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Sareum Holdings (LSE:SAR) — General Meeting

General Meeting hosted by Sareum Holdings (LSE:SAR) on Investor Meet Company, held 2022-02-28.

Mon, February 28, 2022 at 9:30 AMendedReplay
Sareum Holdings (LSE:SAR) — General Meeting
Company
Sareum Holdings PLC (LSE:SAR)
Date
Mon, Feb 28, 2022, 9:30 AM ET
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Watch the replay on this page · 58 min
Results news release
Results of EGM · Mon, Feb 28, 2022

On 6ix: 6ix.com/event/sareum-holdings-plc-sar-general-meeting

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Transcript

Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.

0:01 Good afternoon, ladies and gentlemen, and welcome to the SAREUM HOLDINGS PLC EGM and Half Year Results Investor Presentation. Throughout this recorded meeting, investors will be and attendees will be in listen only mode. Questions are encouraged. They can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Please just 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 will review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll for those online. I'm sure the company would be most grateful for your participation. I'd now like to hand over to Doctor. Stephen Parker, Chairman from SAREUM HOLDINGS. Good afternoon, sir. Good afternoon, ladies and gentlemen. I'm Steven Parker, and I'm the chairman of the company. Since it's now 02:30 and 02:31, I will start the meeting and welcome all of you.

0:52 I'm informed that at least two members of the company entitled to vote at the meeting or present in person or by proxy. A quorum is therefore present, and the meeting can proceed. The circular containing the notice convening this meeting was sent to the company's shareholders on the 02/04/2022. The notice sets up the resolutions proposed to be passed on this meeting. Does anyone object if I take this notice so the meeting is read? No. You. In accordance with article 56 of the company's articles of association, voting today will be done on a show of hands. By appointing the company's registrar, Link Asset Services to act as scrutineers. I will now proceed to take the meeting through the resolutions proposed at this extraordinary general meeting. Just so you understand the format, we will deal with the formal business first, and there have been a few questions received specifically regarding the, particularly, the share consolidation proposed share consolidation.

1:52 Deal with those before we go to the formal vote. And then once the voting is completed, we'll go to the the half yearly review and deal with any other questions that arise after that's been completed. So if I then perhaps if I should I should remind you that resolution one is a special resolution. Resolution two is the ordinary resolution regarding the consolidation of shares. So one of the questions that has been received is addressing the question that a higher relative price is more attractive to institutional investors.

2:44 And I have to say that in my thirty five plus years experience of dealing with city companies and investment funds, I have found this to be absolutely the case. It may not be logical, but it is it is absolutely absolutely the case that penny stocks are strongly disliked by institutions in pretty much any country. And and and shares which are measured in in multiples of pence or preferably pounds are much more easily tradable and favored by by the institutions, which is the fundamental reason why we are seeking to make this change. I would also point out that institutions may choose to come into any future fundraising, but, of course, are free to to trade on secondary markets, and I'm hoping to see both of those events taking place as a as a result of the consolidation once it's happened.

3:57 I think that's the the the main question that has been raised with this. Just so it's open to people in the room, do you have any questions specifically on on this on on the topics? Not specifically on the consolidation, though. I don't understand exactly. You. In in which case, I will proceed to formal placing of resolution. Resolution one is for the purpose of adopting new articles of association of the company. Such resolution along with the summary of the proposed changes is set out in full in the notice of extraordinary general meeting. For this resolution to be passed, it requires votes in favor of none less than 75% of the votes cast. Will all those in favor of the resolution please raise their hands.

4:46 Thank you. Any against?

4:50 Thank you. Accordingly, I declare resolution one duly passed as a special resolution. As mentioned earlier, I can now tell you the votes that have been received. Votes for 813,549,009. Votes against a 129,225,243, which represents majority of 86.3% and, therefore, duly passed. Resolution two. Resolution two is for the purpose of approving the share consolidation. Such resolution is set out in full in the latest of extraordinary general meeting. For this resolution to be passed, it requires votes in favor of more than 50% of votes cast.

5:43 Will all those in favor of this resolution, please raise their hands. Thank you. Those against thank you. Accordingly, I declare resolution to duly pass as an ordinary resolution. Votes received from proxies were votes for 809,024,537. Votes against 135,837,347, representing a majority in favor of 85.6%, and therefore, is duly carried. Thank you for that. The final results of of the the voting, including the proxies, will be announced through the RNS and and published on the website as soon as reasonably practical.

6:37 If there's no other business, that concludes the business of this extraordinary general meeting. Thank thank you for attending the formal part. I declare the meeting closed. I am very happy to pass over to Tim Mitchell who will take us through the half year results update. Thank you, Steven. Good afternoon, everybody. Thank you for attending the meeting. So, yes, myself and John will take you through a quick update that that we published in our half year results recently. So if I I'll top and tail, and John will take us through the the technical parts. I'll just move past the disclaimer. So just to remind everybody, we're working in two principal areas at SAREUM.

7:27 Internally, we're looking at our TYK2 JAK1 inhibitors for autoimmune diseases, including the severe respiratory symptoms of COVID and other viral infections and also in cancer. These programs are in preclinical, and the 18 o one autoimmune COVID program is is just completing its preclinical journey, and we'll we'll spend most of the the technical time on on that program. And then also, we have the checkpoint kinase one program that's partnered with Sierra Oncology. And again to remind you it's completed two phase two trials one as monotherapy one in combination with low dose gemcitabine Recently SAREUM have noted that they are finalizing the designs on some further trials in combinations with other anticancer agents, and we'll give you a quick update of that. But that's based entirely on what Sierra have made public.

8:26 So if I just run through some recent highlights then for HTC 18 o one, the autoimmune and COVID program then, we're good progress towards clinical developments. We so we've successfully completed the final toxicology studies to to file the first exploratory clinical trials author authorization. Those were completed at the end of last year. So so that's the experimental stage. Preliminary results all look fine. We're expecting the final report in q one, so that that's gonna be next month now. So our intention is still to file that CTA in mid twenty twenty two and then start a a phase one a trial in healthy volunteers. This is to assess safety and and dose levels in the second half of this calendar year.

9:16 The the production of the drug substance, that's actually an active ingredient and the drug product, and that that's essentially the formulated product, is is progressing to plan. Again, John will provide a few more details on that when when we get into the details. For eight for eighteen o two, the the cancer program, we continue to design translational studies to work out the optimal cancer application before we complete the toxicology and manufacturing studies on this program. And then just as a note, the IP property was further strengthened with a a another US patent granted on that program. And then highlights from the the CHECK one program, that's the SRA seven thirty seven molecule. As I said earlier, SARE is finalizing design of several new clinical trials, which we hope will start in 2022.

10:10 The the first patient dosed in any of these trials will trigger a a milestone payment to SAREUM worth $550,000, and, again, we look forward to that. And SAREUM indicated that the potential types of trial that they could study seven thirty seven in is in combination with their newly in licensed BET inhibitor. This is s r a seven s r a five one five, which they licensed from AstraZeneca. That's in blood cancers. Another combination with s r a five one five, including standard of care in in other solid tumors. And then I suppose a study that they have been planning for some time. So this is seven thirty seven plus low dose gemcitabine plus immunotherapy. And if you recall to some of the slides we've shown before when we've seen some very good results in small cell lung cancer, they'll be looking at this triple combination in solid tumors.

11:04 Well, that's what they say they're finalizing designs of. And in terms of finances then, we raised a total of £6,300,000 in calendar year 2021, so that left us with cash in bank of 5,600,000 as at the end of December last year comparing to 1,300,000 at the end of December twenty twenty. And that gives us sufficient funds to complete the Phase 1a trial with SDC1801 and also to accelerate the preclinical development of SDC1802. With that introduction from me, if I hand over to John for for a more deeper dive into the technical aspects. Thank you, Tim. So the JAK inhibitors are emerging targets of increasing industry interest.

11:54 JAK family of kinase is a key component in maintaining the balanced and healthy immune system. The strong and emerging clinical validation of JAK inhibitors, particularly in the autoimmune disease area from BMS and Pfizer for their tick two in the case of BMS, tick two selective, and then a dual tick two JAK one inhibitor from Pfizer. They're publishing some nice data in psoriasis and psoriatic arthritis. There are a number of mid stage clinical trials of TYK2 and dual TYKJAK inhibitors ongoing for lupus, ulcerative colitis, Crohn's disease, and vitiligo with some readouts that have come out recently and others into 2024.

12:42 There's good scientific evidence for the role of JAKs in modulating the severe inflammatory responses and for respiratory symptoms arising from coronavirus and other viral infections. Several JAK family inhibitors have been tested or are in the process of being tested against the severe respiratory symptoms of COVID infection. And in 2020, the JAK inhibitor market size was $18,000,000,000, and there's quite dramatic growth projected over the next few years up to $320,000,000,000 by 2026. And as an example of that, BMS are forecasting in excess of $4,000,000,000 sales for their TYK2 inhibitor, ducravacitinib, by 2029.

13:31 Slide shows some of the key immunoregulatory cytokines that are affected by JAK signaling proteins and how JAK inhibition will interfere with these signaling pathways. You can see in the diagram a number of cytokines that are affected by TIC two and JAK one. So I think our areas of principal interest of the interferon alpha, IL-twelve and IL-twenty three, they have roles in psoriasis, IBD, lupus and potentially resistance to immuno oncology therapies and the viral or bacterial pneumonia.

14:17 Interestingly and importantly JAK2 and JAK3 inhibition has been associated with the FDA black box warnings for serious infections, lymphoma and thrombosis that Xeljanz, the JAK1, JAK3 inhibitor from Pfizer, and Olumiant, the JAK1 JAK2 inhibitor from Eli Lilly have been issued with. So we're focused on selective and potent inhibitors of TYK2 JAK1 inhibitors, so we want to avoid this inhibition of JAK2 and JAK3. I think there are significant clear opportunities available. There are no marketed products with selectivity for TYK2, which is important for differentiation.

15:05 And there are no selective TYK2 inhibitors in clinical trials for cancer. So we believe we have a first in class opportunity with SDC1802.

15:16 So SDC1801 and SDC1802 are potent and selective inhibitors of TYK2 and JAK1. They have a favorable selectivity profile versus JAK2 and JAK3 in contrast to tofacitinib and baricitinib. They are orally bioavailable. We use them twice daily when dosing to our preclinical disease species in mice, but we believe there's potential for once daily oral dosing in humans. There's also this potential to treat the cytokine storm immune system overreaction that that is frequently fatal in COVID nineteen patients. And as Tim mentioned earlier, we have a strong intellectual property portfolio protecting these candidates in the key markets.

16:05 Focusing on SDC eighteen oh one then, which is our autoimmune disease candidate. This slide shows some timelines and our development strategy. Our internal focus is on progressing SDC1801 into its first in human Phase 1a clinical trial. We're working with a consultancy that has been appointed to assist in developing the clinical plan and selecting the initial indication for clinical studies beyond the phase 1a so this will be in patients in an envisaged phase 1b clinical trial. The strategy is to seek development partners for commercial licensing at the early to mid clinical stage.

16:50 And that strategy balances the costs versus the risk versus the potential returns of an early deal versus a later opportunity, balancing that with the requirement for additional funding. So in q four twenty twenty one, we completed all of the laboratory work for the SPC 18 o one toxicology studies. The reporting for this is in progress at the moment. We expect to have that complete by q one twenty twenty two. We have seen all the data. We know what it's gonna say, but there's an awful lot of GLP type activities that need to go on before that report is finally signed off on. In q one twenty twenty two then, we are aiming to complete the synthesis of the SDC eighteen o one drug substance and the GMP conditions and to finalize the clinical plan.

17:49 In the next quarter, q two twenty two, we will complete the drug product development. This is the SPC eighteen o one in its capsule formulation, and we aim to file the CTA with the MHRA in The UK. And then in half two of twenty two, we aim to initiate the phase one a clinical trial to bring healthy volunteers with SDC eighteen o one. In the meantime, we're exploring the potential for further funding of SDC eighteen o one in severe COVID nineteen from UK government therapeutics task force or agile clinical development platform or one of the other equivalent programs.

18:42 Moving on to SDC eighteen oh two then, this is targeting multiple cancers. We've seen good efficacy in a number of immunotherapy disease models against multiple types of cancer. The antitumor effects have been seen in models of kidney, colorectal, skin cancers, and B cell lymphoma. There's evidence that the SDC eighteen o two induces its anti cancer activity through an immunotherapeutic mechanism. And we've seen these positive results when dosed orally as a monotherapy and in combination with several chemotherapeutic agents. Again, patent grants have strengthened the IP portfolio in the major territories, territories, which we've published on, and currently underway various translational studies designed to define the optimal cancer application.

19:34 There will be additional biomarker studies to really dig deep into the mechanism of action of the molecule, really with the objective of identifying a suitable patient population for a phase one clinical trial. And we aim to complete this before we move on to the completing of the toxicology and the manufacturing studies. I think the experience that we've had in the development of eighteen o one will enable the development of eighteen o two to be more rapid than it has been for eighteen o one. For example, the significant overlap in the chemical synthesis of the two molecules. We'll be taking what we've learned with eighteen oh one forward into the synthesis of eighteen oh two. And then moving on to SRA737, which is the inhibitor of checkpoint kinase, which we discovered in a collaboration with various cancer research UK organizations and is out licensed to Sierra Oncology.

20:38 We're showing here a slide from Sierra's corporate presentation from November of last year, I believe.

20:48 And, yes, really just to reiterate what Tim said already, a number of clinical trials are in the planning process by Sierra, combinations with the BET inhibitor that they've been licensed recently from AstraZeneca, and and other combinations planned with immuno oncology agents, low dose gemcitabine. There is a $550,000 milestone payment due to SAREUM upon achievement of the next milestone event, which will be the first patient in the next clinical trial. We remain eligible for up to $79,750,000 in total milestone payments plus royalties, a share of royalties.

21:37 And obviously, we will aim to keep our shareholders updated as the program progresses.

21:46 So I'll hand back to Tim now to conclude the rest of the presentation. Thank you, John. So if we move to the results that we've put out recently then. If we look at the income statement, just running down from the top,

22:09 the the expenses, so so that includes sort of generally admin expenses and r and d are increased significantly over the corresponding period last time. This is because of the extra expenses in the preclinical studies we've been doing. I mean, you can sort of see that reflected in the tax credit, which is significantly higher than the same period last year. So admin expense has been pretty much the same. That extra spend is pretty much all in r and d, giving us a a loss for the half year of 850,000 after tax. If we just have a quick look at the balance sheet, I I suppose the highlight there is is the 5,600,000 cash we've got. So that's significantly higher than previous periods.

23:04 That's essentially building our war chest to run the the phase one a studies. Obviously, we're we're very pleased to have that, and and are very grateful to our recent high net worth subscribers over the last year. And there's not really much more to say about the the figures. Obviously, if there's anything particular you wanna ask a question about, if you post it in the q and a, and I'll be happy to answer it if I can. So I'll just move on to a quick look ahead at the coming year and things that you might be expecting to publish. And it's really all about the transition of SDC eighteen o one into the clinic. So we'd look to submit the exploratory CTA in the middle of the year, obviously subject to obtaining approvals and finalizing the drug substance and drug product.

24:02 And I suppose dependent on how quickly the MHRA can can turn around our submission, we'd be looking to start the clinical trial in the second half of this year. We'll also finalize the the initial indication for the phase one b trial that John mentioned, and the intention would be to tack that onto the end of the Phase Ib study. And then we'll also be looking to provide some further updates on the preclinical progress of SDC18002. And then for seven thirty seven, this should well, we're hoping this will all be about the the new trials of of seven thirty seven with with the various agents we've already mentioned. So the the low dose gemcitabine, an immune checkpoint inhibitor, and the the SRA five one five BET inhibitor combination.

24:56 So it's the the initiation of the trials in those areas, so potentially three new trials. And and as we already mentioned, the the first patient dosed in in the first of these trials will initiate will will trigger the milestone payment for us. So we're we're expecting to report a lot of important preclinical and clinical progress during during 2022 for all three of the products, but I suppose primarily 1801 and 737, but also 1802. So that concludes my part of the presentation. Mark, do you just want to That's hand very kind of you, Tim. Thank you so much for your update and presentation this afternoon. Ladies and gentlemen, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your screen.

25:42 But just while the company take a few moments to review those questions submitted already, I'd like to remind you that a recording of this presentation, along with a copy of the slides and the published Q and A, can be accessed via your Investor Meet company dashboard. Tim, I haven't given you a long while, but as you all know, you received a number of questions ahead of today's event. And of course, investors and attendees have had the ability to submit a number of questions throughout your presentation. Perhaps, if I may, if I could just hand back to you to read out any questions and give a response where it's appropriate to do so. Yes. Thank you, Bob. Before we do that, perhaps, well, we do we do have shareholders in the room, and I think it might be appropriate if there's the opportunity to ask questions from those shareholders first. Yeah.

26:28 Can I make an observation?

26:31 Also, there's a question at the end of this. In in August 2019, it was stated it was the company's attention and intention to advance our first tick two JAK1 inhibitor in 2020. You also stated that the program continues to attract interest from international pharmaceutical companies. And in terms of where we are now, the share price is now half where it was six months ago. It reached a peak, motivated by the active client network of individuals investment. And as a shareholder, I'm concerned in terms of any potential slippage to these programs because, clearly, as the news flow is slow, the share price slips. We've lost a lot of momentum, And I was wondering if either you, Tim or John or Steve would like to comment in terms of how slippage can be prevented in the coming twelve months. Okay. So I'll take that again.

27:34 So we did have a delay, as you say, sort of 2019, 2020. We stumbled across a formulation issue, which took us several months to finally crack. So I think that's the reason for the slippage there. I'd like to well, I I suppose the further down the the track we go, the less problems that are solved. So I'm I'm I'm hoping that as we near the the the final hurdle that, you know, that there's there's very few problems left to solve. So the chances of further slippage are lower. But, obviously, you know, research is is an uncertain business, and we we can't make guarantees. And and, of course, we can never predict what problems or how long they are gonna take to solve. So any estimates we give are are assuming a a reasonable degree of success. And, of course, if things go wrong, then then then generally timelines get longer than than and and get shorter.

28:35 But I think it's fair to say that we're we'd like to think we're on a a fairly easy path now to to that finish line. Yeah. I I guess with all the usual health warnings. I wouldn't say easy, but there are certainly fewer obstacles to overcome that because, yeah, as you progress, you're clearing more than all hurdles, and there are fewer hurdles ahead of you. But there are still hurdles. As you can say, it's research. Things unexpected things can happen, and you you have to work your way through them. Okay. I mean, bearing in mind that, you know, back back when I approached it from the RNS, there was this interest from international policies with companies and I understand understand what you've just said to him, Joel, that's, you know, there's consultancy helping with the design of the trials. Presumably, that is being done in mind of who may be interested either acquiring or licensing the molecules from us?

29:30 Yes. So yes, certainly. I mean, part of the trial design is to create a package that will position the compound very favorably for licensing. Yes. I mean, there's I suppose, from our point of view, there's there's two results we'll get from the trial. One is to clear the path towards the next set of trials, and as you say, to to also to to populate a a data package with the information that that a a pharma partner would look for in a licensing deal. Right. Okay. So we're taking a strategy of being therapeutic agnostic. So we're we're developing a package whereby a larger company, and that's with the development experience, can take the data that we're gonna generate and say, okay. Yep. It's safe. That's the main that's the most important thing at this stage.

30:19 And there's evidence that it might work in this disease, that disease, the other disease. So that's really what we're trying to position. Now we are planning for phase one b subject to everything going well in a specific disease population. Not quite yet decided, but to be decided shortly Right. Which will obviously, it'll provide data in that specific disease, but it will also provide data that could be extended out to other diseases. Right. So that that's being done with a view to improving shareholder value in in what we've invested Absolutely. Yes. Over over the the past past ten ten years. Years. I think it's a thing. That's a very important point in terms of a reduction risk and where we're going to in terms of potential value, whether it's licensing or whatever.

31:04 So I'm also assuming that the business model has published on SAREUM SAREUM website has not changed in that sense. Okay. Looking for that earlier rather than later. Yeah. Yes. I mean, I suppose not I suppose, you know, the the fact that we're funded through phase one a now, yeah, it means means that we're we can we can probably be be a little bit more choosy with who we partner with. That's right. Yes. So we we could we can we're Tim, we have just lost connection with you, sadly. If you could just please reconnect.

31:54 It would appear that you've just lost Internet connection. Ladies and gentlemen, please do bear with us, and we'll shortly recommence with the team at the general meeting. So please do bear with us. Thank you very much indeed. Ladies and gentlemen, I do apologize. We are just writing reconnection from the venue. Hopefully, that won't be too much longer. But please do bear with us, and I will give

33:25 you updates in a moment's time. I do apologize, ladies and gentlemen. We are just waiting at reconnection. I will update you shortly.

34:38 We have made contact, ladies and gentlemen, with the venue. They have had a small issue with the connection. That should be back on very, very shortly. So I do apologize once again, and then we can pick up with the q and a where Tim and the team left off. Thank you very much indeed again. We are, as I say, just waiting for reconnection.

35:40 So we do have they are aware of the disconnection locally, and we will hopefully have them reconnected shortly. So please do bear with us. James m, thank you for your message. We are here. And, obviously, as soon as we have contact, we will reconnect you. Thank you once again. Please don't feel that I'm telling you the same thing, but we are just awaiting for the team to connect back online.

36:45 But, obviously, I'm mindful that there is silence, and that's probably not good for you if you're just waiting there, seeing nothing change. So if I do come on and tell you the same thing a 100 times, I do apologize. But just so you know that we are still trying to reconnect you. Thank you. Hi. Ladies and gentlemen, I do believe that we do have connection. If you just bear with me one second, we should have you connected back in two seconds' time, and then we can carry on.

38:00 Bear with me just one second, please. Thank you. If you just acknowledge the control, and I'll be able to turn on your microphone. That's it. Perfect. Thank you very much indeed. Tim and Mark? Hi, Tim. Can you hear us okay? Yes. Yes. Apologies for that. We've had a a slight technical issue here with the Don't worry. I thought power might have gone or something. Yes. Yeah. I thought I thought it may have done. Well, look. You've reconnected now. I I have held everybody on. We still have nearly 200 people still on the call. So thank you once again to everybody for for being so patient during that outage. If I may, Tim, if I could just hand back to you to carry on. Obviously, I think we got the last question that was submitted from the room. Obviously, you know you got the online questions there as well. Thank you. So I'll hand back to you now. Thank you.

38:55 Okay. Okay. I'll be brief. Very good news to see we're making some progress with 77 at last. One thing I was slightly surprised about is I do recall conversations in the past about the combination of PARP inhibitor. And I don't know whether that is not on the agenda or So we haven't seen that on SAREUM plans. So, Yeah. Yeah, there there's preclinical data that that looks very encouraging, but we haven't seen that. Yeah. So so Sarah haven't you know, and we only know what Sarah tell us. So we haven't seen any more information on that. Be that, but we just don't know it. Yeah. It's okay. Fine. I think I've probably taken up enough time for that. Thank you. Yeah.

39:46 So, Steven, you're gonna some more of those? They also hand it to John for some I think most most of these ones now are are technical. Okay, John. Do you want to there there were some pre posted technical questions. Okay. Yeah. Okay. Let me take this one. From SAREUM's statement on toxicology, the assessment has successfully determined the organs which are affected by eighteen o one. Are Are these in line with other tick two compounds which have recently been shelved, or do these initial results provide current side effects as being projected to be less severe than competitors? Well, the first thing I'll say, it's it's it's impossible to compare with competitors' molecules, of course, because nobody really publishes their toxicology results. So we're not able to compare direct our data with what our competitors' compounds are showing in the clinic.

40:52 What I will say is just a reminder that toxicology the purpose of toxicology studies is to look at higher concentrations of your molecule than you would expect to use in the clinic and with the objective of finding some toxicity and identifying what organs that toxicity affects. Our toxicology studies have been successful, and I would just say, really, we're only seeing JAK inhibitor typical JAK inhibitor effects. And but as I say, it's impossible to compare them with with competitor compounds. And we're very confident that we have a suitable therapeutic window so that the concentrations we're looking at where we saw those those effects is much greater than we would expect to achieve in the clinic.

41:48 Let me what next? So once so yeah. Okay. So there are a few tick two failures noted recently. Can you explain what SAREUM's key differentiator is, got some indication that SAREUM's tick two would not immediately fall into the same failure bucket? I'm I'm assuming this refers to the BMS allosteric inhibitor gefacitinib, which did not achieve its primary endpoint in a clinical trial against inflammatory bowel disease. I mean, just to say our molecule does have a mechanism of action. It's an our it it is not an our steroid inhibitor. It's a direct inhibitor of the capsulitic site of tick two, and it also has JAK one activity.

42:46 So, you know, that's not to say that we will definitely take it into an IBD trial or that if someone licenses the compound, they will take it into an IBD trial. But I don't think that that single failure really reads through to our molecule. I I I know there were also a couple of disappointing results from the Theravance clinical trials. They're really looking at pan JAK inhibitors where where they are tissue specific. So, for example, they have a compound that only stays in the lung. It does not get systemic exposure, and it's I think it's been fair to say it's been disappointing in an asthma trial. And I believe they had an IBD trial, which was also disappointing.

43:35 Again, that molecule pan jacked and was restricted to the gastrointestinal tract. Again, Again, that and so our our molecule is quite different. We have aiming for systemic deliveries. So so, you know, the molecule was in the bloodstream, and we have the tip two JAK one selectivity profile. There's another question about a recent type one diabetes study of TYK2 allosteric MS molecule showed a negative correlation between TYK2 and KRAS. Does our TYK2 have similar results preclinical? And what does this mean for safety of the molecule? Secondly, have SAREUM initiated any preclinical models of SDC eighteen oh one against type one diabetes?

44:24 Do you see this as a potential target in the future? If I can take the second part first, we haven't done any preclinical models of s b c eighteen o one against type one diabetes. I I don't know if we were still connected when I was addressing the gentleman who's in the room here with us. I was asking a question about therapeutic areas. We've tried to take a very agnostic view with therapeutic areas. So we're looking for, you know, biomarker driven effects, which should give some indication of the therapeutic areas to focus on. It may be that type one diabetes is one of those. You know, there's certainly an interferon alpha effect in t one d and our molecule inhibits interferon pathway sickening. So there's potential there, but we have not looked at it. I think the question about the negative correlation between TYK2 and KRAS giving us safety concern, I mean, we haven't seen it, but we haven't looked for it.

45:31 What I will say is the BMS molecule has been used for multiple years now in the clinic. They are not seeing any increase in cancer, which I imagine is what the question is concerned about this KRAS increase. I think the other thing just to quickly say without getting too technical, KRAS driven cancers are driven by mutations in KRAS generally, which switches on KRAS permanently. So it's constantly signaling, and I don't think that an increase in expression of KRAS would have the same effect. So I'm not brushing that, you know, under the carpet as a concern, but I think that there's a lot of safety data being generated both by BMS, other JAK inhibitors, Pfizer molecule, and there's no reports of increased cancer at least driven by the KNAS pathway.

46:27 So I hope that addresses those concerns. There was Another question. What is what is the delay with the toxicology results? I'm not sure there is a delay. As I mentioned earlier Tim, I think you've you've lost connection one more time. Just bear with us one second while we try to reconnect you. Thank you.

48:23 Do bear bear with us, ladies and gentlemen. Thank you very much, and, I do apologize for the, inconvenience. This is being localized at the venue, so do bear with us. Ladies and we have just spoken to the venue. They are attempting now to dial in, I hope. So it shouldn't be too much longer, and then we can carry on with the q and a. Thank you very much indeed.

49:57 Yes. James, the sound has gone. We are waiting for the the venue. This is localized to the venue, so we do apologize. But bear with us. We should be with them. They've just kicked kicked back in now. So Hi. Hi. Hi, Tim. Just to say you're you're back in the room. I have I have supplied the venue with a dial in number. So in the event that that happens, they'll make that available But you're back in there. Yes. Can you hear me now? I can hear you, sir. Yes. Can you tell me now? Yeah. That's gone. You had the other mic open. You're You're good to go, sir. Great. Thank you. John, are you are you are you getting that?

50:53 Am. Let me just let me just remove the other link from the room, and then you just have that one link. Oh, hang on, mate. Your screen's gone in the room. That's fine. If you could just carry on with this link. So the use this one? Yeah. Yeah. Please. If you could, that'd be great. The the the link in the room, Tim, has gone right. The screen one has gone, so you should be just using the one in front of you now. Yeah. It's just shuttering this one. Have you got decent battery on that one? Yes. It's fully charged. Okay. Great. Hi, Mark. Yep. Please go ahead, Tim. We can hear you. And if you carry on with the q and a, I have turned off the other link that was causing you the echo. So if you could just use this one in the meantime, that'd be great. You have a 170 people on the call currently. Yeah. Thank you. So apologies again, everybody. We have a new laptop here and with a full charge, so hopefully, we'll see us through.

51:42 I think you've finished up, John, with with the pre posted questions. I think so. Yeah. Hopefully, everyone got to the end of my answer, but, obviously, you know, we'll we'll address these online anyway. So answers will be posted on our website to all of the questions we've received. Okay. So I'll just pick through. We we've got about five or ten minutes left now. So I'll I'll just pick through some of the questions that have been posted live, and and thank you again for posting those. So question from a Glenn g. Are there any plans to dual list on Nasdaq? The answer is no. We don't have any plans to dual list on Nasdaq. I did see some questions on sorry. Bear with me. There's there's some questions on the timing of the toxicology report.

52:33 I think we have covered this in the presentation, though. As John said, the the experimental stage of the toxicology studies were were completed at the back end of last year. The report is quite a complex document that has to be produced to good laboratory practice. But we we we said that we're expecting it by q three by the end of March, and and and and we're still on track for that q one. Sorry. Q one. Sorry. Yes. Sorry. Month three. Yes. Paul b has asked the question about, can you give details on how the capsule is progressing and what the current date for completion is expected to be? So that is progressing to schedule, and we are expecting to have have the the capsules this summer, I think, is probably a yeah.

53:27 It's the current expected date. We don't actually have to receive the the capsules before we file the CTA. They they just have to be fully under in progress. So we can file for the clinical trials authority, yeah, before we've we've actually received in our hands capsules for the study. Question from a Phil m. Please, can you clarify what patents are being granted and what patents are awaiting decision? If you look on our website on the patents and publication stage, that that lists all the patents that have been granted or that have been published and awaiting final grants.

54:21 So there there's a lot of them. I can't really go through them all now, but the the website contains all all that information for you. Question from Paul b. Yeah. So what will you be able to share in terms of details of the TOPS results? And I and I think looking through the questions, there there's a number of questions related to this. So as as John mentioned, it's not usual practice or or no other companies publish this level of detail of the toxicology results, and we have no intention of doing that either. There's a question about the consolidation. So consolidation price would be close to business today. I think that's my understanding that as markets open tomorrow, then then that's when the new share price will appear.

55:24 Okay. That's that concludes all the the questions that we can give an immediate verbal answer to. We will as as John says, we'll we'll publish answers to the questions online in due course, but this concludes our session now. Mark, shall I hand back to you? I'm sorry. Yeah. No. That's that's to Stephen for a final word. Yeah. That's great. But just as I say, to remind investors that that that Tim, as as soon soon as as you you and the team have had a chance to review these questions, we will notify everybody on the call that they're ready for their review. So absolutely, thank you for that, Tim. As you've quite rightly said, Tim, I'll surely redirect investors to and attendees to give you their thoughts and expectations and feedback. Apologies for that they've experienced today. But perhaps before I finish up, if I could hand back to doctor Steven Parker, just for a few closing comments before redirecting investors.

56:18 Principally to thank you all for both attending this EGM and and briefing and your forbearance with the technical issues that that we came across. We would expect to, obviously produce news as it arises, but with next brief following our year end results, which is, of course, June, and that would be sometime in the in the autumn round about October, November time. So thanks for bearing with us. Thank you for your support from the company for the company, and we look forward to producing more news and more data as time moves on. Thank you. That's great. Thank you very much indeed, doctor Steven Parker. Adrian, please could I ask you not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order the management team can better understand your views and expectations.

57:15 This will only take a few moments to complete, but I'm sure will be greatly valued by the company. And once again, any apologies for the localized issues, that, the company experienced this afternoon. On behalf of the management team of SAREUM HOLDINGS PLC, we'd like to thank you very much for your time today. That concludes today's session, and good afternoon to you all.

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Dr Tim Mitchell

COO at SAREUM HOLDINGS PLC

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