Sareum Holdings (LSE:SAR) Q2 2026 Earnings Call

0:00 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 six 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. uh there is of course the usual disclaimer do please um 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 uh that's very usual but it's as well to remind you just then to remind you about the company um we uh we have the three programs uh tick to um tick to jack one 1801 and 1802 and the uh check one inhibitor sra 737 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 a new leading global cro

1:30 as we were able to say this morning all subjects have commenced dosing in that study uh as you know we were unfortunately had to discontinue the previous study with a with a different cro um after the unexpected findings uh that uh that came up came about there um we have uh so so that unfortunately set us back about six months Then the phase one data of course just to remind you gave a very favorable safety and tolerability profile in human patients and the pharmacokinetics support one dose daily dosing which is very good.

2:22 um so we're working to optimize the formulation the capsule formulation of 1801 and that is nearly completion uh 1802 as we indicated at the end of uh 2025 um we think we've got as far as we can in scoping out the the opportunities with 1802 but it's 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 SRA 737 That exercise is moving forwards 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 US. So anybody who takes on that program will be able to move forward in a very rapid manner.

3:44 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 coming towards towards the end of phase one for 1801 getting phase two ready uh coming towards the clinic for 1802 and obviously the earlier program in the new neuroscience area so with that i'm going to pass you over to uh our cso dr john reader uh who will take you through those programs in in a little more detail john thank you stephen

4:42 So to talk about the TIK2 JAK1 space first of all and in particular SDC1801 we see this as a very supportive commercial environment with really well validated science we talk about science first of all there's a TIK2 inhibitor selective TIK2 inhibitor from BNMAS called so TIK2 has no black box warnings and that gives us great confidence in the TIK2 class earlier first generation jack inhibitors do carry black box warnings it should be said then AbbVie's jack one inhibitor rinvoc does have a black box warning but has been extremely well tolerated in long-term safety studies and they'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, Preovant's dual TIK2-JAK1 inhibitor brepacitinib is the first targeted therapy that's achieved a positive registrational trial in a skin disease dermatomyositis and believe Preovant are moving forward to NDA with that molecule in the near future.

5:59 so good precedent there there's 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 dollars back in 2023 bms are forecasting peak sales of 3 billion for so tick to a cicada of paid four billion dollars for Nimbus Therapeutics TIK2 inhibitor which was in phase two at the time and just for Japanese rights in the Illumis TIK2 inhibitor Kaken Pharmaceutical paid 140 million dollars so you can see there are some 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 tick to approve for psoriasis but also for psoriatic arthritis likewise ring box approved for rheumatoid arthritis psoriatic arthritis atopic dermatitis and inflammatory bowel diseases.

7:07 And there are TIK2JAK 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 SDC1801 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 TIK2 JAK1 inhibitor, which is being developed for autoimmune diseases with an initial focus on psoriasis.

7:53 positive data from the phase one clinical trial, which we carried out in Australia. We did a single ascending dose, a multiple ascending dose, a fairly standard design of phase one trial. And we saw really favorable safety and tolerability profile for the molecule and the 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 for phase one, we've been working on these phase two enabling activities.

8:38 And as Steven mentioned a moment ago, post period, we restarted the GLP toxicology program for SDC1801 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. Current dosing is expected to complete mid-2026 and the full phase 2 enabling regulatory package is anticipated to be complete by year end.

9:26 We have been manufacturing and have completed manufacture of a GMP batch of SDC1801 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 two trial with a sensible number of capsules per day so we're looking to dose one two maybe three capsules per day to achieve the exposures that we want to in a subsequent phase two trial Now, I mentioned brepacitinib two slides ago. That's the preovant molecule that's moving forward.

10:12 I have a successful phase three study in dermatomyositis. How do we stand apart from brepacitinib? Well, I think the main side effects caused by brepacitinib 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 brepacitinib 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 brepacitinib at 100 we don't see any of those changes to blood cell count. Brepacitinib also causes an increase in a 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.

11:13 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 brepacitinib. and although both are suitable for once daily dosing repositinib because of its shorter half-life to get the exposure they need this higher c-max 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 prepositinib had none of the clinically relevant effects on blood cells or kidney function and a advantageous pk profile which should allow us to move forward with a higher dose of sdc-1801 compared to Now we think Repositiv has demonstrated that dual TIK2-JAK1 inhibition can be more effective than single TIK2 or dual JAK1-2 inhibition in clinical studies. And what I'm showing you here is data from several clinical studies.

12:27 Just a word of caution, it's difficult to compare between studies. These are different patients, different protocols, different timings, et cetera. But I think the data does support the fact that dual TIK2JAK1 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 the psoriasis area and severity index a score of psoriasis symptoms and it's it's a common clinical goal to achieve a 75% reduction and you can see that brepacitinib does better after 12 weeks dosing at a 30 mg dose than Ducrevacitinib or the the selective TIK2 inhibitors Ducrevacitinib and TAK279 and is better than the first generation JAK1-2 inhibitor varicitinib brevacitinib additionally has shown meaningful symptom improvements in patients with a whole range of diseases you can see the list at the bottom there um and so you know i think it's really demonstrating the potential of dual tic-2-jac-1 inhibition and uh if we have a better molecule in prepositinib we would hope to achieve even better results uh in subsequent clinical trials why we think there's a good chance for that for for 1801 to have potential best in class

14:00 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 a gold standard score for psoriasis patients now in clinical trials. You can see on the slide that biologics such as Skyrizi or Binzelx, these are IL-23 antibodies. So Skyrizi, you get an 18% of patients achieve PASI 90 after four 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 uh such as icotrokinra uh 56 percent pazzy 90 score after 16 weeks and that improves as time goes by up to 65 The TIK2 single inhibitors, so TIK2 and zazacitinib TAK279, are less effective. So TIK2 27%, Casi90 improving to 33% after 24 weeks. Zazer a bit better.

15:12 Now if you look on that slide, the week 4 top left, you're seeing brepacitinib at 100 mg once daily. Pfizer carried out a phase one trial in psoriasis patients where they dosed for four weeks and they saw really spectacular results at this 100 mg once daily dose about 90 percent 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 the 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 brepacitinib.

16:04 Our molecule in the MADD cohort, that's the top dose, 140 mgs per day, achieved a similar area under the curve, 7,000 nanogram hours per mil. However, we didn't see any of those side effects that brepacitinib 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 brepacitinib in human whole blood cytokine assays. So we're getting the same exposure as top dose brepacitinib without the side effects. That's why we believe 1801 has the potential to achieve the same PASI 90 scores as brepo at 100 mgs per day, but without those dose limiting toxicities.

16:49 And that's why we are prioritizing SDC1801 in our portfolio. Moving on to SDC1802, it's another member of our TIK2 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 in indications of significant unmet medical need and primarily in hematological cancers such as T-cell acute lymphoblastic leukemia, TALL and B-cell lymphoma.

17:40 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 SDC1801 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 TIK2 and JAK1 inhibition into central nervous system diseases targeting neuroinflammatory diseases in particular. Again, there's a strong scientific rationale for inhibiting these two kinases in the CNS. A lot of evidence coming out in the literature supporting in particular the role of TIK2 in these diseases.

18:50 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 implicating tic2 as a key neuro immune modulator in these diseases so we wanted to make use of our experience and our existing data sets uh 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 three 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.

19:38 They designed the first batch of compounds which were synthesized and have completed their early stage testing in both biochemical anatomy 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 four-month partnership was designed to complete two 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 four-month period and then receptor designed the second round of chemistry which is what we're doing at the moment.

20:55 They've done that using their virtual screening and predictive PK modeling. We've been responsible for compound synthesis, testing and admet 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 CHECK1 kinase inhibitor. Again, there's a well validated scientific principles underlying this program.

21:40 CHECK1 is a part of the DNA damage response pathway, which is well validated pathway for cancer therapeutics. The molecule itself is very well tolerated in clinical studies. And there are synergies between CHECK1 inhibitors, including 737, and many different types of chemotherapy, targeted therapies, immunotherapies, a huge array of literature reporting interesting findings and synergies with CHECK1 with other agents. There are currently no approved CHECK1 inhibitors, so that creates a first in class opportunity for 4SRA737. There have been earlier generation CHECK1 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 very good selectivity profile against checkpoint kinase 2 and we think that creates a great opportunity for a selective check one inhibitor such as sra737 again there's broad potential applicability in a wide range of diseases clinical and preclinical data to support selective check one a selective check one inhibitor 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

23:20 two phase two trials as monotherapy and in combination we hold the license for 737 on improved economic terms currently 63 and a half percent of all future revenues compared with our previous 27 and a half percent share 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 usfda that's an investigational new drug application to conduct a phase one trial in patients with acute myeloid leukemia and myelodysplastic syndromes and we have 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 could hit the road very quickly get get this trial running very rapidly 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.

24:55 Okay, I'm going to hand over to Tim now to take you through the preliminary financial results.

25:04 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. um the share of loss of associates that that is the uh the income or expenses with the partnership with um the crt pioneer fund for the 737 project uh now now that we are the full owners of the um uh the 737 program and the cpf are out of the picture uh that line will soon disappear once all the historical numbers are aren't reported um and so uh say yeah um lost well a tax credit of of 200 000 uh so lost for the year of uh 1652 uh as it was in cash terms of say approximately half what it was uh last year actually you'll you'll notice on for the four-year figures um there's a finance charge uh associated with the warrants that 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 um so looking at the balance sheet um yeah so two and a half million uh pounds in cash

26:42 um trade and other receivables i'll i'll just touch on that because i i've seen a question posted on that so so around 750 000 uh 200 000 of that uh is is due to the tax credit uh noted in the income statement um um uh yeah uh so so that that's answers one of the questions that's been posted Again, we see the warrant charge on the balance sheet. It's an accounting factor to do with the warrants. Many of these warrants were four year warrants from nearly four years ago, and they will expire throughout the year. So that sort of accounting anomaly, if you like, will disappear off the figures soon.

27:33 so yeah so so leaving net assets but that's sort of of of uh around 1.2 million but there's the the as the one liability goes goes away uh that that that 1.6 million will will come back onto the the net assets okay uh so that's a a quick tour around the numbers uh there's obviously a fuller description of everything in the statement released uh this morning uh with that i will hand back to Stephen to sum up thank you tim uh so just brief briefly summing because you've heard it all now several times uh we're moving forwards with 1801 with the the phase two 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 uh a package of the the data collated so far um for a partnering exercise and we would hope to find a partner to take that up uh uh in the in the blood the blood-based cancer area uh 737 we continue to make progress uh in looking for and speaking to potential licensees for the area um as you saw we are continuing to uh

29:04 bolster the the ip estate in that area so that um we're trying to ensure that this is not a wasting asset going forwards 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 uh from the ai exercise uh and they've been tested in the lab so looking forwards i think we're going to have a a very interesting year through 2026 i thank you for being with us still uh i know this has been a long and winding road but nonetheless uh we are very pleased to to have you with us uh as our shareholders and uh with that i'm going to pass back to tim who's going to be the mc for the the q a side so thank you all very much That's great. Fantastic. Thank you very much indeed for your presentation.

30:13 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 take a few moments to read those questions submitted today, I would like to remind you the recording of this presentation, along with a copy of the slides and the published Q&A can be accessed via our best 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.

30:37 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.

31:23 These are about the current state of the TOC study. Have subjects been dosed? Some idea of timelines? 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?

31:44 um yeah sure i think well hopefully um the announcement today and the presentation have answered a lot of these questions but um it's it's all about when did we start toxicology study i think also um just to say that when we made the announcement in february dosing had already commenced uh 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 um when we made the announcement so yeah all the uh all the animals are being dosed that's ongoing uh we stick to the original timelines at the moment we're expecting dosing to complete in mid 26 uh and the full phase two enabling package uh by year end so in terms of how we'll keep people updated as 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 comprehensive data set at the end will be available under confidentiality agreements to potential licensed partners once the full package is complete and uh and may or may not be submitted to regulatory authorities depending upon the strategy at the time so if you know 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

33:16 so hopefully that addresses those questions about timing

33:22 thank you john um then sticking with uh 1801 um how confident are we that the issues seen in the previous 1801 toxicity study will not be repeated in the current study um well the so the adverse findings in the previous study and just a reminder we had to terminate that study on animal welfare grounds

33:46 um 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 pharmacokinetics 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 um so i'd say we're highly confident but you know bear in mind we can we're conducting a research um program here so uh 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 uh we're working with a new cro as well with with extensive experience in long-term tox programs so yeah um that's all i can say really at the moment great thank you john um then there's a question yes pre pre-posted and the number have come up during the presentation it's really about the um

35:07 Who's at fault for the previous TOC study and is any compensation forthcoming? Stephen, I think you will address this one for us. 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 them that the issues you're now facing was the garage's 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 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.

36:37 This was an international US-based or US-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

37:00 any any recompense we got is going to be de minimis compared with the with the outgoings to try and prove the point great thank you stephen uh so i hope that's clear to everybody now um so moving on to 737 i've got a question on uh combination studies uh so it's about the oncology sector um placing a lot of emphasis on combination therapies particularly bypass tumor resistance can we provide an update on specific rationales we've been presented or 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 we one or bet inhibitors.

37:59 John, can you pick that up, please?

38:02 Yeah, sure. So the I mean, the clinical rationale for 737 is backed up by the phase one two data that demonstrated good tolerability as a mono therapy and promising activity in combination with low dose gemcitabine. We saw that particularly in a no genital cancers where there's a significant unmet need I think as you know a selective check one inhibitor targets cancer cell replication and DNA damage repair mechanisms so there's clear potential for mechanistic synergy with a with a wide range of different combinations but there's been a lot of publications for example around uh combinations with we1 inhibitors with bet inhibitors with parp inhibitors uh even with cancer immunotherapy and that's specific to sra737 so uh this data is all in our is in our data room uh where we own the rights to it as such and of course we point out the literature to uh potential partners uh where they're not already um aware of it um so with uh adcs we don't have any specific data for 737 combinations of adcs it's yes it's a nice idea i mean like likewise for targeted radio pharmaceuticals uh there is potential there um certainly we'd be very supportive if a potential partner

39:36 wanted to pursue that approach um but i think that you know this idea of rational combinations plays directly to 737 strengths um because of its hat just it's very good safety profile as a mono therapy uh lends its to being used in combination with with other things and in fact the any toxicities we really saw from 737 were associated with on target or check one inhibition so i think you know as a molecule to prove the hypothesis of combination with all sorts of different mechanisms uh 737 is is as good as you can get to do that job um

40:20 we have a better economic position so 63 and a half percent of future revenues we can be uh flexible and gives us a strong negotiating position as we uh look to move the asset forward thank you john uh actually another one for you now uh on the tick two neuroscience program i think this has been largely answered in the presentation but it's it's when we receive information on the um uh the recent collaboration um i'm i take it we is it will be

40:51 uh the shareholders at large as and when we make it public rather than us as a company but maybe you could address both bits of that yeah so um hopefully i did answer during the presentation but just to reiterate the collaborations progressing to plan with receptor ai we had a first batch of compounds designed synthesized got them tested in the early stage assays over biochemical and the uh in vitro you know sort of test tube admi assays uh fed that data back to receptor they use that data to design a second batch of compounds and those are in synthesis uh 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 and the early admi testing again and then you know take a view as to as to what needs to be done next which it could be that some of those molecules we then push forward into more advanced assays uh start to look in vivo so all these molecules getting into the brain are they affecting the target in the brain uh what are their general properties like all round But 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 will have gathered by that stage. So

42:24 I Don't think there's been a delay in the program We're on we're on track Okay, thank you and then there's a question on the commercialization of the

42:38 the tick to neuroscience program um so is is the objective to secure an out licensing deal at the pre-clinical or clinical trials authorization ready stage um to capture the sex sectors premium for brain penetrant compounds um so um just to recap then so the tick to neuroscience program is looking for uh blood blood i can't say blood brain barrier penetrants uh selective tick to jack one inhibitors uh for neuroinflammatory conditions such as alzheimer's parkinson's and multiple sclerosis uh and as the questioner uh points out there there's a lot of interest from the industry in this area um so um so our objective is to advance these molecules through early validation and to position for out licensing uh at any point really so um i think we'd be happy to discuss partnering with these compounds as soon as we can so so whether that's um through the journey through the throughout the journey through the preclinical stages um or at the cta reggie stage i think that that's really will will take a view of that uh depending on partner interest and 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'd take it at an early stage rather than wait to get the program CTA ready.

44:09 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 has been synthesized and we're able to share that data with We have some commercial and financial questions. uh across the um the lead programs what are these 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 um stephen can you take that please yes of course um The long and oft 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 forwards and take them to the market.

45:38 And that has not changed. um the uh and so therefore for for each of these programs um we are we are moving forwards on that on that sort of same to the same drumbeat 1801 obviously is going further uh in-house at the moment but we will be very keen to get a uh a partnership a licensing deal at the phase two ready stage um 1802 as you heard we've taken a decision rather earlier that this is a very specialist area with the the blood cancers and that uh we think we that the the program will fare better if it's partnered into a specialist company at an earlier stage and 737 as we as we said when we announced last year that we are um when we took control of that program and increased our economic interest from 27.5% to 63.5% blended that this is something which we feel has a rightful place with a pharma company. There are various options of routes forwards for the drug and we are certainly talking

47:09 actively to some partners at the moment to secure that transaction. um obviously no deal is done until it's done and i'm not going to put a a time target uh against against it but um uh but we we are confident that uh we can get an outcome for that thanks jim thank you um uh actually another one for you steven module um so um

47:47 so the question says it um 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 uh well uh within a reasonable time frame um yes it it's uh that's the thing with these sorts of partnering arrangements that sort of from the outside nothing appears to be happening until everything has happened um uh we are we are moving forward sometimes faster sometimes slower um but we are moving forwards uh and uh 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

48:54 It's been returned twice, once by Sierra, once by a US startup. 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 economic terms. So 63 and a half percent instead of 27 and a half percent. The phase 1-2 data that previous partners Sierra Oncology conducted demonstrated very good tolerabilities on monotherapy and actually much better tolerability than previous CHEK1 inhibitors.

49:40 Also showed promising activity in combination with gemcitabine in a number of cancers, particularly anogenital, which is an area of unmedical 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 Sarah Oncology as a partner were looking at the program. 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 we've got a good long pattern life on the molecule so an open imd 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 uh i'll pick that one up um so noting the board's upcoming attendance by europe spring um can we confirm

51:12 we're actively leveraging the partnering one system to secure meetings with potential licensees and it's are the asset profiles of our various uh programs all uh registered on the program for potential partners to see um So perhaps just to explain how the partnering systems work. The Bio Europe and the US Bio Partners partnering meetings are all centered around a partnering system. Bio Europe uses one called Partnering One. 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.

52:04 So we use that. extensively uh to arrange our meetings at the conference and all of our assets so 1801 1802 tick to 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 uh 737 um also are the the us um business development consultancy which we have referred to a number of times they will also be present at the meeting and that they they will be able to assist us in in meetings as well okay so that concludes the the 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.

53:03 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. um so john it's john's one for you it's uh on the the publication of the the clinical trial for sdc 1801 uh do we have any dates when that will be published have we had any feedback on that data can you give us an update of where we are with this forthcoming publication yes certainly so uh

53:39 no phase one data for 1801 has been published yet we have submitted a paper to a peer-reviewed journal and this encapsulates all of the phase one 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 timelines 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

54:20 let's hope it's within the next quarter or so but it's it's it's sort of out of our hands at the moment because we've submitted it thank you um there uh there's a question uh again it's one for you john um on the uh gmp batch i think it's probably referring to 1801 but i guess it could be a political 737 at all

54:43 uh but how confident that the is the gmp batch that it's going to be okay for a uh a phased uh a phase two trial so can you comment about these stability studies that are ongoing yeah yeah okay so yeah the um si is presumably sdc 1801 yeah there's a batch of gmp grade material that's completed uh synthesis uh last year and is in storage um yes in terms of stability so we have uh 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 four years for 1801 as a powder if you like the GMP batch so yeah you look at things like uh but does the does the crystal form change do these does the side effect profile change in any way does the water content change things like that um yeah no all good out for four years at least so we'd um have a high degree of confidence that that gmp batch will be suitable for uh use in trials in 2027 um yeah

56:10 Great, thank you John. A question about the US Business Development Consultancy. Are they primarily focused on 1801 or the broader pipeline 2? I'll pick that one up. So their primary focus is on 1801 and SRA 737. We felt we ought to give them some focus as to what they were doing and so the higher value clinical programs are their particular area of focus but obviously if they uncover prospective partners interested in any of the other programs then obviously they'll hand them over to us and we will be the primary handler of those inquiries.

57:03 Another question on the phase two package for you, John. So on phase two enabling package, TOCS 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 other key activity involved.

57:27 yeah that is the main i mean it's the cmc side of things so the chemistry manufacturing and control um aspect of 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 can 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 it'll be you know hopefully hopefully one maybe two maybe three possibly four capsules a day for a phase two trial and we are let's say we're closing in on selecting our final formulation at the moment hope to have that completed uh 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 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 three years possibly four years and you look at a variety of different conditions for storage of your capsule so you mimic a sort of you know

58:58 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

59:17 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 I perhaps I will hand back to Alex to sum up and say that we'll 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 uh uh you you've you've submitted both prior to the the session and and during it i hope that you feel that uh we've been able to answer many of the the pressing pressing questions uh obviously we we look forward to the the period coming uh and uh and and to uh present to you the full year figures which will be sometime i imagine in in october um uh in in the next of these sessions so in the meantime thank you very much thank you for your continued support uh i know sometimes it's it's uh it feels a bit hard uh but then this is biotech um so thank you again and

1:00:48 we'll hand you back to alex Fantastic, thank you all very much for updating investors today. Could I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback 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 afternoon to you all.