yeah, I'll just add to that. I think we have got the first set of target compounds back from Receptor.ai, the suggested synthesis targets. We've commissioned the synthesis of them, and that's in progress at the moment, expecting those to be completed within the next couple of weeks, actually. We'll start the testing process on those. That will be putting them through the kinase inhibition assay, the biochemical assay. Do these molecules actually inhibit TYK2 and JAK1? We'll be looking at the in vitro, so the test tube type predictive ADMET experiments, looking at how quickly the molecules are metabolized by liver cells, in essence. Of course, looking at the likelihood that they'll be able to pass through the blood-brain barrier.

Probably, I hope before the end of the year, we will have some idea of whether any of those molecules actually do pass into the brain in some PK studies that we hope to conduct. I think by the end of this calendar year, we should start to have some significant pieces of data to take forward.

Jessica Hodgson
Partner, ICR Healthcare

Thank you. Going back to the STC-1801 study, John, I think possibly again a question for you. Can you identify the anticipated length of delay to completion of the toxicology studies? A rough estimate is fine.

John Reader
CSO and Co-founder, Sareum Holdings PLC

We are speaking to more of several CROs at the moment. We've got initial quotes back. We are, I think, in a position to move forward with a preferred option at the moment. Unfortunately, there are time penalties that have to be paid, negotiating contracts, et cetera, and then getting a start date for the study. Unfortunately, these are not things you can just pick up the phone and say, "Start me a tox study on next Monday, please." There are slots that the CROs make available to begin these studies. I'd like to think we could get started before the end of this calendar year. I think given that many of these places shut down to new business, obviously, existing business continues over the Christmas period, but new business, they tend to shut down too. It's likely to be early in the new year.

I would hope we could get started early in January next year.

Jessica Hodgson
Partner, ICR Healthcare

Thank you. John, one additional one for you, I think. Is regulatory approval required to restart the toxicology study?

John Reader
CSO and Co-founder, Sareum Holdings PLC

No, regulatory approval is not required. We need to have the approval of the license holder at the CRO. This is someone who is responsible for, I suppose, ensuring that the study is ethical and complies with the animal welfare requirements. We will need to share the data that we've generated from this recent study with them. We won't be able to just proceed with exactly the same process as we did already because there's obviously been some problems associated with it. We will need to make some changes to the design, but then we should be good to go. In terms of the regulators, we'll need to report these findings in what's called the investigator's brochure, which is one of the key documents that does go before regulators when you're applying for a clinical trial. It will be a very brief report on findings. We did the study.

This is what happened. We concluded that there was no significance due to STC-1801. That will be that. Don't anticipate any problems from that.

Jessica Hodgson
Partner, ICR Healthcare

Great. Thank you very much. I think in the interest of time, we'll probably conclude the live Q&A section now, but answers to questions will be posted in due course. I might at this point hand back to Stephen.

Stephen Parker
Executive Chairman, Sareum Holdings PLC

Thank you all very much for being on the call. I hope that we've managed to answer many of the pressing issues that you've had. As I said earlier, the full list of answers to questions will be published. You'll have a chance to compile them, and you hopefully will find answers to other questions at that stage. With that, I'd just like to wrap up by thanking you again. Looking forward to seeing as many of you as we can in December at the AGM, and to thank you once again for your continued patience and enthusiasm for the company. Back to YMC.

Operator

That's great, Stephen, Tim, John. Thank you once again for updating investors today. Could I please ask investors not to close this session? As you will 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 it will be greatly valued by the company. On behalf of the management team of Sareum Holdings PLC, we'd like to thank you for attending today's presentation, and good afternoon to you all.

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